The Danish Healthcare Quality Programme - IKAS · 2016-01-22 · The board of IKAS is aware that the best results are achieved through involving the parties who are going to work

Danish Institute for Quality and Accreditation in Healthcare

The Danish Healthcare Quality Programme

Accreditation standards for community pharmacies 2nd version

June 2012

Foreword Accreditation standards for community pharmacies - 2nd version - June 2012Page 2 of 122

Foreword

This is the 2nd version of the Danish Healthcare Quality Programme (DDKM) for community pharmacies.

The development of the accreditation standards of the Danish Healthcare Quality Programme is based on the

agreement between the Association of Danish Pharmacies and The Ministry of Health regarding

determination of the community pharmacies’ gross profit for 2011-2012. The conditions of this agreement

are subsequently implemented in collaboration between The Association of Danish Pharmacies and Institute

for Danish Quality and Accreditation in Healthcare, IKAS.

The Danish Healthcare Quality Programme (DDKM) is part of the national strategy in Denmark for quality

development in the healthcare system. Decision-making parties placed the duty to develop a joint Danish

quality programme with Danish Institute for Quality and Accreditation in Healthcare (IKAS).

Over time, DDKM is intended to become a complete, integrated, joint system for quality development and to

assess the strategic importance of services and activities in the healthcare system. Overall, DDKM is designed

to support and promote systematic, continuous quality development within the sectors included in the

programme. Focus on clear pathways across units and across sectors is especially emphasised. Apar t from

the present accreditation standards for community pharmacies, DDKM also includes standards for hospitals

and private hospitals, the pre-hospital sector, and municipal healthcare services. Standards for general

practices and practising medical specialists are being prepared, and other sectors will be included over time.

The board of IKAS is aware that the best results are achieved through involving the parties who are going to

work with and live up to the standards in the development stage; this ensures healthcare of a high level,

even by international level. Thus, this present 2nd version of the standards has been developed on the basis

of the pharmacies' and surveyors' experiences with the 1st version.

The fundamental basis of the new version first and foremost concerned a minor revision based on

experiences with the application of the 1st version. Thus, the set of standards does not contain new areas.

The intention of the revision was to make the standards more clear and flexible as well as more applicable as

rating achievement tool in many different connections. Likewise, the intention of the 2nd version was to

move focus from preparation of documents to implementation of quality improvements. The number of

standards has been reduced from 42 to 34 from the 1st to 2nd version.

IKAS wishes to thank the Association of Danish Pharmacies and Pharmakon and the individuals who have

contributed to the development of the standards.

Finally, we wish everybody good luck in the forthcoming work with the 2nd version and we strive together to

achieve a joint, systematic development of quality in the Danish healthcare system that will make a

difference nationally and is of a world-class level.

Vagn Nielsen Jesper Gad Christensen

Chairman of the board Chief executive officer

List of contents Accreditation standards for community pharmacies - 2nd version - June 2012Page 3 of 122

List of contents

Foreword ............................................................................................................................................... 2 How to read this document ................................................................................................................. 5

Publication of accreditat ion standards for community pharmacies ................................................. 6

Introduction.......................................................................................................................................... 7 General comments ............................................................................................................................... 8

Rules and regulations .......................................................................................................................... 8

Working environment........................................................................................................................... 8 The content of the Danish Healthcare Quality Programme ............................................................... 9

Quality development ............................................................................................................................ 9

Structure, organisat ion and interpretation of accreditation standards in DDKM ..........................10 Structure of accreditation standards in DDKM ...................................................................................... 10

Organisation of accreditation standards in the Danish Healthcare Quality Programme ............................ 13

Interpretation of accreditation standards ............................................................................................. 13 De-selection of a few accreditation standards ...................................................................................... 14

Terminology ...................................................................................................................................... 14

Accreditation.......................................................................................................................................15 The accreditation process ................................................................................................................... 15

Criteria for awarding of accreditation status ........................................................................................ 15

Consequences of temporary accreditation ........................................................................................... 17 Consequences of suspended accreditation........................................................................................... 17

Consequences of not obtaining accreditation ....................................................................................... 18

Specifically about step 4..................................................................................................................... 18 Survey report .................................................................................................................................... 18

Appeal .............................................................................................................................................. 18

Publication of accreditation ................................................................................................................ 18 Help with the Danish Healthcare Quality Programme .....................................................................19

IKAS provides help with the Danish Healthcare Quality Programme ...................................................... 19

Guidance from IKAS........................................................................................................................... 19 Courses............................................................................................................................................. 19

FAQ .................................................................................................................................................. 19

"Handbook in DDKM for pharmacies" .................................................................................................. 19 Guidance in understanding the accreditation standards ........................................................................ 19

Management .......................................................................................................................................21

1.1.1 Business mission (1/5) .............................................................................................................. 21 1.1.2 Assignment of managerial responsibility and functions (2/5) ........................................................ 23

1.1.3 Planning and operation (3/5) ..................................................................................................... 25

1.1.4 Waiting time (4/5)..................................................................................................................... 27 1.1.5 Interior design of the pharmacy, facilities, cleaning, accessibility and safety (5/5) ......................... 29

Quality and risk management ...........................................................................................................31

1.2.1 Quality management (1/5) ......................................................................................................... 31 1.2.3 Risk management (2/5) ............................................................................................................. 34

1.2.6 Handling of product warranties (3/5) .......................................................................................... 36

1.2.7 Registration, reporting, analysis and follow-up of adverse events (4/5)......................................... 37 1.2.8 Handling of comments on service (5/5) ...................................................................................... 40

List of contents Accreditation standards for community pharmacies - 2nd version - June 2012Page 4 of 122

Documentation and data management ............................................................................................41

1.3.1 Document management (1/2) .................................................................................................... 41

1.3.2 Data safety and confidentiality (2/2) .......................................................................................... 43 Employment and competence development.....................................................................................45

1.4.1 Employment and introduction of new staff (1/3) ......................................................................... 45

1.4.2 Competence development (2/3) ................................................................................................. 47 1.4.3 The training pharmacy’s tasks and responsibilities (3/3) .............................................................. 49

Preparedness and supplies ................................................................................................................51

1.5.1 Precautions in emergency situations (1/1) .................................................................................. 51 Equipment and technology ................................................................................................................53

1.6.2 Handling of equipment at dose dispensing pharmacies (1/1) ....................................................... 53

Medicine and medicine counselling...................................................................................................55 2.1.1 Handling of prescriptions (1/11) # ............................................................................................. 55

2.1.2 Service of medicine on system breakdown (2/11) ....................................................................... 58

2.1.3 The pharmacies’ shifts (3/11) .................................................................................................... 60 2.1.4 Handling of dose dispensed medicine (4/11) # ........................................................................... 62

2.1.5 Dispatch (5/11)......................................................................................................................... 65

2.1.6 Counselling on medicine and on self-care to individuals (6/11) # ................................................. 67 2.1.7 Health promotion and disease prevention (7/11) ......................................................................... 71

2.1.8 Product handling (8/10) ............................................................................................................ 73

2.1.9 Stock of medicine and non-medical products (9/11) .................................................................... 75 2.1.10 Monitoring of euphoriants (10/11) ............................................................................................ 77

2.1.11 Production of dose dispensed medicine (11/11) ........................................................................ 79

Information and communication.......................................................................................................81 2.2.2 Written and electronic information material (1/1) ........................................................................ 81

Coordinat ion, cont inuity and transitions ..........................................................................................83

2.3.1 Supplier collaboration (1/3) ....................................................................................................... 83 2.3.2 Agreement on division of responsibilities and operation of OTC Outlets (2/3) ................................ 85

2.3.3 Agreement on division of responsibility and operation of medicine delivery facility (3/3) ................ 87

Healthcare services ............................................................................................................................89 3.1.5 Check on inhalation (1/2) .......................................................................................................... 89

3.1.8 Healthcare delivery (2/2) ........................................................................................................... 91

Appendix 1 – What is new in the 2nd version of the accreditation standards ...............................93 Appendix 2 – Detailed overview of changes from the 1st version to the 2nd version of

DDKM for community pharmacies .....................................................................................................97

Appendix 3 – Overview of elements of the standard at step 3 .....................................................108 Appendix 4 – List of terms ...............................................................................................................115

Appendix 5 – Valuable information for working with DDKM.........................................................121

Reading guide Accreditation standards for community pharmacies - 2nd version - June 2012Page 5 of 122

How to read this document

Accreditation standards for pharmacies, 2nd version includes accreditation standards, an introduction and a

range of appendices.

The "Introduction" section sets out the content and structure of the accreditation standards as well as the

principles for accreditation. In addition, the introduction includes valuable information for pharmacies that are

going to work with the Danish Healthcare Quality Programme, DDKM. Finally, there is a short overview of t he

guidance that IKAS provides.

It is important that all service users of DDKM get acquainted with the content of the introduction. The

introduction provides instructions on how to interpret the accreditation standards and rating achievement

principles used for deciding the accreditation status. These instructions complement the accreditation

standards and must be applied when decisions regarding assessments and decisions on awarding of

accreditation status are made. Thus, one cannot expect to be able to fully comprehend the standards without

having read the introduction. References are especially made to "Description of the basic templates for

accreditation standards".

Appendix 1 describes "What is new in 2nd version of the accreditation standards" Here service users

acquainted with the 1st version get a quick overview of the most important updates in relation to the content

of the accreditation standards. Appendix 2 includes an overview of the changes from 1st to 2nd version.

Along with the revisions to the accreditation standards for community pharmacies, the rating achievement

principles have also been revised. "Criteria for awarding accreditation status" includes an overview of the new

rating achievement principles which will apply for accreditations based on the 2nd version of the accreditation

standards for community pharmacies. The memo "Rating achievement principles in DDKM 2012 - Guidance

for surveyors and accreditation award committee available on www.ikas.dk in connection with Håndbog i

DDKM for apoteker [Handbook in DDKM for community pharmacies], provides a more thorough review of the

rating achievement principles.

To enhance the usefulness of this guide as a reference tool, there is some repetition across the introduction

and the appendices.

Validity of and transition to the 2nd version

Validity of DDKM

The 2nd version of accreditation standards forms the basis of the assessments made on all on-site surveys

initiated after 1 January 2013.

In case of follow-up assessment (submitted documentation, focused return visit, focused resurvey), the same

version which was used for the original on-site survey is used for follow-up.

As of 1 January 2013, all pharmacies, irrespective of time for 2nd accreditation, must work according to the

2nd version of the standards. As of 1 January 2013 as well, the quality monitoring must follow the

requirements in the 2nd version.

http://www.ikas.dk/

Reading guide Accreditation standards for community pharmacies - 2nd version - June 2012Page 6 of 122

Transit ion to the 2nd version

In connection with the transition to the 2nd version, pharmacies accredited according to the 1st version,

must show continuous quality monitoring throughout the entire period between the two accreditations. The

shape of monitoring may change during the course of the period. In those cases where the 2nd version

requires quality monitoring, which was not part of the 1st version, a plan for the quality monitoring and at

least one measurement up until 1 July 2013 are adequate. Hereafter quality monitoring is required

corresponding to 2nd version.

Pharmacies not previously accredited must present a plan for quality monitoring and at least one

measurement or evaluation at on-site survey.

For an element of the standard at step 3 to be met, it is not adequate that data have been collected. Data

also have to be evaluated and quality improvement must have been initiated where the quality does not meet

the required goals.

When the 3rd version of the standard is published, it will specify the transition date from the 2nd version to

the 3rd version. The transition date is expected to be 1 January 2016.

The accreditation certificate will indicate which version of the standards was applied for accreditation.

Publication of accreditation standards for community pharmacies

The entire, authorised and updated version of accreditation standards for community pharmacies is available

on www.ikas.dk. In addition, the accreditation standards are available in book form.

Introduction Accreditation standards for community pharmacies - 2nd version - June 2012Page 7 of 122

Introduction

The Danish Healthcare Quality Programme (DDKM) is a joint quality development system for the Danish

healthcare system.

The Danish Institute for Quality and Accreditation in Healthcare, IKAS, was established in 2005 by the Danish

Health and Medicines Authority, the Ministry of Health, the Association of County Councils in Denmark and

The Capital Region of Denmark with the purpose of developing a joint Danish quality model - The Danish

Healthcare Quality Programme.

Today the board of IKAS consists of representatives from the Danish Health and Medicines Authority,

Denmark, the Ministry of Health, Danish Regions and Local Government Denmark. The Danish Chamber of

Commerce and the Association of Danish Pharmacies are represented in the board by appointed members.

The purpose of DDKM is to:

improve the quality of patient pathways

improve the development of quality at the clinical, organisational and patient levels

to make the quality in the healthcare system transparent

to create learning and quality development in the healthcare system

DDKM aims to include the entire Danish healthcare system. By doing so, the programme is better helping to

meet the need for a coherent patient pathway of a consistent high quality – across sectors. At present, DDKM

includes community pharmacies in the primary sector, public hospitals and private hospitals treating patients

according to the extended free choice of hospital, the municipal healthcare system and the pre-hospital

sector. DDKM for general practice is under development, and preliminary work is taking place among

practising medical specialists and dentists.

In terms of methods, DDKM is an accreditation system, and thus includes a set of accreditation standards

and an accreditation process.

There is room for the individual pharmacy to adapt the programme. DDKM does not determine how to make

quality developments – it only sets out goals for ensuring quality; it is the individual pharmacy owner who is

responsible for daily operations and thus the pharmacy's level of quality. Therefore, there are a number of

areas where the pharmacy has to prepare its own clarifications of what the pharmacy understands by good

quality; the implementation of DDKM is also determined by the individual pharmacy.

Not only does DDKM focus on quality but it also focuses on the working procedures, processes and structures

supporting the pharmacy’s activities. Therefore, the programme applies to all employees working at the

community pharmacy.

All over the world, The International Society for Quality in Healthcare (ISQua) ensures the quality of

accreditation programmes in the healthcare system through formal requirements for accreditation standards

and accreditation organisations. For more information about ISQua, see IKAS' website www.ikas.dk. All

complete sets of standards developed by IKAS are presented before ISQua with a view for accreditation.

http://www.ikas.dk/


DDKM's accreditation standards are continuously being reviewed and further developed and revised versions

of the accreditation standards are published approximately every three years. Thus, new areas will be

included in the programme, and likewise the demands made on the healthcare system’s services will evolve

to meet the requirements for continuous development of quality.

DDKM for community pharmacies is based on legislation as well as on Apotekernes Strategi [The Community

Pharmacies' Strategy].

General comments

Rules and regulations

The legal framework for the healthcare system is based on legislation, including consolidated acts and

guidance from public authorities. As such, the accreditation standards are based on current legislation. An

element of the standard can only be rated as met if legislation in relation to the specific standard has been

met. It is always the current legislation at the time of the on-site survey which is going to be referred to.

The references only include the most important legislation which has to be included when guiding documents

are going to be prepared. The references apply from the time of the publication of the standard. By searching

the number or wording of an act on www.retsinformation.dk, it is possible to see if the document in question

has been replaced by a new updated document.

Working environment

A good working environment is an important part of a high quality healthcare system; this is also reflected in

the ISQua requirements for accreditation standards. However, Denmark already has a comprehensive set of

rules for the working environment including requirements for regular evaluations. A special system for

supervision ensures compliance with such rules.

DDKM is not another system describing requirements to the working environment in a wide sense and to

assess the compliance with the requirements. The accreditation standards relate to selected aspects of the

working environment which naturally fits into the remaining content and intentions of the set of standards.

For example: Standard 1.1.5 Interior design of the pharmacy, facilities, cleaning, accessibility and safety,

standard 1.4.1 Employment and introduction of new staff and standard 1.5.1 Precautions in emergency

situations.


The content of the Danish Healthcare Quality Programme

Quality development

DDKM is based on the basic model for systematic quality development which in turn is based on the quality

circle. Figure 1 shows the quality circle, also called the PDSA circle, which contains four steps:

Plan; the pharmacy must have guiding documents describing how the quality goal in the given accreditation

standard is met (assessed with the elements of the standard at step 1).

Do; the pharmacy must ensure the implementation of the strategies outlined in the guiding documents

(assessed with the elements of the standard at step 2).

Study; the pharmacy must monitor the quality of the structures and processes and the services delivered

(assessed with the elements of the standard at step 3).

Act; the pharmacy must assess the results of the monitoring and prioritise and organise initiatives where

there are quality flaws (assessed with the elements of the standard at step 4).

Figure 1: The quality circle

Quality development is a learning process and the quality circle is designed to be applicable to hospital's day-

to-day activities. DDKM is designed with the intent of supporting a systematic approach to developing quality

through using the principles in the quality circle.

Plan (step 1)

Study (step 3)

Act (step 4)

Do (step 2)


Structure, organisation and interpretation of accreditation

standards in DDKM

Structure of accreditation standards in DDKM

All accreditation standards are based on the template seen in figure 2 below. The template uses the same

ordering, headings and terms for each standard. Figure 2 defines the function of each of the individual

sections and the general requirements at each of the four steps:

Tit le Includes the theme and title of the

accreditation standard, a number

corresponding to the theme of the

standard, an individualised number for

the standard itself, and a sequential

number indicating the standards' place

within the total number of the

standards for the theme

Number

Sector Pharmacy Version 2 Edition 1

Category Describes which of the three categories

(organisational, general or specific) the

standard belongs to.

Theme Describes which theme

the accreditation

standard belongs to

Standard Describes the overall objective of the accreditation standard

Purpose Describes the purpose of the accreditation standard

Background Provides an outline of the background for the accreditation standard to help

understand how to interpret the standard. In addition, this space includes any

elaboration needed to fully comprehend the standard. It concerns the following

types of information:

Explanation of terms used

Explanations illustrating how to interpret standard in different contexts

Specification of requirements to content in the guiding documents

Finally, the space points out which accreditation standards the standard in

question is connected to.

Considerations on how to implement and work with the standard are based on

the information in this space.

Step 1 Step 1 requires the presence and content of guiding documents. This could be a

business mission, plans, check lists, guidelines or instructions depending on the

focus area of the accreditation standard.

As a principal rule, the accreditation standards do not require a person

responsible for preparation of these documents. Instructions reflect the

pharmacy's daily routines.

The pharmacy itself decides how to organise its guiding documents. Thus, it is










Number






the accreditation

standard belongs to

not necessary that one and only one independent guiding document

corresponds to each accreditation standard.

Validity period of guiding documents

Guiding documents included in DDKM are revised when needed so they are

updated - at least every third year.

Step 2 Step 2 shows whether the pharmacy works in accordance with the pharmacy's

guiding documents.

The elements of the standard describe the basis on which the pharmacy is

evaluated during on-site survey. The elements of the standard do not

necessarily cover all aspects of how a standard is implemented.

Unless otherwise stated, there are no requirements for written documentation

at step 2. The assessment will be based on observations and interviews

conducted during on-site survey.

Step 3 Step 3 supports the quality monitoring of the compliance with the accreditation

standard or parts of the standard. The quality monitoring is based on

formulated quality targets.

It is widely left for the pharmacy to choose the methods for monitoring. Since i t

will not be possible to monitor all aspects of the implementation of the standard

in practice, the pharmacy must prioritise its own efforts for quality monitoring.

Some accreditation standards require that the pharmacy conducts regular

evaluations as quality monitoring. The pharmacy itself decides how to conduct

the evaluation.

Other accreditation standards require on-going monitoring. It is not possible to

provide a general definition of what is understood by this. It is not necessarily

to be interpreted as a requiring continuous quality monitoring, but depending

on the character of the task, the pharmacy owner determines the interval of the

monitoring which is more frequent than every six month. For the element of the

standard to be rated as met, it is crucial that there is a plan for how the

monitoring is implemented and that this plan is followed.

Appendix 4 includes an overview of all elements of the standard at step 3.

Further references can be found in the memo "Rating achievement principles in

DDKM 2012 - Guidance for the surveyors and the accreditation award










Number






the accreditation

standard belongs to

committee" available on www.ikas.dk in connection with Handbook in DDKM in

which the rules for assessing the rating achievement of the elements of the

standard at step 3 are described in detail.

Step 4 Step 4 requires data from step 3 to be analysed and assessed. On the basis of

this, the pharmacy makes a management decision whether the quality level is

satisfactory or whether, on the basis of the analysis, quality improving initiatives

should be implemented, including whether quality monitoring needs to be

intensified.

When the pharmacy has implemented initiatives to improve the quality, the

effect of the initiatives is evaluated and the management of the pharmacy

decides whether the initiatives had the desired effect. If the desired effect has

not been reached, new improving initiatives will be launched. This ensures a

continuous quality development.

When assessing whether a step 4 element has been met, it is emphasised that

continuous quality development is indeed an on-going process. Thus, having a

specific number of assessments or initiatives per standard is not mandated.

Further references can be found in the memo "Rating achievement principles in

DDKM 2012 - Guidance for the surveyors and the accreditation award

committee" available on www.ikas.dk in connection with Handbook in DDKM for

pharmacies in which the rules for assessing the pharmacy's prioritisation of its

efforts are described at step 4.

References

In this space, selected references for the accreditation standard in question are detailed. The

references mainly consist of Danish legislation; but do not aim to include all legislation which

could be related to or substantiate the standard, only legislation which should be familiar and

taken into account when guiding documents are being prepared.

The references furthermore refer to relevant sector requirements and recommendations.

The references are current at the time of the publication of the standard. On

www.retsinformation.dk the current legislation is available.

Figure 2: Basic template for accreditation standards in the Danish Healthcare Quality Programme

http://www.ikas.dk/


Organisation of accreditation standards in the Danish Healthcare Quality Programme

The accreditation standards for the community pharmacies are organised into three categories:

organisational, general and specific standards. Each of these three categories includes several themes; there

are ten themes in all. The themes and the topics of the individual accreditation standards are based on joint

descriptions in DDKM across the healthcare system but adjusted to the pharmacy’s reality. The themes are

selected by IKAS in collaboration with the Association of Danish Pharmacies and based on relevance,

usefulness and potential to ensure and develop the quality at the Danish community pharmacies.

Organisational activitiesManagement (5*)Quality and risk management (5)Documentation and data management (2)Employment and competence development (3)Preparedness and supplies (1)Equipment and technology (1)

General customer pathway themesMedicine and medicine counselling (11)Information and communication (1)Coordination and continuity (1)

Specific customer pathway themesHealthcare services (3)

The Danish Healthcare Quality Programme

Accreditation standards for community pharmacies 2nd version

*Number of accreditation standards per theme

Figure 3: DDKM for pharmacies 2nd version

In total, the ten themes comprise 34 accreditation standards.

If there is a need for new themes in the model, new accreditation standards will be developed; likewise the

existing accreditation standards will be adjusted in accordance with alterations of the legislation, increased

requirements or changes of the pharmacy’s operation.

Interpretation of accreditation standards

Framework standards

The organisational accreditation standards include three accreditation standards called framework standards.

They describe the framework for the other accreditation standards. These accreditation standards are


regarded as the central elements for the pharmacies' forward-looking quality development. The framework

standards i.a. describe basic requirements to business mission, document management and quality

improvements which are not repeated in the other accreditation standards. It concerns the following three

accreditation standards:

Standard 1.1.1 Business mission, describes mission, vision and values for the pharmacy

Standard 1.2.1 Quality management, describes the framework for quality management at the pharmacy

Standard 1.3.1 Document management , describes i.a. requirements to those documents which are

going to be prepared as part of the implementation of the Danish Healthcare Quality Programme

It is necessary that the pharmacy has studied the content of these accreditation standards thoroughly to

understand and implement DDKM.

De-selection of a few accreditation standards

As a rule the entire set of standards applies for all community pharmacies. Thus, it is not possible for a

pharmacy to deselect an accreditation standard because the quality goal, which the standard shows, is found

less relevant in relation to the pharmacy's duties. An accreditation standard can only be regarded not

relevant if it concerns services or duties which do not appear at all or cannot appear at the pharmacy, for

example that the pharmacy does not have shifts or does not provide healthcare services.

Terminology

To ensure consistency in the material, the following terms are used:

Accreditation standards DDKM's use of the word "accreditation standard" is meant to refer to

accreditation standards applicable to healthcare organisations. This should not be confused with other uses

of the word "standard(s)". The word "standard" is used in substitution for the full term "accreditation

standards" to make the language more fluent for the reader.

References to Requirements are mentioned within accreditation standards or elements of the standard not

to be confused with legal regulations which bind the pharmacies; these are simply prerequisites for a

pharmacy to completely meet the standard or element of the standard. As appears from the rating

achievement principles, it is no prerequisite that the pharmacy completely meets all the standards to be

awarded accreditation.

Legislation is used as an umbrella term for laws, consolidated acts, guidelines etc. which have been

prepared in accordance with various laws.

Requirements included in the legislation are always binding.

Terms. For the development of the accreditation standards, choices of words were made to ensure

consistency in the material. Thus, the material includes a list of terms explaining words and definitions

(appendix 4).


The pharmacy owner is the person authorised to run the pharmacy. The pharmacy owner runs the

pharmacy and may choose to delegate parts of the operation to employees at the pharmacy. The distribution

plan of functions shows what the pharmacy owner has delegated and to whom.

The management could be the pharmacy owner but it could also be the persons who have been delegated

managerial tasks and responsibility.

The pharmacy covers the person(s) at the pharmacy who perform(s) the specific task.

Staff covers all employees at the pharmacy.

Accreditation

The accreditation process

There will be new requirements in the 2nd version of the standards which have to be identified and

addressed in the same way as the set of standards was handled in the first session of accreditation. For the

second accreditation, the pharmacy must ensure that its guiding documents are maintained and especially

that systematic work of quality monitoring and quality development takes place.

IKAS recommends the pharmacy to complete a baseline assessment within a limited period of time after

receiving the standards (e.g. three months). The purpose of the baseline assessment is to get an overview of

the pharmacy’s achievement level of the requirements in the 2nd version of the accreditation standards.

Thereafter, the pharmacy may start implementing general initiatives and action plans for the further process.

IKAS recommends pharmacies to conduct mock survey approximately six months before the on-site survey.

Mock surveys can be conducted internally at the pharmacy or by a person from a partnering pharmacy. Mock

surveys may be regarded as a test run of an on-site survey and may make the pharmacy aware of relevant

issues to be addressed before the on-site survey. For further information see IKAS' website www.ikas.dk.

In addition, IKAS provides the pharmacy with recommendations on how to work with DDKM. Appendix 4

includes a description of "Good advice for working with DDKM".

Criteria for awarding of accreditation status

Below is an overview of how rating achievement on elements of the standards and awarding of accreditation

status are decided. The detailed criteria are described in the memo "Rating achievement principles in DDKM

2012 - Guidance for surveyors and accreditation award committee" which is available on www.ikas.dk.

The assessment of the pharmacy's overall compliance with the requirements in DDKM is carried out by

assessing compliance with each element of the standard; the overall rating forms basis for the awarding of

the accreditation status. The surveyors' final assessment for each elements of the standard is based on a

four-point-scale:


Level of rating achievement Definition

Met All requirements have been met

Largely met Some requirements have been met and non-compliance does not

constitute a significant part of the requirement

Partially met Some requirements have been met and non-compliance constitute a

significant part of the requirement

Not met No requirements have been met or only plans exist

For each of the four steps, the memo includes a guideline for rating achievement of each element of the

standard. No independent assessment for each individual standard is awarded. However, the survey report is

prepared in such a way that it provides an overview of which specific standards have elements requiring

follow-up. In order to be awarded accreditation, it is required that all elements of the standard are rated as

met (M) or largely met (LM).

However, for the three critical patient safety standards (see text box below), it is required that all elements of

the standard at step 1 or step 2 have been rated M.

The three critical patient safety standards (marked with an # after the title of the standard)

2.1.1 Handling of prescriptions

2.1.4 Handling of dose dispensed medicine

2.1.6 Counselling on medicine and on self-care to individuals

If not all elements of the standard have been M/LM, but for at least 85% of the elements the pharmacy will

be awarded temporary accreditation However, for the three cri tical patient safety standards, it is required that

all elements have been rated M or LM at step 1 and step 2.

If the pharmacy does not meet these requirements, the accreditation award committee decides whether the

pharmacy can be awarded status as temporarily accredited or if the accreditation should be suspended. The

same is the case if all elements of a standard have been rated not met (NM).

The accreditation award committee's decision includes an assessment of whether elements of the standard

for which there is non-compliance have significant impact on the pharmacy's ability to ensure the citizens'

safety and legalised rights. In this context, safety means safety prevention of injurious events and guarding

against injuries due to insufficient efforts on the pharmacy's part.

In very special cases, the accreditation award committee can deny a pharmacy accreditation if justified.


Accreditation award committee

Accreditation award committee

New survey (from the beginning) after a specifc assessment

Accredited

Accredited with comments

Not accredited

On-site survey

Temporarily accredited

>85 - <100 %

HO/BO

100 % HO*/BO°

Final accreditation status

Accreditation suspended

Follow

up

≤ 8

5 %

HO

/BO

Individual decision made

by accreditation award

committee

Preliminary accreditation status

100 % HO/BO

100 % HO/BO

>85 - <100 %

HO/BO

>85 - <100 %

HO/BO

≤ 85 %

HO/BO

*FM = Fully met element of the standard

°LM = Largely met element of the standard

Figure 4: Overview of the process from on-site survey to accreditation status.

Pharmacies awarded the status “accredited with comments” are regarded as accredited but will require

different amounts of subsequent quality development work depending on their standing.

Consequences of temporary accreditation

The survey report will require follow-up on elements of the standard which have been partially met (PM) or

NM (or LM for the three critical patient safety standards). The follow-up could consist of:

Submission of documentation within three months

Focused revisit within six months

If the follow-up then results in the pharmacy now meeting the requirements, the pharmacy's status changes

to accredited. If not, the status will be accredited with comments.

Consequences of suspended accreditation

The survey report will require follow-up on the elements of the standard which have been PM/NM (or LM for

the three critical patient safety standards). The follow-up consists of a focused resurvey within three months,

and there may be a requirement for follow-up within one month for any standards rated PM/NM that are

particularly critical for the safety of the customers.

Depending on the results of the follow-up, the pharmacy is then awarded status as accredited, accredited

with comments or not accredited.


Consequences of not obtaining accreditation

At a later date, after a concrete assessment by IKAS, the pharmacy can undergo a new on-site survey where

the assessment process starts all over.

Specifically about step 4

It is possible for the pharmacy to downgrade some of the step 4 elements of the standard. In order to be

awarded accreditation or accredited with comments, maximum 50% of all relevant elements of the standard

at step 4 must be deselected as "not prioritised". Elements of the standard at step 4 are not relevant if the

activity or service which the element of the standard concerns do not exist at the pharmacy or if the

pharmacy meets the stated quality goals.

Not relevant elements of the

standard

Not prioritised elements of the standard

Max. 50 %

Elements where level of rating achievement has to be rated – min. 50 %

Elements where the quality goals have been reached

Part of decision in awarding of accreditation status

Figure 5: Not prioritised elements of the standard at step 4.

Survey report

After on-site survey, the pharmacy receives a survey report which includes:

A summary assessment of the pharmacy

Substantiated ratings for all relevant elements of the standard

An overview of the standards for which elements of the standard have been rated PM/LM (for the three

critical patient safety standards also LM) and the related requirements for follow-up

It is possible for the pharmacy to object to the report before it is presented to the committee for decisions on

the accreditation status or require follow-up.

Appeal

It is possible to appeal the accreditation award committee's decisions. IKAS provides further information

about this on www.ikas.dk.

Publication of accreditation

The accreditation status and accreditation report are published on www.sundhed.dk and www.ikas.dk.


Decisions on the possibility for focused resurvey and the survey report, which forms the basis for the

accreditation decision, are published in the same way.

Help with the Danish Healthcare Quality Programme

IKAS provides help with the Danish Healthcare Quality Programme

IKAS offers to train employees at the pharmacy who will be working with DDKM. A pharmacy which applies

for accreditation appoints an employee at the pharmacy who will be trained to participate in the pharmacy’s

implementation of the accreditation standards and the day-to-day work with DDKM, and guide the pharmacy

through the accreditation process and assist IKAS in planning and implementing on-site survey in connection

with the accreditation.

Guidance from IKAS

The pharmacy will be assigned a named consultant from IKAS whom the pharmacy may contact when

needed. The consultation provides help in understanding the accreditation standards and helps make

recommendations on the accreditation process.

Courses

IKAS offers courses for pharmacies working with DDKM. The purpose of the courses is to support the

pharmacies in the work with the accreditation process by means of presentations and exercises. The courses

are offered on IKAS’ website.

FAQ

Via IKAS' website, all pharmacies working with DDKM may ask IKAS questions regarding the accreditation

standards and the accreditation process. The questions and responses which IKAS finds to be of importance

to the general public will be repeated via the FAQ on IKAS' website.

"Handbook in DDKM for pharmacies"

On IKAS' website, the electronic version of "Handbook for pharmacies" helps with implementation of the

accreditation process. The handbook includes recommendations on how the pharmacy can work with all

parts of the accreditation process. For further information see IKAS' website.

Guidance in understanding the accreditation standards

During the pharmacies' implementation of the accreditation standards and when the standards are used by

the surveyors and the accreditation award committee, there may be difficulties of comprehensible character.


In such cases, IKAS provides instructions on how to understand the standard. These instructions are

available for all service users of the accreditation standards in the following ways:

On IKAS' website www.ikas.dk, relevant FAQs are linked to each individual standard. Any practice of

evaluation from the accreditation award committee will be available on the same website.

If IKAS finds it suitable, particular instructions ("need to know") will be incorporated into the standard under

the space "Background of the standard". IKAS will use this opportunity restrictive ly, but on the other side it is

IKAS' goal that the essential parts of the standard should be understood without having to read FAQs or the

rating practice. All changes in the accreditation standards will appear from a log on www.ikas.dk

It is emphasised that by doing so, no changes may be made in the requirements of the standard. It is merely

instructions which serve as a better understanding of the requirements in the standard.

The above-mentioned means that the version of standards on www.ikas.dk must be regarded as the

applicable version. The version in book form may differ a little from the web version.

List of appendices

Appendix 1 – What is new in the 2nd version of the accreditation standards

Appendix 2 – Detailed overview of changes from the 1st version to the 2nd version

Appendix 3 – Overview of elements of the standard at step 3

Appendix 4 – List of terms

Appendix 5 - Valuable information for working with DDKM

Management, standard 1.1.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 21 of 122

Management

Tit le 1.1.1 Business mission (1/5) Number 1.1.1


Category Organisational standards Theme Management

Standard The pharmacy works according to a business mission which is a joint

foundation for management, operations and development.

Purpose That the pharmacy defines mission, vision and values for the pharmacy and to

ensure that these are reflected in the pharmacy’s overall handling of tasks.

Background The standard is a framework standard and sets the framework for the other

accreditation standards.

The standard is fundamental for the pharmacy's business and is reflected in the

pharmacy's other guiding documents.

The business mission is based on the pharmacy's legal authorisation and the

strategy for the pharmacies in Denmark. The business mission reflects the

obligation and the rights which it entails to have a pharmacy licensing.

The business mission consists of mission, vision and values for the duties which

the pharmacy handles. In addition, a business mission very often includes focus

areas/goals which the pharmacy has to work with to meet the mission and

vision. The business mission is integrated in the daily management and is

reflected in the pharmacy's management structure and staff policy.

The business mission is fundamental for the pharmacy's professional and

ethical role in relation to customers, collaborators and staff. Thus, there is a

clear connection between the business mission and the signals which the

pharmacy sends, for example via window and pharmacy decorations, product

range, press contact, customer contact and dialogue with customers.

Part of this standard concerns implementation of the business mission. The

work with the business mission is based on a dialogue between the

management, the quality group and the staff.

The business mission thus becomes a joint platform for management,

operations and development for all employees at the pharmacy.

The pharmacy's evaluation of whether there is coherence between the business

mission, the practice of the pharmacy and the determined quality goals,

including the staff's experience of the coherence could be identified as a part of

a larger staff development interview, customer satisfaction survey and in

relation to compliance of service goals.

The standard is connected to:

Steps 1 and 4 in all accreditation standards as the business mission forms the

basis for the pharmacy's work.

1.1.3 Planning and operations. The business mission is the starting point for the

pharmacy's planning and operations.

Step 1 Element 1 There is a business mission reflecting the pharmacy's desired role in the local

community and the health care field and which describes the pharmacy's:

a) mission


Tit le 1.1.1 Business mission (1/5) Number 1.1.1



b) vision

c) values

Step 1 Element 2 There are guidelines describing how the management ensures that the

business mission forms the basis for the day-to-day work.

Step 2 Element 3 The pharmacy owner and staff are familiar with the business mission which

forms the basis for the day-to-day work.

Step 3 Element 4 Once a year the management evaluates the business mission.

Step 3 Element 5 Once a year the management evaluates whether there is coherence between

the business mission, the pharmacy's practice and the determined quality goals,

including the staff's experience of the coherence.

Step 4 Element 6 Based on the quality monitoring, the management takes action on specific

initiatives for any quality improvements and follows up on whether the

initiatives had the desired effect, cf. standard 1.2.1 Quality management.

References

1. Lov om apoteksvirksomhed. LBK nr. 855 af 04/08/2008

2. Strategi for apotekerne i Danmark – Medicin og sundhed med omtanke


Tit le 1.1.2 Assignment of managerial

responsibility and functions (2/5)

Number 1.1.2



Standard The pharmacy documents assignment of managerial responsibility and

functions.

Purpose To ensure that managerial responsibility and responsibility for the pharmacy’s

other functions are assigned to named persons at any times.

Background The standard concerns the documents which, with different degree of detail,

describe assignment of managerial responsibility and functions.

Organisation chart provides an overview of the pharmacy's structure and could

e.g. provide an overview of the pharmacy's units, functions or positions.

Plan for division of functions gives a more detailed division of functions. The

plan states which staff is involved in which tasks and how they are involved at

any time.

Job description includes a detailed description of responsibility and authority.

The standard requires job descriptions for substitutes and the person

responsible for quality. The pharmacy can assess whether it is appropriate to

prepare job descriptions for several areas of responsibility.


1.1.3 Planning and operations. The planning ensures the pharmacy that the

correct staff-related resources are present.

1.2.1 Quality management. Coherence between the job description for person

responsible for quality and the quality organisation's work.

1.4.2 Competence development. When preparing the plan for division of

functions etc., the pharmacy assesses whether there is a need for further

training of staff.

Step 1 Element 1 Managerial responsibil ity and functions are stated in the following documents:

a) organisation chart for all units of the pharmacy

b) job description for substitute for the pharmacy owner where responsibility

and authorities are described

c) job description for person responsible for quality where responsibility and

authorities are described

d) documentation of division of roles and responsibility, e.g. in the shape of a

plan for division of functions, including statement of person responsible,

substitute and performer for the individual functions

Step 2 Element 2 The pharmacy works in accordance with the documents which describe

managerial responsibility and functions.

Step 3 Element 3 The management regularly evaluates if the documents describing the division

of managerial responsibility and functions are in accordance with the actual

conditions at the pharmacy.

Step 3 Element 4 Once a year the management evaluates whether the division of managerial

responsibility and functions are appropriate.



Tit le 1.1.2 Assignment of managerial

responsibility and functions (2/5)

Number 1.1.2



initiatives for any quality improvements and follows up on whether the initiates

had the desired effect, cf. standard 1.2.1 Quality management.

References


2. Bekendtgørelse om apoteker og apotekspersonale BEK nr. 1215 af 07/12/2005

3. Bekendtgørelse om distribution af lægemidler. BEK. nr. 1243 af 12. december 2005 (GDP)


Tit le 1.1.3 Planning and operation (3/5) Number 1.1.3



Standard The pharmacy’s management and planning of work are based on the

pharmacy’s duties.

Purpose To ensure coherence between the pharmacy's duties and resources.

Background The standard concerns the pharmacy owner's use of management tools to

ensure coherence between the pharmacy's duties and resources. The

pharmacy's duties are defined on the basis of the pharmacy's legal authority,

the strategy for the pharmacies in Denmark and the pharmacy's business

mission.

The pharmacy uses management tools to create coherence between the

pharmacy's duties and resources in the day-to-day operation and the overall

management of the pharmacy.

The management tool could be development of key figures, including statistics

of earnings, trade returns, activity development, monthly balance sheet, daily

analyses of waiting time and compliance of deadline in the dispatch, staff

development interview and scheduling.

The pharmacy's choice of management tools helps ensuring coherence

between the pharmacy's duties and resources. The coherence is shown in the

specific work planning, scheduling and the pharmacy's service goals.

The overall scheduling uses the pharmacy's principles for daily staffing, special

tasks, time off in lieu, holiday etc. The principles can be part of the staff's

employee handbook.

By comparing the current results with the pharmacy's quality goals and uncover

reasons for any deviations, the pharmacy owner is provided with important

management information for planning of future actions.

On evaluation of the coherence between resources and tasks, the management

involves the staff's experience of the coherence.

This can be discussed in connection with appraisals, employee satisfaction

surveys or the like.


Steps 3 and 4 in all accreditation standards. The quality monitoring in the

individual accreditation standards can form the basis for larger quality

improving initiatives and thus be significant for the operation and scheduling.

1.1.1 Business mission The pharmacy's operation and activities are seen in

connection with the pharmacy's mission, vision and values.

1.4.2 Competence development The coherence between duties and resources

and competences.

Step 1 Element 1 There are guidelines describing the pharmacy owner's management tools to

create coherence between the pharmacy's tasks and resources in the daily

operation and the overall management of the pharmacy.

Step 2 Element 2 The pharmacy owner creates coherence between the pharmacy's duties and

resources in the daily operation and the overall management of the pharmacy

in accordance with the guidelines.


Tit le 1.1.3 Planning and operation (3/5) Number 1.1.3



Step 3 Element 3 The pharmacy owner regularly considers whether there is coherence between

resources and duties.




References



Tit le 1.1.4 Waiting time (4/5) Number 1.1.4



Standard The pharmacy determines, documents and publishes service goals for waiting

time and compliance of service goals for waiting time.

Purpose To ensure that the pharmacy determines, observes and publishes a goal for

waiting time based on the sector's requirements to service goals for waiting

time.

Background The standard addresses the pharmacy's handling of its waiting time by

determining, observing and publishing service goals for waiting time. The

pharmacy's service goal is based on the sector's recommendations and the

pharmacy documents how the goal described in the sector's recommendations

is reached.

The pharmacy assesses whether it is appropriate to set out goals for the

waiting time at a pharmacy outlet.

Pharmacies directly serving prescriptions only establish and document service

goals for waiting time. Pharmacies not directly serving prescriptions, both

establishes and documents waiting time and waiting time for prescriptions.

When the pharmacy evaluates the waiting time, it could be appropriate to look

at patterns in the registered waiting time, e.g. in relation to staffing, breaks and

customer flow.

If the pharmacy does not have an electronic queue numbering system, spot

checks can be taken when quality monitoring. The pharmacy registers the

waiting time at representative times during the pharmacy’s entire opening

hours. Depending of the size of the pharmacy, there may be much difference in

the method of measuring the waiting time. This can be reflected in the service

goals for waiting time for the individual pharmacy.

If the pharmacy has an electronic queue numbering system, the waiting time is

regularly registered; the pharmacy contributes with measurement results for a

comprehensive statistic regarding the average waiting time by the counter for

Danish pharmacies.

The national sector measurements can be part of the pharmacy's quality

monitoring of the waiting time.


1.1.1 Business mission Coherence between observance of service goals for

waiting time and the business mission.

1.1.3 Planning and operations. Coherence between the waiting time and work

load, staffing, work planning etc.

1.1.5 Interior design of the pharmacy, facilities, cleaning, accessibility and

safety. Publication of service goals in the business premises and publication of

observance of service goals.

1.2.8 Handling of comments on service. Comments on service regarding waiting

time are included in the quality monitoring.

Step 1 Element 1 There are guidelines describing:

a) how the pharmacy determines service goals for waiting time


Tit le 1.1.4 Waiting time (4/5) Number 1.1.4



b) how and when the pharmacy registers waiting time

Step 2 Element 2 The pharmacy determines service goals for waiting time based on the

requirements of the sector.

Step 2 Element 3 The pharmacy registers waiting time.

Step 3 Element 4 Three times a year, the pharmacy evaluates the waiting time, and whether

there exist patterns and tendencies in the registered waiting time.

Step 3 Element 5 Every third year, the pharmacy evaluates the customers' satisfaction with the

pharmacy's waiting time.

Step 4 Element 6 Based on the result of the quality monitoring, the management takes action on

specific initiatives for any quality improvements and follows up on whether the

initiatives have the desired effect, cf. standard 1.2.1 Quality management.

References

1. Bekendtgørelse om servicemål for apotekers distributionsopgaver og faglig rådgivning og

information. Lægemiddelstyrelsen. BEK nr. 1235 af 17/12/2002


Tit le 1.1.5 Interior design of the

pharmacy, facilities, cleaning,

accessibility and safety (5/5)

Number 1.1.5



Standard The pharmacy assesses interior design of the pharmacy, facilities, cleaning,

accessibility and safety.

Purpose The interior design and facilities of the pharmacy ensures that the pharmacy

is accessible, safe and functional for staff and customers.

Background The standard concerns the pharmacy's assessment of whether the pharmacy's

premises are properly fitted for the pharmacy's operation and with the

greatest possible accessibility and safety for staff as well as customers.

In addition, the pharmacy considers discretion for service and counselling.

Furthermore, the pharmacy considers maintenance, cleaning and facilities for

e.g. hand hygiene and change of clothes. In addition to that, the pharmacy

decides how to take the environment into considerati on for example by

making energy-saving arrangements.

The pharmacy considers how to ensure accessibility to the pharmacy,

including how to contact the pharmacy, e.g. by phone, mail or other

electronic correspondence.

Considerations are made to physical accessibility and other service initiatives

in connection with the pharmacy's service of disabled persons.

When assessing access and safety for customers and staff, the pharmacy can

consider access roads for customers and staff, safety with locking of doors

and the conditions for working alone and at shifts.

The pharmacy's environmental organisation could be involved in the work

with this standard with advantage.

In this standard, the pharmacy decides how and when the pharmacy

publishes all service goals and the compliance of them in the business

premises and in other relevant places.


1.2.3 Risk management. The standard ensures that the pharmacy all in all

acts in relation to safety and risks.

1.2.8 Handling of comments on service. Registration of comments on service

regarding interior design of the pharmacy, facil ities, cleaning, discretion,

accessibility and safety.

2.1.3 The pharmacies’ shifts. Accessibility and safety for staff and customers

during shifts.

Step 1 Element 1 There are guidelines for the interior design, facilities and accessibility of the

pharmacy describing:

a) interior design providing discretion

b) telephonic and electronic accessibility

c) physical accessibil ity and service of disabled persons

d) hand hygiene


Tit le 1.1.5 Interior design of the

pharmacy, facilities, cleaning,

accessibility and safety (5/5)

Number 1.1.5



Step 1 Element 2 There is a check list for assessment of the pharmacy's interior design of the

pharmacy, facilities, cleaning, accessibility and safety.

Step 1 Element 3 There are guidelines for publication of service goals and compliance of service

goals describing:

a) how the pharmacy publishes service goals in the business premises and

at other relevant places

b) how the pharmacy publishes compliance of service goals in the business

premises and at other relevant places

Step 2 Element 4 The interior design, facilities and accessibility of the pharmacy are in

accordance with the guidelines.

Step 2 Element 5 The pharmacy assesses that the interior design of the pharmacy, facilities,

cleaning, accessibil ity and safety are in accordance with the check list.

Step 2 Element 6 The pharmacy determines service goals for physical accessibility and service

of disabled persons.

Step 2 Element 7 The pharmacy publishes service goals in the business premises and at other

relevant places.

Step 2 Element 8 The pharmacy publishes compliance of service goals in the business premises

and at other relevant places.

Step 3 Element 9 Based on the check list, the pharmacy evaluates the interior design of the

pharmacy, facilities, cleaning, accessibility and safety once a year.

Step 3 Element 10 Every third year the pharmacy evaluates the customers' satisfaction with the

Interior design of the pharmacy, facilities, cleaning, accessibility and safety.

Step 3 Element 11 Every third year the pharmacy evaluates the staffs' satisfaction with the

Interior design of the pharmacy, facilities, cleaning, accessibility and safety.




References



2. Vejledning i god distributionspraksis for lægemidler ti l humant brug. EF’s vejledning af 1994

3. Bekendtgørelse om apoteker og apotekspersonale. BEK nr. 1215 af 07/12/2005

Quality and risk management, standard 1.2.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 31 of 122

Quality and risk management

Tit le 1.2.1 Quality management (1/5) Number 1.2.1


Category Organisational standards Theme Quality and risk

management

Standard The pharmacy owner determines the framework for quality management.

Purpose To ensure that:

the pharmacy has established a quality organisation

there is continuity in the pharmacy's quality work

the quality work is implemented and developed as an integrated part of

the pharmacy's development and operations

the pharmacy prioritises quality improvements

Background The standard is a framework standard and sets the framework for the other

accreditation standards. The standard is central for the pharmacy's on-going

quality development.

The standard concerns how the pharmacy's work with quality development is

rooted in the management at the pharmacy and is an active part of the

pharmacy's operation.

As a minimum, the quality organisation consists of a representative from the

management and the person responsible for the quality. Meetings are held

and they are documented in minutes. The quality organisation has a

coordinating role in the pharmacy's work with quality development, but it is a

joint task to contribute with input for quality monitoring and suggestions for

quality improvement.

The quality organisation:

implements initiatives preventing quality flaws, and at least once a year it

reviews the results of the quality monitoring which have been made since

the last review

prioritises quality improving initiatives, including preparation of action

plans and follows up on initiated action plans.

The pharmacy's evaluation of the overall quality can include an evaluation of

the quality organisation's method of working such as meeting structure and

frequency of meetings, involvement of staff and how the pharmacy owner

uses DDKM as a managerial tool.

The evaluation of the overall quality could be spread over the year with

advantage. The follow-up includes implementation of the quality monitoring

(step 3) as planned and that the quality improvements (step 4) have the

intended effect. The management must ensure coherence between the

pharmacy's planning and operations and the pharmacy's business mission in

relation to the overall prioritisation.

As part of the quality improving work, the pharmacy prepares action plans

determining the goal for the effort, person responsible for initiating the work,

any risks connected with the change and how follow-up consequently is

performed.





management


Steps 3 and 4 in all accreditation standards. This standard concerns the

pharmacy's overall quality and large quality improving initiatives within the

individual accreditation standards. It must be seen as part of a greater whole

and prioritised across the accreditation standards.

1.1.1 Business mission The business mission reflects the pharmacy's work

with quality development and improvement.

1.1.2 Assignment of managerial responsibility and functions. The quality

organisation appears from the organisation chart and/or plan for division of

functions, and there is a job description for the person responsible for the

quality.

1.1.3 Planning and operations. The necessary resources are present in

relation to working with quality development and improvement.

1.4.2 Competence development. Training and development needs for staff

involved in the quality work.

Step 1 Element 1 There are guidelines for quality management describing how the pharmacy

owner ensures:

a) managerial responsibility for quality management, including delegation of

responsibility

b) sufficient resources for working with quality management have been

allocated

c) involvement of staff in the quality work, including how the quality work is

used for learning and quality improvement

d) preparation of and follow-up on action plans

Step 1 Element 2 There are guidelines for the quality organisation's work describing:

a) frequency of meetings and documentation for holding of meetings

b) how the quality organisation determines, implements, maintains and

develops the pharmacy's quality development work

c) how the quality organisation reports to the pharmacy owner

d) fora for the quality organisation's communication of the pharmacy's work

with quality development

Step 1 Element 3 The pharmacy has an overall plan for quality monitoring.

Step 2 Element 4 The pharmacy's quality management is in accordance with the guidelines.

Step 2 Element 5 The quality organisation works in accordance with the guidelines.

Step 2 Element 6 The pharmacy performs quality monitoring in accordance with the pharmacy's

plan for quality monitoring.

Step 3 Element 7 Once a year the pharmacy evaluates the work with quality management,

including the quality organisation's work and follow-up on initiated action

plans.

Step 3 Element 8 Once a year the management evaluates the overall quality at the pharmacy





management

based on the pharmacy's quality monitoring.

Step 4 Element 9 The pharmacy implements initiatives to improve the quality if the work with

the individual quality monitoring has shown comprehensive quality flaws or

lack of achievement of goals.

Step 4 Element 10 Based on the evaluation of the overall quality at the pharmacy, the

management prioritises focus areas for quality improvement.

Step 4 Element 11 Action plans are prepared for the pharmacy's efforts in areas where

comprehensive quality flaws have been identified or there is a need for large

quality improving initiatives.

Scope and degree of detail of the action plans are adjusted to the specific

context, but overall the action plans describe the following:

specific goals for the effort

Initiatives to be implemented

time frame for implementation

person responsible for the implementation

resources available for the implementation of the effort

any risks which can be predicted in connection with the implementation

monitoring of the achievement of goals

follow-up on the effect of implemented initiatives

person responsible for follow-up

action plans, if implemented initiatives do not have the desired effect

References



Tit le 1.2.3 Risk management (2/5) Number 1.2.3



management

Standard When implementing significant changes, the pharmacy works proactively on

identifying and reducing risks for customers, staff and the pharmacy.

Purpose To ensure that risks are identified and minimised when implementing significant

changes.

Background The standard concerns the pharmacy's actions in relation to safety and risks

when significant changes have to be implemented. Implementation of

significant changes thus takes place involving the greatest possible safety for

customers and staff.

The pharmacy's work with risk management ensures that the pharmacy is at

the cutting edge of possible risks as far as possible when significant changes

are implemented and that the pharmacy tries to act before something goes

wrong in advance.

In order to support the pharmacy's risk management, there must be guidelines

for risk management.

The pharmacy identifies significant changes to be reviewed in relation to risk

management on significant changes. This could be:

reconstruction and restoration

implementation of new technology

changes of the composition of staff

new working procedures and tasks

amendment of current legislation



safety.

Step 1 Element 1 There are guidelines for risk management on implementation of significant

changes describing:

a) when the pharmacy is going to make a risk assessment

b) how risks are identified

c) how risks are assessed

d) how risks are prioritised

Step 1 Element 2 There is a check list for implementation of significant changes which include:

a) purpose

b) description of risks which could affect customers, staff and the pharmacy

c) actions to avoid risks

d) involvement of relevant staff

e) preparation of time schedule

f) follow-up plan

Step 2 Element 3 The pharmacy regularly assesses whether there are situations where risk

management is relevant in accordance with the guidelines for risk

management.


Tit le 1.2.3 Risk management (2/5) Number 1.2.3



management

Step 2 Element 4 The pharmacy implements significant changes in accordance with the check

list.

Step 3 Element 5 Once a year the pharmacy evaluates the working procedures for risk

management on implementation significant changes.

Step 4 Element 6 Based on the result of the quality monitoring the management takes action on



References


Tit le 1.2.6 Handling of product warranties

(3/5)

Number 1.2.6



management

Standard The pharmacy has a system to handle product warranties.

Purpose To ensure that the product warranties are handled.

Background The standard concerns the pharmacy's handling of product warranties.

The pharmacy regularly receives warranties about the pharmacy's products. It

is important to handle these requests in the same way. The pharmacy has

working procedures ensuring feedback to the producer so he/she is able to

quality assure his/her product to the benefit of the customers.

The pharmacy decides how the pharmacy handles product warranties in

relation to customers and collaborators. This could include considerations in

relation to dialogue with customers and collaborators with product warranties,

when to deliver a compensation product to ensure that the medical treatment is

not interrupted and feedback and repayment to customers regarding product

warranties.


2.1.8 Handling of products. Making sure that the quality of the product is not

reduced while under the custody of the pharmacy.

2.1.9 Stock of medicine and non-medical products. Updating of stock on

dispensing of compensation product.

Step 1 Element 1 There are instructions for handling product warranties which describe:

a) how the pharmacy receives, registers, documents and passes on product

warranties

b) how the pharmacy handles product warranties in relation to customers and

collaborators.

Step 2 Element 2 The pharmacy handles product warranties in accordance with the instructions.

Step 3 Element 3 Twice a year the pharmacy evaluates the handling of product warranties.




References



Tit le 1.2.7 Registration, reporting,

analysis and follow-up of adverse

events (4/5)

Number 1.2.7



management

Standard The pharmacy registers, analyses and follows up on adverse events and

reports relevant adverse events to Danish Patient Safety Database.

Purpose To ensure appropriate handling and learning of adverse events in order to:

prevent adverse events

contribute to improve the patient safety

Background The standard concerns adverse events. An adverse event is defined as an

event which has injured the customer or involves risk of injury. This could be

in the shape of wrong delivery, faulty delivery or wrong counselling. Adverse

events also include events which were prevented before or did not occur due

to other circumstances (near misses).

There is a distinction between registration and reporting of adverse events.

Registration is used for events which have occurred at the pharmacy and are

handled internally at the pharmacy. Reporting is used for events which are

reported to Danish Patient Safety Database (DPSD). This could be events

which the pharmacy itself is involved in, observes among others or

subsequently becomes aware of.

In the guiding document the pharmacy must consider how adverse events

occurred at the pharmacy, are registered, assessed and analysed, and how

the pharmacy subsequently follows up on the event. The goal is to create

learning and quality development and thereby prevent that the same type of

event happens again and again. The pharmacy itself determines criteria for

which events are going to be thoroughly analysed. This could for example be

frequent episodes or events which had serious consequences or could have

had serious consequences if not been discovered beforehand. The pharmacy

itself chooses the analysis method.

The pharmacy includes adverse events, which it becomes aware of from e.g.

other pharmacies, the Membership site, the Region or the National Agency for

Patients' Rights and Complaints, in the further work for the benefit of the

patient safety.

The pharmacy assesses when it is relevant to follow up in relation to persons

who are implicated in the event. This could be healthcare personnel, the

customer, relatives and staff involved.


2.1.1 Handling of prescriptions. Adverse events and near misses in connection

with service of prescription

2.1.4 Handling of dose dispensed medicine. Adverse events on handling of

dose dispensed medicine, e.g. errors occurred when creating and updating

dosing charts

2.1.5 Dispatch. Adverse events in relation to faulty delivery

2.1.6 Counselling on medicine and self-care to individuals Adverse events in




events (4/5)

Number 1.2.7



management

relation to absent, inadequate or wrong counselling/identification of needs

Step 1 Element 1 There are guidelines for handling adverse events occurring at the pharmacy

describing:

a) how registration and categorisation take place

b) how the registered events are assessed

c) how the registered events are analysed

d) principles for implementation of preventive initiatives and communication

of learning

e) when and how to follow up in relation to the persons involved

f) who is responsible for analysis and follow-up

Step 1 Element 2 There are guidelines for reporting of adverse events to Danish Patient Safety

Database (DPSD) describing:

a) types of events to be reported to Danish Patient Safety Database (DPSD)

b) types of events which can be reported to Danish Patient Safety Database

(DPSD)

c) who reports

Step 1 Element 3 There are guidelines for the pharmacy on how to learn from adverse events

occurred in the pharmacy sector which the pharmacy becomes aware of.

Step 2 Element 4 The pharmacy handles adverse events occurred at the pharmacy in


Step 2 Element 5 The pharmacy assesses each individual adverse event with a view for further

handling.

Step 2 Element 6 The pharmacy makes a thorough analysis of selected adverse events to

identify cause of events.

Step 2 Element 7 The pharmacy reports adverse events to Danish Patient Safety Database

(DPSD) in accordance with the guidelines.

Step 3 Element 8 Twice a year the pharmacy evaluates handling and learning of adverse

events.

Step 3 Element 9 Twice a year the pharmacy evaluates the registered adverse events based on

an overview of the registered events and patterns, if any.

Step 3 Element 10 Twice a year the pharmacy evaluates its follow-up in relation to the parties

involved in an adverse event.

Step 3 Element 11 Twice a year the pharmacy evaluates its working procedures and efforts on

reporting of adverse events to Danish Patient Safety Database (DPSD).

Step 4 Element 12 Based on the result of the quality monitoring, the management takes action

on specific initiatives for any quality improvements and follows up on whether

the initiatives have the desired effect, cf. standard 1.2.1 Quality management.




events (4/5)

Number 1.2.7



management

References

1. Sundhedsloven, kap. 61 om patientsikkerhed

2. Bekendtgørelse om rapportering af utilsigtede hændelser i sundhedsvæsenet mv.

Sundhedsstyrelsen. Bekendtgørelse nr. 925 af 14/07/2010

3. Vejledning om rapportering af utilsigtede hændelser i sundhedsvæsenet mv. Sundhedsstyrelsen.

Vejledning 67 af 14/07/2010

4. Dansk Patient-Sikkerheds-Database (DPSD) www.dpsd.dk

http://www.dpsd.dk/


Tit le 1.2.8 Handling of comments on

service (5/5)

Number 1.2.8



management

Standard The pharmacy handles comments on service from customers and collaborators.


comments on service are handled and included in the quality development

the pharmacy learns from the registered comments on service

Background The standard addresses the pharmacy's handling of comments on service.

The pharmacy regularly receives requests concerning the pharmacy's work. The

pharmacy learns from these requests and includes them in the work with

quality development and improvement.

Comments on service include positive and negative comments and complaints

from the customers regarding service, accessibility, waiting time, service,

counselling and discretion.

The pharmacy handles and registers incoming comments on service in

preparation for quality development. Registration can take place regularly or in

selected periods, e.g. in selected weeks which can provide a representative

picture.


1.1.1 Business mission Comments on service regarding the pharmacy in

general.

1.1.4 Waiting time. Comments on service regarding waiting time.

1.1.5 Interior design of the pharmacy, facilities, accessibility and safety.

Comments on service regarding the pharmacy's business premises, opportunity

for discretion, accessibility etc.

2.1.5 Dispatch. Comments on service regarding the pharmacy's dispatches.

2.1.6 Counselling on medicine and self-care to individuals. Comments on the

staff's way of communicating and opportunity for discretion

Step 1 Element 1 There are guidelines for how the pharmacy receives, registers, categorises and

handles comments on service.

Step 2 Element 2 The pharmacy handles comments on service in accordance with the guidelines.

Step 3 Element 3 Twice a year the pharmacy evaluates whether there are patterns in the

incoming comments on service.

Step 3 Element 4 Once a year the pharmacy evaluates how the pharmacy learns from the

comments on service.




References

Documentation and data management, standard 1.3.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 41 of 122

Documentation and data management

Tit le 1.3.1 Document management (1/2) Number 1.3.1


Category Organisational standards Theme Documentation and

data management

Standard The pharmacy applies a document management system for the documents

included by the pharmacy’s quality management.


the pharmacy’s documents are available, up-dated and approved

valid documents are unambiguously identified

Background The standard is a framework standard and sets out the framework for other

accreditation standards.

The standard concerns management of the guiding documents, e.g. business

mission, instructions, guidelines, check lists and plans which describe the

pharmacy's working procedures and services in relation to DDKM. In addition,

the standard concerns appurtenant forms and other documents which are

prepared on the basis of the requirements in the accreditation standards in

DDKM.

It may be an advantage to manage documents which describe working

procedures or services not included by DDKM as the pharmacy then ensures

version control of the document.

Documents included by the pharmacy's quality management are updated at

least every third year.

The standard is significant for all documents which the pharmacy prepares in

relation to DDKM as the pharmacy uses document management of these

documents.

Step 1 Element 1 There are guidelines for the pharmacy's document management describing:

a) responsibility for ensuring document management

b) structure of the document management system, including assessment of

whether the pharmacy's documents should be in paper version or in an

electronic version

c) indication of when the individual document becomes effective

d) updating of documents

e) assessment of history of documents and version management

f) working procedures for preparation, approval and revision of documents

g) availability of documents

h) deletion/relocation of invalid documents

i) backup of the pharmacy's documents

Step 2 Element 2 The pharmacy controls the documents included by the pharmacy's quality

management in accordance with the guidelines.

Step 2 Element 3 The pharmacy appoints a person who is responsible for document

management.


Tit le 1.3.1 Document management (1/2) Number 1.3.1



data management

Step 3 Element 4 Once a year the pharmacy evaluates the work with document management.




References


Tit le 1.3.2 Data safety and confidentiality

(2/2)

Number 1.3.2



data management

Standard The pharmacy processes and destroys person identifiable data in a safe and

secure manner.

Purpose To ensure

confidentiality and appropriate and controlled access to relevant use of data

against misuse and loss of person identifiable data

correct registration of data

Background The standard addresses the pharmacy's considerations in relation to handling

and destruction of person identifiable data, so data are handled in a

confidential and appropriate manner.

Person identifiable documents and data are those documents and data which

relate to information about the customer's statement of health and use of

medicinal products, e.g. information about service, prescriptions and receipts

with civil registry numbers.

The pharmacy considers when it is necessary to collect consent to get access to

data or when passing on information and how the pharmacy handles this in

practice - e.g. on the pharmacy's access to the Medicine Profile.

The standard also concerns confidential documents and data relating to

personnel matters.

Data safety i.a. includes how the pharmacy ensures that backup of data is

made to the extent necessary and how the pharmacy ensures that only staff

that needs access to person identifiable data get access, and that the pharmacy

documents this by using personal log-in for electronic access to person-

identifiable data.

Data discipline includes security of the pharmacy's correct registration of data,

e.g. the prescribing doctor's General Medical Council Registration Number.


1.4.1 Employment and introduction of new staff Rules for duty of confidentiality

and handling of personal documents.

2.1.1 Handling of prescriptions. Log-in and correct entry of data

Step 1 Element 1 There are guidelines for data confidentiality describing:

a) rules for passing on confidential information and handling of duty of

confidentiality

b) when it is necessary to collect the customer's consent

c) how the pharmacy handles person identifiable documents and data,

including information to the customer about person identifiable data on

receipts

d) how the pharmacy destructs person identifiable documents and data

Step 1 Element 2 There are guidelines for data safety and data discipline describing:

a) how the pharmacy ensures correct registration of data

b) the pharmacy's log-in procedure with electronic data processing


Tit le 1.3.2 Data safety and confidentiality

(2/2)

Number 1.3.2



data management

c) the pharmacy’s backup procedures

d) precautions on breach of safety in the attempt of unauthorised access

e) decision making on breach of safety

Step 2 Element 3 The pharmacy handles data confidentiality in accordance with the guidelines.

Step 2 Element 4 The pharmacy handles data safety and data discipline in accordance with the

guidelines.

Step 3 Element 5 Once a year the pharmacy evaluates the compliance of the rules of duty of

confidentiality, including handling and destruction of person identifiable data.

Step 3 Element 6 Once a year the pharmacy evaluates the working procedures for data safety

and data discipline.




References

1. Bekendtgørelse om recepter. Lægemiddelstyrelsen. Bekendtgørelse nr. 1390 af 15/12/2011

2. Bekendtgørelse om dosisdispensering af lægemidler. Lægemiddelstyrelsen. Bekendtgørelse nr. 80

af 5. februar 2003

3. Sundhedsloven. Indenrigs- og Sundhedsministeriets lov nr. 913 af 13/07/2010

4. Lovgivning om behandling af personoplysninger, Lov nr. 429 af 31/5 2000 med senere ændringer

Employment and competence development, standard 1.4.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 45 of 122

Employment and competence development

Tit le 1.4.1 Employment and introduction of

new staff (1/3)

Number 1.4.1


Category Organisational standards Theme Employment and

competence

development

Standard The pharmacy determines the framework for employment and introduction of

new staff.

Purpose To ensure:

framework for employment of new staff

that new staff becomes acquainted with conditions, duties and requirements

at the pharmacy

Background The standard helps setting the framework for employment procedures. The

standard concerns the process from the decision of employing new staff until

the pharmacy has selected and employed a person. The standard concerns

permanent employment as well as employment of temps.

The pharmacy has an employment procedure where the pharmacy considers

e.g.:

the pharmacy's needs when advertising for new staff

job profile

professional and personal competences necessary to handle the vacant

position

appointment of an appointments committee

The employment procedure could include a check list which includes:

documentation for relevant exam

preparation of employment contract including information about the

conditions and terms of the employment which must be available before

start

preparation of job description based on job tasks and areas of responsibility

The induction programme includes introduction to all relevant guidelines

regarding work tasks, safety instructions and working with quality.

In connection with the tree-month conversation, the pharmacy could receive

input for improvements of the work planning which can be part of the

pharmacy's work with quality improvement.


1.1.1 Business mission The newly appointed person must be familiar with the

business mission.

1.1.2 Placement of managerial responsibility and functions. The newly

appointed person is informed about who is assigned which functions and areas

of responsibility.

1.2.1 Quality management. All staff is familiar with the pharmacy's work with

quality.


Tit le 1.4.1 Employment and introduction of

new staff (1/3)

Number 1.4.1



competence

development

1.2.3 Risk management All staff is familiar with the pharmacy's work with risk

management.

1.2.7 Registration, reporting, analysis and follow-up of adverse events. All staff

is familiar with the pharmacy's work with adverse events.

1.3.2 Data safety and confidentiality. Duty of confidentiality and safe handling

of data.

1.5.1 Precautions in emergency situations. The newly appointed person is

familiar with his/her tasks and options on acute, threatening or dangerous

situations.

Step 1 Element 1 There are guidelines for employment of staff.

Step 1 Element 2 There are induction programmes for newly appointed persons which include:

a) The pharmacy's business mission and organisation

b) Own areas of responsibility, including guiding documents concerning the

new employees’ function

c) Rules of confidentiality

d) The pharmacy’s work on quality management and quality development

e) Introduction to working environment

f) Plans and responsibility on acute, threatening or dangerous situations

g) Registration, repor ting, analysis and follow-up on adverse events and risk

management

h) Interview with new employees not later than three months after the

employment

Step 2 Element 3 The pharmacy hires new staff in accordance with the guidelines.

Step 2 Element 4 Introduction of new staff takes place in accordance with the induction

programme.

Step 3 Element 5 Once a year the pharmacy evaluates employment of new staff.

Step 3 Element 6 On the three-month interview, the pharmacy evaluates the course in connection

with employment and introduction in collaboration with the newly appointed

person.

Step 3 Element 7 Once a year the pharmacy evaluates the induction programme.




References

1. Ansættelsesbevisloven. Bekendtgørelse af lov om arbejdsgiverens pligt til at underrette

lønmodtageren om vilkårene for ansættelsesforholdet. Lovbekendtgørelse nr. 240 af 17/03/2010



Tit le 1.4.2 Competence development (2/3) Number 1.4.2



competence

development

Standard The pharmacy works systematically with competency development based on

the pharmacy's overall needs for staff development and training of staff.

Purpose To ensure that the pharmacy and the staff:

possess the competences necessary to solve the pharmacy’s tasks, at any

time

have an updated and adequate knowledge level to handle the tasks

are updated on current rules and legislation

develops personal and professional competences

Background The standard concerns how the pharmacy owner ensures that the staff's

personal and professional competences are adequate and updated in relation to

the pharmacy's operations. The pharmacy owner ensures that relevant staff is

updated on professional recommendations, current rules and legislation.

To identify needs for development and training of the staff, the pharmacy

owner holds appraisals. Based on the appraisal, the pharmacy owner prepares

a training and development plan for each employee.

The training and development plans can be based on the results of quality

monitoring which shows the need for training and competence development.

The pharmacy's documentation of the staff's competence development could

be morning meetings, internal training and further training.


1.1.1 Business mission. Coherence between business mission and the

pharmacy's training and development plans.

1.1.2 Managerial responsibility and functions and 1.1.3 Planning and

operations. Changes in the division of responsibility and tasks could lead to

changes of the plans for division of functions and planning of the daily work.

2.1.1 Handling of prescriptions. The pharmacy considers competence aspects

2.1.4 Handling of dose dispensed medicine. The pharmacy considers

competence aspects.

2.1.6 Counselling on medicine and on self-care to individuals. The pharmacy

considers competence aspects.

3.1.5 Check on inhalation. The pharmacy considers competence aspects when

offering the healthcare service Check on inhalation.

3.1.8 Healthcare delivery. The pharmacy considers competence aspects when

healthcare services are offered.

Step 1 Element 1 There are guidelines for competence development describing:

a) how the pharmacy owner and the staff are professionally updated in

relation to tasks and functions.

b) time frames and content of annual appraisals

c) follow-up on appraisals

d) use of training and development plan for the individual employee


Tit le 1.4.2 Competence development (2/3) Number 1.4.2



competence

development

e) how to make an overall assessment of the staff’s competences in relation to

the pharmacy’s present and future tasks

f) How to document competence development

g) how the pharmacy owner and the staff are professionally updated in

relation to current rules and legislation.

h) resources allocated to competence development

Step 2 Element 2 The pharmacy owner's and the staff's competence development takes place in


Step 2 Element 3 The pharmacy holds appraisals in accordance with the guidelines.

Step 3 Element 4 Once a year the pharmacy owner evaluates all the pharmacy's competences in

relation to the pharmacy’s business mission and daily operations.

Step 3 Element 5 Once a year the pharmacy evaluates the use of appraisals and development

plans in relation to individual competence development.

Step 3 Element 6 Once a year the pharmacy owner evaluates the staff's satisfaction with the

pharmacy's work with competence development.

Step 3 Element 7 The pharmacy owner continuously evaluates whether the staff needs further

knowledge about current rules and legislation.




References



Tit le 1.4.3 The training pharmacy’s tasks

and responsibilities (3/3)

Number 1.4.3



competence

development

Standard The pharmacy contributes to the training of pharmaconomist trainees and

pharmacy students based on the individual trainee's/student's needs and

applicable study and training programmes.

Purpose To ensure that the pharmacy supports the pharmaconomist trainees in

completing their education and the pharmacy students in completing their

study visit at the pharmacy.

Background The standard concerns how the pharmacy supports the pharmaconomist

trainees and the pharmacist students in completing their educations. In support

of this, the pharmacy has guidelines for the pharmacy's tasks and

responsibilities as training pharmacy based on current study and training

programmes.

The pharmacy schedules the work so the trainee/the student have the

necessary framework for learning so the pharmacy meets the trainee's/the

student's individual needs for guidance. For example the person whom the

trainee/the student can refer to when a prescription has to be controlled, how

to plan introduction to the work in the counter and how to plan study days.


2.1.1 Handling of prescriptions. Trainees/students' competences and

possibilities on service of prescription.

2.1.6 Counselling on medicine and on self-care to individuals.

Trainees/students’ competences and possibilities in relation to counselling

2.1.7 Health promotion and disease prevention. Trainees/students'

competences and possibilities.

Step 1 Element 1 There are guidelines for the training pharmacy’s tasks and responsibilities with

the training of pharmaconomist trainees and pharmacy students describing how

the pharmacy ensures:

a) presence of resources and competences when being a training pharmacy

b) planning of trainees' work taking their education into consideration

c) that the pharmacy completes interviews with trainees about education

d) appropriate planning of the students' stay at the pharmacy

Step 2 Element 2 The pharmacy plans the work for trainees and students based on the

guidelines.

Step 2 Element 3 The pharmacy completes interviews with pharmaconomist trainees about

education

Step 3 Element 4 Once a year the pharmacy evaluates the course of studies for pharmaconomist

trainees.

Step 3 Element 5 The pharmacy evaluates the course of the students' stay at the pharmacy in

collaboration with the students.


Tit le 1.4.3 The training pharmacy’s tasks

and responsibilities (3/3)

Number 1.4.3



competence

development

Step 3 Element 6 Once a year the pharmacy evaluates the task as training pharmacy.

Step 4 Element 7 Based on the result of the quality monitoring the management takes action on



References

Preparedness and supplies, standard 1.5.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 51 of 122

Preparedness and supplies

Tit le 1.5.1 Precautions in emergency

situations (1/1)

Number 1.5.1


Category Organisational standards Theme Preparedness and

supplies

Standard The pharmacy has plans describing precautions regarding emergency situations

or imminent or dangerous situations or situations of acute health character.

Purpose To ensure:

that the pharmacy avoids imminent and/or dangerous situations as far as

possible

action on imminent or dangerous situations and situations of acute health

character

follow-up in relation to customers and staff

Background The standard concerns the pharmacy's actions before, during and after

emergency situations or imminent or dangerous situations and situations of

acute health character.

Emergency situations could be fire, robbery, violence, threats, assault or

suspicion about theft where an immediate decision is required to act upon.

Emergency situations could also be acute health-related problems where

customers or staff need help.

The pharmacy acts proactively to avoid acute, imminent or dangerous

situations from happening.

The pharmacy has plans for handling different situations. The plans include the

staff's responsibility, tasks and options in different situations, e.g. deployment

of alarm button, contact to police or always to move away from the situation.

The pharmacy describes options for action regarding acute health-related

situations, e.g. handling of first aid and call of an ambulance.

The plans regarding fire describe the staff's responsibility and tasks, including

evacuation of customers and staff. The fire authority assesses the risk of fire.

The plans are prepared on the basis of an overall assessment of risks and

safety for customers and staff.

The pharmacy's working environment organisation is included when the plans

are prepared and the plans are part of the pharmacy's employee handbook.

The plans consider how to follow-up in relation to those involved in emergency

situations, e.g. options for crisis counselling.



safety. To avoid acute or dangerous situations, the pharmacy must take them

into account, e.g. interior design of the pharmacy.

1.4.1 Employment and introduction of new staff. The plans are part of the

introduction of new staff.

Step 1 Element 1 There are guidelines for emergency situations describing:

Preparedness and supplies, standard 1.5.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 52 of 122

Tit le 1.5.1 Precautions in emergency

situations (1/1)

Number 1.5.1


Category Organisational standards Theme Preparedness and

supplies

a) handling of emergency situations which the pharmacy finds imminent

and/or dangerous

b) handling of emergency situations of health-related character

c) follow-up in relation to customers and staff

d) implementation of the plans

Step 2 Element 2 The staff acts in accordance with the plans on emergency situations.

Step 3 Element 3 The pharmacy evaluates the applicability of the plans when an emergency

situation or an imminent or dangerous situation has taken place.




References

Equipment and technology, standard 1.6.2 Accreditation standards for community pharmacies - 2nd version - June 2012Page 53 of 122

Equipment and technology

Tit le 1.6.2 Handling of equipment at dose

dispensing pharmacies (1/1)

Number 1.6.2


Category Organisational standards Theme Equipment and

technology

Standard Staff using equipment at dose dispensing pharmacies is trained in correct use,

maintenance and qualification of equipment.

Purpose To ensure:

relevant training of staff using and/or maintaining equipment

effective, safe and correct handling and maintenance of equipment

effective, safe and correct function of equipment

qualification of critical equipment

Background That staff operating equipment used for production of dose dispensed medicine

has the necessary training.

Operation of this equipment also includes cleaning, control and qualification of

the equipment and the necessary maintenance.

Cleaning and maintenance of equipment include e.g. packing machine,

deblistering machine, ventilation systems and equipment for control.

Critical equipment could be cassettes and packaging machines before use the

first time and after repair of important parts.


1.4.2 Competence development. Qualification requirements in handling of

equipment at dose dispensed pharmacies.

2.1.11 Production of dose dispensed medicine Working procedures for

production of dose dispensed medicine.

Step 1 Element 1 There are guidelines for handling of equipment used for production of dose

dispensed medicine describing working procedures, competence and

documentation in connection with the following:

a) relevant training of staff using and/or maintaining equipment

b) cleaning of equipment

c) maintenance of equipment

d) qualification of critical equipment

e) completed cleaning and maintenance of equipment

Step 2 Element 2 Staff handles equipment used for production of dose dispensed medicine in


Step 2 Element 3 Staff using and/or maintaining equipment receives relevant training.

Step 2 Element 4 There is documentation in accordance with the guidelines.

Step 3 Element 5 Once a year the pharmacy evaluates the handling of equipment for production

of dose dispensed medicine.

Equipment and technology, standard 1.6.2 Accreditation standards for community pharmacies - 2nd version - June 2012Page 54 of 122

Tit le 1.6.2 Handling of equipment at dose

dispensing pharmacies (1/1)

Number 1.6.2


Category Organisational standards Theme Equipment and

technology

Step 3 Element 6 Once a year the pharmacy evaluates the training of staff operating equipment

for production of dose dispensed medicine.




References

1. Bekendtgørelse om fremstilling og indførelse af lægemidler og mellemprodukter. Bekendtgørelse

nr. 1242 af 12. december 2005 (GMP)

2. Bekendtgørelse om dosisdispensering af lægemidler. Bekendtgørelse nr. 80 af 5. februar 2003

Medicine and medical counselling, standard 2.1.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 55 of 122

Medicine and medicine counselling

Tit le 2.1.1 Handling of prescriptions

(1/11) #

Number 2.1.1


Category General standards Theme Medicine and medicine

counselling

Standard Handling of prescriptions and dispensing of prescribed medicine are properly

and carefully performed.


prescriptions are handled in a safe and correct manner so risk of errors are

minimised.

the pharmacies’ statutory documentation of prescription interventions is

used as a follow-up and quality improvement tool of the pharmacy’s

working procedures and in collaboration with the pharmacy's prescribers.

Background The standard concerns service of prescription.

The pharmacy's instruction for handling of prescriptions describes working

procedures and competences, including control of prescription and reflects

the different types of prescriptions and medication. The different types of

prescriptions could be electronic prescriptions, handwritten prescriptions and

EU prescriptions. Types of medication order could be prescriptions for

magistral medicine and medicine with compassionate use permit.

Working procedures and routines make it possible to find out who has

participated in the service of a prescription for at least three months after the

service of the prescription and who has:

checked that the prescription is correct

carried out pharmacological control and clarification of interaction

questions

checked that the prescription has been served and that the medicine is

labelled in accordance with the prescription’s directions

Control could be linked with initials in IT-system, e.g. valuations, bar code

scanning or delivery or it could appear from initials written directly on the

prescription or receipt of prescription.

In situations where the pharmacy double checks the prescriptions, the

pharmacy describes what the checking includes and how the pharmacy

documents who has made the checking.

When trainees and students participate in the service, the instruction

describes how the pharmacy documents which trained staff has made the

checks.





1.2.7 Registration, reporting, analysis and follow-up of adverse events. Wrong

delivery and other events in relation to prescription service are handled as



(1/11) #

Number 2.1.1



counselling

adverse events.

1.3.2 Data safety and confidentiality. Log-in and correct entry of data

1.4.2 Competence development. Competence requirements on prescription

service

Step 1 Element 1 There are instructions for handling of prescriptions describing:

a) working procedures and competences in relation to prescription service

b) checking that the prescription is correct

c) pharmacological control, including control of potency, dosage and

indication, interaction and contraindications

d) registration of prescription interventions, including contact to prescriber in

case of errors, lacks or doubt and documentation of the result of the

contact

e) checking that the prescription is correct

f) checking that the medicine has been labelled in accordance with the

prescription's directions.

g) students’, trainees’ and unskilled persons’ competences in relation to

prescription handling

h) proper identification of the customer

i) proper identification of medication order by choice from the prescription

server

j) reception of telephoned prescriptions, including proper identification of

prescriber

k) handling of false prescriptions

Step 1 Element 2 Branch pharmacies only manned by pharmaconomists have instructions

describing the situations where to contact a pharmacist.

Step 1 Element 3 There are guidelines for the pharmacy's service goals regarding:

wrong deliveries describing:

a) how the pharmacy determines its goals for the highest acceptable

number of wrong deliveries

b) how the pharmacy registers wrong deliveries

Step 2 Element 4 The pharmacy serves prescriptions in accordance with the instructions.

Step 2 Element 5 The pharmacy registers all prescription interventions.

Step 2 Element 6 The pharmacy registers all wrong deliveries.

Step 2 Element 7 The pharmacy determines service goals for wrong deliveries.

Step 3 Element 8 Twice a year the pharmacy evaluates whether the service of prescription

takes place in a safe and correct manner.

Step 3 Element 9 Twice a year the pharmacy evaluates the registered prescription interventions

based on an overview of the registered prescription interventions and

patterns, if any.



(1/11) #

Number 2.1.1



counselling

Step 3 Element 10 Twice a year the pharmacy evaluates the registered wrong deliveries based on

an overview of the registered wrong deliveries and patterns, if any.




Step 4 Element 12 Based on the evaluation of patterns in the prescription interventions, the

management assesses whether the prescribers involved need to be contacted

in relation to learning and quality improvement.

References






Tit le 2.1.2 Service of medicine on system

breakdown (2/11)

Number 2.1.2



counselling

Standard On system breakdown which is critical for service of medicine, the pharmacy

has working procedures for service of medicine.

Purpose To ensure that medicine is served and delivered in a safe and correct manner

on system breakdown critical for the service of medicine.

Background The standard describes how to ensure the pharmacy's working procedures on

system breakdown critical for service of medicine.

The pharmacy is dependent on many systems important for the pharmacy to

serve medicine.

System breakdown could for example concern: hard ware, internet connection,

prescription server, pharmacy systems, CTR [the Danish Medicines Agency's Central Reimbursement Register] and pharmacy robots.

On system breakdowns of longer duration, it is important to inform all relevant

parties, e.g. customers, doctors, pharmacy outlets, OTC outlets and the

municipality, e.g. nursing homes and home care.

The assessment could include consequences for customers, patient safety,

economy, staff and wrong deliveries.


1.2.7 Registration, reporting, analysis and follow-up of adverse events.

Registration of adverse events on system breakdown critical for service of

medicine.


regarding service of medicine on critical system breakdowns

2.1.1 Handling of prescriptions. Service of prescriptions on critical system

breakdowns

Step 1 Element 1 There are guidelines for safe and correct service and delivery of medicine on

system breakdowns which describe:

a) identification of system breakdowns which have consequences for safe an

correct delivery of medicine

b) how the pharmacy acts on system breakdown to ensure that the pharmacy

is able to serve and deliver medicine to the customer to the greatest

possible extent at any time

c) when and how the pharmacy informs customers, distribution units and

collaborators about the consequences of system breakdown.

d) persons who acts on the pharmacy on system breakdown

Step 2 Element 2 The pharmacy serves medicine on system breakdown in accordance with the

guidelines.

Step 3 Element 3 Once a year the pharmacy evaluates the working procedures on system

breakdown.



Tit le 2.1.2 Service of medicine on system

breakdown (2/11)

Number 2.1.2



counselling



References


Tit le 2.1.3 The pharmacies’ shifts (3/11) Number 2.1.3



counselling

Standard At shifts, the pharmacy handles special conditions regarding enquiries and

service in a safe and secure manner.

Purpose To ensure:

that the pharmacy distributes medicine in a safely and correct manner

outside opening hours

that the pharmacy informs about the shifts

working procedures in relation to the specific working conditions on shifts

Background The standard concerns those conditions which are different on shifts compared

to the pharmacy's opening hours.

It is important that customers and collaborators know the opening hours for the

shifts and the type of shifts at the pharmacy. This makes the availability of

medicine and counselling transparent outside normal opening hours.

The pharmacy ensures that staff, who attends the shifts, knows how to act

under the special conditions which exist on the shifts.

The guiding document could be prepared as a handbook for shifts, so staff

attending shifts is quickly informed about the special conditions.

The evaluation could include whether there are special conditions which could

be taken into account in the future. This could be absent stock of medicine,

situations where staff or customers are insecure and absent deliveries.


1.1.3 Operations and planning. Adequate resources on shifts.


safety. Accessibility and safety for staff and customers during shifts.

2.1.1 Handling of prescriptions. Handling of prescriptions on shifts.

2.1.2 Service of medicine on system breakdown. Special conditions on shifts.

2.1.6 Counselling on medicine and on self-care to individuals. Counselling

during shifts takes place according to current principles for counselling in

opening hours.

2.1.9 Storage of medicine and non-medical products. Degree of service,

including adequate storage of products relevant for shifts.

Step 1 Element 1 There are guidelines for working procedures for specific conditions during the

pharmacy’s shifts describing:

a) information to customers and collaborators about the pharmacy’s shifts,

including charges

b) contact to emergency doctor

c) handling of prescription intervention when prescriber cannot be contacted

d) possibility for dispatch at shifts

e) possibility for procurement of medicine not in stock

f) possibility of paging acute extra staffing

g) Disclosure of relevant information when changing shifts


Tit le 2.1.3 The pharmacies’ shifts (3/11) Number 2.1.3



counselling

Step 1 Element 2 If the shift is manned with pharmaconomists, there are instructions

describing:

a) in which situations a pharmacist has to be contacted

b) which pharmacist to contact in case of questions

Step 2 Element 3 The pharmacy handles special conditions on shifts in accordance with the

guidelines.

Step 2 Element 4 Pharmaconomists handle the shift in accordance with the instructions.

Step 3 Element 5 Once a year the pharmacy assesses working procedures for special conditions

during shifts.




References


2. Bekendtgørelse om apotekernes åbningstid og vagttjeneste. BEK nr. 344 af 13/04/2011


Tit le 2.1.4 Handling of dose dispensed

medicine (4/11) #

Number 2.1.4



counselling

Standard Handling of prescriptions for dose dispensing, creation and updating of dosing

charts and dispensing of dose dispensed medicine take place in a safe and

correct manner.


handling of dose dispensed medicine takes place in a safe and correct

manner

risk of errors on preparation and updating of dose dispensed medicine is

minimised

the pharmacy collaborates with prescribers and other collaborators about

dose dispensed medicine

Background The standard concerns the pharmacy's handling of dose dispensed medicine.

The pharmacy's instruction for handling dose dispensed medicine describes

working procedures, competence conditions and documentation.

Working procedures and routines ensure that at least three months after

delivery of dose dispensed medicine, it is possible to clarify who participated

in:

dose dispensing and dispensing of dose dispensed medicine

checking that the prescription is correct

pharmacological control and clarification of interaction questions

checking creation and updating of dosing charts

The pharmacy determines the service provided to the customers and

collaborators, e.g. in connection with:

establishment of new customers using dose dispensed medicine

implementation of acute/non-acute changes

offer of packet inserts

Information to the customer

The pharmacy collaborates with other providers, e.g. prescribers and the

municipality's home care, so the service user benefits from the dose

dispensed medicine in order to prevent adverse events. The collaboration

includes agreements about coordination, division of work and responsibility

for medication order, suspension/discontinuation, who responsible for

procuring new prescriptions, who are informed about expiry of prescriptions

and the pharmacy's information to healthcare professionals.





1.2.7 Registration, reporting, analysis and follow-up of adverse events. Errors

when creating and updating of dosing charts are handled as adverse events.

1.4.2 Competence development. Standard 2.1.4 Competence requirements on

service of dose dispensed medicine.



medicine (4/11) #

Number 2.1.4



counselling

2.1.1 Handling of prescriptions. Prescription interventions, including contact to

prescriber in case of doubt or correction of prescriptions for dose dispensing

and documentation of the result of the contact.

2.1.6 Counselling on medicine and self-care to individuals. Counselling to

service users of dose dispensed medicine.

2.3.1 Supplier collaboration. Collaboration agreement with the package

pharmacy

Step 1 Element 1 There are instructions for handling of dose dispensed medicine describing:

a) working procedures, competence aspects and documentation

b) checking that the prescription is correct, including period of time

c) pharmacological control of prescriptions, including control of potency,

dosage and indication, interaction and contraindications

d) registration of prescription interventions, including contact to prescriber

on errors, lacks or doubt and documentation for the result of the contact

e) how the pharmacy prepares and updates dosing charts, and what does

the control of the dosing chart encompass and how is it documented

f) handling of information about changes from the package pharmacy due

to substitution or changes of assortments

g) control on reception of dose dispensed medicine and before delivery of

dose dispensed medicine

Step 1 Element 2 There are guidelines for the pharmacy's service goals regarding dose

dispensed medicine describing:

a) how the pharmacy determines service goals for the highest number of

errors accepted when preparing and updating dosing charts

b) how the pharmacy registers errors on preparation and updating of dosing

charts

Step 1 Element 3 There are guidelines for the pharmacy's service level in relation to customers,

who receive dose dispensed medicine, and collaborators.

Step 1 Element 4 There are guidelines for the pharmacy's collaboration with external parties in

relation to dose dispensed medicine.

Step 2 Element 5 The pharmacy handles dose dispensed medicine in accordance with the

instructions.

Step 2 Element 6 The pharmacy determines service goals for the highest number of errors

accepted when preparing and updating dosing charts.

Step 2 Element 7 The pharmacy registers errors when preparing and updating dosing charts.

Step 2 Element 8 The pharmacy's service level in relation to customers who receive dose

dispensed medicine is in accordance with the guidelines.

Step 2 Element 9 The pharmacy collaborates with external parties about dose dispensed

medicine in accordance with the guideline.



medicine (4/11) #

Number 2.1.4



counselling

Step 3 Element 10 Once a year the pharmacy evaluates whether the pharmacy's handling of

dose dispensed medicine takes place in a safe and correct manner.

Step 3 Element 11 Once a year the pharmacy evaluates the registered errors when creating and

updating dosing charts based on an overview of the registered errors and

patterns, any.

Step 3 Element 12 Once a year the pharmacy evaluates the service level which the pharmacy

provides customers who receive dose dispensed medicine.

Step 3 Element 13 Once a year the pharmacy evaluates the collaboration with external parties

about dose dispensed medicine.




References






Tit le 2.1.5 Dispatch (5/11) Number 2.1.5


Category General standards Theme Medicines and

medicine counselling

Standard Delivery from the pharmacy is performed in a safe and correct manner.

Purpose To ensure:

that the delivery is executed in consideration of not impairing the quality of

the medicine during delivery

that the correct medicine is delivered to the correct person, institution or

pharmacy unit

Background The standard concerns all types of dispatch to e.g. private customers,

collaborators, municipal institutions and pharmacy units such as pharmacy

outlets, OTC outlets and delivery facilities etc.

The pharmacy is responsible for the quality of the medicine until the medicine

is delivered to the recipient. The medicine is transported so it is store in a safe

manner and not exposed to unacceptable amounts of warmth, cold, humidity or

other injurious influences.

Very often direct dialogue between the pharmacy and the recipient is

impossible. The pharmacy ensures that necessary information about the

dispatch, e.g. time for delivery and storage is informed to the recipient.


1.2.6 Handling of product warranties. Handling of product warranties which

concerns delivery.


which concerns dispatch.

1.2.7 Registration, reporting, analysis and follow-up of adverse events. Faulty

deliveries are registered and handled like adverse events

2.1.6 Counselling on medicine and on self-care to individuals. This standard

concerns counselling to customers who receives dispatches.

Step 1 Element 1 There are guidelines for the pharmacy's dispatch describing:

a) the pharmacy's options for delivery

b) how customers and collaborators are informed about the pharmacy's

options of delivery

c) information to the customer about expenses for the delivery

d) when acute dispatch is performed

e) when to document delivery/reception of the dispatch

Step 1 Element 2 There are instructions for the pharmacy's handling of dispatch which describe:

a) working procedures

b) that the pharmacy ensures that the correct medicine is delivered to the

correct person, institution or pharmacy unit

c) that the pharmacy guarantees that the quality of the medicine has not

been impaired after service and during delivery

d) how the customers are informed about delivery conditions

e) the delivery man's authorities when there is doubt about payment, address,

no one home and in connection with specific questions regarding the


Tit le 2.1.5 Dispatch (5/11) Number 2.1.5


Category General standards Theme Medicines and

medicine counselling

medicine

f) how faulty deliveries are registered

Step 2 Element 3 The pharmacy delivers in accordance with the guidelines.

Step 2 Element 4 The pharmacy handles dispatches in accordance with the instructions.

Step 2 Element 5 The pharmacy registers faulty deliveries.

Step 3 Element 6 Once a year the pharmacy evaluates the types of dispatches which the

pharmacy provides.

Step 3 Element 7 Once a year the pharmacy evaluates whether the dispatch takes place in a safe

and correct manner.

Step 3 Element 8 Twice a year the pharmacy evaluates the registered faulty deliveries based on

an overview of the registered faulty deliveries and patterns, any.


pharmacy's dispatch.




References



Tit le 2.1.6 Counselling on medicine and

on self-care to individuals (6/11) #

Number 2.1.6



counselling

Standard The pharmacy provides counselling to individuals based on the individual

customer's needs.

Purpose To ensure that the pharmacy’s counselling:

is based on the individual customer's needs

is planned on the basis of the sector's requirements to counselling at the

counter

contributes to correct, safe and rational use of medicine

contributes to appropriate self-medication and self-care

contributes to identify, solve and prevent medicine-related problems

contributes to a customer-friendly experience

Background The standard concerns what the pharmacy is obliged to inform individuals

about, including medicine, use of medicine, storage of medicine, prises and

substitution, according to legislation.

The pharmacy's guidelines for counselling helps to ensure that counselling

takes place and that it is adjusted to the recipient's needs.

The sector's recommendations, defined in "Sector requirements for

counselling at the counter" forms the basis for the pharmacy's counselling to

the customers at the counter.

The pharmacy also has a duty to inform service users of medicine which the

pharmacy has no contact with at the counter. It could be dose, delivery,

telephone and e-commerce customers and customers who do not themselves

pick up the medicine.

The pharmacy determines service goals for the pharmacy's professional

counselling and information about medicine to customers at the counter as

well as customers who receive dispatches.

The pharmacy's counselling includes assessment of symptoms in connection

with sale of over-the-counter drugs and recommendation of self-medication,

self-care, healthcare promotion and prevention of disease as well as contact

to general practitioner and other healthcare professionals. Counselling on self-

care includes medicine and non-medical products relating to health and

disease.

When the pharmacy determines the principles for communication, the staff's

expected approach on communication with the pharmacy's customers could

be considered, e.g. in relation to language usage, behaviour and the staff's

options in connection with communicative barriers, e.g. language, difficult

customers and need of discretion. The pharmacy's way of communication

meets the customer's needs for discretion.

The professional assessment includes whether the counselling provided is

professionally correct, meets the customers' needs and is communicated in a

way which is understandable for the customer.

The accreditation standards are connected to:




Number 2.1.6



counselling

1.1.1 Business mission. Dialogue with customers takes place in accordance

with the pharmacy's business mission


safety. Publication of service goals in the business premises and publica tion of

observance of service goals and the interior design of the pharmacy and

possibility for discretion

1.4.2 Competence development. The staff's competences to counsel

customers.

1.2.7 Registration, reporting, analysis and follow-up on adverse events.

Registration of absent, inadequate or wrong counselling which has caused

damage or risk of damage on the user of the medicine is handled as adverse

events.


regarding communication with customers and discretion.

2.2.2 Written and electronic information material Use of written and electronic

information material for counselling.

Step 1 Element 1 There are guidelines for counselling on medicine and self-care to individuals

describing:

a) how the pharmacy ensures that counselling at the counter takes place

and that it is adjusted according to the recipient's needs based on the

sector's requirements

b) counselling in situations where the pharmacy does not have direct contact

with the service user at the counter

c) determination of the pharmacy’s own requirements and goals according

to the sector's requirements to counselling at the counter

d) assessment of symptoms and recommendation for contacting the general

practitioner or other healthcare professionals

e) information about notification of adverse drug reactions

f) counselling on health promotion and prevention of disease

g) information about possible cheaper and substitutable medicine, including

price differences.

h) principles for communication, including involvement of local, ethnic and

cultural conditions in the counselling

i) ensuring discretion in the counselling

j) competences for counselling

k) students’ and trainees’ competences on counselling

l) professional assessment of pharmaconomists and pharmacists w ho

provide counselling on medicine and self-care to individuals.

Step 1 Element 2 There are guidelines for the pharmacy's service goals regarding counselling

describing:

a) how the pharmacy determines service goals for counselling

b) how the pharmacy registers counselling




Number 2.1.6



counselling

Step 1 Element 3 There are guidelines for the pharmacy's registration of customers and

healthcare professionals' comments on absent, inadequate or wrong

counselling.

Step 1 Element 4 There are guidelines on how the pharmacy contributes to safe use of

medicine describing:

a) when the pharmacy must reject sale of over-the-counter-drugs for special

groups of customers where the authorities have determined limited

delivery

b) when the pharmacy is allowed to reject selling over-the-counter-drugs

c) when the pharmacy reports wrong use or misuse of over-the-counter-

drugs to the authorities

d) when and how the pharmacy counsels the customers on the possibility of

reporting adverse drug reactions

Step 2 Element 5 The pharmacy counsels on medicine and self-care to individuals in accordance

with the guidelines.

Step 2 Element 6 The pharmacy registers the pharmacy's counselling.

Step 2 Element 7 The pharmacy determines service goals for counselling.

Step 2 Element 8 The pharmacy registers customers and health professionals' comments on

absent, inadequate of wrong counselling.

Step 2 Element 9 The pharmacy contributes to safe use of medicine in accordance with the

guidelines.

Step 3 Element 10 Once a year the pharmacy performs a professional assessment of

pharmaconomists and pharmacists who counsel individuals on medicine and

self-care

Step 3 Element 11 Once a year the pharmacy evaluates the pharmacy's counselling.


pharmacy's counselling.




References





4. Lov om lægemidler. LOV nr. 1180 af 12/12/2005




Number 2.1.6



counselling

5. Vejledning om apotekets pligt til substitution og pligt til at informere om billigere kombinationer

af flere ens mindre pakninger. Lægemiddelstyrelsen. Vejledning nr. 45 af 29. maj 2006


Tit le 2.1.7 Health promotion and disease

prevention (7/11)

Number 2.1.7



counselling

Standard The pharmacy contributes to health promoting and disease preventing

activities.

Purpose To ensure that the pharmacy:

contributes to information to citizens about appropriate health promotion

and disease prevention

participates in health promoting and disease preventing activities initiated

locally and nationally

Background The standard concerns how the pharmacy participates in health promotion and

disease prevention as part of the healthcare system.

Health promoting and disease preventing activities are defined as activities

which inform and reduce the risk of future disease, prevent development of a

disease process which is pending, or reduce the sequelaes from a disease, or

activities in relation to being better in handling a disease.

Activities within health promotion and health prevention could relate to life style

factors (e.g. diet, smoking, alcohol and exercise) infectious diseases,

vaccinations, recommended supplements of vitamins etc. for special groups of

customers (e.g. pregnant women, elderly).

The activities could include counselling of customers in specific target groups,

division of material which the pharmacy provides, activities in collaboration with

the municipality, patients associations or other relevant providers. It could be

activities rooted at the pharmacy in the shape of different campaigns or

activities rooted in the local community such as health days. In relation to the

pharmacy's health promoting and disease preventing activities references are

made to the pharmacy's healthcare services and other relevant health offers in

the municipality.

The evaluation of the pharmacy's activities could be based on activities which

the pharmacy has participated in nationally and locally in the previous year and

on the customers' feedback. The evaluation could include satisfaction among

the customers and the pharmacy’s profit.


1.1.1 Business mission. The pharmacy’s role in relation to health promotion


1.4.2 Competence development. Competence to inform about health promotion


2.1.6 Counselling on medicine and on self-care to individuals. Counselling in

connection with the pharmacy's participation in activities regarding health

promotion and disease prevention.

2.2.2 Written and electronic information material. Use of written and electronic

information material on the pharmacy's participation in activities regarding

health promotion and disease prevention.

3.1.8 Healthcare delivery. Handling of measuring equipment for implementation


Tit le 2.1.7 Health promotion and disease

prevention (7/11)

Number 2.1.7



counselling

of local activities.

Step 1 Element 1 There are guidelines for the pharmacy's activities within health promotion and

disease prevention describing:

a) the pharmacy’s own activities within health promotion and disease

prevention

b) the pharmacy's participation in activities on a local and national level within

health promotion and disease prevention

c) handling of measuring equipment used for local activities within health

promotion and disease prevention, including

a) maintenance

b) hygiene

c) cleaning

d) calibration according to the vendor's advice

Step 2 Element 2 The pharmacy participates in activities within health promotion and disease

prevention in accordance with the guidelines.

Step 2 Element 3 The pharmacy handles measuring equipment in accordance with the guidelines.

Step 3 Element 4 Once a year the pharmacy evaluates the pharmacy's work within health


Step 3 Element 5 Once a year the pharmacy evaluates the completed activities within health


Step 3 Element 6 Once a year the pharmacy evaluates the handling of measuring equipment if

the activities completed have included use of measuring equipment.




References



Tit le 2.1.8 Handling of products (8/10) Number 2.1.8



counselling

Standard Each product which the pharmacy receives from a vendor for onward sale is

handled and stored in a correct manner.

Purpose To ensure the quality of the products from reception to delivery.

Background The pharmacy vouches for the quality of the products which the pharmacy

handles.

Medicine, which the pharmacy is in charge of, is stored according to the

conditions determined in the product summary.

The temperature is checked and documented regularly in all rooms storing

pharmaceuticals and products under the food legislation thereby ensuring that

the products are stored within the prescribed temperature range.

Thermometers used for measurement of temperature are calibrated regularly

in accordance with the vendor's advices.

On reception of products, it is important to be aware of whether the condition

of the products corresponds to the expected. There are special requirements

to some medicine, e.g. euphoriants or products requiring a special storage

temperature, which are handled immediately after reception.

When a product is recalled, the pharmacy ensures that it is deleted from the

saleable stock at the pharmacy and from other places of sale.

Products under the food legislation are handled as described in industrial

classification code for pharmacies. The industrial classification code is

assessed by Danish Veterinary and Food Administration and among others it

describes requirements to the pharmacy's own-check.

On reception of hazardous waste and drug residues for destruction, the

pharmacy ensures to avoid confusion with saleable products.


Standard 2.1.10 Monitoring of euphoriants. Control on reception of

euphoriants.

Step 1 Element 1 There are instructions for handling of products describing:

a) principles for acceptance testing

b) principles for placing the products

c) principles for control of expiry

d) principles for returning to vendor

e) handling recalls of pharmaceuticals

f) actions on suspicion of falsified medicine

g) how to assess in when medicine, which have been outside the pharmacy's

custody, can be placed back to the saleable stock

Step 1 Element 2 There are instructions for measurement of temperature describing:

a) registration of temperature of storage room

b) actions on deviations of temperature in storage room

c) calibration of thermometers


Tit le 2.1.8 Handling of products (8/10) Number 2.1.8



counselling

Step 1 Element 3 There are guidelines for the pharmacy's handling of food which describe:

a) self-control of food

b) handling of recall of food

Step 1 Element 4 There are guidelines describing the pharmacy's handling of drug residues and

hazardous waste received for destruction.

Step 2 Element 5 The pharmacy handles products in accordance with the instructions.

Step 2 Element 6 The pharmacy handles measurement of temperature in accordance with the

instruction.

Step 2 Element 7 The pharmacy handles food in accordance with the guidelines.

Step 2 Element 8 The pharmacy handles drug residues and hazardous waste for destruction in


Step 3 Element 9 Once a year the pharmacy evaluates handling of products.

Step 3 Element 10 Once a year the pharmacy evaluates handling of measurement of

temperature.

Step 3 Element 11 Once a year the pharmacy evaluates handling of food.

Step 3 Element 12 Once a year the pharmacy evaluates handling of drug residues and hazardous

waste received for destruction.




References



Tit le 2.1.9 Stock of medicine and non-

medical products (9/11)

Number 2.1.9



counselling

Standard The pharmacy has an appropriate degree of supplies, and the stock reflects

the local demand and meets the expectations to the pharmacy as being part

of the healthcare system and as supplier of medicine for citizens.


medicine is available when it is requested by the customer

assortment of non-medical products is fixed on the basis of the

requirements of the sector.

Background The standard concerns the pharmacy's stock of medicine and non-medical

products.

The pharmacy's most important task is to distribute medicine. As a lot of

medicine is only sold at pharmacies, the pharmacy decides whether the

composition of the stock is appropriate so the customers do not return empty-

handed and have to go without the medicine. T he pharmacy also decides how

the pharmacy handles non-delivery of products, and how the pharmacy

follows up on customers if the prescribed medicine is in back order.

The composition of the stock ensures that the pharmacy is able to provide the

customer with the cheapest medicine within the groups of substitution.

In order to assess the pharmacy's external level of delivery, the pharmacy

registers how often it is unable to meet the customers' inquiries in connection

with collection or dispatch. It may be advisable to register why the pharmacy

was unable to meet the customer's inquiry, e.g. delivery problems, that the

medicine is not in stock at the pharmacy or incorrect storage.

When the pharmacy evaluates the pattern of delivery on substitution, the

pharmacy could for example use the Danish Health and Medicines Authority's

ABC statistics where it is possible to make a comparison either in relation to

the national average or in relation to the nearby pharmacies' figures.

The pharmacy actively relates to the pharmacy's assortment of non-medical

products so the pharmacy is able to offer products free of additives, which are

suspected of being unhealthy.


1.1.1 Business mission. Agreement between the pharmacy's assortment and

business mission.




2.1.3 The pharmacies’ shifts. Opportunity for delivery from distributor on

shifts.

2.3.1 Supplier collaboration. Collaboration agreement with vendors of

medicinal products.

Step 1 Element 1 There are guidelines for handling the pharmacy’s stock of medicine


Tit le 2.1.9 Stock of medicine and non-

medical products (9/11)

Number 2.1.9



counselling

describing:

a) ordering and delivery of products

b) follow-up on back orders

c) follow-up on differences at the stock

d) how the composition of the stock makes it possible for the pharmacy to

provide the customers with the cheapest medicine.

Step 1 Element 2 There are guidelines for the pharmacy's service goals regarding external level

of delivery describing:

a) how the pharmacy determines service goals for the pharmacy's external

level of delivery for medicine

b) registration of external level of delivery

Step 1 Element 3 There are guidelines for the pharmacy's selection of non-medical product

based on the sector's requirements to non-medical products.

Step 2 Element 4 The pharmacy's handling of the pharmacy's stock of medicine is in accordance

with the guideline.

Step 2 Element 5 The pharmacy determines service goals for external level of delivery for

medicine.

Step 2 Element 6 The pharmacy registers the pharmacy's external level of delivery for medicine.

Step 2 Element 7 The pharmacy's assortment of non-medical products is in accordance with the

guidelines.

Step 3 Element 8 Twice a year the pharmacy evaluates the stock of medicine, including the

external level of delivery.

Step 3 Element 9 Twice a year the pharmacy evaluates the delivery pattern for substitution.

Step 3 Element 10 Once a year the pharmacy evaluates the assortment of non-medical products

based on the sector's requirements to non-medical products.




References



2. Vejledning om apotekets pligt til substitution og pligt til at informere om billigere kombinationer

af flere ens mindre pakninger. Lægemiddelstyrelsen. Vejledning nr. 45 af 29. maj 2006


Tit le 2.1.10 Monitoring of euphoriants

(10/11)

Number 2.1.10



counselling

Standard The pharmacy keeps score of sale and stock of euphoriants (Section 4-

medicine).

Purpose To ensure:

consistency between the actual stock and the registered stock of

euphoriants (Section 4 medicine) at any time.

minimisation of the staff's possibil ity for ineligible acquisition of euphoriants

(Section 4 medicine)

Background The standard concerns the pharmacy's monitoring of the pharmacy's turnover

and stock of Section 4 medicine. The pharmacy's stock of euphoriants (Section

4 medicine) is subject to monitoring as these types of medicine may be

misused.

At least once a month, it is necessary to take stock of the euphoriants and

check with the account.

When stock-taking euphoriants, the pharmacy takes random samples of 3-5

product numbers for which accounts are prepared. This means that all

prescription receipts - also electronic - are found and filed for documentation

together with the accounts. Thus, the electronic prescriptions are printed to be

filed together with the accounts.

As precautions against the staff's misuse of euphoriants, the pharmacy

determines a practice where it is not possible to predict when which product

numbers are controlled. It is recommended that different persons pick out

product numbers for random samples, count the physical stock and compares it

with the prescriptions.

It could be part of the pharmacy's employee handbook how the pharmacy

handles a situation where staff unauthorised gets access to euphoriants for

own use.


2.1.8 Handling of products. Control on reception of euphoriants.

Step 1 Element 1 There are guidelines for monitoring the pharmacy’s stock of euphoriants

(Section 4 medicine) describing:

a) account of increase and decrease and stock of each individual product

number

b) stocktaking

c) spot checking of prescription receipts

d) handling differences of the stock

Step 2 Element 2 The pharmacy monitors the pharmacy's stock of euphoriants (Section 4

medicine) in accordance with the guidelines.

Step 2 Element 3 The pharmacy performs stocktaking of euphoriants and the result is compared

with the accounts of increase and decrease for each product number.


Tit le 2.1.10 Monitoring of euphoriants

(10/11)

Number 2.1.10



counselling

Step 2 Element 4 The pharmacy performs spot checking of prescription receipts.

Step 3 Element 5 Once a year the pharmacy assesses its working procedures on monitoring the

pharmacy's stock of euphoriants.

Step 3 Element 6 Once a year the pharmacy evaluates the handling of possible differences in the

stock of euphoriants.




References

1. Bekendtgørelse om apotekernes regnskab med omsætning og lagerhold af euforiserende midler.

Sundhedsstyrelsen. Bekendtgørelse nr. 671 af 19. august 1993

2. Bekendtgørelse om euforiserende stoffer. Sundhedsministeriet. Bekendtgørelse nr. 557 af

31/05/2011


Tit le 2.1.11 Production of dose dispensed

medicine (11/11)

Number 2.1.11



counselling

Standard Production of dose dispensed medicine is performed in a safe and correct

manner.


production of dose dispensed medicine takes place in a safe and correct

manner so risk of errors are minimised.

the necessary documentation and quality control are performed

Background The standard concerns production of dose dispensed medicine at package

pharmacy.


1.2.6 Handling of product warranties. Handling of product warranties from

delivery pharmacies regarding content in bags with medicine,

1.2.7 Registration, reporting, analysis and follow-up of adverse events. Errors

in the production of dose dispensed medicine are handled as adverse events.

1.2.8 Handling of comments on service. Handling of comments on service in

relation to the package pharmacy.

Handling of equipment a t dose dispensing pharmacies. Cleaning, control and

qualification of equipment of packaging of dose-dispensed medicine.

Step 1 Element 1 There are guidelines for preparation of production of dose-dispensed medicine

describing:

a) working procedures and competences in relation to production of dose-

dispensed medicine

b) reception and handling of dosing charts from delivery pharmacy

c) change and maintenance of assortment

d) approval of dose dispensing of other products than medicine

e) planning of production

f) deblistering of tablets, including control of line clearance

g) hygiene in relation to activities in the production premises

Step 1 Element 2 There are guidelines for production of dose dispensed medicine describing

working procedures, competences and documentation for the following:

a) Production of dose dispensed medicine

b) Control of dose dispensed medicine, including identification and counting

of tablets and adjustments of errors when dose dispensing

c) Legalisation of production

d) Cleaning of premises

Step 1 Element 3 There are guidelines for the package pharmacy's goals for errors occurred

when producing dose dispensed medicine describing:

a) criteria for determination of goals for the highest number of errors

accepted when producing dose dispensed medicine

b) how the pharmacy registers errors occurred when producing dose

dispensed medicine.


Tit le 2.1.11 Production of dose dispensed

medicine (11/11)

Number 2.1.11



counselling

Step 2 Element 4 The dose dispensing pharmacy prepares for production of dose dispensed

medicine in accordance with the guidelines.

Step 2 Element 5 The pharmacy produces dose dispensed medicine in accordance with the

guidelines.

Step 2 Element 6 The pharmacy determines goals for the highest number of errors accepted

when producing dose dispensed medicine.

Step 2 Element 7 The pharmacy registers errors when producing dose dispensed medicine.

Step 3 Element 8 Twice a year the pharmacy evaluates the production of dose dispensed

medicine.

Step 3 Element 9 Twice a year the pharmacy evaluates the registered errors based on an

overview of the registered errors and patterns, if any.

Step 3 Element 10 Every third year the package pharmacy evaluates the delivery pharmacies'

satisfaction with the package pharmacy.




References

1. Bekendtgørelse om fremstilling og indførelse af lægemidler og mellemprodukter. Bekendtgørelse

nr. 1242 af 12. december 2005 (GMP)



Information and communication, standard 2.2.2 Accreditation standards for community pharmacies - 2nd version - June 2012Page 81 of 122

Information and communication

Tit le 2.2.2 Written and electronic

information material (1/1)

Number 2.2.2


Category General standards Theme Information and

communication

Standard The pharmacy provides written and electronic information to the customers.

Purpose To ensure that the information material:

is available

is assessed and updated

is used in the counselling

Background The standard concerns the information material which the pharmacy provides

and uses in its counselling to the customers, likewise the pharmacy decides

how the material is used at the pharmacy, e.g. as part of the pharmacy's

counselling.

Written and electronic information material can include:

pamphlets

written material for sale

documents and information available on the pharmacy's website

websites where the pharmacy recommends the customers to search

information

The written and electronic information material may be prepared by authorities,

trade associations, patients associations, the pharmacy itself or other relevant

healthcare organisations.

When deciding which material to make available for customers, the pharmacy

can consider the following:

the sender

whether the content is in accordance with current recommendations

whether the content is serious, i.e. whether it is advertisement or

information

whether the content is in accordance with the pharmacy's business mission

need for material which meets e.g. persons of different ethnic and cultural

background as well as the demographic composition in the local area

In order to ensure updated material, the pharmacy also decides how to handle

ordering, recall and maintenance and how the pharmacy makes decisions

regarding new information material.


1.1.1 Business mission. Choice of material made available for customers is in

accordance with the pharmacy's business mission.

2.1.6 Counselling on medicine and on self-care to individuals. Use of

information material

2.1.7 Health promotion and disease prevention. Use of information material

Step 1 Element 1 There are guidelines about written and electronic information material

Information and communication, standard 2.2.2 Accreditation standards for community pharmacies - 2nd version - June 2012Page 82 of 122

Tit le 2.2.2 Written and electronic

information material (1/1)

Number 2.2.2


Category General standards Theme Information and

communication

describing:

a) choice and assessment of information material

b) ordering of the material

c) maintenance of information material

d) recall of information material

e) the information material's availability for customers and staff

f) use of information material for counselling

g) use of information material in relation to health promoting and disease

preventing activities

Step 2 Element 2 The pharmacy handles and uses written and electronic information material in


Step 3 Element 3 Once a year the pharmacy evaluates the selected written and electronic

information material.

Step 3 Element 4 Once a year the pharmacy evaluates the use of written and electronic

information material.




References

Coordination, continuity and transfers, standard 2.3.1 Accreditation standards for community pharmacies - 2nd version - June 2012Page 83 of 122

Coordination, continuity and transitions

Tit le 2.3.1 Supplier collaboration (1/3) Number 2.3.1


Category General standards Theme Coordination,

continuity and

transitions

Standard The pharmacy owner enters into collaboration agreements with vendors of

medicine and with vendors of important services.

Purpose To ensure that regular vendors of medicine and of important services meet the

pharmacy's quality requirements.

Background The standard concerns the pharmacy's entering into collaboration agreements

with regular vendors of medicine and important services.

Regular vendors are e.g. vendors of medicine, including package pharmacy and

magistral pharmacies, vendors of the pharmacy's IT equipment and programs

and vendors of the pharmacy's robot.

Before entering into a supplier agreement, the pharmacy has established its

quality requirements to a given vendor.

The quality requirements could include:

ability to supply

delivery terms

management and documentation of wrong deliveries and complaints

service

support

that the vendor of medicine holds a section 39 authorisation as provided by

section 39 of the Danish Medicines Act.

The determined quality requirements subsequently serve as the basis for a

discussion with the vendor about entering into a collaboration agreement.

The pharmacy assesses whether the individual vendors meet the quality

requirements stipulated in the collaboration agreement and whether the quality

requirements are satisfactory.

The pharmacy ensures that the pharmacy's vendors hold a section 39

authorisation in order to store and sell medicine. Sale and storage of medicine

may only take place with the permission of the Danish Health and Medicines

Authority, cf. the Danish Medicines Act.

Step 1 Element 1 The pharmacy decides which regular vendors it is relevant to enter into

collaboration agreements with.

Step 1 Element 2 The pharmacy defines criteria for determination of quality requirements to

regular vendors.

Step 2 Element 3 The pharmacy enters into collaboration agreements with regular vendors based

on determined quality requirements for the individual vendor.

Step 2 Element 4 The pharmacy ensures that vendors of medicine have a S 39 permission to

handle and store medicine.


Tit le 2.3.1 Supplier collaboration (1/3) Number 2.3.1



continuity and

transitions

Step 3 Element 5 Once a year the pharmacy evaluates whether the regular vendors meet the

collaboration agreements.




References



Tit le 2.3.2 Agreement on division of

responsibilities and operation of OTC

Outlets (2/3)

Number 2.3.2



continuity and

transitions

Standard The pharmacy enters into collaboration agreements with business locations

about establishment and operation of OTC outlets.

Purpose To ensure correct and safe supply of medicine to customers via the OTC outlet

Background The standard concerns the collaboration between the pharmacy and the store

manager running the OTC outlet. The pharmacy supplies customers with

medicine and other products via OTC outlet.

It is the responsibility of the pharmacy that medicine at the OTC outlet is

handled in a correct and safe manner. The pharmacy enters into a collaboration

agreement with the store manager about division of responsibility for the

operation of the OTC outlet.

The pharmacy supports the work at the OTC outlet by describing the correct

working procedures for storage and dispensing bags of medicine and over-the-

counter drugs etc. in an instruction. This is further described in the pharmacy's

collaboration agreement.

The pharmacy supervises the OTC outlet and the result is informed to the store

manager in an inspection report. The inspection report forms the basis for the

pharmacy's evaluation of the collaboration with the store manager.


1.2.6 Handling of product warranties. Passing on product warranties received at

the OTC outlet.

1.2.8 Handling of service. Passing on comments on service received at the OTC

outlet.

2.1.5 Delivery from pharmacy to OTC outlet.

Step 1 Element 1 There is a collaboration agreement between the pharmacy and the store

manager about the division of responsibilities and operation of OTC outlets

which includes:

a) How execute distribution of over-the-counter medicine

b) appointment of person responsible for the operation of the OTC outlet

among the staff at the OTC outlet

c) familiarity with the regulation among the OTC outlet’s staff

d) duty of confidentiality

e) storage and dispensing of medicine packed by the pharmacy

f) passing on complaints to the pharmacy

g) passing on comments on service to the pharmacy

h) instruction to store manager about working procedures at the OTC outlet

i) returning/destruction of medicine

Step 1 Element 2 There is a check list for supervision of OTC outlet in accordance with current

legislation.



responsibilities and operation of OTC

Outlets (2/3)

Number 2.3.2



continuity and

transitions

Step 2 Element 3 Collaboration between the pharmacy and the OTC outlet is in accordance with

the guidelines.

Step 2 Element 4 A least twice a year the pharmacy supervises the OTC outlet in accordance with

the check list.

Step 3 Element 5 Twice a year the pharmacy evaluates the collaboration with the pharmacy's

OTC outlet based on the inspection report and the daily collaboration.




References

1. Bekendtgørelse om apoteker og apotekspersonale. Kapitel 5 § 15 – 19. Lægemiddelstyrelsen.

Bekendtgørelse nr. 1215 af 7. december 2005

2. Bekendtgørelse om forhandling af håndkøbslægemidler fra håndkøbsudsalg.

Lægemiddelstyrelsen. Bekendtgørelse nr. 109 af 09/02/2011

3. Vejledning om forhandling af håndkøbslægemidler fra håndkøbsudsalg. Lægemiddelstyrelsen.

Vejledning af 7. marts 2011



responsibility and operation of

medicine delivery facility (3/3)

Number 2.3.3



continuity and

transitions

Standard The pharmacy enters into collaboration agreements with business locations

about establishment and operation of delivery facilities.

Purpose To ensure correct and safe supply of medicine to customers via the delivery

facility.

Background The standard concerns the collaboration between the pharmacy and the store

manager in the shop which runs the delivery facility.

It is the responsibility of the pharmacy that dispatches packed by the pharmacy

are handled in a correct and safe manner. The pharmacy enters into a

collaboration agreement with the store manager about division of responsibility

in connection with the operation of the delivery facility.

Correct working procedures on storage and delivery of dispatches are further

described in the collaboration agreement.

The pharmacy supervises the delivery facility and the result is informed to the

store manager in an inspection report. The inspection report forms the basis for

the pharmacy's evaluation of the collaboration with the store manager.


1.2.6 Handling of product warranties. Passing on product warranties received at

the delivery facility

1.2.8 Handling comments on services. Passing on comments on services

received at the delivery facility.

2.1.5 Dispatch from pharmacy to delivery facility.

Step 1 Element 1 There is a collaboration agreement between the pharmacy and the store

manager about the division of responsibilities and operation of the delivery

facility which includes:

a) storage and dispensing of dispatches packed at the pharmacy

b) duty of confidentiality

c) passing on product warranties to the pharmacy

d) passing on comments on services to the pharmacy

e) returning of dispatches to the pharmacy

Step 1 Element 2 There is a check list for supervision of the delivery facility in accordance with

current legislation

Step 2 Element 3 Collaboration between the pharmacy and the delivery facility is in accordance

with the collaboration agreement.

Step 2 Element 4 A least twice a year the pharmacy supervises the delivery facility in accordance

with the check list.

Step 3 Element 5 Once a year the pharmacy evaluates the collaboration with the pharmacy's

delivery facility based on the inspection reports and the daily collaboration.



responsibility and operation of

medicine delivery facility (3/3)

Number 2.3.3



continuity and

transitions




References

1. Bekendtgørelse om apoteker og apotekspersonale. Kap. 6 § 20-23 Lægemiddelstyrelsen.

Bekendtgørelse nr. 1215 af 7. december 2005

Healthcare services, standard 3.1.5 Accreditation standards for community pharmacies - 2nd version - June 2012Page 89 of 122

Healthcare services

Tit le 3.1.5 Check on inhalation (1/2) Number 3.1.5


Category Specific standards Theme Healthcare services

Standard The pharmacy provides the healthcare service Check on inhalation according to

fixed framework.

Purpose To ensure:

the professional quality of the delivery of the pharmacy's healthcare services

Check on inhalation

that Check on inhalation is performed by certified staff

Background The standard concerns provision of the pharmacy's healthcare service Check on

inhalation to customers at the pharmacy or by means of mobile staff.

The pharmacy complies with the sector's manual Check on inhalation for first-

time users of medicine for inhalation or regular customers who e.g. have

problems with their inhalation medicine. The service is also an offer to parents

to children who use inhalation medicine.

The pharmacy ensures the necessary competences to perform Check on

inhalation by certification according to the sector's requirements.

On evaluation of delivery of Check on inhalation, the pharmacy uses

documentation collected on implementation of the service. The pharmacy

evaluates the identification of medicine-related problems and whether there is a

difference on the counselling for first-time users and customers used to the

medicine. The pharmacy decides whether the necessary facilities are available,

internal resources and an adequate number of certified staff so the pharmacy

can provide the service. In addition, the pharmacy evaluates the collaboration

with relevant collaborators.

The pharmacy evaluates number of services provided, e.g. in relation to

benchmarking for sectors and which customers are offered the service.

Furthermore, i t is identified whether the customer base can be expanded in

connection with mobile Check on inhalation.


1.1.1 Business mission. The pharmacy's healthcare services correspond with

the business mission.

1.4.2 Competence development Training and development needs for staff

providing healthcare services.

Step 1 Element 1 Based on the instruction Check on inhalation, there are guidelines for the

pharmacy's healthcare delivery Check on inhalation which includes:

a) description of the service

b) description of the necessary framework, materials and resources

c) overview of competence in relation to different devices of inhalation

d) ensuring hygiene when demonstrating inhalation devices

e) description of collaboration and dialogue with relevant collaborators


Tit le 3.1.5 Check on inhalation (1/2) Number 3.1.5



Step 2 Element 2 The pharmacy provides Check on inhalation in accordance with the guidelines.

Step 2 Element 3 Pharmacists and pharmaconomists who implement Check on inhalation are

certified.

Step 3 Element 4 Once a year the pharmacy evaluates the delivery of the service Check on

inhalation

Step 3 Element 5 Once a year the pharmacy evaluates number of delivered services Check on

inhalation.




References


Tit le 3.1.8 Healthcare delivery (2/2) Number 3.1.8



Standard The pharmacy delivers healthcare services which meet the demand from

customers according to fixed framework.

Purpose To ensure the professional quality in the healthcare services which the

pharmacy delivers experienced by the customers.

Background The standard concerns how the pharmacy's handles the quality of the

healthcare services which the pharmacy has decided to deliver to customers

and citizens in the municipal, regional and state offers. It can for example

consist of a few healthcare services which are delivered to the customers at

the pharmacy or through an operating and collaboration agreement with e.g.

a municipality or as part of projects.

Healthcare services could be medicine review, quality control of handling of

medicine, instruction of carer and counselling on smoking cessation.

The pharmacy complies with the sector's manuals for healthcare services and

requirements to certification, training or the like.

The pharmacy adjusts the healthcare services according to collaborators' and

customers' needs based on the sector's manuals, other sector requirements

and authorisation in the legislation.

In connection with delivery to collaborators, there is typically a collaboration

agreement or project description with comments on quality in delivery.

References can then be made to the collaboration agreement or project

description.

The pharmacy ensures the necessary competences to provide healthcare

services. If a certification meets the sector's requirements, the pharmacy

ensures the presence of the necessary competences via the certification.


1.1.1 Business mission. The pharmacy's healthcare services correspond with

the business mission.

1.1.2 Assignment of managerial responsibility and functions. Appropriate use

of the pharmacy's resources

1.4.2 Competence development Training and development needs for staff

providing healthcare services.

Step 1 Element 1 There are guidelines based on the sector's instructions for providing

healthcare services describing:

a) the service

b) division of work, cut face for and dialogue with collaborators/buyers of

healthcare services

c) the necessary facilities and resources

d) how the pharmacy documents and maintains the necessary professional

and communicative competences

e) consequences of deviations from the instruction, if any

Step 1 Element 2 There are guidelines for handling measuring equipment and hygiene

describing:


Tit le 3.1.8 Healthcare delivery (2/2) Number 3.1.8



a) correct handling of necessary measuring equipment, including

a) maintenance

b) hygiene

c) cleaning

d) calibration according to the vendor's advice

b) hygiene on delivery of healthcare services

Step 1 Element 3 There are guidelines for the quality of healthcare services describing:

a) how the pharmacy uses certifications, if any, for services which are

included by them

b) considerations on how the professional assessment relating to healthcare

services are made in cases where there are no certification

c) considerations on how the pharmacy evaluates the quality perceived by

customers on delivery of healthcare services

d) quality requirements to services where there are no instructions for

delivery of the service

Step 2 Element 4 The pharmacy delivers healthcare services in accordance with the guidelines.

Step 2 Element 5 The pharmacy handles measuring equipment and hygiene in accordance with

the guidelines.

Step 2 Element 6 Pharmaconomists and pharmacists, who implement healthcare services, have

the necessary competences. If there is a certification, the pharmacy ensures

the presence of the necessary competences via the certification.

Step 3 Element 7 Regarding services not included by certification, the pharmacy performs a

professional assessment of pharmaconomists and pharmacists delivering

healthcare services once a year.

Step 3 Element 8 Once a year the pharmacy evaluates whether the necessary resources have

been present.

Step 3 Element 9 Once a year the pharmacy evaluates whether the necessary competences

have been present.

Step 3 Element 10 Once a year the pharmacy evaluates the quality perceived by customers on

delivery of healthcare services.




References

Appendix 1 – What is new in the 2nd version of the accreditation standards Accreditation standards for community pharmacies - 2nd version - June 2012Page 93 of 122

Appendix 1 – What is new in the 2nd version of the accreditation

standards

Changes in the set of standards in general

Introduction

The introduction is a prerequisite to understand and use the accreditation standards. It is not possible to use

the accreditation standards without having read the introduction thoroughly. The introduction has been

improved compared to the 1st version of the standards.

Changes in the template for the accreditation standards

New space "Background"

"Background" includes information which serves as an elaboration of the comprehensibility of the standard. It

concerns the following types of information:

explanation of the reason for the standard

used terms

explanations illustrating how the standard is interpreted in different contexts

guidelines for understanding the elements of the standard

specification of requirements to content in the guiding documents

comment on relevant legislation

coherence to other accreditation standards

"Background" provides a guideline in how to understand the standard seen from the pharmacy's point of

view. Considerations regarding implementation of the standard are therefore based on this space.

"Background" can serve as a check list for the implementation.

It is the intention that the space in the electronic version of the standard should be a "working space" if there

are ambiguities requiring further guidance when using the standard at the pharmacy, at survey and on

awarding of accreditation status.

Changes in the structure of the elements of the standard

Elements

In terms of structure, the elements of the standard have been changed. The purpose was to transform the

elements into a more precise tool for the external evaluation. In consequence of the changes of the elements

of the standard, the number of elements has been increased considerably. This per se is not an expression of

increased requirements in DDKM, but it is a more precise wording of what is being evaluated. At the same


time the wording of the elements of the standard has become more short and concise than in the 1st

version.

Each element of the standard aims to be:

One-dimensional, i.e. what it describes must be present to varying degrees, but it cannot be divided into

parts which can be more or less met independent of each other.

Coherent, so conditions logically interconnected are not divided into different elements of the standard.

Significant, i.e. describes something which cannot normally be expendable or be replaced by something

else.

Unique, i.e. actual findings during survey can only be assigned to one element of the standard.

Independent of other elements of the standard, i.e. it is not possible to conclude that a given element

is met because another element is met. On the contrary, it is possible that a given element has not been met

if another element is not met. Rating achievement of element A of the standard may be a necessary

prerequisite, but it may not be an adequate prerequisite for element B to be met. It must be admitted that

the specific elements hardly can meet these criteria.

Step 1

No major changes have taken place at this step.

Step 2

Step 2 has become more action-oriented. The 1st version of the standards often wrote: staff is familiar with

and uses; now the pharmacy must demonstrate that it works according to the guiding documents.

Step 3

The quality monitoring is most often evaluation. Most often the pharmacy itself decides the method for

evaluation. Appendix 4 shows and overview of elements of the standard at step 3.

Step 4

Step 4 in the 1st version of the standards required prioritisation of implementation of specific actions for

quality improvements in the shape of action plans. In the 2nd version the requirement has been tightened:

Based on the result of the quality monitoring, the management takes action on specific initiatives for quality

improvements and follows up on whether the initiatives have the desired effect.

In order to meet step 4 in a given standard, it is required that specific action to take have been implemented

in relation to the content of the standard. This does not mean that it is necessary to make initiatives i n

relation to all accreditation standards. The pharmacy can be awarded accreditation even though the elements

of the standard at step 4 have not been met in some standards (for further information, see section about

rating achievement principles).


Reduction of the number of accreditation standards from 1st to 2nd version of the standards

The following accreditation standards from the 1st version have been removed as independent accreditation

standards:

1.6.1 Handling of measuring equipment

2.2.1 Communicating with customers

3.1.1 Medicine review at nursing homes and in the home care

3.1.2 Quality control of medicine handling at nursing homes

3.1.3 Instruction of nursing staff at nursing homes and in the home care

3.1.4 Medicine review – get hold of the medicine

3.1.6 Counselling on smoking cessation

3.1.7 Establishment, delivery and assessment of other healthcare services

The following accreditation standards from the 1st version are now part of another standard:

1.2.2 The quality organisation is now part of 1.2.1 Quality management

1.2.4 Implementation of significant changes is now part of 1.2.3 Risk management

2.2.1 Communication with customers is now part of 1.1.1 Business mission

The previous standards on healthcare services, 3.1.1, 3.1.2, 3.1.3, 3.1.4, 3.1.6 and 3.1.7 are now part of an

overall standard about healthcare services 3.1.8 Healthcare delivery.

The following accreditation standards from the 1st version have been changed from one to two accreditation

standards:

1.2.6 Handling product and service complaints

This is now:

1.2.6 Handling of product warranties

1.2.8 Handling of comments on service

Appendix 2 shows a detailed overview of the changes from the 1st version to the 2nd version of the

accreditation standards for each individual standard.

Framework standards

1.1.1 Business mission

1.1.2 Quality management.

1.3.1 Document management

Standard 1.1.1 Business mission. This standard has become a framework standard as it is governing for the

pharmacy's work with the other accreditation standards and it forms the basis for the operation of the

pharmacy and is reflected in the pharmacy's other guiding documents.


Standard 1.1.2 Quality management. The previous framework standards 1.2.1 Quality control and 1.2.2

Quality organisation have merged from the 1st version to the 2nd version. This is due to the fact that the

establishment of a quality organisation is naturally connected to the pharmacy's quality management.

Standard 1.3.1 Document management. In terms of content, this standard is unchanged in relation to the 1st

version of the standards.

Terminology

Whereas the 1st version mentioned managers and staff, staff is now used for all employees at the pharmacy.

Rating achievement principles

In connection with the revision of the standards, an evaluation and revision of the rating achievement

principles have been performed. The revised rating achievement principles apply to all on-site surveys

performed on the basis of this set of standards. The rating achievement principles are described in the

introduction and on www.ikas.dk.

Appendix 2 – Detailed overview of changes from the 1st version to the 2nd version of DDKM for community pharmacies Accreditation standards for community pharmacies - 2nd version - June 2012Page 97 of 122

Appendix 2 – Detailed overview of changes from the 1st version to the 2nd version of DDKM for

community pharmacies

1st version of DDKM for community pharmacies 2nd version of DDKM for community pharmacies No of

standard Name of standard Changes

New no of

standard New name of standard

1.1.1 Business mission

Purpose of standard has been rephrased.

New addition: The management ensures that the

business mission forms a basis for the daily work

(element 2 of the standard).

Step 3: Two new elements of the standard which partly

evaluate the business mission (element 4) partly

whether there is coherence between the business

mission, the pharmacy's practices and the determined

quality goals, including the staff's perception of the

coherence (element 5).

1.1.2 Assignment of managerial responsibility and

functions

New addition: job description for the person responsible

for quality (element 1, bullet c)

1.1.3 Planning and operations

Wording and purpose of standard have been rephrased.

Step 1 has been rephrased. The guideline describes the

management tools which the pharmacy owner uses.

Step 2: Rephrased.

Step 3: Rephrased.

1.1.4 Waiting time


New addition: Guidelines for determination and

registration of service goals for waiting time.

Previous elements 4 and 5 of the standard have been

deleted.




New no of


1.1.5 The pharmacy's premises and other facilities


New addition: Guidelines for the interior design of the

pharmacy, facilities and accessibil ity (element 1).

New addition: Guidelines for the pharmacy's publication

of service goals and compliance of service goals

(element 3).

Step 3: Two new elements of the standard: The

pharmacy publishes service goals (element 7) and

compliance of service goals (element 8) in the business

premises and any other relevant places.

New addition: staff satisfaction survey (element 11).

Interior design of the

pharmacy, facilities,

cleaning, accessibil ity and

safety.

1.2.1 Quality management


New addition: Guidelines for the quality organisation's

work (element 2).

New addition: Plan for quality monitoring (element 3).

1.2.2 Quality organisation Does no longer exist as an independent standard.

Incorporated into 1.2.1 Quality management.

1.2.3 Risk management

Wording of standard has been rephrased.

New addition: Check list for implementation of

significant changes (element 2)

1.2.4 Implementation of significant changes Does no longer exist as an independent standard.

Incorporated into 1.2.3 Risk management.

1.2.5

Registration, analysis and follow-up on

drug-related adverse events (deleted as of 1

February 2011)

Replaced by new standard on commencement of

Executive order on reporting of adverse events in the

healthcare system etc.

1.2.6 Handling product and service complaints

Now this standard solely concerns product warranties.

New additions: How the pharmacy handles product

warranties in relation to customers and collaborators

Handling of product

warranties




New no of


(element 1, bullet c).

1.2.7 Registration, reporting, analysis and follow-

up on adverse events

Previous element 1 is now divided into three elements:

Guidelines for handling adverse events emerged at

pharmacy (element 1), guidelines for reporting adverse

events to Danish Patient Safety Database (DPS D)

(element 2) and guidelines for the pharmacy's learning

on the basis of adverse events (element 3).

New addition: The pharmacy evaluates handling and

learning when registering adverse events (element 8)

and when reporting adverse events to Danish Patient

Safety Database (DPSD) (element 11).

This standard concerns reception, registration,

categorisation and handling of comments on service.

1.2.8

Handling of comments on

service-

1.3.1 Document management

Element 1 of the standard is simplified.

New addition: The pharmacy evaluates the work with

document management (element 4).

Deleted: Review of the document overview (previous

element 4).

1.3.2 Data safety and confidentiality

Wording of standard is rephrased.

Step 1: Guidelines for data confidentiality (element 1)

and data safety and data discipline (element 2).

New addition: The pharmacy evaluates compliance with

rules regarding working procedures for data

confidentiality (element 5) and data safety and data

discipline (element 6).

1.4.1 Employment and induction of new staff Step 1 is divided into two elements of the standard:

Guidelines for employment (element 1) and induction




New no of


programme (element 2).

New addition: The pharmacy evaluates the recruitment

procedure (element 5).

1.4.2 Competence development and evaluation

New addition: Guidelines on how the pharmacy owner

and staff are professionally updated in relation to

duties and functions (element 1, bullet a).

New additions: Guidelines on how the pharmacy owner

and staff are updated in relation to current rules and

regulations (element 1, bullet g).

New addition: Decisions on how to document

competence development (element 1, bullet f).

Step 3: Two new elements evaluating the staff's

satisfaction (element 8) and whether the staff needs

further knowledge about current rules and regulations

(element 7).

1.4.3 The training pharmacy’s duties and

responsibilities


Step 1: Now guidelines for the training pharmacy's

duties and responsibilities also include that the

pharmacy must ensure presence of resources and

competences in relation to being a training pharmacy

(bullet a), and that the pharmacy plans the trainees'

work taking their education into consideration (bullet b)

and appropriate planning of the students' stay at the

pharmacy (bullet d).

Step 3: The pharmacy evaluates the educational

course for pharmaconomist trainees (element 4) and

the students' stay at the pharmacy (element 5) and

how the pharmacy handles being a training pharmacy




New no of


(element 6).

1.5.1 Fire, robbery and assault


New addition: Handling of emergency situations

(element 1 bullets a and b), follow-up in relation to

customers and staff (element 1, bullet c) and how the

plans are implemented (element 1, bullet d).

Precautions in emergency

situations

1.6.1 Handling of measuring equipment

Does no longer exist as an independent standard.

Incorporated into accreditation standards where it is

relevant to describe use and calibration of measuring

equipment (2.1.7 Health promotion and disease

prevention, 2.1.8 Handling of products and 3.1.8

Healthcare delivery).

1.6.2 Handling of equipment at dose dispensing

pharmacy


The standard now focuses on the fact that staff using

equipment at dose dispensing pharmacies has the

necessary education.

New addition: The pharmacy evaluates handling of

equipment (element 5) and training of staff (element

6).

2.1.1 Handling of prescriptions

Element 1. New bullet: Safe identification of medication

order by choice from the prescription server.

New addition: Instructions for branch pharmacies

manned by pharmaconomists (element 2) and guideline

for service goals (element 3), including how the

pharmacy determines goals for the highest acceptable

number of wrong deliveries (bullet a).

New addition: The pharmacy evaluates whether service

of prescription takes place in a safe and correct manner




New no of


(element 8).

New addition: The pharmacy evaluates the registered

prescription interventions (element 9) and wrong

deliveries (element 10) based on an overview of

registrations and patterns, if any.

2.1.2 Service of pharmacy restricted medicine on

system breakdown


New addition: The standard now includes all medicine

and all systems significant for service of medicine.

New addition: Guidelines for safe and correct service

and dispensing of medicine on system breakdown

(element 1), including identification of system

breakdowns which are significant for dispensing

medicine in a safe and correct manner (dot a).

Service of medicine in the

event of system breakdown

2.1.3 The pharmacies' shifts


New addition: Possibility for procurement of medicine

not in stock (element 1, bullet e).

New addition: Possibility of paging acute extra staffing

(element 1, bullet f).

New addition: Instructions for shifts attended to by

pharmaconomists describe whom to contact in case of

doubts (element 2, bullet b).

2.1.4 Service of dose dispensed medicine


New addition: Step 1 is divided into four elements

which partly concern an instruction for dispensing of

dose dispensed medicine (element 1), partly concerns

guidelines for the pharmacy's service goals regarding

dose-dispensed medicine (element 2), including criteria

for determination of service goals for the highest

Handling of dose dispensed

medicine




New no of


acceptable number of errors occurred on preparation

and updating of dosing charts (bullet a), the

pharmacy's level of service in relation to customers who

get dose-dispensed medicine (element 3) and the

pharmacy's collaboration with external parties (element

4).

New addition: The pharmacy publishes compliance of

service goals.

New addition: The pharmacy evaluates the pharmacy's

dispensing of dose dispensed medicine (element 11),

the pharmacy's level of service (element 13) and the

collaboration with external parties (element 14).

2.1.5 Dispatch

Purpose has been rephrased.

Change: Dispatch is executed in consideration of not

impairing the quality of the medicine during delivery

New addition: Guidelines for the pharmacy's dispatch

(element 1).

2.1.6 Counselling on medicine and on self-care to

individuals


New addition: Guidelines for service goals for

counselling (element 2), and how the pharmacy

determines service goals for counselling (dot a) for

registration of customers and healthcare professionals'

comments on absent, inadequate or wrong counselling

(element 3) and how the pharmacy contributes to safe

use of medicine (element 4).

New addition: Registration of customers' and health

professionals' comments on counselling (element 8)

2.1.7 Health promotion and disease prevention Purpose of standard has been rephrased.




New no of


New addition: Evaluation of the pharmacy’s activities

within health promotion and disease prevention

(element 4).

New addition: Evaluation of the pharmacy's handling of

measuring equipment (element 6).

2.1.8 Handling of products

New addition: Instruction for measurement of

temperature, including calibration of thermometers

(element 2), handling of food (element 3), handling of

drug residues and hazardous waste for destruction

(element 4).

New addition: The pharmacy evaluates handling of

products (element 9) handling of measurement of

temperature (element 10), handling of food (element

11), handling of drug residues and hazardous waste for

destruction (element 12).

2.1.9 Stock of medicine and non-medical products

New addition: The standard now concerns medicine

and non-medical products.

New addition: Guideline for service goals for external

level of delivery (element 2), including how the

pharmacy determines service goals for the pharmacy's

external level of delivery for medicine (bullet a) and

guideline for the pharmacy's selection of non-medical

products (element 3).

New addition: The pharmacy evaluates the stock of

medicine (element 8), pattern of dispensing for

substitution (element 9) and the assortment of non-

medical products (element 10).

2.1.10 Monitoring of euphoriants New addition: The pharmacy evaluates monitoring of




New no of


stock of euphoriants (element 4) and handling of

possible differences (element 5).

2.1.11 Production of dose dispensed medicine

The wording and purpose of the standard have been

rephrased.

New addition: Guidelines for preparing production

(element 1), the production itself (element 2) and goals

for errors (element 3).

New addition: The pharmacy evaluates the production

of dose dispensed medicine (element 8), the registered

errors (element 9) and the delivery pharmacies'

satisfaction (element 10).

2.2.1 Communication with customers Does no longer exist as an independent standard.

Incorporated into 1.1.1 Business mission

2.2.2 Written and electronic information material


rephrased.

Guidelines for written and electronic information

material have been simplified (element 1).

New addition: The pharmacy evaluates the selected

information material (element 3) and its use (element

4).

2.3.1 Supplier collaboration


rephrased.

New addition: The pharmacy decides the regular

vendors which it is relevant to enter into collaboration

agreements with (element 1), as well as criteria for

quality requirements for vendors (element 2).

2.3.2 Agreement on division of responsibilities

and operation of OTC outlet

The purpose of the standard has been rephrased.

New addition: Check list for supervising OTC outlet is




New no of


an independent element of the standard (element 2).

New addition: The pharmacy evaluates the

collaboration with the OTC outlet (element 5)

2.3.3 Agreement on division of responsibility and

operation of delivery facility


New addition: Check list for supervising delivery facility

is an independent element of the standard (element 2).

New addition: The pharmacy evaluates the

collaboration with the delivery facility (element 5).

3.1.1 Medicine review at nursing homes and in

the home care

Is no longer an independent element but is included in

standard 3.1.8 Healthcare delivery

3.2.1 Quality control of medicine handling at

nursing homes



3.1.3 Instruction of nursing staff at nursing

homes and in the home care



3.1.4 Medicine review – get hold of the medicine Is no longer an independent element but is included in


3.1.5 Check on inhalation


New addition: The standard refers to the sector's

certification.

New addition: The pharmacy evaluates delivery of

Check on inhalation (element 4) and the number of

services provided (element 5).

3.1.6 Counselling on smoking cessation Is no longer an independent element but is included in


3.1.7 Establishment, delivery and evaluation of

other healthcare services



3.1.8 Includes all healthcare services which the pharmacy 3.1.8 3.1.8 Healthcare delivery




New no of


provides, except from Check on inhalation which is

described in standard 3.1.5.

Appendix 3 – Overview of elements of the standard at step 3 Accreditation standards for community pharmacies - 2nd version - June 2012Page 108 of 122

Appendix 3 – Overview of elements of the standard at step 3

When Standard No of standard (no of element

of the

standard)

Quality monitoring

Current Assignment of managerial

responsibility and functions

1.1.2 (3) The management evaluates whether the documents, which

describe the division of managerial responsibility and

functions, are in accordance with the actual conditions at the

pharmacy.

Planning and operation 1.1.3 (3) The pharmacy owner determines whether there is coherence

between resources and duties

Employment and induction of new staff 1.4.1 (6) The pharmacy evaluates the course of employment and

introduction in collaboration with the newly appointed person

at the interview after three months' employment

Competence development 1.4.2 (7) The pharmacy owner evaluates whether the staff needs

further knowledge about current rules and legislation

The training pharmacy’s duties and

responsibilities

1.4.3 (5) The pharmacy evaluates the course of the students' stay at

the pharmacy in collaboration with the students.

Precautions in emergency situations 1.5.1 (3) The pharmacy evaluates the applicability of the plans when

an emergency situation or an imminent or dangerous

situation has occurred

3 x yearly Waiting time 1.1.4 (4) The pharmacy evaluates the waiting time, and whether there

are patterns and tendencies in the registered waiting time

2 x yearly

Handling of product warranties 1.2.6 (3) 1.2.6 The pharmacy evaluates the handling of product

warranties

Registration, reporting, analysis and

follow-up on adverse events

1.2.7 (8) The pharmacy evaluates handling and learning of adverse

events



of the

standard)

Quality monitoring

1.2.7 (9) The pharmacy evaluates the registered adverse events based

on an overview of the registered events and patterns, if any

1.2.7 (10) The pharmacy evaluates its follow-up in relation to the parties

involved in an adverse event

1.2.7 (11) The pharmacy evaluates its working procedures and efforts

when reporting adverse events to Danish Patient Safety

Database (DPSD)

Handling of comments on service 1.2.8 (3) The pharmacy evaluates whether there are patterns in the

incoming comments on service.

Handling of prescriptions 2.1.1 (8) The pharmacy evaluates whether service of prescription takes

place in a safe and correct manner

2.1.1 (9) The pharmacy evaluates the registered prescription

interventions based on an overview of the registered

prescription interventions and patterns, if any

2.1.1 (10) The pharmacy evaluates the registered wrong deliveries

based on an overview of the registered wrong deliveries and

patterns, if any

Dispatch 2.1.5 (8) The pharmacy evaluates the registered faulty deliveries based

on an overview of the registered faulty deliveries and

patterns, if any

Stock of medicine and non-medical

products

2.1.9 (8) The pharmacy evaluates the stock of medicine, including the

external level of delivery

2.1.9 (9) The pharmacy evaluates the pattern of delivery for

substitution

Production of dose dispensed medicine 2.1.11 (8) The package pharmacy evaluates the production of dose-

dispensed medicine



of the

standard)

Quality monitoring

2.1.11 (9) The package pharmacy evaluates the registered errors based

on an overview of the registered errors and patterns, if any

Agreement on division of responsibility

and operation of OTC outlet

2.3.2 (5) The pharmacy evaluates the collaboration with the

pharmacy's OTC outlet based on the inspection reports and

the daily collaboration

1 x yearly

Business mission 1.1.1 (4) The management evaluates the business mission

1.1.1 (5) The management evaluates whether there is coherence

between the business mission, the pharmacy's practice and

the determined quality goals, including the staff's perception

of coherence

Assignment of managerial

responsibility and functions

1.1.2 (4) The management evaluates whether the division of

managerial responsibility and functions are appropriate

Interior design of the pharmacy,

facilities, cleaning, accessibility and

safety

1.1.5 (9) The pharmacy evaluates the interior design of the pharmacy,

facilities, cleaning, accessibility and safety on the basis of the

check list

Quality control 1.2.1 (7) The pharmacy evaluates the work with quality management,

including the quality organisation's work and follow-up on

initiated action plans

1.2.1 (8) The management evaluates the overall quality at the

pharmacy based on the pharmacy's quality monitoring

Risk management (5) 1.2.3 (5) The pharmacy evaluates the working procedures for risk

management on implementation of significant changes

Handling of comments on service 1.2.8 (4) The pharmacy evaluates how the pharmacy learns from the

comments on service

Document management 1.3.1 (4) The pharmacy evaluates the work with document

management



of the

standard)

Quality monitoring

Data safety and confidentiality 1.3.2 (5) The pharmacy evaluates the compliance of the rules of duty

of confidentiality, including handling and destruction of

person identifiable data

1.3.2 (6) The pharmacy evaluates working procedures for data safety

and data discipline

Employment and induction of new staff 1.4.1 (5) The pharmacy evaluates employment of new staff

1.4.1 (7) The pharmacy evaluates the induction programme

Competence development 1.4.2 (4) The pharmacy evaluates the pharmacy's overall competences

in relation to the pharmacy’s business mission and daily

operation

1.4.2 (5) The pharmacy evaluates the use of appraisals and training

plans in relation to individual competence development

1.4.2 (6) The pharmacy owner evaluates the staff's satisfaction with

the pharmacy's work with competence development.

The training pharmacy’s duties and

responsibilities

1.4.3 (4) The pharmacy evaluates the educational course for the

pharmaconomist trainees

1.4.3 (6) The pharmacy evaluates the pharmacy's handling of the duty

as a training pharmacy

Handling of equipment at dose

dispensing pharmacy

1.6.2 (5) The pharmacy evaluates the handling of equipment used for

production of dose dispensed medicine

1.6.2 (6) The pharmacy evaluates the training of staff who operates

equipment for production of dose dispensed medicine

Dispensing of medicine on system

breakdown

2.1.2 (3) The pharmacy evaluates working procedures on system

breakdown

The pharmacies' shifts 2.1.3 (5) The pharmacy evaluates working procedures for specific



of the

standard)

Quality monitoring

conditions during shifts

Dispensing of dose dispensed medicine 2.1.4 (10) The pharmacy evaluates whether the pharmacy's dispensing

of dose dispensed medicine takes place in a safe and correct

manner.

2.1.4 (11) The pharmacy evaluates the registered errors when creating

and updating dosing charts based on an overview of the

registered errors and patterns, if any

2.1.4 (12) The pharmacy evaluates the service level which the pharmacy

provides customers who receive dose dispensed medicine

2.1.4 (13) The pharmacy evaluates the collaboration with external

parties about dose dispensed medicine

Delivery 2.1.5 (6) The pharmacy evaluates the types of dispatch which the

pharmacy provides

2.1.5 (7) The pharmacy evaluates whether the dispatch takes place in

a safe and correct manner

Counselling on medicine and on self-

care to individuals

2.1.6 (10) The pharmacy performs a professional assessment of

pharmaconomists and pharmacists who counsel individuals

on medicine and on self-care

2.1.6 (11) The pharmacy evaluates the pharmacy's counselling.

Health promotion and disease

prevention

2.1.7 (4) The pharmacy evaluates the pharmacy's activities for health

promotion and disease prevention

2.1.7 (5) The pharmacy evaluates the completed activities within

health promotion and disease prevention

2.1.7 (6) The pharmacy evaluates the handling of measuring

equipment if the activities completed have included use of

measuring equipment



of the

standard)

Quality monitoring

Handling of products 2.1.8 (9) 1.2.6 The pharmacy evaluates the handling of products

2.1.8 (10) 1.2.6 The pharmacy evaluates the handling of measurement

of temperature

2.1.8 (11) 1.2.6 The pharmacy evaluates the handling of food

2.1.8 (12) The pharmacy evaluates handling of drug residues and

hazardous waste received for destruction

Stock of medicine and non-medical

products

2.1.9 (10) The pharmacy evaluates the assortment of non-medical

products based on the sector's requirements to non-medical

products

Monitoring of euphoriants 2.1.10 (5) The pharmacy evaluates its working procedures when

monitoring the pharmacy's stock of euphoriants

2.1.10 (6) The pharmacy evaluates the handling of possible differences

in the stock of euphoriants

Written and electronic information

material

2.2.2 (3) The pharmacy evaluates the selected written and electronic


2.2.2 (4) The pharmacy evaluates the use of written and electronic


Supplier collaboration 2.3.1 (5) The pharmacy evaluates whether the regular vendors meet

the collaboration agreements

Agreement on division of responsibility

and operation of delivery facility

2.3.3 (5) The pharmacy evaluates the collaboration with the

pharmacy's OTC outlet based on the inspection report and

the daily collaboration

Check on inhalation 3.1.5 (4) The pharmacy evaluates the delivery of the service "Check on

inhalation"

3.1.5 (5) The pharmacy evaluates the number of delivered services

"Check on inhalation"



of the

standard)

Quality monitoring

3.1.8 Healthcare delivery 3.1.8 (7) The pharmacy performs a professional assessment of

pharmacists and pharmaconomists who provide healthcare

services not included by a certification

3.1.8 (8) The pharmacy evaluates whether the necessary resources

have been present

3.1.8 (9) The pharmacy evaluates whether the necessary competences

have been present

3.1.8 (10) The pharmacy evaluates the customer perceived quality with

healthcare delivery

Every third year Waiting time 1.1.4 (5) The pharmacy evaluates the customers’ satisfaction with the

pharmacy’s waiting time

Interior design of the pharmacy,

facilities, cleaning, accessibility and

safety

1.1.5 (10) The pharmacy evaluates the customers' satisfaction with the

pharmacy's interior design, facilities, cleaning, accessibility

and safety

1.1.5 (11) The pharmacy owner evaluates the staff's satisfaction with

the pharmacy's interior design, facil ities, cleaning,

accessibility and safety

Dispatch 2.1.5 (9) The pharmacy evaluates the customers’ satisfaction with the

pharmacy’s dispatches

Counselling on medicine and on self-

care to individuals

2.1.6 (12) The pharmacy evaluates the customers’ satisfaction with the

pharmacy’s counselling

Production of dose dispensed medicine 2.1.11 (10) The package pharmacy evaluates the delivery pharmacies'

satisfaction with the package pharmacy

Appendix 4 – List of terms Accreditation standards for community pharmacies - 2nd version - June 2012Page 115 of 122

Appendix 4 – List of terms

The list of terms is attached to the entire set of accreditation standards and is prepared to ensure a common

understanding of terms and words used and it corresponds to the application in Danish pharmac y practice.

The list of terms is intended for those who are going to work with the set of accreditation standards, i.e.

mainly staff at the pharmacy.

Where possible, definitions decided by Dansk Selskab for Kvalitet i Sundhedssektoren [The Danish Society for

Health Sector Quality] are used.

Term Definition/explanation

Accreditation Procedure, where a recognised body assesses whether an activity,

service or organisation meet a set of joint accreditation standards.

Accreditation is a formal recognition that persons or organisations are

competent to perform their duties.

Accreditation consultant A person employed at IKAS and who counsels the accreditation

coordinator/the pharmacy during the entire accreditation process,

including planning of on-site survey.

Accreditation coordinator A person employed at the pharmacy and appointed by the pharmacy

owner. The accreditation coordinator is the link between the

pharmacy and the accreditation consultant at IKAS. The person is

trained to participate in the pharmacy’s implementation of the

accreditation standards and to guide the pharmacy through the

accreditation process as well as assisting IKAS in planning and

implementing the on-site survey.

Accreditation standard A standard which describes requirements and forms the basis for

accreditation.

Action plan In general, action plan includes actions initiated on the basis of an

evaluation. The action plans describe the following cf. standard 1.2.1

Quality management:

specific goals for the effort

Initiatives to be implemented

time frame for implementation

person responsible for the implementation

resources available for the implementation of the effort

any risks which can be predicted in connection with the

implementation

monitoring of achievement of goals

follow-up on the effect of implemented initiatives

person responsible for follow-up

action plans, if implemented initiatives do not have the desired

effect

Adverse events An unintentional event which injures the patient/customer or causes

risk of damages due to the healthcare system’s actions or lack of



actions.

In the pharmacy sector, adverse events are defined as events that

occur in connection with supply or information about medicine

Appraisal Regular interviews between employee and his/her manager.

Baseline assessment Systematic self-assessment of the level of rating achievement of the

requirements in the accreditation standards.

Certificat ion Method for documenting that staff who provides healthcare services

has the necessary competences.

If a certification arrangement exists which meets the sector's

requirements, it must be used.

Check list A pre-defined list of topics which must be documented in a given

situation.

Collaborators Collaborators include:

Medical professionals

Authorities

Other collaborators, e.g. the municipal sector

Comments on service Comments on the pharmacy's service covering positive and negative

comments and complaints from customers and collaborators for

example regarding service, accessibility, waiting time, service and

discretion.

Competence development Activities implemented to develop ability to perform actions. The

activities could be teaching, self-tuition, learning in practice, peer-to-

peer training.

Complaint The pharmacy’s complaints against vendors of medicine and IT-

services.

Counselling Communication of knowledge and dialogue with customers,

authorities and medical persons about, e.g. use and storage of

medicine, the medicine’s effect, relevant adverse events, interactions

and contra-indications and tools for use of medicine. Counselling at

the pharmacy also includes counselling on self-care, self-medication,

health promotion and disease prevention. Counselling is based on

current, professional recommendations. Counselling must be

individually adjusted the target group’s needs.

Customer Customers are individuals

Customer satisfaction survey Survey of the customers’ satisfaction.

Documenting Presentation of written or electronic proof for compliance of goal or

requirement.

Educat ional and development

plans

Plan for the individual employee describing development and

education agreed between the individual employee and his/her

immediate manager.



Element of the standard A measurable variable used to monitor and assess the quality.

Error Action which has unwanted consequences

Evaluat ion Documented systematic assessment of an effort to see to see how it

goes and if it meets the determined goals or requirements. The

evaluation forms the basis for forward-looking decisions about quality

improvements.

Faulty deliveries A delivery to a customer which does not reach the right destination

or a wrong delivery from a supplier.

Guideline Document describing purpose, scope, organisation and responsibility

and procedures for solving of tasks. The content of a guideline is

described in the individual accreditation standard.

Guiding documents Step 1 of the accreditation standards requires the presence and

content of a guideline. This could be a business mission, plans, check

lists, guidelines or instructions dependent on the focus of the

accreditation standard.

Healthcare professional Healthcare professional; i.e. a person who is qualified within a

healthcare subject, e.g. doctor, nurse or social and healthcare

assistant, pharmacist or pharmaconomist.

Healthcare services Services which the pharmacy provides and delivers to individuals,

municipalities and other collaborators. It may be clinical and

preventive healthcare services.

Identificat ion of needs Identification of the customer's needs for counselling Identification of

needs takes place in a dialogue with the customer. Identification of

needs can be carried out by means of questioning models

Instruction Document describing specific directions on how people are going to

perform specific duties.

Level of delivery The degree to which a customer’s needs for prescribed medicine is

immediately met by collection or dispatch in relation to number of

inquiries/orders.

measuring equipment Measuring equipment such as carbon monoxide meters,

sphygmomanometer, thermometers, scales, etc. used for services to

customers or for operation of the pharmacy.

Medicine Medicine is any product which:

1. is presented as a suitable mean for treatment or prevention of

disease with people or animals or

2. can be used or given to people or animals either to re-establish,

change or to affect physiological functions by performing a

pharmacological, immunological or metabolic effect or by making

a medical diagnosis.

Medicine includes prescribed medicine, over-the-counter medicine,

non-pharmacy-reserved medicine, magistral medicine, herbal



medicine, powerful vitamins and minerals and homoeopathic

medicine.

Mock survey Systematic assessment of the level of rating achievement of the

requirements which is performed by persons from own pharmacy,

from other of the pharmacy’s units or a partnering pharmacy.

Near misses Near misses are adverse events prevented or adjusted in time before

they reach the customer.

On-site survey Systematic assessment of level of rating achievement of the

accreditation standards performed by external surveyors.

Organisation chart Plan describing the functions/job categories which are part of a

certain organisation.

Patient safety Protection of the patient against injuries or risk of injuries due to the

healthcare system's effort and services or lack of same.

Patterns Patterns are defined conditions which the pharmacy can identify

when taking an overview of a number of registrations.

Person identifiable data Data which can be identified/referred directly to a customer or

person employed at the pharmacy.

Prescription intervention An act in relation to contacting the prescriber, e.g. a correction of the

prescription.

Product warranty A complaint from a customer about an error/flaw by a product.

Professional assessment Documented assessment of the counselling which pharmaconomists

and pharmacists provide to the customers. The professional

assessment includes whether the actual counselling

is professionally correct

meets the customers' needs

is informed in a way which is understandable for the customer

Qualificat ion Controlling that equipment complies with specifications.

Qualification of equipment must take place:

before new equipment is used

after repair/change of vital parts of the equipment

Quality All qualities by a service or a product which determine the service’s or

product’s ability to meet the needs and expectations. The quality

concept includes several elements which all together express the

quality:

1. High professional standard

2. High patient satisfaction

3. Continuity in the patient pathway

4. Minimal risk for patient

5. Effective use of resources

Quality flaw Failure to comply with quality goals or increased occurrence of errors.



Queue wait ing t ime Time from the customer enters the pharmacy until he/she gets

contact with the counter staff.

Registration To enter data into a form/record and to describe an event – written

or electronic.

Regular vendors A vendor is a regular vendor when it is a vendor which the pharmacy

uses for e.g. delivery of medicine, including dose dispensed medicine

and magistral pharmacies, delivery of the pharmacy's IT equipment

and programs and delivery of the pharmacy's robot.

Risk Risk is a possibility that something unfortunate or unwanted will

happen.

Risk management Risk management is part of the quality management with the

purpose of identifying, analysing, limiting and preventing damage

and risk of damage.

Risk waste Waste for destruction, e.g. sharp or point objects or mercury.

Self-care A customer’s decisions and behaviour in connection with health and

disease. Self-care covers self-medication, other types of self-

treatment and prevention, including lifestyle changes.

Service goals Quality goals for the service which the pharmacy provides its

customers, cf. Objectives for pharmacy's distribution, advice and

information service.

Staff All employees at the pharmacy', e.g. skilled staff, service assistants,

temps, trainees and students.

Symptom assessment Assessment of a customer’s symptoms based on a systematic

identification of needs. Symptom assessment is performed to counsel

on self-care and to recommend contact to a doctor.

The management Can be the pharmacy owner but can also be the persons to whom

the pharmacy owner delegated managerial tasks and responsibility.

The pharmacy In the context of the standards, the term identifies the person(s) at

the pharmacy who perform the task in question.

The pharmacy owner The person authorised to run the pharmacy.

Vendor Collaborator who provides services to the pharmacy.

Waiting t ime for prescript ions The time from a customer has delivered the prescription and until the

medicine is ready for delivery.

Wrong delivery Errors occurred on service of prescription where the medicine has

been delivered to the customer. Errors could be the following:

Wrong medicine

Wrong amount

Wrong label (name, dosage, indication)

Wrong customer



Wrong dosing chart

Dispensing of medicine that has surpassed its expiry date

Inadequate, pharmacological control on the dosage and indication

of the medication order

Appendix 5 - Good advice for working with DDKM Accreditation standards for community pharmacies - 2nd version - June 2012Page 121 of 122

Appendix 5 – Valuable information for working with DDKM

It is recommended that the pharmacy starts on the following initiatives after reception of the accreditation

standards:

1. Reception of accreditation standards: It is recommended that the pharmacy owner and the quality

organisation, including the accreditation coordinator, who is the link between the pharmacy and IKAS, read

the introduction to DDKM thoroughly and get acquainted with the content of the framework standards and

communicate this knowledge to the remaining staff at the pharmacy. The introduction is an important part of

the standard material.

After reception of the accreditation standards, the pharmacy may deselect the accreditation standards not

relevant for the pharmacy. For example, standard 2.1.3 The pharmacies’ shifts which is only relevant for

pharmacies which have shifts.

2. Guiding documents: At step 1 of the accreditation standards, guiding documents are requested, e.g.

plans, guidelines or instructions. As the majority of the accreditation standards concern the pharmacy’s daily

life, the pharmacy itself must prepare the requested guiding documents. In this way the pharmacy ensures

that the guiding documents fit the working routines and other conditions applying for the individual pharmacy

in the best possible way.

In four accreditation standards, step 1 requests legal instructions for specific working procedures and/or

competences. These concern:

Standard 1.2.6 Handling of product warranties. Instruction for handling of product warranties

Standard 2.1.1 Handling of prescript ions. Instructions for handling of prescriptions

Standard 2.1.4 Handling of dose dispensed medicine. Instructions for handling dose dispensed

medicine

Standard 2.1.8 Handling of products. Instruction for handling of products

Standard 2.1.8 Handling of products. Instruction for measurement of temperature

3. Implementation of guiding documents: The pharmacy owner must ensure that work is in accordance wi th

the guiding documents from step 1, cf. step 2 in the accreditation standards. Step 2 requires a targeted effort

for information, well-defined communication paths and adjustment of working procedures and competence

development of the staff. Already during preparation of the documents, it is important to include the staff in

the implementation. It is important to emphasise that there may be several methods which ensure the

implementation of step 2. It is the intention that the quality development reaches far out in the organisation

and thus it is important to involve the relevant employees and managers and clearly assign the responsibility

for the implementation.

4. Quality monitoring: According to standard 1.2.1 Quality management, an overview of the pharmacy’s

overall quality monitoring must be prepared, cf. step 2 in the accreditation standards. As starting point, the

pharmacy may use the outline of elements of the standard at step 3 which is attached to the accreditation

standards (appendix 3). All element of the standard at step 3 are listed according to their frequency of

implementation. It may be necessary to support the implementation of the registrations, teach staff and

develop tools for evaluation and analysis. The quality monitoring chosen in the individual accreditation

Appendix 5 - Good advice for working with DDKM Accreditation standards for community pharmacies - 2nd version - June 2012Page 122 of 122

standard illustrates the content or parts of the content in the individual accreditation standard. The intention

of the selected elements of the standard is to use the registrations and/or assessments to assess to which

degree the pharmacy complies with the accreditation standard.

5. Quality improvement: Quality improving initiatives are launched on the basis of the quality monitoring, cf.

step 4 in the accreditation standards. Careful consideration on prioritisation of focus areas is important as is

the person responsible for implementing the action plans and in consequence hereof any increased

requirements for already planned implementation and quality monitoring. In the 2nd version, step 4 requires

a continuous development of the quality. The pharmacy must ensure that data from the quality monitoring

will be used as the basis for the decisions regarding quality improving initiatives, that the initiatives decided

will be implemented, that the effect of the initiatives will be eval uated and that the efficiency assessment will

be used to assess whether there is a need for further initiatives.

An overview of changes from the 1st version to the 2nd version of the standards is available in appendix 1 -

What is new in the 2nd version of the accreditation standards.

A detailed overview of the changes is available in appendix 2 – Detailed overview of changes from the 1st

version to the 2nd version of the standards.