DIT Education Presentation Athlone

AMNCH Presentation to Health ICT Managers/Technical 2003

Technicians’ Experiences and Career Pathways.

AMNCH Presentation to Health ICT Managers/Technical 2003

AMNCH

Approx 600 bed hospital employing 3000 staff. Provides child-health, adult, psychiatric and age-

related healthcare. National Urology Centre, Regional Dialysis Centre

and a Regional Orthopaedic Trauma Centre. Oncology & Haematology services, Day Wards.

Pharmacy Department – approx 60 staff incorporating 31 pharmacists, 24 pharmacy technicians, 3 pre-registration pharmacists & 1 pharmacy aide.

AMNCH Presentation to Health ICT Managers/Technical 2003

Differences between Community &Hospital Technicians

On going education Training courses Educational meetings Management roles Rotate through different departments/specialities More varied work load Larger workforce Team support Monday to Friday – limited weekend work

AMNCH Presentation to Health ICT Managers/Technical 2003

Pharmacy Technician roles within the Pharmacy Dept

Management based– Dispensary Team Leader– Ward Based Technician Supervisor– Purchasing Supervisor– Ward Top-Up Supervisor

Dispensary based Ward based Aseptic Unit

AMNCH Presentation to Health ICT Managers/Technical 2003

What is an Aseptic Unit?

Aseptic = “without sepsis” or infection. An Aseptic Unit (AU) minimises the risks associated

with the handling, reconstitution and administration of intravenous drugs by providing isolators for their preparation. The isolators provide a balance between operator and product preparation in order to provide high levels of safety for both the patients and the staff.

The AU prepares all injectable chemotherapy (cytotoxic) and anti-biotics/ant-fungals (non-cytotoxic) for the hospital. This is also known as CIVAS or Centralised Intravenous Additive Service.

The AU is a 3 roomed suite consisting of the clean room, the preparation room & the office/gowning area.

AMNCH Presentation to Health ICT Managers/Technical 2003

Technician Roles within the Aseptic Unit in AMNCH

Team Leader Microbiology/Quality Control Technician Standard Operating Procedure (SOP) writing Pre & In-process checking role Chemotherapy & CIVAS Compounding Prescription processing & drug calculations

AMNCH Presentation to Health ICT Managers/Technical 2003

Team Leader (Senior Role)

Co-ordinates the work of technical and other staff in the Aseptic Unit ensuring that specialist areas are covered, that all duty rosters are covered and completed.

Co-ordinates the work of pharmacists rostered in the Aseptic Unit to optimise checking turnaround and workflow and rostering technicians within the Aseptic Unit.

Processes prescriptions. Completes in-process checks within the unit.

AMNCH Presentation to Health ICT Managers/Technical 2003

Team Leader contd.

Supervises work experience staff in the Aseptic Unit. Organises & supervises training of new staff. Deals with issues arising in the Aseptic Unit -

equipment failure etc. Assists the Aseptic Unit Manager with the planning and

development of the service. Writes, updates and supervises relevant procedures in

conjunction with the Aseptic Unit Manager.

AMNCH Presentation to Health ICT Managers/Technical 2003

Pre & In-process checking role

In-process checking includes checking the technicians diluent and infusion volumes prior to addition to the final container.

During this check the diluent, drug vial, infusion fluid, equipment and label are checked for appropriateness.

This check can involve a total of 15 individual checks at two separate steps (diluent checks and final volume checks).

The worksheet is then signed on completion of each step. This is a new role for technicians in AMNCH and involved

procedural changes and training.

AMNCH Presentation to Health ICT Managers/Technical 2003

AMNCH Presentation to Health ICT Managers/Technical 2003

South West In-Process Checking Course

The course takes place over 2 days in Bristol, UK.

The main topics covered in the course are: the aim of the accuracy assessment who can complete the assessment what is a check? how to complete the assessment errors legal issues

Assessment & Accreditation

Legality – hospital indemnity scheme checked to ensure that technicians were legally covered to carry out in-process checks in ROI

In-house training over 4 weeks 100 in-process checks (drug diluent & volume) carried out –

no errors allowed – double checked & signed off by a pharmacist

Filling in of all relevant paperwork Submission of portfolio to South West Medicines

Information & Training Board Accreditation achieved (transferable)

AMNCH Presentation to Health ICT Managers/Technical 2003

AMNCH Presentation to Health ICT Managers/Technical 2003

Microbiology Quality Control Technician(Senior Role)

Ensure that the following QC tests are carried out in accordance with the SOPs (Settle/contact plates, particle counts, air sampling, swab testing, validations).

Completes a monthly QC report & ensures that it is read by unit staff.

Organises the validation of all equipment in the aseptic unit.

Carries out in-process checks.

AMNCH Presentation to Health ICT Managers/Technical 2003

Microbiology Quality Control Techniciancontd.

Participate in the training of new or rotating staff, including contract cleaners according to agreed Aseptic Unit SOPs.

Train other operators/students in relation to all aspects of QC.

Write and update relevant procedures in conjunction with the Aseptic Unit Team Leader, or the Aseptic Unit Manager.

Ensuring all pressures in rooms and isolators are within range.

AMNCH Presentation to Health ICT Managers/Technical 2003

Continuing Education/Opportunities

Aseptic Preparation & Dispensing of Medicines Course, Leeds– Covers the principles & practice of asepsis & updates the

knowledge of standards, practices & QA relating to the aseptic prep & dispensing of medicines.

Higher Certificate in Good Manufacturing Practice & Technology – BSc Pharmaceutical Technology

– offers operators, team leaders and supervisors an opportunity to acquire a foundation in the sciences relevant to industry and to develop a broad perspective of Good Manufacturing Practice, relevant core science and production management which pertains to a pharmaceutical manufacturing facility or hospital.

Continuing Education/Opportunities

The South West Medicines Information & Training Pre & In-Process checking course (Aseptic Services), UK.

– To enable pharmacy technicians to be assessed in pre & in-process checks with the overall aim of preventing & reducing errors within an aseptic unit.

http://www.swmit.nhs.uk/PIPCAseptic.htm

http://www.healthcare.leeds.ac.uk/study/CPD/PTQA/APDM/

http://www.it-tallaght.ie/PartTimeCourses/Science/Name,17530,en.html

AMNCH Presentation to Health ICT Managers/Technical 2003

Medicine management

Medicine management is a method of working that aims to prevent, detect and address medicines related problems and to achieve the optimum use of medicines and ensure patient focused care.

Medicine management course done with southwest medicine information and training in Bristol

Its an accredited training scheme for pharmacy technicians Course is designed to facilitate the development of pharmacy

technicians into performing ward based roles in the uk.

The Framework

pre course work Essential and recommended reading 8 tasks & activities Read up on your policies and procedures

Post course supervised Training period – you have a mentor to facilitate the local implementation of the scheme and to provide support guidance and feedback

The Framework

Ranges of experience for each module Final work based assessment with mentor Regional assessment interview – panel interview

you. Usually 20 to 30mins. Discuss your portfolio and your practise activity.

Receive your certificate of achievement which means you are accredited for 2 years.

Medicines managementfour modules

1. Managing supply of non- stock medicines

2. Assessment of Patients own medicines

3. Managing the supply of one stop dispensing

4. Drug History Taking

Ward Based Technicians (WBT) In AMNCH

In Tallaght Hospital we are not set up to do all four modules so I have completed module 2 managing supply of non stock medicines.

There are 3 ward which have a Ward based Technician-WBT

There are two trained WBT’s in AMNCH

WBT Responsibilities

Daily visit to the allocated ward each day - first point of contact between pharmacy and the ward

Review all patients’ prescription charts and order any non stock medications required including nutritional feeds, blood products and dressings

WBT’s endorse all prescription charts stock , non-stock, MDA, Patients Own Medicines, Fridge item

WBT’s liaise with the ward pharmacist with regard to any medication errors/queries found on ward/chart

Ward stock top up

Advantages of service to the Department

Improves workflow – pharmacy workload controlled

Risk management – issues relating to drug administering, transcription errors and communication have been addressed

Improves pharmacy standards Improves working relationships between

pharmacy and ward

Advantages for technicians

Increased job satisfaction Feel more involves and responsible More job variety and interest Improves motivation Reconigition of their skill Team building

Benefits of service for Patients

They receive a more efficient and seamless service Patient care is improved by more pharmacy clinical input Medicines should arrive from pharmacy in a more timely way Patients receive more counselling on drugs and feel more

empowered Should reduce medication errors Gives the patient a positive image of the service Patient benefits from having a regular medicine review

Future

We hope to roll out the WBT service to other wards and eventually throughout the hospital

Take on drug History taking and then the clinical pharmacist can be involved in more clinical work at ward level

The Role of the Pharmacy Technician in Purchasing, A.M.N.C.H.

Yvonne Sheehan

Senior Pharmacy Technician I.I.P.M.M

27 March 2010

Aim of Presentation

Background on purchasing in Public Sector.

Purchasing roles: order placement to payment

The fundamentals of purchasing : the 5 rights

Future roles for Purchasing Technician.

Purchasing in the Public Sector

The hospital is a non-profit making organization.

Pharmacy accounts for 8 – 10% hospital budget

Pharmacy generates a small income through clinical trials

Funded by the tax payer

Transparent. Ethical (conflicts of

interest; tendering process)

Best Value for money.

(optimum combination of cost + quality)

The Pharmacy Service

Pharmacy is a patient focussed service The core aim of the pharmacy service is to deliver: The correct drug In the correct form To the right person At the right time At the most economic cost to the health economy.

Purchasing rolesPurchasing to payment.

Order Placement Reactive Supply on Demand

Proactive Planning, controlling, cost reduction. Best value for money.

The Five Rights of Purchasing

Right Quality – fitness for purpose, specifications, legislative req’r

Right Quantity- Minimum order levels

Right Place- Transportation, delivery points

Right Time - Total lead times

Right Price- Different types of cost, negotiation, contracts.

Proactive PurchasingPurchase to payment.

Supplier Selection. Sourcing (unlicensed medicines)

Supplier Management- measure, control, relationship.

New Products- meetings, journals, Medicines information, requests from customers. New product development.

Proactive PurchasingPurchase to payment

Negotiation: contracts, legal implications, tendering.

Meeting with customers. Defining specifications. Service level agreements

Materials ManagementPurchase to payment.

Stock Control Inventory = Money

Stock takes , valuation reports (data integrity) Locations Product recalls. Obsolete stock. New products IT system Pharmacy aide Policies and Procedures

Invoice reconciliation and Payment

Contract Prices. Variances in invoices. Queries Credits. Finance reports

Future Roles for Purchasing Technicians

Group buying for hospitals. More tendering and contract management. Electronic ordering systems. Bar coding, automation. Management of IT systems.

Pharmaceutical Technicians and Clinical Trials

Pharmaceutical Technician Conference

27 March 2010

Points to be covered

Introduction to clinical research Principles of ICH GCP Technician responsibilities Examples of Audit findings

Introduction to clinical research

Clinical research is part of the complex procedure to demonstrate the effectiveness, safety and value for money of drugs and other products of the pharmaceutical industry.

Introduction to clinical research

Of 100,000 chemicals screened for potential clinical activity, only about 15 will be looked at for further study Out of these 15 only about 5 will enter into clinical trials in humans.

Of these 5 only on average one drug will eventually be licensed and be available to all on prescription.

It costs about 800 million euros and takes about 11 years to develop one drug.

Introduction to clinical research

Phase I Conducted in human volunteers. Provide an early evaluation of short-term safety and

tolerability Can provide pharmacodynamic and pharmacokinetic

information needed to choose a suitable dosage range and administration schedule for initial exploratory therapeutic trials.

Introduction to clinical research

Phase II

The first time the drug is tested in patients .

Usually only conducted in small numbers of patients.

The major aim of this stage is to evaluate the dose and regimen for further studies. In addition further safety and efficacy parameters are evaluated.

Introduction to clinical research

Phase III Larger scale studies of efficacy & safety. Confirm the efficacy and safety of the drug in large

numbers of patients.

Application for a product authorisation.Includes all Phase I to IV data and all pre-clinical data

Introduction to clinical research

Phase IV

Begins after product license has been granted by the regulatory authorities. Must be related to the approved indication. Commonly conducted studies include additional drug-drug interaction, dose-response or safety studies and studies designed to support use under the approved indication, eg mortality/morbidity studies.

WHAT IS GCP

Good Clinical Practice is an international ethical & scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Why have GCP?

Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki

OBJECTIVE OF ICH GCP

The objective of the International Conference of Harmonisation GCP guidelines is to provide a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

EC Clinical Trial Directive (2001/20/EC)

Key Objectives– To extend the principles of Good Manufacturing

Practice to IMPs– To provide “mutual recognition” for notification &

approval– To harmonise & mutually recognise procedures for

inspection & enforcement– To establish a harmonised procedure for clinical

safety reporting

Irish Law

EU regulations transposed into Irish Law in 2004

SI No 190 of 2004

Superseded the Control of Clinical Trials Act 1997

EU Directive definitions

Investigational Medicinal Product

– A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unlicensed indication or when used to gain further information about the authorised form.

ICH PRINCIPLES

There are thirteen principles; These state as follows:

ICH PRINCIPLE 1

Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)

ICH PRINCIPLE 2

Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks

ICH PRINCIPLE 3

The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society

ICH PRINCIPLE 4

The available nonclinical and clinical information on an investigational product should be adequate to support the proposed trial.

ICH PRINCIPLE 5

Clinical trials should be scientifically sound, and described in a clear, detailed protocol

ICH PRINCIPLE 6

A trial should be conducted in compliance with the protocol that has received prior independent ethics committee approval

ICH PRINCIPLE 7

The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

ICH PRINCIPLE 8

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)

ICH PRINCIPLE 9

Freely given informed consent should be obtained from every subject prior to clinical trial participation

ICH PRINCIPLE 10

All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification

ICH PRINCIPLE 11

The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the regulatory requirements(s)

ICH PRINCIPLE 12

Investigational products should be manufactured, handled, and stored in accordance with GMP. They should be used in accordance with the approved protocol

ICH PRINCIPLE 13

Systems with procedures that assure the quality of every aspect of the trial should be implemented

The Research Team

Sponsor Chief Investigator Principal Investigator Research Nurse Pharmacy

Pharmacy’s role

Delegation of product accountabilityReceipt

Storage

Dispensing

Returns

Destruction

Pharmacy Responsibilities

To safeguard trial subjects, staff and the hospital

To ensure IMPs are used as per protocol To ensure our procedures comply with current

guidelines and regulations

Pharmacist Responsibilities

Protocol Review Negotiation with investigator/sponsor Establishment of pharmaceutical implications Liaison with other sections within the pharmacy Preparation of S.O.P.’s Ongoing liaison with investigator/sponsor

Technician Responsibilities

Daily management of ongoing studies Monitoring of storage conditions Ordering and receipt of drug supplies Dispensing of prescriptions Processing of patient’s drug returns Drug accountability Maintance of records Supervision of CRA visits

Facilities

Adequate storage for IMPs & returns

Environment monitoring systems

Storage & management of study files & prescriptions

Documentation

“If it wasn’t written down then it never happened”

Responsibility to provide proof of IMP audit trail during lifetime of study at site from initial receipt to removal

Pharmacy File-Documentation

Good, clear, complete documentation Black Pen Remember to initial & date all corrections NO correction fluid- all alterations must be

legible Staff signature/initial list

Dispensing Logs

Should identify which drug was dispensed to which patient, when and by whom.

Record batch numbers & expiry dates All drugs returned from the patient must be

documented (partially used, used & unused) Document issues with drugs dispensed but not given to

the patient. Document issues with reconstitution of drug. Dispense trial stock

Management of IMPs

Drugs are manufactured to GMP standards and are labelled in accordance with Annex 13.

Daily temperature check. Refrigerators should have alarms to sound if product

goes out of temperature range. Temp excursions need to be documented & guidance

sought for whether the product is suitable for use. Expiry dates need to be checked.

Examples of audit findings in pharmacy

Unable to track all IMPs Errors on dispensing logs-issues with

accountability Documentation issues Missing receipts & prescriptions Temperature logs not completed

Examples of audit findings in pharmacy (2)

Lack of training of personnel on trial-related issues or poorly documented training

No training of staff on recall procedures Non compliance with SOPs CVs for personnel missing or not dated