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Assist. Prof. Dr. Mohamed Awad Mousnad,
B.Pharm (Hons), M.Sc, PhD, RPh
Assistant professor of Pharmacy Practice at International University of Africa (IUA), Khartoum
1
Certificate Course in Global Health Pharmacy, Khartoum, Sudan
22nd – 24th of December, 2017.
Introduction
Overview of drug utilisation
Methods used in drug utilisation studies
Drug classification systems
Identifying Problems with Medicine Use
Drug utilization Challenges and Opportunities in
developing countries
Presentation outlines
2
Introduction
Pharmacy profession has shifted from product oriented to patient and service oriented professional.
A number of new disciplines were developed such as pharmaceutical care, clinical pharmacy, Pharmacoeconomics and Pharmacoepidemiology.
Pharmacotherapy ( safety, efficacy, cost components and quality of life measures)
Pharmacoepidemiology is the study of the use of, and effects of, drugs in large numbers of people (Strom, 1994)
3
No discussion on the historical development of
pharmacoepidemiology will be complete without referring
to the history of drug utilisation.
DUS – Europe
DUR –USA
In last decades, studies were mostly of a descriptive
nature
Recently, social and behavioural aspects become involved
to achieve a higher quality of drug use.
4
Introduction cont.
Introduction cont.
Terms
Epidemiology ―the study of the distribution and determinants of
health-related states and events in the population, and the
application of this study to control health problems‖.
Clinical pharmacology ―the study of effect of drugs in
humans.‖
Pharmacoepidemiology ―the study of the utilization and effects
of drugs in large numbers of people.‖
5
Disease
Drug Population
Clinical pharmacology
Pharmaco-epidemiology
Epidemiology Public Health
Relationship between Clinical pharmacology , Epidemiology and
Pharmacoepidemiology
6
7
Medicines are part of everyday life.
Frequently little is known about :-
How many drugs people take ?
What sort of drugs are taken ?
How much the drugs cost?
Who influences the way drugs are prescribed and
How the drugs are actually taken ?
Drug utilisation aims to answer these questions.
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Overview of drug utilisation
Definition of drug utilisation
The World Health Organisation (WHO) defined Drug
utilisation as: "The marketing, distribution,
prescription, and use of drugs in society, with special
emphasis on the resulting medical, social, and
economic consequences"
(WHO,2003)
9
Overview of drug utilisation cont.
Levels of drug utilisation
Drug utilisation can be studied at different levels depending
on the purpose of the study and the facilities and
information available.
Each drug utilisation study must also be related to a
specific time period (for example, a year, a quarter, a month
or a day) and to a specific unit of the population.
10
Overview of drug utilisation cont.
11
Basic levels of drug utilisation research
First level Second level Drug All drugs
Groups of drugs
Single drugs/products
Area/sources Country/countries
Region(s)
Pharmacy/pharmacies
Health insurance system(s)
Hospitals/hospital wards/hospital beds
Physician(s)
Patient(s)
Levels of therapy Wholesale/overall pattern
Prescriptions
Patient compliance/non-compliance
Unit of measurement Cost , Quantity, DDD
(Adapted from lunde, et al., 1979)
A systems view of drug utilisation
In any setting, drug utilisation can be viewed as an evolving
management system applied to an underlying health care
system.
Each system typically consists of input, process and output
components.
12
Overview of drug utilisation cont.
Output
for example, a specified percentage of decreased costs,
hospitalisations or drugs per patient.
Input
The health care system and available data structure).
Process
The establishment of criteria, the application therefore,
intervention strategies and finally evaluation.
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Overview of drug utilisation cont.
14
INPUT
PROCESS
OUTPUT
CRITERIA
APPLICATION
INTERVENTION
EVALUATION
OUTCOMES
Process
Ongoing feedback
ffffffffffffffffffffff
eedfeefeedback
and modification
(Adapted from Jones, 1991)
Systems View of Drug Utilisation
15
1. Methods used in qualitative studies;
2. Studies on prescription habits;
3. Studies on patient compliance;
4. Studies on drug effects;
5. Studies on patients' knowledge about drugs;
6. Descriptive studies, determinants of drug
utilisation and impact of drug use; and
7. Consumption studies.
16
Methods used in drug utilisation studies cont.
Common language.
For international, regional, national, country comparison of
drug utilization trends.
The system allow easy comparison after collected the
utilization data in uniform way.
( WHO,2003)
18
Classification systems in drug utilization
Only three classification well-known world wide in drug
utilization practice:-
1- Anatomical Therapeutic (AT) classification
Developed by the European Pharmaceutical Medicine
Market Research Association (EphMRA).
used worldwide by International Medical Statistics (IMS)
for providing the medicine industry with market research
statistics
19
Classification systems in drug utilization cont.
2-Anatomical Therapeutic Chemical (ATC)
classification
Developed in Norway in the early 1970s
Based on the EPhMRA classification
20
Classification systems in drug utilization cont.
3-American Society of Health-System Pharmacists
(ASHP) Classification System
is more commonly used in North America;
it is a pharmacological/therapeutic classification
system.
21
Classification systems in drug utilization cont.
ATC classification
Anatomical
Therapeutic
Chemical
22
Classification systems in drug utilization cont.
Main purpose of ATC
To serve as a tool for presenting drug utilization research in order to improve quality of drug use.
An international language for grouping of drugs.
Recommended by the WHO Headquarters as the international standard for drug utilization studies
(WHO, 2008)
23
Classification systems in drug utilization cont.
Currently, guidelines for the ICD-10 section,
preferably using an internationally widespread and
recommended standard system such as the ATC
( WHO,2009) 24
Classification systems in drug utilization cont.
25
ATC system main groups
A Alimentary tract and metabolism
B Blood and blood forming organs
C Cardiovascular system
D Dermatologicals
G Genito urinary system and sex hormones
H Systemic hormonal preparations, excl. sex hormones and insulins
J Antiinfectives for systemic use
L Antineoplastic and immunomodulating agents
M Musculo-skeletal system
N Nervous system
P Antiparasitic products, insecticides and repellents
R Respiratory system
S Sensory organs
V Various
26
Structure of the ATC system A ALIMENTARY TRACT AND METABOLISM
(1st level, anatomical main group)
A10 DRUGS USED IN DIABETES
(2nd level, therapeutic subgroup)
A10B BLOOD GLUCOSE LOWERING DRUGS,
INSULINS (3rd level, pharmacological subgroup)
A10BA BIGUANIDES
(4th level, chemical subgroup)
A10BA02 METFORMIN
(5th level, chemical substance)
(ATC INDEX WITH DDDs, 2008)
27
Indicator study methods
Use data collected at the individual level patient, health
facility
Aggregate data methods
Use routine data (e.g., stock records)
In-depth investigation of medicine use
Prescription audit, patient record review
Drug use evaluation (DUE)
Qualitative methods to understand causes of a medicine
use problem
28
Indicator Studies Methods
Irrational medicine use is widespread and results in—
Poor patient outcome
High cost of inappropriate medicine use
Increased risk of ADRs
Increased risk of antimicrobial resistance
Measuring medicine use problems is the first step to
improving use
29
A major function of a DTC in Hospitals is to identify
medicine use problems and to implement corrective
measures
Performing an indicator study is useful method to—
Identify medicine use problems at the individual patient
level
Monitor medicine use by prescribers
Evaluate the impact of interventions
30
WHO/INRUD indicators in primary health care
Prescribing indicators
Patient care indicators
Facility indicators
Hospital indicators
31
Aggregate data methods
A major function of a DTC is to identify medicine use problems and to implement corrective measures
Aggregate methods are a useful way to gain an overview of medicine use problems using routine data not collected at the individual patient level.
Examples of a aggregate data methods include—
DDD
VEN analysis
ABC analysis
32
Defined daily dose (DDD)
The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.
(WHO Collaborating Centre for Drug Statistics Methodology,2008)
33
The DDD
should not be considered as a
―correct dose‖ but as an
international compromise
based on review of available documentation
34
Unit of measurement cont.
Most frequently used methods
DDDs
DDD/1000 inhabitants/day (DID)
DDD/100 bed days
35
Unit of measurement cont.
DDD calculations
No. of DDDs = Q*Strength/DDD value
DDD/1000 inhabitants/day = Q*Strength*1000/Total sample size*DDD
(WHO Collaborating Centre for Drug Statistics Methodology,2008)
36
Unit of measurement cont.
37
Some DDD examples :-
38
Sales of agents used for hypertension in Norway 1973 - 2006
0
50
100
150
200
250
300
1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005
DD
D/1
00
0 i
nh
ab
ita
nts
/da
y
ACE-inhibitors + angiotensin II antagonists (C09)
Calcium channel blockers (C08)
Beta blocking agents (C07)
Diuretics (C03)
Antihyperteinsives (C02)
Solveig Sakshaug, 2008
39
Consumption of antibacterials in primary care in 26
European countries 2002
0
5
10
15
20
25
30
35
FR GR LU PT IT BE SK HR PL IS IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL
DD
D p
er
10
00 in
h.
per
da
y
Others
J01B+J01G+J01X
Sulfonamides and
trimethoprim
J01E
Quinolones
J01M
Macrolides, Lincosam.,
Streptogramins
J01F
Tetracyclines
J01A
Cephalosporins
J01D
Penicillins
J01C
Goossens H. et al, 2005
40
Challenges
Priority that the health sector receives in the budget in
developing countries ( developed countries 6-12 % GDP).
Regulatory efforts and national drug policies.
Lack of appropriate statistics on medicine.
limitations in funding of drug utilization research.
Lack access to evidence-base publications
41
Opportunities
Drug utilization studies identify and analyze problems
related to prescribing, dispensing, and ingestion of
medicines, monitor changes in utilization patterns, and
evaluate the impact of interventions to change medication
use.
Number of approaches were developed according to the
purpose and information needs of policy makers,
manufacturers, program managers, practitioners, and
consumers.
42
Availability of international standardized indicators are
enabling drug utilization studies in developing and
transitional countries. Many strategies could be proposed,
tested, and implemented to improve the quality of
medication use.
The increasing availability of computerized databases.
The increasing availability of software (modelling )
43
44
Thank you