Rational Use of Drugs 10 B

Rational use of drugs:
an overview
The rational use of drugs requires that patients

receive medications appropriate to their clinical
needs, in doses that meet their own individual
requirements for an adequate period of time, and at
the lowest cost to them and their community.
WHO conference of experts Nairobi
1985
correct drug
appropriate indication
appropriate drug considering efficacy, safety, suitability for
the patient, and cost
appropriate dosage, administration, duration
no contraindications
correct dispensing, including appropriate information for
patients
patient adherence to treatment
Department of Essential Medicines and Pharmaceutical Policy
TBS 2008
Adequacy of diagnostic
process
Source: Thaver et al SSM 1998, Guyon et al WHO Bull 1994, Krause et al TMIH 1998,
Bitran HPP 1995, Bjork et al HPP 1992, Kanji et al HPP 1995.

TBS 2008
Variation in outpatient antibiotic use in

26 European countries in 2002
D D D p e r 1 0 0 0 in h . p e r d a y
35
30
25
20
15
10
0
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
Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

TBS 2008
Overuse and misuse of antimicrobials

contributes to antimicrobial resistance
Source: WHO country data 2000-3
Malaria
choroquine resistance in 81/92 countries
Tuberculosis
0-17 % primary multi-drug resistance
HIV/AIDS
0-25 % primary resistance to at least one anti-retroviral
Gonorrhoea
5-98 % penicillin resistance in N. gonorrhoeae
Pneumonia and bacterial meningitis
0-70 % penicillin resistance in S. pneumoniae
Diarrhoea: shigellosis
10-90% ampicillin resistance, 5-95% cotrimoxazole
resistance
Hospital infections
0-70% S. Aureus resistance to all penicillins & cephalosporins
TBS 2008
Definition of rational use of medicines

Patients receive medications appropriate to their clinical needs, in doses that
meet their own individual requirements, for an adequate period of time, and at
the lowest cost to them and their community. (WHO, 1985).
Do The right things right (K-action)

5 `rights' of medication:
right patient
right drug
right dose
right route
right frequency
TBS 2008
Adverse drug events

Source: Review by White et al,
Pharmacoeconomics, 1999, 15(5):445-458
4-6th leading cause of death in the USA

estimated costs from drug-related morbidity &
mortality 30 million-130 billion US$ in the USA
4-6% of hospitalisations in the USA & Australia
commonest, costliest events include bleeding,
cardiac arrhythmia, confusion, diarrhoea,
fever, hypotension, itching, vomiting, rash,
renal failure
TBS 2008
Many Factors Influence Use of Medicines
Information
Scientific
Information
Influence
of Drug
Industry
Habits
Social &
Cultural
Factors
Treatment
Choices
Workload &
Staffing
Workplace
Intrinsic
Prior
Knowledge
Infrastructure
Relationships
With Peers
Societal
Economic &
Legal Factors
Authority &
Supervision
Workgroup

TBS 2008
The problem of irrational use

Worldwide more than 50% of all medicines are prescribed,
dispensed, or sold inappropriately, while 50% of patients fail
to take them correctly. Moreover, about one-third of the
worlds population lacks access to essential medicines.
Common types of irrational medicine use are:
the use of too many medicines per patient (polypharmacy);
inappropriate use of antimicrobials, often in inadequate dosage, for
non-bacterial infections;
over-use of injections when oral formulations would be more
appropriate;
failure to prescribe in accordance with clinical guidelines;
inappropriate self-medication, often of prescription only
medicines.
TBS 2008
Assessing the problem of irrational use

To address irrational use of medicines, prescribing, dispensing and
patient use should be regularly monitored in terms of:
the types of irrational use, so that strategies can be targeted
towards changing specific problems;
the amount of irrational use, so that the size of the problem is
known and the impact of the strategies can be monitored;
the reasons why medicines are used irrationally, so that
appropriate, effective and feasible strategies can be chosen. People
often have very rational reasons for using medicines irrationally.
Causes of irrational use include lack of knowledge, skills or
independent information, unrestricted availability of medicines,
overwork of health personnel, inappropriate
promotion of medicines and profit motives from selling medicines.
TBS 2008
Selected WHO/INRUD* drug use indicators for primary

health care facilities (WHO, 1993)
Prescribing Indicators:
Average number of medicines prescribed per patient encounter
% medicines prescribed by generic name
% encounters with an antibiotic prescribed
% encounters with an injection prescribed
% medicines prescribed from essential medicines list or formulary
Patient Care Indicators:
Average consultation time
Average dispensing time
% medicines actually dispensed
% medicines adequately labelled
% patients with knowledge of correct doses
Facility Indicators:
Availability of essential medicines list or formulary topractitioners
Availability of clinical guidelines
% key medicines available
Complementary Drug Use Indicators:
Average medicine cost per encounter
% prescriptions in accordance with clinical guidelines
TBS 2008
Strategies to Improve Use of Drugs

Educational:
Inform or persuade
Health providers
Consumers
Managerial:
Guide clinical practice
Information systems/STGs
Drug supply / lab capacity
Use of
Medicines
Economic:
Offer incentives
Institutions
Providers and patients
Regulatory:
Restrict choices
Market or practice controls
Enforcement

TBS 2008
Challenges of Rational Drug Use
Despite the growing body of knowledge on rational use interventions,

numerous studies have documented the continuing widespread irrational
prescribing of drugs.
injection therapy can also be an example of irrational drug use.
knowledge alone is not enough to change behaviour, and that complex and
multifaceted solutions are needed.
Many new drugs and second-line drugs are very expensive and accordingly
unaffordable for many governments and consumers.
Drugs and therapeutics committees may have difficulty to run in situations
where Medical and pharmacy training is still very traditional; with much
emphasis on drug knowledge and very little on public health, prescribing
skills, drug management and patient care.
Influence of pharmaceutical representatives
Doctors often gets visits from these representatives introducing new drugs
or reminding doctors of their products.
Doctors should stick to the principles of rational prescribing.

TBS 2008
Challenges of Rational Drug Use (... Continues)

* The consumer takes the final decision about whether and where to seek health
care, what medicine is actually taken , how much and when, and from what source.
These decisions are influenced by knowledge, culture, drug promotion and
personal finances.
* Independent drug information and public education about drug use are
complicated and costly and have always been underserved and underfunded. They
also tend to be organized by NGOs thus with informal networks and objective
evaluation of interventions and publication of the results are not easily arranged.
* Lack of independent drug information and advice. Worldwide, some 50% of
people fail to take their medicines correctly. Part of the problem is that selfmedication is widespread.
* Purchases of drugs in certain localities take place in the private sector, where
prescribing and selling functions are often combined. Profit motives and pressure
to please the patient can lead to over-treatment of mild illnesses, overuse of
injections and misuse of anti-infective drugs.
TBS 2008
Twelve core interventions to promote more rational use

of medicines
1. A mandated multi-disciplinary national body to coordinate medicine
use policies
2. Clinical guidelines
3. Essential medicines list based on treatments of choice
4. Drugs and therapeutics committees in districts and hospitals
5. Problem-based pharmacotherapy training in undergraduate curricula
6. Continuing in-service medical education as a licensure requirement
7. Supervision, audit and feedback
8. Independent information on medicines
9. Public education about medicines
10. Avoidance of perverse financial incentives
11. Appropriate and enforced regulation
12. Sufficient government expenditure to ensure availability of
medicines and staff
TBS 2008
1. A mandated multi-disciplinary national body to coordinate

medicine use policies
A national body is needed to coordinate policy and strategies at

national level, in both the public and private sectors. The form this
body takes may vary with the country, but in all cases it should
involve government (ministry of health), the health professions,
academia, the RA, pharmaceutical industry, consumer groups and
non-governmental organizations involved in health care. The
impact on medicine use is better if many interventions are
implemented together in a coordinated way, single interventions
often having little impact.

TBS 2008
2. Clinical guidelines
Evidence-based clinical guidelines are critical to promoting

rational use of medicines.
Firstly, they provide a benchmark of satisfactory diagnosis and
treatment against which comparison of actual treatments can be
made.
Secondly, they are a proven way to promote more rational use of
medicines provided they are: (1) developed in a participatory way
involving end-users; (2) easy to read; (3) introduced with an
official launch, training and wide dissemination; and (4)
reinforced by prescription audit and
feedback.
TBS 2008
3. Essential Medicines List based on treatments of choice

Using an essential medicines list (EML) makes medicine management easier in
all respects; procurement, storage and distribution are easier with fewer items,
and prescribing and dispensing are easier for professionals if they have to know
about fewer items. A national EML should be based upon national clinical
guidelines. Medicine selection should be done by a central committee with an
agreed membership and using explicit, previously agreed criteria, based on
efficacy, safety, quality, cost (which will vary locally) and cost-effectiveness.
EMLs should be regularly updated and their introduction accompanied by an
official launch, training and dissemination. Public sector procurement and
distribution of medicines should be limited primarily to those medicines on the
EML, and it must be ensured that only those health workers approved to use
certain medicines are actually supplied with them. Government activities in the
pharmaceutical sector (e.g. quality assurance, insurance reimbursement policies
and training), should focus on the EML.
TBS 2008
4. Drugs and therapeutics committees in districts and

hospitals
A committee designated to ensure the safe and effective use of
medicines in the facility or area under its jurisdiction. Such
committees are well-established in industrial countries as a
successful way of promoting more rational, cost-effective use of
medicines in hospitals.
Factors critical to success include: clear objectives; a firm
mandate; support by the senior hospital management;
transparency; wide representation; technical competence; a
multidisciplinary approach; and sufficient resources to implement
the DTCs decisions.
TBS 2008
5. Problem-based training in pharmacotherapy in

undergraduate curricula
The quality of basic training in pharmacotherapy for
undergraduate medical and paramedical students can significantly
influence future prescribing. Rational pharmacotherapy training,
linked to clinical guidelines and essential medicines lists, can help
to establish good prescribing habits. Training is more successful
if it is problem-based, concentrates on common clinical
conditions, takes into account students knowledge, attitudes and
skills, and is targeted to the students future prescribing
requirements. The Guide to Good Prescribing describes the
problem-based approach, which has been adopted in a number of
medical schools.
TBS 2008
6. Continuing in-service medical education as a licensure

requirement
CME is likely to be more effective if it is problem-based, targeted,
involves professional societies, universities and the ministry of health,
and is face-to-face. Printed materials that are unaccompanied by face-toface interventions, have been found to be ineffective in changing
prescribing behavior. CME need not be limited only to professional
medical or paramedical personnel, but may also include people in the
informal sector such as medicine retailers. Often CME activities are
heavily dependent on the support of pharmaceutical companies, as
public funds are insufficient. This type of CME may not be unbiased.
Governments should therefore support efforts by university departments
and national professional associations to give independent CME.

TBS 2008
7. Supervision, audit and feedback

Supervision is essential to ensure good quality of care. Supervision that is
supportive, educational and face toface, will be more effective and better
accepted by prescribers than simple inspection and punishment. Effective forms
of supervision include prescription audit and feedback, peer review and group
processes. Prescription audit and feedback consists of analyzing prescription
appropriateness and then giving feedback. Prescribers may be told how their
prescribing compares with accepted guidelines or with that of their peers.
Involving peers in audit and feedback (peer review) is particularly effective. In
hospitals, such audit and feedback is known as drug use evaluation. Group
process approaches amongst prescribers consist of health professionals
themselves identifying a medicine use problem and developing, implementing
and evaluating a strategy to correct the problem. This process needs facilitation
by a moderator or supervisor. Community case management is a special type of
supervised group process involving community members in treating patients.
TBS 2008
8. Independent medicine information
Often, the only information about medicines that practitioners

receive is provided by the pharmaceutical industry and may be
biased. Provision of independent (unbiased) information is
therefore essential. Drug information centers (DICs) and drug
bulletins are two useful ways to disseminate such information.
Both may be run by government or a university teaching hospital
or a nongovernmental organization, under the supervision of a
trained health professional. Whoever runs the DIC or bulletin must
(1) be independent of outside influences and disclose any financial
or other conflict of interest, and (2) use evidence-based medicine
and transparent deduction for all recommendations made.
TBS 2008
9. Public education about medicines

This will require:
Ensuring that over-the-counter medicines are sold with adequate labeling
and instructions that are accurate, legible, and easily understood by
laypersons. The information should include the medicine name, indications,
contra-indications, dosages, drug interactions, and warnings concerning
unsafe use or storage.
Monitoring and regulating advertising, which may adversely influence
consumers as well as prescribers, and which may occur through television,
radio, newspapers and the internet.
Running targeted public education campaigns, which take into account
cultural beliefs and the influence of social factors. Education about the use
of medicines may be introduced into the health education component of
school curricula or into adult education programs, such as literacy courses.
TBS 2008
10. Avoidance of perverse financial incentives

Financial incentives may strongly promote rational or irrational use. Examples include:
Prescribers who earn money from the sale of medicines (e.g. dispensing doctors), prescribe
more medicines, and more expensive medicines, than prescribers who do not; therefore the
health system should be organized so that prescribers do not dispense or sell medicines.
Flat prescription fees, covering all medicines in whatever quantities within one prescription,
lead to over-prescription; therefore user charges should be made per medicine, not per
prescription.
Dispensing fees, calculated as a percentage of the cost of the medicines, encourage the sale
of more expensive medicines; therefore a flat dispensing fee irrespective of the price of the
medicine is preferable. Although it may lead to price increases for cheaper medicines, it
lowers the price of higher cost medicines.
* Patients prefer medicines that are free or reimbursed. If only essential medicines are
provided free by government or reimbursed through insurance, patients will pressure
prescribers to prescribe only essential medicines. If medicines are only reimbursed when the
prescription conforms to clinical guidelines, there may be an even stronger pressure
on prescribers to prescribe rationally.

TBS 2008
11. Regulatory measures to support rational use

registration of medicines to ensure that only safe efficacious medicines of good quality
are available in the market and that unsafe non-efficacious medicines are banned;
limiting prescription of medicines by level of prescriber; this includes limiting certain
medicines to being available only with a prescription and not available over-the-counter;
setting educational standards for health professionals and developing and enforcing
codes of conduct; this requires the cooperation of the professional societies and
universities;
licensing of health professionals doctors, nurses, paramedics to ensure that all
practitioners have the necessary competence with regard to diagnosis, prescribing and
dispensing;
licensing of medicine outlets retail shops, wholesalers to ensure that all supply
outlets maintain the necessary stocking and dispensing standards;
monitoring and regulating medicine promotion to ensure that it is ethical and unbiased.
All promotional claims should be reliable, accurate, truthful, informative, balanced, upto-date, capable of substantiation and in good taste.
TBS 2008
12. Sufficient government expenditure to ensure availability

of medicines and staff
Lack of essential medicines leads to the use of nonessential medicines, and
lack of appropriately trained personnel leads to irrational prescribing by
untrained personnel. Furthermore, without sufficient competent personnel
and finances, it is impossible to carry out any of the core components of a
national program to promote rational use of medicines. Poor clinical
outcome, needless suffering and economic waste are sufficient reasons for
large government investment. Governments are responsible for investing
the necessary funds to ensure that all public health facilities have sufficient,
appropriately trained health professionals and enough essential medicines at
affordable prices for all the population, with specific provisions for the poor
and disadvantaged. Achieving these will require limiting government
procurement and supply to essential medicines only, and investing in
adequate training, supervision and health staff salaries.
TBS 2008
Educational Strategies
Goal: to inform or persuade

Training for Providers
Undergraduate education
Continuing in-service medical education (seminars, workshops)
Face-to-face persuasive outreach e.g. academic detailing
Clinical supervision or consultation
Printed Materials
Clinical literature and newsletters
Formularies or therapeutics manuals
Persuasive print materials
Media-Based Approaches
Posters
Audio tapes, plays
Radio, television

TBS 2008
Training courses related to the rational use of medicines
Promoting the rational use of drugs (medicines), in collaboration with

the International Network for the Rational Use of Drugs (INRUD)
coordinated by Management Sciences for Health, USA. This course teaches
the investigation of medicine use in primary health care and how to
promote rational use of medicines by providers.
Promoting rational drug (medicine) use in the community, in
collaboration with the University of Amsterdam, The Netherlands. This
course teaches the investigation of medicine use in the community, and
how to promote rational use of medicines by consumers.
Drugs and therapeutics committees, in collaboration with the Rational
Pharmaceutical Program coordinated by Management Sciences for Health,
USA. This course teaches methods for evaluating medicine utilization and
how to promote rational use of medicines in hospitals and districts.

TBS 2008
Training courses related to the rational use of medicines
Problem-based pharmacotherapy teaching, in collaboration with Groningen

University, The Netherlands, the University of Cape Town, South Africa, the
University of La Plata, Argentina (in Spanish) and the National Centre for
Pharmacovigilance, Ministry of Health, Algiers, Algeria (in French). This course
teaches a problem-based approach to rational prescribing based on WHOs Guide to
Good Prescribing.
Pharmacoeconomics, in collaboration with the University of Newcastle,
Australia. This course teaches how to do economic evaluation in medicine
selection.
Drug (medicine) policy issues for developing countries, in collaboration with
Boston University, USA. This course teaches about general medicines policy
including aspects relating to promoting more rational use of medicines.
ATC/DDD methodology for medicine consumption, in collaboration with the
WHO Collaborating Centre for Drug Statistics Methodology. This course provides
an introduction to the application of ATC/DDD methodology in measuring medicine
consumption.
TBS 2008
Managerial strategies
Goal: to structure or guide

decisions
Changes in selection, procurement, distribution
to ensure availability of essential drugs
Essential Drug Lists, morbidity-based quantification, kit
systems
Strategies aimed at prescribers

targeted face-to-face supervision with audit, peer group
monitoring, structured order forms, evidence-based standard
treatment guidelines
Dispensing strategies
course of treatment packaging, labelling, generic substitution

TBS 2008
Economic strategies:
Goal: to offer incentives to providers an consumers
Avoid perverse financial

incentives
prescribers salaries from drug sales
insurance policies that reimburse nonessential drugs or incorrect doses
flat prescription fees that encourage
polypharmacy by charging the same
amount irrespective of number of drug
items or quantity of each item
TBS 2008
Regulatory strategies
Goal: to restrict or limit

decisions
Drug registration
Banning unsafe drugs - but beware unexpected results
substitution of a second inappropriate drug after banning a first
inappropriate or unsafe drug
Regulating the use of different drugs to different

levels of the health sector e.g.
licensing prescribers and drug outlets
scheduling drugs into prescription-only & over-the-counter
Regulating pharmaceutical promotional activities
Only work if the regulations are

enforced
TBS 2008
Why does irrational use

continue?
Very few countries regularly
monitor drug use and
implement effective nationwide interventions - because
they have insufficient funds or personnel?
they lack of awareness about the funds wasted
through irrational use?
there is insufficient knowledge of concerning
the cost-effectiveness of interventions?
TBS 2008
WHO-sponsored training programmes

INRUD/MSH/WHO: Promoting the rational use of
drugs
MSH/WHO: Drug and therapeutic committees
Groningen University, The Netherlands / WHO:
Problem-based pharmacotherapy
Amsterdam University, The Netherlands / WHO:
Promoting rational use of drugs in the community
Newcastle, Australia / WHO: Pharmaco-economics
Boston University, USA / WHO: Drug Policy Issues
TBS 2008
WHO model (Guide to Good Prescribing)

Process of Rational Prescribing
Define the patients problem
Specify the Therapeutic objective
Verify whether your P-Treatment is suitable for this patient
Start the Treatment
Give information, instructions and warnings
Monitor and stop treatment
TBS 2008
WHO model (Guide to Good Prescribing)

Process of Rational Prescribing Rahmans modification
Define the patients problem (after careful evaluation)
Specify the Therapeutic objective
Management Plan
(Pharmacological and Non-pharmacological)
Choose and verify P-Drug
Write Prescription
Give information, instructions and warnings
Execute Treatment
Cont./stop
treatment
and stop treatment
Department of
Essential MedicinesMonitor
and Pharmaceutical
Policy
TBS 2008
Review
treatment
Conclusions
Irrational use of medicines is a very serious global
public health problem.
Much is known about how to improve rational use of
medicines but much more needs to be done
policy implementation at the national level
implementation and evaluation of more interventions,
particularly managerial, economic and regulatory
interventions
Rational use of medicines could be greatly improved

if a fraction of the resources spent on medicines
were spent on improving use.
TBS 2008
Summary
Drugs need to be used rationally

Irrational use of drugs is occurring
Definition of rational use of drugs need to consider national, economic
and socio-cultural background in respective community
Efforts to promote RUD is worldwide
Focus of activities should be at international, national, prescribers and
consumers level
There are many challenges in tackling irrational use of drugs
Cooperation among parties involved in promotion of RUD including
pharmaceutical industry should be strengthened
Doctors must maintain the noble status of their profession

TBS 2008

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Rational use of drugs:

The rational use of drugs requires that patients

Department of Essential Medicines and Pharmaceutical Policy

Variation in outpatient antibiotic use in

Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

Overuse and misuse of antimicrobials

Definition of rational use of medicines

Do The right things right (K-action)

Adverse drug events

4-6th leading cause of death in the USA

Many Factors Influence Use of Medicines

Department of Essential Medicines and Pharmaceutical Policy

The problem of irrational use

Assessing the problem of irrational use

Selected WHO/INRUD* drug use indicators for primary

Strategies to Improve Use of Drugs

Department of Essential Medicines and Pharmaceutical Policy

Challenges of Rational Drug Use

Despite the growing body of knowledge on rational use interventions,

Department of Essential Medicines and Pharmaceutical Policy

Challenges of Rational Drug Use (... Continues)

Twelve core interventions to promote more rational use

1. A mandated multi-disciplinary national body to coordinate

A national body is needed to coordinate policy and strategies at

Department of Essential Medicines and Pharmaceutical Policy

Evidence-based clinical guidelines are critical to promoting

3. Essential Medicines List based on treatments of choice

4. Drugs and therapeutics committees in districts and

5. Problem-based training in pharmacotherapy in

6. Continuing in-service medical education as a licensure

Department of Essential Medicines and Pharmaceutical Policy

7. Supervision, audit and feedback

8. Independent medicine information

Often, the only information about medicines that practitioners

9. Public education about medicines

10. Avoidance of perverse financial incentives

Department of Essential Medicines and Pharmaceutical Policy

11. Regulatory measures to support rational use

12. Sufficient government expenditure to ensure availability

Goal: to inform or persuade

Department of Essential Medicines and Pharmaceutical Policy

Training courses related to the rational use of medicines

Promoting the rational use of drugs (medicines), in collaboration with

Department of Essential Medicines and Pharmaceutical Policy

Training courses related to the rational use of medicines

Problem-based pharmacotherapy teaching, in collaboration with Groningen

Goal: to structure or guide

Strategies aimed at prescribers

Department of Essential Medicines and Pharmaceutical Policy

Avoid perverse financial

Goal: to restrict or limit

Regulating the use of different drugs to different

Regulating pharmaceutical promotional activities

Only work if the regulations are

Why does irrational use

WHO-sponsored training programmes

WHO model (Guide to Good Prescribing)

WHO model (Guide to Good Prescribing)

Rational use of medicines could be greatly improved