Professional Documents
Culture Documents
Promoting Rational Use of Medicines: Core Components
Promoting Rational Use of Medicines: Core Components
Policy
Perspectives
on Medicines
Promoting rational use of
medicines: core components
September 2002
World Health Organization
Geneva
P
atients receive medications appropriate to their To address irrational use of medicines, prescribing,
clinical needs, in doses that meet their own indi- dispensing and patient use should be regularly
vidual requirements, for an adequate period of time, monitored in terms of:
and at the lowest cost to them and their community.
(WHO, 1985). 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
The problem of irrational use problem is known and the impact of the strategies
can be monitored;
Irrational or non-rational use is the use of medicines in a the reasons why medicines are used irrationally,
way that is not compliant with rational use as defined so that appropriate, effective and feasible strategies
above. Worldwide more than 50% of all medicines can be chosen. People often have very rational
are prescribed, dispensed, or sold inappropriately, reasons for using medicines irrationally. Causes of
while 50% of patients fail to take them correctly. irrational use include lack of knowledge, skills or
Moreover, about one-third of the worlds population independent information, unrestricted availability
lacks access to essential medicines. Common types of medicines, overwork of health personnel, in-
of irrational medicine use are: appropriate promotion of medicines and profit
motives from selling medicines.
the use of too many medicines per patient (poly-
pharmacy); There are several well-established methods to meas-
ure the type and degree of irrational use. Aggregate
inappropriate use of antimicrobials, often in inad-
medicine (drug) consumption data can be used
equate dosage, for non-bacterial infections;
to identify expensive medicines of lower efficacy
over-use of injections when oral formulations would
or to compare actual consumption versus expected
be more appropriate;
consumption (from morbidity data). Anatomical Thera-
failure to prescribe in accordance with clinical
peutic Classification (ATC)/Defined Daily Dose (DDD)
guidelines;
methodology can be used to compare drug con-
inappropriate self-medication, often of prescription- sumption among institutions, regions and countries.
only medicines. WHO drug use indicators (Box 1) can be used to iden-
Lack of access to medicines and inappropriate doses tify general prescribing and quality of care problems
result in serious morbidity and mortality, particularly at primary health care facilities.
for childhood infections and chronic diseases, such as Focused drug use evaluation (drug utilization review)
hypertension, diabetes, epilepsy and mental disorders. can be done to identify problems concerning the use
Inappropriate use and over-use of medicines waste of specific medicines or the treatment of specific
resources often out-of-pocket payments by patients diseases, particularly in hospitals. The qualitative meth-
and result in significant patient harm in terms of poor ods employed in social science, (e.g. focus group
patient outcomes and adverse drug reactions. discussion, in-depth interviews, structured observation
Furthermore, over-use of antimicrobials is leading to and structured questionnaires), can be used to inves-
increased antimicrobial resistance and non-sterile tigate the motives underlying irrational use. The data
injections to the transmission of hepatitis, HIV/AIDS and collected can then be used to design appropriate
other blood-borne diseases. Finally, irrational over-use interventions and to measure the impact of those
of medicines can stimulate inappropriate patient interventions on medicine use.
demand, and lead to reduced access and attend-
ance rates due to medicine stock-outs and loss of WHO, with partners, runs several international
patient confidence in the health system. courses on how to measure medicine use and
Page 1: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components
Box 1 Selected WHO/INRUD* drug use Box 2 Training courses related to the
indicators for primary health care facilities rational use of medicines
(WHO, 1993) For further details email: medmail@who.int or visit the WHO
medicines website: http://www.who.int/medicines/
Prescribing Indicators:
Average number of medicines prescribed per patient Promoting the rational use of drugs (medicines),
encounter in collaboration with the International Network for the
% medicines prescribed by generic name Rational Use of Drugs (INRUD) coordinated by
% encounters with an antibiotic prescribed Management Sciences for Health, USA. This course
% encounters with an injection prescribed teaches the investigation of medicine use in primary
% medicines prescribed from essential medicines list or health care and how to promote rational use of
formulary medicines by providers.
Patient Care Indicators: Promoting rational drug (medicine) use in the
Average consultation time community, in collaboration with the University of
Average dispensing time Amsterdam, The Netherlands. This course teaches the
% medicines actually dispensed investigation of medicine use in the community, and
% medicines adequately labelled how to promote rational use of medicines by
% patients with knowledge of correct doses consumers.
Facility Indicators: Drugs and therapeutics committees, in collabo-
Availability of essential medicines list or formulary to ration with the Rational Pharmaceutical Programme
practitioners coordinated by Management Sciences for Health, USA.
Availability of clinical guidelines This course teaches methods for evaluating medicine
% key medicines available utilization and how to promote rational use of
medicines in hospitals and districts.
Complementary Drug Use Indicators:
Average medicine cost per encounter Problem-based pharmacotherapy teaching,
% prescriptions in accordance with clinical guidelines in collaboration with Groningen University, The
Netherlands, the University of Cape Town, South Africa,
* International Network for the Rational Use of Drugs 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
implement interventions to promote more rational use
on WHOs Guide to Good Prescribing.
of medicines (Box 2).
Pharmacoeconomics, in collaboration with the
University of Newcastle, Australia. This course teaches
how to do economic evaluation in medicine selection.
Working towards rational use Drug (medicine) policy issues for developing
of medicines countries, in collaboration with Boston University, USA.
This course teaches about general medicines policy
A major step towards rational use of medicines was including aspects relating to promoting more rational
use of medicines.
taken in 1977, when WHO established the 1st Model
List of Essential Medicines to assist countries in formu- ATC/DDD methodology for medicine consumption,
lating their own national lists. The present definition of in collaboration with the WHO Collaborating Centre for
rational use was agreed at an international confer- Drug Statistics Methodology. This course provides an
introduction to the application of ATC/DDD
ence in Kenya in 1985. In 1989, the International Net-
methodology in measuring medicine consumption.
work for the Rational Use of Drugs (INRUD) was formed
to conduct multi-disciplinary intervention research
projects to promote more rational use of medicines
(email: inrud@msh.org website: http://www.msh.org/
of training were variable and often unsustained,
inrud). Following this, the WHO/INRUD indicators to in-
possibly due to differences in training quality and the
vestigate drug use in primary health care facilities
presence or absence of follow-up and supervision.
were developed and many intervention studies con-
ducted. A review of all the published intervention stud-
ies with adequate study design was presented at the
1st International Conference for Improving the Use of
Core policies to promote more rational
Medicines (ICIUM) in Thailand in 1997. Box 3 shows a use of medicines
summary of the magnitude of prescribing improve-
ment by type of intervention. The effect varied with Although many gaps remain in our knowledge, a
intervention type, printed materials alone having summary of what is known concerning core policies,
little impact compared to the greater effects associ- strategies and interventions to promote more rational
ated with supervision, audit, group process and com- use of medicines is presented in the following sections
munity case management. Furthermore, the effects and summarized in Box 4.
Page 2: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components
on medicine use is better if many interventions are
implemented together in a coordinated way, single
Box 3 Review of 30 studies in developing countries
interventions often having little impact.
size of drug use improvements with different interventions
Page 3: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components
4. Drugs and therapeutics committees 6. Continuing in-service medical education
in districts and hospitals as a licensure requirement
A drugs and therapeutics committee (DTC), also Continuing in-service medical education (CME) is a
called a pharmacy and therapeutics committee, is a requirement for licensure of health professionals in
committee designated to ensure the safe and effec- many industrialized countries. In many developing
tive use of medicines in the facility or area under its countries opportunities for CME are limited and there
jurisdiction. Such committees are well-established in is also no incentive since it is not required for contin-
industrial countries as a successful way of promoting ued licensure. CME is likely to be more effective if it
more rational, cost-effective use of medicines in hospi- is problem-based, targeted, involves professional
tals (Box 5). Governments may encourage hospitals to societies, universities and the ministry of health, and is
have DTCs by making it an accreditation requirement face-to-face. Printed materials that are unaccompa-
to various professional societies. DTC members should nied by face-to-face interventions, have been found
represent all the major specialities and the adminis- to be ineffective in changing prescribing behaviour.
tration; they should also be independent and declare CME need not be limited only to professional medi-
any conflict of interest. A senior doctor would usually cal or paramedical personnel, but may also include
be the chairperson and the chief pharmacist, the people in the informal sector such as medicine retail-
secretary. ers. Often CME activities are heavily dependent on
the support of pharmaceutical companies, as public
Factors critical to success include: clear objectives; funds are insufficient. This type of CME may not be un-
a firm mandate; support by the senior hospital man- biased. Governments should therefore support efforts
agement; transparency; wide representation; tech- by university departments and national professional
nical competence; a multidisciplinary approach; and associations to give independent CME.
sufficient resources to implement the DTCs decisions.
Page 4: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components
influences and disclose any financial or other conflict Patients prefer medicines that are free or reimbursed.
of interest, and (2) use evidence-based medicine and If only essential medicines are provided free by
transparent deduction for all recommendations government or reimbursed through insurance,
made. The WHO Model Formulary provides independ- patients will pressure prescribers to prescribe only
ent information on all medicines in the WHO Model essential medicines. If medicines are only reim-
List of Essential Medicines. bursed when the prescription conforms to clinical
guidelines, there may be an even stronger pressure
on prescribers to prescribe rationally.
9. Public education about medicines
Without sufficient knowledge about the risks and ben-
11. Appropriate and enforced regulation
efits of using medicines and when and how to use them,
people will often not get the expected clinical out- Regulation of the activities of all actors involved in
comes and may suffer adverse effects. This is true for the use of medicines is critical to ensuring rational use
prescribed medicines, as well as medicines used with- (Box 6). If regulations are to have any effect, they must
out the advice of health professionals. Governments be enforced, and the regulatory authority must be
have a responsibility to ensure both the quality of sufficiently funded and backed up by the judiciary.
medicines and the quality of the information about
medicines available to consumers. This will require:
Ensuring that over-the-counter medicines are sold Box 6 Regulatory measures to support
with adequate labelling and instructions that are rational use
accurate, legible, and easily understood by lay-
persons. The information should include the medi- registration of medicines to ensure that only safe
cine name, indications, contra-indications, dosages, efficacious medicines of good quality are available in
drug interactions, and warnings concerning unsafe the market and that unsafe non-efficacious medicines
are banned;
use or storage.
limiting prescription of medicines by level of prescriber;
Monitoring and regulating advertising, which this includes limiting certain medicines to being
may adversely influence consumers as well as pre- available only with a prescription and not available
scribers, and which may occur through television, over-the-counter;
radio, newspapers and the internet. setting educational standards for health professionals
Running targeted public education campaigns, and developing and enforcing codes of conduct; this
which take into account cultural beliefs and the requires the cooperation of the professional societies
and universities;
influence of social factors. Education about the
licensing of health professionals doctors, nurses,
use of medicines may be introduced into the
paramedics to ensure that all practitioners have the
health education component of school curricula
necessary competence with regard to diagnosis,
or into adult education programmes, such as prescribing and dispensing;
literacy courses. licensing of medicine outlets retail shops, wholesalers
to ensure that all supply outlets maintain the
10. Avoidance of perverse financial incentives necessary stocking and dispensing standards;
monitoring and regulating medicine promotion to
Financial incentives may strongly promote rational or ensure that it is ethical and unbiased. All promotional
irrational use. Examples include: claims should be reliable, accurate, truthful, informative,
balanced, up-to-date, capable of substantiation and in
Prescribers who earn money from the sale of medi- good taste. WHOs ethical guidelines (1988) may be
cines (e.g. dispensing doctors), prescribe more used as a basis for developing control measures.
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.
12. Sufficient government expenditure to
Flat prescription fees, covering all medicines in
ensure availability of medicines and staff
whatever quantities within one prescription, lead Lack of essential medicines leads to the use of non-
to over-prescription; therefore user charges should essential medicines, and lack of appropriately trained
be made per medicine, not per prescription. personnel leads to irrational prescribing by untrained
Dispensing fees, calculated as a percentage of personnel. Furthermore, without sufficient competent
the cost of the medicines, encourage the sale personnel and finances, it is impossible to carry
of more expensive medicines; therefore a flat out any of the core components of a national pro-
dispensing fee irrespective of the price of the gramme to promote rational use of medicines. Poor
medicine is preferable. Although it may lead to clinical outcome, needless suffering and economic
price increases for cheaper medicines, it lowers waste are sufficient reasons for large government
the price of higher cost medicines. investment.
Page 5: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components
WHO/EDM/2002.3
Original: English
Governments are responsible for investing the neces- Quick JD, Rankin JR, Laing RO, OConnor RW, Hogerzeil HV,
sary funds to ensure that all public health facilities Dukes MNG, Garnett A. Managing Drug Supply, 2nd ed.
have sufficient, appropriately trained health profes- West Hartford: Kumarian Press; 1997.
sionals and enough essential medicines at affordable Weekes LM, Brooks C. Drugs and Therapeutics Committees
prices for all the population, with specific provisions in Australia: Expected and Actual Performance. British
for the poor and disadvantaged. Achieving these will Journal of Clinical Pharmacology, 1996;42(5):5517.
require limiting government procurement and supply *World Health Organization. Essential Drugs Monitor,
to essential medicines only, and investing in adequate 1997;23:10.
training, supervision and health staff salaries. *World Health Organization. Ethical Criteria for Medicinal
Drug Promotion. Geneva: WHO; 1988.
*World Health Organization. Guide to Good Prescribing.
Geneva: WHO; 1994.
Monitoring medicine use and using the collected
*World Health Organization. How to Develop and Imple-
information to develop, implement and evaluate
ment a National Drug Policy. 2nd ed. Geneva: WHO;
strategies to change inappropriate medicine use
2001.
behaviour are fundamental to any national
programme to promote rational use of medicines. *World Health Organization. How to Investigate Drug Use
A mandated multi-disciplinary national body to in Health Facilities. Selected Drug Use Indicators.
coordinate all activities and sufficient government Geneva: WHO; 1993.
funding are critical to success. *World Health Organization. WHO Medicines Strategy:
Framework for Action in Essential Drugs and Medicines
Policy 20002003. Geneva: WHO; 2000. (WHO/EDM/
2000.1).
Key documents *World Health Organization. WHO Model Formulary.
Geneva: WHO; 2002.
Grimshaw JG, Russell IT. Effect of Clinical Guidelines on World Health Organization. The Rational Use of Drugs.
Medical Practice: A Systematic Review of Rigorous Report of the Conference of Experts. Geneva: WHO;
Evaluations. Lancet, 1993;342:1317132. 1985.
Hogerzeil HV. Promoting Rational Prescribing: An Interna- *World Health Organization. Teachers Guide to Good
tional Perspective. British Journal of Clinical Pharmacol- Prescribing. Geneva: WHO; 2001. (WHO/EDM/PAR/
ogy, 1995;39:16. 2001.2).
Hogerzeil HV, et al. Field Tests for Rational Drug Use in * World Health Organization. The Selection and Use of
Twelve Developing Countries. Lancet, 1993;342: Essential Medicines: Report of the WHO Expert Commit-
14081410. tee (including the 12th WHO Model List of Essential
Medicines). Geneva: WHO; 2002 (in preparation).
Laing R, Hogerzeil HV, Ross-Degnan D. Ten Recommenda-
tions to Improve the Use of Medicines in Developing The documents marked with * are also available on http://www.who.int/
Countries. Health Policy and Planning, 2001;16(1):1320. medicines/
Page 6: WHO Policy Perspectives on Medicines Promoting rational use of medicines: core components