WHO Promoting rational use of medicines: core components
Publication date: 2002
Page 1: WHO Policy Perspectives on Medicines — Promoting rational use of medicines: core components WHO Policy Perspectives on Medicines September 2002 World Health Organization Geneva Promoting rational use of medicines: core components 5 Definition of rational use of medicines Patients receive medications appropriate to theirclinical needs, in doses that meet their own indi- vidual requirements, for an adequate period of time, and at the lowest cost to them and their community.” (WHO, 1985). The problem of irrational use Irrational or non-rational use is the use of medicines in a way that is not compliant with rational use as defined above. 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 world’s population lacks access to essential medicines. Common types of irrational medicine use are: • the use of too many medicines per patient (poly- pharmacy); • inappropriate use of antimicrobials, often in inad- equate 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. Lack of access to medicines and inappropriate doses result in serious morbidity and mortality, particularly for childhood infections and chronic diseases, such as hypertension, diabetes, epilepsy and mental disorders. Inappropriate use and over-use of medicines waste resources – often out-of-pocket payments by patients – and result in significant patient harm in terms of poor patient outcomes and adverse drug reactions. Furthermore, over-use of antimicrobials is leading to increased antimicrobial resistance and non-sterile injections to the transmission of hepatitis, HIV/AIDS and other blood-borne diseases. Finally, irrational over-use of medicines can stimulate inappropriate patient demand, and lead to reduced access and attend- ance rates due to medicine stock-outs and loss of patient confidence in the health system. 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, in- appropriate promotion of medicines and profit motives from selling medicines. There are several well-established methods to meas- ure the type and degree of irrational use. Aggregate medicine (drug) consumption data can be used to identify expensive medicines of lower efficacy or to compare actual consumption versus expected consumption (from morbidity data). Anatomical Thera- peutic Classification (ATC)/Defined Daily Dose (DDD) methodology can be used to compare drug con- sumption among institutions, regions and countries. WHO drug use indicators (Box 1) can be used to iden- tify general prescribing and quality of care problems at primary health care facilities. Focused drug use evaluation (drug utilization review) can be done to identify problems concerning the use of specific medicines or the treatment of specific diseases, particularly in hospitals. The qualitative meth- ods employed in social science, (e.g. focus group discussion, in-depth interviews, structured observation and structured questionnaires), can be used to inves- tigate the motives underlying irrational use. The data collected can then be used to design appropriate interventions and to measure the impact of those interventions on medicine use. WHO, with partners, runs several international courses on how to measure medicine use and “ Page 2: WHO Policy Perspectives on Medicines — Promoting rational use of medicines: core components implement interventions to promote more rational use of medicines (Box 2). Working towards rational use of medicines A major step towards rational use of medicines was taken in 1977, when WHO established the 1st Model List of Essential Medicines to assist countries in formu- lating their own national lists. The present definition of rational use was agreed at an international confer- ence in Kenya in 1985. In 1989, the International Net- 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: email@example.com website: http://www.msh.org/ inrud). Following this, the WHO/INRUD indicators to in- vestigate drug use in primary health care facilities 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 Medicines (ICIUM) in Thailand in 1997. Box 3 shows a summary of the magnitude of prescribing improve- ment by type of intervention. The effect varied with intervention type, printed materials alone having little impact compared to the greater effects associ- ated with supervision, audit, group process and com- munity case management. Furthermore, the effects of training were variable and often unsustained, possibly due to differences in training quality and the presence or absence of follow-up and supervision. Core policies to promote more rational use of medicines Although many gaps remain in our knowledge, a summary of what is known concerning core policies, strategies and interventions to promote more rational use of medicines is presented in the following sections and summarized in Box 4. Box 1 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 to practitioners Availability of clinical guidelines % key medicines available Complementary Drug Use Indicators: Average medicine cost per encounter % prescriptions in accordance with clinical guidelines Box 2 Training courses related to the rational use of medicines For further details email: firstname.lastname@example.org or visit the WHO medicines website: http://www.who.int/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 collabo- ration with the Rational Pharmaceutical Programme 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. • 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 WHO’s 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. * International Network for the Rational Use of Drugs Page 3: 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 interventions often having little impact. 2. Clinical guidelines Clinical guidelines (standard treatment guidelines, prescribing policies) consist of systematically devel- oped statements to help prescribers make decisions about appropriate treatments for specific clinical conditions. 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 pro- vided they are: (1) developed in a participatory way involving end-users; (2) easy to read; (3) introduced with an official launch, training and wide dissemina- tion; and (4) reinforced by prescription audit and feedback. Guidelines should be developed for each level of care (ranging from paramedical staff in primary health care clinics to specialist doctors in ter- tiary referral hospitals), based on prevalent clinical conditions and the skills of available prescribers. Evidence-based treatment recommendations and regular updating help to ensure credibility and ac- ceptance of the guidelines by practitioners. Sufficient resources are needed to reimburse all those who contribute to the guidelines, and to cover the costs of printing, dissemination and training. 3. Essential Medicines List based on treatments of choice Essential medicines are those that satisfy the priority health care needs of the population. Using an essential medicines list (EML) makes medi- cine management easier in all respects; procurement, storage and distribution are easier with fewer items, and prescribing and dispensing are easier for profes- sionals 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 ac- tually supplied with them. Government activities in the pharmaceutical sector (e.g. quality assurance, insur- ance reimbursement policies and training), should focus on the EML. The WHO Model List of Essential Medicines can provide a starting point for countries to develop their own national EML. Box 3 Review of 30 studies in developing countries size of drug use improvements with different interventions 1. A mandated multi-disciplinary national body to coordinate medicine use policies Many societal and health system factors, as well as professionals and many others, contribute to how medicines are used. Therefore, a multi-disciplinary approach is needed to develop, implement and evaluate interventions to promote more rational use of medicines. A national regulatory authority (RA) is the agency that develops and implements most of the legislation and regulation on pharmaceuticals. Ensuring rational use will require many additional activities which will need coordination with many stakeholders. Thus a national body is needed to co- ordinate 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, pharmaceuti- cal industry, consumer groups and non-governmental organizations involved in health care. The impact Box 4 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 Large group training Small group training Diarrhoea community case mgt ARI community case mgt Printed materials/guidelines Group process Supervision/audit Drug supply/management (mgt) Economic strategies 0 10 20 30 40 50 60 ModerateNone/minor Large Improvement in outcome measure (%) Adapted from: Essential Drugs Monitor, 1997 ARI=Acute Respiratory Infection Page 4: WHO Policy Perspectives on Medicines — Promoting rational use of medicines: core components 4. Drugs and therapeutics committees in districts and hospitals A drugs and therapeutics committee (DTC), also called a pharmacy and therapeutics committee, is a committee designated to ensure the safe and effec- tive 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 hospi- tals (Box 5). Governments may encourage hospitals to have DTCs by making it an accreditation requirement to various professional societies. DTC members should represent all the major specialities and the adminis- tration; they should also be independent and declare any conflict of interest. A senior doctor would usually be the chairperson and the chief pharmacist, the secretary. Factors critical to success include: clear objectives; a firm mandate; support by the senior hospital man- agement; transparency; wide representation; tech- nical competence; a multidisciplinary approach; and sufficient resources to implement the DTC’s decisions. 6. Continuing in-service medical education as a licensure requirement Continuing in-service medical education (CME) is a requirement for licensure of health professionals in many industrialized countries. In many developing countries opportunities for CME are limited and there is also no incentive since it is not required for contin- ued licensure. 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 unaccompa- nied by face-to-face interventions, have been found to be ineffective in changing prescribing behaviour. CME need not be limited only to professional medi- cal or paramedical personnel, but may also include people in the informal sector such as medicine retail- ers. Often CME activities are heavily dependent on the support of pharmaceutical companies, as public funds are insufficient. This type of CME may not be un- biased. Governments should therefore support efforts by university departments and national professional associations to give independent CME. 7. Supervision, audit and feedback Supervision is essential to ensure good quality of care. Supervision that is supportive, educational and face- to-face, 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 analys- ing prescription appropriateness and then giving feedback. Prescribers may be told how their prescrib- ing 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, implement- ing 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. 8. Independent medicine information Often, the only information about medicines that practitioners receive is provided by the pharmaceuti- cal industry and may be biased. Provision of independ- ent (unbiased) information is therefore essential. Drug information centres (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 super- vision of a trained health professional. Whoever runs the DIC or bulletin must (1) be independent of outside Box 5 Responsibilities of a drugs and therapeutics committee • developing, adapting, or adopting clinical guidelines for the health institution or district; • selecting cost-effective and safe medicines (hospital/ district drug formulary); • implementing and evaluating strategies to improve medicine use (including drug use evaluation, and liaison with antibiotic and infection control committees); • providing on-going staff education (training and printed materials); • controlling access to staff by the pharmaceutical industry with its promotional activities; • monitoring and taking action to prevent adverse drug reactions and medication errors; • providing advice about other drug management issues, such as quality and expenditure. 5. Problem-based training in pharmacotherapy in undergraduate curricula The quality of basic training in pharmacotherapy for undergraduate medical and paramedical stu- dents 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 suc- cessful if it is problem-based, concentrates on com- mon 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. Page 5: WHO Policy Perspectives on Medicines — Promoting rational use of medicines: core components influences and disclose any financial or other conflict of interest, and (2) use evidence-based medicine and transparent deduction for all recommendations made. The WHO Model Formulary provides independ- ent information on all medicines in the WHO Model List of Essential Medicines. 9. Public education about medicines Without sufficient knowledge about the risks and ben- efits of using medicines and when and how to use them, people will often not get the expected clinical out- comes and may suffer adverse effects. This is true for prescribed medicines, as well as medicines used with- out the advice of health professionals. Governments have a responsibility to ensure both the quality of medicines and the quality of the information about medicines available to consumers. This will require: • Ensuring that over-the-counter medicines are sold with adequate labelling and instructions that are accurate, legible, and easily understood by lay- persons. The information should include the medi- cine 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 pre- scribers, 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 programmes, such as literacy courses. 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 medi- cines (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 reim- bursed when the prescription conforms to clinical guidelines, there may be an even stronger pressure on prescribers to prescribe rationally. 11. Appropriate and enforced regulation Regulation of the activities of all actors involved in the use of medicines is critical to ensuring rational use (Box 6). If regulations are to have any effect, they must be enforced, and the regulatory authority must be sufficiently funded and backed up by the judiciary. 12. Sufficient government expenditure to ensure availability of medicines and staff Lack of essential medicines leads to the use of non- essential 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 pro- gramme to promote rational use of medicines. Poor clinical outcome, needless suffering and economic waste are sufficient reasons for large government investment. Box 6 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, up-to-date, capable of substantiation and in good taste. WHO’s ethical guidelines (1988) may be used as a basis for developing control measures. Page 6: WHO Policy Perspectives on Medicines — Promoting rational use of medicines: core components Governments are responsible for investing the neces- sary funds to ensure that all public health facilities have sufficient, appropriately trained health profes- sionals 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. Key documents Grimshaw JG, Russell IT. Effect of Clinical Guidelines on Medical Practice: A Systematic Review of Rigorous Evaluations. Lancet, 1993;342:1317–132. Hogerzeil HV. Promoting Rational Prescribing: An Interna- tional Perspective. British Journal of Clinical Pharmacol- ogy, 1995;39:1–6. Hogerzeil HV, et al. Field Tests for Rational Drug Use in Twelve Developing Countries. Lancet, 1993;342: 1408–1410. Laing R, Hogerzeil HV, Ross-Degnan D. Ten Recommenda- tions to Improve the Use of Medicines in Developing Countries. Health Policy and Planning, 2001;16(1):13–20. Monitoring medicine use and using the collected information to develop, implement and evaluate strategies to change inappropriate medicine use behaviour are fundamental to any national programme to promote rational use of medicines. A mandated multi-disciplinary national body to coordinate all activities and sufficient government funding are critical to success. WHO/EDM/2002.3 Original: English Quick JD, Rankin JR, Laing RO, O’Connor RW, Hogerzeil HV, Dukes MNG, Garnett A. Managing Drug Supply, 2nd ed. West Hartford: Kumarian Press; 1997. Weekes LM, Brooks C. Drugs and Therapeutics Committees in Australia: Expected and Actual Performance. British Journal of Clinical Pharmacology, 1996;42(5):551–7. *World Health Organization. Essential Drugs Monitor, 1997;23:10. *World Health Organization. Ethical Criteria for Medicinal Drug Promotion. Geneva: WHO; 1988. *World Health Organization. Guide to Good Prescribing. Geneva: WHO; 1994. *World Health Organization. How to Develop and Imple- ment a National Drug Policy. 2nd ed. Geneva: WHO; 2001. *World Health Organization. How to Investigate Drug Use in Health Facilities. Selected Drug Use Indicators. Geneva: WHO; 1993. *World Health Organization. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000–2003. Geneva: WHO; 2000. (WHO/EDM/ 2000.1). *World Health Organization. WHO Model Formulary. Geneva: WHO; 2002. World Health Organization. The Rational Use of Drugs. Report of the Conference of Experts. Geneva: WHO; 1985. *World Health Organization. Teacher’s Guide to Good Prescribing. Geneva: WHO; 2001. (WHO/EDM/PAR/ 2001.2). * World Health Organization. The Selection and Use of Essential Medicines: Report of the WHO Expert Commit- tee (including the 12th WHO Model List of Essential Medicines). Geneva: WHO; 2002 (in preparation). The documents marked with * are also available on http://www.who.int/ medicines/ Contacts at WHO Headquarters: Essential Drugs and Medicines Policy Health Technology and Pharmaceuticals Cluster WHO Headquarters, Geneva, Switzerland: Dr Jonathan Quick Director, Essential Drugs and Medicines Policy Department Tel: +41 22 791 4443 E-mail: email@example.com Dr Hans Hogerzeil Team Coordinator, Policy, Access and Rational Use Tel: +41 22 791 3528 E-mail: firstname.lastname@example.org Dr Lembit Rägo Team Coordinator, Quality and Safety: Medicines Tel: +41 22 791 4420 E-mail: email@example.com Dr Germán Velásquez Team Coordinator, Drug Action Programme Tel: +41 22 791 3509 E-mail: firstname.lastname@example.org Dr Xiaorui Zhang Team Coordinator, Traditional Medicine Tel: +41 22 791 3639 E-mail: email@example.com © World Health Organization 2002. All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: firstname.lastname@example.org). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use.
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