REGIONAL COMMITTEE Sixty-fourth Session Jaipur, Rajasthan, India 6–9 September 2011
Provisional Agenda item 5.5 SEA/RC64/16 21 July 2011
National Essential Drug Policy including Rational Use of Medicines Irrational use of medicines is a serious public health crisis that is causing considerable harm to patients in terms of poor patient outcomes, impoverishment (through large and unnecessary expenditure), unnecessary side-effects, antimicrobial resistance, morbidity and death. It is estimated in low- and middle-income countries that more than half of all medicines are used inappropriately. There are multiple causes of irrational use, including economic, legal, information related, workplace and workgroup factors, as well as educational ones. Due to these multiple causes, which involve many stakeholders, WHO has long advocated a comprehensive approach to address this issue and recommends a core set of medicines policies. Unfortunately, most efforts globally and in the Region to promote rational use of medicines have been educational in nature, small-scale and fragmented, with very limited impact. Furthermore, implementation of national medicine policies has been sub-optimal. A coordinated effort between so many different stakeholders is difficult in health systems where there is often no forum to meet nor a mandated body to facilitate the process. The Intercountry meeting on Promoting Rational Use of Medicines, held in the South-East Asia Region in July 2010 recognized these problems and recommended that the issue of how to tackle irrational use of medicines be discussed at the Regional Committee and that a comprehensive regional strategy be developed. The meeting further recommended that countries establish a dedicated, fully resourced unit in the government to monitor medicines use and coordinate the implementation of national policy to promote rational use of medicines; that the unit be guided by a broad-based steering committee involving all stakeholders; that each country undertake a situational analysis to develop a roadmap for action; and that WHO-SEARO support countries in these endeavours. The attached working paper is submitted to the Sixty-fourth Session of the Regional Committee for its review and recommendations.
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1. Rational use of medicines 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. This definition was formulated at the Conference of Experts on the Rational Use of Drugs held in Nairobi, Kenya in 1985, the contents of which formed the revised drug strategy endorsed by the World Health Assembly resolution WHA39.27 on “The rational use of drugs”. In recent times, rational use of medicines has been referred to in World Health Assembly resolutions, WHA54.11 on “The Revised Medicines Strategy (2001)” and WHA58.27 on “Improving the containment of antimicrobial resistance (2005)”. At the SEA Regional Committee Meeting, the issue has been referred to in RC resolutions, SEA/RC55/R4 on “Accessibility to Essential Medicines (2002)” and SEA/RC63/R4 on “Prevention and containment of antimicrobial resistance (2010)”. However, the issue of promoting rational use of medicines was discussed for the first time in detail at the World Health Assembly only in 2007 when resolution WHA60.16 on “Progress in the rational use of medicines” was adopted. The issue has never been discussed in detail at the Regional Committee meetings. 2. About US$ 5.3 trillion is spent annually, globally, on providing health services and a quarter of this is spent on medicines1. In some countries of the Region more than 40% of the health budget is spent on medicines. Unfortunately, world-wide, up to half of all medicines may be used inappropriately. WHO has been monitoring medicines use through a database of all published and unpublished (with sufficient information) surveys, done in primary care and using standard indicators, in developing and transitional countries. Data from 679 studies in 97 countries show that in low and middle income countries in primary care, less than 40% of medicines are prescribed in compliance with clinical guidelines in the public sector and less than 30% in the private sector and that the situation has not improved over the last 20 years2. Data from the WHO South-East Asia Region shows that only 55% diarrhoea cases received oral rehydration while 54% received antibiotics inappropriately and that only 53% of pneumonia cases received the correct antibiotic while 50% of viral upper respiratory tract infection cases received antibiotics inappropriately. It was also found that: 40% of antibiotics were prescribed in “under-dose”; the patient-dispenser interaction time was less than one minute; only 40% of patients were given dosage instructions; very few drugs were adequately labelled; and that only 60% of patients knew how to take their medicines. 3. Irrational use of medicines causes serious harm. Not only does it result in poor patient outcome and waste the resources of both individuals and governments, it also results in increased frequency of adverse drug reactions and medication errors, increased antimicrobial resistance and the spread of blood-borne infections through the use of unsterile injections. Outof-pocket expenditure causes severe financial hardship for the poor and marginalized. Antimicrobial resistance causes significant morbidity and mortality, longer hospital stays and treatment with more expensive second- or third-line drugs and has been estimated to cost annually US$ 4-5 billion in the USA3 and US$12.8 billion in Europe4. Adverse drug reactions and medication errors also cause significant morbidity and mortality, and have been estimated to cost US$ 607 million annually in the UK5 and US$ 5.6 million per hospital per year in the USA6 . It has been estimated that more than six billion unsterile injections are given annually, the highest number being in the South-East Asia Region, causing millions of infections of hepatitis B and C and over 100 000 new infections of HIV per year7.
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4. There are multiple causes for the irrational use of medicines. Firstly, there are intrinsic factors such as lack of prescriber knowledge (particularly for those insufficiently qualified) and prescriber habit (since it takes time to look up guidelines). Secondly, there are societal factors including social and cultural factors (which contribute to patient demand), legal factors (e.g. defensive medicine) and economic factors (e.g. profit motives in prescribers who sell medicines). Thirdly, there are workgroup factors such as lack of supervision (often lacking for many health workers) and peer relationships (whereby prescribers will follow the poor prescribing habits used by their seniors and peers). Fourthly, there are workplace factors such as drug supply (e.g. poor availability of essential medicines but good availability of non-essential medicines), lack of staff and overwork (leading to patient consultation times of less than one minute and dispenserpatient interaction times of a few seconds). Fifthly, there are informational factors including the poor availability of unbiased drug information (e.g. clinical guidelines and national formulary) as opposed to excessive availability of information from the pharmaceutical industry (which is often biased). 5. Prescribers who gain an income from the sale of medicines prescribe more medicines and more expensive medicines than prescribers who do not gain any income from medicine sales8, 9. Data from Ministries of Health10 shows that 50% of low-income and 20% of middle-income countries use revenue from medicines to pay prescriber salaries in the public sector. In many countries of the South-East Asia Region, where the private sector provides the majority of care, many prescribers are gaining an income from the sale of medicines and this is likely to be contributing significantly to over-prescription and the use of overly expensive medicines. Often medicine expenditure impoverishes the poor and marginalized and sometimes expenditure may be catastrophic. In such circumstances universal health coverage for all will be difficult to achieve. 6. Most efforts to improve the use of medicines have been fragmented and centered on the training of prescribers and has had very limited success. Most evidence for what kinds of interventions are successful comes from developed nations. The WHO Database on Medicines Use identified 386 interventions (described in 313 studies) that had been implemented but only 121 of these (in 81 studies) had been evaluated for their impact on medicines use in an adequate manner11. About half of these studies came from the South-East Asia Region. The overall findings are that provider education and/or the distribution of printed materials alone have an impact of less than 10% in terms of improvement whereas multi-component interventions involving education of providers and consumers together with regular supervision can improve use by more than 30%. Unless interventions are repeated their impact is not sustained. The experience is similar in the South-East Asia Region where it has been found that multi-component interventions aiming to increase the use of medicines (e.g. training and supervising community members to treat children with pneumonia with antibiotics) are more effective than interventions to reduce use of medicines (e.g. training pharmacy workers not to sell antibiotics for cases of mild viral upper respiratory tract infections)12.
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7. Due to the multiple causes of irrational use involving many actors, WHO has long advocated the need for a comprehensive approach and recommended a core set of drug policies13, summarized as follows:
Establishing a mandated multidisciplinary national body to coordinate medicine use policies and monitor their impact. Formulating and using evidence-based clinical guidelines for health professional training and supervision and for supporting critical decision-making about medicines. Selecting essential medicines lists based on treatments of choice which are used in drug procurement and insurance reimbursement. Setting up drug and therapeutics committees in districts and hospitals to undertake quality of care improvement cycles with regard to medicines use. Promoting problem-based training in pharmacotherapy in undergraduate curricula. Making continuing in-service medical education a requirement of licensure. Promoting systems of supervision, audit and feedback in institutional settings. Providing independent information (including comparative information) about medicines. Promoting public education about medicines. Eliminating perverse financial incentives that lead to irrational prescribing. Drawing up and enforcing appropriate regulation, including that for promotional activities. Reserving sufficient government expenditure to ensure equitable availability of medicines and health personnel.
Without such policies rational use of medicines can never be attained and most of these interventions lie within the technical and financial capacities of all Member States. 8. Unfortunately, implementation of policies to promote rational use of medicines is suboptimal, globally and in the Region14, 15. WHO has been monitoring the medicines policy through questionnaires sent to the Ministries of Health once every four years - in 2003, 2007 and again in 2011 (country pharmaceutical profiles). Table 116 shows the implementation of policies to promote rational use of medicines both globally and in the Region as reported in 2003 and 2007. While most countries in the region have an updated Essential Medicines List (EML), half or less have updated Standard Treatment Guidelines (STGs) or Drug and Therapeutic Committees (DTCs) in half or more of their hospitals. No country in the South-East Asia Region has reported having undertaken any prescription audit in the last two years. The situation may be worse than appears here because many of the policies may not be implemented in an optimal manner.
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Table 1: Medicines policies to encourage rational use of medicines globally and in the South-East Asia Region National Policies implemented* Sample size of countries responding to questions in the policy questionnaire Prescription audit in the last two years National strategy to contain antimicrobial resistance Antibiotic non-availability over-the-counter Public education on antibiotics undertaken DTCs in more than half of general hospitals National Drug Information Centre for prescribers Obligatory Continuing Medical Education for doctors Training for medical students on EML and STGs National EML used in public sector procurement National EML updated in the last two years National STGs updated in the last two years Globally 2003 n>90 28% 36% 30% 45% 53% 40% 49% 67% 56% 46% 23% 2007 n>85 40% 43% 25% 51% 58% 52% 56% 68% 84% 58% 34% S. E. Asia Region N=10 (overall) 2003 n=9 11% 22% 0% 56% 44% 67% 56% 44% 78% 33% 22% 2007 n=6 0% 50% 0% 67% 50% 83% 67% 67% 67% 83% 50%
*If a country did not respond to a particular question, it was assumed that the policy did not exist in that country.
9. In addition, it was reported that in 23% of low-income countries, personnel with less than one month’s training are sometimes prescribing prescription-only medicines in the public sector. In many countries of the South-East Asia Region, in the private sector prescribing and dispensing are often done by unqualified personnel. Drug regulatory bodies in the Region are often underresourced and have difficulty to enforce regulations. Finally, only 22% of low-income countries and 41% of middle-income countries reported having a national programme and/or a multidisciplinary body involving government with or without civil society and/or professional bodies to monitor the use of medicines and coordinate strategies to promote the rational use of medicines. In the absence of any dedicated body to do this, how will the needed monitoring and policy implementation be done? 10. The evidence concerning how to promote rational use of medicines was reviewed at the 2nd International Conference on Improving the Use of Medicines (Chiang Mai, Thailand, 2004) which was supported by WHO. It was noted that most interventions that had been carried out were small-scale and that there was a need to scale up successful interventions to a national scale. It was further noted that many different aspects of health systems and medicines policies can impact on medicines use, including: insurance systems; financing; selection, pricing and availability of medicines; pharmaceutical promotion; regulation; quality improvement structures such as Drug and Therapeutic Committees to undertake monitoring and supervision; public education and the availability of trained health-care professionals.
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11. A coordinated effort between so many different stakeholders is difficult in health systems where there is often no forum to meet nor a mandated body to facilitate the process. Therefore, the conference recommended that countries have national programmes to promote the rational use of medicines through coordinated implementation of sustainable and multifaceted interventions, scaled up to the national level and with in-built systems for monitoring medicines use in order to evaluate progress17. This recommendation was incorporated into the World Health Assembly resolution WHA60.16 on “Progress in the Rational Use of Medicines” in 2007. Similarly the need for a coordinating mechanism to implement policy has been recognized with regard to containing antimicrobial resistance in World Health Assembly resolution WHA58.27 on Improving the containment of antimicrobial resistance” and SEA Regional Committee resolution SEA/RC63/R4 on ”Prevention and containment of antimicrobial resistance”. 12. An intercountry meeting on promoting rational use of medicines was held at WHO-SEARO in July 201018 and nine Member States participated. At this meeting, it was also noted that most efforts to promote rational use of medicine had been small-scale and fragmented. This meeting reaffirmed the need for a coordinated national approach to promoting rational use of medicines and also noted that a situational analysis in each country was needed in order to know where to start. The meeting recommended that the issue be discussed at the Regional Committee, and that a resolution be adopted and a comprehensive regional strategy developed. Recommendations for countries included: establishing a dedicated unit to promote rational use of medicines in the government guided by a broad-based steering committee involving all stakeholders; implementing medicines policies (as summarized in paragraph 7) and undertaking a situational analysis to develop a roadmap for action. WHO-SEARO was asked to support Member countries in these endeavours. 13. Irrational use of medicines is likely to increase unless action is taken. Firstly, the use of medicines is significantly worse in the private sector compared with the public sector19 and the private sector is providing an increasing proportion of health-care delivery worldwide and in the Region. Secondly, many major global initiatives to increase access to essential medicines focus only on access and not on the fundamental and widespread problem of inappropriate use. Thirdly, despite mounting evidence of the need for a coordinated health systems approach, accompanied by robust and comprehensive medicines policies to promote the rational use of medicines, countries and the international community are still approaching this issue in ways that are small-scale and fragmented. 14. In summary, irrational use of medicines is an extremely serious public health crisis that is causing patient harm in terms of poor patient outcomes, impoverishment (through large unnecessary expenditure), unnecessary side effects, antimicrobial resistance, morbidity and death. There is now evidence that a coordinated implementation of medicine policies implemented by a dedicated body in the government is needed in all countries if significant progress is to be made to promote rational use of medicines. In the current financial circumstances and relative lack of focus on this area, WHO is unable to respond to the problem of irrational use of medicines. A regional resolution would help focus attention to this area and this would, in turn, help to generate resources so that WHO can effectively support Member States in their endeavours to promote rational use of medicines.
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References (1) (2) (3) (4) (5) (6) (7) (8) (9) World Health Organization; World Medicines Situation 2011; WHO, Geneva. World Health Organization; Medicines use in primary care in developing and transitional countries; Document WHO/EMP/MAR/2009.3. WHO Geneva 2009. Institute of Medicine; Microbial threats to health: emergence, detection and response; Washington DC, National Academics Press; 1998. Strategic Council on Resistance in Europe; Resistance: a sensitive issue, the European roadmap to combat antimicrobial resistance; SCORE 2004. Wiffen P, Gill M, Edwards J, Moore A; Adverse drug reactions in hospital patients: a systematic review of the prospective and retrospective studies, Bandolier extra, June 2002; http://www.ebandolier.com Anon.; Reducing and preventing adverse drug events to decrease hospital costs; Agency for Healthcare Research and Quality, 2000; http://www.ahrq.gov/qual/aderia/aderia.htm Yvan J F Hutin, Anja M Hauri, Gregory L Armstrong, Use of injections in healthcare settings worldwide, 2000: literature review and regional estimates, BMJ Volume 327, 8 November 2003 Trap B, Hansen EH, Hogerzeil HV. Prescription habits of dispensing and non-dispensing doctors in Zimbabwe. Health Policy and Planning. 17(3), 288-295. 2002. Park S, Soumerai SB, Adams AS, Finkelstein JA, Jang S, Ross-Degnan D. Antibiotic use following a Korean national policy to prohibit medication dispensing by physicians. Health Policy and Planning. 20(5), 302-309. doi:10.1093/heapol/czi033. 2005.
(10) World Health Organization, Country Pharmaceutical Situations: Fact Book on WHO Level 1 indicators 2007, Document WHO/EMP/2010.1. Geneva, WHO, 2010. (11) World Health Organization, Medicines use in primary care in developing and transitional countries; Document WHO/EMP/MAR/2009.3. WHO Geneva 2009. (12) Holloway K.A., Promoting rational use of antibiotics, Regional Health Forum WHO South East Asia Region, 2011, Volume 15 (1), pp.122-130. (13) World Health Organization, Promoting rational use of medicines: core components. WHO Policy Perspectives on Medicines no. 5. Document WHO/EDM/2002.3. Geneva, WHO, 2002. (14) World Health Organization, Country Pharmaceutical Situations: Fact Book on WHO Level 1 indicators 2007, Document WHO/EMP/2010.1. Geneva, WHO, 2010. (15) World Health Organization, Using indicators to measure country pharmaceutical situations: Fact Book on WHO Level I and Level II monitoring indicators, Document WHO/TCM/2006.2. Geneva, WHO, 2006. (16) Holloway K.A., Promoting rational use of antibiotics, Regional Health Forum WHO South East Asia Region, 2011, Volume 15 (1), pp.122-130. (17) Recommendations of the International Conference for Improving the Use of Medicines, Chiang Mai, Thailand, 2004, URL: http://mednet3.who.int/icium/icium2004/recommendations.asp (18) World Health Organization Regional Office for South East Asia; Promoting Rational Use of Medicines: report of the inter-country meeting New Delhi, India, 13-15 July 2010, Document SEA-Drugs-161, WHO/SEARO, New Delhi, India, 2010. (19) World Health Organization, Medicines use in primary care in developing and transitional countries; Document WHO/EMP/MAR/2009.3. WHO Geneva 2009.