1. Improving Use of Medicines - Where are we today? Kathleen A Holloway Regional Advisor Essential Drugs and Other Medicines World Health Organisation, South East Asia World Health Organization Regional Office for South-East Asia

2. A history Definition of rational use of drugs Nairobi 1985 –WHO Resolution WHA 39.27 endorses definition and recommends strategy to promote rational use of drugs/medicines (RUM) INRUD formed in 1990 –WHO/INRUD indicators & training courses developed ICIUM 1 in 1997 –Experience of interventions mostly in public PHC shared –Recommendations to (1) work on hospital DTCs & drug use indicators, (2) community drug use & (3) impact of policies on use ICIUM 2 in 2004 –Experience in 25 areas of drug use shared –Recommendations to (1) implement national programs to improve use, (2) scale up successful interventions in sustainable way & (3) implement interventions in the community Resolution WHA60.16 on rational use of medicines, 2007 –Incorporated major recommendations from ICIUM 2, but …. –Lack of funds to implement recommendations

3. WHO Actions WHA60.16: Progress in rational use of medicines, 2007 –Urges Member States to “consider establishing and/or strengthening…a full national programme &/or multidisciplinary national body, involving civil society and professional bodies, to monitor and promote the rational use of medicines” SEAR/RC64/R5: Nat. Essential Drug Policy & RUM, 2011 –Urges Member States to “establish or strengthen a dedicated department/division/unit in the government, guided by a broad-based, long-term, independent steering committee …to monitor medicines use and coordinate strategies to promote rational use of medicines … and to develop a roadmap for action based on a situational analysis” WHO activities 2007-2011 - with very limited funds –Promoting Essential Medicines Concept – EMLs, STGs –Supporting training on promoting RUM in community, PHC, hospitals –Monitoring (1) drug use in PHC & (2) drug policy implementation –Research on cost-effective interventions & evidence-based advocacy –Developing situational analysis tool for use by countries to identify problems and solutions to inform national planning

4. WHO database on medicines use in primary care 1990-2009 ICIUM 2011: Abstracts 337 & 338 Irrational use continues …

5. Intervention impact: largest % change in any medicines use outcome measured in each study Intervention typeNo. studiesMedian impact25,75 th centiles Printed materials6 8% 4%, 10% National policy617% 4%, 23% Economic strategies813% 8%, 19% Provider education2917% 9%, 22% Consumer education326%13%, 27% Provider+consumer ed1621%11%, 24% Provider supervision2618%14%, 31% Provider group process936%19%, 59% Essential drug program427%22%, 40% Community case mgt1033%28%, 39% Provider+consumer educ & supervision 740%18%, 54% ICIUM 2011: Abstracts 337 & 338

6. National policies in place to promote rational use Source: MOH Pharmaceutical policy surveys 2003 & 2007

7. Do countries with drug policies have better use than those without? Data sources: –WHO databases on pharmaceutical policy (as reported by MOHs in 2003 & 2007) and medicines use 2002 - 2008 from 58 countries Outcome: –Difference in 12 medicine use indicators between countries with policy & without policy, expressed as % better (+) or % worse (-) use Analysis: –Median of % better or worse use across all 12 indicators calculated for countries with policy as compared to those without policy –Linear regression of the number of policies identified to “impact” on drug use positively vs each drug use indicator in each country ICIUM 2011: Abstract 339

8. % better/worse drug use associated with policies Policy (+ = better; - = worse)Composite indicator Indicator median (25,75 percentiles) Drug & Therapeutic Committees in > hosps+ 21%+ 8% (1,16) Drugs free: <5years and all ages+15 to 21%+10 to12% (3,18) Undergrad nurse/doc training on EML/STG+8 to 23%+ 7 to 12% (4,19) Dedicated MOH unit on Rational Drug Use+ 12%+ 9% (5,21) National Drug Information Centre+ 8%+ 6% (3,11) Public education on Antibiotic use+ 6%+ 8% (2,11) National strategy to contain AMR+18%+ 5% (3,16) Ess.Med.List (EML) updated in last 2 years+15%+ 3% (1,6) Antibiotics available Over the Counter-21%- 9% (-12,-2) Drug sales revenue used for salaries-12%- 6% (-12,-1) Prescribing by staff of < 1 month training-20%- 2% (-4,-1) Continuing Med. Education for health staff-8 to -20%- 13% (-16,-1) ICIUM 2011: Abstract 339

9. Correlation of AB use for viral upper respiratory tract infection and number of policies ♦ Country Nigeria China India Brazil Malaysia Oman R=-0.57 B=-3.24 P<0.001 ICIUM 2011: Abstract 339

10. Other progress European AMR containment strategies –EARSS / ESAC surveillance, National coordination programs (Cars 2007), public education programs (Huttner et al 2010) Quantitative reviews intervention effectiveness –IMCI (HPP 2010), Health Worker Performance (abstract 445) Development of a national situational analysis tool to inform national planning to promote rational use of drugs –SE Asian region (abstract 611), S.Africa (abstract 420) Development of monitoring tools, indicators and intervention to improve adherence to ARVs –Sub-Saharan Africa (abst. 505, 532, 542, 543, 544, 545, 817, 1121) Costing of irrational use –Using WHO databases (abstracts 343, 358) Community-based surveillance of antibiotic use and AMR –India & South Africa (abstracts 340, 341, 353, 354, 556, 582, 584)

11. Situational Analyses S. E. Asia 2010-2011 Sri Lanka, Bangladesh, Maldives, Bhutan, Indonesia, Nepal, Myanmar Few countries know what drugs they are using: –Little monitoring of drug consumption or prescription audit –Drug supply systems are mostly manual and inefficient with poor quantification and stock management Most countries have multiple brands of the same drug: –500+ ‘brands’ of some drugs e.g. ABs, analgesics in some countries –“We cannot limit the number of products for a particular molecule registered because of complaints of the monopolies commission” –“Having so many ‘brands’ makes it difficult to regulate the market and convince doctors and patients to follow any EML” –“We had to choose the lowest priced tender because of new government financial rules even though we knew it may result in non-delivery due to supplier default” Essential Drug Lists are generally not used: –By public hospitals, the private sector or insurance companies Workshop to discuss issues and identify solutions: –Greatly appreciated in all countries

12. Indonesian “puyer”: pulverizing 2 or more (often 5-10) drugs into a powder and then allocating doses by eye

13. Indian private practice: every 4 th 'patient' is a drug company representative

14. Nepal Health Worker Views Auxiliary Health Worker (1 year trained paramedic in Health Post) “For children under 5 years with pneumonia I must give amoxy syrup according to IMCI guidelines. Since we are short of amoxy syrup & have short-dated chloramphenicol syrup, I am prescribing it to children of more than 5 years with pneumonia in order to use up the stock.” Peon (untrained assistant in sub-HP) “When doctor saab is not here I do dressings and give out cetamol. For young children I give cotrim.” Funeral pyre in remote N. E. Nepal First, do no harm. How can we ensure that drug misuse does not contribute to untimely deaths?

15. Challenges Lack of institutionalisation to promote RUM –Often there is no unit in MOH doing monitoring or coordination of interventions & policies to promote RUM Lack of investment & policy implementation Fragmentation of health systems, largely driven by donors Imbalance of drug information –Most prescribers get their information only from drug company representatives Lack of pharmaceutical public health experts –Medicine issues are not taught in most public health degrees –Public health has fragmented into sub-specialities with limited pharmaceutical public health & general public health expertise Research needs –How to develop national integrated health system approaches to promote RUM & how to monitor policy implementation –Impact of “non-health” (e.g. fiscal) policies on health & medicine use

16. The Reality Continued irrational use & lack of action to tackle it is the biggest public health scandal of the 21 st century Irrational use is bad news & nobody likes to hear about it –Many countries are unwilling & most donors do not fund projects to promote rational use of medicines WHO programs on promoting RUM –Most international training & research stopped due to lack of funds –Unless funds come, WHO's databases to monitor drug use, intervention impact & pharmaceutical policy will be abandoned and there will be no data for advocacy or another WHA Resolution Searching for funds for WHO post WHA60.16 (2007) –Many proposals & letters of intent developed but not one accepted –Donors not happy even to have RUM component in umbrella grant –"We only deal with getting the drugs to the country, WHO should deal with how the drugs are used" –"This project would take too long & we need results in 3 years"

17. Ways Forward Develop contextualised national coordinated plans of action based on a situational analysis –WHO developing a tool but lacks funding Training & research in the pharmaceutical sector –Schools of public health should teach about the pharmaceutical sector, clinical pharmacology & pharmacy courses should teach the skills of drug use monitoring, formulary management, DTCs –Journals should publish much more on drug policy & use research Continue to monitor the situation and any progress: –Drug use, intervention impact & pharmaceutical policy impact to provide evidence for advocacy + another WHA Resolution Spend 5% of all medicines budget on promoting RUM –All donors should contribute Move from research to activism for change and replace competition with collaboration and cooperation

18. Continue the debate We know what to do but we are not doing it, so we need continued political pressure and debate –WHA60.16 requires 2 yearly reporting to the WHA, so use the opportunity to continue the debate & get another Resolution –Lobby for national, regional, international multi-stakeholder collaboration in development of the pharmaceutical sector e.g. …. –All donors supplying medicines agree to allocate some of their funds to monitoring use & promoting RUM (for ALL medicines) –Pharma companies agree to limit & publicly declare their promotional activities & stop all adverts promoting inappropriate use For adoption of WHA 60.16, my sincere thanks go to: Member States International Network for Rational Use of Drugs WHO Colleagues Networks and NGOs –Essential Drug Project, UK; Ecumenical Pharmaceutical Network; Health Action International; REACT: Action on Antibiotic Resistance