Promoting Rational Drug Use in the Community

1. Promoting Rational Drug Use in the Community Setting the Scene The Essential Drugs Concept

2. Session Objectives • History essential drugs -public health context • Main components of national drug policy • Main actors and their roles • Trends and challenges Setting the scene Promoting Rational Drug Use in the Community

3. Drug Policy and Use Understood in the Context of : • Changing ideas about health and health care • Development of the pharmaceutical industry • The development of modern pharmacotherapy • Pharmacy: herbal medicines patent remedies • Chemical innovation during the 19th century • Increased understanding of germs and bacteria – major steps forward in 20th Setting the scene Promoting Rational Drug Use in the Community

4. Decline in TB (UK)Nuffield Provincial hospitals trust Setting the scene Promoting Rational Drug Use in the Community

5. Deaths of children under 15 attributed to scarlet fever,diphtheria, whooping cough, measles in England and Wales Setting the scene Promoting Rational Drug Use in the Community

6. Early Landmarks in Drug Development • 1941 penicillin • 1943 chloroquine • 1944 streptomycin • 1948 tetracyline and chloramphenicol • 1954 sulphonylureas (diabetes) • 1955 first trials oral contraceptives Setting the scene Promoting Rational Drug Use in the Community

7. Miracles Turn to Disasters: • 1930s sulphanilamide scandal resulted in the establishment of US FDA • 1960s thalidomide (8000 children in 46 countries seriously handicapped) • 1950 - 1970s diethylstilbestrol • 1970s clioquinol caused widespread neurologic disease in Japan Setting the scene Promoting Rational Drug Use in the Community

8. Major Challenges Became Evident • Access • Proper and safe use • Harness drug development to peoples’ need Setting the scene Promoting Rational Drug Use in the Community

9. Problems in Providing Access to Medicine • Differences between rich and poor countries • Differences between urban and rural populations • Proliferation of brand name products • Lack of information/evidence about therapeutic value Setting the scene Promoting Rational Drug Use in the Community

10. Essential Drugs • Essential Drugs are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms. (WHO) Setting the scene Promoting Rational Drug Use in the Community

11. Primary Health Care • Education (health problems/control prevention • Promotion of food supply and nutrition • Adequate supply of safe water/basic sanitation • Maternal and child health care (including family planning) • Immunisation against major infectious diseases • Prevention-control of locally endemic diseases • Appropriate treatment common diseases and injuries • Provision of essential drugs Setting the scene Promoting Rational Drug Use in the Community

12. National Drug Policy • Determine standards and values to guide actions in the drug sector • Define global objectives • Identify which strategies to meet these objectives Setting the scene Promoting Rational Drug Use in the Community

13. Steps in the development of NDP • Organise the process • Identify the main problems • Detailed situation analysis • Set goals and objectives for policy • Draft text of policy • Circulate and revise ...process important • Secure endorsement • Launch Setting the scene Promoting Rational Drug Use in the Community

14. Components of National Drug Policy • Selection of drugs • Affordability • Drug financing • Supply systems • Regulation and quality assurance • Rational use • Research • Human resource development • Monitoring and evaluation Setting the scene Promoting Rational Drug Use in the Community

15. Objectives South Africa NDP • Health objectives • Availability essential drugs • Ensure drug safety, efficacy, quality • Ensure good dispensing/prescribing • Promote rational use through provision of necessary training, education and information • Promote the concept of individual responsibility for health, preventive care and informed decision-making Setting the scene Promoting Rational Drug Use in the Community

16. Objectives of the South African National Drug Policy • Economic objectives • Lower cost of drugs in private and public sectors • Promote the cost-effective and rational use of drugs • Establish a partnership between government bodies and private providers • Optimise the use of scarce resources Setting the scene Promoting Rational Drug Use in the Community

17. Objectives of the South African National Drug Policy • Development objectives • Improve knowledge, efficiency, management skills • Reorient medical, pharmacy and paramedical education • Support the development of local industry and local production of essential drugs • Promote the acquisition, documentation and sharing of knowledge and experience Setting the scene Promoting Rational Drug Use in the Community

18. Interests of Different Stakeholders • National governments • Pharmaceutical industry • International organisations • Health professionals • Ngos • Consumers • Insurers Setting the scene Promoting Rational Drug Use in the Community

19. Current Trends and Challenges • Reduced role of government • Reductions in public sector spending exacerbate access problems • Social solidarity and support to the public sector is less of a priority • More difficult to control and regulate • Move from public to private has been accompanied by reduced government regulatory control of pharmaceuticals (eg Latin America) • Focus on private/public partnership can disrupt priority setting Setting the scene Promoting Rational Drug Use in the Community

20. Current Trends and Challenges • Increased role of the private sector (The private sector includes private pharmacies drug sellers, private not-for-profit ngos and the informal or illegal sector) • many drugs exchange hands through market stalls or are sold again after being prescribed • private sector harder to regulate/control /influence than public sector • Improving drug use and implementing ED concept in the informal and illegal sectors is hard Setting the scene Promoting Rational Drug Use in the Community

21. Trends and challenges Promotion to prescribers and consumers Massive increase in dtca (relaxation of regulations worldside) • 137 million US$ on Claritin • 93 million US$ Viagra*: to improve sexual perfomance • 75 million US$ on Xenical*: to reduce weight • 57 million US$ on Zyrtec • 54 million US$ on Zyban*: to quit smoking Setting the scene Promoting Rational Drug Use in the Community

22. Current Trends and Challenges • Changing relationships between professionals and consumers • Changing consumer expectations • Increased access to information • Tendency to look for technological solutions to medicalise problems Setting the scene Promoting Rational Drug Use in the Community

23. Setting the scene Promoting Rational Drug Use in the Community

24. Setting the scene Promoting Rational Drug Use in the Community

25. Current Trends and Challenges • Changing morbidity and mortality patterns • Epidemiological transition • HIV/AIDS • Tuberculosis • Drug resistance Setting the scene Promoting Rational Drug Use in the Community

26. Current trends and challenges • HIV AIDS – access to medicines • Access to and appropriate use of ARVs (antiviral market in 2002 over 10 billion and predictions for 17 billion by 2008 • 6 million in urgent need of ARV treatment in developing countries – about 400,000 being treated • Prequalification • WTO Setting the scene Promoting Rational Drug Use in the Community

27. Antiretroviral therapy coverage for adults, end 2003 400,000 people on treatment: 7% coverage 60 50 40 30 % 20 10 0 Africa Asia Latin America and the Caribbean Eastern Europe and Central Asia North Africa and Middle East Source: UNAIDS/WHO, 2004 Setting the scene Promoting Rational Drug Use in the Community 2004 Report on the Global AIDS Epidemic (Fig 33)

28. Prices (US$/year) of a first-line antiretroviral regimen in Uganda: 1998−2003 14 000 12 000 Launch of Accelerating Access Initiative (AAI) 10 000 8 000 Price US$ Generic companies’ offer of price reduction to Uganda Negotiatiations with R & D Pharma within AAI Further price reductions by AAI companies 6 000 Negotiations by William J. Clinton Foundation with 4 generic companies Further discussion with generic companies 4 000 2 000 0 Jun 98 Jul 98 Aug 98 Sep 98 Jun 00 Oct 00 Nov 00 Dec 00 Jan 01 Feb 01 Mar 10 Apr 01 May 01 Jun 01 Jul 01 Aug 01 Mar 03 Sep 03 Oct 03 1 200 1 100 1 000 900 800 700 600 Price US$ 500 400 300 200 100 0 Nov 00 Dec 00 Jan 01 Feb 01 Mar 01 Apr 01 May 01 Jun 01 Jul 01 Oct 03 Source: UNAIDS/WHO, 2004 Setting the scene Promoting Rational Drug Use in the Community 2004 Report on the Global AIDS Epidemic (Fig 34)

29. Millenium Development Goals – shared agenda but fragmented response • WHO estimated scaling up to meet targets needs at lease 77 billion by 2007 • Variety of global inititiatives to increase resources – Global fund, Clinton fund, Gates fund..... • Coordination often lacking and country priority setting an issue Setting the scene Promoting Rational Drug Use in the Community

30. Essential medicines concept – no less relevant – new strategy 2004 -2007 • Additional emphasis on access • Changed selection of list • Role of traditional medicine • Country support strengthened • Focus on financing and supply systems • Consumer education for rational drug use (PRDUC and country follow up) Setting the scene Promoting Rational Drug Use in the Community

31. Summary • Double problem - poor access and irrational use • Health and drug policy inextricably linked • Essential drug policy key public health concept • National drug policy framework crucial • Many stakeholders/different interests • Many new challenges and threats – HIV AIDS Setting the scene Promoting Rational Drug Use in the Community