1. 10/15/2015 046:127 Pharmaceutical Management for Underserved Populations 1 Drug Management Cycle: Selection Essential Drugs Treatment Guidelines Formularies Class Period #4, 7 February 2007 Prof. Hazel H. Seaba

2. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 2 Drug and health commodity management cycle Selection Procurement Distributio n Use Policy and Legal Framework Managemen t Support

3. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 3 Objectives Define an essential medicine, essential medicines lists (EMLs), formularies and standard treatment guidelines (STGs) Apply evidence-based criteria to medication selection Explain the benefits of STGs and essential medicines formularies (EMF) Describe the importance of proper development and active implementation of EMF and STG

4. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 4 Equitable access to essential medicines: a framework for collective action. WHO Perspectives on Medicines, March 2004.

5. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 5 List of common diseases and complaints Training and supervision Financing and supply of drugs Standard treatment guidelines Treatment choice Prevention and care Essential medicines formulary Essential medicines list

6. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 6 Essential Medicines Definition Essential medicines are –those that satisfy the priority health care needs of the population –selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness –intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information and at a cost that individuals and the community can afford

7. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 7 WHO Model List of Essential Medicines 1977: First model list published with about 200 active substances List is revised every 2 years by WHO Expert Committee on the Selection and Use of Essential Medicines based on submissions Last revision (March 2005) contains 312 active substances Composed of a core list and a complementary list http://www.who.int/medicines/publications/essential medicines/en/index.htmlhttp://www.who.int/medicines/publications/essential medicines/en/index.html

8. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 8 Dispensary SS All medicines worldwide Registered medicines National list of essential medicines Levels of use Supplementary specialist medicines CHW Health center Hospital Referral hospital Private sector The Essential Medicines Target CHW: community health worker with an essential drugs list of 12-18 items

9. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 9 156 Countries with Essential Medicines Lists There are 156 countries with an official selective list for training, supply, reimbursement, or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists. National Essential Medicines List < 5 years (127) > 5 years (29) No EML (19) Unknown (16)

10. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 10 Table 1: Selected country progress indicators 1999–2003 1999 2003 Target for 200719992003 Target for 2007 Countries with an official national medicines policy implementation plan— new or updated within the last 5 years 41/106* 39% 49/103 48% 61% Countries with a national list of essential medicines – updated within the last five years 129/175 74% 82/114 72% 75% Countries implementing basic medicines regulatory functions 70/138 51% 90/130 69% 74% Source: WHO Medicines Strategy :Countries at the Core, 2004– 2007. Essential Medicines Lists

11. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 11 Number of Medicines on National Essential Medicines Lists Source: Selected MSH studies

12. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 12 Availability of Essential Medicines Lists in Health Facilities Source: Selected MSH studies, 1993–2001.

13. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 13 Medicines Formulary Definition A continually revised compilation of pharmaceuticals (plus important ancillary information) that reflects the current clinical judgment of the medical staff. [American Society of Hospital Pharmacists] A restricted list of medicines from which appropriate therapy can be selected. Drug-oriented The WHO Model Formulary http://mednet3.who.int/EMLib/ http://mednet3.who.int/EMLib/

14. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 14 Formulary Management Principles Select drugs on the basis of need (diseases and conditions that have been identified locally) Select drugs that can be used by personnel available Consider cost (total cost of treatment) and financial resources Select “drugs of choice,” safety and efficacy demonstrated Product: assured quality, bioavailability, and stability Maintain a limited number of drugs (avoid duplications) Use INN (generic) names (versus trade names) Use combination products (fixed dose) only in specific proven conditions e.g. TB

15. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 15 Definition: Standard Treatment Guideline (STG) A systematically developed statement designed to assist practitioners and patients in making decisions about appropriate treatment for specific clinical circumstances Treatment-oriented Source: Managing Drug Supply

16. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 16 Examples of Standard Treatment Guidelines United States: National Guideline Clearinghouse http://www.guideline.gov/ http://www.guideline.gov/ WHO: Health Topics, http://www.who.int/topics/en/http://www.who.int/topics/en/

17. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 17 The International Pharmacopoeia, Volume 5, 3 rd Edition Part I. guidance on the correct performance and application of certain general tests and other methods (recommended quality specifications and methods of analysis for selected pharmaceutical products, excipients, and dosage forms) used in quality control, followed by general requirements pertaining to the testing of different dosage forms. Part II. (more extensive) presents monographs for 24 substances included in the WHO Model List of Essential Drugs. Each monograph provides exact instructions concerning which tests are required and which method should be used. http://www.who.int/medicines/publications/pharmacop oeia/en/http://www.who.int/medicines/publications/pharmacop oeia/en/

18. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 18 Benefits of Standard Treatment Guidelines (and Essential Medicines Formularies) Providers –Provides expert consensus –Provider can concentrate on diagnosis –Especially helpful where expertise limited (e.g. newly qualified doctors) –Simple basis for monitoring Patients –Consistency amongst prescribers –Most effective treatments –Improved drug supply –Lower cost

19. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 19 Supply Managers –Procurement, quality control, storage, & distribution easier and more efficient –Pre-packs of common items –Drug demand more predictable Health Policy Makers –Funds used more efficiently –Assess quality of care –Therapeutic integration of special programs –Information & training easier & more focused

20. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 20 Key Steps in developing STGs and Essential Medicines Formularies (EMF) Determine the target user groups Identify all the relevant stakeholders Set up a STG or EMF Committee Establish roles/responsibilities of committee members Agree on the scope and content of the STG or EMF

21. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 21 Establish methods of medicines and treatment selection process –Use of unbiased information –Evidence-based selection –Major criteria: efficacy, safety, cost, convenience –Method of establishing consensus where level of evidence appears inadequate Revise the draft based on wide consultation with external reviewers Field test the document before formal launch

22. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 22 Role of Drug and Therapeutics Committees Develop or adapt STGs/EMF Assess adherence to STGs/EMF Develop and implement appropriate strategies to ensure adherence

23. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 23 Some Indicators Relating to Guidelines and Formularies Is there a national STG with standardized treatments? Is there a national EMF manual with basic information? Are STG and EMF consistent with the national list of essential drugs? Is there a National Drug Policy statement to encourage use of STG/EMF?

24. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 24 Are STG and EMF used for basic and in- service training of health personnel? What % of public-sector health facilities has a copy of STG and/or EMF? What % of prescriptions in public-sector health facilities complies with the STG? Source: Managing Drug Supply

25. Percentage of Medicines Prescribed from Essential Medicines List, by Sector Source: MSH SEAM studies, 2001

26. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 26 Malaria Medicines Antimalarial medications for prophylaxis and treatment chloroquine, sulfadoxine-pyrimethamine (SP), artemether- lumefantrine (Coartem), quinine, mefloquine, atovaquone- proguanil (Malarone), tetracycline (doxycycline), primaquine Intravenous glucose and other fluids Medication for treatment of anemia

27. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 27 Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria Multiple single agents and fixed-dose combinations Multiple regimens approved (for HIV/AIDS) Differing laboratory monitoring facilities Differing and often weak pharmaceutical management capacities Different recommendations for special groups, e.g., pregnant women, children

28. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 28 Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria (2) Newer facts and recommendations becoming available fast, e.g, in HIV/AIDS treatment Treatment failure/drug resistance patterns Cost and logistics in changing from one regimen to another Need to mobilize both public and private sectors Non-pharmaceutical management and counseling issues

29. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 29 Exercise Part 1 – 20 minutes: Read the case study in your handout Prepare a list of responses Part 2 – 10 minutes Whole group discussion of responses

30. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 30 Small Group Exercise Part 1 – 20 minutes: Read the case study in your handout Discuss the questions within your group and prepare a list of responses Part 2 – 10 minutes Group reports - be prepared to report out your responses to the whole group

31. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 31 Percentage of Prescribed Medicines That Were Actually Dispensed Source: Selected MSH studies, 1992–2001

32. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 32 Percent of Patients Prescribed Antimalarials on STG Source: Selected MSH studies

33. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 33 Average Cost of Medicines Prescribed as a Percentage of Cost if IMCI Treatment Guidelines Were Followed Source: Selected MSH studies, 1999–2002

34. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 34 Why Are STGs and EMF Not Followed? Not based on adequate evidence Lack of transparency during development process, which leads to the lack of credibility and acceptance Lack of involvement from respected members of the professional community Do not reach the right people Lack of appropriate dissemination & implementation of STGs Pharmaceutical products recommended in STGs or EMF not available in the health facility Not updated regularly

35. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 35 HIV/AIDS-Related Pharmaceuticals ARVs: –Postexposure prophylaxis –Prevention of mother-to- child transmission –Clinical AIDS Anti-infectives (antibacterials, antifungals, and antivirals) for prevention and treatment of opportunistic infections STI treatment Tuberculosis treatment Analgesics and palliative care pharmaceuticals Anticancer pharmaceuticals Pharmaceuticals for noninfectious and other complications: –Cardiac –Renal –Hepatic –Neuropathic –Dermatologic –Hematologic –Pulmonary –Gastrointestinal/diarrhea –Oral and esophageal –Psychiatric

36. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 36 TB Medicines Treatment (single agents and fixed-dose combination products): –Rifampicin –Isoniazid –Pyrazinamide –Streptomycin –Ethambutol Treatment for MDR TB: –Capreomycin –Cycloserine –Para-aminosalicylic acid –Ethionamide –Amikacin –Kanamycin –Ciprofloxacin

37. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 37 Malaria Medicines Antimalarial medications for prophylaxis and treatment chloroquine, sulfadoxine-pyrimethamine (SP), artemether- lumefantrine (Coartem), quinine, mefloquine, atovaquone- proguanil (Malarone), tetracycline (doxycycline), primaquine Intravenous glucose and other fluids Medication for treatment of anemia

38. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 38 Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria Multiple single agents and fixed-dose combinations Multiple regimens approved (for HIV/AIDS) Differing laboratory monitoring facilities Differing and often weak pharmaceutical management capacities Different recommendations for special groups, e.g., pregnant women, children

39. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 39 Complexities in establishing and implementing STGs for HIV/AIDS, TB, and Malaria (2) Newer facts and recommendations becoming available fast, e.g, in HIV/AIDS treatment Treatment failure/drug resistance patterns Cost and logistics in changing from one regimen to another Need to mobilize both public and private sectors Non-pharmaceutical management and counseling issues

40. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 40 Summary STG and EMF can have considerable impact if developed and used properly They can also be an expensive waste of effort With STGs and EMF, the processes of production and use are as important as the products

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45. 10/15/2015046:127 Pharmaceutical Management for Underserved Populations 45 Role of Drug and Therapeutics Committees Develop or adapt STGs Assess adherence to STGs Develop and implement appropriate strategies to ensure adherence