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Drug Management Cycle: Selection Essential Drugs Treatment Guidelines Formularies

Drug Management Cycle: Selection Essential Drugs Treatment Guidelines Formularies. Class Period #4, 7 February 2007 Prof. Hazel H. Seaba. Drug and health commodity management cycle. Selection. Management Support. Procurement. Use. Distribution. Policy and Legal Framework. Objectives.

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Drug Management Cycle: Selection Essential Drugs Treatment Guidelines Formularies

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

  2. Drug and health commoditymanagement cycle Selection Management Support Procurement Use Distribution Policy and Legal Framework 046:127 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 046:127 Pharmaceutical Management for Underserved Populations

  4. Equitable access to essential medicines: a framework for collective action. WHO Perspectives on Medicines, March 2004. 046:127 Pharmaceutical Management for Underserved Populations

  5. List of common diseases and complaints Treatment choice Standard treatment guidelines Essential medicines formulary Essential medicines list Training and supervision Financing and supply of drugs Prevention and care 046:127 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 046:127 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/essentialmedicines/en/index.html 046:127 Pharmaceutical Management for Underserved Populations

  8. National list of essential medicines Registered medicines Levels of use All medicines worldwide Dispensary CHW S S Health center Supplementary specialist medicines Hospital Referral hospital Private sector The Essential Medicines Target CHW: community health worker with an essential drugs list of 12-18 items 046:127 Pharmaceutical Management for Underserved Populations

  9. 156 Countries with Essential Medicines Lists National Essential Medicines List < 5 years (127) > 5 years (29) No EML (19) Unknown (16) 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. 046:127 Pharmaceutical Management for Underserved Populations

  10. Essential Medicines Lists Source: WHO Medicines Strategy :Countries at the Core, 2004–2007. 046:127 Pharmaceutical Management for Underserved Populations

  11. Number of Medicines on National Essential Medicines Lists Source: Selected MSH studies 046:127 Pharmaceutical Management for Underserved Populations

  12. Availability of Essential Medicines Lists in Health Facilities 046:127 Pharmaceutical Management for Underserved Populations Source: Selected MSH studies, 1993–2001.

  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/ 046:127 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 046:127 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 046:127 Pharmaceutical Management for Underserved Populations

  16. Examples of Standard Treatment Guidelines United States: National Guideline Clearinghouse http://www.guideline.gov/ WHO: Health Topics, http://www.who.int/topics/en/ 046:127 Pharmaceutical Management for Underserved Populations

  17. The International Pharmacopoeia, Volume 5, 3rd 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/pharmacopoeia/en/ 046:127 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 046:127 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 046:127 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 046:127 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 046:127 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 046:127 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? 046:127 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 046:127 Pharmaceutical Management for Underserved Populations

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

  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 046:127 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 046:127 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 046:127 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 046:127 Pharmaceutical Management for Underserved Populations

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