Course Program

SUNDAY, OCTOBER 27, 2002

4:00 pm Registration

6:00 pm Reception

3. Gallery of Experts Instructions
4. WHO/EURO The Patient in Focus A strategy for pharmaceutical sector reform in Newly Independent States EUR/ICP/QCPH 06 22 02 WHO/DAP/98.8, Executive Summary
5. Laing R. The world health and drug situation, International Journal & Safety in Medicine 12 (1999) 51-57, IOS Press
6. Guidelines for Developing National Drug Polices, WHO 2002

Session 2. National Drug Policy Country Experiences

This session will require participants to review and compare the elements of their national drug policies.

Faculty: Richard Laing, Nata Menabde, Kees de Joncheere

Readings:

1. How to develop and implement a National Drug Polices, second edition, WHO Geneva, 2001
2. The Patient in Focus WHO/EURO 1998, Sections 3.1&3.2

3. EDM and Newsletters available in English and Russian (examples)

Reception Key Speakers Minister of Health, U.S. Ambassador, USAID, WHO Country Representative, Rector of Tashkent Pharm Institute Ahmat Yunuskhodjaev, Nata Menabde , Grace Hafner, Richard Laing

DAY 2-TUESDAY, OCTOBER 29, 2002
Session 3. Introduction to Indicators For Monitoring Of National Drug Policies Drug use and drug pricing. Prepare for field work

This session will present examples of indicators for systematic assessment and monitoring of NDP implementation, measuring drug prices and assessing drug use.

Faculty: Richard Laing, Talgat Nurghozin, Kees de Joncheere.

1. WHO Core Indicators for assessing EDPs
2. The Pharmaceutical Study in Ferghana Oblast, Uzbekistan, Zdrav-Plus, June 2001
3. Reports on Bulgaria and Kyrgyzstan
4. Petrova GI Monitoring of National Drug Policies – regional comparison between Bulgaria, Romania, Macedonia Bosnia Herzegovina Centr. Eur. J. Pub Health 9 2001 4 205-213
5. WHO Programme for Pharmaceuticals Action Programme on Essential Drugs. The patient in Focus, Annex D, EUR/CP/QCPH 06 22 02 WHO/DAP/98.8
6. Prices and Availability of Pharmaceuticals in Kazakhstan Pharmacies.

   

    

Session 4. Field work to use indicators with reporting

This session will involve field visits to different facilities to use the WHO Indicators. At the end of the visits groups will meet to review the results of the visits. This will be a long session that is likely to end at about 6pm.

FACULTY Talgat Nurghozian Umida Salixbaeva

Session 5. Financing Issues

This session will review the possible financing alternatives. The importance of getting the most out of pharmaceutical expenditure will be discussed.

Faculty: Jonathan Quick (WHO)

Readings:

1. Health Reform and Drug Financing WHO/DAP 98.3
   http://www.who.int/medicines/library/dap/who-dap-98-3/who-dap-98-3.htm
2. WHO Guide to Drug Financing Mechanisms Demoulin J, Kaddar M, Velasquez G WHO 1998
3. Drug Polis Drug Reimbursement Pilot System, Kutaisi Georgia, 1998 Report, EUR/QCPH 08 32 03 WHO/EURO 1999

 Background readings (english only)

1. Financing Drug Supply, Chapter 40, Managing Drug Supply, MSH, Kumarian Press 1997.
2. Global Comparative Pharmaceutical Expenditures with related reference information EDM/PAR/2000.2

Session 6. Pharmacoeconomics and Drug Pricing

This session will review basic concepts of health economics as applies to pharmaceuticals using an Australian Case study. The session will include a discussion of how health economics feeds into policymaking and decisions about how drugs are included on reimbursement lists. Issues around measuring and regulating drug pricing will also be presented.

Faculty: Cheryl Cashin, Richard Laing

1. Australian Productivity Commission 2002 International Pharmaceutical Price Differences Research report, AusInfo, Canberra Summary See Also http://www.pc.gov.au/research/commres/pbsprices/finalreport/pbsprices.pdf
2. Drug Pricing Systems in Europe, An Overview WHO/EURO June 1994
3. Summary of Pricing and Cost containment Methods from "Pricing and reimbursement in Western Europe 1998: A Concise Guide. "Ed Burstall ML Pharma Pricing review report"
4. Summary, Market Controls in Nine European countries, Austrian health Institute Vienna Nov 1998
5. European Health Care Reform, Analysis of current strategies, WHO Regional Publications, European Series, No. 72, page 174-196
6. S. Jacobzone, Pharmaceutical Policies in OECD countries: Reconciling social and industrial goals, table 13, Price controls. Full report is available from: http://dcc2.bumc.bu.edu/prdu/Other_Documents/oecd.pdf, and will be available for inspection.

Session 7. Public-Private Issues

This session will review issues related to public and private issues related to pharmaceuticals.

Faculty: Jonathan Quick (WHO)

Readings:

WHO Public-Private Roles in the Pharmaceutical Sector Implications for Equitable Access and Rational Drug Use. WHO/DAP/97.12
http://www.who.int/medicines/library/dap/who-dap-97-12/who-dap-97-12.htm

Session 8: Production Issues, Procurement Issues And Donations

This session will address issues related to procurement of drugs. The issues related to local production, procurement from external sources and receipt of donations will be addressed. There will be a discussion related to donations.

Faculty: Henk den Besten, (IDA) Richard Laing (BUSPH)

1. De Goeje M. 25 years of essential drugs: The quality issue: Ideals, attainments and failures Int J Risk & Safety 12 (1999) 59-65 [Available in Russian-Abt has this]

2. Foster S. Drug production in low and middle-income countries: an issues paper. Draft paper produced under contract to WHO/EDM.

B) Procurement

1. Joint WHO/WB/UNICEF/UNFPA Guidelines. Operational Principles for Good Pharmaceutical Procurement. Sept. 1999. http://www.who.int/medicines/library/par/who-edm-par-99-5/who-edm-par-99-5.htm
2. Technical Note on Procurement of Health Goods by World Bank Projects available in Russian and English
3. Drug Supply Strategies, Chapter 6, Managing Drug Supply, MSH, Kumarian Press, 1999 (Optional reading). English only

1. WHO, Guidelines for Drug Donations Revised 1999 WHO/EDM/PAR/99.4

2.     CMC, Guidelines on Equipment Donations, Contact, October, pp 11-14, 1994

Session 9. Financing Conference: Drug Pricing, Health Insurance, Revolving Drug Funds, Drugs & Hospitalization, Procurement and QA

Chairs Jonathan Quick and Cheryl Cashin

Financing and Pricing Drugs

Health Insurance – the Kyrghstan experience Ainura Ibraimova

Hospital Drug Procurement The Kazahk Experience Larissa Kuznetsova

Drug Price Monitoring Experience in Armenia Movses Aristakesyan

Drug Price Monitoring Ferghana & Karaganda Talgat Nurgozhian

Sessions 10. Impact of Global Treaties On Pharmaceuticals

This session will address how different global treaties such as TRIPS and WTO, and other global treaties and agreements affect countries' abilities to make decisions about pharmaceutical issues.

Faculty: Jonathan Quick

Readings: --

1. Globalization and Access to Drugs Velasquez G. and Boulet P, WHO/DAP 98.9 REVISED. http://www.who.int/medicines/library/dap/who-dap-98-9-rev/who-dap-98-9.htm Geneva
2. Globalization, TRIPS and access to pharmaceuticals – WHO Policy Perspectives on Medicines No. 3 March 2001, WHO Geneva
3. Historic ministerial declaration on public health and TRIPS, Essential Drugs Monitor, Issue No. 30, pages 4-5, 2001Resource Material [Distributed in English]

4. INTEGRATING PUBLIC HEALTH CONCERNS INTO PATENT LEGISLATION IN DEVELOPING COUNTRIES Carlos Correa, University of Buenos Aires, Argentina published by the South Centre Geneva 2000 http://www.southcentre.org/publications/publichealth/toc.htm

Session 11. Drug Selection, Formulary Policies and Evidence Based Medicine including Essential Drug Lists in CAR countries

Review of the process of how Essential Drug List, National Formularies, and Treatment Guidelines have been developed in different countries.

Faculty: Hans Hogerzeil (WHO) and David Henry (University of Newcastle), Aziz Jafarov

Readings:

1. Revised Procedure for updating the WHO Model List of essential Drugs a summary of proposals and process Paper submitted to WHO Executive Board 2002 EB108/INF.doc./2
   http://www.who.int/medicines/organization/par/edl/procedures.shtml
2. WHO, The Selection and Use of Essential Medicines – the Twelfth Report of the WHO Expert Committee 2002, http://www.who.int/medicines/organization/par/edl/expertcomm.shtml
3. Azizkhon Jafarov, Selection of essential drug lists in Central Asian Republics. Comparison and discrepancies May 2002 http://dcc2.bumc.bu.edu/richardl/RPM+_Project/Aziz.htm
4. Managing Drug Selection, Chapter 10, Managing Drug Supply, MSH, Kumarian Press, 1997
5. WHO Programme for Pharmaceuticals Action Programme on Essential Drugs. The patient in Focus, Rational Drug Selection and Use, EUR/CP/QCPH 06 22 02 WHO/DAP/98.8., page 9

Session 12. Promoting Rational Drug Use including hospital pharmacy and therapeutic committees

This session will focus on changing use of drugs at primary care level and in hospitals.

Faculty: Hans Hogerzeil, Sri Suryawati and Richard Laing (BUSPH)

Readings:

1. Ten recommendations to promote improved use of medicines in developing countries, Laing R, Hogerzeil HV, Ross Degnan D, Health Policy and Planning 16(1): 13-20
2. Promoting Rational Prescribing, Chapter 31, Managing Drug Supply, MSH Kumarian Press –
3. English onlyWHO, Tried Tested and Ready for Use –the New Guide to Good Prescribing, Essential Drug Monitor, No. 20, 1995, pp 18-19
4. [Available in Russian]WHO, From Research to Action, the Gunungkidul Experience, Essential Drug Monitor, No. 20, 1995, pp 21-22-
5. [Available in Russian]WHO Manual on Establishing an Effective Drug & Therapeutics Committee Latest Draft—

Others Resource Materials:

MSH Manual on Drug and Therapeutic Committees. [Russian and English][English only]

Special Open Session

The Australian Experience with Therapeutic Pricing

Chair – David Henry

Selection and Rational Use of Medicines

Development of Standard Treatment Guidelines in Russia Lilia Ziganshana

Drug use in Ferghana & Karaganda Talgat Nurgozhian & Sergey Muratov

The role of NGOs in RUD Moldova experience Natalia Chebotarenko

Changing Injection Use in Indonesia Sri Suryawati

Session 14: Role of Consumer Organizations and NDP’s

This session will review the role of consumer organizations and methods that can be used to inform and mobilize consumers around Essential Medicines issues. This session will use a video of an innovative technique used in Indonesia. [Surya to add]

Faculty: Sri Suryawati (Gadjah Mada University, Indonesia)

1. To explain the role of consumer organizations as important stakeholders in the development and successful implementation of NDP.
2. To highlight the role consumer organizations have played, and are playing, in various settings in the development of the NDP.
3. To familiarize the course participants with the global movement for treatment-access led by international civil society.
4. To familiarize the participants with the conceptual issues involved in the role of consumer organization.
5. To describe the possible strategies for and with consumer organizations to make NDPs successful.
6. To help participants to think about the role of consumer organizations in their countries and how they can develop strategic alliances with them

1. Advocacy and Networking, the Case of the Philippine Drug Action Network (PDAN) (Case study contributed by Michael Tan)
2. Indonesia Case report

   

Session 15. Legislation Regulation and Quality Assurance Issues

This session will discuss issues regarding regulation, legislation, and enforcement of laws related to pharmaceuticals. The session will also review the ICH process and the WHO Certification scheme.

Faculty: Lembit Rago

Readings:

1. Marketing Authorization of Pharmaceutical Products with Special reference to Multisource (Generic) Products WHO/DMP/RGS/98.5 http://www.who.int/medicines/library/qsm/manual-on-marketing/multisource-contents.html
2. Global harmonization and the ICH, Essential Drugs Monitor, Issue No. 30, pages 9-10, 2001, WHO, Geneva

   

Session 16: Human Resources and the Pharmaceutical Sector

This session will review and discuss various aspects of human resource planning in the national drug policy process, and the pharmaceutical sector. In addition participants will review basic training and continuing education needs for pharmaceutical staff in developing countries. The policy implications will be discussed.

Faculty: Nina Sautenkova, Sri Suryawati and Anna Soloninina

1. Revision of Undergraduate Pharmacy Curricula: Report on an informal consultation in Nyanga, Zimbabwe. WHO Action Programme on Essential Drugs 18-20 April 1997. WHO/DAP/98.1.
2. Ballington DA. The Pharmacy Technician: A Challenge for Pharmacy Education, AJPE, Vol. 57, Sum 93 pp 139-142.
3. The South African Pharmacy Council. Unit Standards for Pharmacists and Pharmacists Assistants. Pretoria: SAPC, 1999.
4. The South African Pharmacy Council. Staffing norms for pharmaceutical services in the public sector. Executive Summary. Pretoria: SAPC, November 1998.Role of Consumer Organizations and National Drug Policies

Session 17. Legislation, Regulation and Human resources Conference

Registration & Licensing Costs, Enforcement, Generics and Quality, Curriculum Change for pharmacists & Doctors

Chairs Nata Menabde, Lembit Rago & Ilias Kulmaganbetov

Session 18: Drug Policies And Public Health

This session will bring together the lessons of the two weeks. Policy influences external to the pharmaceutical sector will be discussed. Issues such as the demographic transition, health financing reforms, the balance between quality access and cost, AIDS and TB will be raised. The importance of the Global Funds will be addressed. The implications of these factors for the pharmaceutical sector will be discussed.

Faculty: Richard Laing, (BUSPH), Susanna Khachatrian (MSH), Grace Hafner ZdravPlus)

Readings:

1. The World Health and Drug Situation. Laing R. Presentation at IDA 25th Anniversary, November 1997.Int. J. Risk & Safety 12 51-57 1999 (In Session 1).
2. The Global Drug Facility for TB http://www.stoptb.org/GDF/default.asp
3. The Global Fund for AIDS, TB and Malaria http://www.globalfundatm.org/

Activity: GROUP WORK/DISCUSSION - SEE DISCUSSION GUIDE

Sessions 19: Country Experiences with Implementation Issues

This session will examine real life examples of how National Drug Policies have been implemented. The enabling and opposing forces likely to be encountered will be described. Strategies that may be used to deal with obstacles and increase support will be discusses.

Faculty: Richard Laing

Readings:

1. Increased availability of affordable drugs in hospitals in Armenia and Georgia, September 1999
2. Trap B, Todd C, Moore H, Laing R. The impact of supervision on stock management and adherence to treatment guidelines: a randomized controlled trial, Health Policy and Planning, 16(3): 273-280, 2001