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Managing Procurement and Logistics of HIV/AIDS Drugs and Related Supplies Introduction and Overview May 30 to June 4, 2005 Abuja, Nigeria Priority Setting and Effectiveness • Prioritizing Programs of Care for People with HIV/AIDS • Potential Priority Populations for the Distribution of Antiretroviral Drugs • Avoiding the Pitfalls: Ways to Reduce Costs and Improve Effectiveness of HIV Control Programs 2 Intellectual Property Rights • IPR: What are they? • National Regulatory Situation – TRIPS compliant flexibilities for different countries (e.g., LDCs Developing) • Specific provisions affecting developing country members of WTO providing public health flexibilities (e.g, compulsory licensing, government use) 3 Financing and Pricing What determines drug prices? • Market segmentation, differential and equity pricing • Additional price determinants in retail markets • How can public purchasers bargain for low prices 4 Pharmaceutical Systems Managing the Supply Side • Who does what? What tasks need to be done? Who is already carrying out these tasks? Who can help in selection and quantification? Who can help with regulatory issues, registration, IPRs and import? Who can help with procurement, storage and distribution? 5 Product Selection & Quantification Areas of Treatment • Highly Active Antiretroviral Therapy (HAART) for adults and adolescents • Treatment of opportunistic infections • Treatment of HIV infection in women of childbearing potential, or pregnant women • Treatment of HIV in children • Prevention of Mother-to-Child transmission • Post-exposure prophylaxis 6 Product Selection & Quantification Essential Medicines for ARV Treatment • WHO publishes the authoritative list of essential medicines for HIV/AIDS, including a list of antiretrovirals (ARVs) • Medicines should be selected by a multidisciplinary team • Consult www.who.int on a regular basis 7 Product Selection & Quantification What quantities of drugs need to be bought? There are several options available to order optimal quantities: • Track usage • Track usage and adjust the data for other sites • Estimate number of patient using the drugs and disease data 8 Quality Assurance • To introduce non-experts to pharmaceutical quality control and regulation • Drugs must be safe, effective and of consistent quality • Adherence to GMP and compliance with quality specifications are key 9 Procurement • • • • • • Assessing capacity Commodities that support the HIV/AIDS program Planning procurement Registering products Choosing procurement methods Pooled procurement (national or regional) 10 Supply Chain Management Storage Inventory Control LMIS 11 Rational Drug Use Impact of RDU on other parts of the pharmaceutical system Drug use as a management function Factors influencing rational drug use Irrational use of drugs 12 The Training Program How is the Training Program organized? Training Modules • Summary • Background • Case Studies • Instructor and Participant Versions 13