Reproductive HealthReproductive HealthEssential medicines andEssential medicines and

commodities:commodities:

Margaret Usher-Patel, ScientistDepartment of Reproductive Health and Research,

World Health Organization July 2008

A public health priorityA public health priority

Increasing accessIncreasing accessto contraceptives is a best practiceto contraceptives is a best practice

Just by increasing access tocontraceptives has the potential toreduce poverty and hunger, avert32% of all maternal deaths, nearly10% of childhood deaths, contributeto womens' empowermentachievement of universal primaryschooling and long termsustainability

Lancet: Sexual and Reproductive Health: September 2006

Improving access to quality ReproductiveImproving access to quality ReproductiveHealth Essential Medicines and CommoditiesHealth Essential Medicines and Commodities

ActionPARTNERSHIP

The World Health Organization, Department of Policy Standards and Medicine (WHO/PSM)

WHO Department of Reproductive Health and Research,United Nations Population Fund, (UNFPA)PATHand other partners of the Reproductive Health SuppliesCoalition (RHSC)

Harmonization and consensus buildingHarmonization and consensus buildingTo develop evidence-based guidelines, technical tools (3 Publications)

The Interagency List ofThe Interagency List ofE s s e n t i a l M e d i c i n e s i nE s s e n t i a l M e d i c i n e s i nR e p r o d u c t i v e H e a l t hR e p r o d u c t i v e H e a l t hhttp://whqlibdoc.who.int/hq/2006/Whttp://whqlibdoc.who.int/hq/2006/WHO_PSM_PAR_2006.1_eng.pdfHO_PSM_PAR_2006.1_eng.pdf

Essential Medicines forReproductive Health: GuidingPrinciples for Their Inclusion onNational Medicines Listswww.who.int/entity/medicines/publications/EssMeds_RHealth.pdf

16 Policy Briefs onkey essentialreproductive healthmedicinesIn WHO model list ofessential medicines :core list (revised March2005)www.who.int/entity/medicines/publications/EssMeds_RHealth.pdf

WHO and UNFPA ensures the quality ofWHO and UNFPA ensures the quality ofessential medicinesessential medicines

Through a prequalification scheme:Is a formal and systematic process designed todetermine the experience, capability and capacity of amanufacturer to produce a consistent quality productin accordance with international standards and WHOrequirements and specifications.

Reduces the risk of awarding a contract to amanufacturer who is unable to meet qualityrequirements

Ensures the availability of supplies of affordableproducts that are safe to use and retain theireffectiveness throughout the stated shelf-life

WHO and UNFPA ensures the quality ofWHO and UNFPA ensures the quality ofessential medicinesessential medicines

Through a prequalification scheme:

Medicines already prequalified include– 62 antiretrovirals– 33 medicines for HIV/AIDS-related diseases;– 2 antimalarial and 6 drugs for tuberculosis

WHO and UNFPA are prequalifying a core list ofReproductive Health Essential Medicines includingcontraceptives, condoms and IUDs

PrequalificationPrequalificationof RH Essential Medicinesof RH Essential Medicines

Antibiotics included in prequalification– azithromycin, cefixime, ceftriaxone, ciprofiloxacin, clindamycin,

clotrimazolePrequalification started:– Oral and injectable contraceptives

To be prequalified– Oxytocin (injectable oxytocic). magnesium sulfate injection,

misoprostolTo be added to the list: levonorgestrel-releasingimplant– Cyclofem (DMPA+estradiol cypionate)– levonorgestrel-releasing implant

Prequalification of condoms and IUDsPrequalification of condoms and IUDs

Creating a generic system for UNFPA tomaintain a list of prequalified manufacturing sitesfor condoms and IUDsSupporting the development of internationalstandards male/female condoms and IUDs.Technical meetings to update the IUDspecificationReviewed manufacturing process to approveFC2 for bulk procurement

Prequalification of condoms and IUDsPrequalification of condoms and IUDsWHO/UNFPA Pequalification Scheme for Male Latex Condoms andTCu380A published.Guidance documents to implement the prequalification schemedrafted and ready for publication.Revision of IUD specification drafted and manual underdevelopment.Male latex condom specification to be updated 2007/8Publication – Male Latex Condom: Guidelines for prequalificationand procurement to be revised 2008/9Systematic review: Copper containing, framed intra-uterine devicesfor contraception: systematic review of randomized control trials".published 2006, updated 2007: Journal article Contraception, April2008.Supporting the development of international standards male/femalecondoms and IUDs.

6 Capacity Building Workshops6 Capacity Building Workshops

Procurement Officers RegulatoryBodies, Reproductive Health

Programme Manager

•West Africa:Dakar, Senegal –December 2007

•LAC: Managua,Nicaragua –

January 2008

•Europe:Copenhagen,Denmark – 2008

Manufacturers, RegulatoryBodies, Bulk Procurement

Agencies, InternationalOrganizations

•Beijing, ChinaJanuary 2008•S.E. Asia:Bangkok, ThailandJanuary 2008•New Delhi, IndiaFebruary

Proposal for a new work itemProposal for a new work itemfor IBP partnersfor IBP partners

Procurement, logistics, distribution, programmingProcurement, logistics, distribution, programming

Project outcome is to develop a web-based resource to improveaccess to and the use of RH essential medicines.

The proposal to partners:

To develop "Your questions answered" resource centre

1 page evidence-based answers to frequently asked questions from the field

Linked to resources produced by partners

Linked to a searchable data-base.

Promote sharing and exchange of knowledge in and among countriesby supporting virtual on-line Communities of Practice.

Review the YQAReview the YQACondom resource centreCondom resource centre

Please sign up to review the YQA ResourceCentre.Send your review to Margaret Usher-Patelusherpatelm@who.intPlease review for:– Ease of use– Clarity– Lack of ambiguity– Whether or not you found it a useful tool

Web access: http://www.infoforhealth.org/condoms/Username: yqacondomsPassword: info23