Surveys on Quality of RH Medicines

Because everyone counts
UNFPA Update
IPC meeting December 2014, Washington DC
Procurement Services Branch, Copenhagen
Commodity Security Branch, New York
UNFPA ERP for RH Pharmaceutical
 Products
 Since 2011 –
 6 rounds of EOI
 Challenges
 Some products still not enough that are WHO PQed
Misoprostol – 2 ERP (pack size 4)
Injectable hormonal contraceptives – 1 ERP
Oxytocin – none, ERP Cat 4
 Uptake of Generic RH medicines – Hormones
Training of National Procurement Agencies
 E-learning Modules
 Good Governance of Medicines – in collaboration with WHO
 Introduction to Quality Assurance of Reproductive Health Medicines
 In-country trainings
 2 weeks training
 Institutionalisation of the training
 Mongolia, Burkina Faso, Myanmar
Surveys on Quality of RH medicines
 Multi-country, multi-level survey on quality of selected
RH medicines and hormonal contraceptives under
Assess the quality of the products at distributor, central
medical stores, health facilities, unauthorised outlets
To be adopted to each region (SEARO, APRO, LAC etc)
In collaboration with WHO
Because everyone counts
Surveys on Quality of RH MedicinesOxytocin
 Oxytocin
 Cold chain interruption/break study protocol under
Throughout the supply chain
In collaboration with Monash University
 Monitoring temperature of shipments from
manufacturer through to the lowest level of service
Ghana shipments
In collaboration with WHO RHR, MoH Ghana and Ghana
Food and Drug Authority
Because everyone counts
Non-hormonal Contraceptives
 Review and update of TCu380A IUD Specification and Prequalification
Guidelines on-going
 Specification update d and usability enhanced
 Additional guidance on stability studies, sterility assurance, and QA
monitoring by procurers added
 Updated list of WHO Prequalified RH non-hormonal contraceptives
available on line (male condoms, female condoms , IUDs)
 Female condom WHO/UNFPA Technical Review Committee meeting –
16-17 June 2014
 8 products reviewed, including 2 for requalification.
 Lubricants – systematic review which will feed onto development of
technical specifications
Global Program to enhance RHCS
2014 allocations: $202.7 million
capacity building/HR
Capacity Development
 Demand/consensus forecasting for contraceptives and LS medicines
 Country level coordination and partnership, policy & advocacy,
national budget allocation for contraceptives/ RH commodities
Demand generation for FP uptake
Support for developing, establishing and implementing LMIS
Capacity development in SCM/procurement, LMS/LMIS, service
delivery, inventory management, etc.
Procurement efficiency, storage and distribution
QA-Prequalification/ERP (with WHO)
Environmental risk mitigation/safe disposal & management of unused,
unwanted contraceptives
Co-convening the UNCoLSC supply chain & local market and MH &
RH commodities TRT,
AcccessRH online catalogue
 AccessRH enables governments and NGOs to make the best use of
limited resources by delivering quality supplies in a cost-effective and
reliable way
Through AccessRH, governments and NGOs can partner with UNFPA
to utilize the unique procurement expertise provided
Save time: UNFPA conducts competitive, transparent bidding,
creating long term supplier agreements for a wide variety of RH items
Ensure quality: All products undergo stringent UNFPA/WHO quality
assurance processes
Gain value for money: The significant volume of contraceptives and
related items procured by UNFPA allows for competitive pricing.
UNFPA passes these savings on to partners via AccessRH
UNFPA procures RH supplies for governments and NGOs in over 140
countries (Find out how at
Policies and Guidelines
 UNFPA QA Policy for RH Medicines revision
 Generic Substitution
 Quality Monitoring
 Guidelines for Procurement on RH Medicines
 Provides for operational guidance on procurement and quality assurance of RH
 Based on WHO QA of pharmaceuticals
 Started as part of the QuRHM programme
 Safe Disposal and Management of Unused, Unwanted Contraceptives
 To provide guidance on the safe disposal of unusable contraceptives
 To guide countries in developing or updating country-specific waste disposal
policies and guidelines that include disposal of contraceptive wastes
 To build awareness and capacity in managing of contraceptive waste
 QA Framework – summary of the QA system
Green Procurement
 2013. UNFPA launched its Green Procurement strategy
 2014. On-going activities:
UNFPA Green Production Questionnaire (all UNFPA suppliers)
RFQ 14/017: Research on specific actions to reduce the environmental impact of the
manufacturing and use of condoms (under evaluation)
Joint UN Programme on Greening Procurement in the Health Sector (UNDP, UNFPA, WHO,
UNDP-UNFPA Funding proposal: Development of a Green Procurement Index in the Health
Sector (summited to UNDP-UNFPA Innovation funds)
 Next Steps:
Establishment of environmental baseline criteria for each group of products based on the results
of the UNFPA Green Production Questionnaire
Thank you