RHSC Conference brings forth joint statement on oxytocin management and guiding principles on QA

by | Apr 4, 2019

On March 25-28, 2019, PFSCM attended the 19th General Membership Meeting of the Reproductive Health Supplies Coalition (#RHSupplies2019) in Katmandu, Nepal, from which two important pieces of news emerged.

Firstly, WHO, UNICEF, and UNFPA issued a joint statement on “Appropriate Storage and Management of Oxytocin — a Key Commodity for Maternal Health.”

Oxytocin is essential to the prevention and treatment of postpartum hemorrhage, as well as other indications. Managing the oxytocin supply chain — from procurement to cold chain management to clear and consistent product labeling — is critical to ensuring that the medicine is effective when it reaches women.According to the statement, “Several studies confirm that oxytocin currently circulating in many low- and middle-income countries (LMICs) frequently fails to meet acceptable quality standards. Like vaccines, when oxytocin is not of sufficient quality or when it is not managed in cold chain, the medicine will rapidly degrade and become ineffective.”

WHO, UNICEF, and UNFPA strongly urge the following three actions to ensure effective management of and access to good quality oxytocin:

  1. Ensure that oxytocin is managed in a cold chain of 2-8 °C (35-46 °F) for distribution and storage.
  2. Procure oxytocin that meets the quality requirements established by WHO or a regulatory authority recognized by WHO.
  3. Label oxytocin to clearly indicate storage and transport requirements at 2-8 °C (35-46 °F).

See the joint statement here.

Secondly, the Interagency Supply Chain Group (ISG) — established in 2014 to provide more effective support to country efforts to ensure sustainable access to high-quality essential health commodities — presented its final guidance on the “Guiding Principles for Donors Regarding Quality Assurance of Essential Medicines and Other Health Care Commodities.”

“Donors realize that a disease cannot be treated with a poor-quality product and should not be treated with a product whose quality is uncertain,” the guidance states. “Any amount of poor-quality medicine is unacceptable because it increases morbidity and mortality, jeopardizes the credibility of health services and programs, and in the case of antimicrobials contributes to the development of antimicrobial resistance. In addition, one cannot extrapolate the clinical trial experience (in which quality assured products are used) to the larger patient experience if non-quality assured products are used.”

The ISG sets out six agreed guiding principles that provide the framework to help assure the quality of finished pharmaceutical products that are procured with donor funds.

Read the guidance document here.

The ISG comprises 15 global agencies that support supply chain efforts across all disease areas: the Bill and Melinda Gates Foundation, DFID, Global Affairs Canada, the Global Drug Facility, KfW, the Global Fund, Gavi, NORAD, UNDP, UNFPA, UNICEF, USAID, the World Bank, the World Food Programme, and the WHO.

For more information on outcomes of the RHSC Conference, please contact Marcel Hendriks, PFSCM’s Strategic Advisor, Procurement, at mhendriks@pfscm.org.