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

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).

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.


mweaverling Much progress made by the GAP-f working group in recent months

The Global Accelerator for Paediatric Formulations (GAP-f) — an evolving collaboration among a number of partner organizations — has continued to develop in 2018 and has announced some recent key accomplishments:

New website

The GAP-f website has been launched, which brings together key information on paediatric drug optimization and aims to be the place to go for updates in this broad area of work. The website includes links to guidance (such as the PADO list of priority paediatric ARVs and the IATT paediatric ARV formulary), important peer-reviewed publications, and past and upcoming events.

 

 

Papers published in JIAS and the Lancet

Two peer-reviewed commentaries recently published by the GAP-f outline pre- and post-approval activities coordinated by the GAP-f, key features of the GAP-f and its phased implementation, and future opportunities for change that will contribute to ensuring rapid development and uptake of key paediatric drugs in age-appropriate formulations:

  • “Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries,” published in JIAS in February. This paper is part of a supplement on “Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030,” convened by CIPHER and guest-edited by Douglas Webb, Chewe Luo, and Lucie Cluver. It is available here.
  • “Catalysing the development and introduction of paediatric drug formulations for children living with HIV: a new global collaborative framework for action,” published in The Lancet HIV in early May. It is available here.

Webinar hosted

On April 24, the AIDS Free Working Group co-chairs hosted a webinar among Vatican meeting participants and other key stakeholders to provide an update on their efforts to monitor implementation of the Rome Action Plan and to allow those who made commitments to provide updates. The webinar showed that activities are ongoing on the majority of action points. An overall assessment of implementation status across the Action Plan will be performed to identify any significant gaps.

A recording of the webinar is available upon request to Tamar Gabelnick (tgabelnick@pedaids.org).

 

 

Satellite session to be held at AIDS 2018

At the upcoming 22nd International AIDS Conference (AIDS 2018), GAP-f partners will be hosting a satellite session to present GAP-f concepts and work outcomes so far. The session – to be held Monday, July 23, 10:15-12:15, in Hall 11B of the RAI Convention Center – will include perspectives from different disease angles and stakeholders. More information will be circulated closer to the conference.

PFSCM’s role in GAP-f

In 2017, PFSCM joined this newly formed working group that builds on global efforts to promote a faster, more efficient, more focused approach to paediatric formulation development. Wesley Kreft, PFSCM’s Director of Global Supply Chain, serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.

Read more about the GAP-f in a post from January on this blog.