Sinette Goosen World AIDS Day 2019: Supply Chains in the Fight to End HIV/AIDS

The Partnership for Supply Chain Management (PFSCM) was established to improve and strengthen supply chains and health systems to bring lifesaving HIV diagnostic, prevention, and treatment products to countries with a high number of HIV infections.

PFSCM set up shop in 2005 when the HIV crisis was at its peak with more than 30 million people infected on the African continent alone. For over a decade the organization executed one of the largest public heath supply chains in history, making a lasting impact in the lives of millions of people.

Today, the fight to end HIV is still at PFSCM’s core, and each year on World AIDS Day, we reflect on the importance of public health supply chains in ensuring:

  • HIV and other healthcare commodities reach the point of care, on time and in full.
  • Best-value, and best-quality products are procured to make available funds go further.
  • Recipients have access to value-added rental agreements that enable them to use the best in diagnostics, medical devices, and laboratory equipment, at a reduced total cost of ownership.
  • Infrastructure, such as storage facilities, are developed along the supply chain to ensure compliant pharma-grade storage of products.
  • Chain of custody is enforced through technology that captures information about shipment location, product integrity, and patient consumption.
  • Ethical practices are upheld in all phases of the supply chain to reduce waste, and prevent counterfeit products from entering the supply chain.

Today, PFSCM also reflects on a decade’s worth of work in supporting one of the biggest donor-funded projects on the globe.

Over the last 10 years, PFSCM has:

  • Procured and delivered $2.9 billion worth of HIV commodities – including test kits, condoms and antiretrovirals (ARVs) – to low- and middle-income countries helping diagnose, prevent and treat HIV.
  • Procured enough of the bestselling one-a-day ARV product to treat at least 11.4 million people for a year.
  • Seen the cost of the top procured one-a-day ARV treatment drop from around $17 per unit in 2010 to below $6 in 2019.
  • Purchased more than 2.6 million boxes of the bestselling HIV rapid diagnostic test (HRDT) kit. Enough to test 260 million people once.
  • Seen the cost of the bestselling HRDT kit decrease from around $111 in 2010 to around $82 in 2019.
  • Delivered more than 10940 shipments of HIV products to over 70 countries. Countries that procured most HIV commodities: Malawi, Tanzania, Mozambique, Uganda and Nigeria.

PFSCM Perspective: Procurement, Quality Assurance and Logistics

PFSCM buys HIV commodities from the leading global suppliers of diagnostic and pharmaceutical products, ensuring reliable quality, and supply.

Our suppliers have either been approved by a Stringent Regulatory Authority (SRA) or prequalified by the World Health Organization (WHO).

PFSCM also prequalifies suppliers to maintain and grow a supplier network for our clients. Our prequalification audits cover aspects of the WHO’s cGMP and “A Model Quality Assurance System for Procurement Agencies” (MQAS).

Further, we work closely with country recipients and manufacturers to facilitate forecasting and demand discussions for better production and storage planning.

For example, earlier this year, PFSCM was alerted of the tragic HIV outbreak in a poor southeastern town in Pakistan. We reacted promptly to release extra, and emergency shipments of HRDTs and ARVs needed to test and treat hundreds of people – mostly children.

PFSCM’s procurement unit worked closely with various vendors to determine- and release available stock, and plan for the immediate replenishment to supply the new and ongoing orders to Pakistan.

PFSCM also collaborated with the donor and recipient country to clear the waivers as soon as possible. Overall, PFSCM’s freight estimation and purchase order was prepared in only two hours and the supply- and waiver lead time was reduced by 7 to 10 days.

In terms of storage planning, PFSCM has continued to make a notable impact in Uganda in 2019.

In Uganda — one of the top countries for the procurement of HIV products — PFSCM entered a public-private partnership to manage a transit warehouse which takes pressure of the Central Medical Stores (CMS). Products are moved to the transit warehouse before further distribution to the CMS, this prevents products overstaying at ports of arrival and accruing demurrage and detention costs.

The facility has been a great solution for the storage of large amounts of HIV commodities arriving in Uganda. In 2019, Uganda acquired more than $60 million worth of HIV commodities through PFSCM, and over the last 10 years the country purchased almost $360 million worth of products.

In addition, PFSCM participates in global meetings such as the WHO suppliers’ gatherings, the ARV Procurement Working Group and the Global Accelerator for Paediatric Formulations, to stay abreast of developments and treatment guidelines in the HIV sector, while contributing to the development of policies for best procurement practices that drive optimal public health program outcomes.

Most recently, PFSCM strengthened its expertise in areas related to self-testing, medical devices, early infant diagnosis, laboratory equipment, and viral load testing.

A new chapter

For the last 10 years, PFSCM served as the procurement services agent for ARVs for the Global Fund to Fight AIDS, Tuberculosis and Malaria’s Pooled Procurement Mechanism (PPM).

In September this year, PFSCM retired at the PSA for ARVs, and was awarded new product categories:

  • Rapid diagnostic tests (HIV and malaria)
  • Viral load and early infant diagnosis tests
  • Other diagnostics
  • Laboratory and medical supplies and equipment

PFSCM has extensive experience managing these product categories, which are among the most complex health products to source, procure, transport, and store.

Between 2006 and 2016, PFSCM and its partners collaborated to manage the procurement and distribution of laboratory commodities for The President’s Emergency Plan for AIDS Relief’s Supply Chain Management System.

During this time, PFSCM procured more than $500 million worth of laboratory items, developed an innovative laboratory quantification tool, facilitated training courses for laboratory staff, and vetted local vendors for in-field office managed procurement, among other technical support services.

In the meanwhile, we have been procuring various rapid diagnostic tests kits for the Global Fund PPM, and have also procured many non-pharma and laboratory products for both PPM and non-PPM clients.

PFSCM still procures and ships ARVs globally for other clients, and remains an expert supply chain manager in this field.

 


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.