Antibiotic supply chains are “on the brink of collapse” and procurement has a part to play in “rebuilding the market”, according to a report.
The report, from the Access to Medicine Foundation (AMF), said many countries had or were currently experiencing shortages of vital antibiotics because they are only produced in a few factories, they offer slim margins for manufacturers and demand mainly comes from poorer countries.
The report said antibiotic supply chains were complex with batches passed between multiple distributors before reaching the patient, leading to low visibility and accountability, shortages and poor quality.
This lack of visibility is also leading to excessive use of antibiotics and the growth of antimicrobial resistance (AMR), among the key medical challenges facing the world.
“Governments with high purchasing power are using increasingly stringent tendering processes focused on price, creating competition among producers that puts further pressure on already slim margins,” said the report.
“What’s more, when a new antibiotic enters the market, it will be used sparingly due to the risk of AMR, meaning there is little prospect of ensuring the high-volume sales that may be needed to justify the investment in R&D. As a result, there is little commercial incentive to develop new antibiotics.”
AMF said there were 148 antibiotic shortages in the US between 2001 and 2013 and in 2010 15 countries experienced national shortages of an antibiotic used to treat tuberculosis. An ongoing penicillin shortage is currently affecting at least 39 countries, including Brazil, Germany, the Netherlands, the US and India.
The report said antibiotics were produced mainly in China and India. A global shortage of piperacillin-tazobactam was caused by an explosion in 2016 at a Chinese factory, the single producer of the necessary active pharmaceutical ingredient (API).
“As APIs and other raw materials are frequently in short supply, procurement practices must be efficient and effective to avoid global shortages, national stockouts and the risk of procuring poor quality products,” said the report.
“Recognising this risk, pharmaceutical companies can opt to purchase from multiple sources to keep suppliers active and in business.
“Procurement practices must also include supplier qualification processes — a crucial step in ensuring quality, safety and efficacy. This process includes site audits, compliance history review, and risk assessments as well as ongoing monitoring and evaluation.
“Without a quality assurance system in place, companies risk sourcing substandard or contaminated products leading to major disruptions in the supply chain.”
AMF also called for procurement to engage with local suppliers to build capacity and suggested “pooled procurement mechanisms” could “improve the procurement outcomes for individual group members or countries”.