Fragile Antibiotic Supply Chains Are Leading to Frequent Shortages, Worsening Antimicrobial Resistance

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Antibiotic supply chains are fragile and at risk of collapsing, warns a new white paper from the Amsterdam-based Access to Medicine Foundation. Shortages of specific antibiotics are causing price hikes, delayed treatment and the prescription of lower doses or alternative antibiotics — which worsens the growing threat of antimicrobial resistance.

Similar to the situation that the U.S. Department of Defense is in with its munitions procurement, the primary culprit in the instability of antibiotic supply chains lies in a shortage of producers.

The comparatively low profits of antibiotics and reliance on a handful of manufacturers (compounded by pharmaceutical companies leaving the market) have led to a global shortage. As antibiotics command a lower price and are meant to be taken for a short period of time, they are less profitable than other drugs. The risk of antimicrobial resistance also limits how often an antibiotic will be used.

Consequently, pharmaceutical companies both large and small have opted to stop manufacturing antibiotics altogether. The result is that there are only a few producers of the active pharmaceutical ingredients (APIs) used in antibiotics, which poses a considerable risk for antibiotic supply chains. In the U.S. alone, there were 148 national antibiotic shortages between 2001 and 2013.

The commonly prescribed benzathine penicillin G (BPG), for example, was unavailable in at least 39 countries in 2015, including Germany, India and the U.S. That year, Brazil was experiencing an outbreak of syphilis, and the BPG shortage led to an increased number of babies born with congenital syphilis.

BPG is particularly crucial for its role as the primary treatment for syphilis and rheumatic heart disease. However, the BPG supply chain relies on only four API manufacturers, in addition to the fact that the drug itself offers little profit to its makers, disincentivizing production.

Demand planning, ensuring uninterrupted supply, and strengthening the distribution chain ought to be the top priorities, according to the white paper.

A cornerstone of good supply chain management, demand planning relies on the ability to collect reliable consumption and stock-management data. However, this can be a challenge for health facilities in low- and middle-income countries, where some of the highest needs for antibiotics are.

The authors suggest that “data sharing and engagement with stakeholders (such as healthcare workers, government health ministries and public health organizations) to align supply and demand can reduce the uncertainty of future projections.” GlaxoSmithKline and Johnson and Johnson both work with the World Health Organization in forecasting supply and demand, and Mylan works with the government of Kenya on its forecasts of demand for HIV/AIDS medications.

Ensuring uninterrupted supply is the next step. In the U.S., difficulties in sourcing raw materials and manufacturing are a primary cause of the fact that injectable antibiotics have the highest level of shortages.

Therefore, it is crucial for pharmaceutical companies to spread their spending on APIs and other raw materials among multiple suppliers. This would help keep suppliers in business, which in the long term benefits the pharmaceutical company, as it decreases the risk that a key ingredient will suddenly become unavailable.

Other suggestions from the report include producing antibiotics locally (thus reducing lead times and costs) and establishing mechanisms to allow for quick and agile responses to supply chain problems.

For instance, “to ensure supplies can reach countries quickly and to promote local manufacturing capacity development, Mylan is setting up packaging and manufacturing facilities in sub-Saharan Africa, starting with Zambia and Kenya and evaluating options in South Africa,” the authors write.

To strengthen the distribution chain, the authors recommend that companies tackle the following areas: information sharing through partnerships; ensuring affordability; ensuring quality; and product/packaging adaptation.

Many companies are already participating in partnerships like the non-profit Pharmaceutical Supply Chain Initiative (PSCI) or the Africa Resource Center for Supply Chain Management. When resources are limited, partnerships with logistics companies and public sector organizations can help pharmaceutical companies overcome logistical and supply chain obstacles.

In conclusion, the report provides six recommendations for how pharmaceutical companies can strengthen their antibiotic supply chains:

  1. Think long-term in improving processes for inventory and risk management.
  2. Develop distribution reach beyond urban areas.
  3. Improve agility in face of public health needs.
  4. Work with local communities in tackling challenges and opportunities.
  5. Invest in capacity building for supply chain strengthening.
  6. Minimize supply issues by using multiple, possibly shared, production sites.

Read the white paper here.

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