Risk Management Plans to Mitigate Drug Shortages also affect Medical Devices

In a draft document, the FDA has presented risk management plans to mitigate drug shortages. What are those plans?

Drug shortages have become a serious problem in the healthcare system, which can lead to delayed therapies or even the failure of therapies. The main cause of drug shortages is associated with quality issues. With reference to some publications, the FDA notes in this draft document that proactive consideration of risks associated with the drug manufacturing process, supply chains and market demand can maintain a robust market supply. The reasons for drug shortages can be manifold. The draft document again mentions quality issues, supply chain disruptions due to natural disasters but also due to cyberattacks, and unpredictable market demand. Although the number of drug shortages has decreased since their peak in 2011, they have remained at a high level since 2018. The aim of the draft document is to develop, maintain and implement risk management plans (RMPs) to prevent drug shortages.

It is explicitly mentioned that risk management principles according to ICH Q9 are already in place in the pharmaceutical industry. These should also be used to avoid supply chain disruptions that could lead to drug shortages.

In the following, the groups ("stakeholders") affected by drug shortages are named. Manufacturers of medicinal products, APIs and medical devices:

  • that are life-sustaining
  • which are life-supporting
  • which are used to prevent or treat debilitating diseases
  • APIs in prescription medicines that include the above categories
  • medical devices used in conjunction with the above products

are explicitly addressed.

An RMP is recommended for:

  • Medicinal products for rare diseases
  • Medicinal products without alternatives
  • Medicinal products used to "protect against " potential health threats to the population (e.g. terrorist attacks).
  • Products from only one "source"
  • Medicinal products with only one active ingredient manufacturer
  • Medicinal products produced by only one manufacturer
  • Medicinal products manufactured in one production facility that had received an "official action indicated" (OAI) in the last 5 years without production alternatives.

For combination products, the draft document also recommends using ISO 14971, if applicable.

For the preparation of RMPs, the draft document shows the ICH Q9 process with corresponding notes on drug shortages and then describes the ICH Q9 process according to the individual stages (risk identification, risk analysis, risk assessment, risk reduction, risk acceptance) up to risk communication.

Finally, an appendix lists risk considerations for specific RMPs in relation to concerned stakeholders.

The draft can be accessed on the FDA website.

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