The European Medicines Agency (EMA) published a new guidance that lists 10 steps that stakeholders can take to address potential drug shortages. The recommendations center around transparency and information sharing between parties such as manufacturers, distributors and regulators.
Drug shortages have increasingly become a concern for regulators around the world after supply chains were disrupted during the COVID-19 pandemic. To address the issue, EMA published a guidance on 17 May for marketing authorization holders (MAHs), manufacturers, national competent authorities and other stakeholders to follow in order to prevent drug shortages.
“Medicine shortages are a global health problem and are increasingly affecting European countries,” said EMA. “Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care.”
“In addition, patients may need to use less effective alternatives and face an increased risk of medication errors,” the agency added. “Ensuring the availability of authorized medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.”
The recommendations laid out in the guidance include calling on MAHs and manufacturers to inform competent authorities about potential and actual drug shortages as early as possible so they can work together to find solutions. EMA has also asked stakeholders to establish drug shortage prevention plans, increase resiliency of supply chains, and increase transparency regarding drug manufacturing and distribution.
Sharing drug shortage information with regulators is a key stop to prevent drug shortages according to EMA.
“Based on the information from some Member States, some critical pieces of information are often missing from notifications or not fully completed,” said the agency. “To illustrate, not elucidating the specific manufacturing delays means that it is difficult to understand the impact and evaluate the likely timeframe for the resumption of supply.”
“Additionally, understanding if a shortage will affect one or multiple countries is important, as are details about affected [active pharmaceutical ingredients] manufacturing sites, if appropriate (e.g. active versus dormant sites,) as this would assist in accurately determining the impact (including possible implications for the supply of other similar medicines) and understanding the options available to mitigate or prevent the shortage,” it added.
EMA notes that its recommendations are based on an analysis of drug shortages as well as direct experience garnered from regulators. The guidance was developed by a task force put together by EMA and the Heads of Medicines Agencies (HMA).
In addition to the recommendations laid out in the guidance, EMA says stakeholders should also use the European Commission’s Pharmaceutical Strategy that includes principles for addressing drug shortages.
The current guidance also compliments a May 2022 guidance issued by EMA/HMA that addresses drug shortages but aimed at patients and healthcare providers.
“The global nature of the medicine supply chain will require more international collaboration and alignment to ensure the security of medicine supplies and shortage prevention,” said EMA. “The Commission aims to put forward legislative and non-legislative proposals to address medicine shortages, including preventative and mitig
ation strategies.”
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