The two guidance documents were issued to marketing authorisation holders (MAHs) and to European Union (EU) national competent authorities.
The documents were put together by the European Medicines Agency (EMA)’s drug shortages task force, which was set up in December 2016 to specifically address issues of medicine supply. The US Food and Drug Administration (FDA) set up a similar working group last year.
EMA's definition of a medicine shortage
“A shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level.”
The EMA said in a statement, “Both documents lay the foundations for an improved and harmonized EU approach in reporting of and communication on medicines’ shortages and availability issues, a key public health priority for the EU network.”
The agency explained that the documents had been put together through consultation with stakeholder groups, as “shortages and availability problems are complex with no quick solutions.”
Advice to MAHs
In its advice to MAHs, the agency advised that such companies are in the ‘best position’ to assess relevant information to determine whether a shortage is likely.
In order to do so, the EMA outlined three actions to be taken to maintain the resilience of the supply chain:
- Regularly assessing supply information provided by their manufacturers and suppliers
- Regularly assessing market needs based on the information provided by wholesale distributors, community pharmacies, hospital pharmacies, retailers, healthcare professionals/veterinarians or patients groups
- Developing shortage prevention and response plans
If an MAH does foresee likely shortages of their product, the EMA advised the company to notify the relevant EU competent authority as early as possible, with EU legislation requiring such a warning to arrive two months prior to any possible interruption.
Information for the public
The second document relates to how EU national competent authorities should react to a medicine shortage. In this document, it stressed that communication, including timing, the information provided and the audience, needs to be carefully considered, given the potential for medicine stockpiling to exacerbate supply issues.
During its own research, the EMA discovered that 87% of national competent authorities publicly publish shortage information on their websites, but 69% do not have specific criteria on what is published.
The EMA noted that there is a similar picture in regard to addressing shortages globally, noting that the FDA also publishes a web listing of medicine shortages. However, it noted that the FDA does not include information on supply issues of brief duration.