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New EMA guidance on management of medicine shortages

The European Medicines Agency (EMA) has published new guidance documents related to the availability of medicines for use by marketing authorisation holders and authorities. These guidance documents aim at improving and harmonising the management of medicine shortages and related reporting and communication.

What actions should marketing authorisation holders take?

Marketing authorisation holders must monitor the supply and demand situation of their medicines and have open and continuous communication with all their operators in the supply chain, outlines Liisa Toppinen, Regulatory Expert at DRA Consulting.

– By reporting medicine shortages in a timely manner and leaving sufficient time for measures needed for handling the situation, effects on patients and healthcare can perhaps be prevented.

According to the guidance, the authorities should also be notified of anticipated or expected medicine shortages.

National reporting timeframes for notifications of medicine shortages vary. We mapped these practices in the EU countries at our open discussion meeting for experts last spring.

Also, all parties must be alert for signals which could result in a medicine shortage. Particular attention should be paid on medicines for which no or only limited generic alternatives are available on the market, and where the medicine shortage could result in a potential risk to public health or animal health and welfare.

What are the requirements for the authorities?

The guidance document for the authorities provides key principles and examples of good practices for communication. However, each member state decides their own practices independently.

– At national level, all medicine shortages in a specific country should be communicated in a list format with a search function. In addition to this, medicine shortages of significant importance should be communicated as separate news releases.
– Information given on a medicines shortage should include the details of the medicine as well as the anticipated duration of and the reason for the disruption, any alternative medicines available and recommended actions in the situation, summarises Liisa.

When communicating about medicine shortages and choosing the timing and level of visibility, the risk of stockpiling should also be considered.

Do these guidance documents also lead to actions?

In future, all information on medicine shortages in the EU countries may be available in a single portal.

Fimea has already announced that they will on basis of this guidance change their communication practices on medicine shortages as well as the forms provided for marketing authorisation holders or their representatives for notifying Fimea of medicine shortages.

– It remains to be seen how the authorities in the other EU/EEA countries and the EMA will change their practices, says Liisa.

EMA also indicates that a shortage prevention plan for critical products may be required in the future from marketing authorisation holders.

Read more about this topic: Why pharmacies run short of medicines – should we be worried?