New guidance by the EU’s European Medicines Agency and the Heads of Medicines Agencies is intended to promote best practice in how the public is informed of shortages.
More systematic involvement and interaction with stakeholders, especially on issues with potential impact on patients, is needed, according to the guidance.
Guarding against stockpiling
"Timely and comprehensive information is necessary to ensure planning, rationing of existing stocks and prevention of stockpiling," it states.
The guidance, released last month, seeks to "ensure adequate public information" and aims to promote good practice by "enhancing current communication to the public".
As comms practices vary between member states, it noted that "there is a need to review and consolidate existing practices into a single document providing clear and harmonised guidance".
In addition to measures to improve the reporting and management of shortages, measures aimed at improving communication of such issues to the public play an important role in minimising their potential impact, it says.
Advice to healthcare professionals and patients on potential alternative medicines is often needed.
"This approach to communicating shortages would also help to maintain and improve trust in the regulatory system," the guidance states.
Timing is everything
It warns that "potential negative effects that could follow communication such as stockpiling need to be considered when communicating and choosing the optimal timing and level of visibility are important to minimise this risk".
It recommends that authorities should communicate on all shortages occurring nationwide. In situations where there is a "high impact on patients", the use of comms tools such as press releases should be considered.
"Regardless of the tools used, all shortages issues should be easily accessible on a webpage of the regulatory authority," the guidance states.
Another recommendation is for communication with the public to be conducted at an early stage, with updates issued to reflect any change in the situation.
"The language used in any communication should be public-friendly, concise and should use lay terms," it says.
And EU national competent authorities should "explore ways to multiply their communication" by using the comms channels of relevant organisations such as patient groups and healthcare organisations.
Rushing for the exit
The guidance comes with Britain less than three months away from potentially crashing out of the EU without a deal.
And Brexit Secretary Steve Barclay recently announced that vital medicines would take precedence over food, parts for nuclear power plants, and water in the Government’s priority imports to ensure continued supplies of the most important items.
Responding to the guidance, a Department of Health and Social Care spokesperson told PRWeek: "We have been closely involved in the EMA’s medicines shortages working group. We are always considering new strategies to optimise the management of medicine shortages, including how we communicate with patients."
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