Under current legislation, manufacturers have to include a hard copy patient information leaflet in every “original box of relevant medicine” they supply, the Department of Health and Social Care (DH) said in its Medicines and Medical Devices Bill Impact assessment, published earlier this month (February 10).

However, pharmacists are currently not legally required to include a patient information leaflet with repackaged prescriptions, the DH said.

As part of the Medicines and Medical Devices Bill, which was presented to parliament on February 13, the DH is considering introducing “a requirement for manufacturers to provide and maintain up-to-date statutory information about certain medicines on a variety of digital platforms and for all packs dispensed to signpost these resources”.

The second reading of the bill in parliament is taking place today (March 2).

Potential benefits

“Electronic delivery of the statutory information could ensure patient access to the latest safety information about their medicines,” the DH said in the impact assessment.

This could help “potentially avoid adverse health outcomes” and generate savings for manufacturers by “reducing the provision of hard-copy leaflets”, the DH said.

Access to digital information

Commenting on the proposal, Alistair Murray, chief pharmacist at distance-selling pharmacy Echo, told C+D last month (February 19) that “we should signpost all patients who want access to digital information to appropriate resources”.

“Benefits include real-time content updates, which doesn't happen once a paper leaflet has been printed. It would also be quicker not having to print extra copies of patient information leaflets,” he said.

However, this change should be implemented “in a sensible manner”, Mr Murray added.

“The signposting message should be printed automatically via the pharmacy patient medication record system and pharmacy teams can support patients in accessing this. Adding an extra stage to the dispensing process and competing for space on a product box would be counterintuitive.”

A National Pharmacy Association spokesperson told C+D last month (February 19) that while the organisation is awaiting further details on this proposal, “we are likely to welcome a digital information option for those who want it".

"[However, we] would want to ensure that new systems would not reduce access to those who are not digitally enabled,” they added.

“Any policy like this would have to be considered carefully to ensure that there is no negative impact on health inequalities.”