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Drug Safety Update

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Context

Drug Safety Update was developed by the MHRA and its independent advisor the Commission on Human Medicines to inform healthcare professionals about the latest safety information for medicines and vaccines to support safer use. The MHRA is responsible for continuously monitoring the safety, efficacy, and quality of medicines in the UK. When there are important changes to the way a medicine should be prescribed or used, we aim to inform professionals via our Drug Safety Update bulletin (as updates to product information can often take some time to appear, especially in print).

Aims
  • To help healthcare professionals stay up to date with the latest prescribing advice to promote the safer use of medicines.

  • To explain what new or updated information has come to light about a medicine or group of medicines, the evidence base behind the information, and what professionals need to do differently as a result

  • To help explain what information they may also need to give to patients or carers to support safer use of a medicine

  • To encourage the sharing of information about potential adverse drug reactions by linking to the UK’s Yellow Card Scheme for reporting such events

Description

Drug Safety Update is an online e-bulletin. Articles are published on a monthly basis. Each article contains:

  • A summary of the safety issue with the medicine (or medicine class) in question

  • Advice listed as action points for the healthcare professional to take or pass on to colleagues, patients or carers

  • A summary of the evidence underpinning the advice being issued (eg Yellow Card reports, cases in scientific literature), with references and links to further information where appropriate

The bulletin enables professionals to see timely, impartial safety information for (a) medicine(s)

Readers can search for specific articles of interest, or can look at articles relevant to a particular therapeutic area

Professionals can sign up to receive an email alert when each monthly issue is published

Implementation

Reader surveys since launch (in 2007) show the bulletin is a useful resource; qualitative data highlights it has helped clinicians to change (or at least consider changing) practice. Bulletin uptake continually measured through webhits. Implementation highlights key challenge of raising awareness of bulletin rather than improving product quality per se.

Suggestions for further implementation

Question not fully relevant to Drug Safety Update. Our focus is on maximising readership and sharing among all UK healthcare professionals. Model lends itself to a bulletin for the general public/patients or carers; at present such information is ad hoc according to public health importance of the topic.

Challenges and learning

Drug Safety Update is continually evolving to take into account any reader feedback or opportunities to enhance the presentation, dissemination, and uptake of information. We have greatest impact when we can partner with producers of other trusted sources of information. Most notably, this includes our relationships with the British National Formulary and the NICE Medicines Prescribing Centre (who both promote our information), and with individual professional bodies for particular topics relating to a specific therapeutic area or specialty.

Quality assurance/MHRA registration

Production of Drug Safety Update is overseen by an internally audited quality process of risk management and communication, outlined in Standard Operating Procedures and underpinned by relevant EU and UK pharmacovigilance legislation. This process by which the bulletin is produced is accredited by NICE (currently undergoing revalidation https://www.nice.org.uk/about/what-we-do/accreditation).