MHRA guidelines on what should be reported include:
• Serious reactions
• Anything that involves a medicine on additional monitoring
• An unlisted reaction in product information
• Anything you are unsure about reporting.
It is often asked ‘what constitutes a serious reaction’? An ADR which was fatal or life-threatening would be obviously classified as serious. However, there are other categories of serious reaction: these might include an ADR that results in hospitalisation or a prolonged hospital stay; one that results in disablement; or those causing congenital abnormalities.
Medically significant ADRs are also classified as serious reactions. These are those that do not meet the other criteria but where the ADR might result in harm to the patient and might require treatment.
Causality does not need to be established when submitting a yellow card. The MHRA’s guidance is, if in doubt – report it. So how can community pharmacists increase reporting?
The conversations community pharmacists have with their patients make them ideally placed to identify any ADRs:
• MUR and NMS consultations are specifically designed to highlight any issues a patient might be having with their medicine, including ADRs, leading to a yellow card report
• As suppliers of herbal and OTC medicines, pharmacists can identify any issues when talking to patients about these drugs
• Patients may not be aware that they can report ADRs. By talking to patients, running yellow card awareness events, and having the reporting telephone number and website address on hand, reporting may be increased.
Increasing your knowledge about ADRs and yellow cards and that of your team will also help. Useful sources of further information include:
• CPPE’s e-learning course for pharmacy professionals on ADRs, yellow cards and pharmacovigilance: cppe.ac.uk
• MHRA guidance on the yellow card scheme for healthcare professionals: gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals
• Signing up for monthly updates at gov.uk/drug-safety-update
• The yellow card mobile phone app, which allows a watch list to be created to receive medication alerts and yellow cards to be submitted.
The MHRA guidance is – if in doubt, report it