Medicines are the most widely used intervention in health. Research evidence shows that medication errors and adverse drug reactions are common and associated with a high cost in terms of patient outcomes as well as financial consequences due to additional treatment or litigation. Medication safety is a core element of the priorities of the Medicines Optimisation team. Resources and information aligned to the ICB’s medication safety priorities may be found in the categories below, along with national mechanisms to report medicines-related incidents or adverse reactions:
- MHRA Drug Safety Update: Valproate use in men: as a precaution, men and their partners should use effective contraception (Sept 2024)
- MHRA Drug Safety Update: Valproate: new safety and educational materials to support regulatory measures in men and women under 55 years of age (Jan 2024)
- MHRA National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (Nov 2023)
- MHRA Guide for healthcare professionals: Information on the use of valproate in all patients
- Location of the Valproate referral form in Ardens
- Annual Risk Acknowledgement Form (ARAF) for females (for completion by specialists)
- Risk Acknowledgement Form for male patients starting valproate (for completion by specialists)
Patient resources
- Valproate - Easy read patient leaflet (available in 30 languages)
- MHRA: Advice for male patients on valproate to use contraception
- MHRA: Patient guide: What you need to know about valproate
- NHSE: Is valproate the right epilepsy medication for me?
- NHSE: Bipolar disorder: Is valproate the right medication for me?
- Epilepsy Action: New rules for taking sodium valproate
- Epilepsy Action: Sodium valproate medicines and risks in pregnancy
- Epilepsy Society: Sodium valproate
- Epilepsy Society: New prescribing practices for valproate
- Young Epilepsy: New safety measures for valproate
The Yellow Card Scheme is used for the reporting of suspected adverse drug reactions (side effects) to any medicines and medical devices. It also includes any suspected defective or counterfeit medicines and medical devices.
Yellow Card | Making medicines and medical devices safer (mhra.gov.uk)
Research has shown that organisations who regularly report patient safety incidents have a stronger learning culture, where patient safety is a higher priority. For those working in primary care, you can report patient safety incidents using the national “Learn from patient safety events”(LFPSE) reporting service or through your locality’s incident reporting systems.
• Primary care information on the national LFPSE service: LINK
• To register and/or record a patient safety incident via LFPSE service: LINK
The Primary Care Patient Safety Strategy, first launched in September 2024 describes the national and local commitments to improve patient safety in primary care, supporting all areas in this sector to fully implement the NHS Patient Safety Strategy (2019).
• NHS England: Primary care patient safety strategy (2024) LINK