Empowering you to meet regulatory and best practice requirements

This month’s Patient Safety Champions’ letter focuses on the importance of the key dispensing processes that must be in place to support the safe dispensing and supply of valproate and the positive impact this has on patient safety.

With your Patient Safety Champion, please undertake the ‘Team Activity’ included in this month’s letter to check your understanding of the valproate guidance and the associated dispensing processes. Use this activity with your Patient Safety Champion to identify any opportunities for SMART-ER actions that you may require to support patient safety in relation to the safe dispensing and supply of valproate.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a Drug Safety Alert on 20 February 2024 with advice to healthcare professionals on the reclassification of codeine linctus (oral solution) to a prescription-only medicine (POM) following a public consultation. Please refer to the BootsLive Calendar Alert sent on 21 February 2024 and ensure that all actions have been completed.

The Drug Safety Update issued by the MHRA in January announced new guidance for the prescribing of systemic fluoroquinolone antibiotics. In order to reduce the identified risk of disabling and potentially long-lasting or irreversible side effects, these must only be prescribed when other commonly recommended antibiotics are inappropriate. The full MHRA update, which includes advice for healthcare professionals to provide to patients and caregivers, is available here.

The MHRA’s Drug Safety Update issued in January also included the new valproate safety and educational materials that have been introduced for men and women under 55 years of age to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.

These materials support the new regulatory measures that were announced in the National Patient Safety Alert on 28 November 2023 and can be accessed here.

Team members should ensure that the SOPs relevant to their role continue to be read, understood and implemented and the Responsible Pharmacist (RP) should ensure that the pharmacy task and role matrix, detailing the roles and responsibilities of pharmacy staff, is updated accordingly. Please refer to SOP RP5 for further guidance; this can be accessed via MyHub. Copies of the pharmacy task and role matrix, as well as the associated review table, can be accessed on BootsLive.

For those stores that are welcoming university undergraduate students on placements, please ensure the RP on the day is aware that they will be attending and has identified how they can best help them with their learning to get the most out of their placement. When the student first arrives in store, they must present their signed authorisation form (which confirms they agree to follow Company procedures including Health and Safety and Information Governance); a copy of the signed authorisation form should be retained in the store’s Core Filing.

Before a student attends for a placement, a risk assessment is carried out by a Healthcare Academy Trainer and a Professional Standards & Quality Manager (and a copy of the risk assessment is emailed to the Store Manager). During their time in the store, the student must only undertake the tasks that are detailed in their risk assessment and with the appropriate level of supervision. The RP must therefore have access to the student’s risk assessment. If the student will be carrying out a task that is detailed in an SOP, they must read the SOP on MyHub (using their university’s generic account access) and sign their paper SOP training log to confirm they understand and will follow the SOP; the RP should then subsequently countersign the training log when they deem that the student is competent in following the process steps.