Pharmacists must ensure they comply, and can evidence, compliance with new MHRA guidance on dispensing of valproate-containing medicines to avoid GPhC sanctions.
Your role and responsibility as a pharmacist, under the new legislation
Under the new guidance issued by the Medicines and Healthcare products Regulatory Agency (MHRA), unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack from 11 October 2023. Pharmacists must either round up or down so that the patient receives their supply in the manufacturer’s original full pack and ensure that they receive an amount that is as close as possible to that prescribed. You must not subsequently re-package any valproate-containing medicine into plain dispensing packaging.
This will ensure that all the safety warnings associated with taking valproate-containing medicine are clearly visible and available to patients. Providing the manufacturer’s original full pack with instructions about the safe and effective use of a product is an important patient safety measure.
Exceptional circumstances
The manufacturer’s original full pack does not have to be supplied where:
(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied valproate-containing medicines in different packaging from its manufacturer’s original full outer packaging (for example, in a monitored dosage system) and
(ii) assuming that the product is authorised, there are processes in place to make sure that the patient receives the Patient Information Leaflet. That is not the case for unauthorised medicines, unless they are only unauthorised as a result of an assembly process.
The MHRA confirmed it will provide links to templates for example risk assessments once available.
The role of the GPhC in regulating the supply of supplying valproate
Managing and identifying the risks associated with pharmacy services including medicines containing valproate is the responsibility of the whole pharmacy team. The safe dispensing of medicines forms a significant part of the GPhC’s standards for pharmacies and pharmacists. In previous articles, we made the point that both the pharmacists, and their staff, must know these standards and ensure they achieve, and maintain, regulatory compliance or face the prospect of sanctions.
The GPhC previously confirmed that:
“When inspecting pharmacies, our inspectors are looking to see whether our standards are being met, and will systematically check compliance with the PPP for valproate during inspections of registered pharmacies.”
The GPhC’s “Inspection decision making framework”, for example, states that pharmacies would meet their standards where there is evidence of “appropriate clinical checks are carried out (for example for high risk medicines including valproate”.
GPhC registered pharmacies, enforcement and fitness to practise
The GPhC have statutory powers to act “to protect the public and to uphold public confidence in pharmacy” if it receives concerns about a registered pharmacy. These powers include enforcement options and enforcement powers:
- Improvement action plans – Generally the first enforcement option and where there is no immediate risk to the public or patients. Improvement action plans require pharmacy owners to develop an improvement plan, setting out what they will do, within a set time, to put right the issues and meet the standards.
- Conditions on registration – Registered pharmacies can have conditions attached to their registration when this is necessary for the purpose of “securing the safe and effective practice of pharmacy at those premises”. Unless there is deemed to be an immediate public safety risk, pharmacy owners will have “reasonable notice” in writing of the condition(s) to be imposed and failure to comply with conditions can lead to an improvement notice.
- Improvement notices – Where the GPhC have reasonable grounds for believing there is a failure to meet standards for registered pharmacies, or a failure to meet conditions relating to the standards, they can serve an improvement notice. Pharmacy owners are responsible for making sure that the improvement work is carried out within the timeframe set out in the improvement notice (at least 28 days).
Enforcement and Fitness to Practise
If a pharmacy owner fails to comply with the improvement notice, the matter must be referred to the GPhC’s Fitness to Practise Committee for consideration as a “disqualification case”.
The GPhC’s Fitness to Practise Committee can disqualify a pharmacy owner for failing to meet the standards and remove their premises from the register. The fitness to practise committee can also suspend a pharmacy premises in lieu of a full hearing, prior to a disqualification decision or removal direction taking effect.
Disqualification and removal directions may be given for a limited period, meaning that premises entries will be restored at the end of that period.
Kings View Resolutions
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Disclaimer: This article is for guidance purposes only. Kings View Chambers accepts no responsibility or liability whatsoever for any action taken, or not taken, in relation to this article. You should seek the appropriate legal advice having regard to your own particular circumstances.
