Since July 2020, the GPhC has taken enforcement action against 36 pharmacy premises and a pharmacy professional following intelligence-led inspections or investigations relating to unusually high sales of codeine linctus.
Codeine linctus, classified as a Pharmacy (P) medicine under the Medicines Act 1968 and the Human Medicines Regulations 2012, can be only be sold without a prescription from a pharmacy, under a pharmacist’s supervision. The medicine, which can be used for a dry cough, is high risk because of well-known problems associated with its misuse, abuse or overuse.
“Following these inspections, the pharmacies had conditions put on their registration that they must not sell or supply any codeine linctus preparations to anyone without an NHS prescription. A warning has also been issued to the superintendent pharmacist and regular responsible pharmacist of one of the pharmacies involved. The individual was found to have allowed the supply of codeine linctus without sufficient checks and safeguards and relying on questionnaires and limited clinical information. Fitness to practise investigations continue into other superintendent and responsible pharmacist implicated in similar failings.”
It might be helpful for pharmacists and pharmacy owners to understand the GPhC’s enforcement approach and actions, rights of appeal and fitness to practise consequences.
The GPhC said
GPhC as Regulator
To practise in Great Britain, pharmacists and pharmacy technicians must be registered with the GPhC and meet the GPhC’s standards. Equally, pharmacies must also be registered with the GPhC (including pharmacy departments based in a hospital or health centre) to operate in Great Britain and to use the title ‘pharmacy’.
The GPhC have statutory powers to act “to protect the public and to uphold public confidence in pharmacy” if it receives concerns about a 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.
Right of Appeal
Certain GPhC enforcement actions are appealable. Pharmacy owners can appeal the following actions:
- Improvement notices to the Magistrates’ court, or in Scotland to the sheriff. An appeal must be brought within 28 days beginning with the date on which the improvement notice was served. The Court may suspend an improvement notice pending the determination or abandonment of the appeal. On appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without change.
- Disqualification, removal directions & interim suspensions to the High Court (or the Court of Session in Scotland) within three months beginning with the date on which the direction is given.
In all other cases, judicial review proceedings might apply depending on the individual circumstances.
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.