GPhC registered pharmacies, enforcement and fitness to practise

Registered pharmacies can face enforcement action by the GPhC, including fitness to practise, referrals, for not complying with GPhC standards.

Enforcement notices for codeine linctus

It was recently reported that the General Pharmaceutical Council (GPhC) said it has seen “high numbers of enforcement notices served” concerning high purchase numbers of codeine linctus.  In total, it served 27 enforcement notices, of which 21 related to a lack of governance and risk management around the sale of over-the-counter medicines, including codeine linctus and promethazine preparations.

Following on from this, Kings View Chambers have had contact from a number of pharmacy owners.  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.

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’.

GPhC Enforcement

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.

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