Fitness to practise implications when a pharmacy is the subject of enforcement action

The General Pharmaceutical Council (GPhC) has a range of enforcement powers that will carry fitness to practise implications for pharmacists and pharmacy owners.

GPhC Improvement Plans, Notices and Conditions

In cases where a pharmacy fails to meet GPhC standards, the GPhC has a range of enforcement powers at its disposal, summarised as:

• Action plans – Usually the first and most common step the GPhC will take. This will be an agreed set of remedial actions taken by a pharmacy owner while the pharmacy continues to operate normally. An action plan is in most cases enough to address any patient risk. Action plans are used when standards are not met, but any ongoing patient risk is considered to be manageable.
• Improvement notices – Where there is evidence of ongoing patient risk which requires more urgent action, an inspector can serve an improvement notice. An improvement notice will identify a specific failing, the risk it creates, and what is needed to be done to address it.
• Conditions – Where there is evidence of ongoing patient risk which requires more urgent action, the Registrar can impose conditions on the pharmacy. A condition will usually restrict the pharmacy from providing a service which we believe puts patients at risk. An example of a condition would be to stop the sale and supply of certain medication or cease a particular service.

Pharmacists & Pharmacy Professionals’ Role

The enforcement powers described above relates to the pharmacy, or premises.  Clearly linked to this are the people responsible for running the premises (or pharmacy).

The GPhC guidance goes on to say that:

“Individual pharmacy professionals working in various roles and capacities such as SIs, RPs, or PIPs may have played a role in the system failings we have identified. They may be working routinely within these pharmacies and involved in implementing, maintaining, or having oversight of the activities of the pharmacy.”

Therefore, the conduct of individual pharmacy professionals cannot be separated from the system failures.

Fitness to practise implications

In cases where the GPhC has taken, or, started enforcement action against the pharmacy and pharmacy owner, a fitness to practise investigation may also be launched focussing on the individual professionals involved “to look into their potential failings as pharmacy professionals with a role in overseeing pharmacy services”.

The GPhC’s view is that “it would not be in the public interest to allow the pharmacy professional who has potentially played a key role in the unsafe system to continue in their practice without any restrictions just because we have dealt with the unsafe system.”

The GPhC provides the following example:

“For example, a pharmacy using an unsafe system of dispensing POMs could face disqualification. But if the unsafe dispensing system has come about through the acts or omissions of an SI to manage the dispensing system, then we will investigate the SI’s conduct so that any appropriate action can be taken against the SI.”

A further fitness to practise issue may arise as a result of the failure by the pharmacy owner to comply with plan, notices or conditions.  Under these circumstances, the GPhC “will” refer a pharmacy owner to the Fitness to Practise Committee (FtPC) for disqualification. Disqualification can lead to a pharmacy or pharmacies being removed from the Register.

Rights 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.

Online sale and supply of habit-forming medicines – Beware

The number of online pharmacies in Britain has increased significantly in recent years and continues to grow. But so too has the GPhC’s enforcement caseload against online pharmacies.  It was recently reported that almost a third of online pharmacies are not currently meeting the General Pharmaceutical Council’s (GPhC) standards.  The GPhC is therefore focussing a lot of its time and resources taking enforcement action against online pharmacies.

Online pharmacies must be particularly careful to ensure they have sufficient and robust processes and checks in place. The GPhC cites the following as “examples of poor practice” (not exhaustive):

• Prescribing decisions being made in a relatively transactional way, that is, using a questionnaire consultation, and minimal checking with a GP. Operating models may lack a real-time or face to face consultation between the patient and prescriber, or an adequate alternative. Checking of patient history or suitability with GPs can be absent or inadequate.
• The sale and supply in some pharmacies can be streamlined with minimal levels of clinical checking with a commercial, rather than a clinical, focus
• Poor or weak checking and monitoring of multiple or repeat supplies, despite dealing with habit-forming medicines which are known for their potential to be abused, with evidence of more frequent or larger supplies than their policies allow
• Patient reports of history and symptoms can be taken at face value without adequate verification or appropriate identification checks. For example, patient reports of a current diagnosis, such as to justify a particular medicine, being accepted as sufficient reason to prescribe.