Running Your Business
Lessons from enforcement action in online sales
Following several press investigations highlighting potential issues with online supplies, in April 2019 the General Pharmaceutical Council (GPhC) published new guidance for pharmacies that supply medicines online. This guidance, which was particularly directed towards the online ‘prescribing and supply’ model, was quite a shift from how pharmacies supplying medicines at a distance had been operating up until then. It was followed later in 2019 by guidance for pharmacist prescribers which, again, referred specifically to those prescribing for online supply businesses.
Concerns were raised at the time that the guidance was being implemented without much (if any) consultation. However, the GPhC has used both of these 2019 guidance documents to support enforcement action.
This action has largely focused on areas of the online medicines supply model that the GPhC believes are higher risk, such as:
- Carrying out appropriate identity checks and having systems in place to ensure that repeat orders are flagged
- Having sufficient information about a patient to make informed clinical decisions
- Dialogue with the patient’s GP, either before the supply to confirm the diagnosis provided by the patient or after supply so that the patient’s GP records are up-to-date
- Considering, in particular, medicines that are higher risk or are liable to abuse.
Enforcement action taken
In late 2019, the GPhC undertook a series of targeted inspections of online pharmacy providers. Most inspections found that its guidance was being followed, or largely being followed. However, a number of inspections resulted in enforcement action being taken. Enforcement action is also being taken by the GPhC where an ‘intelligence-led’ inspection takes place which raises concerns.
It's important that the public – and pharmacists – have faith in the regulator to enforce standards effectively and fairly
The GPhC’s primary route of enforcement has been to impose conditions on the pharmacy’s premises registration – for example, a condition that certain medicines cannot be supplied from the registered premises. However, in at least one case, the pharmacy’s premises registration was suspended. This is a quick and easy route of enforcement, but it can be lacking in appropriate oversight.
Concerns have been raised by pharmacists that enforcement decisions are often opaque, with a lack of dialogue between the pharmacy owner and inspector before a decision is made. Decisions are made without a hearing and conditions can only be challenged by an application to the administrative court, which can be both time-consuming and costly. And while an affected pharmacy can apply to the registrar for the conditions to be varied or removed, again this is a paper exercise with no right to a hearing.
The other route to enforcement is for the GPhC to bring fitness to practise proceedings against the responsible pharmacist or superintendent pharmacist working at the online pharmacy. Unfortunately, the fitness to practise process itself is mired in delays, which has led to criticism recently by the GPhC’s own regulator, the Professional Standards Authority.
Patient safety is, of course, at the forefront of pharmacy practice, and the GPhC has a central role in protecting the public from harm by enforcing appropriate standards in the profession. But it is also important that the public – and pharmacists – have faith in the regulator to enforce standards effectively and fairly.
As more and more health services move into remote (including online) settings, pharmacists and pharmacy owners need to be supported to enable them to develop services that meet the changing needs of patients confidently. Where enforcement action is taken, it is important that this done in a balanced way, and that basic human rights to a fair hearing are maintained.
The above is a general overview and we recommend that independent legal advice is sought for your specific concerns.