From a regulatory perspective



In these uncertain times, pharmacists have a lot of questions about what they can and cannot do. We look at some of the more commonly asked questions and give some thoughts from a regulatory perspective:

Can pharmacies during this time offer POM medicines for out of stock OTC?
The normal rules on the licensing and classification of medicines have not been changed, so that pharmacists should only routinely supply P-marked packs OTC.
However, the General Pharmaceutical Council (GPhC) has consistently stated that care of patients should be pharmacist’s primary concern, so that pharmacists may consider supplying a POM-marked product as a P in exceptional circumstances.

Do we know where it’s clinically appropriate to use P medicines out of licence?
This would be a decision to take on a case-bycase basis. The pharmacist (in conjunction with the prescriber where appropriate) would have to weigh up the risks and benefits of an off-label supply, and this should be explained to the patient to allow the patient to make an informed decision. Records should be kept of these discussions.

If as a superintendent pharmacist I make a mistake – dispensing or clinical will the exceptional circumstances I am working under be taken into consideration?
The circumstances surrounding a mistake would always be taken into account if they are relevant, and the GPhC has indicated that it understands the signifi cant pressure that pharmacies are under at the moment and the important role they play in protecting and promoting good health.

What are the legal rights of employees who may just choose to not come in anymore – without any notice or consideration of the impact to care provision?
If staff have particular concerns about coming into work then pharmacy owners should listen carefully and constantly review whether any further steps can be taken to protect staff.

Consideration should also be given to more flexible working hours, avoiding staff having to travel on public transport in busy commuter times where possible, or extra parking being made available to staff.

Clearly employers cannot force staff to come into work. If staff refuse to come to work then consider any alternative arrangements, such as taking holiday or unpaid leave (although a business does not have to agree to this) before considering whether employment should be terminated (through the normal disciplinary procedures).

What are the implications of IR35 postponement?
Changes to IR35 off-payroll working, which were due to come into force in April 2020, have been postponed to April 2021. This means that locums and pharmacy owners have another year to adjust to the changes.

Can pharmacists split OTC packs, such as large packs of paracetamol?
Assembling medicines products (including splitting and re-boxing packs) should only be done in accordance with a prescription, which means that OTC packs should not be split. However, the GPhC has indicated that pharmacists may, exceptionally, split packs to meet an urgent patient need.

What is the GPhC doing in respect of regulating pharmacists and pharmacy owners?
The GPhC has made several announcements recently to support pharmacists:

  • It has indicated that, where staff shortages mean that a pharmacist is not present on the premises when patients come in to collect their prescriptions, items which have already been dispensed and bagged up (by, or under the supervision of, a pharmacist) may be supplied in the absence of the RP.
  • routine pharmacy inspections have been suspended to avoid an inspection taking place when pharmacists are working hard to meet patient needs.
  • final fitness to practise hearings that were due to take place in the next two months will be adjourned. The GPhC will continue to consider cases such as interim order applications and review hearings, but will deal with those as much as possible remotely (for example via video-link or by consent).
  • Revalidation submissions that were due between March 2020 and August 2020 have been postponed

The GPhC has also warned that profiteering risks bringing the profession into disrepute. The Council is likely to take action where it believes that pharmacists are not acting in the best interests of patients and the wider community.

I cannot open my pharmacy because of staff shortages. What will NHS England do?
If a pharmacy is unable to open (or can open but is not able to supply prescribed medicines, for example, because there is no pharmacist), the pharmacy owner should notify NHS England as soon as possible of the suspension of services.

In normal circumstances, staffing problems would not be accepted by NHS England as a reason beyond the pharmacist’s control to justify a suspension, but these are extraordinary times, and it is anticipated that NHS England would have more sympathy than normal with the pharmacy owner.

However, NHS England may ask the pharmacist to provide details of the staffing issue, and may ask them to explain what efforts were made to find alternative cover (for example, through locum agencies), so pharmacy owners should make every effort to stay open.

Pharmacies will need to re-open as soon as possible once any staffing issue has been resolved, and should signpost patients to nearby pharmacies in the meantime.

Noel Wardle is a senior solicitor and partner at Charles Russell Speechlys LLP.

The above is a general overview and we recommend that independent legal advice is sought for your specific concerns. If you require further information in relation to the points raised in this article you should contact Noel Wardle, who is a solicitor and member of the Pharmacy Transactions Team at Charles Russell Speechlys LLP, specialising in Employment. Noel can be contacted on [email protected]