2023-05-07 19:31:24
A decision of the General Pharmaceutical Council’s Fitness to Practise Committee (GPhC) following a hearing on 4 and 5 April 2023 raises a number of interesting issues including:
- The approach to online pharmacy
- The approach to supplies of opioids and the role of pharmacists as “gatekeepers”
- The role of a superintendent pharmacist
- What the GPhC’s standards entail in terms of teamworking
- Remaining as superintendent pharmacist while on maternity leave
The case, like so many currently being dealt with by the GPhC concerns an online pharmacy. The registrant was the superintendent pharmacist of the company that operated a website. Prospective patients would use the website to seek a supply of medicines and pharmacists (not would the superintendent pharmacist) were responsible for making supplies. A very high proportion of the supplies contained high-risk codeine, dihydrocodeine, zopiclone and zimovane (both of which were referred to as “z drugs”).
In general terms, the allegations against the superintendent included that she failed to ensure that the pharmacy had robust procedures in place to ensure that sufficient checks were made when supplying medicines, failed to audit systems which ensured that patient identity was verified, failed to detail and record random checks and failed to ensure that medicines supplied were appropriate and safe.
The allegations were all admitted. There was no evidence of harm to patients.
The Fitness to Practise Committee (FtPC) referred to the version of section 71 of the Medicines Act 1968 that was in force at the time of the alleged misconduct. Although the Act was amended with effect from 1 December 2022, the amendments place greater responsibilities on superintendent pharmacists than those in force at the time of the alleged misconduct; so the decision and reasons of the FtPC are not likely to have been different if the alleged misconduct occurred after 1 December 2022.
We set out below what the FtPC said in a strongly-worded decision, with some comments of our own in Italics.
Misconduct and whether the registrant’s fitness to practise was impaired
“The Pharmacy was essentially operating by way of a commercial transactional model, with minimal checking, and was not a service geared to address patient needs and safety.”
“The Registrant as [superintendent pharmacist] was under a legal obligation to ensure the effective conduct of the Pharmacy”.
The second quotation is strange, because there was no such legal obligation until section 72AA was introduced into the Medicines Act with effect from 1 December 2022.
“[The GPhC’s] Standard 2 requires pharmacy professionals to demonstrate effective team working. The Registrant was in a position of responsibility as Superintendent Pharmacist and did not appear, on her own evidence…to have more than the very vaguest idea of what was happening at the Pharmacy. The Committee was astounded to hear from her that she had no idea that 70% of the prescribing was for opioids and another 5% was for z-drugs…there was no documentation to confirm discussions either with the [responsible pharmacist] or with prescribers in relation to Standard Operating Procedures…failed in her duty to demonstrate effective team working in order to ensure that medication was supplied in the best interests of patients.”
This extremely strongly-worded passage gives interesting examples of how the FtPC applied the GPhC’s standard requiring effective teamworking.
“…fundamental deficit in her ability to put patients and patient safety at the heart of her practice as a pharmacist. There does not appear to have been any appreciation of risk from the supply of habit-forming Controlled drugs, the majority being opioids and z-drugs. The Committee considered that the Registrant did not appear to have any appreciation of the need for clinical checks and proper safeguards to protect vulnerable patients at risk of harm from the abuse of habit-forming CDs.”
“After her child was born…, the Registrant took about six months off work, however, she nevertheless remained in the role of [superintendent] for the Pharmacy. The Committee was satisfied that, having retained her statutory and professional responsibilities as [superintendent], the Registrant ought to have ensured that appropriate systems were in place and properly audited to ensure the safety of patients and the public.”
Many years ago, in R v The Statutory Committee of the Royal Pharmaceutical Society of Great Britain ex parte Lewis & Jeffreys Limited, the High Court noted that a superintendent could go on holiday and delegate responsibility for the superintendent’s functions, but it may now be unwise for a superintendent pharmacist to remain in post while on maternity leave.
“…reckless disregard for the welfare and safety of the end-users of the medications prescribed and dispensed by the Pharmacy.”
Impairment
“The Committee was mindful that there was no evidence of harm to patients. However, the role of a pharmacist is to act as gatekeeper of medications which are known to be open to misuse and abuse. Without the appropriate procedures in place, there is undoubtedly a risk of harm and indeed of death…”
“…systems in place were woefully insufficient to ensure patient safety.”
“The provision of pharmacy services at a distance is now well known by pharmacists to carry particular risks…this Committee is well aware, as the Registrant should have been, of the significant and growing issue of opioid misuse and abuse in this country. Pharmacists are in the trusted position of having access to these medications and it is their professional duty to ensure at all times that they are only ever allowed into public circulation as clearly indicated by appropriate health professionals in relation to the clinical needs of specific patients.
Sanction
“The aggravating features include:
(a) The Registrant was the Superintendent and was responsible by statute for overall control of the management of the Pharmacy…”
The allegations of misconduct were largely predicated on the registrant being the superintendent pharmacist and it therefore seems odd that being the superintendent pharmacist should, of itself, be an aggravating factor.
“The Committee does consider that the public interest considerations raised by the facts of this case are especially acute because prescribing at a distance carries particular risks in relation to which the Registrant, as Superintendent, had an overriding responsibility imposed by statute.”
This passage, like other aspects of the decision, could probably be applied to every case involving internet pharmacy now or in the future.
Outcome
The FtPC directed that the registrant be suspended from the register for 9 months and made suggestions as to the evidence that would assist a future FtPC reviewing the suspension.