The Pharmacy Law and Ethics Association held its annual seminar recently. Subjects covered included a notional pharmacist being charged with manslaughter, pharmacy premises regulations and medicinal cannabis. David Reissner reports

The trial of a pharmacist accused of manslaughter was acted out during the Pharmacy Law and Ethics Association annual seminar.

The pharmacist (referred to as ‘Ian Thurdock’) had dispensed at regular monthly intervals a patient’s prescriptions for morphine sulfate tablets 10mg. The patient’s wife then took the prescriptions to another pharmacy for several months. Then, one Friday evening, the patient brought Mr Thurdock a prescription for 2 x 50mg tablets to be taken every four hours.

The prescriber could not be contacted and Mr Thurdock, concerned that the patient should not be left in pain, dispensed the prescription. It turned out that the doctor had made an error and the patient died.

The audience was taken through the law as set out by the courts in the recent cases of optometrist Honey Rose and Dr Hadiza Bawa-Garba, both of whom had been convicted of manslaughter. Shortly before the seminar, the Court of Appeal had overturned a decision to strike off Dr Bawa-Garba. At intervals, as the facts of the case were laid out for the audience, who acted as the jury, a sample vote was taken. A significant number of people changed their vote to guilty after learning that Mr Thurdock had access to the patient’s summary care record but had not consulted it. However, at the final vote, 70 per cent of the audience voted not guilty.

Delegates were told that, if convicted, Mr Thurdock would probably have received an immediate prison sentence. Even if he had been acquitted, he was likely to have been the subject of an interim suspension by the GPhC pending a full fitness-to practise hearing (which could not take place before the trial), where he might face being struck off, or suspended for up to 12 months.

Premises, premises...

Claire Bryce-Smith, director of insights, intelligence and inspection at the GPhC, spoke about the new standards for regulating pharmacy premises and its even newer enforcement policy for pharmacy premises.

Referring to the GPhC’s 26 standards, Ms Bryce-Smith explained that pharmacies must meet all the standards from their first day in operation. The GPhC’s approach to regulation was that it should not stand in the way of innovation, she said. Instead, its focus would be on outcomes, which was reflected in the new inspection model. Inspections should reflect the daily experience of the public in pharmacies.

From this summer, inspection reports will be published on a new website – a knowledge hub – and linked to the GPhC’s public register. Examples of notable practice will be published on the knowledge hub, which the GPhC hopes will drive improvement. The inspection reports will state whether or not all standards were met.

Routine inspections will take place about every four years. Other inspections will be intelligence-led or themed, with the latter looking at underlying causes or issues such as safeguarding.

Medicinal cannabis

Speaking about the legal and ethical implications of medicinal cannabis, Professor Roger Knaggs expressed the opinion that we are living through a social experiment.

As a controlled drug, cannabis comes within the responsibility of the Home Office, he said, where the focus is harm and risk, rather than the Department of Health and Social Care, where the focus is on the potential therapeutic value of a drug.

Press stories in mid-2018 concerning children such as Alfie Dingley and Billy Caldwell highlighted considerable public concern about their access to medicinal cannabis. Ordinarily, reviewing the legal classification of a drug would take five years or more but, after the first press reports, the Chief Medical Officer carried out a review that was completed within days.

The Advisory Council on the Misuse of Drugs recommended clinical trials be carried out urgently to establish the efficacy of medicinal cannabis, including an assessment of product, dose and interactions. Currently, 80 children are involved in a trial of Epidialex.

By November last year, medicinal cannabis had been reclassified and made available on prescription. Even though there are significant prescribing restrictions, the speed with which the Misuse of Drugs Regulations were amended in the second half of 2018 was “a miracle”, Professor Knaggs said. Meanwhile, for those who can afford the high cost, at least one private cannabis clinic has already been opened.

CBD oil (cannabidiol) – which must not contain more than 0.2% THC (tetrahydrocannabinol) – is already available for purchase as a food supplement. Legal issues concerned the need for labelling requirements, such as whether anyone using it should be warned about driving or using machinery, and the risk that driving after using CBD oil might involve breaching the law on driving under the influence of drugs.

Some might feel it is unethical for pharmacies to sell CBD oil, he said. Others may feel it is preferable to sell CBD oil from pharmacies, since professional advice can be given about its use and possible interactions.

Social media and professional conduct

Kenneth Hamer, a leading barrister in fitness-to-practise cases, spoke about social media and professional conduct. One case he described involved a barrister (A) who had heard in confidence allegations about a fellow barrister (J). A did not know J’s wife, but repeated the allegations in LinkedIn messages to her. Although the messages were private, they would have been upsetting to J’s wife. A’s conduct was considered likely to lower public confidence in the professional standard of the Bar and he was suspended for three months.

When the PDA challenged the lawfulness of the GPhC’s Standards for Pharmacy Professionals in 2017, it argued that it would be wrong to insist that standards were met at all times. In his response, Mr Justice Singh said that in any specific case, a proportionate view would have to be taken, and gave the example of a pharmacy professional who engages in “a racist tirade on Twitter” that may well shed light on how he or she might provide professional services to a person from an ethnic minority.

Another case mentioned by Mr Hamer involved a Sheffield University student who was taking a course leading to registration as a social worker. The student had posted biblical passages on Facebook reflecting his genuinely held beliefs that, amongst other things, same-sex marriage is detestable to God. The High Court refused to overturn the student’s exclusion from his course. At the time of the seminar, an appeal judgment was awaited.

The GPhC’s guidance, ‘Demonstrating professionalism online’, states that social media can blur the boundaries between personal and professional use. Pharmacy professionals should therefore always think about the expectations and perceptions of patients, colleagues and employers. Reliance on human rights, such as the right to freedom of expression, has not assisted registrants where their misconduct has been found to be serious.

• David Reissner is chair of the Pharmacy Law and Ethics Association. Membership of PLEA is open to anyone with an interest in pharmacy law and ethics and is free to students.