New premises standards regulations
Posted: Saturday, April 28th, 2018
The Privy Council has made an Order, bringing The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 into force on 24 May 2018.
The Premises Standards Order:
- gives the GPhC power to enforce premises standards through improvement notices rather than prosecution
- gives the GPhC power to produce premises standards which will extend not only to registered premises but also to "associated" premises, and will take into account the "working environment"
- gives the GPhC power to refer premises standards cases to the Fitness to Practise Committee
- gives the Fitness to Practise Committee power to disqualify pharmacy owners and to remove premises from the register
- gives the Fitness to Practise Committee power to impose an interim suspension pending a full hearing
- gives the GPhC power to publish inspection reports
NHS market entry review
Posted: Sunday, April 15th, 2018
The Department of Health and Social Care has published a review of the operation in England of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
The review concludes that the regulations have "largely achieved" the original policy objectives of encouraging the supply of services without excessive provision in areas already meeting demand. However, the review recommends undertaking a consultation on possible amendments to address certain unintended consequences of the Regulations.
The issues that may give rise to future amendment to the Regulations include:
- GPs directing prescriptions to distance selling pharmacies in which they have a commercial interest
- streamlining the application process for "minor" relocations
- relaxing restrictions on dispensing doctors so as to enable them to dispense from addtional premises if they amalgamate with a non-dispensing practice
- Allowing 100-hour pharmacies to reduce their hours if this is necessary in order to remain financially viable
Dispensing error defence in force
Posted: Sunday, April 15th, 2018
Following an order of the Privy Council, The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 comes into force on 16 April 2018. The Order provides a defence to prosecutions under section 64 of the Medicines Act 1968 because the wrong prescription medicine has been supplied and a patient is harmed.
The defence does not apply to over-the-counter medicines, and a defendant will only be acquitted by proving that certain conditions are met. Typically, these will be that the pharmacist did not know that the wrong medicine was being supplied, and that when the error was discovered, the patient was promptly notified.
Find out more at PLEA's annual seminar on 16 May 2018.
Annual Seminar - Booking now open!
Posted: Wednesday, March 21st, 2018
PLEA Annual Seminar and AGM
“What's new in 2018?”
Wednesday 16th May 2018 10.00 - 3.30
At the offices of Charles Russell Speechlys LLP, 5 Fleet Place, London EC4M 7RD
This year's seminar will look at recent changes in the law affecting pharmacists and pharmacy practice, as well as exploring how fitness to practise is dealt with in other jurisdictions such as Australia, Canada and a US State.
The programme will include
- You, the jury: a mock trial involving new defences to prosecutions for dispensing errors under section 64 of the Medicines Act and how the defences might work (or not) in real life
- Fitness to Practise - a comparison of processes in different common law jurisdictions
- Dishonesty - how it arises and is dealt with in Fitness to Practise cases
- Ethical issues when pharmacists collaborate with GPs
To register to attend please register via the events page. This event is free for PLEA members, £50 for non-members.
The Annual General Meeting of PLEA will also be held at this meeting. Lunch and refreshments will be provided.
Thanks are due to Charles Russell Speechlys for the facilities to hold this meeting of PLEA
New approach to sexual assault in FtP cases?
Posted: Wednesday, March 21st, 2018
The High Court has just rejected the appeal against erasure of a doctor who sexually assaulted two young, femaile nurses in the space of two hours on a single day. He had hugged them from behind, rubbed his hands on their bodies, pressed his erect penis against them and made inappropriate comments to them. There was no criminal investigation or further complaint.
In Mohammed v General Medical Council, Mrs Justice Yip said that the decision of the Medical Practitioners' Tribunal Service could have gone either way. She said there had been a shift in the attitude to and public perception of "low level" sexual offences which were now rightly regarded as being more serious than they once were.
Pharmacy student wins challenge to university exclusion
Posted: Tuesday, March 6th, 2018
In HA v University of Wolverhampton (with the Office of the Independent Adjudicator as an interested party; and the GPhC intervening to make submissions of its own)  EWHC 144 (Admin), a pharmacy student obtained an order quashing a decision to exclude him from his undergraduate course.
The student had failed to disclose criminal convictions dating from when he was a juvenile. Mr Justice Julian Knowles found that the university's fitness to practise panel had, amongst other flaws in its decision-making, failed to take into account the student's considerable mitigation, which mean the panel had not struck a fair balance between the student's rights and the protection of the public. Amongst other things, the panel had failed to take into account that different considerations may apply to convictions at a young age, and the panel also approached the question of sanction in a way that did not ensure proportionality. Unlike the GPhC's Fitness to Practise Committees, which consider sanctions in ascending order of seriousness, the fitness to practise panel had decided that exclusioni was the appropriate outcome without considering less serious alternative outcomes.
Posted: Friday, February 9th, 2018
The Privy Council has signed the Order approving the new statutory defences to prosecutions under section 64 of the Medicines Act 1968. After 8 March, the Government can introduce a commencement order. The commencement order will specify the date the new defences into law. The earliest this can happen is April 2018.
Review into the application of gross negligence manslaughter in healthcare
Posted: Wednesday, February 7th, 2018
Following the outcry in the medical profession over the High Court's recent decision to strike Dr Bawa Garba off the register after her manslaughter conviction, the Secretary of State for Health and Social Care announced in the House of Commons on 6 February 2018 that he has asked Professor Sir Norman Williams to "conduct a rapid review into the applicaiton of gross negligence manslaughter in healthcare".
On the same day as Mr Hunt's announcement of a review, the General Pharmaceutical Council issued a statement saying that it will "actively engage with the rapid review". The focus of the GPhC's statement appears to be on pharmacy owners promoting a culture of openness, honesty and learning when things go wrong. This is to be seen within the proposals for revalidation.
The GPhC says it only takes forward the most serious cases, and a single dispensing error would only be taken forward if there are significant other aggravating factors. This does not seem to take matters any further, because the GPhC would inevitably regard a single fatal dispensing error resulting in a manslaughter conviction as one in which fitness to practise proceedings would be taken.
We welcome the views of PLEA members on the subject manslaughter in healthcare cases and will consider whether we can contribute to the review.
Doctors up in arms over manslaughter judgment
Posted: Tuesday, February 6th, 2018
The medical profession appears to be up in arms about a recent High Court judgment overturning a decision of the Medical Practitioners Tribunal to impose a suspension on a paediatric doctor following her conviction for manslaughter - GMC v Dr Bawa-Garba  EWHC 76 (Admin).
Dr Bawa-Garba had worked a double shift – 13 hours straight – when her errors led to the tragic death of a 6-year-old boy in 2011. A jury found Dr Bawa-Garba guilty of gross negligence manslaughter. The General Medical Council brought fitness to practise proceedings and the Medical Tribunal Practitioner Service decided to impose a suspension, having regard to the mitigation presented to it, including that Dr Bawa-Garba had practised for years without complaint both before the 2011 incident and after. The GMC appealed against the suspension. Two High Court judges ruled that when the Tribunal imposed a suspension, the Tribunal had failed to give weight to the verdict of the jury: in order to convict of gross negligence manslaughter, the jury must have found that Dr Bawa-Garba’s negligence was truly exceptionally bad. In view of this, it would undermine public confidence in the medical profession if the doctor was not erased from the profession. At the end of January 2018, the court allowed the GMC’s appeal and overturned the Tribunal’s suspension decision.
Although the High Court disavowed any suggestion that its ruling meant that striking off is the only possible sanction in the case of a gross manslaughter conviction, it is difficult to imagine a case where a manslaughter conviction will not now result in striking off.
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.