Human Medicines Regulations amended to allow pharmacists to vaccinate against COVID-19
Posted: Monday, December 21st, 2020
The Human Medicines Regulations have been amended for a period expiring on 1 April 2021. The amendments in the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 make the following changes amongst others:
1. Certain providers of NHS and public health services, for example NHS trusts and foundation trusts, may issue Patient Group Directions (PGDs) in relation to parenterally administered medicinal products under powers that previously could only be used to issue PGDs in relation to medicinal products that are not parenterally administered.
2. The PGDs that allow retail pharmacy businesses to administer COVID-19 or influenza vaccines may be used at a location other than a registered pharmacy.
3. Thirdly, doctors, nurses and pharmacists are allowed to prepare or assemble COVID-19 vaccinations, or supervise their preparation or assembly, in circumstances in which they were not previously permitted to do so without the appropriate licences.
4. Authorised medicinal products which are to be used for the reformulation of COVID-19 vaccines, most commonly diluents, may be “assembled” into new products (for example by packing them down into different quantities and relabelling them), without those new products needing to be covered by new marketing authorisations.
The requirement to behave professionally at all times v Article 8 EHCR
Posted: Tuesday, December 1st, 2020
Article 8 of the European Convention on Human Rights concerns the right to respect for private life. There is a tension between Article 8 and the obligation in standard 6 of the GPhC’s Standards for pharmacy professionals which requires pharmacy professionals to behave in a professional manner at all times, not only during working hours. This tension was considered by Mr Justice Singh when the Pharmacists Defence Association challenged the introduction of the Standards in R (on the application of Pitt) v General Pharmaceutical Council  EWHC 809 (Admin); the challenge was unsuccessful because the applicant could not show that regulating behaviour in a registrant’s private life would necessarily infringe the registrant’s Convention right to private life.
In Beckwith v Solicitor’s Regulation Authority  EWHC 3231 (Admin), the High Court allowed the appeal of a senior solicitor whom the Solicitors Disciplinary Tribunal found had acted “inappropriately” by having a consensual “sexual encounter” with a junior colleague after an event at which they had both had too much to drink.
The High Court held that professional rules:
“may reach into private life only when conduct that is part of a person's private life realistically touches on her practise of the profession ... or the standing of the profession ... Any such conduct must be qualitatively relevant. It must, in a way that is demonstrably relevant, engage one or more of the standards of behaviour which are set out in or necessarily implicit from the [professional standards]. In this way, the required fair balance is properly struck between the right to respect for private life and the public interest in the regulation of the ... profession. Regulators will do well to recognise that it is all too easy to be dogmatic without knowing it: popular outcry is not proof that a particular set of events gives rise to any matter falling within a regulator’s remit.”
GPhC fails PSA standards and launches consultation on Fitness to Practise
Posted: Wednesday, November 4th, 2020
The Professional Standards Authority (PSA) has just published its annual review of the GPhC’s performance. The report can be accessed here https://www.professionalstandards.org.uk/docs/default-source/publications/performance-reviews/performance-review-gphc-2019-20.pdf?sfvrsn=1acd7620_8
The GPhC failed to meet three out of five standards and in relation to one of the two standards that were met, the PSA had “significant queries about the robustness of the GPhC’s triage process for fitness to practise referrals” and the PSA’s decision “finely balanced”.
The timeliness of processing fitness to practise cases seems to have been a concern that the PSA has commented on every year. The PSA said:
“… improvements we were expecting to see in the overall end to end timeframe for concluding…cases had not materialised…and our audit found avoidable or unexplained delays in a high proportion of the cases we reviewed.”
All timeframes were heading in the wrong direction. In numbers, it took:
- over 60 weeks from receipt of a referral to a final Investigating Committee decision;
- 40 weeks from final Investigating Committee decision to final Fitness to Practise Committee decision;
- early 100 weeks from referral to a final Fitness to Practise Committee decision
The GPhC had more than twice as many open cases older than 156 weeks than it did in 2015/16.
We reported a few months ago that the GPhC had presented a new Fitness to Practise strategy to its Council. The GPhC has just launched a consultation on the strategy. A link to the consultation is here https://www.pharmacyregulation.org/news/gphc-launches-consultation-fitness-practise-strategy . PLEA plans to respond to the consultation. If you have any particular views you want us to reflect, please email our Chair, David Reissner, at email@example.com by 30 November 2020.
GPhC responds to Times investigation by serving improvement notice
Posted: Thursday, October 29th, 2020
The GPhC continues to make use of its newish powers under the Pharmacy Premises Regulations. Responding to a story about a pharmacy "sell[ing] hormones for trans children online", the GPhC has carried out an inspection and served an improvement notice on the owner of the pharmacy. The improvement notice can be accessed here https://inspections.pharmacyregulation.org/pharmacy/enforcement/1123405-2020-10-21-156.pdf
DHSC consultation on amending Human Medicines Regulations
Posted: Friday, September 18th, 2020
The Department of Health and Social Care has just completed a consultation (conducted over only three weeks) on amending the Human Medicines Regulations (HMR). The aim of the proposed amendments is to enable COVID-19 vaccines (when available) to be used before there has been time to grant a marketing authorisation “if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence”.
Currently, regulation 345 of the HMR gives immunity from liability for loss and damage where the MHRA recommends or requires the use of a product without a marketing authorisation. Regulation 345 currently extends immunity to manufacturers, marketing authorisation holders, their employees and health care professionals. The amendments proposed to the HMR include extending immunity from liability for loss and damage to pharmaceutical companies that place unlicensed products on the market; and also to extend immunity to other health care workers.
GPhC interim suspension extended by High Court
Posted: Monday, August 17th, 2020
On 5 July 2020 reported on GPhC v Kellett and Gamble in which the High Court had refused a GPhC application to continue an interim suspension pending a full fitness to practise hearing. In another case on 11 August 2020, General Pharmaceutical Council v Umar, the High Court continued an interim suspension order for 9 months.
The registrant, Ms Umar, had admitted to her employer that she was addicted to codeine and had been taking codeine products from them over a long period. In September 2019, an interim suspension order was made for 12 months pending an investigation. A criminal investigation for theft had started, was then delayed by the COVID-19 pandemic, and ended with a police caution.
The GPhC argued that a 9-month continuation of the interim suspension was necessary because of the delay to the criminal investigation and other matters.
The Court regarded the allegation of theft from an employer as serious, and the alleged actions posed a risk of harm to the registrant herself and to public confidence in the profession. The prejudice to the registrant resulting from the interim suspension was outweighed by the public interest in preventing her from working as a pharmacist while she was or might be unfit to do so because of her admitted addiction and the risk of her having unrestricted access to medication that might tempt her to self-medicate.
Cumberlege review of Medicines and Medical Devices
Posted: Wednesday, July 15th, 2020
The Independent Medicines and Medical Devices Safety Review published its report on 8 July. Chaired by Baroness Cumberlege, the report is entitled First Do No Harm. The report includes a number of issues that relate to pharmacy.
Baroness Cumberlege’s team investigated what had happened in respect of two medicines and one medical device:
- hormone pregnancy tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;
- sodium valproate, an anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and
- pelvic mesh implants, the use of which has been linked to crippling, life-changing complications.
Baroness Cumberlege referred to the harrowing stories of the women who had been affected by these devices and medicines. The report refers to:
- A system that cannot be relied upon to identify promptly significant adverse outcomes arising from a medicinal product or device because the system lacks the means to do so. The Yellow Card scheme for reporting adverse reactions is decades-old. It is clear there is under-reporting, and the complaints system is “too complex and too diffuse to allow early signal detection”.
- “the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques. Patients are being exposed to a risk of harm when they do not need to be.”
- The statutory duty of candour “has not been entirely effective”. The Professional Standards Authority reports that regulators are not identifying duty of candour breaches or considering them as fitness to practise matters.
- A cultural shift away from blame is needed to create a healthcare system where people are open and honest. The recent emphasis on whistle-blowing will not solve the problem in itself. A no-blame, systems-based approach to delivering redress is essential to deliver a safer NHS where healthcare professionals have no reason to fear being candid and telling the truth to their patients.
- The GPhC discussed with the review team the difficulty of ensuring that information is being communicated in the most effective way, and the problems of having to disseminate information via a variety of alternative channels, such as pharmacy owners, those responsible for governance, and involving non-registered staff, such as counter assistants.
- A recent Company Chemists Association report suggested only half of at-risk patients taking valproate were physically present in the pharmacy to collect medication.
- The majority of mistakes are system errors, yet litigation usually deals with the culpability of individuals such as individual doctors or pharmacists.
- Creating the post of Patient Safety Commissioner.
- A Redress Agency as an alternative to litigation when things go wrong. A healthcare system should aim to eliminate avoidable harm: an open, honest culture in which mistakes are learned from and barriers to disclosure are removed is overdue and essential.
- For both medicines and medical devices, there is a need for more robust, publicly accessible post-marketing surveillance. This should include mandatory requirements on healthcare organisations to report adverse events within a designated time period. The MHRA should provide assessments of the risks of individual medicines or devices and of classes of medicines or device where one or more members of the class carries an elevated risk.
- The Yellow Card system should be reformed to provide a “user-friendly, accessible, transparent repository of adverse event reports.”
- An online system for the Pregnancy Prevention Programme should be accessible by pharmacists at the point of dispensing.
- When the EU Medical Devices Regulation is implemented after the Brexit transition period, the UK should adopt its more stringent standards and there are areas where further improvements should be made.
- A register of medical devices should be created and maintained by the MHRA so that it is possible to know what devices are (or were) on the market at any given time. Entry on the register should be a condition for selling in the UK, with the MHRA having power to de-register devices and remove them from sale, if necessary. The MHRA would be more like a licensing authority than in the past, with a greater emphasis on vigilance.
CMA concludes fludrocortisone case with £2.3m fines
Posted: Friday, July 10th, 2020
The Competition and Markets Authority (CMA) has announced that it has closed its investigation into the supply of fludrocortisone, a prescription-only medicine mainly used to treat primary or secondary adrenal insufficiency, commonly known as Addison’s Disease.
The CMA found that the pharmaceutical companies Amilco and Tiofarma agreed to stay out of the fludrocortisone market so that Aspen could maintain its position as the sole supplier in the UK.
In exchange, Amilco received a 30% share of the increased prices that Aspen was able to charge, and Tiofarma was given the right to be the sole manufacturer of the drug for direct sale in the UK.
Following the agreement, the price of fludrocortisone supplied to the NHS increased by up to 1800%.
All 3 companies involved in the agreement – Aspen, Tiofarma, and Amilco – admitted to taking part in an anti-competitive agreement regarding the supply of fludrocortisone tablets.
The CMA has levied fines totalling just under £2.3 million for this illegal behaviour.
As well as the fines, Aspen approached the CMA last year and agreed to pay the NHS £8 million to help resolve the CMA’s competition concerns in relation to fludrocortisone. This payment has now been made.
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.