PLEA News
Z-drugs, isotretinoin, vaccinations and VGDs
The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. It has announced that the the Summary of Product Characteristics, Patient Information Leaflets and outer packaging of these medicines will have strengthened warnings to better communicate
House of Lords Committee refers to pharmacists in report on Assisted Dying Bill
After receiving evidence on the Terminally Ill Adults (End of Life) Bill, the House of Lords Select Committee has produced a report. The Committee considered the question of conscientious objection. The Committee considered that the conscientious objection provisions in the Bill were narrowly focused on doctors. It pointed out that
Draft Standards for Responsible Pharmacists – commentary
The General Pharmaceutical Council is currently consulting on draft Standards for Responsible Pharmacists. The draft Standards are: Prioritise patient safety Provide the leadership and management needed to ensure the safe and effective operation of the pharmacy Make sure, if using authorisation, to authorise responsibly and make clear the lines of
Draft Standards for Superintendent Pharmacists
The General Pharmaceutical Society’s draft Standards for Superintendent Pharmacists are: 1. Provide strategic and professional leadership 2. Develop a workforce with the right skills, knowledge and experience 3. Delegate responsibly and make sure there are clear lines of accountability 4. Maintain and strengthen governance to ensure safe and effective delivery
Three more consultations – superintendents, responsible pharmacists, pharmacy technicians and naloxone
Allied to the amendments to the Human Medicines Regulations relating to supervision – see our news item of 12 December 2025 – the General Pharmaceutical Council is now consulting on draft rules for Responsible Pharmacists and standards for Responsible Pharmacists and Superintendent Pharmacists. The General Pharmaceutical Council has launched a
Disqualification of pharmacy owners and pharmacy premises
Chemist & Druggist has reported that the General Pharmaceutical Council (GPhC) is developing a “clear and transparent” policy on disqualification with the “ambition” to publish next summer, according to meeting papers. It may be coincidental that, as we reported in our news item of 30 October 2025 (news item 609),
Supervision law changes coming into force
We have previously reported the changes to be made to the Human Medicines Regulations 2012 which will allow the handing out of medicines in the absence of a pharmacist, and which will allow pharmacists to authorise pharmacy technicians to supervise the sale or supply of Pharmacy medicines and Prescription Only
Extending the range of medicines for optometrists and contact lens opticians
Earlier this year (news item 599 on our website), we reported that the Department of Health and Social Care (DHSC) had launched a consultation on extending rights to administer and/or prescribe certain medicines to paramedics, physiotherapists and radiographers. In a separate consultation, DHSC is seeking views on extending the range
Assisted dying – would approved substances be medicines?
The House of Lords received evidence on the Terminally Ill Adults (End of Life) Bill last week. Subject to certain safeguards, the Bill, if passed in its present form, would allow a medical practitioner who is a “coordinating doctor” to provide a terminally ill person with an approved substance that
570 – GPhC Standards for Chief Pharmacists
2025-01-22 16:12:29 Twelve months ago, we reported that the General Pharmaceutical Council was consulting on standards for Chief Pharmacists. Announcing the final version of the standards, the GPhC says that, having regard to the responses to its consultation, it has made some changes. These include adding a requirement for Chief
569 – Court deals with university’s exclusion of medical student.
2025-01-10 18:09:04 HK was an undergraduate student at the University of Dundee. In 2018, he enrolled there to study for the degree of MBChB, and was due to graduate with that degree in May 2025. In September 2022, he also enrolled to study for the intercalated degree of BMSc in
563 – Pharmacy loses appeal against financial penalty for data breaches
2024-12-11 19:31:07 On New Year’s Eve 2019, we reported that the Information Commissioner’s Office had issued its first financial penalty – £275,000 – for breach of GDPR (now UK GDPR), and that the penalty had been imposed on a pharmacy business, Doorstep Dispensaree Ltd. An MHRA investigation had led to
562 – Welsh pharmacy professionals lose exemption for tattooing and body piercing
2024-12-02 9:29:28 The Public Health (Wales) Act 2017 defines each of the following activities as “special procedure”: acupuncture; body piercing; electrolysis tattooing An individual who performs a special procedure on someone else in the course of a business must have a licence granted by the local authority. The licence must
561 – FtP – High Court condemns GPhC for gross incompetence and unfairness
2024-11-27 19:41:19 The High Court (Mrs Justice Lang) has just delivered a scathing judgment of the GPhC’s handling of a fitness to practise case. In Professional Standards Authority for Health and Social Care v General Pharmaceutical Council and R2 [2024] EWHC 3005 (Admin), the judge found the GPhC had made “grossly
560 – Naloxone exemptions coming into force
2024-11-12 15:33:03 We reported in August on intended amendments to the Human Medicines Regulations 2012, involving exemptions for naloxone from the usual requirements when Prescription Only Medicines are supplied. The exemptions will come into force on 2 December 2024 through the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions)
559 – Emergency Prohibition Order on puberty blockers extended
2024-11-08 12:33:19 In August, we reported that the government had extended the 3-month ban on puberty-blockers that took effect in June 2024. The prohibition Order will now be extended to 31 December 2024 through the Medicines (Gonadotrophin-Releasing Hormone Anaglogues) (Emergency Prohinition) (Extension) (No.2) Order 2024. The series of extensions is necessary because
558 – Annual Seminar 2025 – Save the date!
2024-11-04 10:20:49 It doen’t seem 5 minutes since the 2024 seminar in Manchester, however the executive is already planning the 2025 seminar. The seminar will be held in Birmingham on 9 April 2025 – please save the date. If you think you are likely to be attending, could
557 – Medical devices – new regulations on post-market surveillance
2024-10-27 18:58:02 Following the Cumberlege Report – First Do No Harm – which we have covered in previous news items, the Government has now published draft Regulations that will amend the Medical Devices Regulations 2002 and introduce requirements for post-market surveillance of medical devices. The Medical Devices (Post-Market Surveillance Requirements) (Amendment)
556 – Clinical trials – draft Regulations
2024-10-23 9:53:17 In 2023, the Government announced that it would introduce a series of new measures to make it faster and easier to gain approval and to run clinical trials in the UK. It said that the clinical trials application processes in the UK would be “more proportionate, streamlined and flexible
554 – Professor Joy Wingfield Memorial Lecture 2024
2024-10-15 15:23:49 Our member, Steve Simbler, will be delivering the second annual Professor Joy Wingfield Memorial Lecture at the University of Nottingham on 4 November 2024 at 7pm – if attending in person, there will be a reception with refreshments from 6.15pm. Joy was PLEA’s founder and PLEA is
553 – PSA performance review of the GPhC
2024-10-08 15:43:32 Earlier this year, the Professional Standards Authority sought our views as part of its Performance Review of the General Pharmaceutical Council. We sought views before responding, and we received some trenchant criticisms of the GPhC’s handling of fitness to practise cases, especially from our lawyer members. The PSA’s
551 – Hub and spoke implementation update
2024-09-27 12:18:48 At our annual seminar in May, we were fortunate to have speakers from the Department of Health and Social Care giving us a presentation on proposals to amend the Medicines Act 1968 to allow hub and spoke dispensing when the hub pharmacy and the spoke pharmacy do not
548 – Xylazine and other drugs to become scheduled controlled drugs
2024-09-05 15:21:07 The Misuse of Drugs Act 1971 (Amendment) (No. 2) Order 2024 has been laid before Parliament to control xylazine, a high-strength veterinary sedative, as a class C drug. The drug – described as a “zombie drug”, is one of 22 harmful substances that the Government says will be
547 – Original pack dispensing – England
2024-09-05 15:02:41 We reported in July 2023 that the Human Medicines Regulations 2012 (HMR) would be amended to allow original pack dispensing. This amendment was made on 11 October 2023 with the insertion of regulation 217B into the HMR. However, the new provision did not take effect in England and
546 – Ban on puberty-blockers extended
2024-08-23 11:53:19 In May, we reported that the government had introduced an emergency 3-month ban on puberty-blockerrs that took effect in June. A subsequent judicial review challenge was unsuccessful. The ban relates to the sale or supply of these drugs, prescribed by private UK-registered prescribers for gender incongruence or dysphoria
545 – Guidance on NHS market entry applications in England
2024-08-06 10:43:27 In England, the market entry regulations (the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 say that an application for an NHS contract must be refused if someone is already providing NHS pharmaceutical services at the same location or adjacent premises and NHS England considers it is
543 – Windsor Framework – amendments to the Human Medicines Regulations
2024-08-04 17:40:30 Following the agreement between the UK and EU known as the Windsor Framework, the government has laid the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 before Parliament. The Regulations will make extensive amendments to the Human Medicines Regulations 2012. They will come into force on
542 – High Court upholds NHS England restrictions on puberty blockers and emergency prohibition order.
2024-08-01 20:02:25 On 31 May 2024, we reported on an emergency prohibition order regarding the prescribing of puberty blockers and NHS regulations preventing the prescribing of puberty blockers in England. In The King (on the application of (1) Transactual CIC and (2) YY) v Secretary of State for Health and
541 – Non-NHS services by pharmacists and pharmacy technicians in Scotland
2024-06-16 18:55:46 Under the Health and Social Care Act 2008, providers of health services must be registered with the Care Quality Commission in England, Health Improvement Scotland, or Healthcare Inspectorate Wales. In Scotland, independent clinics where services are provided by pharmacists and pharmacy technicians have not been regulated unless those
539 – Prescribing of puberty blockers
2024-05-31 16:15:51 Last month, following the Cass report, the General Pharmaceutical Council updated its guidance on the prescribing and supply of puberty-suppressing hormones https://www.pharmacyregulation.org/about-us/news-and-updates/regulate/gender-identity-services-children-and-young-people-interim-update-pharmacy-teams . This week, the Government laid Regulations – the National Health Service (General Medical Services Contracts) (Prescriptiuon of Drugs etc.) (Amendment) Regulations 2024 – which will
537 – The Medicines (Vitamin B12 Injections) Bill
2024-05-17 12:01:44 Earlier this month, The Medicines (Vitamin B12 Injections) Bill was presented to Parliament to provide that vitamin B12 injections may be sold, supplied or administered by a registered pharmacist without a prescription; and for connected purposes. The Bill is due to have its Second Reading in the HOuse of
536 – Hub and spoke dispensing – DHSC response to consultation
2024-05-13 10:25:34 The DHSC response to the consultation on hub and spoke dispensing has been published this morning. It can be accessed here https://www.gov.uk/government/consultations/hub-and-spoke-dispensing/outcome/government-response-to-the-consultation-on-hub-and-spoke-dispensing For those of you who are able to attend our annual seminar tomorrow, the presentation by DHSC officials could not be more timely. We hope to provide
535 – Annual Seminar and AGM Details
2024-05-10 10:24:49 We are looking forward to welcoming all members who are signed up for the seminar on Tuesday in Manchester. In the interests of reducing paper, we don’t intend to provide paper copies at the AGM but attendees are, of course, free to print and bring their own
533 – Veterinary Medicines Regulations amended
2024-05-01 14:22:20 On 7 March this year, we reported that the Veterinary Medicines Regulations would be amended. We can now report that the amendments will come into force on 17 May 2024. Amongst other things (including provisions intended to reduce the development and spread of antimicrobial resistance): The Secretary of
531 – Pharmacy and Scotland’s Assisted Dying Bill
2024-04-01 10:27:30 If the Assisted Dying for Terminally Ill Adults (Scotland) Bill, recently introduced into the Scottish Parliament were to become law, the involvement of pharmacists would be relatively limited. Clause 1 of the Bill would make it lawful to provide assistance to a terminally ill adult who requests assistance
529 – High Court rules on data protection and confidentiality issues in health case
2024-03-28 12:41:20 Last month, Mr Justice Julian Knowles gave judgment in YSL v Surrey and Borders Partnership NHS Foundation Trust [2024] EWHC 391 (KB). The case raised a wide range of data protection and confidentiality issues. YSL was a patient of the Defendant, which was the data controller. YSL
528 – New GPhC guidance on FtP outcomes (sanctions)
2024-03-25 13:12:14 In late 2022, PLEA responded to a consultation by the General Pharmaceutical Council on guidance on fitness to practise hearings and outcomes. The GPhC has now published the new guidance which takes immediate effect –https://www.pharmacyregulation.org/sites/default/files/document/gphc-fitness-to-practise-hearings-outcomes-guidance-march-2024.pdf . It replaces the GPhC’s previous sanctions guidance. The new guidance highlights the
527 – Racism – misconduct: second PSA appeal in Ali case
2024-03-17 12:26:26 It is unusual for the Professional Standards Authority (PSA) to appeal to the High Court against a decision of a healthcare regulator on two separate occasions in the same case, but that is what has happened in the case of pharmacist Nazim Hussain Ali. In the first appeal,
526 – Veterinary Medicines Regulations – amendments
2024-03-07 15:58:14 The Veterinary Medicines (Amendment) Regulations 2024 have been laid before Parliament. There is no date yet when the amendments will take effect. They will make extensive amendments to the Veterinary Medicines Regulations 2013. The Amendment Regulations are too extensive to describe in detail here. The Regulations can be
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