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

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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

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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

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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),

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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

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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

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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

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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)

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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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