2023-08-08 13:18:53
There has been a number of recent announcements regarding future changes in the law.
The Department of Health & Social Care (DHSC) announced in 2019 that it intended to change the law to make it clear that pharmacists did not have to watch Prescription Only Medicines and Pharmacy medicines being handed out. A practice group set up by a number of pharmacy organisations has recently produced a report for consideration by DHSC https://www.rpharms.com/about-us/news/details/pharmacy-supervision-practice-group–update-and-outcome .
The Supervision Practice Group’s report includes the following recommendations:
- “supervision” should no longer be interpreted to mean observing individual transactions.
- “supervision” requires a pharmacist to be present in the pharmacy.
- The two-hour time limit for absence should remain.
- When a pharmacy is closed to the public “preparation and assembly could be undertaken without an RP being signed in, but instead under the supervision of an absent superintendent pharmacist (“SP”)”.
A consultation by DHSC is awaited.
Changes to the law on medical devices are also in hand.
The Cumberledge report which looked into the life-changing complications suffered by women who had pelvic mesh implants made recommendations for post market surveillance of medical devices. The UK government has just given notice of draft Regulations governing post-market surveillance – the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 – to the World Trade Organisation. Members of the WTO have 60 days in which to comment. The UK government intends to introduce amendments to the Medical Devices Regulations 2002 later this year.