2023-06-11 13:06:04
There have been a number of announcements involving pharmacy law in the last few weeks.
NHS England delivery plan for recovering access to primary care
Amongst other things, the NHS delivery plan (https://www.england.nhs.uk/long-read/delivery-plan-for-recovering-access-to-primary-care-2/) announces:
- DHSC will clarify the roles of pharmacy professionals and enable a better use of skill mix, after consulting on the law on pharmacist supervision in the summer alongside the work the General Pharmaceutical Council is doing to revise the standards on responsible and superintendent pharmacists.
- DHSC will also enable pharmacy technicians to administer and supply medicines under PGDs subject to consultation.
- Government will give pharmacists the flexibility to dispense medicines in their original packs and to widen pharmacy hub-and-spoke arrangements, both of which aim to facilitate greater use of automation to increase efficiency, by progressing legislation following the consultations.
- The Medicines and Healthcare products Regulatory Agency, DHSC and NHS England will work together with suppliers to identify medicines which could be reclassified from ‘available only on prescription (POM)’ to ‘available in a pharmacy (P)’, based on international practice and real-world evidence of safety. This might include different strength medicines to those available today, combination formulations, or medicines manufacturers already offer without prescriptions in other countries.
Professional Standards Authority FtP appeal
The PSA has reported (https://www.professionalstandards.org.uk/what-we-do/our-work-with-regulators/decisions-about-practitioners/section-29-appeals-spring-2023-update?mc_cid=6dbe26f1a1&mc_eid=e5c72d759f ) that it appealed against a decision of a General Pharmaceutical Council Fitness to Practise decision to find that a pharmacist’s fitness to practise was not currently impaired when he had repeatedly falsified records of second checks of medication he dispensed, despite being warned not to. The PSA was concerned that the Committee had failed to adequately consider the public interest engaged by the registrant’s behaviour. The parties have agreed a Consent Order and the Court ordered that the appeal be upheld and that the decision on impairment be quashed and substituted with a finding of impairment and a warning for 12 months.
MHRA to recognise medicines authorised in other jurisdictions
The MHRA has announced https://www.gov.uk/government/news/mhra-announces-new-recognition-routes-to-facilitate-safe-access-to-new-medicines-with-seven-international-partners that it will allow medicines to be placed on the market if they have been authorised by regulators in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
Medicines labelling
Following the Windsor Agreement, the MHRA has announced that from 1 January 2025, to enable medicines across the UK to use the same packaging and labelling, all medicines on the UK market will be labelled as for sale only within the UK. Medicines bearing the “UK only” label will only be able to be sold in the UK and will not be available on the market in Ireland or elsewhere in the EU.
In Northern Ireland, the Falsified Medicines Directive will cease to apply. However, throughout the UK, the MHRA “will expect” all medicine packaging to have anti-tamper devices. Across the UK, medicines in existing packaging that are already on the UK market and within the supply chain can be used until the date of their expiry.
PSA annual review of the Pharmaceutical Society of Northern Ireland
The PSA’s annual review of the PSNI for 2021-22 found that the PSNI had met all its 18 standards https://www.professionalstandards.org.uk/publications/performance-review-detail/monitoring-report-psni-2021-22?mc_cid=6dbe26f1a1&mc_eid=e5c72d759f