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Hub and spoke dispensing response

Posted: Friday, May 13th, 2022

Our detailed response to the Department of Health and Social Care's consultation on hub and spoke dispensing has been submitted. You can read it by clicking on the link on our website home page.

Bell v Tavistock - Supreme Court refuses to hear appeal

Posted: Tuesday, May 10th, 2022

On 19 September 2021, we reported that in Bell v Tavistock and Portman NHS Foundation Trust [2021] EWCA Civ 1363, the Court of Appeal had overtunred the Divisional Court’s decision on the the continuing practice of the Tavistock Cliniic to prescribe puberty-suppressing hormone blockers to children under the age of 18 who experience gender dysphoria. The case turned on the ability of minors to give consent.  The Supreme Court has refused permission to appeal because an arguable point of law was not raised.

Further Medicines Act changes to be made

Posted: Sunday, May 1st, 2022

The Pharmacy Rebalancing Board made proposals for changes in the law on which the Department of Health and Social Care conducted a consultation in 2018. DHSC has just published its intentions in the light of the consultation responses, one of which was submitted by PLEA - https://www.gov.uk/government/consultations/pharmacy-legislation-on-dispensing-errors-and-organisational-governance/outcome/rebalancing-medicines-legislation-and-pharmacy-regulation-programme-consultation-outcome .

The proposed changes are substantial and they will be made through two statutory instruments, the Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order and the Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order. DHSC intends to make only one change to the originally-proposed amendments to the law.

In summary, the statutory defences to prosecutions for dispensing errors that were introduced in relation to community pharmacy in 2018 will be extended to hospital pharmacies provided that certain conditions are met, including a requirement that the hospital has a chief pharmacist whose role will be analogous to that of a superintendent pharmacist in a community pharmacy owned by a body corporate.

In community pharmacies, the roles of superintendent pharmacists and responsible pharmacists will be changed and clarified. Superintendent pharmacists must be a person with a significant role in the making of decisions about how the whole or a substantial part of the activities of the retail pharmacy business.

Currently, a superintendent pharmacist’s role does not extend to general sale list medicines. When the law is changed, superintendents will have a legal duty to secure the save and effective running of the pharmacy business so far as concerns the sale and supply of all medicines.

Superintendents will be permitted to be the superintendent of more than one company and, if the company has the word “chemist” in its name, the superintendent will no longer have to be a member of the board.

The law will make it clear that a responsible pharmacist’s legal duty to secure the safe and effective sale and supply of medicines only relates to the particular premises where they are designated as the responsible pharmacist and only while they are on duty (whereas a superintendent pharmacist’s responsibilities are not time-limited). The duty will cover sales and supplies at or from the pharmacy premises, so as to cover home deliveries.

The current record-keeping obligations of responsible pharmacists will be removed.

A responsible pharmacist will have to be on duty for all sales, including general sale medicines and also when medicines are being assembled, prepared or dispensed. However, a responsible pharmacist will not have to be on duty if medicines are merely being put on shelves.

The GPhC and, in Northern Ireland, the PSNI will be empowered to make rules and standards covering a number of matters that will no longer involve legal obligations. Amongst other things, the rules and standards may include:

 

 

 

Advertising - MHRA annual report for 2021

Posted: Wednesday, April 13th, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has just published its annual report for 2021 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1061427/Annual_Report_2021.pdf

Amongst other things:

Looking at the types of cases investigated:

The MHRA attributes the low number of investigations into pharmaceutical companies to self-regulation through the work of PAGB which reviews advertising for OTC medicines by their members prior to publication.

HMR amended - early access to medicines

Posted: Tuesday, March 29th, 2022

The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 will come into force on 15 April 2022.

The Regulations amend the Human Medicines Regulations 2012 by making provision for the establishment and operation of the statutory version of the Early Access to Medicine Scheme (EAMS) – there has previously been a non-statutory version of the Scheme. The EAMS has the purpose of giving patients with life threatening or seriously debilitating conditions access to medicinal products that are either not authorised or not authorised for that use. The Human Medicines Regulations will have a further exception to the need for certain products to have a marketing authorisation if the licensing authority is satisfied that certain conditions are met regarding ordering, manufacture and distribution. There are also pharmacovigilance requirements and a prohibition on advertising EAMS products.

Hub and spoke dispensing - law change imminent

Posted: Thursday, March 17th, 2022

The Department of Health and Social Care has just launched its long-awaited consultation on hub and spoke dispensing https://www.gov.uk/government/consultations/hub-and-spoke-dispensing 

Currently, one pharmacy cannot dispense medicines for another without a manufacturer's licence, but there is an exemption in section 10 of the Medicines Act 1968 for pharmacies in common ownership. DHSC is proposing to remove the requirement for pharmacies to be in common ownership and is looking at two possible models: (1) where a dispensing hub sends dispensed medicines to a spoke for onward supply to patients; and (2) where supplies can be made directly from the hub to patients. 

Leaving aside the political and economic issues surrounding hub and spoke dispensing, there are significant legal implications. PLEA will submit a response to the consultation. We welcome any views from members that we can consider for inclusion. Comments should be sent to davidreissner1@gmail.com by 5pm on 31 March 2022.

Sexual misconduct - a spectrum

Posted: Sunday, March 6th, 2022

At our annual seminar on 4 May, Mark Harries QC will be talking about Sexual misconduct in healthcare Fitness to Practise cases. Places are still available for the seminar, but please book as soon as possible to enable us to deal with seating and catering arrangements. Meanwhile, members may be interested in the recent case of General Medical Council v Ahmed [2022] EWHC 403 (Admin).

Although the Williams Committee which reported after the Bawa-Garba case recommended that the GMC should lose its right of appeal, this was a case in which the GMC appealed against a two-month suspension imposed by the Medical Practitioner Tribunal.

The allegations against Dr Ahmed were that after a consultation with Patient A, a 14-year-old girl, he located her Facebook account and sent a friend request to her; and that, following a consultation with Patient B, he used her medical records to obtain her personal details to send her a friend request on Facebook and sent WhatsApp messages to her phone. These incidents had occurred 6 years before the hearing.

The Tribunal found the facts proved except that, in relation to Patient A, the Facebook request was not sexually motivated in the sense that they were actions in pursuit of a sexual relationship with Patient A. There had been no inappropriate relationship. In the case of Patient B, the Tribunal found that Dr Ahmed’s actions were sexually motivated although his actions did not go beyond the unwanted WhatsApp messages – there had been no inappropriate physical relationship. Dr Ahmed had been of good character and there were no other complaints against him. The Tribunal found that the incidents were isolated and not part of a pattern of conduct.

Mr Justice Murray dismissed the GMC’s appeal, saying amongst other things:

“While the MPT quite rightly found that Dr Ahmed had committed serious professional misconduct in relation to Patient B, which was sexually motivated, it appears that it considered that, on the spectrum of sexual misconduct, this fell toward the less serious end. I agree. The judgment of Kerr J in the case of Arunachalam v GMC underlines the importance of considering the scale of the offending behaviour, even in a case of sexual misconduct, and appropriately evaluating it by reference to the relevant aggravating and mitigating factors. Erasure is not an automatic consequence in a case involving sexual misconduct. It all depends on the relevant facts. In my view, the [Tribunal] properly approached the assessment of the sanction on this basis and reached a decision on sanction that fell within the bounds of what it could properly and reasonably decide.”

Do you agree with the outcome? Join us on 4 May to air your views.

 

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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.