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Seminar presentation links now fixed

Posted: Tuesday, May 14th, 2019

Apologies to anyone who was unable to access the seminar presentations on our website yesterday.  The links have now been fixed and you can access the presentations at https://www.plea.org.uk/events.htm 

Seminar presentations now on our website

Posted: Monday, May 13th, 2019

We are pleased to confirm that the presentations given at our annual seminar on 9 April are now on the Events page of our website https://www.plea.org.uk/events.htm 

Legal challenge to SSPs fails in the Court of Appeal

Posted: Sunday, May 12th, 2019

The Good Law Project appealed to the Court of Appeal against the refusal by Mr Justice Supperstone to grant permission to apply for judicial review of the amendments to the Human Medicines Regulations that allowed ministers to issue serious shortage protocols. You can read David Reissner's Chemist & Druggist blog published before the hearing by clicking on this link https://www.chemistanddruggist.co.uk/opinion/stop-politicising-medicines-supply-resisting-shortages-powers. The Court of Appeal refused to overturn the refusal of permission. The Good Law Project has said on its Twitter feed that it does not intend to pursue its case further.

Disputing the findings of a FtP tribunal at a review hearing

Posted: Thursday, May 2nd, 2019

When registrants deny a fitness to practise allegation and are suspended from practice, they may face tricky decisions about how to present their case at a review hearing.  For example, if they are found to have lied to the Fitness to Practise tribunal, do they admit at a review hearing that they lied to the Fitness to Practise tribunal?  What if they maintain at the review hearing that they had been telling the truth, even though the Fitness to Practise tribunal disbelieved them? Will maintaining that the Fitness to Practise tribunal’s decision was wrong be seen as a lack of insight that will stop the registrant being allowed to resume practising?  These issues were addressed in Blakely v General Medical Council [2019] EWHC 905 (Admin).

Dr Blakely had been suspended for 6 months by the Medical Practitioners Tribunal after she carried out a botched investigation into her suspicions about another doctor. The Tribunal had held she had acted dishonestly in misleading patients.  Before the end of her suspension Dr Blakely attended a review hearing at which she maintained she had not acted dishonestly.  The Tribunal found that her fitness to practise remained impaired and suspended her for a further 9 months.

On appeal to the High Court, Mr Justice Lewis ruled:

         1 Accepting with the benefit of hindsight that she had acted dishonestly, even if she did not thing so at the time;

         2. Accepting that members of the public might regard her behaviour as dishonest even if she did not;

         3. Indicating that she understood why the tribunal felt that the public would regard her conduct as dishonest.

Dr Blakely’s appeal was dismissed.

Serious Shortage Protocols in the Court of Appeal

Posted: Thursday, May 2nd, 2019

We reported recently that Mr Justice Supperstone had refused an application by The Good Law Project for permission to apply for judicial review of amendments to the Human Medicines Regulations that empower Ministers to introduce Serious Shortage Protocols.

Last week, Lord Justice Hickinbottom granted The Good Law Project permission to appeal against the refusal to the Court of Appeal. There is a single ground of appeal, namely that Ministers did not have power to make the Regulations. Lord Justice Hickinbottom said he found Mr Justice Supperstone's judgment "compelling", but was persuaded that The Good Law Project should have an opportunity to argue its case at a hearing.

Because the case partly depends on whether the UK has a no-deal Brexit, the judge directed an expedited hearing.

 

 

New GPhC guidance on online pharmacy and hub & spoke

Posted: Tuesday, April 16th, 2019

Last year, PLEA responded to a General Pharmaceutical Council consultation on the provision of online pharmacy services. The GPhC has just published new guidance on this and on hub & spoke dispensing.  The guidance is detailed. Here are some of the key points:

The provision of pharmacy services at a distance, particularly online, carries particular risks by its nature. Risk assessments should be carried out.

If a pharmacy works with prescribers or prescribing services operating outside the UK, they should make sure that:

Pharmacies should carry out a regular audit and keep records of

When parts of a pharmacy service take place at different locations (such as in a ‘hub and spoke’ or ‘click and collect’ service) pharmacies must be clear about which pharmacist is accountable and responsible for each part of the service, and which pharmacy technician and other staff are involved. When medicines are not given to the person or their representative in the registered pharmacy, but are delivered by a member of staff or an agent to the person’s home or workplace, there may be more risk of medicines being lost or delivered to the wrong person. Pharmacies must make sure there are clear lines of accountability and responsibility in these circumstances. If pharmacies contract out any part of your pharmacy service to a third party, pharmacies are still responsible for providing it safely and effectively. They should carry out ‘due diligence’ in selecting any contractors.

When there is no face-to-face contact, pharmacies should consider what information they and their staff record and keep to show that the pharmacy service provided is safe.

Pharmacy websites should be clear and not mislead pharmacy service users about the identity or location of the pharmacies involved in providing pharmacy services. This includes the identity and location of any online prescribing service.

Pharmacies should be able to show how they are assured that all prescribers, whether medical or non-medical, follow relevant guidance.

Websites should ensure that a person cannot choose a POM and its quantity before there has been an appropriate consultation with a prescriber.

Websites should display prominently:

Pharmacies should:

Finally, the guidance says that websites should look professional.

 

Bawa-Garba review decision

Posted: Wednesday, April 10th, 2019

Dr Haditha Bawa-Garba's review hearing at the Medical Practitioners Tribunal was taking place at the same time as our annual seminar, making our presentation on gross negligence manslaughter even more topical. During the presentation, we learned that Dr Bawa-Garba had been allowed to resume practice subject to conditions.  The MPTS decision can be found here https://www.mpts-uk.org/hearings-and-decisions/medical-practitioners-tribunals/dr-hadiza-bawa-garba-apr-19 

Brexit amendments to Human Medicines Regulations

Posted: Wednesday, April 10th, 2019

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 were made last week. These Regulations will come into force on the day the UK exits the EU (whenever that is). The Regulations will amend the Human Medicines Regulations 2012 (HMR). The stated purposes are “to ensure [the Regulations] are fit for purpose in a no deal EU Exit scenario” and allows the MHRA to function as a standalone regulator, while continuing to recognise prescriptions from the EU/EEA.

The amendments are numerous. Here is a summary of some of them, based on an Explanatory Memorandum that accompanies the Regulations:

 

 

 

 

 

 

 

EEA and Swiss prescriptions after Brexit

Posted: Sunday, April 7th, 2019

The Department of Health and Social Care has issued guidance for dealing with EEA and Swiss prescriptions in the event that the UK leaves the European Union on 12 April 2019 with no deal.

In short, pharmacists are advised to continute to dispense EEA and Swiss prescriptions in line with current guidance.  The full DHSC guidance can be found here https://www.gov.uk/guidance/prescriptions-issued-in-the-eea-and-switzerland-guidance-for-pharmacists 

High Court rejects legal challenge to serious shortage protocols

Posted: Monday, April 1st, 2019

As we reported on 17 March 2019, the Good Law Project (GLP) had applied for judicial review of the Human Medicines (Amendment) Regulations that had come into force on 9 February 2019. These Regulations had given ministers power to introduce serious shortage protocols (as well as implementing the Falsified Medicines Directive).

The case is The Queen (on the application of Good Law Project Limited) v Secretary of State for Health and Social Care [2019] EWHC 800 (Admin). GLP argued that, amongst other things, the Secretary of State did not have power to make the Regulations, that serious shortage protocols would be inconsistent with section 64 of the Medicines Act 1068, and that there had not been proper consultation, and that he had failed to comply with his public sector equality duty.

In order to bring judicial review proceedings, GLP had to demonstrate an arguable case.  Initially, after considering the papers, Mr Justice Swift had concluded that the case was not arguable.  GLP renewed its application at an oral hearing before Mr Justice Supperstone.  On 29 March 2019, Mr Justice Supperstone delivered a written judgment, finding that an arguable case has not been demonstrated.

In relation to section 64 of the Medicines Act, the judge described serious shortage protocols as "a parallel system to prescriptions". It is implicit in this observation that a pharmacist who made a supply in accordance with a serious shortage protocol could not be prosecuted under section 64 of the Medicines Act if a patient was harmed through receiving an alternative medicine to the one prescribed. Rulings on applications for permission to apply for judicial review usually follow short hearings without full argument, so the judgments that are handed down are not precedents that are binding on judges in future cases.  Nevertheless, Mr Justice Supperstone's ruling may deter any prosecutions and may have some persuasive effect if any prosecution is brought.

 

 

 

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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.