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New DHSC consultation open: "Pharmacy legislation on dispensing errors and organisational governance"

Posted: Tuesday, June 26th, 2018

The Department of Health and Social Care have launched a consultation on two new draft orders. The draft orders are:

  1. The Pharmacy (Preparation and Dispensing Errors – Hospitals and Other Pharmacy Services) Order 2018

  2. The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc) Order 2018

Details of the consultation can be found here

This consultation closes at
11:59pm on 11 September 2018

Williams review of Gross negligence manslaughter in healthcare

Posted: Thursday, June 14th, 2018

Professor Sir Norman Williams and his panel have just delivered to the Secretary of State for Health and Social Care a review on Gross negligence manslaughter in healthcare . The review follows the High Court’s ruling in January 2018 that Dr Hadiza Bawa-Garba, who had been convicted of manslaughter, should be erased from the medical register - a ruling that is now subject to appeal.

In Professor Williams’ covering letter to the Secretary of State, he points out that healthcare professionals go to work to alleviate suffering, not to add to it.  He draws attention to the psychological effect on practitioners when an error leads to death and the stress caused to them by investigations. He points out that patient safety is jeopardised as professionals become cautious about being open and transparent, impeding the opportunity for lessons to be learnt.

In addition to recommendations about closer scrutiny when considering whether to bring a manslaughter prosecution of healthcare professionals, the review makes the following points:

Legal challenge to NHS guidance on homeopathic prescribing

Posted: Friday, June 8th, 2018

On 21 July 2018, NHS England published guidance for CCGS, recommending that prescribers in primary care (in effect, GPs) should not prescribe homeopathic treatments as a new treatment for any patient, and that GPs should be supported in de-prescribing homeopathic treatments for all patients for whom they are currently being prescribed.

CCGs are not subject to any duty to follow such guidance, and nor is there any express duty on CCGs to have regard to guidance issued under the National Health Service Act 2006. However, pursuant to the general principles of the common law, the guidance is likely to be a matter that should be taken into account by CCGs when exercising relevant functions.

In The Queen (on behalf of the British Homeopathic Association ("BHA") V NHS Commissioning Board [2018] EWHC 1359 (Admin), Mr Justice Supperstone rejected a number of grounds raised by the BHA in seeking to have the guidance quashed.  Amongst other things, the BHA argued:

(a) that the consultation that preceded the guidance was flawed because NHS England had made up its mind before the consultation took place - the NHS England press release that accompanied the launch of the consultation described homoeopathy as "at best a placebo and a misuse of scarce NHS funds"

(b) NHS England had breached its public sector equality duty (in section 149 of the Equality Act 2010) because the consultation was conducted online only; and 

(c) The National Health Service Act did not give NHS England power to give guidance on prescribing in the first place.

In relation to the lawfulness of the consultation, the judge said "I consider that NHSE was entitled to form a view on the state of the evidence before going out to consultation. It does not follow from that that NHSE had closed its mind to any further evidence that might be provided by consultees."

As to the public sector equality duty, this requires public bodies to have due regard to the need to eliminate discrimination and advance equality of opportunity. The judge followed earlier authorities in which it has been held that provided the court is satisfied that there has been a rigorous consideration of the duty, so that there is a proper appreciation of the potential impact of the decision on equality objectives and the desirability of promoting them, it is for the decision-maker to decide how to proceed.

The argument that NHS England did not have statutory power to give guidance in the first place received short shrift from the judge.



Publication of GPhC inspection reports

Posted: Thursday, June 7th, 2018

Powers recently conferred on the GPhC will enable it to publish pharmacy inspection reports. The proposals for publication that the GPhC is canvassing in its current consultation are similar to those operated by the Care Quality Commission.

A recent case brought by a care home owner against the Care Quality Commission - R (on the application of Ideal Carehomes (Number One Ltd) v Care Quality Commission [2018] EWHC 886 (Admin) - indicates that despite the reputational damage that may be caused, it will be difficult for pharmacy owners to prevent the publication of reports they disagree with.  David Reissner discusses the case in his latest Chemist & Druggist blog  

DHSC to exercise powers to control cost of specials

Posted: Thursday, May 31st, 2018

In the last week, The Times has published a series of stories about the high prices charged for specials and the cost to the NHS.  The Department of Health and Social Care has announced in answer to a parliamentary question that, pursuant to its powers under the Health Service Medical Supplies (Costs) Act 2017, it is "now finalising Regulations, expected to be laid and to come into force later in summer 2018, which include requirements in relation to special medicinal products which will ensure that the Government obtains information from all manufacturers and importers."

GDPR in force today

Posted: Friday, May 25th, 2018

The Data Protection Act received the Royal Assent yesterday, bringing GDPR into force.

Noel Wardle and David Reissner have written a teaching piece for the Pharmaceutical Journal.

Why GDPR will require pharmacies to have a DPO

Posted: Tuesday, May 22nd, 2018

The Data Protection Act 2018 which will bring GDPR into force in the UK on 25 May 2018 requires public authorities to appoint a Data Protection Officer (DPO).  This is a responsible role and can be burdensome for small businesses because DPOs are expected to be independent of the management of the business (although businesses can share a DPO).  The Act defines all providers of NHS services as public authorities.

Pharmacy organisations and other bodies representing healthcare professionals sought an amendment to the Act, so as to take healthcare providers out of the definition of “public authority”. However, the government rejected the amendment. Chemist & Druggist has just published an article by David Reissner, criticising the government’s reasons for rejecting the amendment.

New pharmacy inspection regime proposed

Posted: Friday, May 18th, 2018

Tied in with the premises standards order which will come into force on 24 May 2018, the General Pharmaceutical Council has just launched a consultation on a new pharmacy inspection regime.
The consultation, which is open till 9 August 2018, proposes, amongst other things:
  1. Changes to the types of inspections - moving to a new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections. This appears to be about responding to information held and "intelligence" received. 
  2. Moving to unannounced inspections as a general rule.
  3. Changing inspection outcomes - there would be two possible outcomes for an inspection overall (‘standards met’ or ‘standards not all met’), and four possible findings at the principle (sic) level (‘standards not all met’, ‘standards met’, ‘good practice’ and ‘excellent practice’).
  4. Requiring all standards to be met to receive an overall ‘standards met’ outcome - if any standard was found not to be met, this would result in a ‘standards not all met’ outcome overall.
  5. Publishing inspection reports, and improvement action plans where relevant, on a new website. 


Successful annual seminar and AGM

Posted: Friday, May 18th, 2018

We enjoyed a successful AGM on 16 May 2018, and had a record turnout for presentations testing the new defence to dispensing error prosecutions under section 64 of the Medicines Act 1968; a comparision of fitness to practise procedures in common law jurisdictions; ethical issues when pharmacists collaborate with GPs; and how the issue of dishonesty is dealt with in Fitness to Practise cases, especially since the Supreme Court decision in Ivey v Genting [2017] UKSC 67.

At the AGM, we updated our constitution so as to open membership to all pharmacy professionals, to ensure that pharmacy technicians could become members.

In his Chair's report, David Reissner said he aimed to use Twitter more, to promote PLEA.  In fact the conference has generated a lot of traffic on Twitter.  Please contribute @PLEA_UK

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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.