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Response to GPhC discussion paper on online pharmacy services

Posted: Sunday, August 19th, 2018

We have responded to the GPhC's discussion paper regarding online pharmacy services. 

Amongst other things

 Our response will be posted to our website shortly and is accessible via Twitter @PLEA_UK. 

Regulating online pharmacy services

Posted: Friday, August 17th, 2018

The GPhC is consulting on proposals to regulate online pharmacy services.  The proposals include a requirement to publish details of prescribers who are not in Britain, even though they may be registered with the GMC.

PLEA will be responding to the consultation (which can be found here https://www.pharmacyregulation.org/online-pharmacy) before the consultation ends on 21 August 2018.

Consultation on implementing Falsified Medicines Directive

Posted: Tuesday, August 7th, 2018

The MHRA is consulting on proposed steps to implement the Falsified Medicines Directive (FMD) which comes into force on 9th February 2019. The Government has made clear that whatever the outcome of Brexit, this Directive will be implemented in the UK. The "safety features" are

Consultation closes on 23rd September

New law to protect vulnerable people in care

Posted: Friday, August 3rd, 2018

The Mental Capacity (Amendment) Bill was introduced to the House of Lords on Tuesday 3 July and seeks to replace the current system known as ‘Deprivation of Liberty Safeguards’ (DoLs).

DoLs is an assessment currently carried out on people who do not have the mental capacity to make their own decisions about their care, for example because they are living with dementia. It was criticised by a 2017 Law Commission review for being too complex and bureaucratic.

The government has now developed a new system, known as ‘Liberty Protection Safeguards’, which will become law through the bill.

Two consultations on rebalancing law

Posted: Friday, August 3rd, 2018

Two draft orders which would amend pharmacy legislation are now out for consultation until 10th September 2018

The 2 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

The first draft order seeks to extend defences that already exist for pharmacy professionals working at or from registered pharmacies in the case of accidental preparation and dispensing errors. It would cover pharmacy professionals working in hospitals and other relevant pharmacy services.

The second draft order seeks to clarify and strengthen the arrangements of registered pharmacies concerning how they are governed. Specifically, it makes the roles of responsible pharmacists and superintendent pharmacists clear in primary legislation.

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 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/714977/Williams_review_into_gross_negligence_manslaughter_in_healthcare.pdf . 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 https://www.chemistanddruggist.co.uk/opinion/what-could-happen-when-gphc-publishes-inspection-reports  

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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.