NICE clarifies cannabis guidelines so as not to deter prescribing
Posted: Wednesday, March 31st, 2021
According to a report in the Guardian https://www.theguardian.com/society/2021/mar/28/parents-of-boy-with-severe-epilepsy-drop-cannabis-challenge , the parents of a three-year-old have dropped a judicial review claim against NICE in which they intended to argue NICE guidelines on the prescribing of medicinal cannabis which, they said “put doctors off prescribing ‘live-saving treatment’”
Prescribing cannabis was legalised subject to certain conditions in 2018. The judicial review claim was dropped because NICE has now clarified its guidance which says there is insufficient evidence to support a recommendation relating to the whole population of people with severer treatment-resistant epilepsy. The clarification says the NICE guidelines:
“should not however be interpreted by healthcare professionals as meaning that they are prevented from considering the use of unlicensed cannabis-based medicinal products where that is clinically appropriate in an individual case. Patients in this population can be prescribed cannabis-based medicinal products if the healthcare professional considers that that would be appropriate on a balance of benefit and risk, and in consultation with the patient, and their families and carers or guardian.”
Pharmacies required to disclose results of lateral flow tests
Posted: Sunday, March 21st, 2021
Last year, COVID-19 was added to the list of notifiable diseases in Schedule 1 to the Health Protection (Notification) Regulations 2010. This Schedule lists diseases that doctors must notify to Public Health England if a case is detected in a patient. The addition of COVID-19 to the list did not have any immediate significance for pharmacies, because the GPhC had banned pharmacies from selling lateral flow tests.
On 15 February 2021, the GPhC changed its position, allowing pharmacies to sell lateral flow tests. This brought Regulation 4A of the Health Protection (Notification) Regulations into play.
Regulation 4A imposes a duty on point of care test providers to notify Public Health England of the results of tests for the detection of the SARS-CoV-2 virus or influenza virus. A “point of care test” is a defined as a diagnostic test which is not carried out in a diagnostic laboratory. A “test provider” is defined very widely and would include any pharmacy carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.
Notification to Public Health England can be made electronically and must be made in writing within 24 hours of the time when a positive or indeterminate SARS-CoV-2 test result is received by the test provider. If the test is negative or void, notification must be made within seven days. In the case of influenza virus, notification must be made within seven days of the test result being received by the test provider.
The details to be notified include, insofar as they are known to the test provider, the patient’s name, sex, date of birth, NHS number, ethnicity, current address (including postcode), and, in the case of a test for SARS-CoV-2 that is positive or indeterminate, a telephone number and email address The test provider must notify its name, the nature of the establishment, specimen identification number (if applicable), specimen type, specimen date, test method, result of test, date on which the test was carried out, and the name of the testing equipment manufacturer.
Failure to notify in accordance with the Regulations without reasonable excuse is an offence punishable on summary conviction by a fine.
Gross negligence manslaughter when a patient overdoses
Posted: Wednesday, March 10th, 2021
There have been no recent manslaughter prosecutions of pharmacists, but the recent case of R v Rebelo ( EWCA Crim 306) sheds light on the legal position if a patient overdoses on a drug of abuse sold in a pharmacy.
Bernard Rebelo ran an online business which sold a chemical, Dinitrophenol (“DNP”), as a food supplement to promote weight loss. DNP is used in the manufacture of dyes, wood preservatives, explosives, and insecticides, amongst other things. It can act as a ‘fat burning’ and weight reducing drug by blocking the normal processes by which energy is stored in the body, causing energy to be released as heat. It is not licensed as a medicinal product. Ingestion can be hazardous, with serious toxic effects that include kidney failure, liver failure and cardiac arrest. Fatalities have been reported in the UK from the ingestion of DNP.
A 21-year-old student, Eloise Parry, purchased a quantity of DNP capsules online from Mr Rebelo. Ms Parry had eating disorders. She consumed eight tablets at one time (described as “a massive overdose”) and died. Mr Rebelo was prosecuted for gross negligence manslaughter (and other offences). Mr Rebelo’s defence was that Ms Parry’s decision to take eight tablets at once was a free, informed and deliberate act that broke the chain of causation after the sale of DNP and that her actions “eclipsed” any negligence by Mr Rebelo.
The Court of Appeal had ruled on an earlier occasion that in determining whether a breach of duty by the defendant was a substantial and operative cause of death, the jury had to be satisfied that the victim had made “a fully free, voluntary and informed decision to risk death by taking the quantity of drug that she ingested”. The victim’s mental capacity was a factor, but it was not the only one.
Mr Rebelo argued that the sale of DNP was simply meeting customer demand; he may have been negligent but not grossly so. Those who purchased DNP knew what they were buying; numerous people took DNP without any adverse effect. The evidence was that Ms Parry was aware of the risks of taking DNP.
The trial judge invited the jury to consider whether Ms Parry was acting under any compulsion, whether caused by her mental health problems or any psychological addiction she may have had to DNP, and whether her ability to resist feeling compelled to take the DNP was impaired.
The jury found Mr Rebelo guilty of gross negligence manslaughter and he was given a 7-year prison sentence. The Court of Appeal dismissed his appeal.
Suspended pharmacist can't get himself removed from register
Posted: Wednesday, February 24th, 2021
The recent decision in General Pharmaceutical Council v Rabadia  2 WLUK 258 illustrates how difficult it can be to remove oneself from the GPhC’s register if fitness to practise proceedings are pending, and how things may change in future.
Mr Rabadia had worked as a locum pharmacist. The owner became suspicious of high volumes of controlled drugs that were ordered on days that Mr Rabadia worked. Mr Rabadia admitted he had been selling the drugs over the counter and to specific people who had placed orders whom he could not name. There was no evidence of these explanations. The owner reported the matter to the police.
The GPhC’s Fitness to Practise Committee imposed an 18-month interim suspension pending a full (principal) hearing. When the interim suspensions had been reviewed, Mr Rabadia had participated in the hearings and accepted he had failed to comply with professional standards, that he had put the public at risk, and had brought the profession into disrepute.
The principal fitness to practise hearing had not taken place because the police investigation was not complete. The interim suspension was about to expire. Mr Rabadia did not consent to an extension of the interim suspension because he wanted the fitness to practise proceedings to be finalised and he wanted to be struck off so that he could move on with his life.
The GPhC applied to the High Court to extend the interim suspension. Mr Tim Corner QC, sitting as a Deputy High Court Judge, held that the court was required to look at the gravity of the allegations, the seriousness of the risk posed to the public, the reasons the proceedings had not yet reached a conclusion, and the prejudice to Mr Rabadia caused by the extension. The judge ruled that the prejudice which Mr Rabadia would suffer was outweighed by the need to protect the public’s confidence in the profession in the light of the seriousness of the allegations. To protect the public, the interim suspension was extended by 12 months which was considered to be a reasonable and proportionate period having regard to the timescale of the criminal investigation.
The recent consultation by the GPhC on its fitness to practise strategy proposes that fitness to practise cases could be resolved with agreed outcomes. The use of such a power might provide a speedy and cost-efficient way to deal with cases like Mr Rabadia’s.
Sad news - Professor Joy Wingfield
Posted: Wednesday, February 17th, 2021
We are deeply saddened to report the death from COVID-19 of our founder, Joy Wingfield.
Joy was chair of the Pharmacy Law & Ethics Association until 2015.
Early in Joy’s career, she was an inspector of the Royal Pharmaceutical Society of Great Britain when it was the regulator of the pharmacy profession. Later, she became Boots Special Professor of Pharmacy Law and Ethics at the University of Nottingham. In 2009, she was also appointed visiting professor of pharmacy law and ethics at the University of Hertfordshire.
Joy was a titan in the field of pharmacy law and ethics. With Gordon Appelbe and, later, Karen Pitchford, she edited Dale & Appelbe’s Pharmacy and Medicines Law (the original title was Pharmacy Law & Ethics) from the fifth edition in 1993 until the eleventh edition in 2017. She was also the co-author of Pharmacy Ethics and Decision Making (2007) and the author of Practical Exercises in Pharmacy Law and Ethics (1997, 2002). Joy made many contributions to the Pharmaceutical Journal and her wit often came through. For example, when writing on the vexed subject of decriminalising dispensing errors, she began a PJ article in 2015 “Well hooray and alleluia! A ray of common sense pierces the clouds of officialdom.”
Following her retirement, Joy became Honorary Professor of Pharmacy Law and Ethics at the University of Nottingham. Until 2017, Joy maintained a pharmacy consultancy, Wingfield Works, enabling pharmacists and organisations to continue to benefit from her expertise and wisdom. She retained an interest in PLEA and was in touch over the date of our 2020 seminar which she had hoped to attend.
In Joy’s long career, she made a major contribution to the subject of pharmacy law and ethics, breaking new ground in the way she brought to the fore the subject of ethics in pharmacy teaching and practice.
We hope to publish a more detailed appreciation of Joy in the near future.
The Medicines and Medical Devices Act 2021
Posted: Monday, February 15th, 2021
The Medicines and Medical Devices Act 2021 received the Royal Assent on 11 February 2021. To a large extent, the Act was necessitated by the pre-Brexit abolition of the European Communities Act 1972. The 1972 Act had provided powers to amend EU legislation that had been introduced in the UK, so a new Act was needed to provide powers to amend the Human Medicines Regulations, the Veterinary Medicines Regulations, the Medical Devices Regulations and other legislation.
Amongst other thingsIt is expect that the powers in the Act will be used to permit independent pharmacies to outsource dispensing (hub and spoke dispensing). The Act has also been used to create a Patient Safety Commissioner in accordance with the recommendation of the Cumberlege Review that followed the PIP breast implant scandal. The statutory core duties of the Patient Safety Sommissioner are to -
(a) promote the safety of patients with regard to the use of medicines and medical devices, and
(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.
Government response to Cumberlege Review and the Medicines & Medical Devices Bill
Posted: Tuesday, January 12th, 2021
Last July, we reported on the Cumberlege Review which followed the PIP breast implant scandal. The Government has just published its response to the review https://www.gov.uk/government/speeches/update-on-the-governments-response-to-the-independent-medicines-and-medical-devices-safety-review . Points of note include:
- The Government has tabled an amendment to the Medicines and Medical Devices Bill to establish the role of an independent Patient Safety Commissioner, in line with Baroness Cumberlege’s second recommendation. The Bill reached its Report Stage in the House of Lords on 12 January 2021.
- The Commissioner will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients. The Commissioner will be established as a statutory office holder, appointed by the Secretary of State for Health and Social Care, and will act independently on behalf of patients.
- The Commissioner’s core duties will be to promote the safety of patients and the importance of the views of patients in relation to medicines and medical devices. To help in carrying out these duties, the commissioner will have a number of powers and functions, including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies.
- The Government did not accept the proposal to establish a redress agency as recommended by Baroness Cumberlege. Baroness Cumberlege had concluded that the MHRA needs substantial revision particularly in relation to adverse event reporting and medical device regulation, and it needs to ensure that it engages more with patients and their outcomes. The Government’s position is that the MHRAhas already begun a substantial programme of work to improve how it involves patients in all aspects of its work, to reform systems for reporting adverse incidents with medicines and medical devices, and to strengthen the evidence base for its regulatory decisions.
- The Medicines and Medical Devices Bill will give Ministers power to establish a UK-wide medical device information system. This system will mean that the MHRA can routinely collect medical device, procedure and outcome data from all NHS and private provider organisations across the UK.
Separately from the Government’s response to the Cumberlege report, the Government has responded to criticisms of the very wide powers in Medicines and Medical Devices Bill. The Government has introduced an amendment to the Bill, stipulating that an overarching objective of making regulations must be to safeguard public health for human medicines and medical devices. In the case of veterinary medicines, the overarching objective must be to promote the health and welfare of animals; the health and safety of the public; or the protection of the environment.
Recent articles by our members - COVID-19 vaccination, Inquest, MURs, professional conduct
Posted: Monday, January 11th, 2021
Members have written a number of articles of interest recently -
Andrea James’ blog on a Coroner’s report into a death after a pharmacy error that followed a prescription change aimed at reducing pharmacy visits http://insights.brabners.com/post/102go2u/prevention-of-future-deaths-report-issued-following-community-pharmacy-error
Noel Wardle’s Chemist & Druggist blog How pharmacists can avoid supplying the COVID-19 vaccine unlawfully https://www.chemistanddruggist.co.uk/opinion/lawyer-reveals-pharmacists-supply-COVID-19-vaccine
Noel Wardle’s Chemist & Druggist blog Pharmacists should be aware of the downsides to new MUR legislation https://www.chemistanddruggist.co.uk/opinion/pharmacists-should-be-aware-downsides-new-mur-legislation
Charles Russell Speechlys’ Pharmacy Brief https://communications.crsblaw.com/17/2268/uploads/pharmacy-brief---december-2020.pdf
Susan Hunneyball’s Chemist & Druggist blog Pharmacists delivering COVID vaccines have some legal protection https://www.chemistanddruggist.co.uk/opinion/pharmacists-delivering-covid-vaccines-have-some-legal-protection-
Susan Hunneyball’s Chemist & Druggist blog Pharmacist expertise is crucial for COVID-19 vaccination programme https://www.chemistanddruggist.co.uk/opinion/pharmacist-expertise-crucial-covid-19-vaccination-programme
Rachel Warren’s blog on professional conduct and the case of Beckwith v Solicitors Disciplinary Tribunal https://blog.charlesrussellspeechlys.com/post/102glbm/beckwith-v-sdt-private-v-professional
Defamation in reporting fitness to practise cases
Posted: Thursday, January 7th, 2021
The tort of defamation (usually involving libel) does not often impinge on pharmacy law. It is covered in the current edition of Dale & Appelbe’s Pharmacy and Medicines Law, but the forthcoming 12th edition will feature other torts instead. The recent case of Onwude v Dyer, Godlee and BMJ Publishing Limited  EWHC 3577 (QB) may be of some interest to members as well as providing comfort to journalists who report fitness to practise cases in the pharmacy press.
Mr Onwude is a gynaecologist. He treated two patients with whom he had had an unrelated busines arrangement. Allegations were made about the treatment and his invoicing. The Medical Practitioner Tribunal (MTP) found allegations of misconduct, including an allegation of dishonesty, were proved. It directed that Mr Onwude’s name be erased from the medical register.
The decision was reported in the British Medical Journal (BMJ) under the headline “Gynaecologist is struck off for dishonesty and intention to cause distress”. The report that followed did not mention that the decision would not take effect until the expiry of a 28-day appeal period. The MPT directed an immediate suspension pending any appeal.
In the event, Mr Onwude appealed to the High Court and his appeal was upheld. The BMJ reported the successful appeal. Mr Onwude sued the BMJ and two journalists for libel, based no the report of the original hearing which had not mentioned that the decision and findings were subject to appeal.
The major issues related to the defences of statutory qualified privilege under section 15 of the Defamation Act 1996 and a public interest defence in section 4 of the Defamation Act 2013.
Mr Onwude told the His Honour Judge Richard Parkes QC (sitting as a High Court judge) that the essence of his complaint was that he had never been struck off: he had been suspended pending appeal, but his name had not been erased.
The judge found that the journalist’s decision not to mention in the first article the existence of a right of appeal was reasonable because this was generally known and understood by the readership. He said that “the reasonable reader is not naïve, nor unduly suspicious”.
Although Mr Onwude complained that the BMJ had declined to publish a corrective piece he had submitted, the BMJ’s refusal to do this was reasonable because it had already published a report of his successful appeal.
To rely on the public interest defence, the journalist had to show that she reasonably believed that publishing the statement complained of was in the public interest. She gave evidence that she reported MPT decisions which related to professional practice because they raised issues from which other doctors could learn, and thus avoid getting themselves into situations where their fitness to practise might be brought into question. The judge said that the decision to erase a doctor from the medical register was “of the highest public interest”. He accepted the journalist’s evidence and decided that the public interest defence was made out.
Revised Caldicott Principles - pharmacies to need Caldicott Guardians in 2021?
Posted: Wednesday, December 23rd, 2020
Every NHS organisation has had to have a Caldicott Guardian since 1998, and each local authority with adult social care responsibilities has been required to do so since 2002.
Caldicott Guardians act as “the conscience of the organisation” as a “senior person within a health or social care organisation who makes sure that the personal information about those who use its services is used legally, ethically and appropriately, and that confidentiality is maintained.”
After a consultation and review of the Caldicott Principles, the National Data Guardian (NDG) has finalised revised Principles including a new eighth principle designed to increase transparency and avoid patients having any surprises about how the data is used https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941865/NDG_CP_and_CG_consultation_response_FINAL_08.12.20.pdf
In addition, the NDG intends to use her statutory power to give guidance which will specify that all public bodies within the health and adult social care sector should appoint a Caldicott Guardian. The list of such bodies may include pharmacies and GP practices.
The guidance will cover the role and responsibilities of Caldicott Guardians, with particular attention given their role in helping to uphold the Caldicott Principles.
Where it may not be proportionate for small organisations to have their own Caldicott Guardian, the guidance may make it clear that the role might be part of a separate role, perhaps that of Data Protection Officer, and one Guardian may serve several organisations or businesses.
The guidance will specify that Caldicott Guardians should have the freedom to act; cover issues around accountability – distinguishing between accountability for advice and decision making; and emphasise the importance of appropriate relationships to boards’ or executive decision-making in relevant organisations.
There will be a consultation early in 2021 with a view to final guidance being published by the end of 2021.
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.