Caldicott Guardians for pharmacies
Posted: Sunday, September 26th, 2021
Last December, we reported that pharmacies may be required to appoint Caldicott Guardians this year.
The National Data Guardian has used her statutory powers to publish new guidance on the appointment, role and responsibilities of Caldicott Guardians https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1013756/Caldicott_Guardian_guidance_v1.0_27.08.21.pdf
The guidance recommends the appointment of a Caldicott Guardian not just by public bodies exercising functions relating to the health service, adult social care or adult carer support in England, but also by other persons or organisations providing services as part of the publicly funded health service. This recommendation would plainly extend to pharmacies (and dispensing doctors) that provide NHS services.
The role of Caldicott Guardians is to assist with processing of confidential data of patients and service users of publicly funded services. The role may overlap with that of Data Protection Officer (DPO) and the same person could carry out the same roles as long as no conflict of interest arises. The Caldicott Guardian need not be an employee, but could be provided by another organisation and/or could be shared with other providers of healthcare services.
According to the guidance, the Caldicott Guardian should "play a key role in helping to ensure that their organisation(s) satisfy the highest ethical and legal standards for processing patient and service user confidential information. Their main concern is confidential information relating to patients, service users and their care. However, in some circumstances the Caldicott Guardian’s judgment may also be needed in relation to the use of information about other individuals, such as staff or relatives of service users." The guidance stipulates that Caldicott Guardians must be afforded the freedom to exercise their judgment and advise or decide in the best interests of patients and service users.
Day-to-day activities of a Caldicott Guardian will vary according to organisation type and size. They may include:
- advising on disclosures of confidential information, in particular whether they can be made in line with the common law duty of confidentiality
- involvement with patients’ or service users’ complaints
- reviewing and advising on data protection impact assessments, data sharing agreements, and instructions to data processors (although noting also the specific role that the organisation’s DPO may also have in relation to these issues
- involvement in audit reporting or recommendations
- involvement in data breach investigations (again noting the potentially overlapping role of the DPO).
Court of Appeal rules on consent by minors to treatment
Posted: Sunday, September 19th, 2021
In Bell v Tavistock and Portman NHS Foundation Trust  EWCA Civ 1363, the Court of Appeal has 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. It was accepted that the prescription of puberty blockers and then cross-sex hormones (two common steps in treatment for gender dysphoria in children) was in itself unlawful.
The Claimant’s aim was to require, as a matter of law, the involvement of the court before anyone under the age of 18 was prescribed puberty blockers thus denying the opportunity of consent to such treatment either individually or with the support of their parents or legal guardians. The argument was that those under 18 were not capable in law of giving valid consent to the treatment. The Divisional Court had agreed with the Claimant.
The case turned on the application of the House of Lords decision in Gillick v. West Norfolk and Wisbech Health Authority  AC 112 (“Gillick”), concerning the provision of contraception. In that case, the House of Lords made clear that it was for the clinician to decide whether a child under 16 could give informed consent to the prescription of contraceptives. Lord Fraser had said at that:
“[t]he only practicable course is to entrust the doctor with a discretion to act in accordance with his view of what is best in the interests of the girl who is his patient.”
He continued that:
“the doctor will … be justified in proceeding without the parents’ consent or even knowledge provided he is satisfied on the following matters: (1) that the girl (although under 16 years of age) will understand his advice; (2) that he cannot persuade her to inform her parents …; (3) that she is very likely to begin or to continue having sexual intercourse with or without contraceptive treatment; (4) that unless she receives contraceptive advice or treatment her physical or mental health or both are likely to suffer; (5) that her best interests require him to give her contraceptive advice, treatment or both without the parental consent.”
In Bell, the Divisional Court had been particularly concerned with difficulties it thought that under-16s would have in understanding and weighing up information. The heart of Tavistock’s appeal was that the Divisional Court had departed from Gillick, which had established that children under 16 could make their own decisions if assessed individually as competent to do so by their treating clinician; and that it was for doctors and not judges to decide on the capacity of a person under 16 to consent to medical treatment.
The Court of Appeal found that there was no difference in principle between the cases of Gillick and Bell. It considered that requiring an application to be made to the court before treatment was given “placed patients, parents and clinicians in a very difficult position. In practice the guidance would have the effect of denying treatment in many circumstances for want of resources to make such an application coupled with inevitable delay through court involvement.”
The Court of Appeal placed greater trust in the judgement of clinicians than the Divisional Court had done, saying:
“Clinicians will inevitably take great care before recommending treatment to a child and be astute to ensure that the consent obtained from both child and parents is properly informed by the advantages and disadvantages of the proposed course of treatment and in the light of evolving research and understanding of the implications and long-term consequences of such treatment. Great care is needed to ensure that the necessary consents are properly obtained. As Gillick itself made clear, clinicians will be alive to the possibility of regulatory or civil action where, in individual cases, the issue can be tested…Those clinicians must satisfy themselves that the child and parents appreciate the short and long-term implications of the treatment upon which the child is embarking. So much is uncontroversial. But it is for the clinicians to exercise their judgement knowing how important it is that consent is properly obtained according to the particular individual circumstances, as envisaged by Gillick itself, and by reference to developing understanding in this difficult and controversial area. The clinicians are subject to professional regulation and oversight.”
Consent, Gillick competence and case examiners
Posted: Wednesday, September 15th, 2021
Consent, Gillick ccmpetence and the role of case examiners were considered in two recent cases.
AB v CD  EWHC 741 (Fam) concerned X, a 15-year-old who wished to continue her hormone treatment to suppress puberty. Following the earlier decision in Bell v Tavistock and Portman NHS Foundation Trust  EWHC 3274 (in which an appeal to the Court of Appeal is currently pending), NHS England issued guidance that a child under 16 could only consent to treatment after an assessment and an application to the court. In X’s case, this would have caused an unacceptable delay in treatment. The court held that X’s parents retained the legal ability to consent to X’s treatment. In view of the decision in Bell, this judgment seems controversial because it appears to enable the NHS England guidance to be circumvented.
We will report further on Bell when the Court of Appeal judgment is available.
In B v General Medical Council  CSOH 85, a complaint had been made to the GMC by a child’s parents about a doctor who wrongly concluded that they were responsible for their child’s illness. The doctor made a safeguarding, referral resulting in the child being taken into care for a period. The GMC’s case examiners decided not to refer the case for fitness to practise proceedings and the child’s parents challenged this decision.
Based on earlier authorities, the parties agreed that case examiners have a limited, filtering, role. They may examine whether the complaint has any real prospect of being established, and in so doing may themselves conduct an investigation into its prospects. They may then refuse to refer the allegation on for a full hearing if satisfied that it has no real prospect of being established, but they must do so with the utmost caution (or, at least, with caution).
The case examiners noted that an expert had not identified any aspects of Dr C’s care “that fell below, or seriously below” the standard of the reasonably competent consultant paediatrician and lead consultant paediatrician for child protection. They also noted that the expert had confirmed that the doctor had followed the guidance issued by the Royal College of Paediatrics and Child Health.
It was also alleged that there had been a failure to obtain the parents consent to some of the child’s treatment in hospital, but, the judge, Lord Harrower, held that the case examiners had not made any error of law when they concluded that the parents, by bringing their child to the Hospital, had given implied consent to her ongoing treatment. To succeed in this allegation, the parents would have had to point to the implied consent being withdrawn at some point.
The case may be of further significance in view of the proposal by the Department of Health and Social Care in England to allocate greater decision-making powers to case examiners – a proposal PLEA commented on in responding to the recent consultation on healthcare regulation, pointing out the difficulty in overturning decisions of case examiners. Our response can be found on the Notice Board on the home page of our website www.plea.org.uk.
Changes to NHS terms of service and to Human Medicines Regulations
Posted: Tuesday, August 24th, 2021
The PSNC, DHSC and NHS England & Improvement (NHSE&I) have announced agreement for year 3 of the 5-year Community Pharmacy Contractual Framework in England. The agreement includes an announcement of regulatory changes to be made to the NHS terms of service in the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and changes to the Human Medicines Regulations. The changes will relate to:
- the clinical governance provisions. Pharmacies will be required to comply with recommendations from government or NHSE&I aimed at protecting staff and patients during a pandemic.
- the market entry provisions to enable NHSE&I to reject Pharmaceutical Needs Assessment-based applications if they provide only a minor increase in opening hours in the area and otherwise additional pharmaceutical services capacity is not needed in an area.
In addition, the PSNC, DHSC and NHSE&I have agreed:
- to continue further conversations regarding the regulation of dispensing and supply of medicines taking into account novel ways of undertaking these activities, while, at the same time, ensuring the integrity of the market entry system, based on Pharmaceutical Needs Assessments.
- to continue discussions on a suitable process to deal with suspected prescription direction issues.
- to seek as soon as possible changes to medicines legislation to enable original pack dispensing and the wider use of hub and spoke dispensing to improve efficiencies and better use of the skill mix in pharmacy teams so that the clinical skills of pharmacists can be directed to helping patients.
PSA to cease annual reviews of healthcare regulators - correct link
Posted: Thursday, August 19th, 2021
We are resending this news item with the correct link. Apologies to anyone who tried to use the link in our earlier email.
The Professional Standards Authority (PSA) carries out annual reviews of 10 healthcare regulators including the GPhC. In its last report on the GPhC, as we reported at the time, the PSA concluded that the GPhC had not met three standards relating to fitness to practise - see PLEA News of 4 November 2020 on our website.
The PSA has just published its response to a consultation on its approach to performance reviews of healthcare regulators https://www.professionalstandards.org.uk/publications/detail/how-we-approach-the-performance-review-process---report-on-consultation . The PSA is considering:
- Ceasing annual reviews.
- Undertaking full reviews of each regulator at predetermined time periods (probably between three to five years).
- In the years in between full reviews, the PSA would continue to monitor the performance of each regulator, including looking at any individual areas which suggested concerns and examining the impact of any significant changes introduced by the regulator.
The PSA will develop a model of how the new processes would work and will conduct a further consultation this autumn with a view to deciding on implementation in January 2022.
MHRA consulting on amending the law for point of care manufacturing
Posted: Wednesday, August 18th, 2021
The MHRA is conducting a consultation on Point of Care (“POC”) manufacturing https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing
According to the MHRA, new types of innovative products are increasingly being manufactured at the point where a patient receives care, eg personalised medicines made for the patient either within or very close to the healthcare setting. Technology enables the creation of new types of medicinal product that have features such as very short shelf lives, unlike typical current products with shelf lives measured in years. Medicines regulation supports the latter, geared to manufacture in factories for global distribution. POC products do not fit the standard model of regulation.
The MHRA is considering a new regulatory framework to enable the safe development of POC products for supply to patients through clinical trial studies and then on to licensing through a marketing authorisation. The MHRA proposes to use new powers in the Medicines and Medical Devices Act 2021 to amend the law.
The regulatory system is proposed to be based on a Control Site. This will be the primary focus of regulatory controls by MHRA. The Control Site will be a physical site that will be named on the clinical trial or marketing authorisation application. The Control Site would be responsible for overseeing all aspects of the POC manufacturing system including the addition of new manufacturing sites and control of each manufacturing location and their activities.
Remote FtP hearings and the demeanour of witnesses - recent cases
Posted: Tuesday, August 17th, 2021
In the GPhC’s recent consultation on its Fitness to Practise strategy, it sought views on when to use remote hearings and what impact they may have. In our response, we set out what we saw as the advantages and disadvantages of remote hearings. We concluded that the default position should be that hearings should not be remote unless the registrant agreed.
One of the potential disadvantages of remote hearings concerns the ability of a tribunal to assess the demeanour of a witness in order to form a view of credibility. However, in three recent fitness to practise cases, the courts have expressed varying views about reaching conclusions based on the perceived demeanour of a witness.
In The Queen (on the application of Dutta) v General Medical Council  EWHC 1974 (Admin), Mr Justice Warby said: “Reliance on a witness’s confident demeanour is a discredited method of judicial decision-making.”
In Khan v General Medical Council  EWHC 374 (Admin), the Medical Practitioner Tribunal found that the Dr Khan had behaved in an inappropriate and sexually motivated way towards three female members of staff. Mr Justice Julian Knowles upheld Dr Khan’s appeal. The Tribunal had approached disputed evidence by first considering whether a witness was credible. The judge criticised this approach and followed Mr Justice Warby’s decision in Dutta (above).
In Byrne v General Medical Council  EWHC 2237 (Admin), Mr Justice Morris heard an appeal by a registrant whose name had been erased from the medical register because of an inappropriate sexual relationship with a vulnerable patient. The medical practitioner had denied having such a relationship. Differing from Mr Justice Julian Knowles and Mr Justice Warby in the other recent cases, Mr Justice Morris gave this guidance on assessing evidence:
- First, the credibility of witnesses must take account of the unreliability of memory and should be considered and tested by reference to objective facts, and in particular as shown in contemporaneous documents. Where possible, factual findings should be based on objective facts as shown by contemporaneous documents.
- Secondly, nevertheless, in assessing the reliability and credibility of witnesses, whilst there are different schools of thought, I consider that, if relevant, demeanour might in an appropriate case be a significant factor and the lower court is best placed to assess demeanour: Despite the doubts expressed in Dutta and Khan , the balance of authority supports this view.
- Thirdly, corroborating documentary evidence is not always required or indeed available. There may not be much or any such documentary evidence. In a case where the evidence consists of conflicting oral accounts, the court may properly place substantial reliance upon the oral evidence of the complainant (in preference to that of the defendant/appellant). There is no rule that corroboration of a patient complainant’s evidence is required.
GPhC warns about provision of online services
Posted: Friday, August 13th, 2021
The GPhC has written to pharmacy owners and pharmacy professionals, reminding them of the need to follow its guidance on providing pharmacy services at a distance, including on the internet.
The letter https://www.pharmacyregulation.org/sites/default/files/document/patient-safety-concerns-relating-to-online-prescribing-services-letter-august-2021.pdf sent by the GPhC’s Director of Insight, Intelligence and Inspection (who spoke at the last PLEA seminar) highlights that since April 2019, the GPhC has taken enforcement action against over 40 pharmacies concerning the provision of online services. The majority of the pharmacies involved were working with online prescribing services that were prescribing medicines liable to misuse and overuse on the basis of online questionnaires. According to the letter, a significant minority of pharmacies and pharmacy professionals are not meeting standards and following guidance.
2021 PLEA Annual Essay Competition Winner Announced
Posted: Wednesday, July 28th, 2021
Each year PLEA runs a law and ethics essay competition to foster wider thinking on issues of the day by students at UK and Ireland schools of Pharmacy.
This years competition title for consideration was "The legal and ethical implications of using volunteers to supply medicines during the COVID-19 pandemic" Discuss
We received 12 entries from 9 schools of pharmacy.
The winners were from the following schools:
Winner – Nottingham
2nd place – Huddersfield
3rd place - Keele
Congratulations to Saz Karim from the University of Nottingham School of Pharmacy who wins £500 and the two runners up who each receive £250
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.