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Hub & Spoke - change to pharmacy law announced
Posted: Tuesday, July 23rd, 2019
In its announcement yesterday of a new funding package for community pharmacy, the Governement also announced that it will will "pursue legislative change to allow all pharmacies to benefit from more efficient hub and spoke dispensing, enabling increased use of automation and all the benefits that that brings".
The Government also proposes to amend the NHS market entry regulations to make it easier for two pharmacies to merge and then close one of them with less risk that someone else will apply for a new pharmacy "contract" to replace the one that closed.
Annual GPhC Fitness to Practise report
Posted: Monday, July 15th, 2019
The General Pharmaceutical Council has published its annual Fitness to Practise report. Amongst other things, the report contains the following information:
By far, the biggest source of concerns came to the GPhC from members of the public – 1439 out of 2,674 (an increase of 345 on the previous year).
167 concerns came from employers, 264 came from inspectors and 360 from other healthcare professionals.
Overall, 1,027 cases were closed at the triage stage in 2018/19 (39% of all concerns raised) compared with 791 in 2017/18 (34% of all concerns raised). The reduction may be the result of using more senior oversight, and the GPhC is currently evaluating the impact of adding more senior oversight into the triage process.
736 cases ended with a letter of advice, and of those that went to a Fitness to Practise Committee hearing the sanctions were –
5 warnings
37 suspensions from the register
13 removals from the register.
Promoting professionalism, reforming regulation – the Governments’ consultation response
Posted: Thursday, July 11th, 2019
The UK Government and the devolved governments have published their response following their consultation on promoting professionalism and reforming the regulation of healthcare professionals - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/815261/promoting_professionalism_reforming_regulation_-_eds_HW.pdf.
In summary:
The structure of healthcare regulation and regulatory bodies
The original consultation paper suggested that there should be some rationalisation of the 9 current healthcare regulators. However, opinions in the responses from consultees were divided and the governments say more work needs to be done on this, so there will be a further consultation. Regardless of the outcome of the further consultation, there will be structural changes to all the healthcare regulators. Their councils will become boards which comprise executive and non-executive directors, appointed on the basis that they have the skills, knowledge and expertise to ensure the regulator discharges its functions effectively. The non-executive directors will always form the majority of the board. Current and former registrants may be appointed to the board, but they will not form a majority. The governments have dropped a proposal for employers to be represented on the regulatory bodies' board, but expects regulatory bodies to actively seek and consider the views of employers.
Fitness to practise processes
The governments say the aim of reform is “to enable the regulators to place a greater emphasis on supporting the professionalism of all registrants, while continuing to take appropriate action to manage concerns about a minority of professionals…At the heart of these changes is the much-needed modernisation of fitness to practise processes.”
The governments believe that regulatory bodies manage complaints about professionals in a largely reactive way, focussing much of their effort and resources on managing concerns about a minority of registrants at the expense of supporting the professionalism of the majority. Investigations into allegations will, they say, always be central to delivering public protection. However, they regard these processes as
“bureaucratic and lengthy, which can be frustrating and stressful for patients and their families, registrants and employers. They are also legalistic and adversarial, and this can be detrimental to the development of a learning culture. Fitness to practise concerns need to be handled in a timely, efficient and proportionate manner to ensure safe, high quality healthcare delivery”.
Future processes will be “more collaborative and less adversarial”, and there will be requirements to update patients and family members on the progress of fitness to practise cases in which they have an interest.
New FtP powers
The most significant changes will enable regulators to resolve fitness to practise cases without the need for a full panel hearing where it is appropriate to do so.
Regulators will be able to:
- use case examiners to consider complaints and, where appropriate, resolve them on a consensual basis;
- include mediation as part of their fitness to practise processes if they wish; and
- remove registrants from the register automatically where they have been convicted of a very serious criminal offence – murder, rape or sexual offences involving children - in the UK.
Regulators have an existing duty to co-operate and the governments will explore whether this needs to be strengthened to enable them to work even more closely together with one another and with other organisations in the health and care system in the exercise of their functions.
The GPhC has published its response to the governments’ conclusions which you can read here: https://www.pharmacyregulation.org/sites/default/files/document/gphc_response_to_promoting_professionalism_reforming_regulation.pdf
Report on 2019 seminar published in Pharmacy magazine
Posted: Wednesday, July 10th, 2019
David Reissner's report on our annual seminar has been published in Pharmacy magazine. You can read it here https://www.pharmacymagazine.co.uk/pharmacy-law-and-ethics-update
Social media and fitness to practise - Ngole decision overturned - university criticised
Posted: Wednesday, July 3rd, 2019
Barrister Kenneth Hamer gave a fascinating presentation at our annual seminar on Social media and professional conduct”. At the time, the Court of Appeal had heard the appeal in The Queen (on the application of Ngole) v The University of Sheffield [2019] EWCA Civ 1127, but had not handed down its judgment. The judgment has just been published. Not only has the Court of Appeal overturned the decision of the University authorities to exclude Mr Ngole from an MA course that would have led to registration as a social worker, but the University came in for considerable criticism and was itself found to have lacked insight.
Mr Ngole is a devout Christian for whom the Bible is the authoritative word of God. He posted on Facebook in response to a US news story a series of comments such as:
“… [S]ame sex marriage is a sin whether we accept it or not”
“…Homosexuality is a sin, no matter how you want to dress it up”
“…[Homosexuality] is a wicked act and God hates the act”
The University of Sheffield brought fitness to practise proceedings against Mr Ngole. Mr Ngole was told that whilst he was entitled to hold his views about homosexuality being a sin, he was never entitled to express such views on social media or in any public forum. Mr Ngole was found to have lacked insight and excluded from his course.
Social workers are regulated by the Health and Care Professions Council (HCPC) and the Court of Appeal considered that the issues were likely to be applicable across all healthcare regulators. The HCPC has published guidance for students. Amongst other things, this says:
“You should keep high standards of personal conduct - You should be aware that conduct outside of your programme may affect whether or not you are allowed to complete your programme or register with us.
You should make sure that your behaviour does not damage public confidence in your profession - You should be aware that your behaviour may affect the trust that the public has in your profession. - You should not do anything which might affect the trust that the public has in your profession.”
The HCPC has also published guidance for registrants, as well as students, about use of social media, designed to explain how to use social media in a way which meets HCPC standards. It reminds registrants as to the importance of ensuring that use of social networking sites is consistent with appropriate professional standards. It states:
“You may use social networking sites to share your views and opinions. Again, this is not something that we would normally be concerned about. However, we might need to take action if the comments posted were offensive, for example if they were racist or sexually explicit.
You may use social networking sites to share your views and opinions. Again, this is not something that we would normally be concerned about. However, we might need to take action if the comments posted were offensive, for example if they were racists or sexually explicit. Social networking sites are a part of many registrants' and students' everyday life. We do not have any concerns about you using these sites, so long as you do so within the standards that we set. …”
“You must make sure that your conduct justifies the public’s trust and confidence in you and your profession. This means you need to think about who can see what you share. … Even on a completely personal account, your employer, colleagues or service users may be able to see your posts or personal information. It is best to assume that anything you post online will be visible to everyone.”
The Court of Appeal pointed out that
“the obligation to maintain confidence cannot extend to prohibiting any statement that could be thought controversial or even to have political or moral overtones. No social worker could be sanctioned for arguing in public that social work was under-funded. The expression of such views in offensive language, however, might well damage confidence. The prevention of the latter would fall within the legitimate aim of the system of professional regulation, prevention of the former would not. The existence of a broad legitimate aim … cannot extend to preclude legitimate expression of views simply because many might disagree with those views: that would indeed legitimise what in the United States has been described as a “heckler’s veto”.
On the other hand, the Court held that the
“legitimate aim of regulation must extend so far as to seek to ensure that reasonable service users, of all kinds, perceive they will be treated with dignity and without discrimination. Social work service users cannot usually choose their social worker. The use of aggressive or offensive language in condemnation of homosexuality, or homosexual acts, would certainly be capable of undermining confidence and bringing the profession of social work into disrepute. As the Guidance makes clear, [Mr Ngole] had an obligation not to allow his views about a person’s lifestyle to prejudice his interactions with service users by creating the impression that he would discriminate against them.”
It became clear during the Court of Appeal hearing that the stance which the University adopted from the time of the fitness to practise hearing amounted to a blanket prohibition against Mr Ngole voicing his religious views on sexual ethics and homosexuality at all in a public forum. In effect, any expression of disapproval of same-sex relations – however mildly expressed – which could be traced back to the person making it, would be a breach of the professional guidelines for social workers as far as the University was concerned.
The Court of Appeal made it clear that the mere expression of religious views about sin does not necessarily connote discrimination against service users; otherwise, no Christian believing as Mr Ngole did would be secure in a healthcare profession, unless they resolved never to express their views on this issue other than in private. Even then, the Court asked rhetorically: what if a private expression of views was overheard and reported?
The right to freedom of expression in Article 10 of the European Convention of Human Rights is not an unqualified right: if Mr Ngole’s comments had been abusive, if he had used inflammatory language of his own, or made a personal attack, such words would fall to be regarded in the same way as would racist views, or inappropriate sexually explicit language. However, the University’s stance that any expression of disapproval of same-sex relations (however mildly expressed) on a public social media or other platform which could be traced back to the person making it, was a breach of the professional guidelines was “untenable”, disproportionate, and an incursion into Mr Ngole’s right to freedom of expression. Moreover, the University’s position went much further than the HCPC guidance.
With regard to the sanction - expulsion from his course - the Court of Appeal held that this was disproportionate. The University should have considered the possibility of a lesser sanction and tried to give Mr Ngole guidance on what he could and could not say when expressing his beliefs. Because the Court was not in a position to decide what Mr Ngole would have said if he had been given advice, the case will now have to be reconsidered by a University fitness to practise panel.
Having excoriated the University, the Court concluded with words that all Universities should heed, especially in times of concern about the expression of unpopular views and about no-platforming:
“We recognise that a more prolonged exploration of a resolution here might well have proved unpopular with some. However, University authorities have an obligation, as do all regulators, to exercise care and restraint, and to take unpopular decisions, if such represent the just and proportionate result.”
Reflection and Fitness to Practise
Posted: Monday, July 1st, 2019
Reflection is a core part of the GPhC’s revalidation model, and pharmacy professionals are encouraged to reflect with others through peer discussion. The position is similar in other healthcare professions.
The use of reflective material in fitness to practise cases was an issue examined by the panel chaired by Professor Sir Norman Williams which was set up by the then Secretary of State to review of the Bawa Garba manslaughter case. The panel heard “widespread fears from healthcare professionals and representative groups that personal reflection where things have gone wrong, and in particular written reflection, might be used as evidence against them in criminal or regulatory proceedings".
The panel was also “concerned to learn that some clinicians are choosing not to engage with reflective learning for fear it could be used against them.”
The Williams report recommended that the General Medical Council and General Optical Council should no longer be able to require registrants to provide reflective material when investigating fitness to practise cases. The panel considered that such a change would help ensure healthcare professionals are not afraid to use their notes for open, honest reflection which supports improvements in patient care.
On 18 June, the GPhC announced that it had issued a statement jointly with the UK’s other 8 healthcare regulators, entitled “Benefits of becoming a reflective practitioner”[i]. The joint statement includes this passage:
“We will not ask those who are on our registers to provide their personal written reflections in order to investigate a concern about them. Registrants can choose to offer them as evidence of insight into their practice.”
[i] https://www.pharmacyregulation.org/sites/default/files/document/benefits_of_becoming_a_reflective_practitioner_-_joint_statement_2019.pdf
New NHS terms of service for SSPs
Posted: Sunday, June 30th, 2019
The NHS terms of service for pharmacies[i] are amended with effect from 1 July 2019, to enable medicines to be supplied under a serious shortage protocol (SSP).
Ordinarily, a pharmacy owner must supply a prescribed product with reasonable promptness. If the prescribed product is the subject of a SSP:
- the pharmacy owner must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription and may refuse to supply what is on the prescription.
- the pharmacy owner may provide a different product or different quantity to what is prescribed if –
- this can be done with reasonable promptness;
- it is in accordance with the SSP; and
- the supply is by or under the direct supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity is reasonable and appropriate.
If a supply is made under an SSP –
- prescriptions must be endorsed appropriately for remuneration purposes
- pharmacy owners must notify prescribers of a supply under a SSP if DHSC has published a recommendation to do so
- patients must be informed of the different supply by including information on the dispensing label.
If an SSP is in place, pharmacy owners do not have to use it. If a pharmacy owner is of the opinion in the exercise of his or her professional skill and judgement that supplying a different product or quantity is unreasonable or inappropriate and is able to supply the prescribed product or quantity within a reasonable timescale, they are allowed to do this and are absolved from the requirement to supply with reasonable promptness. It is to be inferred that “reasonable timescale” involves a longer period than “reasonable promptness”, but the actual period on either case would necessarily depend on the precise facts and circumstances.
Similarly, if a pharmacist is of the opinion, in the exercise of his or her professional skill and judgement that supplying a different product or quantity under a SSP is unreasonable or inappropriate and is unable to provide a different product within a reasonable timescale, a supply under the SSP can be refused. In that case, the patient must be referred back to the prescriber.
[i] Schedule 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
Good character as an aspect of fitness to practise
Posted: Tuesday, May 28th, 2019
Good character, which is an aspect of fitness to practise, came up for consideration in the recent Privy Council case of Layne v Attorney General of Grenada [2019] UKPC 11.
The Appellant, Layne had been convicted of murder following a coup in Grenada in 1979 in which the Prime Minister was murdered. After serving a lengthy prison sentence during which he studied law, he applied for admission to the Bar of Grenada. By the time of his application, Layne was by all accounts a model citizen. His application was nevertheless refused on the ground that his conviction meant he was not of good character. Layne appealed to the Judicial Committee of the Privy Council after exhausting the Caribbean appeals process.
Layne argued that “of good character” meant present good character and that he had demonstrated that he met this requirement.
The Privy Council (by a 4-1 majority) dismissed the appeal. The Privy Council held that:
- Good character must be related to the profession in question.
- Good character has two facets: the candidate’s attributes; and the risk of damage to public confidence in the profession (to which previous convictions were necessarily relevant).
- In relation to public confidence, the question to be considered was whether the public can reasonably be expected to have confidence in the admission of the candidate. This follows from the leading case of Bolton v The Law Society, a decision that is frequently referred to in GPhC determinations.
- Public confidence must be well-founded: and any lack of confidence by the public must be justifiable on an objective basis. It is not enough that the public would misguidedly not have confidence in a particular candidate. As Lady Arden put it: “It is not part of [the decision-maker’s] function to assuage public opinion”.
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
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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.
