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Misuse of Drugs Regulations to be relaxed

Posted: Friday, April 3rd, 2020

The Home Secretary has written to the Chair of the Advisory Council on the Misuse of Drugs to indicate that the Misuse of Drugs Regulations will be relaxed during the pandemic. You can find the details here https://www.gov.uk/government/publications/letter-to-the-acmd-on-emergency-legislation-to-enable-the-supply-of-controlled-drugs/letter-from-the-home-secretary-to-the-chair-of-the-advisory-council-on-the-misuse-of-drugs

Pandemic-related amendments to NHS Pharmaceutical Services Regulations in England

Posted: Thursday, April 2nd, 2020

Power to suspend terms of service

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 govern the provision of NHS services by pharmacies in England, with terms of service set out in Schedule 4 to the Regulations. Breaches of the terms of service can result in NHS England serving a remedial notice requiring remedial action, or a breach notice that include the sanction of a withholding of remuneration.

Under the National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 that came into force on 27 March, NHS England has a power, with the agreement of the Secretary of State, to suspend any of the terms of service in an area. In the event of a suspension, no remedial notice or breach notice can be served.

Mandatory home delivery service

The amendment Regulations provide that if NHS England has announced that certain patients are advised to stay away from a pharmacy in a particular area, pharmacies must provide a home delivery service. If approached by a patient who is covered by the advice the pharmacy must provide a home delivery service. The pharmacy must also provide the service if it has not been contacted by the patient if, using “in the ordinary exercise of professional skill and judgement” what is on a prescription indicates that the patient might be covered by the announcement.

The pharmacist must check whether the supply could be made to a patient by a representative of the patient, such as a carer, family member, friend or neighbour. If so, the pharmacy must provide the service through that person.

If there is no representative who can deliver, the home delivery requirement means:

(a) The pharmacy must deliver to the patient’s home or an alternative address agreed with the patient

(b) The pharmacy can arrange delivery using a different pharmacy;

(c) If neither (a) nor (b) is possible, the pharmacy must not dispense a prescription, but must arrange for another pharmacy that can deliver to do the dispensing.

The home delivery requirement will not apply if the patient comes to the pharmacy; and does not apply to distance selling pharmacies.

Normally, pharmacies must supply prescribed medicines with reasonable promptness. In the case of home delivery, this requirement is changed to supplying “within a reasonable timescale”.

Power to dictate core opening hours

In ordinary times, the Pharmaceutical Services Regulations say that pharmacies must be open for at least 40 core hours. The specific 40 hours will have been notified to NHS England. In calculating these 40 core hours, if a pharmacy would normally be open on a Monday or Sunday, it will be treated as being open on Good Friday and Easter Sunday, even if it is closed.

In ordinary times before directing a change to core pharmacy hours, NHSE must

Under the amendment Regulations, NHS England can, with the agreement of the Secretary of State, change the core or supplementary opening hours in an area for a specified period. This power overrides the terms of service that apply in ordinary times.

To use this power, NHS England must have the agreement of the Secretary of State and must make an announcement that (paraphrasing) this is related to the pandemic. The change must identify an area and must identify a period.

Failure to open can result in remedial notices, breach notices and a withholding of remuneration. There is a right of appeal to NHS Resolution, but NHS Resolution has been unsympathetic to appeals relating to Christmas closures and other unavoidable closures in the past. It remains to be seen if Pandemic-related non-opening would be treated any differently.

 

 

Can cost justify prescribing unlicensed medicines? Court of Appeal answers this and other questions

Posted: Sunday, March 29th, 2020

The Court of Appeal has just handed down its judgment in Bayer PLC and Novartis Pharmaceuticals UK Ltd v NHS Darlington CCG and others [2020] EWCA Civ 449.

Issues

The Court addressed a number of issues, including:

Facts

Darlington CCG and a number of other CCGs, all of which were also Defendants, had adopted a policy that the NHS Trusts from which they commissioned services should use Avastin as the preferred treatment for a form of the eye disease, macular degeneration (WAMD).

WAMD is very common. Avastin was originally developed for the treatment of colorectal cancer and it is licensed for such treatment in the UK. It has been found to be effective in the treatment of WAMD, but no application has been made to license its use in the UK to treat WAMD. Indeed, its formal Summary of Product Characteristics says it is not formulated for intravitreal use.

Avastin is supplied in glass vials. For treating colorectal cancer, the contents of the vial are diluted before administration. To treat WAMD, however, Avastin is not diluted and the contents of a vial are put into a large number of syringes for injection. Under EU law, this is repackaging.

Use of a medicine for a purpose other than the one(s) specified in a licence is generally described as “off-label”. Off-label use of a drug is not necessarily safe or otherwise inappropriate provided that the clinician takes full responsibility for the decision to use it.

There are two licensed products for the treatment of WAMD, Eylea for which Bayer holds the marketing authorisation and Lucentis for which Novartis holds the marketing authorisation in Europe. The evidence before the court was that Avastin was just as safe and effective as Eylea and Lucentis for the treatment of WAMD, but Eylea costs about £800 per injection and Lucentis costs about £550, whereas Avastin costs about £28.

Standard conditions require NHS Trusts to co-operate with CCGs, so they are required to take the CCG’s policy into account.

Bayer and Novartis sued the twelve CCGs and alleged that implementation of the policy would lead to breaches of EU legislation – the Medicines Directive - regulating the marketing and manufacture of medicines, and would also breach the Human Medicines Regulations.

There are exemptions in the Directive from the need for a marketing authorisation. These include medicinal products prepared in a pharmacy in accordance with a prescription for an individual patient; and any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied by patients of the pharmacy.

Ordinarily, preparing, dividing up or changing packaging or presentation – which is done when Avastin is used for WAMD – requires a marketing authorisation.

Judgment

The Court held that:

 

 

 

 

 

 

(a) preparing or dispensing a medicinal product in accordance with a prescription; or

(b) assembling a medicinal product in a hospital or pharmacy under the supervision of a pharmacist.

 

 

 

 

 

                                                            “There is nothing inherently illegitimate in prescribing decisions being influenced by cost considerations where the evidence shows no differences in efficacy or safety.”

The CCGs were held to have acted lawfully and the appeals by Bayer and Novartis were dismissed.

 

 

Coronavirus Bill 2020 - emergency powers

Posted: Sunday, March 22nd, 2020

The Government has introduced the Coronavirus Bill 2020 to provide emergency powers to deal with the current crisis.  Amongst other things, according to the Department of Health & Social Care, when the Bill is passed:

The Bill provides that, when passed as the Coronavirus Act 2020, the powers it contains will lapse after two years unless a power to extend the period is activated.

Excessive drug prices - Court of Appeal rules on Flynn and Pfizer

Posted: Sunday, March 15th, 2020

In December 2016, the Competition and Markets Authority (CMA) found that Pfizer and Flynn Pharma Limited had breached competition law by charging unfairly high prices for phenytoin sodium capsules. Pfizer and Flynn had imposed, overnight, a very large increase in the price of the capsules in September 2012 despite there being no material change in the underlying costs. NHS expenditure on phenytoin sodium capsules rose from about £2 million a year in 2012 to about £50 million in 2013 with, for example, the price of 100mg packs of the drug rising from £2.83 to £67.50. The prices charged in the UK were also many times higher than Pfizer’s prices for the same drug in every other European country it sold capsules in, and several Clinical Commissioning Groups complained about the impact on the services they would be able to offer patients. 

The CMA said it was intervening to protect patients, the NHS, and the taxpayers who fund it. The CMA found Pfizer and Flynn’s conduct to be a particularly serious abuse of a dominant position in the market and imposed fines totalling £90m.

Flynn and Pfizer appealed to the Competition Appeals Tribunal (CAT) which overturned the financial penalties because of errors of fact and law made by the CMA. The CMA appealed against the CAT decision, and the Court of Appeal has now partly upheld the appeal.

In Competition and Markets Authority v Flynn Pharma Limited and Pfizer Inc ([2020] EWCA Civ 339), the Court of Appeal has held that in deciding whether there had been an abuse of a dominant position, a range of methodologies could be used, but the basic test was whether a price was "unfair". In broad terms, a price would be unfair when the dominant undertaking had reaped trading benefits it could not have obtained in conditions of "normal and sufficiently effective competition", namely "workable" competition. A price which was excessive because it bore no reasonable relation to the economic value of the good or service was an example of such an unfair price.

In the light of this ruling, the CMA must now reconsider whether there was an abuse of a dominant position and, if so, what action to take.

New GP contract - fax machines and electronic prescriptions

Posted: Thursday, March 12th, 2020

The Secretary of State has made the National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2020. These Regulations will bring new NHS contracts for GPs into force in England on 1 April 2020.

Of interest to the community pharmacy sector, if GPs have an alternative secure electronic means of communication, such as NHS Mail, they must not use fax machines.

In addition, even if a patient has not nominated a pharmacy for the purpose of electronic prescribing, their GP may issue them with an EPS token, which will include a barcode to allow a pharmacy to retrieve the required information from the NHS spine.

Racist remarks, social media and fitness to practise

Posted: Thursday, March 12th, 2020

At our annual seminar in 2019, barrister Kenneth Hamer spoke about social media in fitness to practise cases. Two recent cases shed further light on how racist remarks may be dealt with and the misuse of social media.

In Professional Standards Authority v Health Professions Council and Roberts, the High Court rejected a challenge by the PSA which challenged a finding that a paramedic’s fitness to practise was not impaired.

The paramedic had decided that a patient should be taken to hospital. When talking to his colleagues, he used a racist acronym to describe the patient’s condition. This was reported to the HPC which regulates paramedics. The paramedic said he was ashamed of his deplorable conduct and had attended courses on cultural awareness. The HPC committee found that the racist epithet was an isolated incident that was unlikely to be repeated.

Mrs Justice Foster held that the test of impairment referred to current impairment and the HPC committee had been entitled to decide that the public interest did not require a finding of impairment.

The case is an interesting contrast to the recent decision in Diggins v Bar Standards Board [2020] EWHC 467 (Admin). Martin Diggins is a non-practising barrister. In 2017, a young black female student posted a message on Twitter that referred to the need for Cambridge University to “decolonize its reading lists and…not to be so arrogant as to assume civilization began with the writing of white men”. Diggins tweeted in reply: “Read it. Now, refuse to perform cunnilingus on shrill negroids who will destroy an academic reputation it has taken aeons to build.” A Disciplinary Panel of the Bar Standards Board found that the tweet amounted to misconduct; it reprimanded Diggins and fined him £1,000.

Diggins appealed to the High Court. Mr Justice Warby held that the Panel’s task was to decide whether the tweet was likely to undermine the trust and confidence reposed by others in Diggins and the Bar. In order to determine this, the Panel had to follow the principles set out by the Supreme Court in Stocker v Stocker ([2019] UKSC 17):

"The judge tasked with deciding how a …tweet on Twitter would be interpreted by a social media user must keep in mind the way in which such … tweets are made and read.

… it is wrong to engage in elaborate analysis of a tweet … this is a casual medium; it is in the nature of conversation rather than carefully chosen expression; and … is pre-eminently one in which the reader reads and passes on.

… Twitter is a fast-moving medium. People will tend to scroll through messages relatively quickly. … The essential message that is being conveyed by a Tweet is likely to be absorbed quickly by the reader."

In short, words used on Twitter should not be the subject of elaborate over-analysis in “the fast-moving and relatively informal context of social media”. On the other hand, this did not mean that a person who is criticised for a tweet can excuse or justify a message merely by saying it was posted casually without thought or inhibition.

The judge rejected Diggins’ claim that a single tweet could not be misconduct. Moreover, the Panel had found that although the tweet was directed to a particular student and the university, it was published to the world at large and the words were seriously offensive to third parties. In contrast to the Roberts case, it was not a momentary lapse that had been acknowledged and apologised for: Diggins had chosen not to delete his tweet. The judge held that, applying ordinary community standards, the words used were “racially charged”

The appeal was dismissed.

 

PSA's annual review of GPhC performance

Posted: Wednesday, February 19th, 2020

The Professional Standards Authority (PSA) has just published a thorough review of the GPhC’s performance in 2018/19 https://www.professionalstandards.org.uk/docs/default-source/publications/performance-review---gphc-2018-19.pdf?sfvrsn=78c17720_0.

Key points include:

 

 

 

 

 

 

 

 

 

 

 

 

 

Medicines and Medical Devices Bill receives first reading

Posted: Sunday, February 16th, 2020

The Medicines and Medical Devices Bill received its first reading in the House of Commons on 13 February.

The explanatory note (which is not part of the Bill) can be found here https://publications.parliament.uk/pa/bills/cbill/58-01/0090/en/20090en.pdf

When passed and the Bill becomes an Act, it will provide powers to amend the existing legislation regulating human and veterinary medicines.

Examples of changes to the current law that are suggested in the explanatory note are:

The Bill is due to have its second reading on 3 March 2020.

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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.