Cumberlege review of Medicines and Medical Devices
Posted: Wednesday, July 15th, 2020
The Independent Medicines and Medical Devices Safety Review published its report on 8 July. Chaired by Baroness Cumberlege, the report is entitled First Do No Harm. The report includes a number of issues that relate to pharmacy.
Baroness Cumberlege’s team investigated what had happened in respect of two medicines and one medical device:
- hormone pregnancy tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;
- sodium valproate, an anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and
- pelvic mesh implants, the use of which has been linked to crippling, life-changing complications.
Baroness Cumberlege referred to the harrowing stories of the women who had been affected by these devices and medicines. The report refers to:
- A system that cannot be relied upon to identify promptly significant adverse outcomes arising from a medicinal product or device because the system lacks the means to do so. The Yellow Card scheme for reporting adverse reactions is decades-old. It is clear there is under-reporting, and the complaints system is “too complex and too diffuse to allow early signal detection”.
- “the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques. Patients are being exposed to a risk of harm when they do not need to be.”
- The statutory duty of candour “has not been entirely effective”. The Professional Standards Authority reports that regulators are not identifying duty of candour breaches or considering them as fitness to practise matters.
- A cultural shift away from blame is needed to create a healthcare system where people are open and honest. The recent emphasis on whistle-blowing will not solve the problem in itself. A no-blame, systems-based approach to delivering redress is essential to deliver a safer NHS where healthcare professionals have no reason to fear being candid and telling the truth to their patients.
- The GPhC discussed with the review team the difficulty of ensuring that information is being communicated in the most effective way, and the problems of having to disseminate information via a variety of alternative channels, such as pharmacy owners, those responsible for governance, and involving non-registered staff, such as counter assistants.
- A recent Company Chemists Association report suggested only half of at-risk patients taking valproate were physically present in the pharmacy to collect medication.
- The majority of mistakes are system errors, yet litigation usually deals with the culpability of individuals such as individual doctors or pharmacists.
- Creating the post of Patient Safety Commissioner.
- A Redress Agency as an alternative to litigation when things go wrong. A healthcare system should aim to eliminate avoidable harm: an open, honest culture in which mistakes are learned from and barriers to disclosure are removed is overdue and essential.
- For both medicines and medical devices, there is a need for more robust, publicly accessible post-marketing surveillance. This should include mandatory requirements on healthcare organisations to report adverse events within a designated time period. The MHRA should provide assessments of the risks of individual medicines or devices and of classes of medicines or device where one or more members of the class carries an elevated risk.
- The Yellow Card system should be reformed to provide a “user-friendly, accessible, transparent repository of adverse event reports.”
- An online system for the Pregnancy Prevention Programme should be accessible by pharmacists at the point of dispensing.
- When the EU Medical Devices Regulation is implemented after the Brexit transition period, the UK should adopt its more stringent standards and there are areas where further improvements should be made.
- A register of medical devices should be created and maintained by the MHRA so that it is possible to know what devices are (or were) on the market at any given time. Entry on the register should be a condition for selling in the UK, with the MHRA having power to de-register devices and remove them from sale, if necessary. The MHRA would be more like a licensing authority than in the past, with a greater emphasis on vigilance.
CMA concludes fludrocortisone case with £2.3m fines
Posted: Friday, July 10th, 2020
The Competition and Markets Authority (CMA) has announced that it has closed its investigation into the supply of fludrocortisone, a prescription-only medicine mainly used to treat primary or secondary adrenal insufficiency, commonly known as Addison’s Disease.
The CMA found that the pharmaceutical companies Amilco and Tiofarma agreed to stay out of the fludrocortisone market so that Aspen could maintain its position as the sole supplier in the UK.
In exchange, Amilco received a 30% share of the increased prices that Aspen was able to charge, and Tiofarma was given the right to be the sole manufacturer of the drug for direct sale in the UK.
Following the agreement, the price of fludrocortisone supplied to the NHS increased by up to 1800%.
All 3 companies involved in the agreement – Aspen, Tiofarma, and Amilco – admitted to taking part in an anti-competitive agreement regarding the supply of fludrocortisone tablets.
The CMA has levied fines totalling just under £2.3 million for this illegal behaviour.
As well as the fines, Aspen approached the CMA last year and agreed to pay the NHS £8 million to help resolve the CMA’s competition concerns in relation to fludrocortisone. This payment has now been made.
GPhC proposed Fitness to Practise strategy
Posted: Friday, July 10th, 2020
Just after we reported High Court criticism of fitness to practise delays by the GPhC, the GPhC presented to its Council for consideration on 9 July 2020 a proposed Fitness to Practise strategy. Excerpts from the strategy include:
“A pharmacy professional may not be fit to practise for a number of reasons, for example if their behaviour is putting patients at risk, they are practising in an unsafe way, or their health may be affecting their ability to make safe judgements about their patients. Our current approach to dealing with concerns about pharmacy professionals is too often cumbersome, lengthy and inefficient. This means it can be frustrating to patients, professionals and employers alike.
We will only use formal fitness to practise processes when it is absolutely necessary and seek early solutions and remediation where appropriate. Most registrants who have difficulties in their practice are willing and able to improve and resolve the problem. We want to break down the barriers that stop them from doing so as early as possible and we will work with employers, other regulators and those that set our standards to achieve this goal.
…shifting the balance towards more anticipatory, proportionate and tailored approaches to regulating pharmacy. We are developing our equality, diversity and inclusion strategy in parallel with this fitness to practise strategy
[Our approach] is still perceived as being overly legalistic, adversarial and time-consuming. It is largely rigid and reactive when it needs to be flexible and proactive
We need to understand more about why BAME professionals are disproportionately represented in the concerns we receive and those that progress through the process. We need to understand more about the impact of a professional not having legal representation, or not attending a hearing, as our analysis indicates these factors can result in a more serious outcome.
We have successfully held some remote hearings during the pandemic with the consent of everyone involved and the response has been positive whilst public protection has been maintained. We are keen to take the positive learning from this period and to hear stakeholders’ views on the potential benefits of continuing with some remote hearings in future, including the types of circumstances when this might be appropriate.
- quickly identify the key regulatory issue(s) on which we should take action
- take swift action when there is an immediate risk to patient and public safety
- recognise that it is not always appropriate or necessary to take formal action in response to a concern or incident, particularly with pharmacy professionals who make honest mistakes and are open about them and show how they have learned from them
- use other ways to resolve concerns swiftly when there’s no need for a full investigation following initial enquiries (see below)
- move cases forward quickly where there’s no disagreement about what has happened.
We will also develop proposals for making more enquiries in the early stages of our process after receiving a concern (triage). Making initial enquiries within a set framework will help us ensure the right concerns are investigated and those that can be resolved through alternative means are dealt with quicker.
We will also:
- broaden the options for concluding concerns to provide support and facilitate reflection and learning as an outcome for certain concerns (as set out above)
- consider wider use of voluntary removal from the register in appropriate cases
- look at the wider context and system risks associated with any patient /public safety issues and where appropriate combine individual outcomes with action focused on bringing an end to any risk caused by the way in which a pharmacy is operating
- share information with our inspection colleagues to inform risk so they can better target inspection resources
- explore mediation as an alternative outcome. Employers may often be best placed to recognise and manage some concerns. So we will actively work with employers to help identify the types of concerns that can be managed locally for faster, focused and fairer resolution.”
GPhC fitness to practise application refused by High Court
Posted: Sunday, July 5th, 2020
On 19 February 2020, we reported that the Professional Standards Authority (PSA) had criticised the General Pharmaceutical Council’s handling of fitness to practise cases. Amongst other things, the PSA concluded that at over 93 weeks on average from the initial complaint, the GPhC is still taking too long to bring cases to a final hearing.
The High Court has just considered an application by the GPhC to extend an interim suspension of two pharmacists pending a full hearing by the Fitness to Practise Committee.
In General Pharmaceutical Council v Kellett and Gamble  6 WLUK 456, the pharmacists, Kellett and Gamble, were a husband and wife who were directors of a company that owned three pharmacies and held a wholesale dealer’s licence. Gamble was the superintendent. In 2016, the police found a large number of Class C controlled drugs, such as zopiclone, at their premises. They were arrested by the police for unlawful possession and supply of Class C controlled drugs. They informed the GPhC of the investigation. They also terminated their wholesale business.
In January 2017, the Fitness to Practise Committee imposed an interim suspension for the maximum period of 18 months to be reviewed every 6 months. The suspension could then be extended by the High Court for successive periods of up to 6 months.
The Medicines and Healthcare products Regulatory Agency (MHRA) began an investigation, but the MHRA’s in-house lawyer did not review the papers until May 2020, only to find that further work was required before a file could be sent to the Crown Prosecution Service (CPS) for a decision on whether to charge the two pharmacists with any offence.
After previous extensions of the interim suspension order, the suspensions were due to run out on 5 July 2020. The GPhC applied to the High Court for a further extension. The MHRA was still not in a position to send the papers to the CPS.
The pharmacists argued that there had been an unconscionable delay of four years, yet there was still no clear indication
Mr Justice Soole ruled that the court had to take into account two competing questions: whether it would be acceptable not to suspend if, at the end of the day, the pharmacists were found guilty, and whether it would be acceptable to suspend if, at the end of the day the pharmacists were acquitted on all charges. Having considered the evidence and submissions, he found:
- The allegations of supply and conspiracy to supply were grave: serious offences were involved.
- Despite four years having passed, there was still no indication what charges, if any, might be brought.
- Even though the GPhC could not be blamed for delays by the MHRA, the GPhC had to share significant responsibility for the consequences. The GPhC had not been pro-active in pressing the MHRA for updates.
- The GPhC had not provided the court with any evidence as to why an extension should be granted.
- The pharmacists had suffered real and substantial prejudice as a result of the delays.
- No decision whether to bring any charges was likely to be made before October 2020.
- It was no longer proportionate or in the public interest to grant any extension, though this could be considered afresh when the investigation was concluded.
VAT change for medicines prescribed by EEA health professionals
Posted: Friday, July 3rd, 2020
Medicines prescribed by medical practitioners are zero-rated, but only if the prescriber is registered with the General Medical Council. Although it has for some time been lawful for prescriptions written by doctors registered in EEA countries to be dispensed in the UK, the medicines dispensed have not been zero-rated. The distinction seems arbitrary and has led to large claims for VAT for some UK pharmacies, mainly ones providing online services. In 2016, Pearl Chemist received a demand for £156,782.41. They unsuccessfully challenged the lawfulness of the restriction of zero-rating for supplies prescribed by doctors not on the GMC register - Pearl Chemist v Revenue and Customs Commissioners  UKFTT 264.
HMRC have just published an amended notice on zero-rating https://www.gov.uk/guidance/health-professionals-pharmaceutical-products-and-vat-notice-70157 adding EEA health professionals to the list of practitioners who can prescribe zero-rated medicines.
COVID life assurance, Amazon, vaping & medical devices
Posted: Wednesday, July 1st, 2020
Recent published articles by our members include:
- Andrea James in Chemist & Druggist on the criteria for COVID-19 life assurance eligibility https://www.chemistanddruggist.co.uk/opinion/what-criteria-60000-covid-19-life-assurance-payout
- Noel Wardle (with Peter Byrd) in Chemist & Druggist on the legal implications of Amazon’s applications for trademarks for “Amazon Pharmacy” https://www.chemistanddruggist.co.uk/opinion/possible-next-steps-amazon-pharmacy
- David Reissner in Chemist & Druggist on the difference between lawful and unlawful COVID-19 tests, and the CE marking of medical devices https://www.chemistanddruggist.co.uk/opinion/legal-view-difference-between-lawful-and-unlawful-covid-19-tests
- Susan Hunneyball’s article on vaping in P3, now available on the Gordons Partnership website https://www.gordonsols.co.uk/vaping/
- The Charles Russell Speechlys Pharmacy Brief https://communications.crsblaw.com/17/2268/uploads/pharmacy-brief---june-2020.pdf
GPhC and CMA complain of profiteering
Posted: Tuesday, June 30th, 2020
The General Pharmaceutical Council and the Competition & Markets Authority have issued a joint letter about profiteering during the COVID-19 pandemic https://www.pharmacyregulation.org/sites/default/files/document/cma_and_gphc_joint_letter_june_2020_v2.pdf .
The two bodies say they have received reports alleging that a small minority of pharmacies are seeking to benefit from the coronavirus pandemic by charging unjustifiably high prices for essential products – including hand sanitiser, face masks and paracetamol.
The CMA recognises that pharmacies may be facing higher operational costs at this time and may be paying higher prices to wholesalers for high-demand products but asserts that these do not justify a pharmacy owner increasing its own percentage mark-up on the wholesale price. The CMA considers that higher costs justify the disproportionate increasing of mark-ups on essential products unless the additional costs specifically relate to those products.
The CMA says it has launched investigations into four retailers, including pharmacies, which it suspects have charged excessive and unfair prices for hand sanitiser products.
The GPhC says it has written to a number of registered pharmacies and, in some cases, they have asked the pharmacy to review the price they are charging for a particular item.
Cannabis-based Epidyolex to be added as Schedule 5 CD
Posted: Friday, June 5th, 2020
The Misuse of Drugs Regulations were amended with effect from 1 November 2018 to allow cannabis-based products for medicinal use in humans to be prescribed by clinicians on the GMC’s specialist register (or doctors acting under their direction).
Epidyolex is a cannabis-based medicine licensed for the treatment of rare forms of epilepsy. It had been granted a marketing authorisation in September 2019. The Advisory Committee on the Misuse of Drugs advised the Secretary of State that because THC is present in Epidyolex only as an impurity and as it has a low risk of abuse potential, low risk of dependency and low risk of diversion, it should be placed in Schedule 5 to the Misuse of Drugs Regulations 2001.
The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2020 have been laid before Parliament and will come into force on 24 June 2020. These Regulations amend the Misuse of Drugs Regulations by adding Epidyolex to Schedule 5 – products exempt from importation.
Dishonesty, entrapment and fitness to practise cases
Posted: Friday, June 5th, 2020
It isn’t easy to challenge a Supreme Court judgment, especially in a lower court, but that’s exactly what the defendant in a recent criminal case tried to do. In R v Barton  EWCA Crim 575 the Court of Appeal was asked to ignore the Supreme Court’s ruling in Ivey v Genting Casinos (UK) Ltd  UKSC 67. In Ivey v Genting, the Supreme Court had overturned the legal definition of dishonest that had been used since 1982, replacing it with an objective test based on whether the defendant’s actions were dishonest according to the standards of ordinary decent people. However, Ivey v Genting was a case about cheating in a casino and not about the test of dishonesty. The defendant in R v Barton therefore argued that the Ivey decision was not binding and that the courts should continue to follow the law as it had been since 1982.
Unsurprisingly, the defendant in Barton was unsuccessful. The courts have been following Ivey v Genting, and so have fitness to practise tribunals. This was reiterated in a recent case, Naqvi v Solicitors Regulation Authority  EWHC 1394 (Admin), in which a solicitor appealed against a striking off decision by the Solicitors Disciplinary Tribunal.
The facts have resonances for some pharmacy fitness to practise cases, a number of which in recent years have arisen from undercover reporting. In Mr Naqvi’s case, a television reporter was investigating bogus immigration applications based on sham marriages. The reporter, pretending to be a client, had carried out undercover interviews in which the solicitor said he would make applications knowing that the marriages in question were not genuine.
Amongst other things, the solicitor argued that the case against him should have been dismissed because he had been entrapped. The Court drew a parallel with the decision in The Council for the Regulation of Healthcare Professionals v General Medical Council and Saluja  EWHC 2784 (Admin) concerning a doctor who had offered in return for payment to provide a fake sick note to a journalist posing as a patient. In that case, the judge had rejected the argument that for a journalist to go into a doctor's surgery and pretend to be a patient is similar to abuse of power by an agent of the state. Cases of entrapment of the kind that sometimes involve undercover police officers were different to proceedings brought against a doctor by his regulator in order to protect the public, uphold professional standards and maintain confidence in the profession.
In the Naqvi case, the solicitor argued that he should not have been found to have been dishonest because, based on the subjective 1982 test of dishonesty, he had not appreciated that what he had done was dishonest. The court rejected this argument, holding that once his actual state of knowledge is established, the question whether his conduct was honest or dishonest is to be determined by applying the (objective) standards of ordinary decent people.
The solicitor also argued that he did not have knowledge that the marriages in question were a sham: the most he had done was turn a blind eye. The court rejected this argument, too. Blind-eye knowledge could be the basis of a finding of dishonesty.
Lexon to appeal against nortriptyline fine imposed by CMA
Posted: Tuesday, June 2nd, 2020
The pharmacy press has reported that Lexon intend to appeal to the Competition Appeal Tribunal against a financial penalty imposed by the Competition and Markets Authority (CMA) in early March.
The CMA found that King Pharmaceuticals Ltd and Auden Mckenzie (Pharma Division) Ltd shared out between them the supply of the antidepressant drug, nortriptyline, to a large pharmaceutical wholesaler in 2014 and 2015. The two companies agreed that King would supply only 25mg tablets and Auden Mckenzie only 10mg tablets. They also colluded to fix quantities and prices. King and Auden Mckenzie admitted breaching competition law and were respectively fined £75,573 and £1,882,238. Accord-UK (which had taken control of Auden-Mckenzie’s nortriptyline business) and Auden McKenzie agreed to make a £1m payment to the NHS.
The CMA also fined King, Lexon (UK) Ltd and Alissa Healthcare Research Ltd for illegally sharing commercially sensitive information to try to keep nortriptyline prices up when the cost of the drug was falling between 2015 and 2017. King and Alissa admitted breaking the law and were fined £75,573 and £174,912 respectively. Lexon did not admit to breaking the law and were fined £1,220,383.
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.