Medicines shortage protocols and FMD - amendments to HMR
Posted: Sunday, January 20th, 2019
The Department of Health has laid the Human Medicines (Amendment) Regulations 2019 before Parliament. The Regulations will amend the Human Medicines Regulations as from 9 February 2019.
Primarily, the amendments address two issues: medicines shortages and implementation of the Falsified Medicines Directive.
Medicines shortages – serious shortage protocols
Where a Minister believes that there is a serious shortage of a specific prescription only medicine (POM), the Minister may issue a written protocol (SSP) that provides for the sale or supply of:
- a different strength, quantity or pharmaceutical form to that prescribed; or
- a different POM
SSPs will be developed with and signed off centrally by clinicians. They may list what alternative products may be supplied by pharmacists without them having to go back to prescribers. Some products, such as those for the treatment of epilepsy, will not be covered by SSPs, and patients will have to be referred back to prescribers.
When a SSP has been issued, pharmacists will be freed from the legal requirement to supply only in accordance with a prescription, provided that they supply:
- a generic equivalent of what has been prescribed;
- in the case of a biological medicinal product, a similar medicinal product; or
- a therapeutically similar POM
Conditions to be satisfied by pharmacists
Any sale or supply under a SSP must be made by or under the supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that:
- if a different strength, quantity or pharmaceutical form is supplied, it is reasonable and appropriate;
- if a different POM is supplied, it is reasonable to do so and the directions for use of the substituted product are appropriate.
Supplying an alternative POM without meeting the SSP conditions would involve the criminal offence of supplying otherwise than in accordance with a prescription.
If a patient is harmed by a permitted substitution, this may still be an offence under section 64 of the Medicines Act 1968.
The Regulations include a clause requiring a review of the serious shortage protocol as soon as is reasonably practical following the end of one year after the first such protocol starts to have effect. This will look at, specifically, any adverse consequences for either the market in prescription only medicines or patient safety. A stakeholder consultation will be conducted as part of the review.
DHSC believes the main benefits of the protocol would be the NHS cost savings associated with GP time, but acknowledges that there may be some risks to patients. DHSC expects that the impact on community pharmacies will be neutral. It believes there will be cost savings through pharmacies not having to liaise with GPs, but pharmacies will need to inform the GP when they dispense against a protocol and they may also be required to do some further checks that they would not do when dispensing against a prescription.
The changes relating to medicines shortages are not dependent on circumstances of Brexit and DHSC believes they will only be used in exceptional circumstances.
Falsified Medicines Directive
The Falsified Medicines Directive (FMD) will require medicines to bear a 2D barcode and an anti-tamper device. Pharmacies will have to verify the authenticity of medicines by scanning, and decommission medicines at the time of supply to a patient.
Breach of FMD will not automatically be an offence. Instead, the MHRA can serve an enforcement notice specifying the breach and the measures to be taken in order to prevent continuation or repetition. Failure to comply with an enforcement notice will be a criminal offence.
MHRA updates no-deal Brexit guidance
Posted: Thursday, January 10th, 2019
The MHRA has updated its no-deal Brexit guidance. Key features of the guidance include:
The EU (Withdrawal) Act will ensure that existing EU rules are converted into UK law at the moment of exit, with changes where necessary to make sure the rules work in the UK.
The EU common logo for online sellers currently allows sale of medicines throughout EU countries and can be issued by the MHRA and other EU competent authorities. In order to sell into the EU, EU-based online sellers have to register, comply with relevant requirements and display an EU common logo linked to the competent authority in which they are based. As they would be outside of the EU, UK-based online sellers would no longer be required to do this. For the UK market, the MHRA proposes to explore requiring the use of new ‘UK logo’ for UK-based online sellers from 2021.
Manufacturing and wholesaling
In the event of a no deal scenario the UK proposes to continue using, until further notice, the EU Good Manufacturing Practice and Good Distribution Practice guidelines.
If there’s ‘no deal’, the UK will unilaterally align to the EU/EEA exhaustion regime from Exit day to provide continuity in the immediate term for businesses and consumers and ensure that parallel imports of goods, such as pharmaceuticals, can continue from the EU/EEA.
All Party Parliamentary Group for Medicinal Cannabis
Posted: Thursday, January 10th, 2019
The Guardian has reported that the All Party Parliamentary Group for Medicinal Cannabis has said there is "a serious cultural block within the NHS around medicinal cannabis".
It appears that few clinicians have been willing to prescribe cannabis since the Misuse of Drugs Regulations were amended in November 2018, and the Group says this cannot have been what the government intended when it agreed to change the law.
The legal and ethical implications of medicinal cannabis will be the subject of a key presentation at our annual seminar on 9 April 2019.
2019 Seminar - 9 April - save the date
Posted: Wednesday, January 2nd, 2019
This year's Seminar will be held on 9 April 2019 at the offices of Charles Russell Speechlys, 5 Fleet Place, London EC4M 7RD. Please save the date. Presentations will include:
- The legal and ethical implications of medicinal cannabis
- The trial of a pharmacist accused of medical manslaughter
- The investigation, inspection and regulation of premises in the context of the GPhC's new approach to regulating pharmacies
Pharmacy inspection and regulation
Posted: Tuesday, December 11th, 2018
Earlier this year, PLEA responded to the GPhC consultation on pharmacy inspection and regulation. The GPhC has just published the outcome of its deliberations following the consultation. In particular:
- the GPhC is moving to a system of unannounced inspection of pharmacies
- there will be two inspection outcomes – either “standards met” or “standards not all met”
- pharmacies will have to meet all standards before being given a “standards met” outcome
- relevant improvement action plans will be published
- pharmacy owners will be expected to display inspection outcomes in their pharmacies.
Professional conduct, religion, vicarious liability and fitness to practise proceedings
Posted: Tuesday, December 11th, 2018
In his recent judgment Brayshaw v Apsley Surgery and O’Brien  EWHC 3286, Mr Justice Martin Spencer had to grapple with interesting and unusual facts including the relationship between professional practice and religion, negligence, vicarious liability and what happens when the court in civil proceedings reaches a different conclusion to a fitness to practise tribunal.
The Claimant suffered from a number of physical and mental health problems. She rang Apsley Surgery and received a call back from Dr O’Brien, a self-employed locum. During a lengthy conversation, Dr O’Brien asked the Claimant about her faith, and allegedly said his wife knew a different way of healing without medication. Dr O’Brien and his wife practised a particular form of Christianity. They befriended the Claimant and inculcated her into their faith, their church and their Christian practices. The Claimant’s relationship with Dr O’Brien and his wife broke down after a church meeting at which a speaker allegedly talked about his involvement in witchcraft and about being saved by God from offering up his son as a blood sacrifice. The Claimant alleged she felt suicidal after hearing the account.
Shortly afterwards, at an appointment with a psychiatrist, the Claimant said that Dr O’Brien had advised her to stop taking her medication, including her anti-depressant and her blood pressure medication, and told her “God is her surgeon” and that everything that was wrong with her was due to the Devil”. The psychiatrist reported Dr O’Brien to the GMC.
Dr O’Brien did not attend or participate in the fitness to practise hearing that ensued, so the Claimant was not cross-examined. Almost all of the allegations of misconduct were found proved and the Medical Practitioner Tribunal Service decided to erase Dr O’Brien’s name from the register. Dr O’Brien did not appeal.
The Claimant then sued the Apsley Surgery and Dr O’Brien, alleging, amongst other things, that Dr O’Brien had suggested to her that she was possessed by demons and told her that she should stop taking her anti-depressant medication and blood pressure medication. It was alleged that these were acts of negligence that contributed to a breakdown in the Claimant’s health, and that Apsley Surgery was vicariously liable for this negligence.
At the trial of the negligence claim, the Claimant was cross-examined by counsel for the Surgery, and her credibility was destroyed. Mr Justice Martin Spencer found she “was not a witness upon whom any reliability could be placed”. He contrasted the damages case with the fitness to practise proceedings in which the Claimant had not been subjected to the same cross-examination, including exploring inconsistencies between her evidence and her medical records. Amongst other things, the judge held that when Dr O’Brien telephoned her from his home, the Clamant knew he was not ringing in his capacity as her GP. The judge rejected the allegation that she had been advised to stop taking her medication. The judge also found that Dr O’Brien had compromised his position as a GP by introducing the Claimant to his family and involving her in their spiritual activities.
The judge held that, given Dr O’Brien’s knowledge of the Claimant, he owed her a duty of care not to subject her to the unreasonable and avoidable risk of harm. It was negligent of Dr O’Brien to expose the Claimant to the witchcraft meeting when, given her psychological and psychiatric make-up, it was foreseeable that she might react adversely in the way that she did. By reason of his zealous promotion of religious aspects, he became blind to the medical aspects and thereby caused or contributed to the deterioration in the Claimant’s mental health.
In 2016, the Supreme Court held that vicarious liability in tort could be imposed on a defendant because of the defendant’s relationship with the tortfeasor. There did not have to be a contract of employment to give rise to vicarious liability. It was sufficient if the tort was committed as a result of activity being undertaken by the tortfeasor on behalf of the defendant, and the activity was integral to the defendant’s business activities, so that by employing the tortfeasor, the defendant had created the risk of the tort being committed. In this case, Dr O’Brien’s negligent acts were not part of the business activity of the Surgery: the Surgery was in the business of providing medical assistance, whereas the activities of Dr O’Brien and his wife were religious rather than medical.
Fitness to practise proceedings
If Dr O’Brien had participated in the fitness to practise proceedings, especially with legal representation, one has to assume that cross-examination of the Claimant would have resulted in the most serious allegations against Dr O’Brien being dismissed. His name might well not have been erased from the medical register. As it is, the Tribunal’s decision still stands.
Supreme Court judgment in Lyrica/Pregabalin case
Posted: Wednesday, November 14th, 2018
The Supreme Court has handed down its judgment https://www.supremecourt.uk/cases/docs/uksc-2016-0197-judgment.pdf in a dispute that affects the potential liability for community pharmacies when a drug patent is infringed.
In Warner-Lambert Company LLC v Generics (UK) Ltd  UKSC 56, the claimant alleged that the launch of generic pregabalin infringed its patent for Lyrica. The Lyrica patent was originally granted to protect the use of the drug in the treatment of seizure disorders, notably epilepsy. However, Warner-Lambert were later granted a second patent for the treatment of neuropathic pain. The latter patent remained current after the patent for treating seizure orders had expired. If Warner-Lambert was right in asserting that the latter patent was valid, it would mean amongst other things that any pharmacy or pharmacist who supplied generic pregabalin to a patient who had a seizure disorder would have breached the patent and be liable for substantial damages or loss of profits, even if the pharmacist did not know the condition for which pregabalin had been prescribed.
The Supreme Court dismissed Warner-Lambert's appeal against rulings of the High Court and Court of Appeal. Amongst other things:
- The Supreme Court was very much alive to the risk that, as argued by Warner-Lambert, pharmacists who acted in good faith could be sued for large sums of money for unintentionally breaching a patent (see, eg paragraphs 63 and 65). The court also recognised that this risk would stifle the generics market and pharmacists would not be willing to supply the generic version if there was a risk of being sued.
- The justices gave different reasons (summarised in paragraph 15) for dismissing the appeal. Lord Sumption and Lord Reed were of the view that if the outward appearance (including packaging, labelling and patient information leaflet – see paragraph 84) was presented as suitable for the patented use, a pharmacist who dispensed it for a non-patented use (such as epilepsy in this case) would not be liable for patent infringement. Lord Mance agreed except to the extent that there might be a rare case in which the context made it obvious that the outward appearance should not be taken at face value.
- The result means that pharmacists are now less at risk of being sued for patent infringement, but there is still some risk if the outward appearance of a patented product suggested a use that was not a patented use.
- It is worth bearing in mind that the case was about “second use” patents ie Warner-Lambert already had a patent for Lyrica for the original use, and were seeking to extend it for use in the treatment of neuropathic pain. If there was no second use and the original Lyrica patent was still current for the treatment of seizure disorders, a pharmacist who supplied a generic version could still be sued and the Supreme Court judgment would not remove the liability.
Civil liability of unqualified staff
Posted: Friday, October 19th, 2018
The Supreme Court has handed down its judgment in Darnley v Croydon Health Services NHS Trust  UKSC 50. The claimant, Michael Darnley, had been struck on the head. A friend drove him to the A&E Department at Mayday Hospital in Croydon. The claimant told the receptionist that he thought he had had a head injury and was feeling very unwell. The receptionist said there was a wait of up to four or five hours. The claimant told the receptionist he was feeling too unwell to wait that long. After waiting 19 minutes, he left because he was feeling too unwell to remain, and went to his mother's home. The claimant's condition worsened, and he suffered severe and permanent brain damage because he had not been treated when he first attended the hospital.
The A&E receptionist had failed to inform the claimant that he would be seen by a triage nurse within 30 minutes of arrival. Had he been told this, he would not have left the hospital. At the trial and in the Court of Appeal, the claimant's claim was dismissed on the basis that the receptionist did not owe the claimant a duty of care, and also because there was no causal link between any breach of duty and the injury.
The Supreme Court allowed the claimant's appeal, holding amongst other things that where there a duty of care, it is not appropriate to distinguish between medical and non-medical staff because the Hospital Trust had given the A&E receptionist the role of being the first point of contact for persons seeking medical assistance and, as a result, the receptionist was responsible for providing accurate information about the availability of medical assistance.
The case may have implications reaching beyond the hospital sector because community pharmacies employ counter assistants who may be the first point of contact when patients enter a pharmacy.
Cannabis on prescription
Posted: Friday, October 19th, 2018
The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 will come into force on 1 November 2018.
Following a review prompted by the well-publicised cases of Alfie Dingley and Sophie Dixon in the Summer, the Misuse of Drugs Regulations will be amended so as to allow a medical practitioner who is on a specialist register to prescribe medicinal cannabis as a special.
MHRA consultation on FMD implementation
Posted: Friday, September 21st, 2018
The MHRA is conducting a consultation - open until 23 September 2019 - on implementing the Falsified Medicines Directive, which will come into force on 9 February next year.
PLEA has submitted a response to just one question in the consultation, which asks whether there should be a range of civil sanctions to deal with breaches. Regulations will include criiminal sanctions but these may be appropriate only for the most serious cases. In our response, drawing on an earlier Law Commission paper, we expressed agreement with the proposal to have a range of civil sanctions which are likely to be a more proportionate way to deal with breaches in most cases.
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.