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16 November 2017

Decriminalisation legislation cannot come soon enough

Draft legislation providing a legal defence for community pharmacists who make a dispensing error, if they can show they did not know that the wrong product was being supplied and take remedial steps promptly, has finally been laid before Parliament, but implementation could still be a way off.

On 14 November, an Order was laid before Parliament purporting to introduce a statutory defence to the offence committed when patients are supplied with the wrong prescription medicine[1].

For many years, it has been a source of anxiety and frustration for pharmacists that if they make such an error they could be prosecuted. Unless a patient dies as the result of gross negligence, no other healthcare profession is exposed to prosecution in this way. The Order does not specify the date when the defence will become available — this will happen only when the Privy Council nominates a date in a new Statutory Instrument.

Section 64 of the Medicines Act 1968 makes it an offence to supply a medicinal product that is not of the nature or quality demanded by the purchaser, resulting in injury to the purchaser or patient. The wording in the Medicines Act was borrowed from post-War legislation designed to protect consumers from food adulteration, and perhaps consumers required such protection at a time when rationing was still in force.

This section is not being abolished, and when the Privy Council’s chosen date is reached, it will still be a criminal offence to supply the wrong medicine. But a defendant would be acquitted if he or she proves they did not know that the wrong product was being supplied (this defence applies only to prescribed medicines), and if all reasonable steps are promptly taken after the error has been discovered.

The case of Elizabeth Lee

A decade ago, pharmacist Elizabeth Lee mistakenly supplied a patient, Carmel Sheller, with propranolol when prednisolone had been prescribed. The patient who received propranolol was terminally ill, and collapsed. She recovered in hospital from the effects of the propranolol, but died soon after as a result of her underlying condition.

When Lee appeared before an Old Bailey judge, the judge passed a prison sentence, causing an outcry in the pharmacy profession that was not felt any less keenly because the sentence was suspended. Mrs Lee initially pleaded guilty to the offence, under section 85 of the Medicines Act 1968, for supplying propranolol labelled as prednisolone. On appeal, the conviction for the labelling offence was substituted with a conviction under section 64 of the Medicines Act.

Since Lee’s case, there have been further prosecutions for dispensing errors, and there have been numerous promises to decriminalise errors — but fulfilment of this promise has remained out of reach. The most recent excuse for the delay from Whitehall was that because decriminalisation required the approval of devolved governments, nothing could be done until Northern Ireland had a new power-sharing government[2]. Even now, the defence cannot become law in Northern Ireland until its health department agrees.

Section 64 of the Medicines Act had been used to prosecute pharmacists only on rare occasions up to the time that Lee, who had been working as a locum pharmacist in a Tesco pharmacy, was prosecuted.

Prosecutions for dispensing errors are extremely rare in the experience of any individual judge. His Honour Judge Beaumont, who presided at Lee’s trial in April 2009, may have assumed that because the case was being heard at the Central Criminal Court, where the nation’s most serious cases are dealt with, it was a case of the utmost gravity.

The Court of Appeal heard Lee’s appeal on 26 May 2010. Giving the judgment of the court, Lord Justice Aikens described the prison sentence as “manifestly excessive”, saying: “We accept that what occurred was an error; it was, at worst, an isolated act of negligence… It was a dreadful error which caused Mrs Sheller to collapse. But, as all accept, the error did not, either as a matter of law or fact, cause her death. She died of other, natural, causes.”

Crown Prosecution Service guidance

In June 2010, mindful of the outcry that had followed Lee’s case, the Crown Prosecution Service published guidance for prosecutors in cases where a dispensing error had occurred. In announcing the guidance, the then director of public prosecutions, Keir Starmer QC, said:

“The Medicines Act exists to protect patients from unscrupulous suppliers of medicines and to safeguard public safety from the illegal sale or supply of medicines or any inaccurate and misleading labelling. The Act also provides for a pharmaceutical mistake to be treated as a criminal offence[3].”

The new guidelines said that in addition to considering the public interest when deciding whether to prosecute, prosecutors should weigh up the following factors:

  • Whether the incorrect dispensing was reckless or intentional;
  • The seriousness of the dispensing error; for example, whether the drugs required very careful handling and additional checks to be in place; or whether the dosage was dispensed substantially greater than that prescribed or substantially beyond the usual treatment range;
  • The consequences of the dispensing error; for example, did it lead to death or moderate or severe harm, or did it have the potential to do so;
  • The actions of the pharmacist, pharmacy technician or any other person following the incident; did he or she report the incident and co-operate with the investigation or was there a failure to record or report the error, or evidence that it was concealed;
  • Evidence of other dispensing errors;
  • Whether regulatory or remedial action has been taken or is likely to be taken.

This guidance was intended to be an interim measure pending a review of section 64 of the Medicines Act. The Order that has just been announced is the product of the review referred to by Keir Starmer QC. However, prosecutions have continued in the meanwhile, despite the fact that none of the prosecutions involve pharmacists who could seriously be described as “unscrupulous suppliers of medicines”[4]. Instead, they have all been well-meaning healthcare professionals who made errors that in some cases left them devastated and unable to resume their careers.

A healthcare assistant’s error

Section 64 does not apply only to pharmacists. In 2008, Georgina Mahoney was a healthcare assistant working at a branch of Lloyds. When a patient came in with a prescription for spironolactone, she picked up sertraline from the dispensary shelves and the pharmacist on duty failed to spot the error. The patient took the medication for three weeks. Both the pharmacist on duty and Mahoney were prosecuted. They were fined £2,065 and £270 respectively. Mahoney unsuccessfully challenged her conviction.

At a High Court hearing that took place while Lee’s appeal was pending, Lord Justice Elias said: “One can readily understand why Parliament might have thought it was necessary to impose criminal liability, even on dispensers and others involved in the supply chain, because the consequences of a mistake can be so serious… Moreover, there is an obvious public interest in ensuring that all those whose failings have led to the selling, wrongly, of a product in this way, should be held accountable.”

As recently as December 2016, Martin White was given a four-month suspended prison sentence in Northern Ireland for making exactly the same mistake that Lee had made a decade earlier — a case in which the English Court of Appeal had said a prison sentence was manifestly excessive.

Very recently, the Statutory Committee of the Pharmaceutical Society of Northern Ireland imposed a seven-month suspension from practice on White. Both Lee and White gave up their careers as pharmacists. At the time of her appeal, Lee was working as a cleaner.

While no one can be oblivious to the suffering of patients who receive the wrong medication, or the distress caused to their families, the fact that well-intentioned healthcare professionals make human errors which they, themselves, find devastating, does not seem to be reflected in the way they have been treated by prosecutors and the courts.

Healthcare regulation has been transformed since the prosecution of Lee. The General Pharmaceutical Council (GPhC), formed in the year her appeal was heard, has powers (with Article 56 of the Pharmacy Order 2010) to suspend immediately any registrant if this is necessary for the protection of the public. Following a full hearing, a registrant may be removed from the register if their fitness to practise is found to be impaired.

It has long been clear that prosecution is not the best way to deal with dispensing errors. Judges who have dealt with prosecutions have not appreciated that dispensing mistakes are mistakes: they are not sinister and the public does not require special protection from pharmacists who make human errors. The GPhC’s fitness-to-practise processes are more than adequate to protect the public from pharmacists who make errors, and there is no need for criminal sanctions. However, the imposition of a seven-month suspension on White remains a cause for concern. The purpose of fitness-to-practise sanctions is not to punish pharmacists who make errors. Future cases will depend on their own facts, but it is questionable whether a suspension is appropriate in the case of a simple human error in a long, unblemished career, unless there is reason to believe that patients and the public would otherwise be at risk.

Fitness-to-practise proceedings are, plainly, a better option than prosecutions. When pharmacists have a defence to the criminal offence of supplying the wrong medication, it will at least be a step in the right direction.


This article was written by David Reissner and published by Chemist+Druggist on 15 November 2017. For further information, please contact David on +44 (0)20 7203 5065 or at david.reissner@crsblaw.com.


References:

[1] The Pharmacy (Prevention and Dispensing Errors – Registered Pharmacies) Order 2018. Available at: http://www.legislation.gov.uk/ukdsi/2018/9780111161524/pdfs/ukdsi_9780111161524_en.pdf (accessed November 2017)

[2] Grace Lewis. ‘2 steps’ until errors decriminalised, but NI causing delays. Chemist and Druggist. 4 July 2017. Available at: https://www.chemistanddruggist.co.uk/news/two-steps-until-errors-decriminalised-ni-causing-delays (accessed November 2017)

[3] Crown Prosecution Service. CPS publishes guidance on prosecuting Medicines Act offences where a dispensing error has occurred. 21 June 2010. Available at: http://www.cps.gov.uk/news/latest_news/cps_publishes_guidance_on_prosecuting_medicines_act_offences_where_a_dispensing_error_has_occurred_/ (accessed November 2017)

[4] Ingrid Torjesen. Defence clause may not equate to decriminalisation. 5 March 2015 The Pharmaceutical Journal Available at: http://www.pharmaceutical-journal.com/news-and-analysis/news/proposals-to-decriminalise-dispensing-errors-may-not-prevent-prosecution-for-inadvertent-mistakes/20067984.article (accessed November 2017)

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