DECRIMINALISATION


ElIzABEtH lEE CASE the initial DH consultation came on the back of the 2009 case of Windsor pharmacist, Elizabeth lee, who stood trial at the old Bailey in April 2009.


Ms lee had erroneously put a dispensing label intended for prednisolone onto a pack of propranolol and she was subsequently charged with two offences under the Medicines Act 1968: attaching the wrong label and providing the wrong product. lee was found guilty of the first offence, while the second was suspended. She received a three-month suspended prison sentence.


following the trial, lee appealed her conviction and her sentence was subsequently reduced to a fine. the whole experience had, however, taken its toll and she left the profession to work as a church cleaner.


the Rebalancing Programme Board was also uppermost in the mind of Community Pharmacy northern Ireland Chief Executive, gerard greene, who not only stressed that the entire situation had been ‘devastating for all concerned’ and that ‘the thoughts and sympathy of everyone in the pharmacy profession go out to the patient’s family circle’, but also acknowledged that ‘as fellow pharmacists, ‘we also understand the devastating effect this will have had on Martin’.


‘these tragic circumstances bring into sharp focus the need to expedite the Rebalancing Medicines legislation work being led by Ken Jarrold,’ greene added, ‘to put in place a defence to the criminal sanction for inadvertent dispensing errors.’


green’s comments refer to the work that’s currently being done by the Rebalancing Medicines legislation and Pharmacy Regulation Programme Board regarding changes to the legislation to distinguish between dispensing errors where a pharmacist deliberately misuses their skills for an improper purpose, such that there is risk of harm to patients, and inadvertent dispensing errors (human error).


Pif asked Ken Jarrold CBE, Chair of the Board, for his comments on the ‘need to expedite’ a defence.


10 - PHARMACY In foCUS


‘the Rebalancing Programme Board have reviewed the legislation related to dispensing errors as a priority and prepared proposals, which received a high level of support in the public consultation,’ Jarrold told Pif. ‘legislation is currently being prepared which we expect to be submitted to the parliamentary process later this year.


‘As chair of the Rebalancing Programme Board, my position has always been that I am committed to putting in place a defence to the criminal sanction for inadvertent dispensing errors, as are Ministers. the case of Martin White is evidence our work is important and we will not abandon our task.


‘our overarching aim has always been and continues to be, to promote a more open culture of transparency and to encourage pharmacists and their teams to come forward and report mistakes, without the fear of being prosecuted.’


gerard greene remains unsure, however, as to whether this defence will come soon enough for the pharmacy profession.


‘the delay in enacting the necessary legislative amendment,’ he told Pif, ‘means that all pharmacists remain exposed to potential criminal prosecution in the event of an inadvertent dispensing error while such action is unlikely for other healthcare professionals who commit similar errors. Unfortunately any legislative change from the rebalancing work will be too late for Martin but for the rest of the profession it is vital these are put in place as quickly as possible.’


While the pharmacy profession holds its breath waiting for dispensing errors to be decriminalised, however, noel Wardle, Partner at Charles Russell Speechlys, points out that the UK government hasn’t actually proposed decriminalising dispensing errors. Rather, he says, it will introduce a defence against prosecution under Sections 63 and 64 of the Medicines Act 1968.


‘Whilst it is not clear from the press reports,’ says Wardle, ‘it is likely that Martin White was prosecuted for a breach of Section 64 of the Medicines


Act 1968. Section 64 states that ‘no person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser’. It is fair to say that Section 64 was enacted at a time when many pharmacists made up medicines in the dispensary and where there was, therefore the risk of adulteration. Section 64 does not really fit with the modern-day pharmacy practice of supplying original patient packs of mass- produced pharmaceuticals, and I doubt it was ever intended by lawmakers to cover the situation where the wrong pack of pills is supplied by a pharmacist in error.


‘Elizabeth lee was also prosecuted for the same offence relating to the same dispensing error back in 2007. She was given a suspended prison sentence, just like Martin White. However, she appealed the sentence. the Appeal Court described the imposition of a custodial sentence (albeit a suspended one) as ‘manifestly excessive’ and replaced it with a fine. It is not clear whether the sentencing judge in Mr White’s case was made aware of the Elizabeth lee appeal.


‘Pharmacists were rightly shocked by the Elizabeth lee case, and demanded decriminalisation of dispensing errors. In 2010, the Crown Prosecution Service in


England published a Code for the prosecution of dispensing errors which effectively ruled out prosecution save in the most serious of cases. However, the Code does not apply in northern Ireland.


‘In october 2012 a Committee was set up by the government to explore the ‘rebalancing’ of medicines legislation. A consultation on decriminalisation legislation took place in early 2015. However, the Committee’s proposals for a statutory defence for pharmacists who make a dispensing error were extremely complicated and were unlikely to be of much comfort to pharmacists. ‘Since the 2015 consultation, the Committee has stated that it is making progress towards decriminalisation, but this has been painfully slow, and, if it happens at all, will sadly come too late to help Mr White.’


CAll to ACtIon fortunately for patients, the incidence of dispensing errors in pharmacy is extremely low. Indeed, in a recent review into the incidence of dispensing errors, it was reported that community pharmacists make a dispensing error in up to 3.32 per cent of medicines dispensed (as compared to gPs’ prescribing error rate of five per cent). Concerns remain, however, that the lower rate for pharmacists is the result of


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