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Medicines regulation and law

Defence clause may not equate to decriminalisation

New proposals seek to end the threat of prosecution for inadvertent dispensing errors but there are concerns that pharmacists will not be fully protected when they make an honest mistake.

Pharmacy organisations have pushed for the decriminalisation of dispensing errors for years, however, the latest changes in the law do not fully protect pharmacists. Elizabeth Lee, a pharmacist, was prosecuted at the Old Bailey (pictured) in 2009.

Source: UK City Images / Alamy

Pharmacy organisations have been actively pushing for the decriminalisation of dispensing errors since the Lee case, which was heard at the Old Bailey in 2009

What the threat of criminal prosecution for an inadvertent dispensing error can actually mean for a pharmacist was brought home sharply when Elizabeth Lee stood in the Old Bailey in April 2009 and received a three-month suspended prison sentence for putting a dispensing label intended for prednisolone on to a packet of propranolol instead. Lee, who was working at a Tesco pharmacy in Windsor at the time of the error, had been charged with two offences under the Medicines Act 1968: attaching the wrong label (Section 85.5) and providing the wrong product (Section 64.1). Lee was found guilty of the first offence and the second charge was suspended.

A pharmacist with seven years’ experience, Lee appealed her conviction at the High Court and the judges ruled that attaching the wrong label was technically an offence that could only have been committed by the owners of pharmacy businesses and not by the staff or locum pharmacists who worked there. Her sentence was reduced to a £300 fine.

Lee decided not to further appeal her criminal conviction. The ordeal had taken its toll; she had made a decision never to work as a pharmacist again, resigned her membership from the Royal Pharmaceutical Society of Great Britain, and began working as a church cleaner.

“The threat of criminal prosecution for dispensing errors has weighed heavy on pharmacists for too long,” says Ash Soni, president of the Royal Pharmaceutical Society (RPS), one of several pharmacy organisations campaigning to have the law changed. “The knock on effect has been a reduction in the potential reporting, sharing and learning from errors.”

Sir Kevin Barron, a UK Member of Parliament and chair of the All-Party Pharmacy Group, an informal cross-party group of MPs, agrees. “For too long pharmacists have been singled out as the only health professionals who risk criminal charges and conviction for making an honest mistake.” Barron argues that the current state of affairs compromises patient safety by discouraging error reporting and preventing learning opportunities.

A literature review[1] into the incidence of dispensing errors reports data that suggest community pharmacists make a dispensing error with up to 3.32% of medicines dispensed, while doctors have a prescribing error rate of 5% in general practice and 7% in hospitals. Rather than being evidence of safe practice, the lower error rate for pharmacists could result from pharmacists not reporting incidents for fear of prosecution.

Since the Lee case, there have been two other cases of dispensing errors reported in the national press — one at a Jhoots Pharmacy in Bristol and another at a London branch of Tesco. No pharmacist has had criminal charges brought against them in either case, but the threat of prosecution remains.

The Lee case caused consternation among the profession of pharmacy, and prompted pharmacy organisations to lobby to have the offences relating to dispensing errors removed from the statute books.

In February 2015, the four UK health departments, on behalf of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, published proposals that are meant to do just that.

The proposals have been widely welcomed, but lawyer Noel Wardle, a partner at Charles Russell Speechlys LLP in London, has warned that pharmacists will remain vulnerable to prosecution for inadvertent dispensing errors under the “horrendously complicated” proposals and other regulations on the statute book. “Pharmacists can’t be sure still that they won’t have committed an offence if they have made a dispensing error,” he says. “There may still be things to argue over.”

The UK government hasn’t proposed to decriminalise dispensing errors, explains Wardle, it will instead introduce a defence against prosecution under Sections 63 and 64 of the Medicines Act 1968. Some of the conditions that need to be met for this defence to apply seem unnecessary and the wording of other conditions vague, which could leave some pharmacists exposed, he says. Furthermore, two offences will still remain in the Human Medicines Regulations 2012 that are not being amended and could be applied to dispensing errors, he adds. The possible sentence for these offences is a two-year prison term.

But putting these concerns aside, if the proposals do become law, some pharmacists who make inadvertent dispensing errors will no longer automatically face the prospect of a criminal prosecution under Section 64.1. Instead, these dispensing errors will be dealt with as a fitness-to-practise issue by the pharmacy regulator — the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland (PSNI) — which would determine what, if any, action is to be taken.

The proposed changes form part of broader proposals for a rebalancing of criminal law and professional regulation in pharmacy, a process that began in October 2012. These long-awaited proposals would also allow the two pharmacy regulators to set general standards rather than set rules for registered pharmacy premises.

Before the proposals can be enacted, however, Parliament must approve two draft orders: the Pharmacy (Preparation and Dispensing Errors) Order 2015 and the Pharmacy (Premises Standards, Information Obligations, etc.) Order 2015. Details of the orders are set out in the consultation document, ‘Rebalancing Medicines Legislation and Pharmacy Regulation’, and the consultation runs until 14 May 2015.

The proposals were developed by an independent board, which includes representatives of pharmacy organisations such as the RPS, the GPhC and Pharmacy Voice, chaired by Ken Jarrold. As well as dispensing errors and premises standards, the board was asked to examine the legislative and regulatory framework for pharmacy owners, superintendent pharmacists and responsible pharmacists (registered pharmacists in charge of a registered pharmacy) to provide greater clarity on their roles, accountabilities and competences. Recommendations on these will follow at a later date, says the consultation document.

Promoting a duty of candour

Pharmacy organisations have been actively pushing for the decriminalisation of dispensing errors since the Lee case. But it was inquiries into safety scandals at an NHS hospital in Mid-Staffordshire that made recommendations — including creating a culture of openness and learning — that seemed to have made the difference.

The Berwick report[2] — ‘A promise to learn — a commitment to act: Improving the safety of patients in England’ — says “errors are not misconduct and do not warrant punishment”, and the Francis inquiry report[3] — ‘Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry’ — calls for a statutory duty of candour to be placed on NHS providers and organisations. However, that duty of candour and a requirement in the 2014–2015 contract between community pharmacies and the NHS in England requiring all errors “that did or could have led to patient harm” to be reported to the National Reporting and Learning Service (NRLS) clearly put pharmacists at risk of a criminal sanction when followed for dispensing errors.

The proposals were developed by an independent board, including representatives of pharmacy organisations, chaired by Ken Jarrold.

Source: Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board

Ken Jarrold chaired the independent board that put forward the proposals

The defence

The proposals are not intended to remove completely the threat of prosecution for dispensing errors. Criminal sanction would be retained for “errors or deliberate acts that are such that the pharmacy professionals responsible for them cannot properly be said to have been acting professionally”.

The Pharmacy (Preparation and Dispensing Errors) Order 2015 includes a new defence to prosecutions under Section 64 (supply of medicines) and Section 63 (a similar clause which relates to preparation of medicines) of the Medicines Act 1968 when certain conditions are met: the medicine was dispensed by a registered pharmacist or registered pharmacy technician, or by someone acting under their supervision; the pharmacist or technician was acting in the course of their profession; the medicine was dispensed from registered premises; the sale or supply of the medicine was in pursuance of a prescription or directions, such as a patient group direction; and, if the error was discovered before the defendant was charged, there was prompt notification of the error.

Patient safety

Civil action for compensation will still be available in the case of an error that causes harm to a patient, explains Joy Wingfield, a pharmacist and honorary professor of pharmacy law and ethics at the University of Nottingham. “Unacceptably lax or reckless care that causes death can still be the subject of a charge of criminal negligence manslaughter with possible prison sentences, and deliberate errors will still be caught by the existing law,” she says. “The new law will expect pharmacists to tell patients about mistakes that may affect their care so that immediate remedies can be put in place.”

Being able to analyse dispensing errors by pharmacists alongside prescribing errors by doctors and administration errors by nurses would give a wealth of information on why errors occur, what safeguards could reduce them and restore confidence in “our battered health service”, she adds.

Arti Shah, a solicitor at FieldFisher, says that the draft orders to decriminalise dispensing errors are a good attempt to increase transparency, particularly in the light of the Francis report.

From a medical negligence point of view, instead of a proving a strict liability test, as for other health professionals, it will be a balance of probabilities test that will need to be proven, she explains. This means showing that there has been a breach of duty (i.e. that the care fell below a reasonable standard) and the action caused harm.

Shah acted for a patient in a recent dispensing error case against Tesco. In August 2011, “Mrs J” was prescribed seven tablets per day of alfacalcidol 0.25mg after her thyroid was removed. She received 39 boxes of alfacalcidol from a Tesco pharmacy, but they were 1mg rather than the 0.25mg prescribed. Within a few weeks she was admitted to hospital with hypercalcaemia leading to acute renal failure, causing dehydration, vomiting, confusion and hallucinations. She issued proceedings against Tesco and a financial settlement was agreed.

Relatives of patients who have been harmed by dispensing errors are not so welcoming of the proposals.

Tammy Haskins, whose mother Dawn Britton died following a dispensing error in 2013, asserts that it is “a ridiculous argument” to say that removing the fear of prosecution will reduce the number of dispensing errors made by pharmacists.

In August 2013, Dawn Britton was given gliclazide tablets by a locum pharmacist at Jhoots Pharmacy in Bristol instead of prednisolone, which she took for Crohn’s disease and breathing difficulties. She was later found unconscious at home by her son and died in hospital the following month from hypoxia caused by hypoglycaemia.

“Surely if there are no sanctions then procedures will become slacker,” Haskins says. “Safeguarding patients using these services should prioritise over the persons providing it.

“In my mum’s case, the CPS [Crown Prosecution Service] decided it was not in the public interest to prosecute the pharmacist, even though there was a dispensing and labelling error.”

Haskins says it should be “compulsory to have two people checking medication before dispensing”.

Renu Daly, a clinical negligence solicitor handling the Jhoots Pharmacy case at Neil Hudgell Solicitors, says of the proposals: “Little has been done to ensure that such [dispensing] errors, which the consultation document seeks to decriminalise, are prevented in the first place.

“In a profession where there is no clear policy regarding the standard to which all pharmacists must adhere to, and a locum pharmacist may legitimately follow their own standard operating procedures (SOPs) without having to conform to those already considered accepted practice within a pharmacy, it means such an individual may be effectively unregulated,” she says.

“Until the process of ensuring the safe supply of medication is better regulated, it will only seek to protect the individual pharmacist and will have a very limited impact on the protection of the public.”

But Wardle thinks the proposals do not go far enough. “Why you would deal with a couple of the potential criminal offences and not the others when the consequences for the pharmacist are the same I don’t understand,” he says. “Unless you are going to do the whole thing, I think this is all a bit pointless.”

Wardle also expresses concern that the proposed changes include “a complex set of rules which the court would have to apply when considering whether a pharmacist was ‘acting in the course of their profession’, which means that a pharmacist could not be sure that his actions would come within the scope of the defence”.

The condition that the dispensing error must have occurred on registered pharmacy premises is also “unnecessary”, Wardle says, because there is already an offence under the Human Medicines Regulations 2012 when the sale or supply of a prescription medicine does not occur on registered pharmacy premises (Regulation 220 of the Human Medicines Regulations). The inclusion of this condition in the new defence precludes most hospital pharmacists from applying it, because few hospital pharmacies are registered premises (see ‘Exceptions to the rule’).

The final condition listed in the defence relates to a duty of candour for pharmacists. The consultation document says that notification of a dispensing error would be deemed unnecessary in certain situations, such as: when the error is trivial; when notification would do more harm than good; or when the patient is already receiving treatment for the consequences of the dispensing error.

These criteria are vague, says Wardle, and it is not absolutely clear how a judgement of whether a notification is necessary should be made. “It is not entirely clear that you would be off the hook if you didn’t notify,” he says.

Risk posed by other legislation

Regardless of the wording of the new defence, Wardle points out, there are still two other offences under the Human Medicines Regulations that leave pharmacists open to prosecution when a dispensing error occurs — supplying a prescription only medicine without a prescription (Regulation 214 (1)) and supplying a medicine not labelled correctly (Regulations 258(1) and 269(2)).

“My reading of the Human Medicines Regulations is that dispensing errors are still criminal offences if the supply is made of a prescription-only medicine except in accordance with a prescription,” Wardle says.

And Wardle warns that the original offence that Elizabeth Lee was convicted of — that of failing to label a medicine correctly when she applied a label to the wrong product — also remains a statutory offence with no criminal defence.

Exceptions to the rule

Most hospital pharmacies are not registered as pharmacy premises. As a result, the proposed defence would not apply to pharmacists working within hospitals. However, the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board is exploring the possibility of whether, instead of requiring hospital pharmacies to be registered, the governance element of the defence could be captured by having a requirement that hospital pharmacy services must be under the direction of a pharmacist.

The consultation document also highlights that pharmacy owners and supervising pharmacists will not be able to rely on ignorance of an error as a defence. The liability “is intended to create a powerful incentive” for owners and supervising pharmacists to remain on top of what is happening.

President of the Royal Pharmaceutical Society Ash Soni says that this should not be an issue for supervising pharmacists and pharmacy owners “if you do the job the way it is designed to be done”. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067984

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  • The proposals were developed by an independent board, including representatives of pharmacy organisations, chaired by Ken Jarrold.

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