Northern Irish pharmacist Martin White made headlines last year when he was served a suspended custodial sentence for mistakenly dispensing propranolol instead of prednisolone, leading to the tragic death of one of his patients.
Unsurprisingly, the news sent shockwaves around the sector. It was a difficult reminder that a simple, one-off mistake can result not only in harming a patient, but also a conviction for the pharmacist. It is, quite simply, every pharmacist’s worst nightmare.
There have been three cases of dispensing errors that resulted in prosecutions in the UK since 2008, and one that resulted in a caution.
An appeal of the original conviction of Elizabeth Lee, who was given a suspended custodial sentence for making the same dispensing error as White, resulted in a clarification of the Medicines Act. However, prosecutions under the Act are still possible.
Despite this, few would argue that the law as it stands should remain. The Department of Health (DH) has expressed its intention to decriminalise inadvertent dispensing errors for several years and is doing so through its Rebalancing Programme Board. But progress has been slow.
With pharmacists’ livelihood at stake every time they hand over a prescription to a patient, it’s high time the law was changed. The Pharmacist investigates the effect that fear of breaking the law is having on pharmacists and why legislative reform has yet to materialise.
What is the law?
When questioned by The Pharmacist, the DH said it will legislate for decriminalisation ‘at the earliest opportunity’.
In 2015, the DH proposed a defence for pharmacists under Sections 63 and 64 of the Medicines Act 1968. Its intention was to remove the threat of criminal sanction for inadvertent dispensing errors, while retaining the criminal sanction for errors where pharmacy staff were not ‘acting professionally’.
The defence was consulted on, but no change in law has happened since. It said it hoped to produce something else by spring 2017, but Ken Jarrold, chair of the Rebalancing Programme Board, has previously said it is more likely to be the autumn at the earliest. But while the Government continues to stall on changing the law, pharmacists are having to live with the reality of running the risk of a criminal conviction simply by turning up to work.
Al Patel, a pharmacy owner from Lewisham, south London, speaks for all pharmacists when he describes how worrying the prospect of making a mistake is. It is ‘very scary’, he says, to think about what steps could be taken against you – whether that be regulatory or criminal action or an investigation by your clinical commissioning group (CCG).
‘Obviously there are a number of steps you can take to minimise errors, but they do still happen,’ he says. ‘It’s an unpleasant situation for the pharmacist.’
For Patel, the prospect of the aftermath of making a dispensing error is a terrifying one, and has the potential to impact on his general wellbeing as well as his career. ‘You can have sleepless nights; you can’t concentrate throughout the day,’ he says. ‘It can actually affect you even more than your [busy] day-to-day routine [in the pharmacy].’
Dispensing errors – offences against Section 63 or 64 of the Medicines Act – are absolute offences with no ‘due diligence’ defence. Prosecution of a pharmacist for the supply of incorrect medication may seem
a measured course of action to protect the public. But, it might in fact be counterproductive.
Owing to the seriousness of a criminal conviction, the law as it stands arguably has the potential to stifle the profession’s ability to learn from dispensing errors.
Everyone agrees this is far from ideal. A DH spokesperson says: ‘Encouraging pharmacists and their teams to come forward when they do make dispensing errors means that patients get better, safer care, and pharmacy professionals will learn from errors and prevent them from happening again.
‘We are committed to putting in place a defence for inadvertent dispensing errors, and will bring forward the relevant legislation at the earliest opportunity.’
The Government’s proposals on this issue would provide a defence for inadvertent dispensing errors in registered pharmacies, predominantly in community pharmacies, provided certain criteria are met.
According to a DH consultation in 2015, these conditions would include showing they had acted ‘in the course of [their] profession’, had made a supply on the back of a prescription or patient group directive (PGD), and ‘promptly’ informed the patient about the error once it had been discovered.
Criminal sanctions should only apply if there is proof ‘beyond reasonable doubt’ that the pharmacist either misused their professional skills ‘for an improper purpose’, or showed ‘a deliberate disregard for patient safety’. Failing to follow the pharmacy’s procedures would not constitute grounds for criminal proceedings on its own.
General Pharmaceutical Council (GPhC) chief executive Duncan Rudkin says that the organisation wants to ‘encourage a culture of openness… whenever adverse incidents occur’. Giving pharmacists ‘further reassurance and clarification in relation to the extent of criminal liability’ is ‘key’ to this, he adds. ‘Anything that acts as a disincentive to the disclosure of adverse incidents, including dispensing errors, is detrimental to public safety.’
‘Not in the public’s interest’
The GPhC is not alone in wanting to see changes to the law. ‘It isn’t appropriate to prosecute healthcare professionals for making a simple error,’ says pharmacy law expert, Noel Wardle.
Wardle, a partner at law firm Charles Russell Speechlys, continues: ‘Where it’s simply an error, it’s not the sort of situation where the criminal law should step in.’
For Wardle, it is unnecessary that dispensing errors are considered a criminal offence when pharmacy’s own regulatory body does not even view it as a fitness-to-practise matter, unless it is a reocurring incident.
‘If you look at the GPhC’s threshold criteria for referring cases for fitness-to-practise consideration, one-off dispensing errors are excluded and do not come within the threshold criteria, save where it relates to controlled drugs or there has been a serious injury or death as a result.
‘It isn’t the sort of case that it is in the public interest to pursue under the CPS guidance.’
As Wardle points out, patients who are dispensed the wrong drug by a pharmacist and injured as a result are already financially compensated, meaning that turning it into a criminal matter is unnecessary.
However, this is different if the dispensing error results in death.
‘There is the separate criminal offence of manslaughter, which is investigated when a patient dies as a result of an error.
‘It doesn’t have to be investigated as a dispensing error; it can be investigated as manslaughter.
‘For a prosecution for manslaughter to succeed, the prosecution has to satisfy the court – the jury – that the error was grossly negligent, and so far below the standard that you would expect of a reasonably competent pharmacist that it was criminally negligent.’
Delays to progress
If the law itself seems fraught with complications, it’s nothing compared with the way in which the Government is going about decriminalising dispensing errors. For Wardle, this could go some way to explaining why the change in law has seen delays.
‘The Government could deal with it incredibly quickly if they just removed these offences from the Medicines Act or disapplied them to supplies made by pharmacists,’
‘But the Government wants to restrict the statutory defence to apply only in certain circumstances.
‘Because it’s decided that it wants to do that, it means that the Rebalancing Medicines Committee has to try and work out a statutory defence that is workable and amounts to a defence, but also secures the Government’s aim of not decriminalising errors just because they’ve been made in a pharmacy.
‘So the committee is trying to walk that fine line, and in fact it has found, I think, that the fine line is virtually impossible to walk.
It came up with a statutory defence a couple of years ago that was so complicated that it was not far off meaningless in terms of its applicability, because it wouldn’t give pharmacists certainty that they would have
a defence if they made an error, so it wouldn’t remove that worry. Pharmacists would still be at risk of prosecution.
‘I think the Government is scratching its head over to what to do now.’
Rebalancing Programme Board
The Government’s Rebalancing Programme Board has been ‘working extensively’ on
a review of the legislation around inadvertent dispensing errors in registered pharmacies, and has developed proposals that received a high level of support in the recent public consultation, the DH said.
Despite this ‘extensive work’, however, the updated legislation has yet to materialise.
Chair of the board, Ken Jarrold, recently said: ‘It is in the interests of patients and the public that this matter is resolved, and we want to play our part in that resolution.
‘The process to gain final clearance of the dispensing error proposals for pharmacy professionals working in the community sector continues to move forward.’
The planned change to the law has been continually delayed since it was first announced two years ago, but the board said it ‘still expects’ that the change will ‘be laid in the UK and Scottish parliaments soon’.
But for pharmacists working at the front line, ‘soon’ simply isn’t good enough. Wardle suggests that making sure the Government implements the case appropriately is as important as seeing the changes go through quickly. ‘I hope it’s not the case that it’ll never happen. But I hope when it does, it’s done in a sensible and productive way.’
There is plenty of support for changing the law, but with such a complicated process to navigate before it happens, it remains to be seen how far off the decriminalisation of dispensing errors really is.
Until the law changes, however, more pharmacists like Patel will be driven to sleepless nights worrying over whether they’re really sure that they dispensed the right medication that day. It’s up to the Government to push ahead with the new legislation and prove that it values the wellbeing of pharmacists just as much as it does the patients the Medicines Act is designed to protect.
Pharmacist – Mihaela Seceleanu
Dispensed wrong patient’s prescriptions
Cautioned under the Medicines Act
Pharmacist – Martin White
Co. Antrim, Northern Ireland
Dispensed propranolol instead of prednisolone
Four-month sentence, suspended for two years
DH held consultation on proposed defence
Crown Prosecution Service legal guidance published
Locum pharmacist – Elizabeth Lee
Dispensed propranolol instead of prednisolone
Three-month sentence, suspended for 18 months
Pharmacist – Juliet Hines and dispensing assistant – Georgina Mahoney
Dispensed sertraline instead of spironolactone
Hines was fined £1,800 and Mahoney £500
Advice in a crisis
Pharmacy lawyer Noel Wardle says that the best thing to do when
a dispensing error occurs is:
• Be open and honest about the error.
• Accept responsibility if you have made an error.
• Do as much as you can to put things right. That includes, for example, speaking to the patient, the prescriber, and the pharmacy team.
• Complete an error report.
• Investigate as thoroughly as you can to see why the error occurred.
• Alter both your own practice and the pharmacy’s practice to reduce the risk of repetition.