A new defence offering pharmacists protection against prosecution for a dispensing error has come into effect but not everybody is confident it will increase the reporting of errors as Neil Trainis discovers…


After years of tough campaigning and more years than pharmacists care to remember working under the unbearable threat of prison for a genuine mistake, the pharmacy profession finally has a sense of closure. The dark clouds have dispersed. The fear has gone. Or has it?

The intense hope underpinning the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 is that pharmacists will no longer feel they could be prosecuted for an inadvertent dispensing error and will therefore be more comfortable reporting an error should it occur.

The reality is very different. Whilst pharmacy bodies have largely welcomed its passage into legislation, community pharmacists are not so sure the new defence will successfully protect them from prosecution should a case end up in court. Some pharmacists have no confidence in it at all.

On one level it must be deflating for the likes of the rebalancing medicines legislation and pharmacy regulation programme board, All-Party Pharmacy Group, National Pharmacy Association (NPA) and Royal Pharmaceutical Society (RPS) who for years have rigorously campaigned for decriminalisation to hear legal experts from Charles Russell Speechlys (CRS) pick holes in the ‘defence.’

Its head of pharmacy Noel Wardle has been a vocal sceptic of the defence’s ability to stave off the threat of prosecution for an inadvertent dispensing error, going as far as to suggest the defence does not decriminalise errors per se but offers protection to pharmacists who commit a dispensing error only in certain situations.

In Wardle’s view protection is not automatically guaranteed because a pharmacist would need to fulfil various parts of the statutory defence and there is scope for ambiguous interpretation of terms within the legislation such as ‘supervision’ and ‘dispensed’ (see the section ‘the new defence in action’ below).

David Reissner, a partner and expert in pharmacy law at CRS, took to Twitter to express his reservations about the defence and called on the pharmacy minister Steve Brine and Crown Prosecution Service to publicly allay the fears of the pharmacy profession over potential prosecution.

When asked if he thought the defence would encourage pharmacists to report errors, he tweeted: “Tough question. Not much increase in reporting, I suspect. What’s needed is a statement from @cpsuk @BrineMinister that pharmacists won’t be prosecuted unless etc.”

In another tweet Reissner said: “The @cpsuk has guidance on prosecuting #pharmacy #dispensing errors. I’m not convinced they are followed. New guidance now needed to reflect the new statutory defences.”

Caution that decriminalisation’s realisation has been exaggerated has been laced with a sense of irritation that pharmacy leaders have perpetuated that illusion.

“Statements from some senior leaders in our profession have given the impression that decriminalisation of inadvertent dispensing errors has now taken place and that pharmacists are no longer at risk of prosecution as a result of this legislation. We are very clear that this is not the case,” said Mark Koziol, chairman of the Pharmacists’ Defence Association (PDA).

He wrote to Brine in March to express his disquiet that the new defence focused on just section 63 and 64 of the Medicines Act 1968 and not other areas of medicines legislation where the risk of prosecution as a result of an inadvertent dispensing error remained.

Koziol would go on to criticise the rebalancing board, berated by some for being something of a closed club lacking transparency, for its inability to “provide a wide ranging and appropriate amendment to the law” and failure to engage with more stakeholders.

“The board did not seek the widest possible support or contribution from the sector, including refusing to adequately involve the very organisation that has responsibility for and considerable expertise of defending pharmacists who are facing prosecution or regulatory sanction,” he said.

“For comparison, we could not imagine that the (Department of Health and Social Care) or any other delegated board charged with responsibility with making similar changes affecting the medical profession would do so without engagement with the Medical Defence Unions.”

Koziol also told Brine in his letter that he could not advise his members to report errors “without also making them aware of the continuing risks.”

Perhaps unsurprisingly the feeling among community pharmacists was not one of encouragement. Or hope. Or optimism. The defence had not assuaged their fears. And they do not believe it will assure pharmacists enough to report errors.

What do community pharmacists think?

Amish Patel from Hodgson Pharmacy in Kent told Pharmacy Business: “No, I do not feel comfortable with the new defence and its ability to protect pharmacists from prosecution. The wording is very vague, and as presented extremely well at the Sigma conference (in Borneo this year) by David Reissner, it is a matter of perspective of the judge on the day following a defence and prosecution. It feels as though it will be harder to prosecute but equally harder to defend should the situation arise.

“I do not feel errors will be reported any more. We have the option to report anonymously, and yet it is perceived that under-reporting takes place. If under-reporting is true, could it be due to other factors, eg, people don’t have the time, people are not aware of the requirement or keep it at the forefront of their mind with everything else they have to do?”

Peter Kelly, a community pharmacist based in London, said: “From reading it and from the changes that were made, I don’t think that the culture will change. I think if someone isn’t reporting errors now, this law isn’t going to reassure them enough to start doing it.

“I don’t think this law is going to have any change on how people are practising. If there are some people who are reporting errors at the moment because they feel that learning from errors is to the greater good and they are philosophical about the law, I think they will carry on.

“If there are people who don’t currently report errors because they are worried about the law, I don’t think this is going to reassure them.”

When asked why he thought the new defence will not reassure pharmacists to report errors, he said: “Because it’s quite vague and it still doesn’t sound like we’ve got rid of the blame game or that you’re not going to get prosecuted for errors. We’re not from a law background and I’m very confused.”

He added: “We are not really going to know how this law will work in practice until there is a couple of cases. I don’t think anyone is going to change their behaviour until they see a couple of cases.

“Now if there are cases that were similar to the past where the pharmacist got convicted but in this instance didn’t get convicted because of how this new law is implemented, then that would change (pharmacists’ behaviour.)”

Altaf Vaiya from Alpharm Chemist in Leicester said: “I am glad we have a new law on dis-pensing errors, however I still believe the new law falls short of offering full protection to pharmacists.

“The new law has stated that it will not remove the fear of prosecution because dispensing errors that harm patients will still be a criminal offence.”

When asked if he thought the defence will encourage reporting of errors, he said: “If pharmacists report errors they may not be prosecuted but there could be a possibility of fitness-to-practice proceedings being brought by the General Pharmaceutical Council (GPhC) which will still cause fear to many pharmacists and pharmacy technicians.

“Hopefully as this law gets into motion we can see if there is a greater uptake on error reporting and we will see what the outcomes are and what learning the profession can make from increased reporting of error. This in due course should lead to better clarity for the profession.”

What do the pharmacy bodies think?

Pharmacy bodies queued up to welcome the new defence as a kind of panacea to pharmacists’ non-reporting of errors.

Gordon Hockey, director of operations and support at the PSNC, said: “Pharmacies have been required to record patient safety incidents in an incident log and report these to the National Reporting and Learning Service since 2005 but now pharmacy professionals can be reassured that when they do report these incidents, generally they don’t need to fear legal repercussion for making inadvertent errors.

“PSNC welcomes this legal protection which we hope will allow the profession to instead focus on ensuring that safeguards are in place to minimise errors and identify areas for improvement.”

Glyn Walduck, head of claims at the NPA, said: “Over the years we have seen a number of prosecutions under section 64 of The Medicines Act which have resulted in some pharmacists being unfairly convicted under a strict liability offence for making inadvertent dispensing errors.

“Criminal sanctions in such circumstances are disproportionate so we believe this new defence is a welcome and significant step forward. The change should enable prosecutors to use section 64 only in the most reckless cases, thus promoting fairness, proportionality and importantly, enabling the profession to continue on the path of openness and learning from mistakes.”

Robbie Turner, director of England at the RPS, said: “I really hope it does (encourage reporting of errors) because for us to maintain and develop a safety culture within pharmacy, one of the significant barriers was the threat of automatic criminalisation for dispensing errors.

“That was a threat that hung over every pharmacist every single day of their career and I remember being a pharmacist and being petrified of making a dispensing error, both the impact that would have on the patients who I knew really well but also on my on career, my livelihood and perhaps my liberty as well.

“We too often saw pharmacists who were trying their best and doing fantastic work being criminalised because of a genuine mistake and it was important that wasn’t allowed to carry on. The RPS has been instrumental in ensuring this was kept at the top of the agenda for politicians and policy-makers across a range of political parties and coalitions and we are pleased we have got to a place that was much better than the place we were at not so long ago.

“As a professional who has practised under the old regulations of being automatically criminalised to now having a defence that means I will not automatically be criminalised I think is a really positive step forward. Pharmacists can have more of an assurance now that they will have a defence that enables them to practice in a way that enables them to report errors and be able to learn from errors which will enable them to be less stressed about doing that.”

When pressed to say if he thought rather than hoped the defence would encourage pharmacists to report errors, Turner said: “I think it will because so many of my colleagues have described to me the reason why they don’t report is because of the threat of automatic criminalisation.

“We are governed by a board of elected pharmacists all of whom are practising pharmacists many of whom work in community pharmacy and they describe to me their current working environment, they have described to me the continued threat that the automatic criminalisation for dispensing errors had on them and the impact that had on them being able to confidently report errors.

“So we have removed one of the significant barriers to reporting errors, so I hope in a positive way that is accepted by pharmacists and they see this enabling them to reflect on errors, learn from them and help their colleagues learn from them.”

Mandeep Mudhar, director of marketing at Numark, described the defence as “a positive step forward in protecting pharmacists from errors that are not as a result of negligence or significant and catastrophic breakdown in pharmacy processes.”

However, he added: “That said we recognise that there needs to be more transparency of exactly what protection pharmacists will receive should an error occur. An untenable situation would be that pharmacists still feel vulnerable irrespective on the steps taken to safeguard them from prosecution and result in them feeling anxious to report errors that occur.”

When asked if he thought the defence will encourage more reporting Mudhar said: “We would like to believe that all pharmacists will act in the interests of their patients and there-fore understand the importance of error reporting. Further, we believe the new defence should encourage wider reporting of errors. However whether that materialises remains to be seen.”

When asked if he was concerned that some Numark members will be reluctant to report errors given the defence’s lack of clarity on some points, he said: “No more concerned than prior to the defence coming in. If anything, whilst lack of clarity on some points, what is clear is that if a pharmacist is following appropriate procedures and reporting errors as soon as they occur and informing the patient immediately then this surely should be enough to avoid prosecution under the terms of the defence as stated.

“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.”

What does pharmacy’s regulator think?

A sense of relief tinged the words of GPhC chief executive Duncan Rudkin as he spoke about the defence and the likelihood it will boost error reporting.

“We have advocated for this change in the law for a number of years and are delighted that it is now in effect. This should help bring real improvements to patient safety, by encouraging improved reporting and learning from errors by pharmacists and pharmacy technicians working in registered pharmacies,” he said.

“We understand a consultation will begin shortly on introducing the same defences for dispensing errors made by pharmacists and pharmacy technicians working in settings other than registered pharmacies, and we are keen to see this change to legislation made at the earliest possible opportunity.

“We know there are already a number of local and national initiatives across England, Scotland and Wales to encourage reporting and learning from errors, which are making a difference. We would encourage everyone working within pharmacy to play their part to contribute to a culture of greater openness and learning, to improve the care people receive.”

Trying to alleviate concerns pharmacists have over potential action by the GPhC, Rudkin added: “We recognise that the possibility of action by the regulator can also deter people from reporting errors. It is important to emphasise that single dispensing errors would not in our view constitute a fitness-to-practise concern unless there were aggravating factors.”

The long-awaited new defence for dispensing errors is aggravating many within pharmacy at present. One wonders how many pharmacists will have reported errors 12 months from now. Are lingering concerns over prosecution justified?

Only time will tell.

The new defence in action

There will be a defence to breaches of section 63 (adulteration of medicinal products) of the Medicines Act 1968 if it is established;

• The person who adulterated the product is or was supervised by a registered pharmacy professional who was acting in the course of his or her profession.
• The adulteration must have taken place at the registered pharmacy.
• If the product has been sold or supplied, it must have been sold or supplied in pursuance of a prescription or direction or under arrangements for the emergency supply of prescription only medicines.
• If an appropriate person becomes aware of the problem, they promptly take all reasonable steps to ensure the patient is notified.

There will be a defence to breaches of section 64 (protection of purchasers of medicinal products) of the Act if it is established;

• The product was dispensed by or under the supervision of a registered pharmacy professional who was acting in the course of his or her profession.
• The dispensing must have taken place at the registered pharmacy.
• The sale or supply must have been in pursuance of a prescription, or directions in the case of a sale, or be an emergency supply of prescription-only medicines in circumstances where a prescription could not be obtained without undue delay.
• If an appropriate person becomes aware of the problem, they promptly take all reasonable steps to ensure the patient is notified.

Source: www.legislation.gov.uk