The long-awaited defence against prosecution for a dispensing error brought relief to the pharmacy profession. But almost 12 months on, has it encouraged error reporting?

Nearly a year after the pharmacy profession secured a legal defence against prosecution for a dispensing error, there appears to be calm after the storm. Or perhaps quiet anxiety.

Decriminalisation campaigners who battled away tirelessly for years to achieve their objective had hoped that once the threat of prosecution had been eradicated, pharmacists would feel more comfortable reporting errors. Yet the introduction on April 16, 2018 of the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 has not precipitated an avalanche of reports.

As if pharmacists did not need reminding, the legislation provides a defence to prosecution under section 63 and section 64 of the Medicines Act 1968 in cases where medicines are prepared or dispensed by a registered pharmacist, registered pharmacy technician or someone acting under the supervision of a registered pharmacy professional.

Calm may be one way to describe the year since the birth of decriminalisation. Anxious hush may be a better description.

One argument is that it is too early to assess whether the defence has encouraged more reporting but it is nevertheless a question worth asking. There have, after all, been concerns the defence is not much of a defence at all, that it only offers protection to pharmacists who commit a dispensing error in particular scenarios.

In other words, there is no guaranteed protection against prosecution. Legal experts have suggested that numerous parts of the statutory defence need to be met and there is the potential for ambiguous interpretation of words such as dispensed and supervision.

The professional leadership body’s view

Yet according to Royal Pharmaceutical Society (RPS) president Ash Soni, the defence has led to what he described as “a general upwards trend in the number of patient incidents being reported to the National Reporting and Learning System.”

“The threat of criminal conviction for making an honest mistake cast a shadow over the pharmacy profession for far too long,” he told ICP.

“It has now been lifted and patients will benefit as the legislation discouraged error reporting and subsequent learning from mistakes. We have seen a general upwards trend in the number of patient incidents being reported to the National Reporting and Learning System but we won’t have more detailed data on medication until later this year.

“It’s too early to judge if there is a link between this data and the introduction of the new defence, but it’s good to see reporting has increased.”

When asked if any RPS members had approached it in the last year with serious concerns about the defence, he said: “We haven’t had any members contact our professional support team with concerns about the defence and the RPS continues to support its introduction.

“We have no reason to see the defence changed but it will be important to make sure it is working in practice to give pharmacists the protection they deserve and if any areas of concern arise we will take these back to the (rebalancing medicines legislation and pharmacy regulation programme board).”

What do pharmacists think?

Ade Williams, who owns Bedminster Pharmacy in Bristol, believes the defence protects pharmacists against prosecution but was troubled by what he regarded as a lack of awareness about its impact on pharmacy practice and the way the General Pharmaceutical Council will respond to such cases.

“I do believe the defence provides effective defence. I think more needs to be done to increase awareness of its impact on practice/considerations by the GPhC. Confidence in the changes maybe the bigger issue,” he told ICP.

When asked if it will, or has already, encouraged him and a member of his staff to report a dispensing error, Williams said: “It has helped to reinforce the culture that already existed. The medicines safety message now has reporting as a key part alongside prevention of errors and reviewing near misses.”

When asked what concerns, if any, he had about the defence, he said: “The full scope. What decision matrix informs defence? How do we update the standard operating procedure to reflect the changes in law?”

Pharmacist Hala Jawad said the defence should be “reviewed at the earliest opportunity.”

“Although it is definitely a step in the right direction, it is wrong to assume that pharmacists who commit an inadvertent dispensing error, will no longer be investigated for a crime,” she said.

“As I understand it, the defence is only applicable to certain circumstances - other areas of legislation mean prosecution and even prison sentences are still possible. It should be reviewed at the earliest opportunity to consider this anomaly.”

When asked if the defence has encouraged her or anyone she has worked with to report a dispensing error, she said many pharmacists she knew would be reluctant to report an error while the shadow of prosecution hangs over them.

“I have always believed in reporting dispensing errors so that we can all learn from our mistakes and prevent a reoccurrence. We are all human and with the best will in the world, errors will happen.

“What we should aim to do is ensure the risk of that happening is as low as possible by having an exchange of information when mistakes occur. Having said that, I know many colleagues will still be understandably reluctant to report inadvertent errors, even minor ones, whilst there is still a risk of prosecution.”

Jawad said she would like to see a review of the defence after a consultation with pharmacy bodies - she named the General Pharmaceutical Committee and Pharmacists’ Defence Association – in order to “to address any concerns they might have.”

“We need to ensure protection for pharmacists and their staff with regards to prosecution for inadvertent errors whilst maintaining adequate, robust safeguards for the public,” she said.

When asked what specific concerns she had about the defence, she said: “Legal experts suggest that although there is now a statutory defence, it is uncertain whether this would apply to any given error - it would be for the pharmacist to prove these defences apply to individual cases.

“It should also be remembered that the defence only applies to medicines supplied on a prescription and not pharmacy or general sales list ones supplied by a pharmacist or their staff acting under their supervision.”

The view of pharmacy bodies

Rajshri Owen, head of professional and patient services at Numark, told ICP that the defence had “partially strengthened an error reporting culture of candour and transparency by reducing the fear of criminal prosecution over an unintentional dispensing error.”

However, she suggested that pharmacy staff “may still be reluctant to openly report all errors.”

“The headline ‘decriminalisation of dispensing errors’ still causes confusion within the profession today,” she said.

“The introduction of conditional defences to sections 63 and 64 of the Medicines Act 1968 did not change the legislation regarding the criminality of an inadvertent dispensing error but provided pharmacists and pharmacy staff with the opportunity to prove that either of the two defences applied to avoid prosecution for a few limited scenarios.

“We believe since its introduction, it has partially strengthened an error reporting culture of candour and transparency by reducing the fear of criminal prosecution over an unintentional dispensing error and has allowed pharmacy professionals to focus on developing safeguards to improve patient safety and share learnings peer to peer.

“However, we recognise it does not provide complete protection and the risk of lengthy police enquiries and criminal court case still exists. One year on, pharmacists still face the threat of criminal and regulatory prosecution unlike other healthcare professionals.

“Furthermore, with the risk of a criminal prosecution and/or confusion around understanding the impact in its entirety, pharmacists and pharmacy staff may still be reluctant to openly report all errors.”

When asked what Numark members thought about the defence, Owen said: “All pharmacy professionals have a duty of candour. However, the defence alone does not promote this. We believe more support is needed to ensure pharmacists and their teams (work) without fear of negative career or registration repercussions and discrimination.”

She insisted that although Numark had not received any serious concerns about the defence, it “does not mean genuine concerns do not exist.”

One of the biggest concerns from Numark’s perspective, she said, was the ambiguity when it came to interpreting the legislation.

“For example, what is meant by ‘product was dispensed at a registered pharmacy’ and ‘acting under the supervision of a person who was a registrant?’ Owen pondered.

“Furthermore, there is still a need to change the defence to incorporate guidance to include differentiation between pharmacists and superintendent pharmacists and clarity as to whether sales of OTC medicines are included.”

Glyn Walduck, head of claims at the National Pharmacy Association, said: “The introduction of the defence should enable the crown prosecution service to utilise section 64 of the Medicines Act to prosecute only in the most exceptional cases where recklessness lays at the heart of the circumstances giving rise to an error.

“This is fairer and more proportionate than the previous situation and is more likely to underpin a culture of openness and learning from mistakes.

“Fortunately prosecutions under the section were relatively rare and it is hoped that they might become a thing of the past. Since its introduction we have not yet had a case to plead the defence before the courts.”

View from the pharmacy chain

Janice Perkins, pharmacy superintendent at Well Pharmacy and chair of the community pharmacy patient safety group, said: “One year after the Order became law, it’s hard to draw any clear conclusions about whether it provides effective protection as, fortunately, there hasn’t yet been a test case.

“However, I do think that the new legislation has achieved an effective balance in removing a potential barrier to community pharmacists reporting dispensing errors to help prevent similar incidents occurring in the future, without removing consequences for those rare cases where the pharmacist has not acted in the normal course of their practice.”

Perkins said the community pharmacy patient safety group will run a survey next month to assess the impact of the defence on incident reporting.

The defence at a glance

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

Let us know what you think about the defence. Do you think it encourages the reporting of errors? Email your thoughts to neil.trainis@1530.com

Picture: Hiraman (iStock)