Dispensing error protection comes into force

After a lengthy campaign from the profession, a legal measure protecting UK community pharmacists from criminal prosecution for inadvertent dispensing errors has come into force on Monday 16 April. The Royal Pharmaceutical Society described this as “excellent news” but said more must be done to extend protection to pharmacists working in other care settings.

The legal defence, Pharmacy (Preparation and Dispensing Errors—Registered Pharmacies) Order 2018, which applies to registered pharmacies throughout the UK, includes clauses stipulating that pharmacists are safe from prosecution if they can provide evidence showing they were unaware a dispensing error had been made, and they had taken appropriate steps to notify patients on becoming aware of an error.

RPS: "A more open culture"

The RPS said that by reducing the fear of legal sanction, the move will create a “more open culture of error reporting,” ultimately increasing patient safety. President Ash Soni said: “This is excellent news for pharmacists, pharmacy technicians and for patient safety.”

“After several years of dialogue with government, the NHS and the profession, our hard work and consistent advocacy on this issue has won through and we now have a new law protecting community pharmacists from automatic prosecution should they make an honest mistake.

“We now need to address this inequity faced by those working in the managed sector, so we will continue pressing the government to create a similar defence for pharmacists working in hospitals and other settings. We are pleased that the pharmacy minister, Steve Brine MP, has reaffirmed his commitment to seeing this happen.” 

NPA: "Criminal sanctions disproportionate"

A week before the defence came into force, Glyn Walduck, head of claims at the National Pharmacy Association 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.”

GPhC: "Will encourage improved reporting"

Duncan Rudkin, chief executive of the General Pharmaceutical Council, said:“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. 

 “For our part, we will be considering how we can better use and share the information we receive about dispensing errors to support learning, reduce risks and improve patient outcomes.

“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.

Legal view

The response to the legislation was nuanced in some quarters. Solicitor Noel Wardle of legal firm Charles Russel Speechlys told Pharmacy Magazine that “the introduction of a statutory defence is a welcome milestone for the pharmacy profession, but it does not go as far as some would have liked and pharmacists still face the risk of a criminal prosecution when an error occurs.”

Mr Wardle specified that although the Order has been described as bringing about ‘decriminalisation’ of dispensing errors, it does not technically do so; rather, “it provides a statutory defence for pharmacists who supply the wrong medication in certain circumstances.” It is incumbent on pharmacists to prove that these defences apply to individual cases, Mr Wardle said.

Mr Wardle said: “By removing the threat of prosecution, the Department of Health hopes that there will be more openness in reporting errors which will allow the pharmacy team to learn from mistakes and improve patient safety. 

“However, given that the Order does not amount to the decriminalisation of errors, there is still significant scope for uncertainty as to whether the statutory defence would apply to a particular error and pharmacists may still be worried about the risk of an investigation by the GPhC, the DH’s lofty ambitions may not be met.”

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