Community pharmacy’s long wait for the threat of prosecution for an inadvertent dispensing error to be removed has arrived after years of campaigning with a new defence which comes into force today.

The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 is a result of the tireless drive by pharmacy bodies to bring about decriminalisation, a cause which has been taken up in recent years by the rebalancing medicines legislation and pharmacy regulation programme board.

The new defence can be used by pharmacists if two conditions, among others, are fulfilled; that the product was sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or patient group direction; and in the case of emergency supplies, a prescription-only medicine was sold or supplied in circumstances where there was an immediate need for it and a prescription could not be obtained without undue delay.

Despite concern that the law has left room for ambiguous interpretation, potentially making legal protection against prosecution tricky to establish if a case went to court, Royal Pharmaceutical Society president Ash Soni described the defence as “excellent news for pharmacists, pharmacy technicians and for patient safety.”

Calling on hospital pharmacists and those working in sectors other than registered pharmacies to be afforded the same legal protection, he said: “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.

“This long-awaited change will be welcomed by the whole profession but I recognise there is still work to do to see similar measures put in place for pharmacists outside of registered pharmacies.

“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.”

General Pharmaceutical Council chief executive Duncan Rudkin 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.

“We understand a consultation will begin shortly on introducing the same defences for dis-pensing 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.

“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.”

The defence, however, has not been greeted with overwhelming relief by the community pharmacy profession. The Pharmacists’ Defence Association (PDA) wrote to the health minister Steve Brine to express their disquiet that the new defence only focuses on two sections – section 63 and 64 of the Medicines Act 1968 – and not other areas of medicines legislation where the risk of prosecution in the event of an inadvertent dispensing error remains.

Legal experts have also raised concerns over the vagueness of the law’s wording. For example, the defence maintains that the individual dispensing the medicine must be a pharmacist, technician or someone acting under the supervision of a registrant although supervision is not defined clearly.

Peter Kelly, a pharmacist based in London and regular contributor to the Pharmacy Business podcast, said the new defence would not encourage pharmacists to report errors while PDA chairman Mark Koziol said he could not advise his members to report errors while the risk of prosecution remains.

The Royal Pharmaceutical Society has published a guide on making things right when there’s been a dispensing error.

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