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New legal defence for dispensing errors to become law on 16 April 2018

New law will take effect on 16 April 2018, allowing a defence against criminal prosecution for inadvertant dispensing errors.

Community pharmacists who inadvertently make a dispensing error will have a new defence from criminal prosecution from 16 April 2018, following a change in the law.

The long-awaited legal protection was signed by the Privy Council on 21 March 2018 — the final step in the legal process to amend the Medicines Act 1968 to introduce the new defence.

The Pharmacy (Preparation and Dispensing Errors — Registered Pharmacies) Order 2018 was laid before Parliament on 14 November 2017, more than 10 years after the Royal Pharmaceutical Society Council officially began the process of trying to decriminalise dispensing errors in 2006.

The reform has been led by the independent Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, which was set up by the government. Its work has, however, been dogged by delays, brought about in part by parliamentary Brexit business.

The Board’s Partners Forum, which includes a wider group of pharmacy representatives, patients and the public, was told in March 2018 that proposals to produce a similar defence for inadvertent dispensing errors made by pharmacists working in hospitals and other settings were expected to be put out for a 12-week consultation in April 2018.

Ash Soni, president of the Royal Pharmaceutical Society, celebrated the introduction of the Order which brought about the change in the law.

He told The Pharmaceutical Journal: “This is absolutely good news; it’s a really important step in improving patient safety. It means for the first time that a pharmacist will be able to report [an inadvertent] error without the risk of prosecution.”

When the Order was first put before parliament, pharmacy minister Steve Brine said the change to the law would “give pharmacy professionals a framework to operate within that will improve the reporting of incidents, increase transparency and allow lessons to be learned — this will ultimately improve patient care and reduce the risk of harm”.

There has, however, been criticism of the new defence from some parties, including the Pharmacists’ Defence Association (PDA), which has argued that the changes do not go far enough and that a risk of criminal prosecution still remains.

Soni, who is also a member of the Rebalancing Board, said: “This [the reform] may not be perfect, but we have got to start somewhere.

“Until it’s enacted, we won’t know if there is any cause for concern — but if there is, it will be about going back to make sure that further amendments are made to the Act going forward.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204607

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