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Draft legislation, which provides a legal defence for community pharmacists who make a dispensing error, has been laid before Parliament.
The Pharmacy (Preparation and Dispensing Errors — Registered Pharmacies) Order 2018 was published on 14 November 2017.
There have been calls for this legislation for more than a decade from organisations including the Royal Pharmaceutical Society (RPS), the Pharmacists’ Defence Association and the National Pharmacy Association.
Paul Bennett, chief executive of the RPS, said: “This is a welcome move and marks the beginning of the end for the automatic criminalisation of inadvertent dispensing errors.
“Addressing this historical imbalance between professional regulation and criminal law will help foster a learning culture, encourage the reporting of errors and ultimately support patient safety.
“The Royal Pharmaceutical Society and others have campaigned to keep this in front of policymakers over a number of years and we appreciate that this has been a long journey for the profession.
“We will continue working with the Rebalancing Board as it seeks to develop similar proposals for hospitals and other pharmacy settings. We hope that it will now take this opportunity to build on this important milestone and engage with wider stakeholders.”
The Pharmacy Rebalancing Board announced, following its meeting in October 2018, that it hoped to see the legislation put before Parliament this calendar year. Earlier this month, pharmacy minister Steve Brine told a meeting of the All Party Pharmacy Group that the order had received cross-party support and would be laid before Christmas.
The order will amend the Medicines Act 1968 to provide new legal defences for preparation and dispensing errors for pharmacists, pharmacy technicians and staff supervised by them, who are working at a community pharmacy.
Because pharmacy technicians are not statutorily registered in Northern Ireland, the defences there only relate to errors made by registered pharmacists and people supervised by them.
To provide a defence when a dispensing error is made, four things must be demonstrated: the person who “adulterated” the product must be a registered pharmacist or technician or acting under their supervision; the adulteration must have taken place in a registered pharmacy; the product must have been sold as a prescription; and if an “appropriate” person, such as the dispenser, becomes aware of the mistake, “all reasonable steps must be taken to ensure that the patient is notified of the mistake”.
There are caveats in the legislation that will regard a pharmacist as not acting in the course of their profession for the purposes of the new defences if “he or she misuses his or her professional skills for an improper purpose or deliberately fails to have due regard for patient safety”.
