Legislation providing pharmacists with a legal defence for inadvertent dispensing errors has been laid before Parliament today (14 November).
The Department of Health (DH) told The Pharmacist that, if passed through the parliamentary process without challenge, the legislation is likely to come into effect early next year.
Pharmacy minister Steve Brine promised delegates at the Royal Pharmaceutical Society (RPS) annual conference in September that he was ‘committed’ to laying the long-awaited legislation, which aims to change the Medicines Act 1968, before Parliament.
Mr Brine said: ‘As promised, we have taken the first step in legislation which will defend pharmacy professionals making genuine dispensing errors – an important step forward in addressing some of the barriers to providing a safer, high quality service.
‘These changes will 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.’
The policy will be reviewed five years after its implementation.
History of the law
The criminalisation of dispensing errors was originally enacted as one aspect of consumer protection offences, which were intended to support the best interests of the patient.
The DH said that ‘there is evidence that fear of prosecution has a counter-productive effect on patient safety as it deters reporting of errors by pharmacy professionals’.
In 2015, the DH proposed a defence for pharmacists under Sections 63 and 64 of the Medicines Act 1968 to avoid criminal sanction for inadvertent dispensing errors, retaining the sanctions for errors where pharmacy staff were not ‘acting professionally’.
Addressing the ‘historical imbalance’
Commenting on the proposals, RPS chief executive Paul Bennett said: ‘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.’
General Pharmaceutical Council (GPhC) chief executive Duncan Rudkin said the regulator ‘welcomed’ the news.
He said: ‘Openness and honesty when things go wrong is a core part of the standards for pharmacy professionals. This change in legislation will remove a barrier to improved reporting and learning from errors and we are pleased to see continuing progress towards changing this legislation.
‘We have consistently been clear that single dispensing errors do not in our view constitute a fitness-to-practise concern, if there is not a wider pattern of errors or significant aggravating factors.’
Prevalence of dispensing errors
Dispensing errors in community pharmacy represents 3% of all items dispensed.
The most common errors include dispensing medicines with similar names or packaging, out-of-date medicines, making incorrect calculations and misreading prescriptions.
There were around 500,000 unreported dispensing errors in 2016 across the UK, by fear of being prosecuded.
Prosecutions to date are ‘rare’ and have only been brought in case of death of a patient.
The latest criminal offence to date is pharmacist Martin White, who was given a four-month sentence last year for dispensing propranolol instead of prednisolone, which led to the death of 67-year-old Ethna Walsh.
A number of alternatives options to the regulation have been considered by the DH, ranging from no actions to the introduction of an exemption from criminal liability when ‘an inadvertent dispensing error occurs’.