Legislation providing community pharmacists with a criminal defence for inadvertent dispensing errors still has ‘serious loopholes’, the Pharmacists’ Defence Association (PDA) has warned.

The legislation came into effect in April 2018 after years of campaigning from the sector but was welcomed tentatively, with Royal Pharmaceutical Society (RPS) president Ash Soni acknowledging there was ‘still work to do’.

Speaking at the PDA’s annual conference – held on Saturday (30 March) in Birmingham – the union's policy manager Greg Lawton said: ‘The conditional defences have various loopholes within them, which means that even if you are prosecuted under those particular sections of the Medicines Act [1968], lawyers could find the holes within them.’


Not protected


A set of conditions must be met in order for the defences to apply but the terms and phrases used within them are not defined and are therefore open to interpretation, Mr Lawton explained.

The conditions include the medicine in question being dispensed at a registered pharmacy by a pharmacist ‘acting in the course of their profession’ and the product being supplied in accordance with a prescription or as an emergency supply.

The pharmacist must also demonstrate that they did not know about the error when they were charged with the offence. Failing this, they must show they took ‘all reasonable steps’ to inform the patient or ‘reasonably formed the view’ that it was not necessary to do so.

Mr Lawton told delegates that if a patient’s relative informed the pharmacist of a mistake before they were charged by the police, the defence could therefore be invalidated.

Similarly, the prosecution could argue that any breach of the General Pharmaceutical Council’s (GPhC) standards means the pharmacist was not ‘acting in the course of his or her profession’.

He added: ‘If that was successful it would mean the entire defence would fail. These are some of the serious loopholes in these defences.’


No defence against other laws


The conference featured an enactment of a fictional dispensing error criminal trial led by Noel Wardle and Rachel Warren from law firm Charles Russell Speechlys LLP that resulted in 63.5% of delegates finding the ‘defendant’ guilty under the current law.

Mr Lawton added that the defences do not provide protection from other areas of medicines law like the Human Medicines Regulations 2012, which can also make dispensing errors a criminal offence.

He said: ‘These defences could be avoided entirely just by prosecuting someone under a different area of medicines law’.


Moving forward


Mr Lawton argued that although the legislation has given pharmacists the impression they no longer need to fear prosecution for inadvertent errors, ‘this is simply not the case’.

He said pharmacy is ‘the only healthcare profession that faces the same risk of criminal sanction in the course of its routine work’.

He told delegates that the law follows the strict liability principle, meaning that pharmacists’ intentions and working conditions are not taken into account.

He added: ‘Our view is that we should have a simpler and broader defence to the applicable areas of law, requiring the prosecution to prove beyond reasonable doubt that the error was not inadvertent.’

The PDA also believes that the ‘appropriate place’ for cases to be heard should be the pharmacy regulator rather than criminal law, and that state prosecutors should solely refer cases to the regulator.

Mr Lawton said: ‘The course of action for the PDA is certainly not to let this drop, we will continue to press for these issues to be resolved.’