Earlier this month, the government finally published legislation which, when it comes into force – expected to be early next year – will decriminalise dispensing errors by pharmacists. At least, that is what the legislation is meant to do, but it doesn’t quite meet its aims.
Why not? Because the government has chosen not to scrap the offence – as set out in section 64 of the Medicines Act 1968 – of supplying a drug that is “not of the nature or quality demanded”, but to introduce a statutory defence. That means that a pharmacist will still have committed an offence if they make a dispensing error, but will avoid conviction if they can prove to the court that the statutory defence applies.
While the profession will no doubt welcome the move towards, at least partial, decriminalisation, the law is unfortunately still incredibly complex. Here are some of the difficulties with the new defence:
- The medicinal product must have been dispensed at a registered pharmacy. But there is no statutory definition of what ‘dispensed’ means, and it is an expression that can mean different things in different contexts.
- The person who dispensed the product must either be a pharmacist, technician, or someone “acting under the supervision of a registrant”. But the word ‘supervision’ is not defined anywhere, and is often used to mean different things.
- Where the person charged with an offence is not the person who ‘dispensed’ the product (for example, where a company is charged in relation to an error by its staff) then the person who dispensed the product must also not have known of the error.
- The statutory defence will only apply to medicines supplied on prescription, so any pharmacist who supplies the wrong pharmacy (P) medicine or general sale list (GSL) medicine will not be able to rely on the statutory defence.
- Similarly, the incorrect supply must be the result of a mistake: a deliberate wrongful supply is not caught by the statutory defence. A pharmacist who deliberately supplies the wrong item (if you could even imagine this would happen) would not be able to use the statutory defence and so would be guilty of the section 64 offence.
- Finally, if the error comes to light before the defendant is charged with an offence, all reasonable steps must have been taken to ensure that the patient was told about the error, unless it was reasonable to take the view that this was neither necessary nor appropriate. Again, there is a potential uncertainty here as to whether the defendant has complied with this obligation.
So what’s my verdict on the decriminalisation legislation? While it’s certainly better than nothing, the government could have been much bolder and eliminated criminal consequences entirely.
Noel Wardle is a partner at law firm Charles Russell Speechlys LLP, specialising in pharmacy law