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New dispensing error legislation is a step forward in protecting pharmacists but is no panacea, says Richard Hough.

After a seemingly interminable wait, the Privy Council has finally approved legislation, which, once adopted, will introduce new defences to what most pharmacy practitioners rightly regard as unwanted, unnecessary and outdated criminal offences concerning dispensing errors that were first introduced into English law 50 years ago under the Medicines Act 1968.

The Pharmacy (Preparation and Dispensing Errors €“ Registered Pharmacies) Order 2018 is due to come into force on 16 April. It aims to protect registered pharmacists, technicians and those working under their supervision in registered pharmacies from fear of criminal prosecution for having made inadvertent preparation or dispensing errors.

The law currently and unfairly considers all dispensing errors to be criminal acts, regardless of whether such errors were intentional or inadvertent and without any consideration of the severity of harm caused. Any person who is guilty of such an offence faces a fine, or imprisonment for up to two years. Notably and tragically, Elizabeth Lee and Martin White have each fallen foul of such offences.

The legislative changes mean that pharmacy professionals who make an inadvertent dispensing error and satisfy the conditions for the new defence will no longer face the risk of criminal prosecution, albeit their conduct will continue to be subject to the scrutiny of the General Pharmaceutical Council.

It is hoped, though this remains to be seen, that the new law will encourage error reporting, increase patient safety, and create a culture of openness among pharmacy professionals to learn from mistakes without the fear of criminal sanctions. So, what comfort does the new law bring?

Article 4 of the Order contains amendments to the Medicines Act 1968, and creates new defences to contraventions of sections 63 and 64 of that Act.

The offences in section 63 relate to adulteration of medicinal products for human use. If the product is not sold or supplied, in order to benefit from the new defence in section 67a, the defendant must prove that:

1. the person who adulterated the product either was a registered pharmacist or pharmacy technician who was acting in the course of his or her profession, or was acting under the supervision of such a registrant
2. the adulteration took place at a registered pharmacy
3. the defendant did not know that the product was being adulterated.

If the product is actually sold or supplied, in order to benefit from the new defence in section 67b, in most cases the defendant must prove (A) and (B) above plus:

D. the product must have been sold or supplied in pursuance of a prescription or directions, or be an emergency sale or supply of a Prescription Only Medicine in circumstances where a prescription could not be obtained without undue delay

E. if an appropriate person becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.

The offence in section 64 relates to the sale, or supply in pursuance of a prescription, of medicinal products for human use which are not of the nature or quality demanded by the purchaser or as specified in a prescription. The elements of the new defence in section 67c which apply in most cases, are similar to those in the new section 67b, namely as (A) and (B) above plus:

F. the sale or supply must have been in pursuance of a prescription or possibly directions, in the case of a sale, or be an emergency supply of a prescription only medicine in circumstances where a prescription could not be obtained without undue delay
G. if an appropriate person becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.

So, let's be clear about this. Whilst the adoption of the new legislation and the statutory defences are to be welcomed, the regulations do not decriminalise dispensing errors, which could have been easily achieved if sections 63 and 64 had been repealed. So, pharmacists can still be guilty of a criminal offence if a dispensing error is made but will avoid conviction if he or she can prove to a court that the statutory defence is met.

And yet despite such a long wait, ambiguities still remain around the scope of the acts of "dispensing" and "supervision", for which no statutory definitions have been provided. Also, the defences do not extend to errors made in respect of OTC sales, so pharmacists will remain at risk for such errors. Mislabelling (where the correct product is supplied but it is wrongly labelled) also still remains a criminal offence and, curiously, no statutory defence has yet been put forward in the regulations for this offence.

The new legislation is a step forward in protecting pharmacists but there is more distance still to be travelled on this highly contentious topic.