Pharmacy law expert Noel Wardle on whether new legislation decriminalising inadvertent dispensing errors gives pharmacists enough protection

Today (16 April) the Pharmacy (Preparation and Dispensing Errors—Registered Pharmacies) Order 2018 is brought into force.

This marks the end of a long journey that began with the conviction of Elizabeth Lee, who received a suspended prison sentence in 2007 following a dispensing error that led to calls for the decriminalisation of dispensing errors by pharmacists.

In fact, the new legislation doesn’t technically decriminalise errors: it provides a statutory defence for pharmacists who supply the wrong medication in certain circumstances.  In particular, to come within the scope of the statutory defence, a pharmacist will have to persuade the court that:

1) The medicine was dispensed at a registered pharmacy – so errors in hospital pharmacies are not caught by the statutory defence

2) The medicine was dispensed by a pharmacist acting in the course of their profession or by a person acting under the supervision of a pharmacist

3) The product was supplied in accordance with a prescription or as an emergency supply – so the sale of General Sales List (GSL) and P medicines are excluded);

4) Before the pharmacist was charged with the dispensing error offence, they either did not know about the error or, if they did know, they took all reasonable steps to inform the patient about the error or reasonably formed the view that it was not necessary to inform the patient.

While the statutory defence is welcomed, pharmacists still face the risk of prosecution where they make an error and may not know whether each part of the statutory defence has been met until the outcome of a criminal trial.

There is plenty of room left for uncertainty, for example because the legislation does not define terms such as ‘dispensed’ or ‘supervision’. There is also a question mark over whether a pharmacist who is acting contrary to the code of ethics – for example, by not being honest and open with patients, by not acting in the patient’s best interests or by ignoring the pharmacy’s procedures – is ‘acting in accordance with his or her profession’.

The statutory defence only applies to criminal offences contained within the Medicines Act 1968. However, other legislation also creates criminal offences – in particular, the Human Medicines Regulations 2012 (HMR 2012), for example, where a labelling error is made.

Pharmacists, and, in particular, pharmacy owners, might find themselves the subject of a criminal charge relating to an offence under the HMR and will not be able to rely on the statutory defence contained within the Order.

In bringing the Order into force, the Department of Health and Social Care (DHSC) hopes that pharmacists will be more willing to report errors to allow the pharmacy team to learn from mistakes.

Given the uncertainty that still remains, and the threat of the General Pharmaceutical Council (GPhC) investigating errors even if no criminal charges are brought, the Order might not be enough to meet the DHSC’s objectives.

Noel Wardle is head of pharmacy at law firm Charles Russell Speechless LLP. You can contact him at [email protected]