A Worrying Trend - Prosecutions Under The Medicines Act

A recent worrying trend is developing in cases where a prosecution under the Medicines Act 1968 has followed a dispensing error if the police have been unable to fnd enough evidence to bring
a charge of manslaughter.

One case which concerns us involved a pharmacist and dispenser who worked in a community pharmacy in Wales. Coincidental with the taking of an incorrectly dispensed medicine a patient died. At the inquest, the coroner held that there was no causal link between the error and the patient’s death. However, the prosecution’s case was that a supply had been made that was to the prejudice of the patient. This constituted a criminal offence and the individuals were charged under Section 64 of the Medicines Act 1968.

The Prosecution’s case was that a supply had been made by a person and that this would include a body corporate or a natural person meaning that both the company and the individuals could be prosecuted. While it could not be said for certain, it was thought that neither the pharmacist nor the dispenser physically handed over the prescription to the patient.

The company and counter assistant’s position

A lawyer retained by the employer represented both the pharmacist and the company. He told the court that as standard operating procedures were in place with regards to the dispensing process, the employer should not be charged; the prosecution agreed with this argument. It was also argued that the involvement of the counter assistant if there was one, was insignifcant.

The defence case

The lawyer then speaking for the pharmacist argued that no-one had any knowledge that the medicine being supplied was incorrect; the question posed was whether or not she should be liable if not actually physically present when the supply is made and has no actual knowledge of it.

A defence argument was also put forward that she was not actually making the supply, only supervising it. If anything, she had only failed to supervise the supply. The dispenser’s (independant) lawyer argued that her role was merely to prepare the prescription she received and her responsibility was then discharged.

The prosecution’s response

The prosecution’s response was that Section 64 did not require any knowledge. With respect to the pharmacist or dispenser having to be physically present, it was argued that supply meant “gives it” and that while it was not known for sure who handed over the medicine, this was immaterial. The case was put that the purpose of Section 64 was to protect the purchasers of
medicinal products.

It acknowledged that the dispenser was not in as a responsible position as the pharmacist; however, she was, nevertheless, accountable for her actions.

The judgment

The Magistrate held that both individuals had a case to answer; it would appear that as the company had been taken out of the firing line early on in the hearing, someone else had to be made accountable. Both defendants, following advice, changed their pleas to guilty. Taking into
consideration their previously unblemished careers and excellent characters the pharmacist’s and dispenser’s fnes were limited to £2,065 and £765 respectively.

Learning points

The solicitor representing the pharmacist also spoke on behalf of the company. This is great cause for concern; the PDA strongly recommends that all parties to a case should have their own advisers to avoid any confict of interest arising.

By pleading guilty (on the advice of the employer’s lawyer) there were no reasons given which could have then been used as the basis of an appeal. The PDA’s starting point in defence
would have been to argue that the company had made the supply because every act by an individual or group of individuals in the course of a company’s business or operation is, in fact, an act of the company.

The PDA would have wanted to investigate in more detail the working conditions and pressures being placed on the pharmacist; if they had been unreasonable, it would have sought to make the employer more accountable. Of course, this is information on which companies in general may not want anyone to focus; naturally, anyone who is representing them may not want to mention it.

With research showing that the dispensing error rate could be as high as three per pharmacy per week, in the future you could have to deal with a similar situation. It will be no great defence to
argue that you were tired and distracted and consequently more prone to making errors (which formed part of the pharmacists and the dispensers mitigation). It is more important than ever that you ensure that you take your rest breaks or flag up safety issues in the pharmacy. If you are not confdent that you are working with competent staff, this also needs to be addressed.

This event illustrates that whilst it was the individual(s) that acquired a criminal record, the company was exonerated! Never settle for legal defence provided by your employer or your employer’s defence association.