The wait is nearly over. Pharmacists have campaigned for the decriminalisation of inadvertent dispensing errors since the infamous Elizabeth Lee case in 2009 – a fatal yet accidental error that resulted in a suspended sentence for the young professional. But progress has been slow. The programme board set up in 2013 to change the law has encountered numerous delays and, when the consultation on its proposals came out in February, it was a year late. 

The argument is that the emphasis is on getting the law change right rather than rushing it through. The Department of Health (DH) urged pharmacists to respond to its consultation and point out any potential pitfalls with its proposals to give pharmacists a new defence against prosecution before it goes ahead. And respond they have – with several issues being flagged up for further attention. 

C+D analysed the responses from the Royal Pharmaceutical Society (RPS), General Pharmaceutical Council (GPhC), Pharmacy Voice, Numark and the Pharmacists’ Defence Association (PDA) to gauge the main points. And we put their concerns to pharmacy lawyer David Reissner to assess how important they are.
 

Issue 1 

Criminal sanctions

Although the government’s work is popularly referred to as decriminalisation, the term is somewhat misleading. Pharmacists could still face criminal prosecution for a dispensing error – they will simply have a new defence if they meet strict conditions. These include showing that they acted “in the course of [their] profession” and made a supply on the basis of a prescription or patient group direction. Under the proposals, criminal sanctions should only apply if there is proof “beyond reasonable doubt” that the pharmacist either misused their professional skills or showed a deliberate disregard for patient safety.

The proposals have prompted a mixed reaction among pharmacy representatives. The RPS, Numark and the GPhC are all in favour of the proposed approach, while Pharmacy Voice and the PDA are less enthusiastic. Pharmacy Voice would have preferred outright decriminalisation, but acknowledges the proposals are “the only current opportunity to move things in the right direction”. 

The PDA is more vehement in its objections. It stresses that the government proposals have not removed the threat of prosecution – simply offered pharmacists “some conditional defences”. This approach would “needlessly embroil pharmacists” in mounting a defence against criminal proceedings, it warns.

The legal view – David Reissner, partner, Charles Russell Speechlys “There is absolutely no need for dispensing errors to remain criminal offences. There are already existing offences that are adequate to deal with deliberate provision of a medicinal product that is not of the nature or quality demanded. Under Offences Against the Person Act, nurse Victorino Chua was sentenced to life imprisonment at Manchester Crown Court for deliberately administering poison to patients at Stepping Hill Hospital.  “These proposals will mean pharmacists still have to mount a defence. In practice, I suspect that if pharmacists are offered a caution, they will choose to accept it rather than go to court.”

 

“These proposals will mean pharmacists still have to mount a defence. In practice, I suspect that if pharmacists are offered a caution, they will choose to accept it rather than go to court.”

David Reissner

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Issue 2

Labelling errors

The defence proposals focus on section 64 of the Medicines Act, which seeks to protect “purchasers of medicinal products”. This is the section of the act most commonly used to instigate criminal proceedings against pharmacists. But it is not the only section of the act capable of doing so – in fact, Elizabeth Lee was initially prosecuted under section 85, which concerns the labelling of medicines.

The failure to address this clause in the consultation concerns the PDA. It stresses that pharmacists could still face prosecution for labelling errors, which could prevent them from reporting mistakes and sharing best practice. The organisation urges the government to address this section of the medicines act to remove this fear. 

Numark echoes the calls. “Inadvertent mislabelling of dispensed medicines would, in most cases, fall into the category of inadvertent dispensing errors, yet would fail to be caught by the new defence,” it points out. Unless this issue is addressed, pharmacists will continue to feel uncertainty over the potential for prosecution, which would defeat the “principal objective” of changing the law, Numark argues.

The legal view  “The Elizabeth Lee conviction was eventually overturned because section 85 [concerning labelling errors] applied to people acting in the course of their business – this meant it only applied to pharmacy owners. In 2012, what was section 85 was changed. Among other things, it was no longer confined to defendants acting in the course of a business owned by them, which made pharmacists more vulnerable. “The MHRA has just decided to restore the words originally in section 85. It will mean the labelling offence will again be restricted to people who are acting in the course of their own business, but this will be of no comfort to pharmacists who run businesses in their own names rather than through a company. They are still vulnerable to prosecution.”

Issue 3

Subjectivity

The defence uses some terms that could be open to interpretation. For example, pharmacists must act “in the course of [their] profession” and must notify patients “promptly” upon discovering an error. But what constitutes a prompt response and in what circumstances will pharmacists be deemed to have acted outside the course of their profession?

Numark raised concerns over the subjectivity of these terms. “We are concerned some of the terms used are rather vague,” it says. “While understanding the general difficulty in drafting appropriately and comprehensively to cover a wide range of situations, this approach will lead inevitably to considerable subjective interpretation”. It worries this lack of clarity will create “some uncertainty” among pharmacists.

The legal view  “The expression ‘acting in the course of the profession’ is certainly vague. Where the criminal law is concerned, everyone is entitled to clarity. The example given in the consultation paper of a pharmacist selling drugs on the street as someone acting outside their profession is, frankly, silly. After all, there are other laws that deal with illicit drug dealing.”

 

“The expression ‘acting in the course of the profession’ is certainly vague. Where the criminal law is concerned, everyone is entitled to clarity”

David Reissner

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Issue 4

The importance of SOPs

The proposals acknowledge that there are times when pharmacists won’t adhere to SOPs. For this reason, non-adherence to SOPs at the time of the error won’t constitute grounds for criminal prosecution.

This approach secured unanimous support from the five consultation responses seen by C+D. The RPS stresses that pharmacists may use their professional judgement to act outside SOPs – and that this judgement must be “valued and encouraged at all times”. 

The PDA is strongly in favour of allowing pharmacists to act outside of procedure. It feels “far too much emphasis and reliance” was placed on SOPs in the responsible pharmacist regulations. “This not only leads to defensive practice, but it also has the effect of curtailing the right and duty of a pharmacist to exercise their professional judgement in the patient’s interest,” it says. 

With that, the PDA calls for an overhaul of the responsible pharmacist regulations to reflect this more flexible approach.

The legal view  “A failure to follow SOPs may make a prosecution more likely. If a pharmacist is convicted, it may be treated as an aggravating factor when it comes to sentencing.”

Issue 5 

The duty of candour requirement

The phrase ‘duty of candour’ has been omnipresent in healthcare documents following the Mid-Staffordshire scandal. So it was no surprise the decriminalisation proposals nodded to this principle in requiring pharmacists to make “all reasonable attempts” to contact the patient once the error is detected. Doing so will now form part of the pharmacist’s proposed new defence against criminal sanctions.

The suggestion has proved divisive. While the GPhC is in favour – it believes being honest and open about mistakes is an “essential duty” for pharmacy professionals – others are not so sure. 

The RPS has questioned the need for a duty of candour to be enshrined in legislation because it would fall under the GPhC’s remit. Numark agrees – it says informing the patient has “no bearing” on the criminality of the offence, but failure to do so should be dealt with through fitness-to-practise procedures. The PDA agrees with the government proposals in principle, but says it must first ensure that pharmacists no longer feel scared to speak out by removing the threat of prosecution for a labelling error (see Issue 2).

And Pharmacy Voice questions the potential impact on pharmacy owners. It stresses that, if a pharmacist makes an error and fails to notify the patient or their employer, the owner should not be held responsible. “We do not believe it will always be reasonable that failings on the part of a pharmacist necessarily lead to a liability on an owner,” it says.

The legal view  “A failure to contact the patient may mean that the new defence is not available, and a pharmacist would have to be convicted.”

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