No more delays with rebalancing medicines legislation and pharmacy regulation

We need fewer empty promises and more action and progress with rebalancing medicines legislation and pharmacy regulation — particularly around dispensing errors.

Lady Justice at the Old Bailey in London

Just before Christmas last year, the pharmacy profession in the UK was informed that a pharmacist has been convicted under the controversial section 64 of the Medicines Act 1968 for a one-off, non-malicious dispensing error (
The Pharmaceutical Journal online, 22 December 2016
). Martin White, a community pharmacist in Northern Ireland, received a suspended prison sentence for, according to the Act, “failing to supply a product that was of the nature or quality demanded by the purchaser”. This resulted in the death of a patient. White had mistakenly supplied the beta-blocker propranolol instead of the corticosteroid prednisolone, as prescribed by the doctor to treat the patient’s chronic obstructive pulmonary disease. The patient took some of the tablets, had difficulty breathing, and was rushed to hospital and subsequently died.

What was striking about this case was that the exact same mistake was made back in 2009. The high-profile case of Elizabeth Lee, a community locum pharmacist also charged under sections 64 (and 85) of the Medicines Act, had supplied propranolol instead of prednisolone to a patient, who later died (although it was concluded that the dispensing error did not contribute to the patient’s death [
The Pharmaceutical Journal 2010;284:257
]). Lee later successfully appealed her conviction and sentence (under section 85) (
The Pharmaceutical Journal 2010;284:521
) but the traumatic experience has left her too distraught to return to practice.

Legislation out of date

Section 64 of the Medicines Act is archaic legislation initially enacted in the post-war years to prosecute people who deliberately adulterate food or medicines, in a time when most medicines were compounded extemporaneously. The main sore point is that there is no legal defence for anyone charged under this part of the Act. So, if found guilty, a criminal conviction is inevitable for the accused.

Additionally, there have always been a number of options patients and their families could pursue. Patients could take the healthcare professional to civil court, suing for compensation for negligence; registered healthcare professionals could be disciplined by their respective professional regulatory body; or if the harm leads to death, criminal negligence charges could be brought against the healthcare professional. The Crown Prosecution Service (CPS) did publish guidance advising against using section 64 to prosecute for inadvertent dispensing errors after the Lee case (
The Pharmaceutical Journal 2010;284:621
), but it covers only England and Wales. Northern Ireland has a separate Public Prosecution Service which is not bound by CPS guidance. This could be why White was charged under section 64.

Unacceptable delays and empty promises

Although there had been other less high-profile cases of pharmacists being charged under section 64 for dispensing errors over the years, Lee’s case arguably paved the way for the government to consider examining the current medicines legislation, with the decriminalisation of dispensing errors forming one part of the Rebalancing Medicines Legislation and Pharmacy Regulation Board’s agenda.

But the journey leading to where we are now (which is not far) was difficult from the start. Since the Lee case, there had been sustained campaigning by the pharmacy profession for legislation changes, and promises from successive governments that this issue was high on their agendas (
The Pharmaceutical Journal 2011;287:547
). However, the rebalancing board was not set up until 2013 to review medicines legislation and professional regulation across the UK — five years after Lee’s conviction.

It is important to note that complete decriminalisation of dispensing errors was never on the cards, but the board’s remit was to agree on a set of defences that could be invoked if someone were charged under section 64, thereby still allowing those who act with malicious intent to be punished.

Since the board was set up, progress has been slow, almost to the point of standing still. Back in April 2014 the timetable for rebalancing medicines legislation and pharmacy regulation had already slipped, with the chairman of the rebalancing board Ken Jarrold saying he hoped that legislation will be passed in the life of the then parliament (
The Pharmaceutical Journal 2014;292:388
). Of course that was wishful thinking.

Further delays were subsequently announced (
The Pharmaceutical Journal online, 20 September 2014
) and, although the defences for section 64 were agreed at a stakeholders meeting in December 2013, there has been no visible progress since then (
The Pharmaceutical Journal online, 31 January 2015

Early in 2016 we were informed yet again there would be more delays (
The Pharmaceutical Journal online, 26 January 2016
). Finally, on 12 January 2017, the government announced it will “shortly” bring forward the necessary legislative changes that will put in place defences for pharmacists against prosecution ahead (
The Pharmaceutical Journal online, 19 January 2017
). But there are no guarantees there will not be further delays as before. These unacceptable setbacks indicate pledges made by successive ministers of parliament and the government were nothing more than empty promises.

We can no longer sit and watch more pharmacists prosecuted under an out of date, indefensible section of the Medicines Act that is in desperate need of update. Nor can we accept the ridiculous lack of progress with the rebalancing medicines legislation and pharmacy regulation programme. Amending section 64 is only one part of the agenda for the board; there are other important pharmacy issues that need addressing as well, including hospital pharmacy, the role of the responsible pharmacist and superintendent pharmacists as well as pharmacy supervision (
The Pharmaceutical Journal online, 13 January 2017

If the government really wants to put pharmacy in the heart of the NHS, then it should make the rebalancing programme a priority, rather than an afterthought.

Last updated
The Pharmaceutical Journal, PJ, January 2017, Vol 298, No 7897;298(7897):DOI:10.1211/PJ.2017.20202222

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