In February 2015, the Department of Health issued a 53-page consultation document entitled ‘Rebalancing Medicines Legislation and Pharmacy Legislation: Draft Orders under section 60 of the Health Act 1999’. Comments and views were sought on two pharmacy related draft Orders being made under the powers of Section 60 of the Health Act 1999 – the most significant of which being the Pharmacy (Preparation and Dispensing Errors) Order 2015.
In summary, the Order makes provision for, inter alia, a defence to prosecution under the Medicines Act 1968 in cases of errors where medicines are prepared by a registered pharmacist, a registered pharmacy technician or under the supervision of a registered pharmacist. The proposals are said to be part of broader proposals for the rebalancing between criminal law and professional regulation, so that matters that “should properly be within the ambit of pharmacy regulators, the General Pharmaceutical Council (GPhC)… are in fact dealt with by them – and by registration sanctions, rather than by the criminal courts” (Consultation paper, p6).
Building on the learning from the Francis and Berwick reports, and work done by the professional and regulatory bodies for pharmacy, it is said that the proposals reflect the safety of users of pharmacy as a core principle. It stresses that there will be accountability for dispensing errors, as the pharmacy regulators will be able to use ‘fitness for practice’ measures to determine what, if any action is to be taken (including the ultimate sanction of striking off), and that criminal sanctions will remain in place for dispensing errors falling outside the proposed defences – for example, where pharmacy professionals act outwith the course of the profession or show deliberate disregard for patient safety.
The proposals, it is said, are designed to contribute to openness and increased reporting of inadvertent dispensing errors so that everyone can learn from mistakes. Further, that removing the threat of criminal sanction for inadvertent preparation and dispensing errors will address a significant fear amongst pharmacy professionals which, it maintains, is “currently inhibiting the reporting of such errors”. It would appear that a row is now brewing between pharmacists, the Department of Health and lawyers representing alleged victims of misprescription of drugs.
In a detailed report examining the issues behind the row, the BBC’s 5Live Investigates has already highlighted how the proposed changes have raised concerns that those pharmacists responsible for making mistakes could soon escape the available criminal sanctions if the mistake was genuine – even if it resulted in the death of a patient. According to NHS figures obtained by the programme, it appears that 1,200 people did suffer some harm through a dispensing error in 2014.
The programme suggests that lawyers are sceptical that the changes would bring about significant improvements in safety. But what would be the impact of the proposed changes? The idea behind it appears to be to encourage a culture of openness with reporting of dispensing errors and near misses. It would also bring the current rules into line with comparable schemes for doctors, nurses and other healthcare professionals. A concern is that in some cases patients would not be told about a dispensing error if the matter were to be considered ‘trivial’ by those making the error (see FSLA May 24 2015, Renu Daly – Neil Hudgell solicitors).
The difficulty with that is, of course, obvious: there would be every incentive for pharmacists subject to such a new rule to decide for him/herself that any error was ‘trivial’ to avoid the need to inform patients and – depending on the circumstances – open themselves up to a potential civil action, if no longer criminal proceedings. Ash Soni, who is president of the Royal Pharmaceutical Society, argues that pharmacists already take public safety extremely seriously, and told the BBC that, when mistakes happen, “We must be open with patients and do everything we can to stop them happening again.” But how that sits with the proposal that trivial errors may not need to be reported to patients is a question that has yet to be answered.
For the full BBC report click here.
For the Renu Daly FSLA article click here.