Pharmacy plays a vital role in the NHS, and it is important that pharmacy legislation and regulation is reviewed to ensure that safety for users of pharmacy services is improved, innovation and development of pharmacy practice is promoted, and unnecessary legislation is removed.

The independent Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board – which I chair – was formed to advise the government and devolved administrations on these issues.

Earlier this year, we saw a major legislative change by which new defences for inadvertent preparation and dispensing errors were made available to registered pharmacy professionals working at or from registered pharmacies. The introduction of these defences will alleviate concerns about the fear of prosecution, encourage the reporting of errors and improve the safety of services.

It is important that we continue to consider what more can be done. I am therefore delighted to launch the government’s public consultation on two further draft proposals.

Dispensing error proposal

These proposals will extend defences for inadvertent preparation and dispensing errors to registered pharmacy professionals working in hospitals and other relevant pharmacy services.

They will also clarify and strengthen the organisational governance requirements for registered pharmacies – especially around the roles and requirements of responsible pharmacists and superintendent pharmacists – in primary legislation.

The first of the proposals builds on the earlier dispensing error order. Errors are rare due to the diligence of pharmacy teams, and prosecutions rarer still. However, I know that there is still fear among some professionals, and I want to assure them that while the risk of prosecution has not been totally removed, these measures aim to significantly reduce this risk.

In setting out the new defences, parliament has made clear its intent that pharmacy professionals should not be prosecuted for inadvertent errors and that a culture of reporting and learning should be encouraged.

It is important to be clear that the defences cannot be relied upon where professionals have shown a deliberate disregard for patient safety or have not discharged their professional duty of candour to advise patients promptly when an error occurs. This is right and provides the necessary confidence for patients and the public.

All errors will also remain potentially the subject of sanctions from the pharmacy regulators, such as fitness-to-practise investigations, and general criminal law; for example, gross negligence manslaughter.

Responsible and superintendent pharmacists

The second proposal, on responsible pharmacists and superintendent pharmacists, is an important step in providing clarity about the respective roles and to ensure that accountability and responsibilities are clear within pharmacy teams and wider organisations.

In addition, the proposals include two technical changes to align the law in Northern Ireland with that of Great Britain, allowing for the appointment of a deputy registrar and requiring superintendent pharmacists to notify when they cease that role.

Have your say

This work has been developed over a long period of time by the rebalancing programme board, with input from numerous professionals, patient/public interests, representative bodies and organisations, and it is important to understand the impact of the changes being made. This is an area of complex law and we want to make sure we have got it right.

During the consultation period, the board will be hosting a partners’ forum event, at which we will ask for thoughts and comments on the proposals and clarify where there may be concerns. This follows on from the previous partners’ forum event, which was held in February of this year.

We will also link into a wide range of stakeholder networks to promote responses to the consultation and explain aspects of the proposals in greater detail. A Q&A has been published on the board’s website here.

After the consultation, the government will consider all responses, with the aim of laying the draft orders before parliament by the end of the year. The orders will require approval by parliament and the Privy Council before they come into force. I encourage everyone to take part in the consultation, which is running until September 11.

Ken Jarrold is chair of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board

The consultation document and draft orders can be found here, and the Q&A document here.