In August 2021, Pharmacy Forum NI responded to the Department of Health Northern Ireland’s proposal for a statutory Duty of Candour and Being Open Framework. Our response has drawn from all areas of pharmacy practice and has been developed with input from members of Pharmacy Forum NI Committees and Board.

Pharmacy Forum NI acknowledges the hurt of every family that was impacted by the issues that the O’Hara report has focused on. Throughout, they have been kept in mind in the consideration and development of our response. The Forum broadly welcomes an organisational Duty of Candour, but believes that an additional individual Duty would be counterintuitive to meet the stated aims and threaten the development of Northern Ireland’s pharmacy profession as well as further aggravate an already precarious broader healthcare system. We believe the emphasis must be on creating the conditions and culture in organisations where reporting errors and speaking up are the norm.

The key points of our response are outlined below. 

Existing standards and sanctions: pharmacy regulation and code

Pharmacy is a strictly regulated healthcare profession. The Forum is confident in the robustness of the current professional regulatory processes relating to the practice of pharmacy here. All pharmacists in NI are required to abide by the PSNI Code (Professional Standards of Conduct, Ethics and Performance for Pharmacists in Northern Ireland). NI pharmacists found in breach can be subject to a complaint of misconduct, which may be heard by the Statutory Committee which can apply appropriate sanctions including giving a direction that a pharmacist should be removed from the register. The Forum regards this potential loss of livelihood for a breach of the Code as sufficiently punitive. Should there be any evidence to suggest failings within the NI pharmacy regulatory framework, the Forum is open to discussing, in collaboration with the DoH, PSNI, and others any amendments to the regulatory framework that will go towards ensuring NI pharmacists’ adherence to the duty of candour.

Appropriate and effective organisational duty of candour

Pharmacy Forum NI believes that a statutory organisational duty of candour – that is appropriate to the business organisational entity – is necessary to ensure that health and social care workers are open and transparent. For registered pharmacists in Northern Ireland, we believe it will also complement the professional duty of candour that they are subject to.

It is vital that pharmacists and all healthcare staff feel supported and if required protected by their employers when they raise concerns and are able to speak up without risking hostility. Embedding protections for those who disclose can act as a mechanism to support open disclosure. We would not want a scenario where an individual employee has acted within all means but is failed by their employer.

We believe the emphasis must be on creating the conditions and culture where reporting errors and speaking up are the norm. Addressing errors needs to consider the system rather than the vast majority of individuals who are doing their best in extremely difficult circumstances.

Threat of individual criminalisation counterintuitive

We do not believe that a broad-brushed approach to criminal liability should be imposed in reaction to the small percentage of professionals who are either underperforming or deliberately choose to do wrong, which our regulatory framework and robust governance frameworks with accountability are set up to redress more expediently than the proposed legislation would allow for.

Based on evidence gathered within pharmacy, we know the solution proposed to introduce an individual statutory duty with criminal sanctions in our already heavily regulated profession is short-sighted and fails to consider basic human response behaviour to threat and fear.

The proposal for a statutory duty of candour for an individual (working in the specified health services), attached to the threat of criminal sanction for non-compliance, reintroduces what the pharmacy profession has strived to remove through the DoH-led Rebalancing Medicines Legislation and Pharmacy Regulation Programme chaired by Ken Jarrold CBE. Before the implementation of this legislation, pharmacy staff were alone among healthcare professionals in having the threat of criminal sanction under section 63 (adulteration of medicinal products) and section 64 (medicinal products not of the nature or quality ordered) of the Medicines Act 1968 when making an inadvertent error. This amendment has been shown to have promoted and encouraged a culture of reporting and learning from errors as well as ensuring patients and their carers are dealt with openly and honestly.

Undermining our health system transformation and workforce development

As with other healthcare professions, pharmacy is experiencing challenges in recruitment, putting increased demands on an already pressurised workforce . The Northern Ireland pharmacy work environment is already a less attractive option compared to much more competitive and attractive conditions offered in neighbouring jurisdictions. Pharmacy Forum NI is greatly concerned that unilaterally introducing this legislation into Northern Ireland will present yet another disincentive to prospective employees, thus undermining the DoH Pharmacy Workforce Review 2020 and exacerbating the workforce crisis.