Letby case sparks PDA's call for regulating non-registered healthcare managers including in pharmacy practice

The life imprisonment sentence given to Nurse Lucy Letby, following her conviction for causing the deaths of seven newborns and attempting six more murders, has sparked crucial conversations about the enduring requirement for improved leadership, management, and transparency within the healthcare sector.

According to The Pharmacists’ Defence Association, the handling of the case demonstrates why lessons still need to be learned when clinical harm occurs, and questions are rightly being asked about the role and accountability of senior managers.

After the criminal case's conclusion and sentencing of Letby, the government ordered an inquiry to pinpoint system failures and suggest ways to prevent such tragedies in the future. While the outcomes of any forthcoming inquiry into the Letby case will require time, the PDA stated that various issues under scrutiny hold relevance across all healthcare domains including pharmacy.

The PDA noted that governments swiftly commission inquiries following prominent cases that expose operational and governance issues within NHS settings. However, they frequently hesitate to adopt the recommendations arising from these inquiries.

Despite many of the inquiries also highlighting the role of managers and senior leaders within the NHS settings where patient harm has occurred, the PDA noted that many aspects around the regulation of these managers have still not been accepted by government.

‘Unregulated pharmacy managers: A major concern’

In the realm of pharmacy practice, the PDA said it holds notable apprehensions about the influence of unregulated managers who wield power over registered pharmacists. This is particularly evident in community pharmacies, where the provision of NHS services is contracted to large private corporations, the union said.

While cases like Letby's have garnered national attention, the PDA noted that there are many less severe situations where patients are affected by the decisions of unregulated managers in positions of power.

The PDA consistently receives member reports about such occurrences including:

• The request for a medicine that the pharmacist deems inappropriate and unsafe, which their non-pharmacist manager has overruled and sold.
• The area manager who has demanded a pharmacist delivers a greater volume of vaccinations, despite the concerns raised by the pharmacist that the rest of the pharmacy operation could not be suitably supervised due to severe shortages of staff.
• The temporary closure of pharmacies for purely commercial reasons depriving patients of access to vital medication.

While these incidents and numerous others might not capture national headlines, they still impact patients and undermine pharmacists' ability to uphold safety, the union added.

Drawing from its members' numerous experiences and in response to the Francis Inquiry report 2013, the PDA held a meeting with the General Pharmaceutical Council in 2015. During this meeting, the PDA advocated for the implementation of regulations for non-registered managers.

“Regrettably, this proposal was not approved,” PDA noted.

‘Duty of candour often neglected’

Responding to the GPhC's consultation on indicative sanctions in 2015, the PDA emphasised, "The Francis Report revealed that the duty of candour was often neglected. However, it also uncovered that healthcare staff's efforts to fulfil this duty could be hindered by the management and organisational culture of their employer."

“Without employer support, or at the very least, the guarantee of no internal disciplinary consequences for discussing errors or issues with patients/healthcare professionals, healthcare staff find it significantly harder to uphold the duty of candour. Consequently, focusing the guidance on sanctions against pharmacists without imposing any obligations on employers and non-pharmacists will result in an imbalanced and disproportionate regulatory approach,” the PDA said quoting the report.

‘Regulation is crucial’

A decade after the recommendations of the Francis Inquiry and 22 years following the suggestions of the Bristol Inquiry, the PDA emphasised that the current time undeniably demands a renewed dedication to enforcing regulations for non-registered healthcare managers at all sites where NHS services are delivered.

The union said the necessity of regulating individuals in management positions should not require another public inquiry or additional patient fatalities to be acknowledged. “This regulation is crucial to prevent the dismissal of raised concerns about individual actions, patient safety, and the potential for harm,” the PDA added.

Meanwhile, the PDA recently highlighted that wage theft is a common issue among pharmacists and trainee pharmacists, involving employers and contractors who often neglect to pay for overtime, make wage deductions, and withhold payments. In 2023, the union aided locum pharmacists in reclaiming £65,000 in unpaid wages. The PDA also emphasised the importance of pharmacists keeping their own copies of agreements and pointed out the range of employment and locum contracts.