The PDA has called for non-registered healthcare managers to be regulated in the wake of the Lucy Letby case.

Lessons still need to be learned around the role of leadership, management and candour when clinical harm occurs, said the union.

“There is currently no regulatory accountability for the actions of non-registered managers who exert power and influence over registered healthcare professionals,” said the PDA.

“Without the appropriate regulatory traction, their decision-making and influence, which has direct impact on patient safety, might never be called into question.

“It is essential that the government accepts the advice of the Kennedy and Francis Inquiries and either constitutes a new arm’s length body to regulate NHS managers or give that task to an already constituted regulator.”

Incidents where non-registered managers influence decisions and operations based on commercial or reputational factors, rather than patient safety, are not uncommon and not isolated to the NHS trust environment, the PDA stressed.

“[We have] significant concerns around the role of unregulated managers who exert authority and control over registered pharmacists. This is especially the case in community pharmacies which are contracted to provide NHS services but are operated by often large private companies.”

The PDA said it routinely received reports from its members of patients being affected by the actions of unregulated managers in positions of authority.

Examples include requests for a medicine that the pharmacist deems inappropriate and unsafe, which their non-pharmacist manager has overruled and sold, or the temporary closure of pharmacies for commercial reasons depriving patients of access to vital medication.

“Ten years on from the recommendations of the Francis Inquiry, and 22 years after the recommendations of the Bristol Inquiry, now is surely the time to double down on the introduction of regulation of non-registered healthcare managers at all sites where NHS services are delivered,” said the PDA.

“It should not take a further public inquiry and/or more patient deaths to recognise that the regulation of those in management posts is essential to ensure that they do not disregard concerns that are raised about the actions of individuals, patient safety, and the risk of harm.”