In Summer 2022, the PDA raised concerns about the seemingly light-touch approach to regulation relating to pharmacy premises, yet inspections still seem to be declaring that ‘standards are met’, when they are evidently falling far short. The PDA therefore asks how bad must evidence of a pharmacy owner’s failure to meet standards be before regulatory action is required?
According to the GPhC’s website, the standards for registered pharmacies set out the requirements for the provision of pharmacy services at or from a registered pharmacy. They state that “Our standards for registered pharmacies are designed to create and maintain the right environment for the safe and effective practice of pharmacy and to improve the quality and safety of services provided to patients and the public”.
More about the GPhC’s standards can be found here.
Standards should need to be met
The GPhC inspection reports from the last quarter of 2022 reviewed by the PDA reveal that there are several essential elements which, despite obviously not meeting the criteria set, the pharmacy premises have been passed as meeting the required quality standards overall.
Concerns found in just one report include;
- Governance
“Entries in the RP [Responsible Pharmacist] record were mostly kept in line with legal requirements, but on occasions some pharmacists had not recorded the time their RP duties had ended”.
- Staffing
“They complete some ongoing training to keep their knowledge and skills up to date. But they do not always have time in the working day to complete this”.
“Over the past few months, the pharmacy was experiencing long customer queues and the team reported that many people were unhappy with the time taken for them to be seen to”.
- Services
“The pharmacy had a process in place for the team to check the expiry date of the pharmacy’s medicines. The team reported to be behind with the process. The inspector found 10 out-of-date medicines. The medicines were not marked as being short dated. So the date checking process was not robust.”
“The pharmacy also stored some medicines in the staff fridge which was mainly used to store food items.”
Despite the findings above, the pharmacy was declared as standards being met in all areas.
A second GPhC inspection report from a pharmacy operated by a different contractor in Scotland, and reviewed by the PDA, states;
- Staffing
“The regular pharmacist was no longer working in the pharmacy and the pharmacy used a mixture of employed relief pharmacists and locums. The pharmacy had opened forty-five minutes late on the day of inspection”.
“The more experienced team members reported regularly working extra hours to help cope with the workload”.
“There were six team members currently undertaking training for their roles. This meant there was limited qualified staff to help the pharmacy to operate safely and effectively.”
“The pharmacy had received recent complaints in connection with long waiting times.”
- Services
“Team members were aware of the Pregnancy Prevention Programme for people in the at-risk group who were prescribed valproate, and of the associated risks. But they did not know where the written information was kept. They gave assurance that it would be located, or a new pack ordered and kept in an accessible place”.
“The team had fallen behind with date checking stock and removing out-of-date medicines from the shelves. Some sections had not been checked for over six months.”
“Three out-of-date medicines were found by the inspector after a random check of 15 randomly selected medicines on the shelves.“
[PDA note: this represents 20% of medicines checked were out of date]
Once again, despite the findings above from the GPhC Inspector, the pharmacy was passed as standards being met.
Failure to drive quality improvement
The examples that are highlighted by the PDA demonstrate a significant level of risk which is being accepted as satisfactory.
PDA members often raise concerns like those highlighted in the inspection reports mentioned above, and the annual Safer Pharmacy Charter Survey also regularly demonstrates the inadequate working conditions and environments that pharmacists find themselves in. By continuing to overlook less than satisfactory standards for pharmacy premises, the regulator is condoning a failure of contractors to invest in their premises and staff, and effectively accepting failures to meet necessary requirements for patient care.
A significant reduction in funding over several years in England is often cited by contractors as a reason for them not being able to invest, however both reports quoted above relate to pharmacies in Scotland, where there has been an increase in funding for pharmacy contractors. Both pharmacies are therefore able to access more favourable operating funds, which includes money for training of all pharmacy staff.
The PDA are once again disappointed but not surprised by these findings and call on a more robust enforcement of pharmacy premises regulation. The PDA accept that an individual pharmacist not practicing to standards could impact on the care of patients. However, a pharmacy, or chain of pharmacies, not meeting standards can evidently impact upon the care of a greater population of patients and on multiple occasions so has the propensity to have far greater impact. For this reason, the PDA believe that the regulation of premises should be at least equivalent to that applied to individual pharmacists when they are found not to be meeting the necessary standards, yet the evidence suggests the opposite is what happens in practice.
Improving compliance with safety standards by employers will not only help to improve services and safety for patients, but it will also create the right culture and environment for driving up quality in working environments and conditions for pharmacists and pharmacy teams.
The PDA will be publishing the results of its latest annual Safer Pharmacy Charter Survey shortly.
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