By Neil Trainis

The Pharmacists’ Defence Association has renewed its criticism of the General Pharmaceutical Council for what it claims is the regulator’s “light-touch approach to regulation” of owners of pharmacy premises.

The GPhC has previously rejected suggestions it has taken a lenient approach to regulating owners but the PDA said the regulator was “continuing to overlook less than satisfactory standards for pharmacy premises” and, as a result, was “condoning a failure of contractors to invest in their premises and staff and effectively accepting failures to meet necessary requirements for patient care.”

The PDA’s latest critique of the GPhC follows its review of inspection reports of pharmacies in Scotland during the last quarter of 2022. The PDA claimed the reports showed the GPhC passed premises as meeting its overall standards despite their failure to fulfil the criteria.

In one report, the PDA said, a pharmacy premises was declared to have met all the standards even though there were concerns about governance, staffing and services. Some pharmacists did not record the time their Responsible Pharmacist duties had ended and staff were not always able to complete their training.

The PDA also said GPhC inspector found 10 outdated medicines which were not marked as out-of-date and some medicines were put in the staff fridge which was normally used to store food.

In another inspection report of a different contractor, the PDA said the pharmacy opened 45 minutes late on the day of the inspection and received complaints about long waiting times. Even though staff were aware of the Valproate Pregnancy Prevention Programme, they did not know where the written information was kept when it came to supplying the medicine to at-risk patients.

The PDA also noted that staff had failed to check the date of all its stock and remove out-of-date medicines.

“Some sections had not been checked for over six months,” it said, revealing that three out-of-date medicines were found during the inspection after a random check of 15 medicines. The GPhC passed both premises as meeting its standards.

The PDA, who said it would shortly publish the results of its latest Safer Pharmacies Charter, said it was “once again disappointed but not surprised” by the findings and called for “a more robust enforcement of pharmacy premises regulation.”

Patient safety is our key focus, insists GPhC

The GPhC’s enforcement powers came into force in 2018 and before that, pharmacies that failed to meet its standards were issued with an improvement action plan.

The regulator told Independent Community Pharmacist that since the GPhC’s creation in September 2010, 2,865 pharmacies which went through 3,441 inspections in total failed to meet all the standards and each of those pharmacies underwent an improvement action plan.

The GPhC also said it has served 113 enforcement notices against 95 pharmacies “to address immediate risks to patients and the public” since it published its enforcement policy in March 2019, with online pharmacies making up “a high proportion” of its enforcement activity.

Insisting patient safety is its “key” focus, the GPhC said: “We have a number of different enforcement options available to us to secure compliance with our standards. These range from improvement action plans to statutory enforcement powers including improvement notices and conditions on registered pharmacy premises.”

The GPhC said if a pharmacy owner fails to “make sufficient improvements” to meet its standards, it then considers “statutory enforcement through service of a Conditions Notice or an Improvement Notice.”