Pharmacy owners and superintendents advised to get ready for big changes to pharmacy regulation

Duncan Rudkin, the Chief Executive of the General Pharmaceutical Council (GPhC), will today tell pharmacy owners and superintendent pharmacists not to underestimate the scale of the changes that the regulator’s new approach to pharmacy regulation will bring.

 

In a speech at the Pharmacy Show, Duncan will call on pharmacy owners and superintendent pharmacists to familiarise themselves with the new standards for registered pharmacies and to begin preparations for when they will need to demonstrate they have met them. 

 

The new standards have now been published and replace the interim standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses.  We are planning to bring in full enforcement powers, although not before  October 2013.

 

The GPhC has two overarching roles as a regulator – the regulation of professionals to practise pharmacy and the regulation of pharmacies. The latter role recognises that the decisions that pharmacy owners and superintendents make have a powerful influence on safety, quality and the standard of services that patients and the public receive.

 

Duncan will explain that the GPhC will have strong enforcement powers once the standards are fully operational.

 

He will say: “Our preference is always to work with pharmacy to focus on securing compliance with our standards but we need to be clear that when these standards are fully enforceable, we will have powers to issue improvement notices, to impose conditions and, ultimately if patient safety is threatened, to close pharmacies.”

 

Duncan will emphasise in his speech that encouraging and supporting professionalism provides the best protection for patients and the public. 

 

Under the new standards, pharmacy owners and superintendents will be required to demonstrate that they meet key requirements that include empowering their staff to demonstrate their professionalism to make decisions in the best interests of their patients.

 

Delegates will hear how the new inspection regime is intended to introduce a more mature relationship between the GPhC, pharmacy owners and superintendents. 

 

The requirement for pharmacy owners and superintendent pharmacists to ensure that medicines are safeguarded from unauthorised access and supplied safely will also be highlighted in the speech. 

 

Duncan will take the opportunity to reiterate that self-selection of pharmacy medicines continues to be prohibited until the GPhC’s full enforcement powers are in place and compliance guidance is published, which will not be before October 2013.  Pharmacists will continue to have to meet the legal requirement to supervise the sale of a Pharmacy (P) category medicine, and the GPhC would have to be notified in advance of any intention to enable self-selection of medicines so that checks can be made that the required standards for the safe supply of medicines are being achieved.

 

The Standards for registered pharmacies are now available on the GPhC website and were launched at the Pharmacy Show, after being approved by Council last month.