Pharmaceutical Regulation Changes – Dec 2016


The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016

PSNC website link : http://psnc.org.uk/contract-it/pharmacy-regulation/

On 5 December 2016, amendments to the 2013 Regulations come into effect. The full extent and nature of these amendments can be found here.

1.Pharmacy consolidations (mergers)

NHS pharmacy businesses may apply to consolidate the services provided on two or more sites onto a single site. Such consolidations could require a change in the ownership of one of the businesses concerned. A process to facilitate such consolidations will be in place.

Applications to consolidate will be dealt with as “excepted applications” under the 2013 Regulations, which means in general terms they will not be assessed against the pharmaceutical needs assessment (PNA). Instead, consolidation applications will follow a simpler procedure, the key to which is whether or not a gap in pharmaceutical service provision would be created by the consolidation. Some provision is also made in respect of continuity of services – for example, if NHS England intends to commission from the applicant “enhanced services” (additional pharmaceutical services, such as minor ailments schemes, that are commissioned locally by NHS England) that have been provided at or from the closing premises, the applicant is required to provide undertakings to continue to provide those services following consolidation.

If NHS England is satisfied that the consolidation would create a gap in pharmaceutical services provision, it must refuse the application.

The opinion of the Health & Wellbeing Board (HWB) on whether or not a gap in pharmaceutical service provision would be created by the consolidation must be given when the application is notified locally and representations sought. If the application is granted and pharmacy premises are removed from the relevant pharmaceutical list, if the HWB does not consider that a gap in service provision is created as a consequence, it must publish a supplementary statement published alongside its PNA recording its view.

If NHS England grants the application, it must then refuse any further “unforeseen benefits applications” seeking inclusion in the pharmaceutical list, if the applicant is seeking to rely on the consolidation as a reason for saying there is now a gap in provision, at least until the next revision of the PNA.

2.Supplementary prescribers

There are provisions for the prescribing and dispensing, as part of NHS primary care services of prescriptions written by therapeutic radiographer independent prescribers and dietitians who are entitled to prescribe as supplementary prescribers. These changes allow pharmacy contractors to dispense against NHS prescriptions issued by these new types of prescriber.

3.Emergency supply and the NHS prescription charge

NHS pharmacy contractors and LPS contractors who undertake emergency supplies of medicines at the request of a patient in accordance with the Urgent Medicine Supply Service are permitted to charge the NHS prescription charge.

4.The terms of service

NHS pharmacy contractors who have such emergency supply arrangements are not obliged to publicise them as part of their clinical governance programme. Clinical governance programmes are not generally required terms of local pharmaceutical services contracts.