The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the PLPS Regulations”). The PLPS Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006, for the provision of pharmaceutical and local pharmaceutical services. The PLPS Regulations include the National Health Service (“NHS”) terms of service of four different types of provider: retail pharmacy businesses on pharmaceutical lists held by the NHS Commissioning Board (known as “pharmacy contractors”); dispensing appliance contractors (known as “DACs”); dispensing doctors; and the retail pharmacy businesses that hold local pharmaceutical services contracts (known as “LPS contractors”). These Regulations also amend the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (“the Charges Regulations”), which include the charges payable for the supply of drugs and appliances as part of the NHS in England.

These Regulations include measures that are part of the response to the coronavirus pandemic, related to which is the expansion of the national programme for immunisation against influenza. The Charges Regulations are amended to ensure that all coronavirus and influenza immunisations administered by NHS providers to eligible patients are to be supplied free of charge (regulation 29). Pharmacy contractors may, with the agreement of the NHS Commissioning Board and for a specified period, limit the NHS pharmaceutical services provided at pharmacies to the administration of vaccinations or immunisations against coronavirus and influenza (regulation 13). Provision is also made so that pharmacy contractors and dispensing doctors are required to supply against so-called “pandemic treatment protocols”, which allow for the supply, without a prescription, of prescription only medicines used for the prevention or treatment of diseases that are, or in anticipation of them being imminently, pandemic. There are supplementary provisions related to this requirement dealing with matters such as dispensing labels (regulations 2(b), 6, 7, 8(b) and 20 to 22).

These Regulations also include a number of service developments, in particular for pharmacy contractors. Pharmacy contractors are required to facilitate remote access to their services (regulation 18), and pharmacy contractors and LPS contractors are required to have, and to have constant and reliable access to, the Electronic Prescription Service (the system used for the transmission of electronic prescriptions between different providers of the NHS primary care services) when they are open for business – in so far as this is within their control (regulations 17 and 28). There are also measures to deal with circumstances when the system is temporarily unavailable (regulations 8(a), 10, 24 and 26). Pharmacy contractors and LPS contractors are also required to have, and to have constant and reliable access to, a networked system of NHS patient summary care records (regulation 16 and 27), and a premises specific NHSmail account – generally with two live NHSmail accounts for their staff. They must also register with and use the Central Alerting System operated by the Medicines and Healthcare products Regulatory Agency. Additionally, pharmacy contractors must have comprehensive and accurate pharmacy profiles in the NHS Digital directory of services and on the NHS.uk website (regulations 2(a), 17 and 28). Also, where pharmacy contractors and LPS contractors are unable to supply a prescription item immediately and instead provide a note of the item that is owed, this may be in an electronic instead of a paper form (regulations 9(a) and 25).

Separately, pharmacy contractors existing obligations in relation to public health campaigns are revised so that the campaigns can relate, more broadly, to health issues – and so as to support service evaluation and policy development (regulations 2(a) and 11). Their clinical governance requirements are also amended, in particular to allow those to accommodate the promotion of healthy living, and around training and certification (regulation 14). Distance selling pharmacies are also required to have a health promotion zone on their website (regulation 15).

The most significant change for pharmacy contractors, however, in terms of the additional services they are expected to provide, is the introduction of a new discharge medicines service. When NHS patients are discharged from hospital or there is, for other reasons, a transfer of care of them between different providers of NHS services, community pharmacies may be asked to perform a three stage service in respect of the patient, principally linked to changes in medication. The second and third stages of this service are linked to the first prescription presented post-discharge or post-transfer. Issues of concern may be raised by the pharmacy contractor not only with the patient or their carer but also with their general practitioner (regulation 12). Partly to support this new service, pharmacies are required to have a consulting room (previously these were needed to support certain non-mandatory pharmaceutical services), although equivalent remote access arrangements are permitted for distance selling pharmacies and some small pharmacies (regulation 15).

There are also changes to the inspection and access to information requirements to facilitate remote monitoring of pharmacy contractors (regulation 19), and some minor, technical changes. Pharmacy contractors are no longer formally required to undertake training in respect of repeat dispensing (regulation 9(b)), both pharmacy contractors and DACs are required to notify the NHS Commissioning Board if they enter into administration (regulation 3) and there are also changes to the notification requirements when pharmacy contractors and DACs open new premises (regulation 4).