New NICE guidance should help to clarify the circumstances under which Patient Group Directions (PGDs) can legitimately be used to provide prescription-only medicines, according to the GPC’s prescribing lead.
The guidance, published this month, comes after NICE found some PGDs had not been approved properly, and following controversy over the use of PGDs to sell drugs including asthma inhalers and antibiotics without a prescription by big pharmacy chains.
NICE says the availability of prescription-only drugs under a PGD must now ‘clearly benefit the patient, not compromise safety and only happen when clear processes and lines of accountability are in place’.
This means any group wanting to develop a PGD must first gain authorisation from a local PGD approval team, under the oversight of the local prescribing or clinical governance lead, as well as from the relevant authorisation body – such as the CCG, local authority, or NHS trust.
The new recommendations state: ‘Development of a PGD should not proceed until the PGD approval group, with the delegated authority of the authorising body, has formally agreed that a PGD is needed.’
They add: ‘Whatever arrangements are agreed for authorising a PGD, the commissioner and provider have a joint responsibility to ensure that this is within the legal framework, and governance arrangements are in place and remain so for each PGD.’
Professor Mark Baker, director of the centre for clinical practice at NICE, said: ‘This guidance provides an opportunity for organisations to review whether their process for authorising PGDs is in line with current legislation, and to ensure that they are not used by healthcare professionals who are not authorised to do so.’
‘PGDs often involve significant resources and are time consuming to produce. The good practice guidance therefore recommends there should be a robust and transparent process for obtaining the agreement of the authorising body before proceeding to develop a PGD,’ he added.
Dr Bill Beeby, chair of the GPC’s prescribing subcommittee, said he was optimistic that the new guidance will tighten up local governance of the approvals process, and said that some existing PGDs – including those used for sale of salbutamol inhalers through pharmacy chains – should now come under review.
Dr Beeby said: ‘The provisos within the NICE document are that whoever authorises the PGD has to make sure that people are appropriately trained, so I don’t see this as something that can be globally issued without [the approval body] ensuring that there are quality controls in the delivery of it.
‘So I don’t see that a professional organisation for pharmacists can develop a PGD that pharmacists anywhere can pick up. It doesn’t exclude pharmacies having a locally commissioned service, which could involve the supply of salbutamol, but [in that case] it would be a PGD approved locally as part of locally commissioned services under the NHS.’
NICE appears to have yielded to some criticisms from the BMA following a consultation earlier this year on the guidance. For example, it has included a statement excluding use of PGDs for treatment of erectile dysfunction, as the BMA requested.
It does not address the BMA’s call for general practices to be included as one of the bodies that can develop PGDs, but Dr Beeby said he was fairly confident that practices would now have freedom to do this through their CCG.
He added: ‘I think it clarifies beyond doubt how things are going to be approved in the future and hopefully CCGs are going to be sufficiently flexible to practice needs without great difficulty. I think this brings [PGDs] back to their original purpose of facilitating integrated care locally.’
