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Patient group directions may not be safest option for patients, says NICE

Bypassing GPs to widen access to prescription-only medications through patient group directions (PGDs) is not always the safest option for patients, says NICE.

In new draft guidance on PGD schemes, NICE says authorising bodies must carefully weigh up whether or not a proposed PGD is appropriate – even if it would be legal to introduce it.  

The guidance also warns that some PGDs allowing access to prescription-only medicines may not been developed following the proper procedures, with some appearing to omit the requirement to gain agreement of an ‘authorising body’.

The advice comes after the National Pharmacy Association was forced to rethink its plans to make a host of prescription-only medicines (POMs) - such as antibiotics and salbutamol inhalers - available directly from pharmacists under a PGD after opposition from the Department of Health and the GPC.

PGDs were introduced in 2000, with the aim of increasing patients’ access to POMs and promote self-care. They enable healthcare professionals to provide medicines directly to groups of patients fitting the criteria laid out in the PGD, without the need for a prescription or an instruction from a prescriber.

But NICE says that they are often introduced when independent prescribing by other healthcare professionals would be a better choice.

The new guidance states: ‘Even in some circumstances when it may be legally possible, the GDG [Guidelines Development Group] agreed that a PGD may not be the preferred and safest approach to individual situations of providing patients with the medicines they need.’

NICE calls for particular caution in decisions on PGDs covering antibacterials, stating their inclusion must not jeopardise strategies to combat increasing microbial resistance. And it stresses that, while correct dosing can be advised under a PGD, it is inappropriate for medicines requiring frequent individual dosing adjustments.

NICE also pointed out that in some cases PGDs were not being developed with the requisite agreement from authorising bodies.

It states: ‘Some organisations had processes in place to obtain the agreement of the authorising body for the PGD before proceeding to develop the PGD. In other organisations this step appeared to be omitted from the process.’

Where PGDs are not appropriate

Management of long-term conditions

Antimicrobial use – ensure clinically essential, will not jeopardise antimicrobial resistance strategies

Where frequent dosage adjustments (e.g. warfarin) or frequent/complex monitoring (e.g. immunosuppressants) needed

High-risk medicines, eg, insulin

Source: Patient Group Directions – Draft NICE good practice guidance


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Readers' comments (3)

  • As my husband would say " No shit Sherlock"

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  • What are "authorising bodies" and how are they held accountable?
    I was never clear about the legal background for the National Pharmacy Association having the remit to issue PGDs: who *is* in a position to issue them? and who is liable if, for any reason, the patient is harmed by medication issued/administered under a PGD?

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  • The NPA does not itself write or authorise PGDs. It is promoting the PGDs of a separate 'independent medical agency' called MPS.

    PGDs are signed by a doctor or dentist, a pharmacist, and a representative of the authorising body.

    The bodies which can authorise PGDs are specified in 'The Human Medicines Regulation 2012'. They include various CQC registered non-NHS bodies and NHS bodies. There are transitional arrangements in place to take account of the need for PGDs written by PCT, and other no longer existing bodies, to be taken over by new bodies, such and CCG.

    Legislation is specific about what a PGD must include and which practitioners can use them. There is also MHRA guidance about PGDs, some of which is referred to in the new draft of NICE guidance.

    The draft guidance from NICE refers to PGDs used in the NHS, although much of the guidance would also be applicable to PGDs for non-NHS use.

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