Astep towards large-scale implementation of patient group directions (PGDs) has been taken this week. In the National Institute for Clinical Excellence (NICE) guidance on zanamivir (Relenza), which recommends its use in at-risk groups, the NICE says that the drug should be made available through PGDs.
In the guidance, zanamivir is recommended for adults in the following at-risk groups when influenza is circulating in the community:
The NICE suggests that PGDs are used to allow direct supply of zanamivir by community pharmacists and nurses. This, and telephone triaging by practice nurses or other health care professionals, could help to minimise additional consultations with general practitioners. In a document about implementing the NICE guidance issued by the Department of Health and the National Assembly for Wales (NAW), the use of PGDs in England is encouraged. "It is possible that local community pharmacies may be able to offer an integrated service, including consultation and supply under PGD. Such arrangements, including fees and reimbursement, would be subject to local negotiation and agreement," the document states.
The DoH adds that there will be amendments to regulations to make it clear that usual prescription charge rules will apply to non-exempt patients and that exempt patients will need to complete a declaration of entitlement. The cost of zanamivir supplied through PGDs will need to be separately reimbursed by health authorities and primary care groups/trusts, the DoH says.
At a press conference launching the NICE guidance on November 21, Mr Andrew Dillon (chief executive, NICE) said that he believed that there was time for PGDs to be set up this year and that they offered big advantages for both the National Health Service and patients. Asked whether he thought a large number of health authorities would implement PGDs, Mr Dillon said "yes". They were they most obvious and convenient way that patients could get zanamivir, he added.
Support for supply of zanamivir through PGDs also came from Dr John Chisholm (chairman, general practitioners committee, British Medical Association). He said in a press release issued on behalf of the committee on November 21: "In order for general practice to have any hope of coping, it is essential that every local health care organisation puts in place arrangements for PGDs which will allow the dispensing of zanamivir to high-risk patients with symptoms of influenza without the need for a face-to-face consultation with a GP."
A spokesperson for Glaxo Wellcome told The Journal on November 22 that PGDs would allow a "more efficient approach to influenza management".
The NICE guidance recommends that zanamivir should be given to patients who present within 36 hours of the onset of influenza-like illness and who are able to commence therapy within 48 hours of symptom-onset. It is because of this need for quick access that the use of PGDs is being encouraged. At the press conference, a NICE spokesperson said that it might be difficult for all patients to get an appointment with their GP in time so PGDs could speed up patients' access to zanamivir. Pharmacists could identify influenza by using a list of symptoms in the same way that GPs do. The DoH says that the symptoms of influenza are rapid onset (hours) from feeling well to very ill, prostrating malaise, profound myalgia, marked fever (>37.8C oral), headache, minimal nasal secretions and limited or absent appetite. Cough, sore throat, nausea and vomiting may also occur. Zanamivir is only recommended when community-based virological surveillance schemes, including those organised by the Royal College of General Practitioners and the Public Health Laboratory Service, have indicated that influenza is circulating in the community. At other times of year, it may be harder for influenza to be distinguished from other viral diseases, the NICE says. The guidance does not apply to a pandemic or to a widespread epidemic of a new strain of influenza to which there is little or no community resistance. In such circumstances, the DoH and NAW might want to reconsider the extent to which the guidance should be varied, said Mr Dillon.
The NICE estimates that the number of patients eligible to receive zanamivir will be between 97,000 and 487,000 patients this season. This could result in a total cost of between £2.3m and £11.7m in England and Wales. However, the NICE adds that decreases in hospitalisation will influence actual costs.
The turn-around from last year's recommendation against the use of zanamivir was brought about by additional trials evidence, the NICE says. For at-risk adults, zanamivir reduces the duration of symptoms by 1.2 days. In addition, evidence showed that zanamivir reduces the absolute risk of complications requiring antibiotics by 6 per cent.
In a press statement issued on November 21, the health minister, Mr John Denham, welcomed the guidance but added "immunisation remains by far the best method of protection against influenza". However, where vulnerable patients developed influenza, zanamivir would give the NHS "a new weapon to combat its effects".
The guidance will be reviewed in 2002.
Comment p773
A patient group direction (PGD) authorises the supply of a medicine to certain groups of patients under specified circumstances. It provides another method for pharmacists to supply a prescription-only medicine apart from against a prescription. A PGD is authorised by a primary care trust, health authority or NHS trust.
The DoH has posted a model PGD for supply of zanamivir on its website (www.doh.gov.uk/zanamivirguidance).