The use of patient group directions for zanamivir in 2000/2001: Cross-sectional survey of primary care organisations in England
Hippisley-Cox J., Pringle M., Cater R., Wynn A., Hammersley V., Coupland C.
Background: In November 2000, the National Institute for Clinical Excellence (NICE) issued guidance on the use of zanamivir for high-risk patients with influenza. The Department of Health introduced patient group directions in August 2000 in order to alow primary care organisations to permit nurses and pharmacists to supply certain medications, such as emergency contraception, under defined circumstances without a general practitioner (GP) prescription. Aims: To report on the implementation of patient group directions for zanamivir, in particular their utilisation, feasibility and acceptability, and to derive recommendations for the future use of patient group directions. Design: Cross-sectional postal questionnaire survey Setting: AD 474 primary care organisations in England in March 2001. Participants: Clinical governance leads. Outcomes: Whether a patient group direction was used or not and the reasons why; the timing of the implementation; the utilisation of patient group directions by pharmacies, practices and patients; the proportion of patients referred to their GP; the number of adverse events recorded; the cost of setting up and running patient group directions and any specific issues which arose. Results: The response rate was 338/474 (71.3%). Forty-three (12.7% of 338 respondents) reported that their organisation used a patient group direction for zanamivir. The main reasons for not using a patient group direction for zanamivir were: time or other resource constraints; concerns over validity and appropriateness of the NICE guidance for zanamivir; concerns regarding the cost-effectiveness of zanamivir, and its appropriateness for a patient group direction approach. Other reasons included competing priorities with other initiatives such as flu immunisation; concerns about the appropriateness or safety of patient group directions for a new black triangle drug; lack of clinical need or demand; an absence of the necessary decision-making processes; lack of agreement between stakeholders; the use of a reasonable alternative; other practical implementation difficulties including inadequate training. Conclusions: The Department of Health's response to the workload implications of the introduction of zanamivir was to introduce patient group directions. However they need to be in place before an epidemic and were not significantly in place for the winter of 2000/2001. In the event of a flu epidemic this winter, on this evidence, primary care is unlikely to cope with a high demand for fast access to zanamivir.