Written medicine information in Australia

Abstract

Thank you for the opportunity to comment on the short research report by Vitry et al. (Vol 31; pp. 154–157). There has been considerable publicity created by this article in Australia, primarily because of the data published on the provision of Consumer Medicine Information (CMI) by community pharmacists. As a researcher in this area, I was concerned at the article’s content, specifically at the lack of referencing to the research on CMI and Package Insert Leaflets (PILs) (e.g. [1–5]), and the limited information on the methods used. Whilst I appreciate that the article was a short research communication and bound by the Journal’s guidelines, I felt that important information had been compromised by the authors. The authors have not reported on other studies which have examined the provision and use of CMI by community pharmacists in Australia [1, 3], nor have they compared their findings to those studies. Historical comparisons are important in light of the date of their data collection (May– June 2005), and as CMI availability has been changing since its inception in 1993. The authors should highlight the proportion of CMI which were available as package inserts and electronic formats for the medicines taken by their consumers, as CMI type has an impact on its provision and use by consumers [2]. Although the reported study was part of a larger project, the authors have not adequately presented the research methods. For example, the following information is missing: community pharmacies’ response rate; number of participating pharmacies per state; the nth value and rationale for selection; consumer sample size calculation and rationale (for both methods); process and rationale for weightings; inclusion/exclusion criteria; was CMI offered and rejected by consumers; survey length and completion time; and most importantly, the questions that asked about CMI provision, their development, validation and reliability checking. Interestingly 46% of phone survey respondents reported that ‘‘they never or rarely received written information on how to use the medicine apart from what is on the bottle or packaging’’. Does this mean that 54% received written information? If so, this does not support the author’s conclusions. Moreover, it is not clear what proportion relates to prescription and over-the-counter (specifically Schedule 2 or 3) medicines. CMI is required only for prescription and Schedule 3 medicines in Australia, not Schedule 2. The authors have concluded that ‘‘the strategy of CMI distribution via pharmacies in Australia has failed to reach acceptable levels’’. The Pharmaceutical Society of Australia’s guidelines on CMI provision do not set acceptable numerical levels. To reach this conclusion, it would be appropriate for the authors to operationally define acceptable levels, provide more detailed data to justify whether a CMI is necessary for the consumer (e.g. actual medicine collected, previous receipt of information, need for information [4], patient characteristics [2]), and compare the recalculated levels of CMI provision against their definitions of acceptable levels. One must not lose sight of the fact that simply providing a CMI (e.g. as a package insert or inside the medicine bag) may not be effective. The CMI is an important educational tool that should be incorporated as part of the verbal counselling of community pharmacists, together with other types P. Aslani (&) Faculty of Pharmacy, The University of Sydney, Building A15, Sydney, NSW 2006, Australia e-mail: parisa@pharm.usyd.edu.au