The availability of antimicrobial agents for self-medication may increase and could include antibacterial agents for oral or topical use. Wholesale deregulation of antibacterials would be undesirable and likely to encourage misuse of classes of agents currently important in the management of serious infections. Changed regulation from Prescription-Only Medicine (POM) to Pharmacy (P) medicine of selected agents with indications for short-term use in specific minor infections and illness is likely to have advantages to the user. However, safeguards to their use would need to be included in the Patient Information Leaflet (PIL). Agents and indications for self-medication are discussed. Any alteration in licensed status from POM to P will require careful risk-benefit assessment, including the likely impact on bacterial resistance. Safety issues also include concerns relating to age of the user, pregnancy, underlying disease and the potential for drug interactions. The importance of appropriate information with the PIL is emphasized, as is the role of the pharmacist, while ways of improving adverse event notification and monitoring are discussed. The paucity of good denominator-controlled data on the prevalence of in-vitro resistance is highlighted, and recommendations for improving the situation are made. There are currently no levels of resistance accepted by regulatory bodies on which to base a licensing decision, be it for granting a product licence, renewal of a licence or a change in licensed status from POM to P. Due consideration should be given to: the validation of user-defined indications in comparison with those medically defined; the enhancement of pharmacy advice in the purchase of such agents; improved safety monitoring; the establishment of systematic surveillance of susceptibility data.

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A survey was undertaken to assess the views of the manufacturers of over-the-counter (OTC) products about (i) the value of patient information leaflets (PILs), (ii) the recent European Community directive relating to PILs and (iii) the procedures which are in place for producing and testing PILs. Although approximately half (15/31) of the respondents (response rate 31/58) thought that PILs were more important for OTC than prescription only medicines, this view was not unanimous. A majority (18/28) thought that the new EC directive would provide too much information to patients although only a small number (2/27) thought that the regulations were unnecessary. Indication for the product was thought to be the most important information for the immediate outer packaging. Only about one-third (35%) of patients are thought to read PILs, in contrast to the majority who read the outer packaging. A wide variety of departments contribute to preparing PILs. The marketing department had a major input particularly with respect to layout and testing of leaflets. On the whole the design and production of PILs involves considerable effort but their testing appears less structured and thorough.

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