SUMMARY
Background NPM market is growing at higher rates than the average pharmaceutical market. In Portugal, non-prescription medicines (NPM) are available, since 2005, outside pharmacies and there is no list Pharmacy-Only Medicines (POM). The first centralized switch (orlistat) opened the door for a new generation of NPM.ObjectivesTo describe: the EU context related to distribution channels and Pharmacy-Only status of NPM; the profile of a new generation of NPM resulting from centralized switch; and the implications for Pharmacy Practice.SettingCommunity PharmacyMethods Literature review.ResultsOTC (including NPM) world sales outgrew pharmaceutical sales for the first time in 2008. In Portugal, NPM represented 7.4% of pharmaceutical sales in 2009. From all 27 EU countries reviewed, 14 have exclusive distribution of NPM through pharmacies. Of the remainder 13 that allow distribution outside pharmacies, only 4 do not have a restricted list with POM status, including Portugal.NPM under General Sales must meet safety criteria and the POM status also often requires pharmacies to fulfill additional obligations.The new generation of NPM from centralized switch is expected to expand to chronic conditions associated to lifestyle modifications.ConclusionsThe diverse legal framework in EU concerning distribution channels and the availability of POM should be reviewed according to a growing NPM market and to a new generation of NPM emerging from centralized switch for the interest of Patient Safety. Pharmacists must prepare themselves to assume higher roles in the dispensing and post-authorization safety monitoring of future NPM.Published in: 70th International Congress of FIP, 28th August to 2nd September, Lisbon, Portugal