Abstract (EN):
The practice of re-packaging of medicines, by patients in different appliances and by the pharmacists in the adherence help systems, requires a preliminary study on the requisites of conservation conditions in the specialties to be re-packaged. Objective: The objective was to know the available information for patients (insert) and pharmacists (summary of product characteristics -SPC- and industry information) about conditions of preservation and eventual alteration of medicines once the original package was removed. Methods: The medicines whose sale in Granada province in September 2000 was superior to the average (only the oral solid forms of pharmaceuticals) were chosen. In December 2000 information from the manufacturing laboratories as to condition of preservation once the original package was removed, the Summary of Product Characteristics and the insert for each specialty included in the study was requested. Results: Of the 162 specialties, 148 replies were received. Only 124 sent inserts and 85 SPC. In 107 (72.3%) of the replies received were qualified as "lack of information"; the same as occurred in 70 (56.4%) of the inserts and 35 (41.0%) of the SPC. The reply for 79 specialties was that studies on stability outside the original package did not exist. Conclusions: The available information on insert and SPC does not allow either citizens or pharmaceutical professionals knowledge on individual conditions of preservation for each pharmaceutical specialty when they can be re-packaged.
Language:
English
Type (Professor's evaluation):
Scientific