[Original preparations versus generics--latanoprost: how similar is different?]. / Originalpräparat versus Generika--Latanoprost : Wie gleich ist unterschiedlich?

BACKGROUND: To test the interchangeability of the commercially available (in Germany) latanoprost drugs and their generics respectively, the concentration of the active substance was tested. Guidelines of the European Medicines Agency postulate a sufficient bioequivalence, if the range of the agent is within 80-125% of the original drug. METHODS: All compounds of latanoprost were procured registered. The concentration of latanoprost and benzalkoniumchloride was measured by high-performance liquid chromatography (HPLC) in a validated reference labroratory for 23 generics. In addition, the mean volume of drops and the pH of the formulation were measured. The packaging label and the readability of the enclosed information leaflet were checked. RESULTS: All products contained less than 50 µg/ml latanoprost. The deviating reduction of the active substance (mean: - 7.39%, ± 2.8%) was accompanied by fluctions of the eyedrops' mass (mean: 0.03 g, ± 0.002 g). The concentration of benzalkonium chloride was mostly increased (median: 5.45%, min: - 2.5%, max: 11.5%). The pH of the original drug and the generics (median 6.78, min: 6.62, max: 6.81) was similar to the original drug, but was significantly different from an unpreserved formulation (pH 7.18). Due to type size, the packaging leaflet was illegible for humans with impaired vision. CONCLUSIONS: Before prescribing generics in ophthalmology, different factors have to be considered, which might influence the amount of IOP lowering in effect. In the absence of healthcare research it is still unclear, how different bottle forms of eyedrops--such as appearance (e.g. Cyrillic characters) or pressure point (administration)--reduce the adherence of glaucoma patients.

["Do you have a remedy for macular degeneration?" A field study about the advice given on dietary supplementation in 60 German pharmacies]. / "Haben Sie ein Mittel gegen Makuladegeneration?" Eine Feldstudie in 60 deutschen Apotheken über die Beratung zu Nahrungsergänzungsmitteln.

PURPOSE: Since completion of the AREDS study, evidence has accumulated to suggest that some form of dietary supplementation may be of value in special individuals who are at risk of progressive age-related macular degeneration (ARMD). We wanted to find out which of the many supplements available are recommended in practice and which instructions, promises, and purchasing arguments are used by German pharmacies. METHODS: A blinded consultation following a standardized protocol was carried out in 60 pharmacies. RESULTS: In 36 pharmacies specific products for dietary supplementation were recommended, but the dosage never complied with the AREDS study, and in 24 pharmacies, the necessity for a medical examination or consultation with an ophthalmologist was not mentioned. Possible interactions with other drugs or side effects were generally excluded. CONCLUSIONS: Potential risks of supplement intake were underestimated. Medical knowledge of the most frequent cause of blindness in the Western world was insufficient. A clear policy of recommendations according to evidence-based criteria is needed.