وجود اطلاعات کلیدی مربوط به داروها در بروشورهای داروهای روان‎پزشکی تولید شده در کارخانجات دارویی ایران

Objectives: The aim of this study was to examine information of package inserts of psychiatric drugs manufactured in Iranian pharmaceutical companies in line with safe prescription and use. Method: 104 brochures of 34 psychiatric drugs manufactured by 29 Iranian pharmaceutical companies were examined against a set of criteria compiled from the literature. The results were reported as numbers and percentages. Results: Information on drug class and action mechanism were given in 10 PIs, pharmacokinetic information in 6 and information on dose adjustment in case of concurrent use with known enzyme inhibitors or inducers drugs in 5 PIs. Also, Information from (human/animal) clinical studies on the safety or potential teratogenicity was available in 3 PIs. 12 PIs had full information on the symptoms of poisoning and required supportive initiatives. For the side effects, 15% of PIs provided qualitative information and 4% had pointed out the prevalence and incidence rate. Conclusion: The results of current study indicate lack of sufficient information in PIs of Iran-manufactured psychiatric drugs regarding their safe and appropriate use. Fundamental changes in these drugs’ PIs structure seem inevitable.