Availability of Drug Key Information on Package Inserts of Psychiatric Drugs Manufactured in Iranian Pharmaceutical Companies

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.
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.
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.
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.