Volume 22, Issue 2 (Summer 2016)                   IJPCP 2016, 22(2): 122-133 | Back to browse issues page


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Zarghami M, Azari A, Ghasemi S, Hormozpour M, Hendouei N. Availability of Drug Key Information on Package Inserts of Psychiatric Drugs Manufactured in Iranian Pharmaceutical Companies . IJPCP. 2016; 22 (2) :122-133
URL: http://ijpcp.iums.ac.ir/article-1-2602-en.html

Department of Pharmacotherapy, Faculty of Pharmacy and Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences , Email:hendoieen@yahoo.com
Abstract:   (2318 Views)

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.

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Type of Study: Original Research | Subject: General
Received: 2016/11/27 | Accepted: 2016/11/27

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