A study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warning

Dass, Ervilla2020-04-232020-04-232018-07Dass Ervilla. A study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warning. International Journal of Basic & Clinical Pharmacology. 2018 Jul; 7(7): 1232-12372319-20032279-0780http://imsear.searo.who.int/handle/123456789/199774Background: The package insert (PI) is important for providing accurate and reliable product information which is essential for the safe and effective use of medications.Methods: A total number of 115 PIs from pharmacological drug class such as antibiotics, drugs acting on central nervous system and drugs acting on endocrine system were collected from pharmacy store. Contents and presentation of the PIs was critically evaluated by comparing the information as listed in the Drugs and Cosmetics Rules, 1945.Results: The results were expressed under headings as listed in the Drugs and Cosmetics Rules, 1945. The information in the package inserts was inadequate in many aspects; for example, adverse drug reactions were not mentioned completely, information for special population and guidelines for use of the drugs also was lacking. Moreover, black box warning was seen only in few PI. For PI of antibiotics; legibility 80%, use in special populations 76.66%, undesirable effects 46.66%. For PI of CNS of legibility 60%, use in special populations 73.33%, undesirable effects 70%. For PI of endocrine system of legibility 70%, use in special populations 70%, undesirable effects 36.66%.Conclusions: The results reveal that, information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.Package insertPrescription drug labelingDrugs and cosmetic ruleA study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warningJournal ArticleIndiaDepartment of Pharmacology, Smt. Bhikhiben Kanjibhai Shah Medical Institute & Research Centre, Sumandeep Vidyapeeth an institution deemed to be University, At. & PO. Piparia, Waghodia, Vadodara 391760, Gujarat, India