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

Background: 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.

FDA's requirements for clinical pharmacology section of prescription drug labeling / 药物评价研究

FDA issued the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (final guidance)in December 2016.The Guidance stipulated that clinical pharmacology section must contain three subsections—echanism of action,pharmacodynamics,and pharmacokinetics;If necessary,it can be added to microbiology and pharmacogenomics subsections etc.,as well as explained that the contents of each subsection should be included,also discussed the writing general principles and the format of the section.This paper introduces the main contents of the guidance,with the hope of helping writing and supervision on our country labeling.