A study on awareness about package inserts among postgraduate medical students: an observational questionnaire based study

ABSTRACT

Background: A package insert is a document approved by the administering licensing authority, which is provided with the package of a drug. A good package insert can prove to be of immense help to doctors as they are evidence based and are updated from time to time. The objective to study the awareness about package inserts among postgraduate medical students.Methods: The present study was a cross-sectional observational study carried out on 68 postgraduate medical students of Acharaya Shri Chander College of Medical Sciences and Hospital Sidhra, Jammu (J & K) in the month of February 2017 after taking approval from the institutional ethical committee. Pre-validated self-administered questionnaire was used to elicit responses from the students. The questionnaire consisted of specified questions regarding knowledge and opinion about package inserts.Results: In the present study, 86.7% of the students understand the relevance of Package inserts (PIs). About 72% of the students think that PIs are a necessary add-on to drug information and 70.6% of the students think that information given on package inserts is necessary for the patients. However, only 2.9% of the students had the knowledge of Drug Acts governing the information to be provided on PIs in India. About 86.8% of the students think that PIs should also be in regional language apart from in English language.Conclusions: It was found from the present study that the majority of the postgraduate students were aware about the package inserts available with the medicines but the information provided on package inserts was not optimally used by them. To achieve the target of optimally utilization of information provided in the package inserts, the PIs should be designed by considering the needs and information of two differently educated target groups i.e; patients and doctors.