A study on awareness about package inserts among postgraduate medical students: an observational questionnaire based study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20191597Keywords:
Awareness, Knowledge, Package inserts, Postgraduate students, QuestionnaireAbstract
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.
References
Sowmya B, Vijayalakshmi, Narayana R. Critical appraisal of patient package inserts in allopathic medicines. J Chem Pharm Res. 2015;7(3).
Deo M. Doctor population ratio for India-The reality. Indian J Med Res. 2013;137(4):632-5.
Chhaya MU. Analysis of package inserts of orally administered drugs available in the Indian market. Int J Res Med Sci. 2017;5:529-32.
Weitbrecht WU, Vosskamper C. Influence of the drug package information paper on compliance of neurological and psychiatric outpatients. Fortschr Neurol Psychiatr. 2000;70(4):178-84.
Bjerrum L, Foged A. Patient information leaflets – helpful guidance or a source of confusion? Pharmacoepidemiol Drug Saf. 2003;12(1):55-9.
Gibbs S, Waters WE, George CF. Prescription information leaflets: a national survey. J R Soc Med. 1990;83(5):292-97.
Mottram DR, Reed C. Comparative evaluation of patient information leaflets by pharmacists, doctors and the general public. J Clin Pharm Ther. 1997;22(2):127-34.
Regner MJ, Hermann F, Ried LD. Effectiveness of a printed leaflet for enabling patients to use digoxin side-effect information. Drug Intell Clin Pharm. 1987;21:200-4.
Dawoodi and Bhosale: Knowledge and awareness of patients about package inserts: A cross-sectional study. Asian J Pharmaceu. 2016;10(2):S97.
Singh KR, Munshi R and Arora D: Assessment of the Degree of Awareness among Physicians and Patients about Drug Package Inserts. Int J Pharm Sci Res. 2016;7(3):1258-62.
Shivkar YM. Clinical information in drug package inserts in India. J Post grad Med. 2009;55:104-7.
Tayyem M, Takrouri MS. Patient’s Safety Information Available on drug package inserts used in Neuroanaesthesia. Internet J Anaesthesiol. 2008;19(2):1-7.
Davis TC, Wolf MS, Bass PF 3rd, Middlebrooks M, Kennen E, Baker DW, et al. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006; 21(8):847-51.
Joubert PH, Skene D. Attitudes of private medical practitioners towards package inserts and other drug information sources. S Afr Med J. 1984;66(8):306-7.
Jin J, Sklar GE, Li SC. Factors affecting therapeutic compliance: A review from the patient’s perspective. J Urban Health. 2007;84(6):742-54.
