A questionnaire-based study to assess the awareness about package inserts amongst the resident doctors in a medical college of North India

Iram Kahkashan, Majid Farooq, Semira Imran


Background: A package insert (PI) is a document certified by the administering licensing authority, provided along the package of a drug. They are a valuable source of knowledge and can be of tremendous help to doctors as doctors are evidence based. The objective of this study was to assess the awareness about package inserts among residents in a teaching hospital in north India.

Methods: The present study was a cross-sectional, observational study carried out on residents in SKIMS Medical College, Srinagar (Jammu and Kashmir) to assess the awareness of participants regarding PIs. The questionnaire was pre-validated and then was used to elicit responses from the residents about their knowledge and opinion regarding the PIs.

Results: A total of 96 residents participated in the study. About 67.7% of the participants agreed that PIs augment drug information but only 47.9% of the residents referred PIs as a source of knowledge for indication/contraindication/ adverse effects. 57.29% asserted it is important to tell the patient to read the package insert. Unfortunately, only 8.3% of the study participants had the knowledge of DRUG ACTS governing the information to be provided on PIs in India.

Conclusions: The present study revealed that the residents have good attitude and knowledge towards PIs. However, the information provided on Package Inserts was not optimally used by them. The results of this study strongly suggest that there is a need to create awareness among resident doctors about PIs.


Knowledge, Attitude, Package inserts, Resident doctors

Full Text:



Sowmya B, Vijayalakshmi, Narayana R. Critical appraisal of patient package inserts in allopathic medicines. J Chem Pharm Res. 2015;7(3):1805-8.

Bansal V, Dhamija P, Mehdi B, Pandhi P. Package inserts-do they have any role? JK-Practitioner. 2006;13(3):152-4.

Saito M, Hirata-Koizumi M, Urano T, Miyake S, Hasegawa R. A literature search on pharmacokinetic drug interactions of statins and analysis of how such interactions are reflected in package inserts in Japan. J Clin Pharm Ther. 2005;30(1):21-37.

Jungermann H, Schütz H, Thüring M. Mental Models in Risk Assessment: Informing People About Drugs. Risk Analysis. 1988;8(1):147-55.

Joubert PH, Skene D. Attitudes of private medical practitioners towards package inserts and other drug information sources. S Afr Med J. 1984;66:306-7.

Ved JK. Package inserts in India: Need for a revision. J Int Pharm Sci Res. 2010;1:454-6.

Chhaya MU. Analysis of package inserts of orally administered drugs available in the Indian market. Int J Res Med Sci. 2017;5:529-32.

Food and Drug Administration, HHS. Requirements on content and format of labeling for human prescription drug and biological products. Fed Regist. 2006;71:3921-97.

Government of India, Ministry of Health and Family Welfare, Drug and Cosmetics Rules. 1945. Available at: file/india-drugs-and-cosmetics-act-1940-act-no-23.pdf. Accessed on 15 January 2022.

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.

Gibbs S, Waters WE, George CF. Prescription information leaflets: a national survey. J R Soc Med. 1990;83(5):292-7.

European Medicines Agency. Guideline on the Packaging Information of Medicinal Products for Human Use Authorized by the Community. 2008. Available at: pharmaceuticals/ eudralex/vol2/c/bluebox_02_2008. pdf. Accessed on 15 January 2022.

Alhomoud FK, Alnemari W, Alfahmi H, Alhomoud F, Cheema E. Incidence and prevalence of prescribing errors in Saudi Arabia: A systematic study. Int J Pharm Pharm Sci. 2016;8:194-8.

Sharma S, Sharma R, Ali SS, Ahmed T, Sachdeva D. A study of package inserts amongst medical, nursing students: A questionnaire-based study. Res J Pharmacol Pharmacodynamics. 2014;6(4):181-3.

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.

Gupta VK. Vision 2015, Medical Council of India. 2011. Available at: tools/announcement/mci_booklet. Accessed on 15 January 2022.

Vikas, Gupta MC. Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective. Int J Basic Clin Pharmacol. 2020;9(6):863-9.

Gupta R, Malhotra A. A study on awareness about package inserts among postgraduate medical students: An observational questionnaire based study. Int J Basic Clin Pharmacol. 2019;8:1034-7.

Prabha MPS, Prabhakaran SS. Assessment of knowledge, attitude and practice about package inserts among medical undergraduate students: A cross sectional questionnaire- based study. Asian J Pharm Clin Res. 2021;14(3):112-5.