ASSESSMENT OF KNOWLEDGE, ATTITUDE, AND PRACTICE ABOUT PACKAGE INSERTS AMONG MEDICAL UNDERGRADUATE STUDENTS: A CROSS-SECTIONAL QUESTIONNAIRE-BASED STUDY

  • SNEHA PRABHA MP Department of Pharmacology, Government Medical College, Thiruvananthapuram, Kerala, India.
  • SONISH S PRABHAKARAN Department of Pharmacology, Government Medical College, Thiruvananthapuram, Kerala, India.

Abstract

Objective: The objective of our study was to assess knowledge, attitude, and practice regarding package inserts (PIs) among medical undergraduates of a Government Medical College in Kerala, India


Methods: A cross-sectional, questionnaire-based study was carried out on 100 medical students. It was conducted with the consent of all participants and after the approval of Institutional Review Board and Ethics Committee. Pre-validated 15 items questionnaire was used to elicit responses about knowledge, attitude, and practice with a scoring scheme of +1 for “yes”/positive response and 0 for “no/I don’t know”/negative response. Data analyzed using “SPSS” and responses were expressed as mean scores and percentages.


Results: Statistical analysis (response rate 98%) revealed that 88.2% have seen PIs but only 18.4% had the knowledge of drug acts governing the information to be provided on PIs in India. About 78.6% agreed PIs are necessary add-on to drug information. About 62.2% opined that PIs must be in regional language along with English. About 100% agreed that written information in PIs is difficult to read and understand. About 66.3% feel that doctors must instruct patients to read PIs thoroughly. About 71.4% have referred PIs as a source of knowledge for Indication/Contraindication/ Adverse Effects/Drug interaction. About 95.9% would like to refer PIs in future while prescribing as physician.


Conclusion: We conclude that participants have positive attitude toward PIs but have less knowledge as compared with developed countries. Results suggest the need for escalating knowledge and awareness among medical students about PIs which, in turn, help to minimize medication errors.

Keywords: Questionnaire, Package inserts, Knowledge

References

1. Srivastava B, Prakash C, Sinha AK. Errors in drug labeling and medico-legal awareness. J Indian Acad Forensic Med 2011;32:228-30.
2. Ved JK. Package inserts in India: Need for a revision. J Int Pharm Sci Res 2010;1:454-6.
3. 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.
4. Government of India, Ministry of Health and Family Welfare, Drug and Cosmetics Rules; 1945. p. 265. Available from: http://www. emergogroup.com/sites/default/files/file/india-drugs-and-cosmetics-act-1940-act-no-23.pdf.
5. Shivalkar YM. Clinical information in drug package inserts in India. J Postgrad Med 2009;55:104-7.
6. 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.
7. Deo M. Doctor population ratio for India-The reality. Indian J Med Res 2013;137:632-5.
8. 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.
9. Gupta VK, Pathak SS. Assessment of awareness and knowledge about package inserts amongst medical students: A questionnaire-based study. IOSR J Pharm 2012;2:215-7.
10. Johnson D, Hima SS, Teena A, Kumaraswamy M, Chopra RS. Self-medication practice among medical, pharmacy, and nursing students. Int J Pharm Pharm Sci 2016;8:443-7.
11. Dutta S, Hazarika K. Pattern of self-medication and drug use behavior among undergraduate students of medical, and non-medical colleges in a city of North-East India -a comparative study. Asian J Pharm Clin Res 2016;9:259-62.
12. Mottram DR, Reed C. Comparative evaluation of patient information leaflets by pharmacists, doctors, and the general public. J Clin Pharm Ther 1997;22:127-34.
13. Gibbs S, Waters WE, George CF. Prescription information leaflets: A national survey. J R Soc Med 1990;83:292-7.
14. Gibbs S, Waters WE, George CF. The benefits of prescription information leaflets. Br J Clin Pharmacol 1989;27:723-39.
15. European Medicines Agency. Guideline on the Packaging Information of Medicinal Products for Human Use Authorized by the Community; 2008. Available from: http://www.ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol2/c/bluebox_02_2008.pdf.
16. Dawoodi I, BhosaleU. Evaluation of knowledge and awareness of patients about prescribed drugs and their package inserts: A cross-sectional study. Asian J Pharm 2016;10:S97.
17. 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.
18. Singh KR, Munshi R, Arora D. Assessment of the degree of awareness among physicians and patients about drug European medicines package inserts. Int J Pharm Sci Res 2016;7:1258-62.
19. European Medicines Agency. Guidelines on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human use Revision; 2009.
20. Songara R et.al. Need for harmonization of labeling of OTC drugs. Int J Curr Pharm Res 2010;1:33-58.
21. Kafeel H. Medication package inserts, concept among doctors pharmacists and laypersons-a beneficial guidance or a source of confusion. J Med Res 2016;2:62-4.
22. Gupta VK. Vision 2015, Medical Council of India; 2011. p. 10. Available from: http://www.mciindia.org/tools/announcement/mci_booklet.
23. Al-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug Healthc Patient Saf 2012;4:33-8.
24. Ahmadi P, Badri SS, Zargarzadeh AH. An investigation on patient attitudes toward package inserts and their accessibility in Iran. J Res Med Sci 2018;23:100.
Statistics
33 Views | 49 Downloads
Citations
How to Cite
PRABHA MP, S., and S. S PRABHAKARAN. “ASSESSMENT OF KNOWLEDGE, ATTITUDE, AND PRACTICE ABOUT PACKAGE INSERTS AMONG MEDICAL UNDERGRADUATE STUDENTS: A CROSS-SECTIONAL QUESTIONNAIRE-BASED STUDY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 3, Mar. 2021, pp. 112-5, doi:10.22159/ajpcr.2021.v14i3.40477.
Section
Original Article(s)