DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20200718

A study on the evaluation of drug package inserts: a prospective observational study

Anita Hiraman Yuwnate, Ananya Chakravorty

Abstract


Background: The package inserts are an important source of information for the patient and the prescribers which are often incomplete in terms of information. Not many of them are patient friendly, usage of technical terms further complicates the scenario amidst inadequate doctor-patient ratio. Aim of the study was to evaluate the completeness of package inserts.

Methods: Hundred package inserts were collected from June 2018 to September 2018 from nearby pharmacies and drug store of a tertiary care hospital, Government Medical College, Akola and evaluated in terms of completeness as per guidelines mentioned in the section D of Drug and Cosmetics Act 1945, language used and addressed to whom. Each guideline followed under section D was given a score of 1 and absence 0 depending upon which grouped as Grade A (>15), Grade B (10-15), Grade C (<10). Result was analysed in Microsoft Excel 2010 expressed in percentage and whole numbers.

Results: Out of the 100 package inserts evaluated the guidelines like mentioning of special circumstances like pregnancy was present in (98%), undesirable effects in 98%. All of them used English with 3% having combination with regional language, 70% had no mention as to whom it is addressed. Grades allotted after evaluation A, B, C, 24%, 74%, 2%.

Conclusions: The present study showed though improvement occurred deficiencies should be corrected and properly scrutinised for better compliance of the patient and effective drug use and to step up the healthcare services in society.


Keywords


Addressed to whom, Language used, Package inserts, Section D of drug and cosmetics act 1945

Full Text:

PDF

References


Sudhamadhuri A, Kalasker V. Evaluation of completeness of package inserts in south India. Inter J Res Stud Biosci. 2015;3(7):102-5.

Kumar A. India has just one doctor for every 1,700 people. The New Indian Express, 2013. Available at: http://www.newindianexpress.com/ magazine/ India-has-just-one-doctor-for-every-1700-people/ 2013/ 09/ 22/article1792010.ece. Accessed 05 May 2016.

Deo MG. Doctor population ratio for India-The reality. Ind J Med Res. 2013;137(4):632.

Khan TM, Hassali MA, Al-Haddad MS. Patient-physician communication barrier: A pilot study evaluating patient experiences. J Young Pharmacists. 2011;3(3):250-5.

Mahatme MS, Dakhale GN, Hiware SK, Wankhede SS, Salve AM, Mahatme SR. Comparison of Indian package inserts in public and private sector: an urgent need for self-regulation. Int J Basic Clin Pharmacol. 2013;2(2):165-9.

Gupta VK, Pathak SS. Assessment of awareness and knowledge about package inserts amongst medical students: a questionnaire-based study. IOSR J Pharm. 2012;2(2):215-7.

Joubert PH, Skene DE. Attitudes of private medical practitioners towards package inserts and other drug information sources. South African Med J. 1984;66(8):306-7.

Food and Drug Administration, HHS. Requirements on content and format of labelling for human prescription drug and biological products. Final rule. Federal Register. 2006;71(15):3921.

European Medicines Agency. Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Community. February 2008. Available at: http://ec.europa.eu/enterprise /pharmaceuticals/eudralex/vol2/c/bluebox_02_2008.pdf. Accessed 12 July 2012.

Kalam A, Anwar S, Fatima A. Drug package inserts in India: current scenario. World J Pharma Pharmaceutical Sci. 2014;3(4):385-92.

Govt. of India, Ministry of Health and Family Welfare. Drug and Cosmetics Rules, 1945. Available at: http://cdsco.nic.in/html/DrugsandCosmeticAct. pdf. Accessed 12 Feb 2012.

Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med. 2009;55(2):104.

Lal A, Sethi A. Drug package inserts in India. Ann Pharmacother. 1996;30(9):1041.

Gharibyar H, Sharif Y. Evaluation of pharmaceutical drug information brochures in the Emirate of Abu Dhabi (United Arab Emirates). J Pharmaceutical Health Services Res. 2012;3(1):57-62.

Bjerrum L, Foged A. Patient information leaflets–helpful guidance or a source of confusion?. Pharmacoepidemiol Drug Safety. 2003;12(1):55-9.

Al-Aqeel SA. Evaluation of medication package inserts in Saudi Arabia. Drug, Healthcare Patient Safety. 2012;4:33

Ramdas D, Chakraborty A, Swaroop HS, Faizan S, Kumar P, Srinivas BN. A study of package inserts in southern India. J Clini Diagnos Res: JCDR. 2013;7(11):2475.

Sudhamadhuri A, Kalasker V. Evaluation of completeness of package inserts in south India. Inter J Res Studies Biosci. 2015;3(7):102-5.

Shruti DA, Sarala N, Bhuvana K. Analysis of package inserts of drugs utilized in a tertiary care hospital. J Young Pharm. 2016;8(3):275-8.

Sudha MJ, Viveka S, Remya S, Udupa A. L. Drug package inserts: how accessible is the information?, Inter J Basic Clini Pharmacol. 2015;4:1132-5.

Kalam A, Anwar S, Fatima A. Drug package inserts in India: current scenario. World J Pharma Pharmaceutical Sci. 2014;3(4):385-92.

Chhaya MU. Analysis of package inserts of orally administered drugs available in the Indian market. Inter J Res Med Sci. 2017;5(2):529-32.

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