Analysis of package inserts of commonly used drugs in obstetrics and gynecology in Jhalawar district: an observational study in Rajasthan, India
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20182931Keywords:
Drugs and cosmetics rule, Over the counter drug, Obstetrics and gynecology, Posology, Package insertsAbstract
Background: Package Insert is the primary source of drug information for the patient. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. Studies on package inserts in India had shown that crucial information was often missing, and they lacked uniformity.
Methods: 100 oral drugs used in Obstertrics and Gynecology from different brands were collected from big pharmacies located at Jhalawar and available package inserts were analysed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.
Results: Out of 100 oral drugs studied, package inserts were found in 72 drugs, most available information in therapeutic indicators was Posology and method of administration (100%) followed by contra-indications (94.4%), use in pregnancy and lactation (83%), interactions (77.8%) whereas less information about antidote and least about ability in driving and use of machine. In pharmaceutical indicators, it is instruction for use (86%), followed by special precautions for storage (76.4%), shelf life in the medical product as packaged for sale (52.8%).
Conclusions: This study showed that many information relevant to the safe and effective use of medication was lacking in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.
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References
Supriya S, Deshmukh Yeshwant A, Mandavi R, Urmila S. Study of drug utilization pattern in the gynecology opd of a tertiary care centre. World J of Phar and Pharmaceu Scienc. 2014;3(12):916-23.
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 M. Doctor population ratio for India - The reality. Indian J Med Res. 2013;137(4):632-5.
Sowmya B, Vijayalakshmi, Narayana R. Critical appraisal of patient package inserts in allopathic medicines. J Chem Pharm. Res. 2015;7(3).
Food and Drug Administration, HHS. Requirements on content and format of labeling for human prescription drug and biological products. Fed Reg. 2006;71:3921-97.
European Commission. Guideline on the Packaging Information of Medicinal Products for Human Use Authorized by the Union; July 2015. Available at: ec.europa.eu/ health/ files/ eudralex/ vol-2/2015-07_14_3_packaging.pdf. Accessed 11 May 2016 .
Govt. of India, Ministry of Health and Family Welfare. Drug and Cosmetics Rules; 1945. Available at: http://cdsco.nic.in/ html/ Drugs andCosmeticAct.pdf. Accessed 11 May 2016.
Gibbs S, Waters WE, George CF. Prescription information leaflets: a national survey. J Royal Soci Med. 1990;83(5):292-7.
Gibbs SH, Waters WE, George CF. The benefits of prescription information leaflets (2). Br J Clin Pharmacol. 1989;28(3):345-51.
Sowmya B, Vijayalakshmi, Narayana R. Critical appraisal of patient package inserts in allopathic medicines. J. Chem. Pharm. Res. 2015;7(3).
Kalam A, Anwar S, Fatima A. Drug package inserts in India: Current scenario. Wor J Pha Pharma Scie. 2014;33(44):385-92.
Menon SJ. Psychotropic medication during pregnancy and lactation. Arch Gynecol Obstet. 2008;277(1):1-3.
Cantrell L, Suchard JR, Wu A, Gerona RR. Stability of active ingredients in long-expired prescription medications. Arch Int Med. 2012;172(21):1685-7.
Morris L. Patient Package Inserts: A new tool for patient education. Public Health Reports. 1977;92(5):421-4.
Hermann F, Herxheimer A, Lionel N. Package inserts for prescribed medicines: what minimum information do patients need? Br Med J. 1978;2(6145):1132-5.
Saha L, Pandhi P, Malhotra S, Sharma N. Adverse drug event (ADE) related medical emergency department visits and hospital admissions: A prospective study from a north Indian referral hospital. J Clin Diag Res. 2008;2:600-4.
Kaikade SB, Jha RK. Assessment of Awareness and Attitude towards Package Inserts Amongst Rural Population, Res J of Pharmace Bio Chem Scienc. 2011;2(4):982.
