Analysis of package inserts of commonly used drugs in obstetrics and gynecology in Jhalawar district: an observational study in Rajasthan, India

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.

Status of package insert guidelines for drugs accessible as over the counter drugs

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs. Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.