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

Abstract

INTRODUCTIONIn order to save time and money, people prefer to selfmedicate themselves for minor ailments like fever, pain, cough, and gastrointestinal disturbances.1 It starts with the home remedies and if it doesn't work, they tend towards the medical shop or internet to find a suitable treatment. Patients receive information regarding drugs from the pharmacists, drug labels, package inserts available with the drugs and internet. 2,3 In India most of the pharmacists are not well trained and internet is neither reliable nor accessible to everyone. This makes package inserts an important and reliable source of information of the drug for the pharmacists and the patients. Even when there is a doctor patient interaction, patient receives oral instructions from the doctor, but it can be missed, forgotten or misunderstood . 4 In these cases also package inserts play a crucial role as they provide written and well-informed instructions which help in the efficacious use of the drug.As per Indian pharmacopoeia, package inserts are part of label which provides information on the article.5 As per ABSTRACT 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.