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.

Study of drug use in outdoor pediatric patients of upper respiratory tract infections in a tertiary care hospital.

Background: Upper respiratory tract infections (URTI) are the most common and frequent occurring infections in the pediatric population. URTI is mostly viral in origin and requires mostly symptomatic treatment. The present study was undertaken to analyze the pattern of drug use in the management of URTI in the pediatric age group. Methods: It is a retrospective study to assess the pattern of drug use in URTI in pediatric outpatient department during the 5 months period from January 2015 to May 2015. Results: A total of 2256 prescriptions were analyzed. Most of the pediatric patients belonged to 1-5 years age group and 58.33% were males, and 41.66% were females. A total of 6332 drugs were prescribed out of which the antibiotics used was 1341. The average number of drugs per prescription used was 2.81. The percentage of prescriptions containing antibiotics was found to be 59.44%. Amoxicillin (70.91%) was the most frequent prescribed antibiotic followed by cotrimoxazole (10.21%). Antihistaminic and expectorant combinations were found to be the most common prescribed class of drugs (29.34%) followed by analgesic and antipyretics (26.45%) and antibiotics (21.17%). Conclusions: The study revealed that the majority of children were below 5 years of age. The most common class of drugs prescribed was antihistaminics and expectorant combinations followed by analgesics and antipyretics. Although the majority of the patients received antibiotics, 40.55% of patients received symptomatic treatment. This is a welcome step as inappropriate use of the antibiotics can potentiate to the increasing trend of antimicrobial resistance.