A study on off-label and unlicensed drug use by community pharmacists: A report from resource-limited settings of South India

Abstract

Introduction: Labeled uses of drug use are approved by the regulatory authorities based on preclinical and clinical data which confirms their safety and efficacy. From the community pharmacist perspective, the most common off-label use is due to physician's prescriptions and usage of over-the-counter (OTC) medications. In India, huge number of medicines is easily available for off-label use from the community pharmacists with or without prescriptions. Objectives: It is a preliminary study to evaluate and describe the off-label drug use by community pharmacists in resource-limited settings. Materials and Methods: It is a prospective cross-sectional study conducted among community pharmacies located in and around of Anantapur district, a rural part of Andhra Pradesh, South India. The data were collected through questionnaire-based semi-structured interview and/or asked the community pharmacists to complete on their own at the spot to avoid manipulation of data. The questionnaire is of two types: the first type evaluates pharmacist perspective on off-label indication for randomly selected drugs (frequent moving) and the second type evaluates dispensing practice of drugs for off-label use based on symptoms. Results: The present study results show that the frequency of off-label drug use is high among community pharmacists; moreover, they dispense the drugs without aware of off-label or inappropriate indication, sometimes as OTC medications. It is an acceptable fact that off-label or unlicensed drug use is not illegal but has plenty of safety and other issues. Conclusion: Thus, the present study provides a preliminary data to frame future educational and interventional programs to improve the rational use of drugs with regard to it.