ABSTRACT:
Off-label is defined as any drug use outside the terms of product license; while the unlicensed use refers to using a drug in children when it has not received marketing authorization for use in them. The objective of the study was to determine the attitude and experience of community pharmacists towards off-label and unlicensed prescriptions for the pediatric population. This study was carried out as a prospective observational study for a period of six months at the community pharmacies in and around Chennai. Validated questionnaire to assess the attitude and experience of community pharmacists towards unlicensed and off-label prescriptions for the paediatric population was given to those community Pharmacists who have registered in the State Pharmacy Council as Pharmacist. Questionnaires issued were self administered by the community pharmacists and the answers recorded by them were collected and then assessed. Over 70% of respondents were familiar with the concept of off-label prescribing, primarily through dispensing experience rather than education. Over 60% of respondents had been asked by the public to sell paediatric over-the-counter medicines, such as antihistamines, analgesics and steroid preparations for off-label use. Most common off-label drug was paracetamol being 32% (BNFC) of all prescribed in this manner. Most common information sources was British national formulary for children (BNFC), Current index medical specialities(CIMS) and local formularies. The majority of respondents (74%) admitted to being familiar with the concept of off-label prescribing .The majority of respondents, 88% agreed or strongly agreed that the pharmacist has a responsibility to inform the prescriber that they are prescribing off-label medicines for children, and 32% unsure that pharmacist also has a responsibility to inform the parents that the medicines prescribed for their children are off-label. Dispensing labeled and licensed drugs in pediatric patients should be promoted among the community pharmacist as well as pediatricians in order to avoid exposing children to unnecessary risk. Participation in Continuing Medical Education should be encouraged among community pharmacist to keep their knowledge updated.