title: Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities.
abstract: Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.
authors.affiliation: Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India .
authors.forename: Sandeep Kumar
authors.initials: SK
authors.lastname: Gupta
authors.affiliation: Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India .
authors.forename: Roopa Prasad
authors.initials: RP
authors.lastname: Nayak
keywords: Clinical trial; key opinion leaders; off-label use; orphan disease; regulatory approval; risk-benefit analysis