Off-label use of anti-cancer drugs in India: To be or not to be!

Abstract

Background: Administering drugs outside the terms of their official labeling is called off-label use. In the West, oncologists often use drugs off-label, which offers several advantages especially while treating patients with multiple comorbidities or advanced cancer. The practice of off-label prescribing of anticancer agents in India is not well documented. Materials and Methods: A survey on prescribing practices of 10 important drugs used in cancer was conducted in March 2010. Ten centers representing all parts of India were identified. One oncologist from each center was contacted by phone or email and explained about the survey. The list of drugs was sent to them by email if they agreed to participate and they were requested to fill all the indications for which these drugs were used in their center. Labeling for each drug was obtained from the Food and Drug Administration (FDA) website. Off-label practice was categorized as those recommended by the National Comprehensive Cancer Network (NCCN) and those without. Results: Nine out of 10 centers agreed to participate in the survey. Four centers responded to the questionnaire. Six out of 10 drugs were used for off-label indications, cisplatin being the most commonly used. All drugs were either used as per FDA labeling or according to the recommendations of NCCN, except for gemcitabine which was used in one center for some indications based on phase II data. Conclusion: Very limited off-label prescribing was found in oncology practice in India. Since off-label use offers several advantages, judicious use of this practice should be encouraged among the oncologists