The Legality Aspects of Off Label Prescription in Malaysia: Challenges Related to Off Label Prescription

Abstract

Off label prescription occurs when a drug is prescribed for an indication, a route of administration, or a patient group that I snot included in the approved product in relation to the Federal Drug Administration (FDA). Off label prescription has been a major challenge for patients as most of time they are not aware of the indication they are prescribed for. For instance, the drug Methotrexate to treat cancer is being prescribed as off label to treat psoriasis. The adverse drug reactions incurring from a cancer drug can cause severe reactions, in which the burden being passed to a patient suffering from auto immune disease and skin disorder such as psoriasis. The legality aspects are certainly importance to enhance the role of the doctors which prescribing the off label prescription to the patients. The lack of awareness by the practitioners while practicing off label prescription for the sake of insufficient medication or lack of medication for certain diseases does not give a room to practice off label prescription. The purpose of this paper is to further define and discuss the status of off-label use of medications in children as the medication of children is lacking compared to adults. The legality of off label prescription has not been addressed and mainly left at the discretion of medical practitioners to apply off label prescription. The legality aspect of off label prescription can be addressed with improvise interpretations under Section 14(4) (d) of the Patents Act 1983.