The Risk of Off Label Prescribing

Where a pharmacogenetic drug has a restricted market due to the possibility of serious ADRs in a section of the patient population, the successful use of the drug will require careful control so that people with the wrong genotype are not given the product (18). In this context, the potential for inappropriate off-label or nonlabel use of medicines is of major concern. A small percentage of the U.K. doctors do not currently follow drug labels carefully enough. In the well-publicized case of the inappropriate long-term use of barbiturates, this has caused very serious problems for the patients involved, including addiction and chronic illness (28). Improved training, strong clinical governance, and improved drug labeling will be required to ensure that the prescribing of pharmacogenetic products to patients with the incorrect genotype does not occur when clinicians are unfamiliar with the technology. New forms of postmarketing surveillance may also be required to monitor the risks of this type of medication and its prescription in particular settings.

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