13
Sep
Off-label use of medicines: The need for good practice guidelines – the International Journal of Risk and Safety in Medicine
Article written by Dooms and Killick in which they present a set of guidelines for...
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For Medical Research
If physicians are encouraged to prescribed medicines outside their authorized indication beyond the cases where there is a real lack of licensed alternatives, the incentive for medical innovation could be undermined.
Companies would be less likely to undergo an expensive and time consuming authorization process and invest in innovative medicines or in expanding the indications of existing medicines, if there is an increasing trend of prescribing unlicensed medicines due to cost-saving measures of national governments.
While it is important that a robust clinical development program continues to be required to ensure the safety, efficacy and quality of medicines, mechanisms to incentivize the extension of drug’s indications could be explored in order to address existing medical needs.
Ultimately, physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.