Key result
Off-label medication use remains an indispensable practice driven by unmet clinical needs, prompting worldwide regulatory efforts to ensure safety and encourage further research.
Why the study?
Off-label drug use remains a challenging, indispensable practice driven by unmet clinical needs, requiring an overview of its regulation, clinical practice aspects, and safety issues.
Systematic Review
Off-label medication use remains an indispensable practice driven by unmet clinical needs, requiring ongoing regulatory efforts to ensure patient safety.
Off-label prescribing remains challenging amid unmet needs; leaves open optimal regulatory and physician guidance strategies.
Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as "off-label", "prevalence", "rare diseases", "oncology", "psychiatry", "pediatrics", and "drug repurposing". There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research.
No takes yet. Share an insight, caveat, or question.
Rusz et al. (2021) conducted a systematic review in Off-label medication use. Off-label medication was evaluated. Off-label medication use remains an indispensable practice driven by unmet clinical needs, prompting worldwide regulatory efforts to ensure safety and encourage further research.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: