Abstract
Off-label drug use which could be defined as the practice of prescribing
a drug for a different purpose than what is permissible by the
regulation is a common practice among clinicians, nevertheless, it is
often subject to ethical and legal uncertainties. In general, clinicians
must balance the need to provide patients with the best possible care
while complying with the regulatory requirements governing drug use.
This paper will review the current literature on off-label drug use,
including its prevalence, the regulatory landscape, and the ethical
issues involved with the aim of formulating an ethical and legal
framework that could guide clinicians in using off-label drugs in
clinical practice in Malaysia. The framework will include ethical
considerations that are centred on the principles of beneficence,
non-maleficence, and autonomy, which require clinicians to balance the
benefits and risks of using off-label drugs while respecting patients’
autonomy. The legal framework consists of federal and state regulations
governing drug use, including the Control of Drugs and Cosmetics
Regulations (CDCR) 1984 and other regulations published by the National
Pharmaceutical Regulatory Agency (NPRA). The aim of this paper is to
provide guidance on how clinicians can navigate the ethical and legal
terrain of off-label drug use by understanding the regulatory
requirements, being obliged to the requirements of obtaining informed
consent from patients and documenting the rationale for off-label use.
Ultimately, by understanding the ethical and legal framework, clinicians
can provide patients with the best possible care while complying with
the regulatory requirements governing drug use.