Compassionate use of medicine plays a strategic role in the development and marketing of drugs and is a source for solicited safety data. Information about such use is required as part of pharmacovigilance DSUR/PSURs and Risk Management. Drug Safety Consult offers audit and consultancy in compassionate use programs and named patient treatment.
In order for a company to protect both patient and product, the handling and control over compassionate use should be covered by standardised procedures. Compassionate use afflicts many company functions. Depending on regulatory status (IMP or marketed product) such use implies a potential risk towards registration and product liability.