Prescribing drugs off-label is commonplace within the medical profession. Indeed, when an off-label prescription is the treatment of choice within the relevant group of health professionals, it is even considered to be the preferred practice. These off-label prescriptions are medicines prescribed for indications for which these medicines have neither been approved nor assessed by the Dutch Medicines Evaluation Board.
According to physicians, the prescription of off-label medicines is dictated mainly by professional guidelines, pharmo-therapeutic handbooks and scientific literature. This is in accordance with the views on off-label prescriptions held by the Dutch Medicines Evaluation Board, the Netherlands Health Care Inspectorate and the Dutch College of General Practitioners. This is also in accordance with the new Medicines Act (Geneesmiddelenwet), which came into effect on July 1st 2007. According to physicians experimental behaviour occurs 'rarely to sometimes'. On the other hand, experimentation based on 'one's own experience' or 'the experience of colleagues' occurs 'sometimes to regularly'. Physicians are duty bound to inform patients and request their permission when prescribing drugs off-label. However, this code of practice is only observed 'sometimes to regularly' by general practioners and paediatricians and 'regularly to often' by medical oncologists, dermatologists and neurologists. Approximately 50% of the physicians admit to either 'rarely or never' asking the patient for permission.
The above information is the result of both a survey carried out among 464 general practitioners and 406 health care specialists, and a study of existing professional guidelines for physicians. The survey illustrates that there is a need among physicians for more information on off-label prescriptions. Depending on their specialism, 22% to 45% of the physicians indicate that they 'regularly' do not know whether a prescription is off-label.
The groups of physicians involved in the survey all indicated an urgent need for a central reporting- and evaluation system within their professional group. General practitioners, in particular, indicated that they only 'rarely or sometimes' evaluate off-label use themselves or with fellow colleagues.
It is still unclear whether or not off-label use leads to increased health risks. Proof of these increased risks is scarce in scientific literature, and these risks remain mainly presumed from theoretical considerations.