Patients should be fully informed if the medicines they are taking have been prescribed off-label, and the regulation and the monitoring of off-label drug use needs to be strengthened, says a new report.
Off-label prescribing is "an overlooked and unregulated area of medicine, mainly because doctors are able to practise it in a discretionary manner," said the Irish Patients Association (IPA) as it released the findings of a survey, conducted by PatientView, which asked 150 patient groups across Europe, representing the interests of around one million people, about the issue.
The IPA points out that, before the survey, no-one knew whether or not patients were generally informed that the products which they had been prescribed were off-label, nor whether they were told about the extra rigour required to self-monitor the effects of off-label medicines, or whether they then knew what to do if they experienced side-effects from the drugs.
Doctors prescribe off-label to support the medical needs of patients, including children, who have life-threatening conditions for which no other, or limited therapies are available, says the Association, and the study found that 69% of the patient groups questioned said they believed off-label prescribing to be an important component of the doctor's repertoire of treatment and care.
However, 66% of the groups also reported that patients were not always fully informed of the fact that a drug was being used off-label, with 12% stating that none of the patients which they represented were aware of being prescribed an off-label treatment.
Moreover, only 42% of the groups said that patients are informed about what to do if side-effects should occur with an off-label medicine, and 23% reported that the patients they represent had experienced side effects.
72% of the groups called for national regulators to strengthen their monitoring of the use of off-label medicines in their own countries, while 65% said that this should be a European-level responsibility.
These findings indicate that there is “a real need for better regulation," says the Association, which also comments that the prescribing of off-label for economic reasons has yet to be quantified, and that another problem is that "some drug companies have been accused of trying to sell more of their products off-label."
Speaking at the report's launch, Anna Moran, external affairs manager of the patient group Fighting Blindness, said that proven safety and efficacy should be the only concern of any debate about treatment. "In situations where an off-label drug could possibly be prescribed, we would urge frank and open dialogue between patients and doctors and all treatment options and potential risks. Safety comparisons, notwithstanding efficacy similarities, are not yet powerful enough to make conclusions that should alter public policy," she said.
"In essence, we want to aim for the gold standard of care found in evidence-based medicine - cost savings should not trump safety concerns," added Ms Moran.