Study: Patients Often Unaware of Off-Label Prescribing Risks

A study of 150 European patient groups conducted on behalf of the Irish Patients Association (IPA) has found that patients are usually not made aware that the medication they have been prescribed is off label or how to respond to off-label side effects, reports The Pharma Times.

Sixty-six percent of groups polled said that their patients were not always aware that the prescribed drug product was off-label, while 12% said that none of their patients were ever aware if this was the case.

Just 42% of groups polled said their patients were informed of how to respond to off-label side effects, while a further 23% said some of their patients had experienced off-label side effects.

The study recommends that patients be informed that the prescribed medication is for off-label uses and that regulation surrounding the practice be strengthened (72%). A further 65% of study participants recommended that strengthened regulations be done at the European-wide level as opposed to a nation-by-nation basis.

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Pharma Times - Off-label drug use "compromising patient safety," says study