As addressed on this page many times before, the FDA is an agency in flux, and while a new commissioner seems dedicated to getting the agency in line, critics can still identify plenty of areas that require attention. Sorting out the problems at the FDA could be a full-time job in itself, as I was reminded while recently researching an article. One topic that emerged in my conversations with experts and that I recently saw highlighted on a neurology discussion board is widespread misunderstanding of off-label drug use.
In reality, off-label prescribing supported by sound science and medical standards is not only legal, but widely and effectively done. Yet, anytime a significant medical malpractice case makes headlines, reports always seem to emphasize the use of “off-label” prescribing, even if the actual problem is a known side-effect, therapy mis-use, patient error, or something unrelated to the implicated drug.
It's essential that patients and policy makers clearly understand the distinction between medication errors and off-label drug use. Medication errors and adverse drug reactions (ADRs) occur due to pharmacy dispensing of the wrong drug, prescribing of a contra-indicated drug, prescribing of a drug to which the patient has a known allergy, excess dosing, and combined use of two or more drugs known to interact. Medication errors are associated with significant morbidity and mortality and astonishing monetary costs. More than two million ADRs are predicted to occur in hospitalized patients annually, resulting in more than 100,000 deaths.There is a risk that as government and third party payors seek to minimize reimbursements overall and the government strives to contain health care costs, limitations on off-label prescribing may be considered. This would be a detriment to patients, and it could actually lead to increased costs. Whereas one non-indicated drug could potentially yield complete symptom control in a patient, that same individual may require the use of multiple agents and perhaps numerous repeat courses of “approved” therapies, to provide a similar level of control.
Health care reform will mean many changes for neurologists (as discussed in our cover story)—both good and not-sogood. Cutting down on medication errors is a laudable goal. Misguided efforts to limit physician autonomy and degrade patient care must be resisted. n
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