What does "off label" medication sound like to you? Does it sound a little scary, a little risky, a little clandestine? Consider this: a whopping one in five outpatient prescriptions in the United States are "off label"! Though the very term might suggest that this means something isn't quite in accordance with the rules, this could not be further from the truth.

Off label prescriptions are all those your doctor prescribed you to take in manners not exactly specified within the medication's package insert, which goes through a rigorous approval process. They are prescriptions offered to patients because they line up with cutting-edge research and the doctor's own knowledge and experience rather than with a slow bureaucracy. Rather than being something dodgy and illegal, off label prescriptions are, most often, the mark of a physician offering their patients the very best care they can: care tailored to the individual's needs. Indeed, your health and wellbeing may very well depend on your doctor being able to use their judgment regarding the type and dose of medication you receive.
Back in 2011, the state of Ohio passed a law that placed restrictions on the manner in which medications used for so-called "medical abortions", namely misoprostol and mifepristone, could be used. Rather than being able to prescribe higher doses of the former and lower of the latter, as had been proven both safer and more effective through research, the law limited physicians to the doses of both set forth in Food and Drug Administration protocols in the year 2000 — forcing physicians to look at regulations instead of their patients.
What effect has this restrictive law had on women seeking to terminate their pregnancies in Ohio? A research team publishing their findings in the journal PLOS Medicine surveyed 2,783 who underwent medical pregnancy terminations between 2010 and 2014 to find out.
While 4.9 percent of women required follow-up care (such as extra doses of the drugs or surgical abortion) before the new law came along, 14.3 percent of women had complications from their medical abortion after off label use of the relevant medications was banned. Likewise, while 8.4 percent of women experienced side effects from abortion medications before the restrictive law was passed, 15.6 percent suffered adverse effects afterwards.
Though the Food and Drug Administration (FDA), responsible for creating the protocols laid forth within package inserts, updated its protocol in March 2016 to better reflect current medical research, the findings of this study raise an important question, as the questionable law remains in place. "This law will continue to require physicians to provide care that may fall below the accepted standard of care, placing them in an ethical dilemma," the research team wrote.
READ Should Ohio Ban Women From Having An Abortion Because Their Baby Has Down Syndrome?
With off label prescriptions totaling an estimated 21 percent of all outpatient prescriptions, a scientifically and socially accepted practice in general, we may wonder, what is so special about medication intended to terminate pregnancies? Do we want women seeking an abortion to have to place their wellbeing in the hands of a bureaucratic apparatus slow to move forward by definition, or do we want women to legally be able to rely on highly-qualified doctors' right to prescribe the medications already scientifically proven to be safest and most effective, in the doses known to be safest and most effective?
- Photo courtesy of Rev Stan via Flickr: www.flickr.com/photos/revstan/4898481879
- Photo courtesy of Rev Stan via Flickr: www.flickr.com/photos/revstan/4898481879
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