Last week the FDA announced that it wants to remove obstacles to America’s most commonly used drug treatments. If the Agency gets its way, some drugs used to control chronic conditions, such as high cholesterol, diabetes and asthma may soon be available without prescription. But in doing so, they have reopened a big can of worms. One that brings into question the very nature of health reforms, preventative medicine and improved access to healthcare.
Here’s the proposal: The FDA would create a new class of “safe use” drugs. While consumers would not need a prescription, they would still need to get clearance from a pharmacist or from specially designed websites to purchase them.
Battle lines are being drawn! With physicians on one side, and patients, pharmacists, pharma and payers on the other.
Doctors are most definitely not thrilled by the idea. Removing the prescription requirement for an inhaler refill, for example, doctors fear they would be taken out of the loop on everyday care decisions.
Insurers, on the other hand are embracing the move. They recognize that they could save big bucks if physician visits weren’t required for run-of-the-mill complaints and ongoing medication monitoring. They might even save on the costs of the drugs themselves because, depending upon how they’re classified, most health plans don’t pay for over-the-counter treatments.
Pharmacists see it as validation of their expertise and pivotal role in primary healthcare and the pharmaceutical industry, who has repeatedly asked for permission to sell such drugs over-the-counter, must surely be cautiously optimistic.
Even normally conservative regulators are supporting the move. “Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers,” former FDA commissioner Scott Gottlieb said via Twitter. “It’s a good idea, long overdue.”
Even so, the FDA will have a fight on its hands as it moves to turn its proposal into reality. The American Medical Association lambasted the idea in USA Today, saying that patients need guidance from doctors. The doctors’ association also points out that giving patients more control could complicate coordinating care, such as, tracking all the drugs a patient uses to prevent interactions.
But, as The Washington Post points out, FDA sees the doctor’s visit as a hindrance to care; some patients don’t seek treatment if they have to see a physician first. “Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” says Nancy Chockley, president of the National Institute for Health Care Management.
About 20% of prescriptions written in the United States currently go unfilled. Removing obstacles that keep Americans from managing their own health care is, according to one patient, namely me, a good thing.
The FDA contends, and I agree, that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner. Earlier this month, I stood in line at my local pharmacy for thirty minutes to pick up a refill prescription for blood pressure meds. On reaching the end of the line I was told that there was no prescription. The pharmacist called my doctor and the lack of prescription was confirmed. I called my doctor and was told I would need to make an appointment to have the prescription renewed. I pointed out that I had done that one month earlier and that nothing had changed regarding my health. I was then informed that it was a new policy to issue prescriptions on a month-by-month basis rather than provide automatic refills. Even when I pointed out that I have a chronic condition that I’m doing my best to manage and part of that management is the medicine I have been taking for years, they wouldn’t sway. No doctors visit, no prescription. And the kicker, I couldn’t get an appointment to see my doctor for a week…meaning, I had to go 7 days without blood pressure meds, all so my doctor could better manage my care!
Practicing medication adherence is very hard when your doctor won’t give you medication…and leaves me wondering if this policy change had more to do with revenue generation than improving chronic disease management.
My personal experience aside, at the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician as a hindrance to care, whereas doctors see that visit as crucial, especially as chronic conditions become increasingly prevalent.
The FDA proposal is still in formative stages, meaning there’s still a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding health policy on what role doctors play in managing patient care – and, at what point, the patient takes charge.
I, for one, can’t wait to see how it plays out, assuming of course that I’m not dead from uncontrolled hypertension!