A new regulatory debate about whether certain medications should require prescriptions makes me reflect on how good things used to be when it comes to obtaining my own diabetes meds over-the-counter.
Insulin, in particular.
Two decades ago when I was on second-generation insulin like Regular and Lente, I could walk into a pharmacy and pick up a bottle of insulin without needing a prescription. That was helpful during those times when I forgot my insulin vial at home. Or dropped the last bottle in just the right way for it to shatter, just when it was needed the most.
Yes, back before I was constantly connected to a continuous drip of insulin via my pump, and before the days of rapid-acting insulin or the many pens that are now available with a doc's Rx, I could just buy insulin at the drugstore; no doctor's orders were needed to just pick up an extra bottle.
I thought that was a good thing. So it made me happy to hear not long ago that the Food and Drug Administration (FDA) announced it was exploring the idea of "expanding the availability" of certain medications, like modern insulin -- possibly opening them up to the over-the-counter (OTC) market where you wouldn't need a doc's prescription to get this stuff.
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You probably know that there are two types of drugs at the moment: those that require a doctor's prescription and those that don't. The latter are assumed to be safe enough for patients to treat themselves without a doctor's guidance. What the FDA is proposing now is that a third class be created, allowing those drugs that would normally require an Rx to be sold OTC under the condition of "safe use." That term could mean a pharmacist assessing whether a patient might need or can use a particular medication, and in certain cases the FDA might require a doctor's visit after a patient obtains a refill or small initial amount of the medication.
To those of us in the Diabetes Community, one of the big questions comes down to what this might mean for access to insulin, which is mostly a prescription-required medication despite some older-generation insulin still being offered OTC.
For those without an endo or who aren't frequent visitors of their regular docs, and especially for those people without insurance coverage, this expanded availability of a life-sustaining medication would be a very welcome change.
Of course, opinions vary and not everyone is open to this change. The American Medical Association (AMA) and other medical societies offered the FDA plenty of comments opposing this move, basically claiming in not so many words that this could be the beginning of an end-run around physician authority. They're pushing back hard.
Surprisingly, the other group of doctors pushing back equally hard is endocrinologists, via the Endocrine Society — representing roughly 15,000 endos worldwide. They also provided the FDA with an earful of protest. Not singling out insulin, the Society states that all diabetes drugs are tricky with respect to "conditions of safe use" because patients may suffer from, or develop, complications. Huh? So why shouldn't they have easier access to the meds they need?
"The Society appreciates that the FDA is evaluating which drugs might be appropriate to designate as nonprescription in an effort to improve access and health outcomes, but strongly believes that diabetes medications should not be considered under these new paradigms."
A recent discussion among the Diabetes Advocates group had quite a few folks riled up about this. After all, shouldn't endocrinologists, supposedly passionate about diabetes care, be at the forefront of making sure people with diabetes can easily access the medications they need to survive?
The Society goes on to state that since "diabetes is an extraordinarily complex disease," only docs are qualified to assess what meds are needed, not the PWD thanks to a whole host of factors such as medical history, lifestyle considerations and more. And any non-physician or pharmacist might not understand the full picture, or be able to offer additional advice if and when it's needed.
So only the endos are qualified to prescribe insulin and no one else — in any situation — is able to make that assessment? No matter what length of time someone has been living with diabetes, and regardless of the type?
Their statement reads like an obvious play of self-preservation — in which the Endocrine Society is basically trying to ensure that people who need insulin and other diabetes drugs can only get access to it by coming through their offices. This resembled moves by the AADE, in not doing enough to allow more people become certified as educators, and the school nurses who pushed for policies mandating that only they are qualified to administer insulin and no one else can be trained to give necessary injections at school because of the "complex medical knowledge" one needs.
I scoffed, and solidified my negative thoughts about the Endocrine Society.
But then, I had a conversation with Dr. Jason Wexler that changed my views to some degree.
This endo at Washington Hospital Center in D.C. chairs the clinical affairs core committee studying these kind of issues, and he says the opposition was not about protecting endos' status. "Self-preservation arguments don't hold, that isn't where this comes from," Wexler said.
Rather, the Society is pushing for safeguards to "make sure people with diabetes aren't making decisions in isolation and there's an ongoing dialogue with their endo or primary care physician."
So there are people out there who just might think they need certain meds or insulin, and go out and buy them without a diagnosis or doctor's consult? Is that really a concern? I asked. Wexler answered: Yes, it is.
He told me about how a half-dozen times a year, he gets patients in his office that say they have a grandmother or parent at home who has some type of diabetes. That individual uses a glucometer and sees a higher-than-recommended number, and decides to just start taking medication or insulin. This kind of medication-sharing is one example of behaviors that could become more common with relaxed FDA regulation on prescriptions, Wexler worries.
"It's about empowering patients to make their own informed decisions, not about getting one more patient in the door," he says.
With a large amount of the population poor and under-insured, Wexler says the danger of blindly taking drugs without a doctor's consultation is even greater — particularly during tougher economic times.
Still, Wexler says the FDA comment period was just a starting point. More information and recommendations could come down the road. Maybe the Endocrine Society would be open to discussing certain exceptions, allowing some restrictions or "safe use conditions" on certain medications, like insulin. At least until a person is able to get with a doctor to talk.
Nothing's official, as these rules would have to go up the ranks of the Endocrine Society and also be considered by the FDA, of course. But the possibility is there and at least they're willing to talk about it.
This was a useful conversation for me, as I realized I'd been looking at this issue only through the lens of a longtime type 1 whose been taking insulin as long as I can remember and who regularly visits an endo. But there's the other side, of those who might actually be self-medicating based on little knowledge about life with diabetes.
Unfortunately, this whole debate came up after the FDA docket closed May 7, so public comments are no longer being accepted. Jay Leno joked (at the 4:05 mark) about the issue a few days before the docket closed, taking it to the mainstream but offering little time for interested people to object if they hadn't known about it earlier.
The process is still underway, as the FDA hasn't made any decision. The agency isn't obligated to listen to the Endocrine Society, or even to holding a public hearing on this issue. But it could.
And that's where we come in. Taking this discussion to the Endocrine Society (and others who have similar views) is the next move on the chessboard here. So, we in the DOC should let them know what we think on this!
The Endocrine Society's comments to the FDA are available to review online in PDF form here. Their PR guy Aaron Lohr tells us we can all submit our own reaction and comments to them by sending emails to societyservices@endo-society.
After all, this is about eliminating barriers — in a safe way — to restrictive health care and policies and practices, and giving PWDs more access to the meds they need to manage their health.