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September 2018

Is the Over-the-Counter Availability of Human Insulin in the United States Good or Bad?

Author Affiliations
  • 1Department of Medicine, Christiana Care Health System, Newark, Delaware
  • 2Section of Endocrinology, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
JAMA Intern Med. 2018;178(9):1157-1158. doi:10.1001/jamainternmed.2018.3332

This may come as a surprise, but certain forms of insulin are—and always have been—available over the counter in the United States. When Congress established federal prescription drug regulation in 1951, the types of insulin available at that time, including neutral protamine Hagedorn (NPH) and Regular, now referred to as human insulins, were exempted.1 By contrast, insulin analogs, which were developed much later, such as insulin glargine, insulin detemir, insulin degludec, insulin lispro, insulin aspart, or insulin glulisine, require a prescription. This little-known fact presents both opportunities and potential dangers to patients. It also poses a challenge to clinicians and the US Food and Drug Administration (FDA): is over-the-counter access to insulin an asset or a liability?

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    2 Comments for this article
    Type 1 Diabetes as a Litmus Test for Health Policy
    Robert Sobel, Internist/Endocrinologist | Feinberg School of Medicine, Northwestern University
    Thank you for bringing attention to this historical quirk that is one of many bureaucratic realities that a patient with type 1 diabetes must face. My survey of patients over 20 years of practice, originally taking patients across the insurance spectrum, would suggest only a small percentage are utilizing this loophole. What is near universal in my inquiries is the experience of having been told "you are early for your insulin" or having to pay cash whenever a vial fracture or out-of-town need arises.

    Increasing co-pays on sensors, out-of-pocket policies leading to $500 monthly out-of-pocket insulin costs,
    and coercion to different insulin formulations, meters, or devices occur more and more frequently. Gaps between durable medical equipment and drug coverage can be confusing to navigate by all parties involved. Even patients with insurance frequency have access issues.

    The challenge for the patient with type 1 diabetes is unique and requires a huge amount of  effort to address. There is no rationale for thinking cost-sharing and other tactics can do anything favorable in this setting, but it is clear that the frequency of adverse events can be increased. The insulin market has been evolving with the expectation that biosimilars will create new challenges. There have been anticipatory price increases.

    An unnecessary loss of life caused by a failed pharmaceutical regulatory scheme is a tragedy. We should be pressing our legislators and leaders in medicine to use improving care for patients with type 1 diabetes as an example to guide effective health care reform. Our patients deserve better.

    Apples and oranges
    Catherine Davis, PhD | Georgia Prevention Institute, Dept. of Population Health Sciences, Medical College of Georgia, Augusta University
    The opinion piece raises an important question: whether it is helpful or harmful to have insulin available over the counter without a prescription. Unfortunately it seems to equate the impact of inability to obtain insulin, a life-sustaining but dangerous medication, with lack of medical supervision over its dosing, as though these were opposite effects of the laws permitting or forbidding over the counter insulin purchase. A clear distinction should be made between these dangers, and the causes correctly identified as access to a life-sustaining medication vs access to medical care for a chronic condition.

    An insulin-dependent person who is
    unable to obtain insulin is at risk of death within days. Such a person who can obtain insulin, but cannot access medical care to supervise its use is also at risk -- in this case, of complications of insulin dosing errors -- but this does not outweigh the risk of being unable to obtain a life-sustaining medication.

    In fact, insulin-dependent diabetes patients typically adjust insulin doses on their own on a day-to-day basis, with intermittent support from medical staff and diabetes educators. Those with access to medical supervision also experience the adverse effects of non-physiologic insulin dosing. This is not attributable to the law permitting them to access their life-sustaining medication, but to the limitations of insulin therapy.
    I look forward to the response of the diabetes community to this exceedingly important and very answerable question, and hope that the laws (e.g., Indiana) keeping insulin out of the hands of those who require it are corrected. The health care environment in the United States is unstable; so many people are denied health care access.