A commentary in State News makes the case for an over the counter (OTC) antidepressant. Psychiatrist Roy Perlis argues the need for better access to therapies that treat depression and mental health disorders has never been greater. He points to surveys claiming that 10% of the population reports needing therapy but unable to get it, while one-forth report has depression or anxiety.
Why should antidepressants be switched from Rx to OTC? Because there is a severe shortage of mental health professionals. Access to mental health specialists and therapists is difficult for many people. Most therapists don’t accept insurance and psychiatrists are booked out far in advance. Here is what Dr. Perlis had to say:
Access to psychiatrists is extremely limited in many areas of the U.S.: long wait times make a mockery of the 2008 mental health parity mandate. That means the vast majority of antidepressants are prescribed by non-psychiatrists, particularly primary care physicians. Yet many primary care practices struggle to provide the same kind of care for depression that they provide for other chronic illnesses. After the Covid-19 pandemic, even access to primary care can be hit or miss.
Dr. Perlis adds that patients are often embarrassed to talk about mental health and have little time to seek care for depression.
People with depression may be uncomfortable talking about their symptoms, or simply unable to schedule and keep appointments because of work or family obligations. Depression itself can make it harder to plan and follow through. Telehealth can fill the gap, but the quality of this care is difficult to measure. And these visits add cost to what could otherwise be inexpensive treatment, without any demonstrated improvement in safety.
Selective serotonin reuptake inhibitors (SSRIs) have been used for three decades in the U.S. They have a record of being a safe and effective therapy for depression and anxiety disorders. Still, the U.S. Food and Drug Administration (FDA) has a relatively high bar for switching Rx medications to OTC.
Food and Drug Administration policy states that non-prescription medications must meet three criteria: they can be used for self-diagnosed conditions; there’s no need for a clinician’s involvement to be used safely; and they have a low potential for misuse and abuse.
SSRIs meet these three conditions, but not all the time for all people. Screening surveys and information found online could help people decide if Prozac or Zoloft are right for them. However, there is no middle ground where a pharmacist could talk to a patient, recommend Zoloft and ask their customer to follow up later. With OTC switching, it’s all or nothing. There are other obstacles, according to Perlis:
Another objection to over-the-counter SSRIs is that not everyone believes in pills for depression. Some still question the biological basis of this disorder, despite the identification of more than 100 genes that increase depression risk and neuroimaging studies showing differences in the brains of people with depression.
Of course, there are alternatives to SSRI drugs, like talk therapy and cognitive behavioral therapy. In a perfect world most patients would use a combination of drug therapy and a mental health counselor, but the cost of therapist and a shortage of therapist makes that a tough sell for people short of spare time and extra cash.
No treatment works for everyone, but around one in three people with depression get well with an initial antidepressant medication. Allowing over-the-counter access is not a panacea, but could open the door to a safe, effective, and inexpensive treatment for many who need it.
The FDA cannot just decide whether a drug is safe enough for consumers to self-medicate OTC. A manufacturer must apply and request switching an approved prescription drug to OTC through a long and drawn-out application process. An application must include studies proving patients can self-diagnose and self-medicate their condition using the drug. Further surveys must illustrate the labeling on the package is easy to understand and provides sufficient information for patients to self-medicate. The drug must generally be recommended by two different FDA panels of volunteer experts. Furthermore, since no SSRIs have been approved for sale OTC manufacturers face an uphill battle getting one approved.
There is little doubt that easier access to drugs like Prozac or Zoloft would benefit millions of Americans who lack access to therapists and are too embarrassed to talk to their doctors about it. As Dr. Perlis says, “…part of the solution is hiding in plain sight…” It’s not just SSRIs, there are numerous classes of drugs available only by prescription that are candidates for over the counter.
Read more at Stat News: The time has come for over-the-counter antidepressants