Psychiatrist and Harvard Medical School professor Roy Perlis, M.D., argues for changing the status of some antidepressants from prescription to over-the-counter (OTC) drugs, in a commentary published by Stat News.
Perlis says that, just like the OTC oral contraceptive Opill, selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Zoloft are safe and meet a “massive public health need,” thereby justifying Food and Drug Administration (FDA) approval of OTC status.
Perlis says access to psychiatrists is “extremely limited” in many states, despite high levels of anxiety and depression. A researcher at Massachusetts General Hospital in Boston, Perlis says antidepressants are overwhelmingly prescribed by non-psychiatrists, especially general practitioners.
Perlis says nonprescription medications must meet three FDA 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.”
Perlis writes that OTC antidepressants are “not a panacea” but will provide a “safe, effective, and inexpensive treatment for many who need it.”
Bar Will Be High
In his commentary, Perlis advocates for setting an age limit on who can purchase OTC SSRIs, requiring younger customers to interact with the pharmacist (that is, behind the counter).
SSRIs have been used for three decades in the United States and “have a record of safety and effectiveness for treating depression and anxiety,” said health economist Devon Herrick, who writes for the Goodman Institute Health Blog.
Yet, Herrick says, “the FDA has a high bar” for approving the switch from prescription to OTC. “Meeting the FDA’s criteria is all or nothing,” said Herrick.
Must Pass Regulatory Hurdles
In addition to meeting strict FDA conditions, there are other roadblocks, says Herrick.
“Manufacturers must apply to switch their approved prescription drug to OTC,” said Herrick. “The application process is long and drawn out. The manufacturer must include studies proving it’s possible for patients to self-diagnose and self-medicate their condition with the drug under consideration. Regulations also require manufacturers to include self-medicating information on the drug label.”
Manufacturers also must persuade two separate FDA panels—a tall order since no SSRI has been approved for OTC sale.
Faster Access, Lower Costs
“Millions of Americans would benefit from easier access to SSRIs,” said Herrick.
Perlis writes that it will take an SSRI manufacturer with “the courage to engage with the FDA and invest the necessary resources” to get approval. Other drugs have taken this path, Perlis writes, including medicines for allergies, acid reflux, and emergency contraception (“Plan B” pills).
Gregg Girvan, a research fellow at the Foundation for Research on Equal Opportunity, says the FDA should look to reduce barriers when possible.
“A big reason prescription drugs are so expensive in the U.S. is because our regulatory system drives up the cost of R&D,” said Girvan. “Granted, SSRIs have been available as generics for a long time, so a switch to OTC will likely deliver modest savings for the drugs themselves.”
But there are other benefits, says Girvan. “The real upside of delivering SSRIs over-the-counter is two-fold: first, patients save time and money since they no longer have to schedule appointments with a psychiatrist, and second, patients get access to treatment much faster.”
Safety Questions
A drug could be safe in one context and dangerous in another, says Marilyn M. Singleton, M.D., J.D., a board-certified anesthesiologist and senior fellow at Do No Harm.
“We Americans have developed a taste for pharmaceutical quick fixes,” said Singleton. “While SSRIs have been around for years and have been found safe when appropriately prescribed, leaving the decision to use mind-altering drugs up to the patient could be disastrous. We just have to look at the fentanyl crisis. Fentanyl in the right hands and the right circumstances is safe.”
One major downside of SSRIs is their association with violent behavior, with some blaming the drugs for mass shootings and murder-suicides.
Singleton said that just as fentanyl can be safe, even something as commonplace as Tylenol can be unsafe. “Any drug can be unsafe when not used properly. Even acetaminophen can cause liver problems in higher, chronic doses,” said Singleton.
OTC Not the Only Solution
Other steps are needed to address the mental health crisis, says Girvan.
“The access issue can be addressed in part by solving our physician shortage,” said Girvan. “We should reform our immigration laws to allow for a greater number of highly-trained foreign doctors to practice here, reform scope of practice laws, and expand medical school and residency slots.”
Singleton says improving physician access would help.
“Expansion of telehealth would appeal to many patients, particularly those in rural areas,” said Singleton. “Perhaps starting urgent care centers with mental health counselors available at convenient hours. We have to deal with the shortage of mental health professionals by making it an attractive career choice with reasonable payment for their skills.”
Eliminate Doctors’ Paperwork
Psychiatrist Robert Emmons, M.D., offers another policy solution.
“At the top of my list would be abolishing Prescription Drug Monitoring Programs, which bring requirements that chew up time for patients, doctors, and pharmacies,” said Emmons. “Medical board officials and experts in the field have already admitted years ago that ‘doctor shopping’ is a very small part of the problem of substance use disorders and misuse of prescription drugs.”
Emmons says reducing red tape would improve care.
“Any policy intervention that reduces the time spent by doctors on documentation will improve access to care in all medical specialties,” said Emmons. “I suppose that’s why we’re talking about OTC antidepressants because, for some reason, that kind of policy change seems easier to get through than reductions in documentation.”
Harry Painter (harry@harrypainter.com) writes from Oklahoma.