Patient, treat thyself. Maybe.

  • by: |
  • 07/18/2014

Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely. The FDA’s September 2011 draft guidance provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. It's fair to say that support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns?  In considering an Rx-to-OTC switch, the FDA looks to see whether patients can use the product safely without the oversight of a physician or pharmacist. This includes ensuring that the right patients use the drug in the appropriate way ("safe use"). The agency is not evaluating the risk-benefit of the product, since that was done earlier when it was approved as a prescription drug.

The journal SelfCare has published "an essential blueprint for designing and implementing any Rx-to-OTC drug development program," says lead author Bill Soller, professor and executive director of the Center for Consumer Self Care at the University of California, San Francisco, School of Pharmacy.  Well, maybe not essential -- but certainly intriguing.

Soller and his colleagues list questions - "OTC Considerations" - based on switch principles FDA set in 1990 and 1998 and questions to post-2002 advisory committees that evaluated first-in-class switches.

The analysis recommends 11 primary questions about the Rx fundamentals of a drug, its "OTCness" and overall risk vs. benefit.

1- Has the Rx product been on the market for a sufficient time and extent to enable full characterization of the drug's safety profile?

2- Can the condition be adequately self-diagnosed or is there a need for physician diagnosis?

3- Is the minimally effective dose known?

4- Are there efficacy studies needed to support the intended OTC use of the switch candidate?

5- What are the patterns of diagnosing, prescribing and patient use in the Rx setting related to OTC intended use?

6- Are the studies supporting OTCness generalizable to the intended OTC target population?

7-Do consumers understand key communication objectives of the label, relating to directions for use, contraindications, in-use warnings and precautions?

8- Do consumers show they would be likely to be able to assess and take action on the treatment effect (e.g., take appropriate action if the drug is not working, serious side effects emerge, or self-monitoring is needed)?

9- Do consumers demonstrate successful self-selection and de-selection of the product under conditions (or simulated conditions) of actual use?

10- Does the pattern of actual use support that the label can be successfully used in practice?

11- Do the benefits of OTC availability outweigh the risks?

The authors say FDA "uses its discretion to select areas of concentration for advisory committee discussions on switch." Factors influencing the agency's questions for advisory committees include the novelty and uniqueness of a proposed OTC indication or Rx active ingredient; intrinsic and extrinsic toxicity of a switch candidate; and robustness of published and NDA-derived data and worldwide post-marketing surveillance evaluations.

But there are other important factors at play that, while not entirely within the scope of FDA’s regulatory authority, need to be considered within the context of the broader Rx-to-OTC switch conversation. These factors fall under the general headline of “the consumer healthcare continuum.”

Today’s healthcare consumer has access to much more information than ever before. (Some of it is even accurate.) More importantly, they seek choice and empowerment. At the same time healthcare providers are under multiple pressures to further decrease the amount of time spent with their patients. Moving certain products from Rx to OTC would certainly decrease (in a safe and appropriate manner) a provider's patient load, while at the same time obviating the need for a patient (otherwise known as a “consumer”) to spend both the time and money (office co-pay as well as time off from work) required for an office visit -- allowing physicians to focus their limited time on high-risk patients or those with more complex conditions.

And what about the evolving role of pharmacists and the important question (among others) of pharmacy scope of practice (blood tests, etc.). The removal of the Rx designation doesn’t require the removal of a learned intermediary.

There is also good research showing that patients on OTC medications demonstrate higher rates of utilization. A 2013 study indicates that offering OTC forms of a prescription medication increased utilization per drug class by 30 percent, potentially closing treatment gaps.  And, in contrast with many Rx treatments for chronic disease (such as high cholesterol), adherence rates are higher for OTC medications.

Patient, treat thyself. That’s one way of looking at it. Knowledge is power. But is a little knowledge a dangerous thing?

The consumer healthcare continuum continues.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog