This article is part of an ongoing series entitled, Beyond RX: OTC Corner, which will include topics such as OTC medications, dietary supplements, and other health care approaches that will help nurse practitioners and physician assistants provide patients with tools to manage their health.
Robert D. Sheeler, MD, is guest editor of the series. He is an associate professor of family medicine, Mayo Clinic, in Rochester, Minn. He is board certified in family medicine, integrative medicine, and holistic medicine.
Although patients do not always understand it intuitively, primary care providers have a meaningful role in advising them on the safe and effective use of nonprescription therapies.
For example, Joe, a 56-year-old Caucasian male truck driver, presents for his Department of Transportation examination. During your interview, he reports taking an over-the-counter (OTC) proton pump inhibitor (PPI) daily for his acid reflux, which started about a month ago. His BMI is 34. He quit smoking three years ago and has since gained 50 pounds. He is hypertensive and takes ibuprofen four times a day. His only other health concern is daily headaches.
As a health care provider, you know that patients older than 50 years with reflux symptoms who are obese, smokers, Caucasian males, have hiatal hernia, or those who have had symptoms for more than five years should be considered for screening esophagogastroduodenoscopy (EGD) to rule out Barrett’s esophagus or underlying gastric neoplasia.1
You also know that one of the side effects of PPIs is headaches. Ibuprofen can cause rebound headaches and peptic ulcer disease, as well as elevate blood pressure. But Joe does not know these things. He presumes they must be safe; after all, he bought them OTC.
SECARR is an acronym describing factors to consider for OTC and supplement treatment: Safety, Efficacy, Cost-effectiveness, Availability, Reliability, Reimbursement
OTC drugs arrive on the market via three pathways: medications such as aspirin that have been on the market for a long time and are tried and tested; medications primarily developed as OTC agents; or medications converted from prescription to OTC status. Many vitamins and mineral and herbal supplements that are marketed in the United States are regulated by the Dietary Supplement Health and Education Act of 1994.
The provider’s role in this circumstance is to apply his or her broad body of knowledge to the patient’s individual circumstance and medical history to determine what agents are safe to take. There is always a risk/benefit ratio for any therapeutic agent, and the provider’s medical knowledge helps patients make informed decisions with the latest knowledge on how an OTC medicine or supplement will benefit in their individual case.
As with safety, the FDA will only allow products with proven efficacy to be marketed for specific conditions. The rules for supplements are less stringent for efficacy. They primarily need to not cause harm, as opposed to the need to prove efficacy, to be on the market. Hence, you will see broad general statements such as “may promote gastrointestinal health,” rather than a specific claim to treat a specific disease or condition. Supplements may be more, less, or equally effective treatments, compared with other choices.
OTC medicines range from very low-cost generic and store brands to moderately expensive brand name PPIs or supplements such as coenzyme Q10 that can cost several dollars a day. Access to OTC medications and supplements provides patients with a sense of empowerment and control in their own health care.
They also avoid provider, facility, and testing costs and reduce time lost from work when visits are avoided. There are instances in which an insurance plan will cover a generic drug at a low co-pay, which will be substantially more cost-effective than purchasing it OTC. The knowledge of the provider in this circumstance can help guide the patient to the most cost-effective approach in treating his or her symptoms or illness.
Common OTC medications are available from a wide variety of locations, from pharmacies to newsstands. A wider variety is available at retail stores, health stores, co-ops, and the Internet.
The FDA regulates OTC medications through the Center for Drug Evaluation and Research. All OTC products have the same standard as prescription drugs in manufacturing using Good Manufacturing Practices. Safety and effectiveness need to be proven through scientific research and clinical trials. The standardized labeling format indicating drug facts, including active ingredient, uses, warnings, directions, inactive ingredients, and other information, is required.2
It is important that patients know where and what to look for when buying a supplement and to obtain it from a reliable source. Below are some excellent information sources, some of which require subscriptions: U.S. Pharmacopeial Convention (usp.org); ConsumerLab.com; NSF International (nsf.org); Natural Medicines Comprehensive Database (naturaldatabase.com); Natural Standard (naturalstandard.com); NIH MedlinePlus Herbs and Supplements Directory (nlm.nih.gov/medlineplus/druginfo/herb_All.html); NIH National Center for Complementary and Alternative Medicine Herb Fact Sheets (nccam.nih.gov/health/herbsataglance.htm); and NIH Office of Dietary Supplements (ods.od.nih.gov).3
Medical insurance covers only a small percentage of OTC medications. Some states will cover OTC medication for those on medical assistance if a prescription is written. There is no reimbursement at this time for dietary or herbal supplements.
With the increasing use of health savings or flexible spending accounts, patients working in a coordinated fashion with their provider can often receive reimbursement through these pathways. Complementary and alternative medicine therapies, such as acupuncture, chiropractic, and massage, are sometimes covered with preapproval from insurance companies for specific conditions.
Often patients think that they do not need a medical provider when they have access to OTC medicines. But as in Joe’s case, this is far from the truth. An effective relationship with a skilled provider may help a patient such as Joe use nonprescription products in a safe and effective way that will also save him money. Joe had an EGD that showed severe reflux esophagitis.
His provider gave him a prescription PPI to use that was cheaper in his insurance plan than an OTC product. In addition, Joe’s provider recommended weight loss, elevation of the head of his bed, and dietary changes that could allow him not to need a PPI.
His change from ibuprofen to acetaminophen lowered his cardiovascular and gastrointestinal risks and reduced the chance of calcium and vitamin B12 deficiencies. Dose limits on his analgesics have resolved his rebound headaches. By working closely with his provider, Joe was able to find the most effective agent, which in his case, was a combination of prescription and OTC medications.
Dawn M. Kaderabek, APRN, CNP, specializes in family medicine at the Mayo Medical Center in Rochester, Minn.
- Who should be screened for acid reflux. Ask Mayo expert. Available at mayoclinic.org
- NIH. Using dietary supplements wisely. Available at nccih.nih.gov/health/supplements/wiseuse.htm
- UpToDate. Overview of herbal medicine and dietary supplements. Available at www.UpToDate.com/contents/overview-of-herbal-medicine- and-dietary-supplements
- Trends in the use of complementary health approaches among adults: United States, 2002-2012. National Health Statistics Reports, no. 79, February 10, 2015. Available at cdc.gov/nchs/data/nhsr/nhsr079.pdf
All electronic documents accessed on June 3, 2015.