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Over-the-Counter Medications: Consumers Take Charge

As with many other aspects of health care today, the market of over-the-counter (OTC) medications is undergoing dramatic change. Once consisting of a relatively small number of medications for treating minor ailments such as colds, heartburn, constipation, diarrhea, fever, and aches and pains, the list of OTC medications has expanded to include agents with claims of beneficial effects on mood, memory, energy, symptoms of prostate disease, and general well-being.

In addition to the traditional mainstays, OTC medications now also include homeopathic remedies; metabolic factors; and dietary supplements, including herbal remedies, vitamins, and minerals. The dietary supplements market has seen the largest growth in recent years, with analysts projecting revenues of close to $6 billion annually.1

Factors Fueling OTC Sales

The phenomenal growth in sales of OTC products stems partly from the Food and Drug Administration’s (FDA) approval of OTC status for many medications previously available by prescription only. Common examples include histamine-2 receptor antagonists and nonsteroidal anti-inflammatory drugs. But the most dramatic changes have occurred in the marketing, production, and use of herbal products.

A major force behind the growth in this area is a federal regulation passed in 1994, the Dietary Supplement Health and Education Act (DSHEA), which classified herbal products as dietary supplements. Under this law, manufacturers are free to make claims on the effects of herbal products on body structure or function (e.g., mood enhancement with St.-John’s-wort or increased energy with ginseng) as long as there is no mention of the treatment of disease. This opened the door for many manufacturers to start producing and marketing herbal products, since they were no longer subject to the more rigorous requirements that govern OTC medications.

One of the primary differences between OTC medications, which are regulated by the FDA, and the unregulated herbal remedies is in the information provided on the packaging. OTC medication labeling requirements, which were revised by the FDA in March of this year, call for information on absolute and relative contraindications for use, precautions regarding drug interactions, information on side effects, and instructions for use. In contrast, herbal remedies are not required to carry any of this information, although a suggestion on daily intake is usually provided. In fact, the label is only required to state the following: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

OTC medications on the market have to be proven safe and effective and have undergone review by the FDA. Herbal remedies, because they are now categorized as nutritional supplements, can be marketed without evidence of effectiveness, as long as no claim of effectiveness is printed on the product label.

Judging Claims of Efficacy

The majority of herbal remedies have not undergone rigorous scientific testing in the United States. There have, however, been numerous monographs on herbal products published in European countries. Much of the information we have about herbal remedies today comes from the German “Commission E,” a regulatory body established in 1978 by the German Federal Health Agency that evaluates the safety and efficacy of herbs on the basis of anecdotal evidence, clinical trials, and other scientific literature. The commission has published over 380 such monographs, which have been made available in English in the past year or so by the American Botanical Council. The information, designed to be printed inside product packaging sold in German pharmacies, includes guidance such as appropriate use, contraindications, potential side effects, proper dosage range, and potential herb or drug interactions.

While there is no U.S. complement to Commission E, the National Institutes of Health (NIH) and other agencies are beginning to provide funding for increased research, and manufacturers are starting to conduct clinical trials of these products to study their safety and effectiveness. Studies in the United States have been conducted with ginkgo biloba for Alzheimer’s disease, St.-John’s-wort for depression, and zinc and echinacea for the common cold. Other studies will be forthcoming, and hopefully they will provide us with more insight into the benefits and adverse effects of herbal remedies.

Although many experts agree that the majority of herbal remedies on the market today are probably not harmful, the evidence of beneficial effects is largely based on personal experience. Word-of-mouth success stories, marketing by manufacturers, and media testimonials have been the primary sources of information promoting the health benefits of these products. In a recent national survey of consumers on the use of herbal remedies, the majority of respondents thought herbal therapies were generally as good as or better than non-herbal remedies in terms of efficacy, safety, and cost. Several organizations, including the NIH’s Office of Complementary and Alternative Medicine and the American Neutraceutical Association, are making efforts to provide educational information to consumers and health care professionals on the appropriate use of these products.

Pharmacists’ Role in Safe Herbal Use

Consultant pharmacists nationwide are witnessing increased interest among both patients and prescribers in the use of herbal medications and dietary supplements. A recent survey of consumers regarding use of alternative medicine published in the Journal of American Medical Association, found that five times as many people admitted to using a herbal remedy in 1997, compared to a similar survey conducted in 1990 (2.5% vs 12.1%).4 The authors estimated that over 15 million of those taking a herbal remedy or high-dose vitamins were also taking a prescription medication concurrently and were thus at potential increased risk for unwanted health effects due to interactions between the products.

As the use of herbal remedies continues to increase, more and more reports of adverse effects and drug interactions are being cited in the literature.2 A recent article in the March 1 issue of American Family Physician reviews adverse effects and drug interactions associated with many herbal remedies.3 As with traditional medications, it is suspected that the elderly population is at increased risk for experiencing adverse effects when using herbal products. It has been estimated that anywhere from 31%–87% of the elderly take OTC medications, a number that is bound to increase with the increased advertising, availability, and popularity of herbal remedies. While clinical studies that focus specifically on the elderly are lacking, it seems only logical that age-specific changes, such as decreased renal function and delayed gastric emptying, may create some special considerations regarding use and dosing of these products for the elderly patient. Additionally, special attention must be paid to the comorbid conditions often present in this population.

The general public perception is that since herbal remedies are “natural,” they must also be safer than traditional medications. This perception may lead under-informed consumers self- treating many types of symptoms and diseases with little regard to drug interactions and issues of questionable efficacy and potential toxicity. As with other OTC medications, patients also tend to neglect to inform their health care providers about herbal remedies they may be taking. Consultant pharmacists can help communicate to patients the importance of informing all members of their health care team about all types of medications they are taking, including OTC medications, dietary supplements, and herbal remedies. Pharmacists should also tell patients to keep an up-to-date list of medications with them at all times. This should include any homeopathic and herbal remedies, vitamins, or special dietary items. The American Association of Retired Persons (800-424-3410) has developed a pocket card, as well as a companion card for placement on a refrigerator, to help consumers keep track of their medications, including herbal products and others.

Lacking scientific data to support the use of these agents, many consultant pharmacists still do not feel comfortable recommending these remedies to patients; yet the rapidly growing use of these remedies indicates that patients are nonetheless using them. It is, therefore, increasingly important that pharmacists are aware of the general biochemical properties of these agents, especially their potential to interact with traditional medications to cause adverse effects. Adverse reactions and drug interactions of some commonly used herbal remedies will be the focus of Consultant Pharmacist Forum articles in upcoming issues of The Consultant Pharmacist.

Final Notes

It is evident that consumers are taking a greater role in their health by utilizing OTC medications and dietary supplements, including herbal remedies, to manage some of their health care needs.

As a readily accessible source of education and information, consultant pharmacists can play a signficant role in helping their patients and families become informed and empowered consumers who are able to reap the potential benefits of dietary supplements while hopefully avoiding harm.

H. Edward Davidson, PharmD, FASCP
Insight Therapeutics, LLC
Norfolk, Virginia

Caren McHenry Martin, PharmD
Neil Medical Group
Greensboro, North Carolina

References
1. Levy S. Don’t miss the boat; nutraceuticals represent a powerful new professional and marketing opportunity. Are you ready for it? Drug Topics 1999;March 1:41–9.
2. Angell M, Kassirer JP. Alternative medicine—the risks of untested and unregulated remedies. N Engl J Med 1998;339:839–41.
3. Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Phys 1999;59:1239–44. Eisenberg DM, Davis RB, Ettner SL et al. Trends in alternative medicine use in the United States, 1990-1997. Results of a follow-up survey. JAMA 1998;280:1569–75.

Patient-Controlled Analgesia: Follow-Up Findings

In July 1997, Kadlec Medical Center in Richland, Washington, made a dramatic change in its patient-controlled analgesia (PCA) order form, making morphine and hydromorphone the preferred medications (Consult Pharm 1998;13: 713–4).

This change has not only altered the prescribing patterns of physicians serving patients at the medical center; we have also seen a decrease in the number of reported adverse effects associated with these medications. Before the form was initiated, there were 24 adverse drug reaction (ADR) reports for meperidine, 10 for morphine, and 0 for hydromorphone (Figure 1). After the form was initiated, the number of ADR reports for meperidine dropped to eight, and those for morphine dropped to four. The number of ADR reports for hydromorphone increased to three (Figure 2). However, six of the meperidine reports were made during the first six months after we started using the form. In addition, there were only two ADR reports for meperidine in 1998 and none so far this year.

Many of the patients with reported ADRs received more than 2,000 mg of meperidine (seven patients before the form was initiated, three after the form was initiated). Three ADR reports arose from our pediatric population. Reported meperidine-associated ADRs included severe, uncontrollable muscle twitching; diaphoresis; hallucinations; and combative behavior.

We received three ADR reports for hydromorphone in 1998 and none so far in 1999. Reported reactions included rash, itching, and one instance of combative behavior. All medications have the potential for causing ADRs and should be monitored carefully. Developing a new PCA order form was a very effective way for our institution to improve patient care and help minimize ADRs.

Pamela Walker-Renard, PharmD, BCPS, FASCP
Kadlec Medical Center
Richland, Washington

 



The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.