Running head: OTC MEDICINE VERSUS HERBAL MEDICINE Over-the-Counter Medicine Versus Herbal Medicine: Which is safer? Huizi Gao Northeastern University 1 OTC MEDICINE VERSUS HERBAL MEDICINE Over-the-Counter Medicine Versus Herbal Medicine: Which is safer? While over-the-counter medicine has been used and relied on for many years now, a new type of medicine, herbal medicine, has emerged and is recently favored by the public. There are many reasons why herbal medicine is chosen, like its affordability. One of the most concerning reasons why patients are selecting herbal medicine is for its debatable safety. Many patients will favor the fact that herbal medicines are natural, so therefore they think herbal medicines are safe to take. On the contrary, there has been very little research on the safety of herbal medicine in the United States (Bent & Ko, 2004). According to the U.S. Food and Drug Administration (FDA), new drugs are considered to be unsafe until they are proven safe through clinical trials. The FDA must also approve any new drug, over-the-counter or prescription, before it can be sold on the market. However, herbal medicines are put under the category of food. They have different regulations than over-the-counter drugs and are considered safe until proven unsafe. A huge concern is that the FDA approval is not needed for selling any kind of herbal medicine. It is up to the manufacturers to make sure all claims and information on the product label are correct. If there is wrongful labeling, it puts the patient’s health in danger (Raynor et al., 2011). Interactions with other products and adverse reactions are also likely for herbal medicine, which is something else that manufacturers need to address correctly (Jeong et al., 2012). Even though over-the-counter medicine is strictly regulated by the FDA, it doesn’t mean it is completely safe either. The major issue is the lack of healthcare professional input. Healthcare professionals rarely ask patients about their OTC (over-the-counter) medication use or give advice to patients before purchasing. Another concern is that OTC medication purchases are not recorded in any system and that there is no healthcare information about the purchasers (Albert et al., 2014). Patients could be buying the wrong OTC medication without realizing it or OTC MEDICINE VERSUS HERBAL MEDICINE they could be buying many OTC medications at a time. Due to its easy accessibility, OTC medicines could be potentially abused by patients (Cooper, 2013). OTC medicines are also known to have serious adverse effects, like liver damage and toxicity. One more issue is that patients might not understand all the ingredients in OTC medicines. Unlike herbal medicine, OTC medicines are chemically made. This could be a problem if the patient is taking another type of prescription medicine and the OTC medicine could interfere (Bond & Hannaford, 2003). In short, both OTC medicine and herbal medicine are very different, but both have positive and negative similarities. Currently, OTC medicine is recommended over herbal medicine because OTC medicine is FDA approved. This does not mean the public should stop using herbal medicines, but they should be informed on how safely take them instead. It is easy to have misconceptions about these two types of medicines. This paper will analyze the differences and similarities between herbal medicine and OTC medicine while focusing on their safety for use. Reflective note: This abstract is a response to a general call for papers for the Pharmacoepidemiology and Drug Safety, published by John Wiley & Sons. Although they are many pros and cons to both herbal medicine and OTC medicine, the goal of this paper is to inform and educate the general public about them. This paper will focus on comparing and contrasting the safety of herbal medicine and OTC medicine. Most of the research process is done through the Northeastern University Library. OTC MEDICINE VERSUS HERBAL MEDICINE References: 1. Albert, S. M., Bix, L., Bridgeman, M. M., Carstensen, L. L., Dyer-Chamberlain, M., Neafsey, P. J., & Wolf, M. S. (2014). Promoting Safe and Effective Use of OTC Medications: CHPA-GSA National Summit. Gerontologist, 54(6), 909-918. 2. Bent, S., Ko, R. (2004). Commonly used herbal medicines in the United States: a review. American Journal of Medicine, 116(7), 478–485. 3. Bond, C., Hannaford, P. (2003). Issues Related to Monitoring the Safety of Over-TheCounter (OTC) Medicines. Drug Safety, 26(15), 1065-1074. 4. Cooper, R. (2013). Surveillance and uncertainty: community pharmacy responses to over the counter medicine abuse. Health & Social Care In The Community, 21(3), 254-262. 5. Dietary Supplements. (2015, April 28). Retrieved June 9, 2015, from http://www.fda.gov/Food/DietarySupplements/ 6. Jeong, T., Park, B., Cho, J., Kim, Y., Ahn, Y., & Son, C. (2012). A prospective study on the safety of herbal medicines, used alone or with conventional medicines. Journal Of Ethnopharmacology, 143(3), 884-888. 7. Raynor, D., Dickinson, R., Knapp, P., Long, A., & Nicolson, D. (2011). Buyer beware? Does the information provided with herbal products available over the counter enable safe use? BMC Medicine, 94(9).