Chapter 4: Overview of Herbal Supplements 5 Contact Hours By: Joanne S. Richards, B.S., R.Ph., J.D., RAC Author Disclosure: Joanne S. Richards and Elite Professional Questions regarding statements of credit and other customer service Education, LLC. do not have any actual or potential conflicts of issues should be directed to 1-888-666-9053. This lesson is $20.00. interest in relation to this lesson. Educational Review Systems is accredited by the Universal Activity Number (UAN): 0761-9999-16-127-H01-T Accreditation Council of Pharmacy Education (ACPE) Activity Type: Knowledge-based as a provider of continuing pharmaceutical education. Initial Release Date: June 1, 2016 This program is approved for 5 hours (0.5 CEUs) of Expiration Date: June 1, 2018 continuing pharmacy education credit. Proof of Target Audience: Pharmacy Technicians in a community-based participation will be posted to your NABP CPE profile within 4 to 6 setting. weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete To Obtain Credit: A minimum test score of 70 percent is needed the course evaluation to receive continuing pharmacy education credit. to obtain a credit. Please submit your answers either by mail, fax, or online at PharmacyTech.EliteCME.com. Learning objectives Define what an herbal supplement is in the United States. Generally discuss the issues and problems associated with Discuss the extent of use worldwide of herbal medicine. scientific testing and reporting of research results on herbal Outline suggested reasons patients do not disclose their use of supplements. herbal supplements to their health care providers. Discuss the historical and current uses for 13 common herbal Explain why all health care providers should incorporate use of supplements. herbal supplements into the patient’s medical and medication Discuss side effects and recommended dosages of 13 common histories. herbal supplements. Itemize factors that have an effect on the quality and therapeutic Give examples of common herbal supplements that interfere with efficacy of herbal products. medical lab tests. Describe the differences between U.S. regulatory review processes Give examples of common herbal supplements that affect blood for drugs and herbal products. coagulation and aggregation. List the information required and prohibited by the FDA on herbal Give examples of common herbal supplements that interfere with supplement labels. liver enzymes, liver function, and drugs metabolized in the liver. Introduction There are numerous health risks and misconceptions associated This course provides an overview of herbal medications and the with herbal supplements, e.g., potential adverse effects, drug-drug regulatory process associated with their manufacture and marketing. interactions, lab test interactions, and dose-to-dose content variability, With some of the more frequently used herbals, it further provides to name a few. More often than not, patients and health care specific information on safety, effectiveness, interactions and side practitioners are unaware of these potential problems. The physician effects. may even be unaware that the patient is taking them at all, either Today, more than ever, patients receive information from and have because the patient does not voluntarily disclose the information or access to a variety of medications, some of which may dramatically because the health care practitioner does not ask. affect the success or failure of the medical treatment they receive. Thus, it is important for those involved in each step in the continuum This lesson emphasizes how important it is for health care providers to of patient care to be aware not only of the extent and type of problems inquire and for patients to disclose what herbal medications the patient they may encounter when patients consume herbal medicines, but also is taking and to be able to discuss and explain the potential risks and to consistently obtain such information from patients and be able to benefits associated with them. discuss the benefits and dangers associated with these commonly used health aids. Herbal supplement use [14, 32, 34, 35, 64, 82, 100, 122, 147, 160-162, 184] Compounds extracted from plants, animals, or microorganisms have cancer drugs. Plants having medicinal or therapeutic properties, flavor, been used to treat or prevent disease for centuries. Examples include and scent used to maintain or improve health are often called herbal digitalis, reserpine, morphine, penicillin, and vinca alkaloid anti- products, botanical products, or phytomedicines. Page 35 PharmacyTech.EliteCME.com As defined by Congress in the Dietary Supplement Health and ● The belief that the physician lacks interest or knowledge about Education Act of 1994, a dietary supplement is a product (other than herbals. tobacco) that: ● Not being asked by their practitioner about taking herbals. ● Is intended to supplement the diet. ● Their use of herbals is a cultural mainstay of therapy and they do ● Contains one or more dietary ingredients (e.g., vitamins, minerals, not even think to disclose it. herbs or other botanicals, amino acids, or essential fatty oils). ● A lack of awareness that herbal medicines can interact with and ● Is intended to be taken by mouth as a pill, capsule, tablet, or liquid. alter the therapeutic efficacy of conventional medications. ● Is labeled on the front panel as being a dietary supplement. To further complicate the issue, detailed information on herbal Recently, the World Health Organization estimated that 70-80 percent supplements is often outside the general knowledge base of medical of people worldwide rely on herbal medicines for some part of their prescribers, either because of limited formal training or inaccurate primary health care, but only 23-40 percent of these people tell their or biased information sources. In addition to physicians and nurses physician. Statistics reveal that the likelihood of consuming herbal who don’t ask patients about their use of herbal medicines, some medicines is higher in persons of higher education and income. community pharmacists who on a daily basis are in a key position Possible explanations for patients’ non-disclosure include: to assess interactions with conventional drugs also may rarely ask ● The belief that natural medicines have no adverse effects. patients about their use of herbals. ● The belief that over-the-counter and non-mainstream medicines Thus, because of the prevalent use, misconceptions, invalid assumptions, are irrelevant to their doctor’s overall treatment plan and outcome. and lack of patient information, it is critical to educate patients and all ● Their concern about a negative reaction from their practitioner. those in the health care delivery chain on the effects that herbal medicine can have on therapeutic outcomes. Pharmacology of herbal supplements [30, 75, 82, 101, 109, 127, 162] In the United States, current good manufacturing practices (cGMPs) while in the body. In addition to a drug’s chemical properties, applicable to food manufacturing are the only quality-control pharmacokinetics depends on patient-related factors, such as renal regulations on herbal medicines. The final marketed product, however, function, genetic makeup, sex, and age. These factors are often used to is impacted by more than just satisfying current good manufacturing predict how a drug will affect a specific population. practices. Pharmacodynamics can be simply explained as what a drug does to Other factors that influence the quality and thus the potential for the body. It involves receptor binding and sensitivity, post-receptor reliable therapeutic effectiveness of herbals include: effects, and chemical interactions. Physiologic changes caused by ● Identification and collection of the botanical source (e.g. leaf, root, disorders, aging, or other drugs can affect a drug’s pharmacodynamics. flower). The pharmacologic response depends on the drug binding to its target. ● Isolation, purification, and concentration of one or more active The concentration of the drug at the receptor site influences the drug’s ingredients. effect. ● Contaminants, e.g., pesticides and micro-organisms. Bioavailability refers to the extent and rate at which the drug or ● Active ingredient source substitution. metabolite enters systemic circulation, thereby accessing the site of ● Preparation process of specimens (e.g., solutions, desiccation, action. Bioavailability of a drug is determined by the properties of the trituration). dosage form, the product’s design, and its method of manufacture. ● Excipients used. Differences in bioavailability among formulations of a given drug can ● Storage conditions. have clinical significance, so knowing whether drug formulations are ● Final product formulation (e.g., solution, suspension, powder, equivalent is essential. tablet, capsules). Chemical equivalence means that the drug products contain the same The impact of these factors is best explained by understanding how active compound and in the same amount. Inactive ingredients in drugs work in our bodies. Pharmacokinetics, pharmacodynamics, and drug products may differ. Bioequivalence means that when the drug bioavailability are terms used to explain this process. is given to the same patient in the same dosage regimen, equivalent Pharmacokinetics is the study of the processes of drug absorption, concentrations of drug in plasma and tissues are achieved. distribution,