Understanding Safety and Adverse Drug Events in Homeopathy: a Fair and Balanced Approach
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CONTINUING EDUCATION THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM BOIRON USA. Understanding Safety and Adverse Drug Events in Homeopathy: A Fair and Balanced Approach FACULTY EDUCATIONAL OBJECTIVES Jeannette Y. Wick, RPh, MBA, FASCP At the completion of this activity, the participant will be able to: Freelance Medical Writer • Examine homeopathic principles and the FDA’s risk-based regulations for homeopathic products Arlington, Virginia • Compare common homeopathic products, the symptoms for which they are used, and the Assistant Director, Office of Pharmacy likelihood of an adverse drug event based on dilutions Professional Development • Analyze Poison Control Center data to assess the safety of homeopathic products University of Connecticut School of • Identify appropriate uses and counseling points for homeopathic products Pharmacy TARGET AUDIENCE: Pharmacists and pharmacy technicians Storrs, Connecticut ACTIVITY TYPE: Application DISCLOSURES RELEASE DATE: December 14. 2020 The following contributors have no EXPIRATION DATE: January 23, 2023 relevant financial relationships with ESTIMATED TIME TO COMPLETE ACTIVITY: 2.0 hours commercial interests to disclose: FEE: This lesson is offered for free at www.pharmacytimes.org. FACULTY Jeannette Wick, RPh, MBA, FASCP PHARMACY TIMES CONTINUING Introduction ($174 million), pain relief ($85 million), EDUCATION™ In the United States, “wellness” is a and children’s medicine ($87 million) the PLANNING STAFF 1 3,4 Jim Palatine, RPh, MBA; Maryjo Dixon, multitrillion-dollar industry. The wellness top sellers. But HCPs frequently lack RPh; Crissy Wilson; Susan Pordon; and industry encompasses alternative therapies knowledge about homeopathy.5 Homeopathy Brianna Winters such as specialized diets, complementary advocates cite its lack of adverse events PHARMACY TIMES® EDITORIAL STAFF and alternative medicines, and home- (AEs), patient-centered approach, and low Davy James An anonymous peer reviewer was part of the opathy. Patients who are dissatisfied with cost as reasons for its popularity. Critics say content validation and conflict resolution and their treatment or disenfranchised with the homeopathy is quackery that has no basis has no relevant financial relationships with 2 commercial interests to disclose. medical system often look elsewhere for in science. Which is it? Homeopathy—a solutions. Health care providers (HCPs) system of traditional medicine that is recog- often worry that when people choose well- nized by the World Health Organization ness products, they may gravitate away (WHO) and a distinct pharmacopeia in the from evidence-based treatments.1,2 Patients United States—differs from conventional sometimes ask pharmacists questions medicine significantly. Exploration of home- about wellness products including home- opathy’s principles can help pharmacists opathy. Many pharmacists lack training in assess its safety and efficacy and counsel wellness approaches in general and home- patients knowledgably. TABLE 1 lists 11 opathy specifically, and cannot speak to commonly used homeopathic products.2,6 safety or efficacy. This continuing educa- tion activity introduces homeopathy with STAR* an emphasis on safety. If a patient asks you to explain The homeopathic product market has homeopathy, what would you say? grown in the past 20 years. In 2018, *S = Stop; T = Think; A = Assess; American consumers spent $437 million R = Review on homeopathic products, with cold and flu Pharmacy Times Continuing Education™ is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 2.0 contact hours (0.20 CEU) under the ACPE universal activity numbers 0290-0000-20-376-H01-P and 0290-0000-20-376-H01-T. The activity is available for CE credit through January 23, 2023. PHARMACYTIMES.ORG 62 JANUARY 2021 www.pharmacytimes.org TABLE 1. COMMON HOMEOPATHIC PRODUCTS2,6 Homeopathic practitioners use infinitesimal doses of substances that in large doses would be toxic to stimulate a Homeopathic product Typical target condition or symptom(s) person’s own healing responses. They propose that using infini- 7 Allium cepa (onion) Common cold and hay fever, tesimal quantities avoids undesirable AEs. especially when there is a Homeopathy emanated from German doctor Samuel Hahn- thin, watery, and burning emann’s (1745–1843) observation that consuming Peruvian nasal discharge cinchona tree bark induced malaria-like symptoms but also Arnica (mountain daisy) Orally: Shock and trauma cured malaria.8 He extrapolated that observation to other from injury, pain, healing acceleration substances and conditions. He concluded that animal, mineral, Topical gels, ointment, or plant substances that cause a particular symptom in healthy or spray: sprains, strains people would cure the same symptoms when administered in bruising on unbroken skin homeopathic doses and forms to ill people exhibiting those Calendula (marigold) Topical: Burn relief symptoms.8 Accordingly, all homeopathic medicines are derived Chamomilla (chamomile) Irritability in infants, from natural animal, mineral, or plant substances and prepared especially from teething or colic using serial dilutions and precise succussions (vigorous shaking with directional strikes).7 Hypericum (St John’s wort) Injuries to the nerves or to highly enervated parts of the Homeopathy was popular in the United States in the 19th body (eg, fingers, toes, and century. By 1900, 22 homeopathic medical schools had produced back); shooting pain more than 1000 homeopathic practitioners. The United States Ignatia (St Ignatius bean) Acute grief, anxiety, and was also home to 100 homeopathic hospitals.9 In the subsequent depression decades, practice of homeopathy dwindled and the majority of Magnesia phosphorica Cramps, including menstrual homeopathic colleges and hospitals disappeared by 1910. The (phosphate of magnesia) cramps last homeopathic hospital closed in the 1950s. Interest in home- Nux vomica (poison nut) Ailments exacerbated by conventional or recreational opathy reignited in the 1970s, although fewer than 100 homeo- drugs; symptoms of pathic practitioners (often called homeopaths) remained active overeating or from drinking at that time. In the next 10 years, that number grew to more than too much alcohol 1000.10,11 Pulsatilla (windflower) A specific pattern of physical Enactment of the Food, Drug, and Cosmetic Act (FD&C Act) symptoms and psychological characteristics (warm- in 1938 was a defining moment in medical history, establishing blooded tendencies, dislike a requirement for the Food and Drug Administration (FDA) to of heat, quickly changing approve all new drugs before they could be marketed; manu- emotional state, and a facturers had to prove each drug’s safety before marketing it. strong tendency to want to 12 please others) It also prohibited false therapeutic claims for drugs. Addi- Rhus tox (poison ivy) Sprains and strains; flu or tional statutes gave the FDA jurisdiction over drug labeling arthritis in people who and the Federal Trade Commission (FTC) jurisdiction over experience rusty gate drug advertising.13 An amendment to the FD&C Act in 1962 syndrome (pain when they start to move that improves transferred authority for prescription drug advertising to the over time) FDA. The FTC retained oversight of OTC drug and supplement advertising. Homeopathic drugs occupy a unique place in the The Basics of Homeopathic Medicine regulatory framework: homeopathic products can make a thera- The term “homeopathy” melds the Greek words “homoion” peutic claim.14 However, these drugs are not subject to the same (similar) and “pathos” (disease). Homeopathy’s advocates level of premarket scrutiny by the FDA as conventional drugs embrace 3 principles: (referred to as allopathic drugs by homeopaths, meaning they • The Law of Similars (also called, “like cures like”) bear no connection to the nature of the symptoms they target). • Minimum dose Homeopathic drugs are listed in a pharmacopoeia all its own. • Single remedy Homeopathic monographs in the Homœopathic Pharmacopœia PHARMACYTIMES.ORG JANUARY 2021 63 of the United States (HPUS) delineate the exact steps necessary All homeopathic products are labeled in a standard way. For to prepare homeopathic products. The HPUS describes 2 types OTC products, the “Drug Facts” section on the label lists the of dilution15: ingredients (using the Latin binomial, the 2-term naming system • X dilutions: The original substance (1 part) is diluted with that classifies species) and dilutions (eg, 6X, 6C, 30X, 30C). liquid (9 parts), providing a tincture with a 1 to 10 dilution, Homeopathic practitioners use low dilutions, such as 6X or 6C, or 1X. The manufacturer repeats the process, diluting the for local symptoms and high dilutions, such as 30X or 30C, for 1X tincture with 9 parts of liquid and creating a more dilute generalized symptoms. To pharmacists trained in traditional tincture with a higher decimal designation (factor of 10) medicine (allopathy), homeopathic dilution is counterintuitive with each successive dilution (eg, 2X, 3X). because these substances are diluted beyond Avogadro’s number • C dilutions: The process begins by taking 1 part of the (the dilution at which traditional chemists indicate no molecular original substance and adding it to 99 parts diluent (water trace of the original substance is present).18 Homeopathy’s or alcohol), followed by succussion, which creates the 2C advocates allege that if homeopathic products