Emerging Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Complementary and Alternative Medical Practices and Dietary Supplement Recommendations

Cohen, Morris; Hrbek, Andrea; Davis, Roger B.; Schachter, Steven C.; Eisenberg, David M.

doi:10.1001/archinte.165.3.289

Cited by 43 publications

(15 citation statements)

References 14 publications

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“…It is a regulated health profession in all jurisdictions in Canada and is licensed in every US state. 4,5 Because back pain is such a common problem and chiropracty is a common response, we use it here to illustrate the responsibilities that CAM practitioners have to patients/parents and the potential for liability when deficient care harms patients. In this article we (1) explain the standard of care health care that providers must meet and (2) examine how these principles apply to CAM providers.…”

Section: Second Opinion On Examination the Pediatrician Discovers Tmentioning

confidence: 99%

Complementary and Alternative Medicine Practitioners' Standard of Care: Responsibilities to Patients and Parents

Gilmour

Harrison

Asadi³

et al. 2011

Pediatrics

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In this article we explain (1) the standard of care that health care providers must meet and (2) how these principles apply to complementary and alternative medicine practitioners. The scenario describes a 14-year-old boy who is experiencing back pain and whose chiropractor performed spinal manipulation but did not recognize or take steps to rule out serious underlying disease—in this case, testicular cancer—either initially or when the patient's condition continued to deteriorate despite treatment. We use chiropractic care for a patient with a sore back as an example, because back pain is such a common problem and chiropracty is a common treatment chosen by both adult and pediatric patients. The scenario illustrates the responsibilities that complementary and alternative medicine practitioners owe patients/parents, the potential for liability when deficient care harms patients, and the importance of ample formal pediatric training for practitioners who treat pediatric patients.

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Section: Second Opinion On Examination the Pediatrician Discovers Tmentioning

confidence: 99%

Complementary and Alternative Medicine Practitioners' Standard of Care: Responsibilities to Patients and Parents

Gilmour

Harrison

Asadi³

et al. 2011

Pediatrics

Self Cite

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“…[4][5][6]9 Ansani et al 4 Seventy percent of the facilities allowed the use of dietary supplements; among these, 79% used the patient's own supply but only 26% reported having requirements for product quality and integrity. The results of both of these small studies are consistent with our findings.…”

Section: Dietary Supplement Policy or Practices In Responding Institumentioning

confidence: 99%

“…[4][5][6][7][8][9][10] Ansani and colleagues 4 surveyed drug information centers regarding the use of dietary supplements in acute care facilities in 2001. Respondents were primarily large university teaching hospitals, which may not be representative of all U.S. hospitals.…”

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National survey of dietary supplement policies in acute care facilities

Bazzie

Witmer

Pinto

et al. 2006

American Journal of Health-System Pharmacy

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“…Often there are insufficient data available to make a sound scientific decision concerning the safety of the product, and without data representing a reasonable certainty of no harm, the FDA does not have the authority to remove it from the marketplace. It should be noted, however, that legal rules governing complementary and alternative medicine are new and evolving (Cohen, 2003;Cohen et al, 2005). A partial list of resources for information on dietary supplement products and/or ingredients is given in alphabetical order in Table 2.…”

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confidence: 99%

Can Claims, Misleading Information, and Manufacturing Issues Regarding Dietary Supplements Be Improved in the United States?

Gibson

Taylor²

2005

J Pharmacol Exp Ther

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The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and selfcare and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".When purchased, over-the-counter (OTC) drugs will most certainly have undergone a Food and Drug Administration (FDA) review that assures the consumer that the drug is safe and effective as labeled. Many Americans assume that dietary supplements have been subjected to the same government regulations as the OTC medications. A recent study of how consumers perceive health claims and nutrient content claims in food labeling stated that 90% of consumers interpreted a nutrient content claim as a claim about the food's health benefits (Levy et al., 1997). The safety and effectiveness of OTC drugs are assessed through the FDA's OTC drug review, and a detailed monograph has been prepared to describe the labeling and formulation of products containing the biologically active ingredient. Prescription drugs are approved through the rigorous new drug application process.In stark contrast, dietary supplements are regulated as foods and are subject to different requirements that place the determination of their safety on the FDA. Essentially, the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness of injury" instead of requiring the manufacturer to provide safety data, as is done wi...

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Emerging Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Complementary and Alternative Medical Practices and Dietary Supplement Recommendations

Cited by 43 publications

References 14 publications

Complementary and Alternative Medicine Practitioners' Standard of Care: Responsibilities to Patients and Parents

Complementary and Alternative Medicine Practitioners' Standard of Care: Responsibilities to Patients and Parents

National survey of dietary supplement policies in acute care facilities

Can Claims, Misleading Information, and Manufacturing Issues Regarding Dietary Supplements Be Improved in the United States?

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