Advising Patients Regarding Dietary Supplements

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rlstanley
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Advising Patients Regarding Dietary Supplements

Post by rlstanley » Thu 22 Jan 2009 0:07

http://www.camlawblog.com/dietary-suppl ... ments.html

Advising Patients Regarding Dietary Supplements

Clinicians often ask:

"How do I advise patients when evidence concerning dietary supplements is non-existent or conflicting?" And: "Does selling supplements in my office create an ethical conflict?"

Here's an approach to tackling these questions.

First, in advising patients regarding any complementary and alternative medical (CAM) therapy, consider four possible categories of therapies, namely, those where the evidence: (A) supports both safety and efficacy; (B) supports safety, but evidence regarding efficacy is inconclusive; (C) supports efficacy, but evidence regarding safety is inconclusive; (D) or indicates either serious risk or inefficacy.

This strategy should apply to therapies across the board, whether "conventional" or "CAM," "herbal," pharmaceutical, or "nutraceutical."

In Region (A), the clinician probably will feel comfortable recommending the therapy. On the other hand, in region (D), the clinician should avoid and actively discourage; and in (B) and (C), the clinician should caution the patient regarding concerns about effectiveness and safety respectively, and in any event, continue to monitor conventionally for effectiveness and safety. Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603.

The law defines malpractice (or negligence) as: (1) providing services below the standard of care for the profession, and (2) thereby injuring the patient. To the extent the clinicians offers a therapy that has serious safety and/or efficacy concerns (i.e., region D), both elements of the tort are likely to be satisfied, meaning that malpractice liability is highly likely.

Most therapies, however, tend to fall in regions B and C, where evidence is mixed; one cannot make a ready prediction of liability, particularly in these regions, but obviously the riskier the therapy and the less evidence supporting its use, the more likely both elements of the tort will be met; hence caution and continued conventional monitoring are critical. (Id.)

Under this analysis, if evidence concerning dietary supplements is non-existent, the therapy probably falls within region (D) - and liability is likely to follow. On the other hand, if evidence is mixed, one may be in either region (B) or (C).

Evidence changes over time, so a therapy can shift from category to category. And liability risk management by and large dovetails with clinical good sense: when a patient is using therapies in regions (B) and (C), the clinician should monitor and stand ready to intervene conventionally if the therapy produces direct toxicity, fails, or creates adverse interactions with conventional therapies (e.g., herb-herb; herb-drug). This "caution and monitor" strategy should help minimize risk of patient injury as well as lawsuits.

As to selling supplements in the office, the American Medical Association's Policy E-8.063 (Sale of Health-Related Products from Physicians’ Offices)unambiguously provides: "In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own."

The policy goes on to state: "(1)Physicians who choose to sell health-related products from their offices should not sell any health-related products whose claims of benefit lack scientific validity. When judging the efficacy of a product, physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic, and reliable fashion." The clinician can spin out how most dietary supplements would fare under this language. Under the Dietary Supplement Health Education Act of 1994 (DSHEA), manufacturers can make "structure-function" and other claims without the same level of scientific substantiation and validity as, say, claims for prescription drugs.

The policy further provides that: "(2) Because of the risk of patient exploitation and the potential to demean the profession of medicine, physicians who choose to sell health-related products from their offices must take steps to minimize their financial conflicts of interest." The enumerated steps include: (a) limiting sales to "products that serve the immediate and pressing needs of their patients;" (b) providing products to their patients "free of charge or at cost;" (c) disclosing "fully" their financial arrangement with a manufacturer or supplier to sell such products; and (d)avoiding "exclusive distributorships of health-related products which are available only through physicians’ offices."

Here is what the Ethics and Human Rights Committee of the American College of Physicians has said on this issue: "The sale of products from the physician’s office raises several ethical issues and may affect the trust necessary to sustain the patient-physician relationship. When deciding whether to sell products out of the office and, if so, which ones, physicians should carefully consider such criteria as the urgency of the patient’s need, the clinical relevance to the patient’s condition, the adequacy of evidence to support use of the product, and geographic and time constraints for the patient in otherwise obtaining the product.

Physicians should make full disclosure about their financial interests in selling the product and inform patients about alternatives for purchasing the product. Charges for products sold through the office should be limited to the reasonable costs incurred in making them available." Povar GJ and Snyder L. Selling Products Out of the Office, Ann Int Med 1999;131:11:863-864 (excerpted on the Bioethics Discussion Blog).

But there are two additional risks beyond the ethical question. The first is that many states regulate clinician sales of dietary supplements. Some states prohibit the practice, while others require disclosure of the clinician's financial interest in the supplements, and still others allow the pracice only with appropriate disclosure and a state-mandated limitation on percentage profits. The second risk is that in a malpractice case, the jury may view selling supplements as enhancing the defendant clinician's culpability. This in fact happened in Charell v. Gonzales, during which the jury viewed the physician's sale of supplements as greedy and therefore constituting recklessness, rather than negligence. (Plaintiffs can get punitive damages for recklessness, whereas they can only receive compensatory damages for negligence).

In short, selling dietary supplements within the office is legally as well as ethically risky.

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LymeEnigma
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Re: Advising Patients Regarding Dietary Supplements

Post by LymeEnigma » Thu 22 Jan 2009 2:30

rlstanley wrote:As to selling supplements in the office, the American Medical Association's Policy E-8.063 (Sale of Health-Related Products from Physicians’ Offices)unambiguously provides: "In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own."

The policy goes on to state: "(1)Physicians who choose to sell health-related products from their offices should not sell any health-related products whose claims of benefit lack scientific validity. When judging the efficacy of a product, physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic, and reliable fashion." The clinician can spin out how most dietary supplements would fare under this language. Under the Dietary Supplement Health Education Act of 1994 (DSHEA), manufacturers can make "structure-function" and other claims without the same level of scientific substantiation and validity as, say, claims for prescription drugs.

The policy further provides that: "(2) Because of the risk of patient exploitation and the potential to demean the profession of medicine, physicians who choose to sell health-related products from their offices must take steps to minimize their financial conflicts of interest." The enumerated steps include: (a) limiting sales to "products that serve the immediate and pressing needs of their patients;" (b) providing products to their patients "free of charge or at cost;" (c) disclosing "fully" their financial arrangement with a manufacturer or supplier to sell such products; and (d)avoiding "exclusive distributorships of health-related products which are available only through physicians’ offices."

Here is what the Ethics and Human Rights Committee of the American College of Physicians has said on this issue: "The sale of products from the physician’s office raises several ethical issues and may affect the trust necessary to sustain the patient-physician relationship. When deciding whether to sell products out of the office and, if so, which ones, physicians should carefully consider such criteria as the urgency of the patient’s need, the clinical relevance to the patient’s condition, the adequacy of evidence to support use of the product, and geographic and time constraints for the patient in otherwise obtaining the product.

Physicians should make full disclosure about their financial interests in selling the product and inform patients about alternatives for purchasing the product. Charges for products sold through the office should be limited to the reasonable costs incurred in making them available." Povar GJ and Snyder L. Selling Products Out of the Office, Ann Int Med 1999;131:11:863-864 (excerpted on the Bioethics Discussion Blog).

But there are two additional risks beyond the ethical question. The first is that many states regulate clinician sales of dietary supplements. Some states prohibit the practice, while others require disclosure of the clinician's financial interest in the supplements, and still others allow the pracice only with appropriate disclosure and a state-mandated limitation on percentage profits. The second risk is that in a malpractice case, the jury may view selling supplements as enhancing the defendant clinician's culpability. This in fact happened in Charell v. Gonzales, during which the jury viewed the physician's sale of supplements as greedy and therefore constituting recklessness, rather than negligence. (Plaintiffs can get punitive damages for recklessness, whereas they can only receive compensatory damages for negligence).

In short, selling dietary supplements within the office is legally as well as ethically risky.
How many LLMDs (and others) are breaking these rules, right now? The above text illustrates the straw to the camel's back that prompted me to drop my LLMD, when I did....

Claudia
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Re: Advising Patients Regarding Dietary Supplements

Post by Claudia » Thu 22 Jan 2009 16:54

ILADS should include this information in their "LLMD" training and information packets if they don't already.

This situation is obviously a big issue in LymeLand, where it's common knowledge that patients will often walk out from some of their so called "llmd's" offices with a bag full of supplements.

rlstanley
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Joined: Mon 3 Dec 2007 2:53

Re: Advising Patients Regarding Dietary Supplements

Post by rlstanley » Thu 22 Jan 2009 17:07

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In-office physician sale of dietary supplements: conflict of interest

http://www.camlawblog.com/dietary-suppl ... erest.html


Can MDs or DOs sell patients dietary supplements from the office?

Can they, alternatively, direct patients to an online site from which they collect a check based on patient revenues?

Both of these can vary according to individual state laws, but the latter especially raises concerns about a potential "kickback" from the supplement company to the physician.

These situations have to be handled carefully.

As an example, consider this regulation:

COMMONWEALTH OF MASSACHUSETTS BOARD OF REGISTRATION IN MEDICINE POLICY 05-01 (Adopted July 20, 2005) SALE OF GOODS FROM PHYSICIANS’ OFFICES

“In [their] fiduciary capacity, physicians have a duty to serve the interests of patients above their own financial or other interests.”

Federation of State Medical Boards, House of Delegates, April 2000

“In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of the patient before their own.” American Medical Association Code of Ethics

Section 8.063 “Sale of Health-Related Products from Physicians’ Offices”, Adopted June 1999. Physicians should not sell, lease or rent any product in a manner that has the potential to exploit patients, including but not limited to exclusive distributorships or personal branding. Physicians should not use their office or their professional relationship with patients to promote any business venture or solicit investors.

In limited circumstances, when it is beneficial to the patient, it may be appropriate for physicians to sell durable medical goods essential to the patient’s care. Prior to any such sale physicians should disclose to patients any financial interest they may have in the transaction. Patients should be informed that they are under no obligation to purchase durable medical goods from the physician and should be informed of the availability of the product or other equivalent product elsewhere.

This information shall be conveyed via an easily understood notice prominently posted in the office. Physicians are encouraged to provide products to patients at cost or free of charge, particularly when it allows treatment to be accessed and initiated more quickly.

Examples of when the sale of durable medical goods is appropriate include:

• Providing a patient with crutches from the physician’s office rather than forcing the patient to travel to a medical equipment distributor.

• Providing a patient with impaired vision with corrective lenses when their vision would otherwise impair their ability to travel to another location.

Some physicians offer supplements to patients as a convenience, and place a limited markup on inventory sufficient to cover stocking and administrative costs. In some case, our law office can draft language alerting patients that physicians have a financial interest in supplements and that patients can obtain the same goods elsewhere; further, that patients' quality of care will not affected by whether they obtain supplements from the physician or elsewhere.

However, the language of the above regulation is fairly strict and makes clear that the Board disfavors physician profit from health-related products except: "In limited circumstances, when it is beneficial to the patient, it may be appropriate for physicians to sell durable medical goods essential to the patient’s care." Notice the words, "limited," "beneficial," and "essential." The Board adds: "particularly when it allows treatment to be accessed and initiated more quickly."

Notice the required conditions: "Prior to any such sale physicians should disclose to patients any financial interest they may have in the transaction. Patients should be informed that they are under no obligation to purchase durable medical goods from the physician and should be informed of the availability of the product or other equivalent product elsewhere. This information shall be conveyed via an easily understood notice prominently posted in the office."

Sometimes the language can also be included on the invoice attached to the product.

Physicians need to understand the laws, regulations and Board practices adopted in their own state.

rlstanley
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Re: Advising Patients Regarding Dietary Supplements

Post by rlstanley » Fri 30 Jan 2009 3:44

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Adverse effects of using prescription drugs with natural health products underreported

http://www.camlawblog.com/dietary-suppl ... orted.html
The adverse effects of using prescription drugs side by side with natural health products (NHP) are being under-reported in Canada. Therefore the potential risks may be underestimated by health-care professionals and the public, a study from the University of Alberta in Edmonton, Canada shows. NHPs are the Canadian equivalent of dietary supplements in the U.S.

A literature review and survey of 132 pharmacists revealed that while 47 per cent reported that they had encountered a patient with a suspected adverse event, only 1.5 per cent reported this to Health Canada. In contrast, 19 per cent of the pharmacists had reported adverse reactions to prescription or non-prescription drugs.

The study, co-authored by the U of Alberta, the University of Toronto and Health Canada, is published in this month's issue of The Annals of Pharmacotherapy.

"The data show that adverse events are not being reported or are being under-reported at a dramatic rate
," said Dr. Sunita Vohra, one of the study authors and an associate professor of pediatrics at the University of Alberta. "Natural health products should be treated with due respect." While the number of potential adverse events is low relative to the rates of NHP use in Canada, such products may be effective, but they may also have side effects, Vohra said. Natural health products include such products vitamins, minerals probiotics, St. John's wort, echinacea and garlic. There are 50,000 such products for sale in Canada.

In the survey, the majority of pharmacists felt they knew enough about just two drug-health product interactions to counsel patients. Adverse reactions can range from mild rashes and headaches to much more serious effects by patients using prescription medication such as blood thinners or insulin.

And while the pharmacists reported that they spent up to 30 minutes per day counselling patients on the use of natural health products, they estimated that only five per cent of patients who purchase products ask about potential drug interactions. "The public is less likely to see natural health products as risky," Vohra noted.

The lack of available data on interactions makes it difficult to provide patients and health care workers with useful advice for managing adverse reactions associated with these products. "To improve patient safety, new ways of capturing data are necessary," Vohra said. Possible ways to do that include active surveillance to monitor for harms. "Select pharmacies agree to be 'sentinel sites', actively asking every patient about possible adverse events, and reporting all data so we can learn which NHP-drug combinations are safe, and which aren't."

From the press release. The study was funded by Health Canada. For more information on this study contact the principal author (a colleague): Dr. Sunita Vohra, Department of Pediatrics, University of Alberta.

rlstanley
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Re: Advising Patients Regarding Dietary Supplements

Post by rlstanley » Fri 13 Feb 2009 0:05

Complementary Therapies in Pediatrics: A Legal Perspective
Michael H. Cohen, JD, MBA* and Kathi J. Kemper, MD, MPH


Full text: http://pediatrics.aappublications.org/c ... /115/3/774

Snippets:
.... This article provides a suggested framework, including asking the following questions:

(1) Do parents elect to abandon effective care when the child's condition is serious or life-threatening?
(2) Will use of the CAM therapy otherwise divert the child from imminently necessary conventional treatment?
(3) Are the CAM therapies selected known to be unsafe and/or ineffective?
(4) Have the proper parties consented to the use of the CAM therapy?
(5) Is the risk-benefit ratio of the proposed CAM therapy acceptable to a reasonable, similarly situated clinician, and does the therapy have at least minority acceptance or support in the medical literature?

Such an approach ideally can help guide the pediatrician toward clinical conduct that is clinically responsible, ethically appropriate, and legally defensible.
.....case reports involving harm from use of CAM therapies include a chemical burn caused by topical vinegar application in a newborn infant33; fatal hypermagnesemia in a child who was treated with megavitamin/megamineral therapy34; multiple organ failure after ingestion of pennyroyal oil from herbal tea in 2 infants35; lead encephalopathy caused by herbal medicine36; quadriplegia after chiropractic manipulation in an infant with congenital torticollis37; tumor progression in 2 pediatric patients who relied on the use of dietary supplements and shark cartilage to treat cancer12; toxic lead ingestion after use of dietary supplements during treatment by folk healers for relief of abdominal symptoms38; iatrogenic brucellosis from the treatment of juvenile chronic rheumatoid arthritis through intradermal injections of folk medicines39; severe side effects or exacerbation of illness caused by homeopathic remedies40–42; and, anecdotally, development of infantile botulism after being given home-grown camomile tea.43 As the above suggests, most common side effects for CAM therapies are reported from herbs and other dietary supplements, whereas there are rare but dramatic side effects from chiropractic.31

Thus, CAM therapies in pediatrics are not "devoid of potential harm"44 and indeed, in the language of the federation guidelines, may cause either direct or indirect harm. Direct harm includes "direct toxic effects, compromising adequate nutrition, interrupting beneficial medications or therapies, or postponing biomedical therapies of proven effectiveness,"16 whereas indirect harm can include an unwarranted financial and emotional burden.16,25
Pediatricians face 2 major legal risks when advising concerning CAM therapies: medical malpractice and professional discipline.
In addition to the legal risks involved in delivering CAM therapies to patients, there are some legal risks involved in referral to a CAM provider who turns out to be negligent. The general rule is that a physician is not liable for the negligence of the provider to whom a patient has been referred.48,49

There are 3 exceptions:
(1) the referral itself was negligent because it caused harm by delaying necessary conventional treatment, (2) the referring provider knew or should have known that the CAM provider was "incompetent," and
(3) the physician had hired the CAM provider or engaged in a highly coordinated "joint treatment" with that provider.48,49 As new models of "integrative" health care evolve, courts are increasingly likely to apply this "joint treatment" exception.49
Including a CAM therapy simply to help the parents believe that "everything has been tried" is both ethically questionable and legally risky. If parents insist on using a CAM therapy with little or no evidence of safety and efficacy, despite the pediatrician's counseling to the contrary, then this should be documented carefully in the medical record and acknowledged in writing by the legally responsible party49; to avoid potential liability for abandonment, the pediatrician who is unwilling to continue to care for the patient under this circumstance should refer the family to a clinician who is willing to continue conventional monitoring and treatment.22
....if a so-called respectable minority of pediatricians nationally accept or support using a specific CAM treatment for a given condition, then the pediatrician may be able, in some states, to rely on that minority opinion and have a defense to a malpractice claim.45,46

Conversely, subjecting the child to a serious risk without sufficient evidence of benefit for a therapy that most physicians consider dangerous or ineffective is likely to trigger professional discipline as well as potential liability.49 Such conduct conceivably would be unethical as well.22

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