Ethical Standards on the Sale of Products in Healthcare

Supplement Sales in Healthcare

As a healthcare provider, selling any product to patients poses a conflict of interest. This is especially true of dietary supplements, which are unregulated in the USA and have no proven health value. (source: American Osteopathic Association).

A variety of professional medical associations from around the world take a strong stand on the sale of products by practitioners. The code of ethics statements are shared below, with significant phrases highlighted in bold.

The organizations which state the practice of influencing and selling products to patients include:

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  1. American Medical Association
  2. American Osteopathic Association
  3. Children’s Hospital of Philadelphia (CHOP)
  4. Academy of Nutrition and Dietetics
  5. American Board of Physician Specialties
  6. American Dental Association
  7. Canadian Medical Association (CMA)
  8. Canadian Medical Protective Association (CMPA)
  9. College of Physicians and Surgeons of New Brunswick
  10. Australian Medical Association
  11. Ministry of Health Pharmacy Board of Brunei
  12. World Medical Association International

 

American Medical Association

The American Medical Association (AMA) Journal of Ethics

Opinion 8.06 – Prescribing and Dispensing Drugs and Devices

(1) Physicians should prescribe drugs, devices, and other treatments based solely upon medical considerations and patient need and reasonable expectations of the effectiveness of the drug, device or other treatment for the particular patient.

(2) Physicians may not accept any kind of payment or compensation from a drug company or device manufacturer for prescribing its products. Furthermore, physicians should not be influenced in the prescribing of drugs, devices, or appliances by a direct or indirect financial interest in a firm or other supplier, regardless of whether the firm is a manufacturer, distributor, wholesaler, or repackager of the products involved.

(3) Physicians may own or operate a pharmacy, but generally may not refer their patients to the pharmacy.

 

Opinion 8.063 – Sale of Health-Related Products from Physicians’ Offices

Health-related products” are any products that, according to the manufacturer or distributor, benefit health. “Selling” refers to the activity of dispensing items that are provided from the physician’s office in exchange for money and also includes the activity of endorsing a product that the patient may order or purchase elsewhere that results in direct remuneration for the physician. (This Opinion does not apply to the sale of prescription items which is already addressed in Opinion 8.06, “Prescribing and Dispensing Drugs and Devices.”)

“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.

(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.

(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.

(a) In general, physicians should limit sales to products that serve the immediate and pressing needs of their patients. For example, if traveling to the closest pharmacy would in some way jeopardize the welfare of the patient (e.g., forcing a patient with a broken leg to travel to a local pharmacy for crutches), then it may be appropriate to provide the product from the physician’s office. These conditions are explained in more detail in the Council’s Opinion 8.06, “Prescribing and Dispensing Drugs and Devices,” and are analogous to situations that constitute exceptions to the permissibility of self-referral.

(b) Physicians may distribute other health-related products to their patients free of charge or at cost, in order to make useful products readily available to their patients. When health-related products are offered free or at cost, it helps to ensure removal of the elements of personal gain and financial conflicts of interest that may interfere, or appear to interfere, with the physician’s independent medical judgment.

(3) Physicians must disclose fully the nature of their financial arrangement with a manufacturer or supplier to sell health-related products. Disclosure includes informing patients of financial interests as well as about the availability of the product or other equivalent products elsewhere. Disclosure can be accomplished through face-to-face communication or by posting an easily understandable written notification in a prominent location that is accessible by all patients in the office. In addition, physicians should, upon request, provide patients with understandable literature that relies on scientific standards in addressing the risks, benefits, and limits of knowledge regarding the health-related product.

(4) Physicians should not participate in exclusive distributorships of health-related products which are available only through physicians’ offices. Physicians should encourage manufacturers to make products of established benefit more fairly and more widely accessible to patients than exclusive distribution mechanisms allow.

 

Clarification of Opinion 8.063

“Do the guidelines discussing the sale of health-related products (8.063) and the sale of non-health-related goods (8.062) apply to physicians’ practice web sites?

Yes.

The physician who provides or sells products to patients must follow the above guidelines regardless of whether the products are provided in the physician’s office or through a practice web site.

Adopted December 2000 as “Addendum III: Council on Ethical and Judicial Affairs Clarification on Sale of Products from Physicians’ Offices (E-8.062 and E-8.063)”

Published in 2015

(source: AMA Journal of Ethics web-based and AMA Journal of Ethics PDF with more detail)

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American Osteopathic Association

H315-A/17 DIETARY SUPPLEMENTS – GUIDELINES FOR NUTRITIONAL AND DIETARY SUPPLEMENTS

“The American Osteopathic Association requests:

(1) the Food and Drug Administration (FDA) to be diligent in their monitoring of all products marketed for human consumption, including nutritional supplements, and that there be close attention to reported adverse events directly caused by any of these products; and

(2) that the US Congress pass legislation requiring dietary supplements to undergo pre-market safety and efficacy evaluation by the FDA.”

(source: American Osteopathic Association Policy Compendium 2019, page 26)

 

H622-A/19 INDUSTRY TRANSPARENCY STANDARDS

The American Osteopathic Association (AOA):

(8) discourages business practices that

  • interfere with the patient-physician relationship,
  • attempt to unduly influence the practice of medicine, or
  • attempt to inappropriately persuade patients to seek services or products

(source: American Osteopathic Association Policy Compendium 2019, pages 86-87)

 

H209-A/18 Sale of Health-Related Products and Devices

“The American Osteopathic Association believes that it is:

(1) appropriate for physicians to derive reasonable monetary gain from the sale of health-related products or devices that are both supported by rigorous scientific testing or authoritative scientific data and, in the opinion of the physician, are medically necessary or will provide a significant health benefit provided that such action is permitted by the state licensing board(s) of the state(s) in which the physician practices; and

(2) inappropriate and unethical for physicians to use their physician/patient relationship to attempt to involve any patient in a program for the patient to distribute health related products or devices in which distribution results in a profit for the physician.”

Adopted 1999; revised 2004; reaffirmed August 2018

(source: American Osteopathic Association Policy Compendium 2019, pages 207-208)

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Children’s Hospital of Philadelphia (CHOP)

Children’s Hospital of Philadelphia Becomes First in Nation to Disallow Use of Dietary Supplements New Hospital Policies Will Improve Patient Safety, Education

Children’s Hospital of Philadelphia Research Institute. Press Release Date: 10/08/2013

(source: CHOP)

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Academy of Nutrition and Dietetics

Academy of Nutrition and Dietetics: Guidelines Regarding the Recommendation and Sale of Dietary Supplements

Recommendations 8, 9, 10, and 13 and Appendix C are of particular interest:

Recommendation 8.

“The dietetics professional may make dietary supplements available to patients/clients with respect to the unique nutrition needs of the individual (based on Principle #8 of the Code of Ethics). The dietetics professional needs to:

  • Avoid bias to ensure patient/client’s choice in selection and use of dietary supplement.
  • Provide appropriate educational materials to patients/ clients about dietary supplements.
Recommendation 9.

“The dietetics and nutrition professional provides disclosure of any financial relationship regarding the sale of dietary supplements to patients/clients (based on Principle #12 of the Code of Ethics). The dietetics professional must disclose any financial arrangements with specific manufacturer(s) or supplier(s) to sell dietary supplements.

  • Disclosure should be accomplished through face-to-face communication or by posting a written notification that is easy to comprehend in a prominent location that is accessible by all patients/clients.
  • Dietetics professionals should inform patients on the availability of products being recommended as well as equivalent products on the market.
Recommendation 10.

“The dietetics professional provides factual information regarding the availability of dietary supplements for purchase and does not advertise in a false or misleading manner.

Recommendation 13.

“Dietetics professionals choosing to sell dietary supplements need to investigate all aspects of business practice. Any sales should be based on sound business practices. The following should be considered (see appendix for further information):

    • Pricing and profit issues
    • Liability concerns, including product liability
    • Inventory
  • Retail policies (products returned by customers, method of payment, etc.)
  • Follow-up sessions related to use of products”

(sources: American Dietetic Association full text and American Dietetic Association PDF)

 

Academy of Nutrition and Dietetics: Guidelines Regarding the Recommendation and Sale of Dietary Supplements

Appendix C

Business considerations for dietetics professionals considering selling supplements (found in this PDF)

Legal Counsel
  • Are there any state laws or other legal restrictions on the sale of ancillary products or services by referring professionals?
  • Are there any state laws or other legal restrictions in terms of recommending ancillary products or services by referring professionals?
  • Are all contracts in your best interests?
  • Are there any potential problems with product liability?
Type of Business
  • What type of business are you in?
  • Would you rather concentrate solely on MNT [medical nutrition therapy] or branch into retail sales?
  • Is the sale of supplements a convenience or service to your clientele?
Profit
  • What will your profit be? Consider time spent ordering and maintaining inventory, making sales, investigating product lines and individual products.
  • Can you return product if it does not sell well?
  • Do you have an environment conducive to shoplifting?
  • Do you want to sell supplements at the suggested retail price, offer clients a discount, or sell at cost?
  • What will your retail policies be?
  • What is your return policy for your customers?
  • Will you accept credit cards or checks?
  • How will you handle the cash?
Follow-Up Sales
  • Will return visits for supplements eat into your follow-up counseling business?
  • Will clients try to use a visit for a supplement purchase as a free follow-up counseling session?
  • Will these return visits red-flag the clients who need followup, so you can make an appointment for them?
Zoning, Ordinances, Business License
  • What are applicable local zoning and other ordinances?
    Start by checking your state Web site’s small business section. Most state Web sites are www.state. (two-letter abbreviation of state) .us (i.e. Massachusetts is state.ma.us
    )
  • Will you need business licenses? Local (city, county) ordinances may require some type of business license as well. Contact your town hall to investigate.
  • Are you familiar with collecting sales tax and that you will need a sales tax license?
  • Is your office zoned for retail sales?
Inventory
  • Do you have the space to hold inventory?
  • Is your inventory maintained out of reach of children?
  • Do you have the capital to tie up in inventory?
  • Are you familiar with inventory practices such as: rotating stock, checking expiration dates, and keeping the inventory clean and dry?
Product Liability
  • Will your malpractice insurance cover sales of supplements? (You will most likely need product liability insurance)”

 

Authored by Cynthia Thomson, PHD, RD, FADA; Connie Diekman, MEd, RD, FADA; Allison Sarubin Fragakis, MS, RD; Carol Meerschaert, RD; Harold Holler, RD; and Cathy Devlin, RD

 

“Guidelines Regarding the Recommendation and Sale of Dietary Supplements” published August 2002 in Journal of the American Dietetic Association of the Academy of Nutrition and Dietetics Volume 102, Number 8

(sources: American Dietetic Association full text and American Dietetic Association PDF)

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American Board of Physician Specialties

American Board of Physician Specialties Code of Ethics

“Accept no personal compensation from any party that would influence or require special consideration in the provision of care to any patient.”

(source: American Board of Physician Specialties)

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American Dental Association

American Dental Association Principles of Ethics Code & of Professional Conduct

5.D.2. MARKETING OR SALE OF PRODUCTS OR PROCEDURES.

“Dentists who, in the regular conduct of their practices, engage in or employ auxiliaries in the marketing or sale of products or procedures to their patients must take care not to exploit the trust inherent in the dentist-patient relationship for their own financial gain. Dentists should not induce their patients to purchase products or undergo procedures by misrepresenting the product’s value, the necessity of the procedure or the dentist’s professional expertise in recommending the product or procedure.

“In the case of a health-related product, it is not enough for the dentist to rely on the manufacturer’s or distributor’s representations about the product’s safety and efficacy. The dentist has an independent obligation to inquire into the truth and accuracy of such claims and verify that they are founded on accepted scientific knowledge or research. 

“Dentists should disclose to their patients all relevant information the patient needs to make an informed purchase decision, including whether the product is available elsewhere and whether there are any financial incentives for the dentist to recommend the product that would not be evident to the patient.”

Adopted November 2018

(source: American Dental Association Code of Conduct (main page) and American Dental Association PDF)

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Canadian Medical Association (CMA)

Canadian Medical Association [CMA] (Association Médicale Canadienne) Code of Ethics

Responsibilities to the Patient

11. Recognize and disclose conflicts of interest that arise in the course of your professional duties and activities, and resolve them in the best interest of patients.

“12. Inform your patient when your personal values would influence the recommendation or practice of any medical procedure that the patient needs or wants.

“13. Do not exploit patients for personal advantage.

“14. Take all reasonable steps to prevent harm to patients; should harm occur, disclose it to the patient.

Responsibilities to the Profession

50. Avoid promoting, as a member of the medical profession, any service (except your own) or product for personal gain.

 

Updated 2004, reviewed March 2018

(source: CMA Policy PDF)

 

Canadian Medical Association [CMA] (Association Médicale Canadienne) Code of Ethics and Professionalism

Physicians and the Practice of Medicine: Managing and Minimizing Conflicts of Interest

“22. Recognize that conflicts of interest may arise as a result of competing roles (such as financial, clinical, research, organizational, administrative, or leadership).

“23. Enter into associations, contracts, and agreements that maintain your professional integrity, consistent with evidence-informed decision-making, and safeguard the interests of the patient or public

“24. Avoid, minimize, or manage and always disclose conflicts of interest that arise, or are perceived to arise, as a result of any professional relationships or transactions in practice, education, and research; avoid using your role as a physician to promote services (except your own) or products to the patient or public for commercial gain outside of your treatment role.”

(source: CMA Code of Ethics and Professionalism and CMA Code of Ethics PDF )

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Canadian Medical Protective Association (CMPA)

Duties and responsibilities: Expectations of Physicians in Practice

“Commercial Interests and How Physicians Can Avoid the Pitfalls” W15-001-E

Physicians are generally discouraged by Colleges from selling or promoting products that are not medically necessary, such as supplements and herbal remedies.”

Adopted January 2015

(source: Canadian Medical Protective Association)

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College of Physicians and Surgeons of New Brunswick

Council of the College of Physicians and Surgeons of New Brunswick

Medical Act, Regulations and Guidelines: Code of Ethics

45. Recognize a responsibility to give generally held opinions of the profession when interpreting scientific knowledge to the public; when presenting an opinion that is contrary to the generally held opinion of the profession, so indicate.
The public needs to be protected against medically irresponsible opinions.

Responsibilities to the Profession

“50. Avoid promoting, as a member of the medical profession, any service (except your own) or product for personal gain.

(source: College of Physicians and Surgeons of New Brunswick)

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Australian Medical Association

Australian Medical Association Code of Ethics

3.5 Managing conflicts of interests

“3.5.1 Ensure your financial or other interests are secondary to your primary duty to serve patients’ interests. Financial and other interests should not compromise, or be perceived to compromise, your professional judgement, capacity to serve patients’ interests or the community’s trust in the integrity of the medical profession.

“3.5.2 Disclose your financial or other interests that may affect, or be perceived to affect, patient care. 3.5.3 If you refer a patient to a facility, or recommend a treatment or product in which you have a financial interest, inform them of that interest and provide the patient with other options, where possible.

“3.5.4 If you work in a practice or institution, place your professional duties and responsibilities to patients above the commercial interests of the owners or others who work within these practices. 

3.6 Advertising

“3.6.1 Confine advertising of professional services to the presentation of information reasonably needed by patients or colleagues to make an informed decision about the availability and appropriateness of your medical services.

“3.6.2 Ensure that any announcement or advertisement directed towards patients or colleagues is demonstrably true in all respects. Advertising should not bring the profession into disrepute.

“3.6.3 Do not endorse therapeutic goods in public advertising.

“3.6.4 Exercise caution in endorsing non-therapeutic goods in public advertising.

“3.6.5 Do not have any public association with products that clearly affect health adversely.

Adopted 2004. Editorially Revised 2006. Revised 2016.

(source: Australian Medical Association main page and Australian Medical Association PDF)

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Ministry of Health Pharmacy Board of Brunei

Ministry of Health Pharmacy Board of Brunei Darussalam

Code of Ethics for Pharmacists – 1st Edition (June 2015)

B. THE PROFESSION

“2. Behave in a way that justifies trust and maintains the reputation of profession.

a) Pharmacists shall act with honesty and integrity to uphold public trust and confidence in their profession.

b) Pharmacists shall maintain proper professional boundaries in the relationships they have with patients and other individuals that they come into contact with during the course of professional practice.

c) Pharmacists shall refuse to knowingly condone the dispensing, promoting, or distributing of drugs or medical devices that are not of good quality, that do not meet standards required by law, or that lack therapeutic value for the patient.

d) Pharmacists shall seek to avoid conflicts of interest and declare any personal or professional interests to those who may be affected.

(source: Ministry of Health Pharmacy Board of Brunei)

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World Medical Association International

World Medical Association International Code of Medical Ethics

Duties of Physicians in General

“A PHYSICIAN SHALL always exercise his/her independent professional judgment and maintain the highest standards of professional conduct.

“A PHYSICIAN SHALL respect a competent patient’s right to accept or refuse treatment.

“A PHYSICIAN SHALL not allow his/her judgment to be influenced by personal profit or unfair discrimination.

“A PHYSICIAN SHALL be dedicated to providing competent medical service in full professional and moral independence, with compassion and respect for human dignity.

“A PHYSICIAN SHALL deal honestly with patients and colleagues, and report to the appropriate authorities those physicians who practice unethically or incompetently or who engage in fraud or deception.

“A PHYSICIAN SHALL not receive any financial benefits or other incentives solely for referring patients or prescribing specific products.

Adopted in 1949, amended in 2006

(source: WMA International Code of Ethics web-based and WMA International Code of Ethics PDF)


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Medical Associations with No Stance on Selling

The following associations provide no reference to any ethical standard on selling, promoting, or financially benefiting from patient product purchases.

 

American Chiropractic Association

Code of Ethics

(source: American Chiropractic Association Today)

 

American Pharmacists Association

Code of Ethics for Pharmacists

(source: American Pharmacists Association)

 

American Association of Pharmacy Technicians (AAPT)

Code of Ethics for Pharmacy Technicians

(source: American Association of Pharmacy Technicians)

American Association of Nurse Practitioners

Standards of Practice for Nurse Practitioners

(source: AANP Standards of Practice and AANP Standards of Practice PDF)

 

Canadian Federation of Podiatric Medicine

Code of Ethics

(source: Canadian Federation of Podiatric Medicine)

 

The Institute of Chiropodists and Podiatrists

The Institute of Chiropodists and Podiatrists Code of Ethics

(source: IOCP)

 

Pediatric Nursing Certification Board

Pediatric Nursing Certification Board Certificant Code of Ethics

(source: PNCB)

 

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Medical Associations Which Condone Selling

Unfortunately, some healthcare associations actually allow or condone the sale of products by their members.

 

American Dental Assistants Association

The “About” page states:

The American Dental Assistants Association is the oldest, largest group representing professional dental assistants. Its members include clinical personnel, those working chairside with the dentist, as well as those on the administrative side: the receptionist, office manager, practice manager and those working behind the scenes in dental product sales, insurance and, of course, educators.

(source: American Dental Assistants Association)

 

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