Utilizing OTC Drugs and Supplements

OTC Drugs and Supplements In Chiropractic Practice

The ICS was instrumental in last year’s legislation that clarified the definition of “chiropractic physician.” The definition now expressly authorizes doctors of chiropractic to provide advice regarding the use of non-prescription products (also called “over-the-counter” drugs or “OTCs”) and to administer atmospheric oxygen.

This clarification of scope has given rise to questions about the role of over-the-counter drugs and dietary supplements in chiropractic practice. The regulatory schemes are different for each of these products, so it is important to be aware of the distinctions before integrating the products into your patients’ health care regimens.

Advertisement

The Regulation of Drugs under the Federal Food, Drug and Cosmetic Act

Both prescription and non-prescription drugs are regulated by the federal Food, Drug and Cosmetic Act, enforced by the federal Food and Drug Administration (FDA). The Act is designed to ensure both the quality (i.e., does the drug work as advertised?) and the safety of products by requiring clinical trials and approval before products may be marketed to the public. The FDA defines “drug” very broadly as follows:

• A substance recognized by an official pharmacopeia or formulary. The United States Pharmacopeia [USP] is the official pharmacopeia of the United States, published together with the National Formulary as the USP-NF. Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF.
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• A substance (other than food) intended to affect the structure or any function of the body.
• A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
• Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)

This broad definition includes both prescription and non-prescription drugs. Any new drug must go through the FDA’s pre-approval process before it may be marketed, and the manufacturer first must prove to the FDA that clinical trials have proven the product to be safe and effective.

Under the recently clarified Medical Practice Act, chiropractic physicians may advise patients about the use of non-prescription (over-the-counter or OTC) products. For example, a patient may present to you saying he takes 12 aspirin per day for arthritis pain and is complaining of upper digestive distress. You may advise the patient to eliminate the aspirin, and you may tell him that he should try acetaminophen because it is less irritating to the stomach.

However, prescription drugs are not within chiropractic scope in Illinois, so chiropractic physicians may not make similar recommendations to their patients about prescription medications. If the same patient presented with the same digestive symptoms but told you he was taking Vicodin for pain, or even a prescription version of ibuprofen (which also comes in an OTC form), you should not recommend that the patient stop, but instead suggest that he or she may want to discuss those matters with a medical or osteopathic physician. By the same reasoning, it is also not within scope for a DC to recommend that a patient receive or not receive a vaccination that is available only by prescription.

Regulation of Dietary Supplements

Although dietary supplements are often marketed as therapeutic, they are not considered drugs and are subject to their own FDA regulation. The DSHEA defines “dietary supplement” as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. According to the FDA, the “dietary ingredients” in these products may include:

• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
• a concentrate, metabolite, constituent or extract.

As physicians who treat human ailments without the use of drugs and without operative surgery, doctors of chiropractic may use dietary supplements within the scope of their practice in Illinois. This may include recommending the use or avoidance of certain supplements or the sale of supplements. If you also sell dietary supplements, you are acting as a distributor and are subject to the applicable regulations. Therefore, you may be acting as both physician and distributor, and you should keep in mind the operative standards of care and regulations for both.

Prior to 1994, supplements were regulated in the same manner as food. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), creating new requirements for the safety and labeling of supplements. Under this law, the manufacturer or distributor is responsible for ensuring that the supplements are safe before they are marketed. Except for supplements with new dietary ingredients, there are no requirements in the law for the FDA to approve supplements before they are sold to consumers; the FDA is responsible for removing products from the market once they are found to be unsafe. However, manufacturers and distributors must report to the FDA any adverse events related to these products. Information on reporting adverse events associated with the use of dietary supplements can be found on the FDA website at Dietary Supplements – Adverse Event Reporting — https://www.fda.gov/food/dietarysupplements/reportadverseevent/default.htm

Dietary supplements may be found in many forms. The FDA requires that they all be labeled as dietary supplements, regardless of form. In addition, the FDA publishes Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products to ensure the identity, purity, quality, strength, and composition of dietary supplements. Of course, any physician who uses or sells supplements in his or her practice should make sure that the manufacturer has complied with these guidelines.

Any manufacturer or distributor who wishes to sell a supplement containing a new dietary ingredient must notify the FDA before marketing the product. A new dietary ingredient is one that was not marketed before October 15, 1994 (the effective date of the DSHEA). The manufacturer (and distributor) must demonstrate to FDA why the ingredient is expected to be safe unless it has been recognized as a food substance and is present in the food supply. If you recommend or sell supplements in your practice, you should first determine whether they contain any new dietary ingredients. If so, make certain the manufacturer has filed the appropriate notices with the FDA. The State of Illinois would no doubt view the sale of unapproved dietary ingredients as unprofessional conduct worthy of license discipline, among other things.

Chiropractic physicians who use or sell supplements also must comply with advertising requirements. Advertising of dietary supplements by manufacturers is highly regulated by the DSHEA and in many ways restricts the claims that a manufacturer may make. When a manufacturer makes a claim regarding the supplement’s effect on bodily structure or function, it is required to include the language: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” However, a physician who recommends and sells supplements in effect holds dual roles as both a health care practitioner and distributor, which would seem to confer greater authority to make statements about supplements, as long as they are supported by valid scientific evidence. How does a physician sort out what he or she can say about a particular supplement?

Physician advertising, in general, must be truthful non-misleading under the Medical Practice Act. The simple answer is to provide only scientifically verifiable information to your patients, regardless of whether it is spoken, contained in a written advertisement or on your website. If you both recommend and sell supplements, you are probably going to be under extra scrutiny because of your financial interest in these products (see Ethical Considerations below). Therefore, you must carefully word the claims you make and make certain they are supported by empirical evidence. Some supplements do have demonstrated effects on certain conditions, but exaggerated claims about any treatments are not permitted, and supplements are no different. As a physician, these statements would fall under the advertising provisions of the Medical Practice Act and violations could result in license discipline.

Ethical Considerations in the Sale of Supplements

The Medical Practice Act does not contain a specific provision addressing the sale of products to patients. However, the Act and Rules contain sufficient general provisions about professional standards that could apply. Obviously, any physician who distributes supplements to patients must make certain he or she is complying with all the of the FDA regulations applicable to distributors. In addition, there are some legal risks such as increased liability for malpractice and adverse reactions. Also, disciplinary issues could result for selling unapproved supplements containing new dietary ingredients (as discussed above), overcharging, exploitation of patients for financial gain and ethical violations in the form of a financial conflict of interest (i.e. a claim that the physician’s financial interest in selling the supplements takes priority over the best interests of the patient) and advertising violations.

To minimize these risks, the physician should document the medical necessity or benefit of the supplement in the patient’s chart, and it should be tailored to each patient’s exam and diagnoses. Although you, the doctor, may believe that every one of your patients could benefit from an entire spectrum of vitamins that you sell, a State of Illinois investigator might be skeptical. In addition, the physician should limit his or her markup to a reasonable and customary amount. It is a good idea to include in the patient consent form that the patient acknowledges the physician is selling the supplements at fair market value, and the patient is aware that he or she could purchase the supplements elsewhere, but that they are provided at the office as a convenience.

Supplements by Injection

A question that the ICS frequently is asked is whether chiropractic physicians may inject dietary supplements to their patients. This is actually a multi-part question about the use of supplements and the use of injections.

First, the supplement must be of a non-prescription variety to be within chiropractic scope. Assuming that it is, the ICS believes that it is within scope because it is not “operative surgery.” However, there are some important caveats. Some supplements are available in both prescription and non-prescription form, so only the non-prescription form of the supplement is within scope. For example, DCs may use or provide oral iron supplements that are available without a prescription, but injectable iron is available only by prescription and is therefore out of scope. The other important caveat is that the Department of Financial and Professional Regulation has not issued an official opinion regarding injections (even of non-prescription products) by chiropractic physicians, so the ICS cannot be certain that the Department would echo the ICS’ opinion that injections are not “operative surgery.”

To Use or Not to Use

If you decide to make recommendations, use or sell these products in your practice, you should review your liability insurance and make certain that it is adequate to cover what may be an increased liability. But regardless of how these products affect your liability or profit, the main incentive for adding them to your patients’ regimen should always, of course, be the betterment of their health. These are items in your arsenal that can be an integral part of a wellness-based health care system when used in compliance with your clarified scope of practice.