Annals of Long Term Care

Herbal and related alternative drug therapies have gained increasing popularity among the public in general, and the elderly in particular.^1,2 According to the National Center for Complementary and Alternative Medicine, complementary and alternative medicine is a group of diverse medical and healthcare systems, practices, and products that are not generally considered a part of conventional medicine.³ While a growing body of data exists on the effectiveness or lack thereof of alternative therapies,^4,5 these therapies are not usually taught in U.S. medical schools, nor are they generally available in U.S. hospitals.

Long-term care (LTC) facilities present a special challenge in this regard, as facilities need to consider their duty to protect residents and facility liabilities while balancing the need for patients to remain empowered to exercise their rights to self-determination and choice.

In this article, a general policy for the use of alternative products in LTC facilities is presented. The policy was formulated by the author, with input from administration and legal counsel, while serving as a full-time medical director in a nursing facility. The policy offers a framework from which administrators and medical directors in other facilities may develop their own policies. Rationale for and comment on various statements are indicated in italics. The author proposes the definition below for alternative drug therapy to define products but not alternative healthcare systems or practices.

Alternative Drug Therapies: Definition and Background

A substance with purported health benefits is considered to be an alternative drug therapy (ADT) when:

1. Its use is not approved or regulated by the U.S. Food and Drug Administration (FDA) regulations, and

2. Its use for a specific condition(s) has not been recommended by a governmental agency such as, but not necessarily limited to, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), or Agency for Healthcare Research and Quality (AHRQ) and

3. No general standard exists in the medical community governing its use.

For a substance to be considered an ADT, all three above criteria must be met.

Additional ADT Considerations:

ADTs include, but are not necessarily limited to, substances for oral ingestion, enteral administration (ie, potential administration per rectum or via gastrostomy tube), inhalation, or topical or nasal application.

ADTs are commonly available for purchase without prescription in pharmacies, supermarkets, and general nutrition stores and include, but are not necessarily limited to, substances such as St. John’s wort, ginkgo biloba, saw palmetto, echinacea, megavitamin and mineral supplements, and various other herbs and extracts.

ADTs do not include drugs and biologics undergoing clinical investigation when such use is governed by the applicable laws of the FDA or other governmental agency (ie, the policy does not pertain to residents who may be enrolled in FDA-approved clinical trials since criteria 1 above would not be met).

POLICIES:

1.The facility and its medical staff have the ethical, legal, and professional duty to provide care consistent with governmental regulations and community standards.

2.The facility and its medical staff have the ethical, legal, and professional duty to protect its residents/patients from harm (primum non nocere).

3.The facility and its medical staff have no ethical, legal, or professional obligation to provide its residents/patients with ADTs.

4.