Warning!

Megan, a home health nurse, is following up on care needs for a man who is under the care of a conventional physician, an acupuncturist and a Chinese herbalist. While Megan completes a brief physical assessment, she listens to Mr. Vincent explain how he is feeling. Prepared to leave, Megan stopped when she saw several small white bottles on the table.

Mr. Vincent tosses a towel over the bottles and thanks Megan for her visit. Megan knows the man is embarrassed, but asks what is in the bottles. He tosses one toward her, and as she catches it, Megan notices that it is a homeopathic remedy for sinus congestion. Megan asks her patient if any of his health care practitioners know he is taking homeopathic remedies. Mr. Vincent says no.

Megan knows that mixing herbal remedies, homeopathic remedies and prescription drugs can not only make each therapy ineffective, it can also be dangerous.

Mr. Vincent and Megan are only one example of the increasing trend toward consumer use of complementary and alternative therapies.

In this column, I will address the growing trends in herbal product use among adults and the elderly in this country as well as its associated risks and implications for home care professionals. The issues surrounding herbal therapy use are important to care providers and their clients, particularly for those clients who are unable to articulate their use of herbals, such as compromised elders or others unable to provide self-care data.

The Herbal Market

It is a fact that the American field of medicine and pharmaceuticals is changing. During 1999, at least 32 percent of Americans report using herbal products for personal health needs, with the herbal market estimated to be a nearly $6 billion annual business. Following closely behind are megavitamins and diet products, which have reached $5 billion in out-of-pocket sales. By 2000, 41 percent of Americans reported use of herbal therapies. Adults are seeking alternatives to conventional medical care, and herbal remedies have become a large part of this trend.

More than 500 herbal products are marketed in retail grocery and drug stores, mail order houses and on the Internet, yet none of the products are regulated by the FDA the way conventional drugs are. Consumers self-prescribe herbal remedies, most often without professional consultation, or without adequate information, and many do not tell their health care providers about their use of herbal supplements.

Herbal supplements are big business in the United States. Full-color advertisements in health magazines, women's magazines and other media have fueled the rapid growth in herbal sales, as has online shopping. As herbal sales have grown, so have the number and type of sponsored research studies on these therapies. While some of the results have been published in medical


Adults are seeking alternatives to conventional medical care, and herbal remedies have become a large part of this trend.
journals, few consumers have ready access to such information, unless surprising findings are reported in the mass media. Individuals often rely on word-of-mouth recommendations and anecdotal reports on the efficacy of a particular herbal product. Both the longstanding herbal use in other cultures and recent research, have shown that many herbal remedies are beneficial in the prevention or treatment of illnes s or for general well-being.

While complementary therapy use is most prevalent in adults ages 25 to 49 with 92 percent reporting usage, nearly 40 percent of adults over age 50 report use. Of U.S. adults using CAM, approximately 53 percent of women report use, and 38 percent of men.

Lack of Communication

Many patients do not feel comfortable revealing their herbal supplement use to health care providers. Among patients who visit conventional medical providers, one-third use herbal supplements and many fail to disclose this fact to their main health care provider. However, adults report that they would disclose herbal use information if asked. Compounding this issue is that few conventional providers have learned how to ask about herbal therapies, or what to do with that information once it is collected. If the health care provider does not ask or gives a negative impression about herbal remedies, the patient or family is not likely to reveal personal use of herbal remedies.

Of 618 adults who used one or more CAM therapies and who had a medical doctor, fewer than 39 percent of the therapies were discussed with their medical doctor. As much as 46 percent of CAM therapy use is unsupervised by either a medical doctor or a skilled alternative therapy practitioner.

Elderly and Herbal Trends

Missed diagnoses are of concern with older adults. For example, it is reported that men's use of Saw Palmetto to treat symptoms that may be as serious as underlying prostate cancer, is further compounded by evidence that physicians vastly


Many consumers do not tell their health care providers about their use of herbal supplements.
underestimated their patients' use of alternative therapies, according to research in the <I>New England Journal of Medicine.<I> Seventy-five percent of elderly patients may be taking conventional pharmaceuticals inappropriately with over-the-counter drugs--including herbal therapies. A recent study reported that 76 percent of patients had stopped taking their prescription taking the wrong dose or taking them with other over-the-counter drugs which their physicians were unaware of. An analysis of 260 imported Chinese herbs revealed that 83 cont ained substances not on the label including pharmaceutical and heavy metals which can be toxic. A recent study indicated that 44 percent of adults had used a CAM therapy in the past year, and 89 percent said they would recommend CAM to others. However, 57 percent of their physicians were unaware these individuals had used CAM therapies. With an increasing proportion of consumers using CAM therapies, physicians and nurses need to know which patients are using CAM to effectively manage care.

Herbal Supplements and Risks

The fact that a plant is natural does not automatically mean that the products made from that plant are innocuous and safe. Hundreds of herbal remedies are available today, many of which do not have well-documented research and publication of side effects and serious toxicity. In 1997, the FDA published warnings about ephedrine alkaloids, marketed as Ephedra, Ma huang, etc., and the hazards of using these products. In addition, in spite of the many promising uses of herbal remedies, they can cause adverse reactions and side effects much like conventional medications. For example, one study found that asthma patients were hospitalized for complications related to self-treatment with herbal remedies, such as Ephedra.

Therein lies one of the greatest risks of herbal remedies, and risk to care providers. Potential risk for improper assessment or failure to assure patient safety may exist if a nurse or case manager does not know to ask about herbal therapy use, or fails to take action when a client reports herbal use that has lead to increased risk--whether physical or financial in nature. Like other over-the-counter medications, the unregulated herbal products may be abused. Abuse can come in the form of improper use of the product, lack of knowledge of the herb's intended effects and side effects, ingesting herbal remedies concurrently with prescription drugs, or failure to inform conventional providers of herbal products used.

In addition, patients with potentially life-threatening illness or serious symptoms are at risk when seeking herbal remedies while foregoing medical evaluation. In some instances, seeking medical advice earlier could mean the difference between life and death, as with atypical chest pains or bleeding.

Implications of Unsupervised Use

In a recent survey, one in five adults were taking prescription medications along with: herbs, high-dose vitamins or both. When extrapolated to the American population, this amounts to 15 million people at risk for potential adverse interactions, with 3 million adults over the age of 65 at risk. Adverse interactions and altered efficiency of drugs and herbal therapies are more likely among individuals with chronic illnesses. At this time, there is no effective mechanism in place to collect relevant data to document the extent of potential drug-herb or drug-vitamin interaction.

Within most nurse practice acts, as well as in the American Nurses Association's standards of practice, are the expectation that the registered nurse completes a full, holistic assessment of a client as the basis for all plans of care. The American Nurses Association has also begun to take a position on CAM therapies and patient care. For example, the Scope and Standards of Gerontological Nursing Practice Fall 2000 draft document addressed nursing's obligation to assess for self-medication, including complementary therapies and practices, and to explore care options that may include complementary or supportive therapies.

Monitoring and Reporting Herbal Therapy Use

Most people are familiar with the FDA's MedWatch program, designed to track and record drug reactions and interactions. Health care providers or consumers can report adverse effects of a drug or an herbal product, confidentially, by telephone or via the Internet. Health care providers who suspect a patient has suffered serious harmful effects or illness due to herbal supplement use should report the event.

Fewer people are aware that in 1993 the FDA established the Special Nutritionals Adverse Event Monitoring System (SN/AEMS). The SN/AEMS monitors illness or injury reports associated with the use of a special nutritional product, including dietary


The home setting may provide the richest source of information on a patient's use of alternative therapies.
supplements. The reports come via MedWatch, FDA field offices, other federal, state, or local public health agencies and letters or phone calls from consumers and health care providers.

The SN/AEMS Web page can be accessed for information on reported adverse events. Actual online reporting is through the MedWatch homepage. The FDA stresses that there may not be enough information online to assert a direct relationship between a supplement and adverse event. It is however, a source of information on numerous herbal supplements and possible adverse events.

Practice Implications

The demand for CAM therapies continues to grow in the United States. Lack of herbal product standardization and standardized prescriptive use presents risks and challenges for clients who choose to use herbal therapies. Comprehensive assessment is a core function of case management practice. It is through nursing expertise, observations and judgment that case managers analyze and synthesize the information obtained in assessment in order to determine the client's priority needs. Development of case management standards and protocols that address client herbal therapy use can guide case managers in thorough assessments on that topic. By becoming knowledgeable of the benefits of herbal therapies as well as the associated risks, case managers can use assessment data to advocate for client safety and choice.

Implications for Home Health Care Providers

The home setting may provide the richest source of information on a patient's use of alternative therapies. Within the home, the case manager or nurse assigned to the case observes the patient's personal environment, and can perform a more accurate assessment of CAM therapies in use. For example, the nurse may assess the medicine cabinet, with the consent of the patient, to identify prescription or non-prescription medications. This assessment can provide fairly obvious cues. While prescription medications are often in traditional small white bottles or containers with printed instructions and provider's name, herbal supplements are packaged in larger white plastic or brown glass bottles with vivid wrap-around labels.

Regardless of care setting, review the client's medical record and case history. When CAM usage is identified or suspected, further assessment of patient and family understanding of the alternative therapy is warranted. This assessment should include:

*Patient's current CAM usage

*Patient and family knowledge about the particular CAM therapy

*Care provider awareness of patient's CAM therapy, possible CAM usage, or patient's expressed desire for CAM therapy.

Key questions can assist in identifying the types of treatments the client has used. For example, asking: What are you doing to maintain your health? or What do you do at home for your health? can open discussion of CAM therapies the client is using or has used in the past.

A thorough assessment assists in identification of significant issues that may interfere with the provision of cost effective, safe, quality care. A thorough and objective assessment is fundamental to successful client outcomes, in the client's home and other areas along the health care continuum.

Table 1: Health conditions, common herbs, and implications, from the Professional Handbook of Complimentary Alternative Medicines

Condition & Supplement

Potential Interactions

Considerations

Arrhythmias:

Angelica

Coumadin

Heparin

Sunlight

Stay out of direct sunlight;

Be alert for signs of bleeding;

Do not take if planning elective surgery

Arthritis:

Chondroitin

Ginger

Glucosamin

Heparin, Coumadin


Heparin, Coumadin

None reported

Use these supplements cautiously if bleeding disorder present;

Some reports of headache and GI symptoms;

Diabetics: monitor BG.

BPH

Nettle

Should not be taken with diuretics

Diuretic affect increased;

Increase dietary potassium.

Dementia

Chaparral

Gingko Biloba

None reported.

Do not take with anticoagulants or antiplatelets medications (ASA, Persantine)

Very toxic to liver. FDA considers unsafe;

Report bruising/bleeding; Ginkgo seeds may be toxic.

Depression

St. John's Wort

Alcohol, OTC flu and cold remedies, narcotics, amphetamines, antidepressants

Health care provider should evaluate depression;

Use care with sunlight; Reports of allergic symptoms

Diabetes

Basil

Fenugreek

Insulin, other DM medications

Anticoagulants, diabetes meds, oral medications

Monitor BG levels (hypoglycemia)

Malabsorption in GI tract.

Male Impotence

Yohimbe

OTC's with caffeine, antidepressants, Tyramine foods

Manic reactions; increase affect antidepressants; elevated heart rate and BP with Tyramine foods.

Menopause

Black Cohosh (Squaw root, Estroven, Femtrol)

Antihypertensives

Monitor BP in hypertensive women;

Large doses may lead to spontaneous abortion

Infections

Echinacea

None reported

Contraindicated in: AIDS, collagen disorders, MS, TB;

Do not take more than 8 weeks

Insomnia

Melatonin

Valerian

Valium, DHEA (anti-aging supplement), magnesium, zinc, methamphetamines

Not use with cirrhosis;

Not use with history of stroke, depression, other neuro disorders;

Can cause headache.

Table 2: How To Reach the FDA MedWatch or the SN/AEMS

Hotline number: (800) FDA.1088
Online: http://www.fda.gov/medwatch/report/hcp/htm
When making a report, you need to provide:

  • The name, address and telephone number of the person who became ill
  • The name and address of the doctor or hospital providing medical treatment, if applicable
  • Description of the problem
  • Name of the product and the store where it was purchased

Table 3

Consumer Advice for Herbal Therapy Safety

  • Tell your health care provider ALL the medications you are taking including herbs and vitamins
  • Purchase herbal medications from a reputable source
  • Read labels carefully
  • Make certain herbal ingredients are "standardized"
  • Pregnant women should not "self-treat" with herbs as there is minimal research done on efficacy and safety in this population
  • Natural does not necessarily mean harmless
  • Follow the prescribed dosages exactly
  • Never ignore symptoms
  • Do not use herbs to delay treatment from traditional health care providers
  • If you are having side-effects, call your health care provider
  • Do not allow your children, friends, or pets to take your herbal medications

Web sites for more information on herbal remedies:

This article originally appeared in the May 2001 issue of HME Business.

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