Complementary/Alternative Medicine Use: Responsibilities and Implications for Pharmacy Services - P&T Community
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Complementary/Alternative Medicine Use:
Responsibilities and Implications
for Pharmacy Services
Kenneth R. Cohen, PhD., RPh, Peter Cerone, MS, RPh, and Robert Ruggiero, PharmD
INTRODUCTION 47% increase over the 427 million visits made in 1990. Americans
omplementary/alternative medicine (CAM) is known by spent approximately $27 billion out-of-pocket (not covered by in-
C a variety of terms, such as complementary, holistic, inte-
grative, unorthodox, and natural medicine. Some types of
alternative medicine include acupuncture, aromatherapy, chi-
surance) on alternative medicine treatments. This is equivalent
to the out-of pocket expense for the same period on U.S. physi-
cian services. The use of herbal medicines increased fivefold be-
ropractic, folk medicine, homeopathy, and herbal medicine. A tween 1990 and 1997; the use of folk remedies increased at a sim-
treatment is called “alternative” when it is used instead of con- ilar rate; and the use of megavitamins and homeopathy more
ventional treatment. A “conventional” treatment is one that is than doubled.1 According to the National Institutes of Health
widely accepted and practiced by the mainstream medical com- (NIH) National Cancer Institute, the use of CAM is even more
munity. If alternative treatments are used in addition to con- prevalent among cancer patients. One study published in the July
ventional treatments, they are referred to as “complementary 2000 issue of the Journal of Clinical Oncology reported that 83%
therapies.” of 453 cancer patients had utilized at least one CAM therapy as
There is a need to integrate these treatments into conven- a part of their cancer treatment.2
tional medical practice and to examine the prevalence of herbal In this article, we discuss herbal and homeopathic remedies.
use across ethnic, age, economic, and other strata as studied by Herbs and homeopathic medicines involve the use of various
the regular medical hierarchy. These therapies are often impli- parts of plants to treat symptoms and promote health. These
cated in patients’ responses to treatment of their chief com- plant extracts are utilized homeopathically to stimulate the body
plaints as well as the progression of their underlying diseases. sufficiently to trigger a healing or prophylactic response. The
Hence, herbal therapies affect the patient’s response to conven- U.S. Food and Drug Administration (FDA) does not currently
tional patent medicines, surgery, anesthesia, and healing. In ad- regulate herbal products, which can be marketed only as dietary
dition, patients receiving acute care will have differing responses, supplements. Manufacturers and distributors cannot make any
depending on their underlying cardiovascular, renal, hepatic, specific health claims without FDA approval.3
and immune system pathology, along with their conventional and Of the 44% of all respondents in the JAMA study (Eisenberg
alternative drug therapies. Any effort on the part of pharmacists et al1) who indicated that they took prescription medication in
to raise these issues with treating physicians must be combined 1997, 18.4% indicated that they also utilized herbal products.
with a presentation of the prevalence of CAM use in their patients. However, in respondents who had a medical condition requir-
This presents a challenge to community and institutional phar- ing treatment, more than 33% used herbal products as well.
macists as they strive to ensure rational drug therapy. Pharma- Therefore, more than 15 million Americans are taking both pre-
cists must obtain and provide information relating to all thera- scription drugs and herbs or high-dose vitamins.
peutic agents the patients are receiving in the following situations: There is a potential for adverse interactions between pre-
scription drugs and herbal products. This problem is com-
• when the patient begins a new conventional therapy pounded because ample data are available about which pre-
• when the patient presents for emergent or urgent care scription medications a particular patient is taking, but poor
• when the patient presents for surgery and other invasive communication between patients and physicians limits our
procedures knowledge of the true extent of alternative therapy usage.
• when the patient is considering a new CAM therapy Gray et al4 demonstrated this gain in popularity by pointing
out that 42% of patients reported using at least one CAM ther-
PREVALENCE OF CAM USE apy, the majority of patients being younger, better educated, and
According to a study reported in JAMA, 40% of Americans use employed. Almost all of these patients integrated CAM as an ad-
some form of alternative medicine.1 Americans visited alterna- junct to conventional therapies but clearly not as a substitute for
tive therapy practitioners 629 million times in 1997, which is a conventional preventive health care.
In a Lancet article, Ernst5 reported that more than 50% of can-
Dr. Cohen is Assistant Director for Clinical Pharmacy Services cer patients were using CAM either with (as supportive care) or
at Brookhaven Memorial Hospital Medical Center in Patchogue, before or after conventional therapies.
New York, and Associate Adjunct Professor of Pharmacy Practice Cherniack et al6 studied the prevalence of CAM use in the geri-
at St. John’s University College of Pharmacy in Jamaica, New York. atric population. They reported that 58% of these patients had
Mr. Cerone is Director of Pharmacy Services at Brookhaven used at least one CAM in the previous year. A higher proportion
Memorial Hospital Medical Center in Patchogue, New York. Dr. of use was reported in patients receiving treatment for thyroid
Ruggiero is Chief of Pharmacy Services at Northport Veterans Ad- disorders and arthritis. This study also upheld the idea that
ministration Medical Center in Northport, New York. CAM prevalence exists in highly educated groups.
440 P&T® • September 2002 • Vol. 27 No. 9Choices and Ramifications of Complementary/Alternative Medicine Use
Robinson et al7 studied the prevalence of use in individuals Today’s consumers want care involving some personal au-
who attended health fairs. In this group, 61% reported CAM tonomy and control over their health care and treatment de-
use. The investigators also noted that patients using CAM also cisions.
used conventional care. • Alternative therapies may seem attractive because they are
Oldendick et al8 reported that 44% of telephone interview re- seen as more compatible and consistent with patient values,
spondents used CAM. This study also associated CAM with a such as the patient’s world view and spiritual or religious
high level of education. The majority of CAM users had a high beliefs regarding the nature of health and illness.
level of satisfaction with their therapy. The authors also re-
ported that 57% of CAM users had not informed their physicians The following independent variables were used to express ra-
of their CAM use. tionale for CAM use:10
In a study of cancer patients by Bernstein and Grasso,9 the
prevalence of CAM use was even higher. Eighty percent re- • the patient’s (dis)satisfaction with conventional medicine
ported some use of CAM, with the majority utilizing herbal • the need for patient control over therapy
products and vitamins. • the patient’s philosophy and values regarding health care
All of these prevalence studies confirm a high use of CAM by • the patient’s belief in the efficacy of conventional medicine
educated individuals who have access to conventional health • the patient’s health
care. In many cases, conventional health care provider physi-
cians are unaware of the therapies being used by their patients. DEMOGRAPHICS
This further underscores the need for pharmacists to obtain ac- Austin’s study demonstrated that most individuals used al-
curate and complete CAM histories for their patient profiles. ternative medicine as an adjunct to conventional medicine.10
This information must be utilized to indicate any interactions and Only 5% used alternative medicine alone. This finding under-
reactions between conventional therapies and CAM. scores the need to have a complete history of all treatments to
Conventional approaches to treatment have generally been take into account the risk of interactions between therapies. In
studied for safety and effectiveness through a rigorous scientific addition, individuals with poorer health status are more likely to
process, including clinical trials with large numbers of patients. utilize alternative therapies. Here again, sicker patients with
Often, less is known about the safety and effectiveness of herbal more complicated treatment regimens increase the risk of un-
products. In addition, because of the lower level of FDA over- toward events caused by interaction of treatments. Austin’s data
sight, similar products from different manufacturers are not re- were then examined to determine whether any trends were ev-
quired to demonstrate equivalence. ident regarding which groups were likely to utilize CAM.
In 1990, 33% of respondents who used alternative therapies In an examination of CAM use and age (Figure 1), the data
used them not for a particular medical condition but rather for suggested substantial CAM use across all age groups. The data
health promotion or disease prevention. In 1997, 58% of alter- were then sorted by race and ethnicity (Figure 2). Although
native therapies were used for these purposes. Despite these dra- there was substantial use across all ethnicities, there was less
matic increases in use, the extent to which patients are disclos- use among African-Americans and more use among Native
ing their use of alternative therapies to their physicians during Americans. When educational level was examined (Figure 3),
history-taking remains low. In the 1990 and 1997 studies, fewer CAM was used across all levels but there was a definite trend
than 40% of patients disclosed their use of alternative therapies toward increased use at higher educational levels. Examination
to their physicians. Therefore, there has been no increase in pa- of use across income areas demonstrated no significant differ-
tient and physician understanding of the need to include alter- ences in prevalence (Figure 4).10
native therapies as a part of the patient history. Before we em- If conventional health care providers operate from the view-
bark on a strategy to develop an increased understanding for the point that their treatments may be used together with alterna-
need to incorporate herbal therapy history into the conventional tive therapies, it is necessary to consider an impact analysis.
medication history of the patient’s medical record, the reasons Historically, orthodox medicine had combatted alternative
for the increased use of alternative medicine need to be ex- practices vigorously by denouncing and attacking them. Ac-
plored. cess was restricted, and alternative treatments were labeled as
At present, there is no definitive response to this question. In unscientific and were considered to be quackery. Often penal-
a national study of the reasons for alternative medicine use, ties were imposed on practitioners of alternative medicine. When
Austin proposed three theories:10 alternative therapies rose in popularity, despite the attitude of the
medical establishment, the establishment began to examine
• Patients have become dissatisfied with conventional treat- them, evaluate them, and consider incorporating them into treat-
ments. Reasons cited include ineffectiveness, adverse ef- ment regimens. Examples include refinement of digitalis into
fects, cost, and a health care system that has become too digoxin tablets.
technologically oriented instead of personally oriented.
• Patients need personal control. Alternative therapies are per- RATIONALE FOR INCREASED CAM POPULARITY
ceived as less authoritarian, less secretive, and more em- Jonas addresses issues leading to the increased popularity of
powering. Patients see conventional health care as origi- alternative medicine.11 The aging of the population and advances
nating from a closed community of doctors who often treat in medicine have led to an increased prevalence of chronic dis-
them without providing them with an understanding of the eases that call for new treatments. In addition, the increase in
methodology, risks, and benefits of these treatments. public access to information and consumerism has led to a de-
Vol. 27 No. 9 • September 2002 • P&T® 441Choices and Ramifications of Complementary/Alternative Medicine Use
creased tolerance of paternalism in the medical profession. Pa- as good ones as it changes and modifies itself. It needs the
tients also have an increased sense of entitlement to a good qual- same level of critical assessment that conventional therapies
ity of life and have a declining faith that scientific breakthroughs have through organizations such as NIH and FDA. Without
will have relevance for their personal disease treatments. Preva- critical assessment of what should be accepted and what should
lence in the literature regarding the adverse effects of existing not, we risk developing a health care system that is less efficient,
drug and conventional therapy and escalating costs have fueled less cost-effective, and less safe. There is also the chance that
the search for alternative approaches to the prevention and the system will fail to address the management of chronic dis-
management of illness. Because of direct patient access to al- ease in a publicly responsible manner.
ternative therapies and a communication gap between the med- The following risks must be evaluated:12
ical establishment and alternative caregivers, there has been a First, quality-of-care issues include the fact that medical physi-
broadening of the communication gap between the public and cian licensure is not required of alternative medicine practi-
the profession that serves their health care needs. tioners. Length of training, training content, testing, certification,
Today, a greater effort is being made to integrate alternative and scope of practice are not delineated. Professional liability,
practice into mainstream medicine. Medical schools have added statutory authorization, and codified disciplinary action are not
this topic to their curricula. Hospitals are creating complemen- stated. Although chiropractic is licensed, many other practi-
tary and integrated medicine programs, and health care suppli- tioners go unmonitored.
ers are expanding benefits to include alternative practices. In ad- Second, the quality of natural products is largely unmoni-
dition, research organizations such as the NIH Office of tored and uncontrolled. Products are available on the market as
Alternative Medicine have developed the National Center for dietary supplements and may be contaminated or may vary
Complementary and Alternative Medicine.With this increased tremendously in content, quality, and safety. Some products
acceptance, however, one must recognize the benefits and risks that appear to have some effectiveness are prepared differently
associated with its use. Alternative medicine, like conventional according to the manufacturer and may not be effective if pro-
medicine, is a dynamic process that promotes bad ideas as well cessing methods vary. There is no consistency for products de-
Figure 1 Prevalence of CAM Use by Ethnicity Figure 3 Use of CAM by Education Level (%)
71%
% of members of group using CAM
% of subjects using CAM
50%
47% 45%
44% 44%
41% 40%
29% 31%
White Black Hispanic Asian Native Other High Some Bachelor’s Graduate
Amer. School or College Degree Degree
Less
Figure 2 Use of CAM by Age Range (%) Figure 4 Use of CAM by Family Income (%)
63%
% of patients using CAM
% of patients using CAM
42% 44% 42% 44% 44%
41%
35% 35% 33%
18-24 25-34 35-49 50-64 >64 $60,000
$24,999 $39,999 $59,999
442 P&T® • September 2002 • Vol. 27 No. 9Choices and Ramifications of Alternative/Complementary Medicine Use
veloped by competing manufacturers as there is for drugs. In ad- CAM remedies contact their malpractice carriers to determine
dition, 15 million Americans are taking high-dose vitamins or whether their coverage will be affected. The American Medical
herbal preparations along with prescription drugs. The adverse Association (AMA) expects an increase in the threat of liability
effects from these interactions are not well documented. if there are economic variables in some CAM-related decisions
Third, the quality of science in the development of alternative made by the physician. Examples include selling herbal products
treatments is not consistent with the methodology utilized for to augment stagnant or declining incomes. The AMA gives scant
conventional treatments. Some standardization in the trial of guidance for CAM because “there is little evidence to confirm the
products and expressing the evidence for safety and effective- safety or efficacy of most alternative therapies.”14
ness must be established. However, attempting to fit alternative Physicians at Exeter University in the United Kingdom are
medicine into the framework of conventional medicine will not taking a course entitled “Familiarization in Complementary
be effective. For one, alternative medicine systems provide more Medicine.”15 The course has been well received, and primary
personal contact and participation in the healing process com- care physicians are indicating that they have gained useful in-
pared with conventional treatments, which often result in a loss formation regarding complementary therapies. However, con-
of personal contact in the subspecialization, technology, and cerns have been voiced regarding poor communication with
economics of modern medicine. This is one of the main reasons CAM practitioners, and doubts of competence have been rein-
for the popularity and effectiveness of some complementary forced by a lack of identifiable qualifications.
treatments, which would be diluted if they were forced into the Physicians must be aware of the possibility of “failure to warn”
conventional framework. The integration of conventional and liability if they do not advise their patients of the untoward effects
complementary therapies must recognize the need to person- of some alternative remedies that they may be taking.14 This ex-
alize both the history-taking and treatment processes. posure may include therapies that the physician becomes aware
of as well as therapies actually recommended by the prescriber.
LIABILITY ISSUES If the patient is seeing an alternative practitioner with a bad legal
Liability issues for practicing physicians in the area of alter- or medical record, the physician might be held liable for failing
native medicine are quite broad. Legal authorities like Michael to warn the patient. However, physicians may also be held liable
J. Cohen, JD, point out the presence of conflicting licensing, reg- for withholding information about an alternative method that
ulatory, and malpractice considerations because of the evolving might be helpful to patients if that remedy has been found to be
nature of complementary/alternative medicine. Relatively little a useful treatment for a particular disease.
has been scientifically proven concerning the efficacy and safety
of CAM treatments. Also, such treatments are viewed as “non- TRENDS IN THE U.S.
standard” care. There is concern about having sufficient safety Cushman et al16 augmented the 1997 JAMA study by survey-
and efficacy data, such as contraindications to make informed ing four focus groups of African-American and Hispanic women
recommendations to patients. in New York City. This was a pilot study for an eventual nation-
Physicians lack knowledge about the interactions that can wide survey of women of various ethnic backgrounds.
occur when a patient “self-medicates” versus when he ingests Few differences in primary health concerns emerged across
medications that are prescribed.13 In addition, they may be un- demographic lines (ethnicity and household income). Herbal
informed about which complementary remedies a patient is medicine was the most common remedy. Younger women ex-
using. Patients taking these agents may require additional pre- pressed more reservations regarding alternative therapies than
cautions before surgery and anesthesia. Examples include com- did older women, and they were skeptical about CAM practi-
plementary therapies, which can affect clotting dynamics or tioners. Older women in these groups often preferred CAM
cause additive sedation prior to surgery. This reinforces the practitioners for a variety of reasons, such as payment terms,
need to ensure that health histories elicit information about the their use of methods that have been handed down from gener-
patient’s use of herbal remedies. Physicians also need to advise ation to generation, language differences, and other cultural is-
patients to discontinue all herbal remedies for a relatively long sues. Survey participants judged the effectiveness of CAM treat-
period prior to surgery. Physicians can be held liable for the un- ments similarly to conventional ones in terms of assessment of
intended consequences resulting from their patients’ use of how they feel and assessments of how they look to others. Most
CAM products regardless of whether they (the physicians) are younger women studied relied on health assessment by regu-
aware that the products are being used. lar doctors whether or not they used CAM.
Doctors and pharmacists must educate patients about the A follow-up study in the Journal of American Medical Women’s
differences between conventional and alternative medicine and Association17 amplified this issue. This study, in conjunction
about the pharmacological similarities between conventional with Latina Magazine, studied CAM use in Hispanic women. In
and alternative treatments. Patients must be made to under- this study, another important factor was raised. More than 60%
stand that these therapies affect the chemical balance in their of the subjects indicated that their physicians had never asked
bodies just as prescription medications do. These therapeutic them if they were using CAM. Forty percent of the subjects in-
substances also have differing bioavailabilities, pharmacoki- dicated that they never voluntarily reported CAM use. Patients
netics, elimination times, allergenic properties, and side effects sometimes felt intimidated by their physicians and perceived a
that must be measured and evaluated.14 sense of disapproval with regard to their physician’s views on the
Physicians who sell vitamin and herbal products in their offices use of CAM. As we can see, this is a problem, particularly when
may be considered to be selling “drugs” for purposes of legal li- one considers drug–CAM interactions and the potential dangers
ability. We recommend that physicians who support or distribute of procedure-related adverse events.
444 P&T® • September 2002 • Vol. 27 No. 9Choices and Ramifications of Complementary/Alternative Medicine Use
CONCLUSION REFERENCES
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