Development of a Complementary and Alternative Medicine (CAM) Pharmacy and Therapeutics (PandT) Subcommittee and CAM Guide for Providers

OBJECTIVES: The objective was 2-fold: (1) to evaluate the feasibility and value of developing a Pharmacy and Therapeutics (P&T) subcommittee aimed at scientifically evaluating complementary and alternative medicine (CAM) products for an integrated managed care organization (IMCO) and (2) to assess provider acceptance and usefulness of a CAM guide. METHODS: Three factors drove the decision to form a CAM P&T subcommittee to evaluate current commonly used CAM products: (1) physicians, pharmacists, and dieticians expressed a desire for an easy-to-use, scientifically based mechanism for evaluating the ever-increasing number of CAM products; (2) Intermountain Health Care Health Plans (Health Plans), the insurance division of this IMCO, offers access to certain CAM products to its members at a discounted price in an effort to remain competitive with other IMCOs; and (3) this IMCO owns and operates more than a dozen community pharmacies that sell CAM products. Some IMCO clinicians believed an efficacy and safety review of the products offered through the organization was warranted. Subcommittee members included clinical pharmacists (IMCO and university), pharmacy directors, a community pharmacist, practicing physicians (from the drug P&T committee), a medical director, dieticians and nutritionists, and a representative from the Health Plans sales department. The primary outcome was the development of a CAM guide listing recommendations for use of CAM products. Outcome measures included survey results (survey sent with guide to physicians and pharmacists) regarding acceptance and usefulness of the guide. RESULTS: The CAM P&T subcommittee met monthly to evaluate current commonly used CAM products. A CAM guide was developed in paperback and electronic versions. The electronic version was downloadable to handheld devices. Thousands of CAM guides were disseminated to IMCO-employed physicians, network pharmacies, dieticians, and nutritionists affiliated with this managed care organization. A survey that accompanied distribution of the first CAM guide in 2003 showed that 89% of physicians and pharmacists felt that the guide would be somewhat or very helpful as a counseling aide; the remainder was unsure. A second CAM guide was disseminated one year later, in 2004. The accompanying survey showed that 78% of physicians and 97% of pharmacists felt that the guide would be somewhat or very helpful as a counseling aide; 7% of physicians and 3% of pharmacists felt the guide would be unhelpful. CONCLUSIONS: A CAM guide developed through the work of a subcommittee of the PandT committee of this IMCO appears to be widely accepted by pharmacists and physicians. A CAM guide should be easy to use and available online with the ability to download to a handheld device.

METHODS: Three factors drove the decision to form a CAM P&T subcommittee to evaluate current commonly used CAM products: (1) physicians, pharmacists, and dieticians expressed a desire for an easy-to-use, scientifically based mechanism for evaluating the ever-increasing number of CAM products; (2) Intermountain Health Care Health Plans (Health Plans), the insurance division of this IMCO, offers access to certain CAM products to its members at a discounted price in an effort to remain competitive with other IMCOs; and (3) this IMCO owns and operates more than a dozen community pharmacies that sell CAM products. Some IMCO clinicians believed an efficacy and safety review of the products offered through the organization was warranted. Subcommittee members included clinical pharmacists (IMCO and university), pharmacy directors, a community pharmacist, practicing physicians (from the drug P&T committee), a medical director, dieticians and nutritionists, and a representative from the Health Plans' sales department. The primary outcome was the development of a CAM guide listing recommendations for use of CAM products. Outcome measures included survey results (survey sent with guide to physicians and pharmacists) regarding acceptance and usefulness of the guide. R E S U LT S: The CAM P&T subcommittee met monthly to evaluate current commonly used CAM products. A CAM guide was developed in paperback and electronic versions. The electronic version was downloadable to handheld devices. Thousands of CAM guides were disseminated to IMCO-employed physicians, network pharmacies, dieticians, and nutritionists affiliated with this managed care organization. A survey that accompanied distribution of the first CAM guide in 2003 showed that 89% of physicians and pharmacists felt that the guide would be somewhat or very helpful as a counseling aide; the remainder was unsure. A second CAM guide was disseminated one year later, in 2004. T h e a c c o m p a n y i n g survey showed that 78% of physicians and 97% of pharmacists felt that the guide would be somewhat or very helpful as a counseling aide; 7% of physicians and 3% of pharmacists felt the guide would be unhelpful.
CONCLUSION: A CAM guide developed through the work of a subcommittee of the P&T committee of this IMCO appears to be widely accepted by pharmacists and physicians. A CAM guide should be easy to use and available online with the ability to download to a handheld device. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that re q u i red for conventional treatments." 1 The work of MCOs in evaluating CAM products was made more difficult by the Dietary Supplement Health and Education Act of 1994, which eliminated the requirement that the U.S. Food and Drug Administration (FDA) review CAM products for efficacy, safety, and manufacturing standards if there is no claim to diagnose, treat, cure, or prevent disease. 2 The first comprehensive and reliable data on the use of CAM in the United States were released in May 2004 by the National Center for Complementary and Alternative Medicine and the National Center for Health Statistics (NCHS, part of the Centers for Disease Control and Prevention). The data were derived from the 2002 edition of the NCHS' s National Health Interview Survey, in which 31,044 noninstitutionalized American adults aged 18 years or older answered questions about their health-and illness-related experiences. The 2002 surv e y showed that 36% of adults are using some form of CAM. When megavitamin therapy and prayer specifically for health reasons are included in the definition of CAM, the proportion of American adults using CAM rises to 62%. 3 The National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health maintains a Web site with a wealth of information on CAM. 4 The Slone Survey in 2001 found that 14% of the population took herbals/supplements. Among prescription drug users, 16% also took an herbal/supplement. The authors concluded that the substantial overlap between use of herbals/supplements and prescription medications raises concerns about unintended interactions. 5 However, many other sources estimate the use of CAM to be much higher. According to NCCAM, more than 42% of the American public used CAM in 1997, at a cost of $27 billion per year, which exceeded out-of-pocket spending for all U.S. h o s p i t a l i z a t i o n s . 6 David M. Eisenberg and colleagues estimated that, in 1990, the number of visits to providers of unconventional t h e r a p y in the United States exceeded the number of visits to all U.S. primary care physicians. 7 Eisenberg reported that 4 out of 10 Americans used CAM therapies in 1997. His study also reported that the total number of visits to alternative medicine practitioners increased 50% from 1990 to 1997, to 629 million visits per year. 8 However, only 53% of CAM users report such use to their primary physicians. 9 Responsible clinicians must be able to help their patients make informed decisions re g a rding therapeutic options, including those they may find unconventional. Patients increasingly want informed and shared decision making about their health. CAM use is an important component of modern health care. For this reason, IMCO clinicians expressed a desire for an easy-to-use, scientifically based mechanism for evaluating the ever-i n c re a s i n g number of CAM products.
Given the desire to be responsive to its customersmembers and providers-Health Plans formed a group comprising an IMCO physician, a clinical pharmacist, and marketing and operations personnel to evaluate its contracted CAM vendor and its products. Health Plans Pharmacy Services began an evaluation of what was being offered and saw a significant opportunity for an intervention. One of its first Evaluation Criteria for Products  actions was to solicit information from physicians, pharmacists, and dieticians to determine how familiar they were with CAM resources. The resounding response was that clinicians are often asked about CAM products but lack proper training and resources to respond. This finding is consistent with current literature. Health Plans Pharmacy Services made the decision to form a CAM subcommittee of the pharmacy and therapeutics (P&T) committee to evaluate current commonly used CAM products for efficacy and safety. Pharmacy Services recruited physicians and pharmacists from the Health Plans P&T committee who e x p ressed an interest in CAM. The same physician and p h a rmacist involved in the initial evaluation group were appointed cochairs of the CAM subcommittee. The pharmacist also recruited a faculty clinical pharmacist from the University of Utah with expertise and experience in CAM. Other recruited clinicians included dieticians and a representative from the Health Plans sales department. The final composition of the CAM subcommittee included 6 pharmacists (a Health Plans clinical pharmacist, the 2 pharmacy directors from Health Plans, the IMCO community pharmacy manager, a University of Utah clinical pharmacist, and a data analyst responsible for maintaining electronic records), 4 physicians (Health Plans P&T chair, 2 other P&T members, and an IMCO physician), 3 dieticians from the IMCO, a representative from Health Plans Sales and Marketing, and a certified pharmacy technician (CPhT) as project coordinator.
The goal and primary outcome measure of the CAM subcommittee was the development of a CAM guide listing recommendations for use of CAM products. Secondary outcome measures included results of a survey of clinicians regarding CAM use and usefulness of the guide (survey sent with guide), and acceptance of the guide, as reflected in the number of requests for copies, information, and speaking engagements.

■ ■ Results
The CAM subcommittee of the P&T committee began meeting monthly in November 2001. The first action items included identifying the evaluation criteria for products, Web sites, and p rograms; evaluating the IMCO' s compliance policy; determ i n i n g the information sources; and establishing the dissemination methods. The evaluation criteria for CAM agents were (1) the listing of proposed uses or common uses; (2) the listing of those indications that are supported by scientific evidence; (3) the listing of adverse events, drug interactions, and cautions; (4) dosing; (5) the listing of origin and formulations; and (6) recommendations for use. All CAM agents were ultimately evaluated under the heading of "Recommendation." The re c o mmendations were either neutral, "use with extreme caution," or n e g a t i v e . Table 1 lists the evaluation criteria for pro d u c t s . Evaluation criteria for Web sites included Internet addresses; sponsoring organizations; purpose; scope of inform a t i o n ; Products Included in the CAM Guide*  assessment of accuracy, quality, and objectivity; ease of use; weaknesses, disadvantages, or cautions; and overall impression.

Examples of Products Included in the CAM Guide
Information sources that were utilized by the subcommittee are listed in Table 2. The products included in the CAM guide are shown in Table 3. Annual publishing of a CAM guide was anticipated, with monthly updates distributed to pharmacists and updates provided in the P&T newsletter. The monthly updates were provided to IMCO pharmacies via e-mail and w e re pre p a red by the Health Plans' clinical pharmacist, community pharmacy manager, and pharmacy data steward. The P&T newsletter is mailed to all physicians in the network on a quarterly basis.
A CAM guide was first printed in paperback form for distribution in January 2003. The first guide was pocket-sized, with 25 pages. After disseminating the guide to providers, the subcommittee reduced meetings to a quarterly schedule. In January 2004, an updated version of the guide, comprising 38 pages, was disseminated. The first guide was sent to all IMCO-employed physicians, all pharmacies in the IMCO network, and to selected IMCO-affiliated dieticians and nutritionists. The insurance division of the IMCO (Health Plans) sent the second version of the guide only to selected IMCOemployed physicians and affiliated dieticians and nutritionists, and to smaller regional, IMCO-owned, or independent pharmacies in 2004. An electronic version of the CAM guide was developed in the fall of 2003 and was made downloadable to handheld devices. It is also accessible to IMCO-employed providers at http://IHCRx. Further annual updates are planned. Table 4 lists four examples of products included in the CAM guide. The 2004 CAM guide includes 85 individual CAM pro d u c t s that have been evaluated and assigned a recommendation. Fifteen products have been given a negative evaluation and are not re c o m m e n d e d for use. These products are androstenedione, bitter orange, blue cohosh, Bromex, cat' s claw, chaparr a l , chromium picolinate, country mallow, devil' s claw, dong quai, ephedrine andma huang (since banned in the United States by the FDA), ginseng, kava kava, and sea cucumber. Creatine, DHEA, hawthorn, kelp, raspberry, and willow received the recommendation of "use with extreme caution." The survey of clinicians was distributed with both the 2003 and 2004 CAM guides. The response rate to the 2003 survey was low (Table 5). Only 13% of physicians and 9.5% of pharm a c i s t s re t u rned the surv e y. Of the respondents, 89% of pharmacists and physicians felt that the guide would be somewhat or very helpful as a counseling aide, 11% of physicians were unsure, and one pharmacist (from a regional chain) felt the guide would be unhelpful as a counseling aide.
In an effort to increase the response rate, an incentive was included in the 2004 survey. Everyone who returned a survey was sent a movie rental gift card. More clinicians returned the 2004 survey (37% of physicians and 26% of pharmacists, Table 6  When asked about the previous version of the guide, 47% of physicians felt the guide was somewhat or very helpful, 7% felt it was not helpful, and 46% responded that they had not received a guide. In comparison, 51% of pharmacists felt the guide was somewhat or very helpful, 5% felt it was not helpful, and 44% responded that they had not received a guide. Tables 5 and 6 report the results of the surveys. The IMCO Health Plans clinical pharm a c i s t / c o m m i t t e e cochair has spoken to many diff e rent groups (including dieticians, pharmacists, physicians, and IMCO management) about CAM products and the guide. This individual has addressed the IMCO network management conference, the IMCO-wide annual dietician conference, and employer groups, among others.

■■ Discussion
CAM is a potentially important component of health care. Patients are increasingly using CAM products, and responsible clinicians must be able to help their patients answer questions. A scientifically based, easy-to-use CAM guide, therefore, has the potential to have a large impact for an MCO. It helps to meet competitive market demands and provides ongoing education to clinicians. It also has the potential to increase the credibility of CAM products and improve patient perception of these pro d u c t s by providing evidence-based information. An important component of an endeavor like this is the relationship of the IMCO and the CAM vendor. IMCO Health Plans has a partnership with its vendor and was thus able to review the products offered through its network and remove items where necessary. This IMCO is also able to control the promotional materials that are associated with CAM products.
Many references do not meet all of the criteria provided in the CAM guide of this IMCO. For example, MICROMEDEX is an excellent comprehensive reference that includes scientific evidence and clinical trial results, but it does not provide a recommendation for use. Many clinicians also lack easy access to MICROMEDEX as well as many other commonly used references. These other references may also not be complete, may be expensive to purchase and difficult to update, and may be burdensome to use due to size or location in the facility. The CAM guide of this IMCO was designed with the clinician in mind. It is a pocket-sized booklet, also available in an electro n i c version that may be downloaded to a clinician' s personal digital assistant. All evaluated products are listed in alphabetical order for easy searching.
The surveys that accompanied both guides illustrate general differences between physician and pharmacist attitudes toward CAM. In this population, more physicians felt that CAM is  either ineffective or unsafe, while more pharmacists tend to believe that CAM is a good alternative to, or add-on to, p rescription medications. This diff e rence may be due to familiarity with CAM, interest in CAM, and experience with counseling. More pharmacists than physicians rated their knowledge of CAM as either above average or excellent. These findings were consistent from year 1 to year 2. Much of the success of this project was due to a direct and important relationship between the CAM P&T subcommittee and the Health Plans P&T committee. Many of the subcommittee' s members came from the Health Plans committee. Also, the full Health Plans P&T committee ultimately reviewed and accepted the recommendations of the subcommittee and supported this project by providing access to the Health Plans P&T newsletter, provider networks, and provider groups for educational and speaking purposes.
Among the limitations of this project was the absence of an estimate of the administrative costs to create the CAM. The only direct costs associated with this project were the printing price for the CAM guide (approximately $1,000 each year), the gift cards used with the surveys (approximately 300 cards at $5 each), and mailing costs for the CAM guide. All of the other costs were indirect. All CAM P&T subcommittee members donated their time for this project. The committee was not paid for participating in the meetings, preparing inform a t i o n , research, travel, or for presentations given to other health care professionals. On the other hand, time was used for this project that could have been spent on other projects, and the maintenance of electronic records required resources taken from other projects. Second, there was probable bias in the responses to the first survey due to the very low response rate, and some response bias could have been created in the second survey by offering gift cards to respondents. Third, CAM medications are not a covered pharmacy benefit for this IMCO, so the impact of the CAM guide on appropriate utilization of CAM products cannot be measured because of the absence of pharmacy claims. F o u rth, it would be useful to determine the continued willingness of the IMCO to fund the continued work of the subcommittee and production of the CAM guide, with possible expanded availability to members and patients of this IMCO.

■■ Conclusion
A scientifically based CAM guide was developed by a P&T subcommittee consisting of a multidisciplinary team of clinicians and administrative personnel. Two surveys of IMCO physicians and pharmacists indicated that the guide was well accepted and had a positive impact on the IMCO. The guide is easy to use; it is available to providers online and is downloadable to handheld devices.