White Paper on Natural Products.

The American College of Clinical Pharmacy (ACCP) published an initial white paper on herbal products in 2000. Since then, the global market for natural products has continued to expand, with tens of millions of consumers using such products on an annual basis in the United States alone. However, despite this expansion, natural products remain largely unregulated compared with prescription medications, have moderate- to low-level clinical evidence for efficacy, and continue to have safety concerns, including adulteration and misbranding. As comprehensive medication management experts, clinical pharmacists are uniquely qualified to navigate these concerns and advise patients appropriately. To develop and recommend a suitable care plan involving natural products, clinical pharmacists must establish a strong pharmacist-patient relationship, assess the appropriateness of therapy, educate the patient regarding key issues, and continuously monitor and follow up on the effectiveness of the care plan. This process should not only occur in an individual community or hospital setting, but also whenever a patient transitions from one care setting to another in cooperation with other clinicians.

Characterization of Complementary and Alternative Medicine-Related Consultations in an Academic Drug Information Service.

PURPOSE: To characterize requests received through an academic drug information consultation service related to complementary and alternative medicines. METHODS: A retrospective review and descriptive analysis of drug information consultations was conducted. RESULTS: A total of 195 consultations related to complementary and alternative medicine were evaluated. All consultation requests involved questions about dietary supplements. The most common request types were related to safety and tolerability (39%), effectiveness (38%), and therapeutic use (34%). Sixty-eight percent of the requests were from pharmacists. The most frequent consultation requests from pharmacists were questions related to drug interactions (37%), therapeutic use (37%), or stability/compatibility/storage (34%). Nearly 60% of complementary and alternative medicine-related consultation requests were able to be completely addressed using available resources. Among review sources, Natural Medicines Comprehensive Database, Clinical Pharmacology, Micromedex, and Pharmacist's Letter were the most common resources used to address consultations. CONCLUSION: Utilization of a drug information service may be a viable option for health care professionals to help answer a complementary and alternative medicine-related question. Additionally, pharmacists and other health care professionals may consider acquiring resources identified to consistently answering these questions.

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

PURPOSE: Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. METHODS: FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. RESULTS: A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. CONCLUSION: Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant.

Comparison of Vitamin D Label Dosing Recommendations to North American National Guidelines.

Supplementation with vitamin D has become increasingly popular over the past decade, and numerous organizations have developed recommendations for the appropriate intake of vitamin D. Vitamin D supplements come in a variety of formulations and strengths and vary in their directions for use. This study was designed to compare vitamin D label dosing information with the recommendations in North American guidelines. A systematic search was conducted to identify 62 single-ingredient vitamin D products of which 1000 IU was the most common strength. Assessment of North American guidelines found recommended vitamin D dosing to range from 400 to 1000 IU daily, depending on age. Twenty-four (39%) of the products recommended a maximum dose within the range of 400 to 1000 IU daily. Thirty-eight (61%) and 19 (31%) products recommended maximum doses more than 1000 IU daily and 2000 IU daily, respectively. Labeled dosing recommendations of commercially available vitamin D supplements are largely inconsistent with North American recommendations.

Survey and Systematic Literature Review of Probiotics Stocked in Academic Medical Centers within the United States.

BACKGROUND: Probiotics have a wide variation in their effectiveness in preventing or treating conditions due to the varying beneficial effects of specific probiotic strains. In other words, there is no "generic equivalency" between different probiotic species. However, it is has been noted that many practitioners consider probiotics in generic terms and may not realize the impact of these differences between probiotics. OBJECTIVE: The aims of this study were to identify probiotics used in US academic medical centers and to determine whether those probiotics were supported by a reliable evidence base. METHODS: A phone survey of 126 inpatient pharmacies in US academic medical centers was conducted to determine which probiotics were stocked. A systematic search was conducted to identify relevant studies that were then critically evaluated to determine whether the identified probiotics are supported by a reliable evidence base. RESULTS: There was a 90.5% (114/126) response rate of academic medical centers that were contacted through the phone survey. Ten probiotic products were identified through the phone survey. The probiotic most often stocked in academic medical centers was Culturelle (27.2%) followed by Lactinex (25.4%). The systematic search identified evidence that evaluated Culturelle, Florastor, Lactinex, and VSL #3. Of those 4 probiotics, none were supported by a strong evidence base. However, the results suggested that both Culturelle and Florastor appear to be supported by more evidence compared to other probiotics. CONCLUSION: A majority of academic medical centers did not stock a probiotic that was supported by a reliable evidence base.