Kelly M. Shields

Safety issues associated with commercially available energy drinks.

OBJECTIVE To describe benefits and adverse effects associated with the consumption of energy drinks. DATA SOURCES Searches were conducted using Medline, IPA (International Pharmaceutical Abstracts), EMBASE, and MANTIS; databases such as Natural Medicines Comprehensive Database, Natural Standard, ALTMEDEX, and AltHealthWatch; and Google (range 1980 to September 2007). Search terms included energy drink, Red Bull, caffeine, glucose, ginseng, guarana, taurine, and bitter orange. DATA SYNTHESIS Most energy drinks contain natural products such as guarana, ginseng, and taurine. As much as 80 to 300 mg of caffeine and 35 grams of processed sugar per 8-ounce serving are commonly present in energy drinks such as Cocaine, Pimp Juice, Red Bull, and Spike Shooter. No reports were identified of negative effects associated with taurine, ginseng, and guarana used in the amounts found in most energy drinks. Commonly reported adverse effects seen with caffeine in the quantities present in most energy drinks are insomnia, nervousness, headache, and tachycardia. Four documented case reports of caffeine-associated deaths were found, as well as four separate cases of seizures associated with the consumption of energy drinks. CONCLUSION The amounts of guarana, taurine, and ginseng found in popular energy drinks are far below the amounts expected to deliver either therapeutic benefits or adverse events. However, caffeine and sugar are present in amounts known to cause a variety of adverse health effects.

Treating Pregnancy-Related Nausea and Vomiting with Ginger

OBJECTIVE: To review literature assessing the safety and efficacy of the use of ginger to treat nausea and vomiting in pregnancy. DATA SOURCES: Iowa Drug Information Service (1966–September 2004), International Pharmaceutical Abstracts (1971–September 2004), MEDLINE (1966–September 2004), and EMBASE (1966–September 2004) were searched. Key terms included ginger, nausea, vomiting, emesis, and pregnancy. DATA SYNTHESIS: Studies evaluating the safety and efficacy of ginger in the management of nausea and vomiting in pregnancy were reviewed. Various doses and forms of ginger were used to treat women during their first and second trimesters of pregnancy. Ginger has been shown to improve the symptoms of nausea and vomiting compared with placebo in pregnant women. CONCLUSIONS: While data are insufficient to recommend ginger universally and there are concerns with product quality due to limited regulation of dietary supplements, ginger appears to be a fairly low-risk and effective treatment for nausea and vomiting associated with pregnancy. In low doses, this may be appropriate for patients not responding to traditional first-line therapies.

Use of Sildenafil for Female Sexual Dysfunction

Objective: To review the pathophysiology of female sexual dysfunction (FSD) and the literature regarding the use of sildenafil in its treatment. Data Sources: Literature was accessed through MEDLINE (1966—April 2006), Iowa Drug Information Service (1966—April 2006), EMBASE (1966—April 2006), and bibliographies of pertinent articles. Search terms included female sexual dysfunction; sexual dysfunction, psychological; phosphodiesterase inhibitors; and sildenafil. Data Synthesis: The lack of a clear understanding of FSD contributes to the limited treatment options available. Studies regarding the safety and efficacy of the phosphodiesterase 5 inhibitor sildenafil in the management of FSD were evaluated. Many trials have been of poor quality, making clinical application of their results difficult. The current literature does not show sildenafil to be an effective treatment option for FSD. Conclusions: Treatment of FSD should include both physical and psychological components. Based on the limited data available, it appears that sildenafil, while well tolerated, offers little or no benefit to most patients with FSD.

Role of Ambrisentan in the Management of Pulmonary Hypertension

Objective: To review the role of ambrisentan in the treatment of pulmonary arterial hypertension (PAH). Data Sources: Literature was accessed through MEDLINE (1950-June 2008), Iowa Drug Information Service (1966–March 2008), EMBASE (1966-June 2008), bibliographies of pertinent articles, and unpublished data provided by the manufacturer and the Food and Drug Administration (FDA). Search terms included ambrisentan, endothelin antagonist, pulmonary hypertension, and pulmonary arterial hypertension. Due to limited literature available, additional criteria to limit searches were not used. Study Selection and Data Extraction: Abstracts and original preclinical and clinical research reports available in the English language were Identified for review. All manufacturer-provided data were also evaluated. Literature related to ambrisentan, endothelin antagonists, pulmonary hypertension, and pulmonary arterial hypertension were included. Four clinical trials evaluated the efficacy of ambrisentan in adults with symptomatic PAH. Data Synthesis: Ambrisentan is the latest endothelin-receptor antagonist (ERA) to obtain FDA approval for the treatment of PAH. It joins the first FDA-approved ERA, bosentan. Like bosentan, ambrisentan is available orally (with once-daily dosing compared with bosentans twice-daily dosing) and has been shown to improve exercise capacity and delay clinical worsening. As with bosentan, the most significant safety concerns with ambrisentan relate to potential liver injury and a contraindication in pregnancy. Although ambrisentan has higher affinity for the endothelin type A receptor than for the endothelin type B receptor, specific advantages of this selectivity, in terms of efficacy compared with bosentan, a nonselective agent, have not been demonstrated. Conclusions: Ambrisentan has been shown to be an effective ERA in patients with PAH. A significant advantage of ambrisentan is the lack of any clinically important drug interactions with warfarin and sildenafil, which are frequently used by patients being treated for PAH.

Self-reported influence of television-based direct-to-consumer advertising on patient seasonal allergy and asthma medication use: An internet survey

BACKGROUND Direct-to-consumer advertising (DDTCA) of medications, a marketing tool used by the pharmaceutical industry to increase patient awareness of products, affects both consumer behavior and, ultimately, physician prescribing practices. Billions of dollars are budgeted each year for DTCA, and its influence is far-reaching. However, little information is available about patient-initiated physician interactions in which television-bbased DTCA has played a role in consumer behavior. OBJECTIVE The objective of this study was to explore the influence of television-based DTCA on treatment changes in patient-initiated medication use. METHODS A 68-item survey instrument consisting of dichotomous, multiple-choice, and open-ended questions was constructed and sent to a convenience sample of US residents during 3 consecutive months ending in February 2005. The survey, which was accessed through an Internet link provided in the e-mail, was designed to capture data about patient perceptions and behaviors regarding television-based DTCA of prescription medications used for seasonal allergy and asthma as well as demographic information. Inferential and descriptive analyses were performed. Key tests included Crosstabs analysis and normal approximation to the binomial test with the z score. RESULTS Surveys were sent to 2500 individuals. A total of 427 valid surveys were returned for a 17.1% response rate. Of the 402 respondents (94.1%) who stated that they had seen DTCA for seasonal allergy medication, 50 (12.4%) said they had discussed the advertised medication with their physician and 22 of those discussions (44.0%) resulted in a change in treatment. Three hundred forty-two respondents (80.1%) stated that they had viewed DTCA for prescription asthma medications, and 23 of those respondents (6.7%) said that they had discussed the brand of asthma medication viewed on television with their physician. Those discussions resulted in a change in treatment for 9 respondents (39.1%). CONCLUSION Within th his limited, self-reported, survey sample, patient-initiated discussions with physicians regarding television-based DTCA of allergy and asthma medications resulted in a change of treatment in 44.0% and 39.1% of respondents, respectively.

Report of the 2017-2018 Academic Affairs Standing Committee

### Introduction and Committee Charges The Bylaws of the American Association of Colleges of Pharmacy (AACP) state that the Academic Affairs Committee shall consider: the intellectual, social, and personal aspects of pharmaceutical education. It is expected to identify practices, procedures, and

Warfarin and Supplement Interactions: Survey of Published Literature

Objective: To review published literature related to potential interactions between warfarin and common dietary supplement products. Data Sources: Tertiary databases including Micromedex, LexiComp, and Natural Medicines Comprehensive Database were used to assess drug interactions with warfarin. Searches of literature from database inception through July 2010 were conducted in MEDLINE, International Pharmaceutical Abstracts, and Iowa Drug Information Service and were restricted to the English language. The following search terms were used: warfarin, ginkgo biloba, St. Johns wort, garlic, coenzyme Q10, ginger, ginseng, red clover, fish oil, dong quai, cranberry, green tea, saw palmetto, bilberry, soy, chamomile, glucosamine, chondroitin, echinacea, interactions, anticoagulation/antiplatelet, bleeding, herbals, and pharmacokinetics/pharmacodynamics. Study Selection and Data Extraction: Thirty-two English language publications were identified and analyzed. Reference lists of each of the included articles were reviewed to obtain related articles for further analysis. Data Synthesis: Quality of existing data for interactions between warfarin and commonly available dietary supplements varies greatly. The majority of information available is derived from case reports, although for some products pharmacokinetic studies have been performed to assess the effect of supplement use in patients concurrently using warfarin. Some of the data that suggest interactions with warfarin were gleaned from case reports or from an understanding of supplement mechanisms of action that would indicate such an interaction. The strength of evidence for the majority of the herbal products studied seems to be lacking and therefore it is difficult to draw firm conclusions. Conclusions: Based on the narrow therapeutic window of warfarin therapy, practitioners should be encouraged to document any potential drug interaction. However, it seems inappropriate to suggest absolute avoidance of all dietary supplements in all patients using warfarin therapy. Instead, diligent monitoring and reporting should be implemented to detect such events.

Mosby's Complementary & Alternative Medicine: A Research-Based Approach, 2nd EditionMosby's Complementary & Alternative Medicine: A Research-Based Approach, 2nd Edition By FreemanLyn PhD. Published by Mosby, St. Louis, MO, 2004. ISBN 0-323-02626-5. Clothbound, xix + 588 pp. (28.5 × 22.5 cm),

macology of drug and substance abuse in North America. It partially fulfills this lofty aspiration. The book is divided into 2 parts. Part One consists of chapters on “psychodepressants,” “psychostimulants,” and “psychedelics,” which detail history, pharmacology, patterns of use, and theories of use for the drug classes covered. The second part is reminiscent of the Natural Medicines Comprehensive Database, with monographs of individual drugs/substances of abuse. An interesting array of information is organized appropriately, although the type of information included seems more appropriate for a college class rather than as a reference book for healthcare professionals. The introduction is intended to provide a brief overview of current drug and substance abuse. It focuses extensively on introducing and explaining the “Meta-Interactive Model of North American Use of the Drugs and Substances of Abuse,” developed by the authors, and describing its usefulness. This seemed out of place, as this model seems to be a technical, theoretical tool with no published studies supporting its use. Additionally, no mention or reference to the tool was found in either Part One or Two of the book. The information in Part One was sprinkled with many interesting anecdotes from the authors’ practices as well as quotes and stories from popular media and publications, in addition to the factual content; this created chapters of considerable length. Some sections of the chapters seemed to have no purpose. For example, the theories of use section in each drug group within the chapter in some cases merely introduced the names of theories, but did not explain what any of the theories were, while an extensive description of the theories was provided for other drug groups. In any case, this type of information seems unnecessary for a guide for the intended audience. The monographs seem to be the more useful part of the book from a practicing clinician’s perspective. Information included for most substances includes names (chemical, brand, street), pharmacologic classification, brief overview, dosage forms and route of administration, mechanism of central nervous system action, pharmacodynamics/pharmacokinetics, current approved indications, desired action/reason for personal use, toxicity (acute, chronic, pregnancy and lactation), abuse potential, withdrawal syndrome, and overdosage. Some additional information that might expand the usefulness of the monographs include drug interactions, laboratory test interactions (particularly detection by urine drug screens), and pharmacologic treatment of overdosage or dependence beyond antidotes. A companion text on treatment of addictions is planned, according to a footnote. There is extensive use of notes at the end of the preface, introduction, each chapter, and many monographs. They provide interesting additional information; however, some seem as though they would be better served within the text, and others seem excessive and detract from the professionalism of the text. Information in the text did not appear to be cuttingedge. For example, little to no discussion of the epidemic of Oxycontin abuse in the US occurs, while there is extensive discussion of heroin and morphine abuse. Overall, there is more information and focus on historical drugs of abuse, while some newer drugs identified as problems are not included or do not have up-to-date information. For example, information on GHB (gamma hydroxybutyrate) does not include its trade name, information on FDA approval for narcolepsy in 2003, and legal use restrictions, and common, newer brand names for methylphenidate (Concerta, Metadate) are not included. Some information seemed to be well referenced, while some important information was unreferenced and at times inaccurate. Previous texts of the authors were frequently referenced in Part One. The book seems expensive for the size, value, and usefulness of the information provided. In summary, this text would be useful in a school of medicine, nursing, or pharmacy for a course on substances of abuse. Streamlining the information included in Part One and making additions to the monographs in Part Two would improve the usefulness as a clinical reference.

59.95. www.elsevierhealth.com

brief discussion on the condition and end with nonpharmacologic or pharmacologic treatment options. Some limitations do exist with this handbook. Each chapter author had discretion concerning what information was published and was allowed freedom in determining what format to use. The reader may find it frustrating to read about staging of a tumor in one chapter, but not in another. Although the aim of the book was a presentation of broad cancer information, a healthcare professional not well versed in oncology would still desire to know specifics such as which chemotherapy regimen is used first or second line and how to monitor tumor improvement (eg, radiologic evaluation, tumor markers) to be able to discuss the case with the oncologist. Additional reference books or articles will be needed to answer some of these questions. Expecting a quick reference, the reader may struggle with the inconsistent formatting of each chapter. After reading the handbook, the healthcare professional should be able to derive a broad understanding of advanced cancer care. The information is presented in a concise, brief style that is easy to read and understand in a short amount of time. The handbook is reasonably priced and serves well as a quick initial reference to answer common oncology questions. Based on the title, Handbook of Advanced Cancer Care, one would generalize that the “handbook” could fit into a pocket, but this 500-page volume is better suited for a reference shelf.