Candy Tsourounis

Dietary supplement use among menopausal women attending a San Francisco health conference.

ObjectiveThis study examined the usage patterns of dietary supplements during menopause, providing information about type, prevalence, and rationale for use. MethodsA survey instrument was distributed to self-identified peri- or postmenopausal women at a San Francisco womens health conference in March 2000. ResultsOf the 100 eligible women, 29% used hormone replacement therapy (HRT) alone, 16% used HRT with dietary supplements (Combo group), 32% used dietary supplements alone, and 13% used no product or used supplements excluded in this survey. The most common dietary supplements were soy (29%), ginkgo biloba (16%), and black cohosh (10%). Only 54% of women using dietary supplements reported such usage to their primary care providers. Women using HRT alone reported relief of hot flashes significantly more often than those using dietary supplements alone (63% vs. 30%;p = 0.016). Women using combination therapy reported enhanced improvement in vaginal dryness, libido, and mood compared with those using HRT alone. Perceived quality of life and overall control of menopausal symptoms were highest among women using dietary supplements alone and women using combination therapy, respectively. Satisfaction with menopausal counseling from a primary care provider was significantly greater in women receiving HRT alone (p = 0.02) and combination therapy (p = 0.006) compared with women receiving dietary supplements alone. ConclusionsDietary supplements were frequently used during menopause. Combined use of dietary supplements and HRT seemed to be associated with enhanced relief of certain menopausal symptoms. Women using dietary supplements alone seemed particularly dissatisfied with the menopausal counseling provided by a primary care provider.

Effects of Uptake and Efflux Transporter Inhibition on Erythromycin Breath Test Results

The erythromycin breath test (EBT) is a standard test used to evaluate the extent of CYP3A4 activity. This study examines whether presumed changes in CYP3A4 activity are in fact related to inhibition of an uptake organic anion transporter using rifampin and inhibition of the efflux hepatic P‐glycoprotein transporter using lansoprazole. Three EBT tests in healthy adults were conducted: EBT alone, with lansoprazole, and with rifampin. For all subjects, lansoprazole treatment increased respiratory 14C excretion by +0.25±0.51 met/h (P=0.07) and rifampin decreased 14C excretion by −0.44±0.40 met/h (P<0.001) compared with baseline. Comparing lansoprazole to rifampin, 14C excretion increased by +0.69±0.50 met/h (P<0.001). Only women had significant changes after drug infusion: 14C excretion after rifampin −0.40±0.36 met/h (P=0.018) and +0.47±0.44 met/h (P=0.018) after lansoprazole. Relying on EBT without considering transporter interactions can lead to errors in interpreting the degree of CYP3A4 metabolism.

Safety review of kava (Piper methysticum) by the Natural Standard Research Collaboration.

This systematic review discusses the proposed uses, dosing parameters, adverse effects, toxicology, interactions and mechanism of action of kava. The widespread concern regarding the potential hepatotoxicity of kava is discussed. A recommendation is made to consolidate and analyse available reports and to continue postmarket surveillance in an international repository to prevent duplicates and promote collection of thorough details at the time of each report so that any association with kava is clearly defined.

Implanon: A Critical Review

OBJECTIVE: To evaluate clinical information on Implanon as a long-term method of contraception and, specifically, to review the efficacy and adverse effect profile of Implanon. DATA SOURCES: A MEDLINE search (from 1966 through June 1999) was performed to retrieve primary and review articles. The search was limited to data on human subjects. Some references were identified through secondary sources. STUDY SELECTION AND DATA EXTRACTION: Pharmacokinetic and pharmacodynamic studies, and clinical trials assessing the efficacy and safety of desogestrel implants were reviewed. Relevancy and consistency of information was assessed for each trial. DATA SYNTHESIS: Implanon is the newest contraceptive implant system that has completed worldwide Phase III clinical trials. It is a single rod that contains a core of 68 mg of 3-keto-desogestrel with a membrane of ethylene vinyl acetate. Inhibition of ovulation occurs within one day of implantation, and effective contraception lasts for three years. Fertility returns within one month after implant removal. Insertion and removal by trained medical professionals is simple, and only minor complications have been documented. Adverse effects are mild and primarily consist of abnormal bleeding, weight gain, acne, breast pain, and headache. CONCLUSIONS: The data on Implanon indicate that it provides effective long-term contraception with limited adverse effects. It appears to be a good addition to the currently available contraceptives.

A review of select vitamins and minerals used by postmenopausal women.

OBJECTIVES The purpose of this review is to summarize the effectiveness of select vitamins, minerals and trace elements in postmenopausal women for their effects on bone health, cardiovascular health, breast cancer, cognition and vasomotor symptoms. METHODS Review of the relevant literature and results from recent clinical studies, as well as critical analyses of published systematic reviews and meta-analyses were obtained from PubMed and Cochrane Library of Reviews. Vitamin A, the B vitamins, vitamin C, calcium, vitamin D, vitamin E, vitamin K, magnesium, selenium and zinc were selected for review. In circumstances where the vitamin, mineral or trace element has not been studied for a given condition, no information was provided. RESULTS AND DISCUSSION All vitamins, minerals and trace elements play an important role in maintaining health and wellbeing among menopausal women. Adequate dietary intake is essential and supplementation should be considered in women with documented malabsorption syndromes or deficiencies. Based on a review of the literature, supplementation with vitamin C, D, K and calcium can also be recommended for proper maintenance of bone health. The only supplement studied for vasomotor symptoms was vitamin E and this vitamin lacked clinical support. Supplementation in healthy postmenopausal women with vitamins and minerals in diet or pill forms cannot be recommended currently for any other indications.

Effects of Creatine Supplementation on Renal Function

Creatine is a popular supplement used by athletes in an effort to increase muscle performance. The purpose of this review was to assess the literature evaluating the effects of creatine supplementation on renal function. A PubMed search was conducted to identify relevant articles using the keywords, creatine, supplementation, supplements, renal dysfunction, ergogenic aid and renal function. Twelve pertinent articles and case reports were identified. According to the existing literature, creatine supplementation appears safe when used by healthy adults at the recommended loading (20 gm/day for five days) and maintenance doses (3 gm/day). In people with a history of renal disease or those taking nephrotoxic medications, creatine may be associated with an increased risk of renal dysfunction. One case report of acute renal failure was reported in a 20-year-old man taking 20 gm/day of creatine for a period of four weeks. There are few trials investigating the long-term use of creatine supplementation in doses exceeding 10 gm/day. Furthermore, the safety of creatine in children and adolescents has not been established. Since creatine supplementation may increase creatinine levels, it may act as a false indicator of renal dysfunction. Future studies should include renal function markers other than serum creatinine and creatinine clearance.

Improving the Reporting of Adverse Drug Reactions in the Hospital Setting

Abstract The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.

Clinical effects of phytoestrogens.

Phytoestrogens, or plant-based sources of estrogen, have received a great deal of attention as a way to treat and manage the symptoms of menopause. Research involving the phytoestrogens has increased consumer interest and subsequent demand for phytoestrogen-rich supplements and foods. This review focuses on the clinical evidence available on the phytoestrogens and their role in the management of menopausal symptoms and associated disease. Many types of phytoestrogens have been described, including coumestans, lignans, and isoflavones. The isoflavones are the best-researched phytoestrogens and are found in soy products, namely soybeans, tofu, and other soy derivatives. The two most prevalent isoflavones in soy foods are genistin and daidzein. Biochanin A and formononetin, precursors for genistin and daidzein, respectively, are found in a variety of legumes and plant sources (chickpeas, broad beans, green split peas). The soybean is the richest source of isoflavones. Soybeans are processed into a variety of products, including soymilk, soy flour, and isolated soy protein. Clinical research involving the phytoestrogens uses isoflavone-rich soy protein as a supplement to the diet, and in some cases, the soy protein is fortified with additional isoflavones. Table 1 provides a summary of the isoflavone and soy protein content from a variety of foods and commercially available products. Genistin and daidzein are biologically inactive; once ingested, gastrointestinal enzymes form the “aglycones,” genistein and daidzein. Further metabolism of genistein and daidzein leads to the end products equol, o-desmethyl-angolensin, and paraethylphenol. Equol, the end product that most resembles estrogen, may be responsible for many of the reported clinical benefits. Genistein and daidzein readily bind to estradiol receptors, estrogen receptor and estrogen receptor . The benefits of the phytoestrogens may be related to their preferential binding and activity at these two types of receptors. The phytoestrogens also seem to possess agonist and antagonist properties resembling selective estrogen-receptor modulators. These unique properties may be responsible for some of the clinical benefits observed with the phytoestrogens. Correspondence: Candy Tsourounis, PharmD, Assistant Clinical Professor, Acting Director, Drug Information Analysis Service, UCSF School of Pharmacy, 521 Parnassus, C-152, San Francisco, CA 94143-0622. E-mail: candy@itsa.ucsf.edu. CLINICAL OBSTETRICS AND GYNECOLOGY Volume 44, Number 4, pp 836–842

An Interprofessional Approach to Reducing the Overutilization of Stress Ulcer Prophylaxis in Adult Medical and Surgical Intensive Care Units

Background: Overutilization of stress ulcer prophylaxis (SUP) in the intensive care unit (ICU) is common. Acid-suppressive therapies routinely used for SUP are best reserved for patients with greatest risk of clinically important bleeding as they have been associated with nosocomial pneumonia, Clostridium difficile infection and increased hospital cost. Objective: The primary objective was to reduce inappropriate utilization of SUP in 2 adult medical and surgical ICU settings at the University of California, San Francisco Medical Center. Secondary objectives included reduction of inappropriate continuation of SUP at ICU and hospital discharge. Methods: To attain the study objective, an interprofessional team developed a bundled quality improvement initiative, including an institution SUP guideline, pharmacist-led intervention, and an education and awareness campaign. To assess the impact of these interventions, we conducted a retrospective cohort study comparing data on prescribing practices at baseline before and after the intervention. Since computerized prescriber order entry (CPOE) was implemented during this time frame, preintervention data collection consisted of 2 periods, one before and one after CPOE implementation. Results: The incidence of the inappropriate use of SUP was not significantly different between the pre-CPOE and post-CPOE groups (20 and 19 per 100 patient-days, respectively; P = .88), but the incidence of inappropriate use of SUP was significantly lower in the postintervention group versus the post-CPOE group (9 and 19 per 100 patient-days, respectively; P = .03). At ICU discharge, 4% of patients in the post-intervention group were discharged inappropriately on SUP compared with 8% in the post-CPOE group (P = .54). At hospital discharge, none of the patients in the postintervention group were discharged inappropriately on SUP compared with 7% in the post-CPOE group (P = .22). Conclusions: Implementation of an interprofessional bundled quality improvement initiative is effective in decreasing inappropriate use of SUP in adult medical and surgical ICUs at a university-affiliated, tertiary care academic medical center.

Pediatric medication administration errors and workflow following implementation of a bar code medication administration system.

&NA; Direct observation was used to detect medication errors and Bar Code Medication Administration (BCMA) workarounds on two pediatric units and one neonatal unit at UCSF Benioff Childrens Hospital. The study (1) measured the frequency of nursing medication administration‐related errors, (2) characterized the types of medication errors, (3) assessed compliance with the institutions six medication administration safety processes, and (4) identified observed workarounds following BCMA implementation. The results of the direct observation were compared to medication administration‐related incident reports (IRs) for the same period. The frequency of medication errors was 5% for the three units. Compliance with the process measures was achieved 86% of the time (range 23–100%). Seven medication administration‐related IRs were submitted during the same observation period. Three BCMA workarounds were identified; (1) failure to visually confirm patients identification, (2) failure to compare the medication to the electronic medication administration record at least twice before administration, and (3) charting administration of medication before actual administration. The direct observation methodology identified a low frequency of medication administration errors (MAEs) consistent with post‐BCMA implementation. The incident reporting system identified different MAEs than direct observation suggesting that both methods should be used to better characterize the scope of MAEs.