Violation of US regulations regarding online marketing and sale of e-cigarettes: FDA warnings and retailer responses.

BACKGROUND: The aim of this study was to characterise all 2018 Food and Drug Administration (FDA) warning letters specific to e-cigarette products and to evaluate whether online retailers complied with FDA requested actions. METHODS: All 2018 FDA e-cigarette warning letters issued by the Center for Tobacco Products to online retailers were reviewed and characterised. Date of issuance, name, type, and location of the retailer, and violation type were recorded. Retailer websites were rechecked a minimum of 30 days after the issuance of the warning letter to assess compliance with enforcement actions. RESULTS: One hundred and thirteen of 124 letters met the inclusion criteria; one duplicate letter and 10 letters unrelated to e-cigarettes were excluded. One manufacturer was cited for associating their e-liquid with prescription drugs, and when analysed, the e-liquid was found to contain phosphodiesterase inhibitors. A majority of violations, 98.2% (111/113), pertained to the sales of an e-cigarette product to a minor and/or use of marketing that appeals to children. The majority of websites (63.7%, 72/113) resolved all violations. However, 19.5% (22/113) inactivated their website, and 16.8% (19/113) did not fully correct all violations. CONCLUSIONS: Sales of e-cigarette products to minors and the purposeful marketing of e-liquids in a manner that appeals to children and adolescents continues to be problematic. While the warning letters were successful in getting a majority of online retailers to correct the stated violation, many sold other products that would be considered a violation of marketing to minors. The appearance of e-liquids that contain prescription medications is also alarming. Comprehensive and continued enforcement of online e-cigarette retailers is urgently needed.

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.

Transforming Health Care from Volume to Value: Targeting Essential Therapies for Improved Health.

The healthcare landscape is evolving rapidly due to escalating costs from the traditional fee-for-service model. Value-based care has emerged as a viable solution, and initiatives focus on areas prone to overuse, waste, or high costs, such as advanced imaging and avoidable acute care resource utilization. Improving medication use is an important component of this work, and it requires organizational commitment, interdisciplinary collaboration, and targeted strategies for specific therapeutic areas. This review article discusses the value-based care approach to optimizing medications and blood product prescribing, spotlighting opportunities to reduce the overuse of opioid, antimicrobial, and proton pump inhibitor medications, alongside the underuse of guideline-based medical therapies in managing chronic diseases like coronary artery disease, heart failure, and chronic obstructive pulmonary disease.

Inhaled corticosteroid metered-dose inhalers: how do variations in technique for solutions versus suspensions affect drug distribution?

OBJECTIVE: To assess the literature that evaluates how variations in metered-dose inhaler (MDI) technique affect lung distribution for inhaled corticosteroids (ICSs) formulated as MDI suspensions and solutions. DATA SOURCES: PubMed (up to November 2012) and Cochrane Library (up to November 2012) were searched using the terms metered-dose inhalers, HFA 134a, Asthma/*drug therapy, and inhaled corticosteroids. In addition, reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles in English from the data sources that assessed MDI technique comparing total lung distribution (TLD) of MDI solutions or suspensions formulated with ICSs were included in the review. Five relevant studies were identified. DATA SYNTHESIS: Five controlled studies compared how variations in MDI technique affect TLD for ICS MDI solutions with suspensions. MDI solutions resulted in greater TLD compared with larger particle MDI suspensions. Delayed or early inspiration upon device actuation of MDI solutions resulted in less TLD than coordinated actuation, but with a 3- to 4-times greater TLD than MDI suspensions inhaled using a standard technique. A sixth study evaluated inspiratory flow rates (IFR) for small, medium, and large particles. Rapid and slow IFRs resulted in similar TLD for small particles, while far fewer particles reached the airways with medium and large particles at rapid, rather than slow, IFRs. CONCLUSIONS: Based on the literature evaluated, standard MDI technique should be used for ICS suspensions. ICS MDI solutions can provide a higher average TLD than larger-particle ICS suspensions using standard technique, discoordinated inspiration and medication actuation timing, or rapid and slow IFRs. ICS MDI solutions allow for a more forgiving technique, which makes them uniquely suitable options for patients with asthma who have difficultly with MDI technique.

Characteristics and trends of drug and dietary supplement inquiries by college athletes.

OBJECTIVE: To characterize the types of drug and dietary supplement inquiries submitted to the National Center for Drug Free Sport through the Resource Exchange Center (REC). DESIGN: Cross-sectional study. SETTING: United States, from July 2009 through June 2010. PARTICIPANTS: Athletes and athletic personnel associated with the National Collegiate Athletic Association (NCAA). INTERVENTION: Tabulation and classification of drugs and dietary supplement inquiries. MAIN OUTCOME MEASURE: Characteristics and trends of drug and dietary supplement inquiries. RESULTS: Inquiries for prescription medications for albuterol inhalers, methylphenidate, amphetamines, and prednisone were the most common using a drug lookup function. The most common inquiries for over-the-counter medications included pseudoephedrine, loratadine, cetirizine, and caffeine. Among dietary supplements, inquiries for amino acids/metabolites, vitamins and minerals, and herbal products occurred most frequently. One dietary supplement, N.O.-Xplode (Bio-Engineered Supplements and Nutrition, Inc.), accounted for the majority of individual dietary supplement inquiries. Banned substances accounted for 30% of all inquiries submitted to the REC and 18% of medications searched in a drug lookup database. CONCLUSION: Almost 25,000 inquiries were submitted to the REC. Pharmacists can use this information to advise, counsel, and refer NCAA athletes regarding the use of banned and permitted substances. Education programs regarding stimulants, dietary supplements, and the risk of using substances such as animal byproducts are needed, and pharmacists can participate in these programs.

Impact of a pharmacist-driven protocol to improve drug allergy documentation at a university hospital.

BACKGROUND: An internal evaluation of the inpatient pharmacy order entry database (WORx) at a university hospital revealed that the nature of the reaction was documented for only 47% of patients with reported drug allergies/intolerance. Insufficient documentation of drug allergy/intolerance may result in administration of drugs that should not be prescribed. Similarly, valuable agents that should be used may not be prescribed due to an unnecessary fear of adverse drug reaction. More complete description of drug allergy/intolerance may result in more correct prescribing of medications. OBJECTIVE: Evaluate the impact of a pharmacist-driven protocol on the quality of drug allergy/intolerance documentation. METHODS: Four pre-intervention evaluations were conducted every 2 weeks documenting the completeness of drug allergy/intolerance information in the pharmacy order entry database. One week following the implementation of a pharmacist-driven protocol intended to improve the completeness of drug allergy/intolerance information, a series of 4 postintervention evaluations was repeated. Proportional analysis of pre- and postinterventional data was performed to evaluate the effectiveness of the intervention. RESULTS: A total of 1,686 allergies from 2,174 patients were reviewed pre and post intervention. The frequency of complete drug allergy/intolerance documentation pre intervention was 52% to 62%. Following implementation of the hospitalwide, pharmacist-driven protocol, this rate increased to 60% to 76%. Pediatric services demonstrated the most substantial improvement, increasing from 53% to 79% to 67% to 93%. Blank reaction fields decreased by 10% in both age groups. CONCLUSION: A pharmacy-driven initiative intended to improve the completeness of drug allergy/intolerance documentation was associated with modest success. Other mechanisms, including electronic health record systems with computerized physician order entry and decision support, are needed to improve the completeness of drug allergy/intolerance information.

Online Marketing of Ephedra Weight Loss Supplements: Labeling and Marketing Compliance with the U.S. Food and Drug Administration Ban on Ephedra.

Objective: To characterize dietary supplements marketed online as "ephedra-containing or ephedra-like products" for weight management and to assess labeling/marketing compliance with the ban on the sale of ephedrine alkaloids. Materials and Methods: This cross-sectional study assessed websites selling ephedra-like supplements using the search term "buy ephedra." For each website, the first three featured products were characterized by evaluating the label for (1) Ephedra sp. or its alkaloid content, (2) serving size, (3) other ingredients, (4) directions, (5) side effects, (6) reported interactions, (7) recommendation to consult a health care provider, (8) recommendation to use with diet and exercise, and (9) Food and Drug Administration (FDA) disclaimer. Results: Thirty-six (71%) of the first 51 websites evaluated sold at least one weight loss product. A total of 105 products were assessed, 93 had labeling with 10 (11%) in possible violation of the ephedra ban. Five were labeled as containing ephedrine or ephedrine hydrochloride, two reported containing ephedrine alkaloids, and two reported containing unidentified Ephedra sp. not formulated as an extract; one reported containing Ma Huang. Sixty-seven (72%) products listed caffeine with a daily serving size averaging 400 mg. Other ingredients with stimulant properties include green tea, yohimbe, and phenylethylamine. Conclusions: Nearly 20% of websites sold weight loss products that potentially violated the 2004 ban of ephedra alkaloids. Ephedrine, unidentified Ephedra sp. not formulated as an extract, and Ma Huang were labeled as present in 11% of products evaluated. Incomplete reporting of adverse effects and drug interactions was common.

Liposomal Bupivacaine Decreases Postoperative Length of Stay and Opioid Use in Patients Undergoing Radical Cystectomy.

OBJECTIVE: To analyze differences in length of stay, opioid use, and other perioperative outcomes in patients undergoing radical cystectomy with urinary diversion who received either liposomal bupivacaine (LB) or epidural analgesia. METHODS: This was a single center, retrospective cohort study of patients undergoing open radical cystectomy with urinary diversion from 2015-2019 in the early recovery after surgery (ERAS) pathway. Patients received either LB or epidural catheter analgesia for post-operative pain control. LB was injected at the time of fascial closure to provide up to 72 hours of local analgesia. The primary outcome was post-operative length of stay. Secondary outcomes were post-operative opioid use, time to solid food, time to ambulation, and direct hospitalization costs. Multivariable Cox proportional hazards regression was used to determine associations between analgesia type and discharge. RESULTS: LB use was independently associated with shorter post-operative length of stay compared to epidural use (median (IQR) 4.9 days (3.9-5.8) vs 5.9 days (4.9-7.9), P<.001), less total opioid use (mean 188.3 vs 612.2 OME, P <.001), earlier diet advancement (mean 1.6 vs 2.4 days, P <.001), and decreased overall direct costs ($23,188 vs $29,628, P <.001). 45% of patients who received LB were opioid-free after surgery, none in the epidural group. On multivariable Cox proportional hazards regression modeling, LB use was independently associated with earlier discharge (HR 2.1, IQR 1.0-4.5). CONCLUSION: Use of LB in open radical cystectomy is associated with reduced LOS, less opioid exposure, and earlier diet advancement.

Integrative Health: An Interprofessional Standardized Patient Case for Prelicensure Learners.

Introduction: Integrative health care and complementary medicine are widely used by the U.S. population, yet health professions learners are typically inadequately educated to counsel patients on the use of these approaches. This interprofessional standardized patient exercise (ISPE) provides learners the opportunity to discuss various health care professionals' roles in caring for a patient interested in integrative health strategies, and to collaborate on a care plan. Utilizing this ISPE format aligns with the principles of integrative health as it requires interprofessional collaboration to address the multifaceted needs of patients. Methods: The ISPE is approximately three hours in duration, and required of all UCSF, third-year dentistry, physical therapy, and medical students; second-year nurse practitioner students, and fourth-year pharmacy students. Social work, nutrition, and chaplain trainees also participated. Working in interprofessional teams of 4-5 learners, team members discuss case information, interview the standardized patient (SP) individually, jointly formulate a care plan, and, discuss the plan with the SP. The experience is debriefed with a facilitator. Results: In 2016-17, 520 learners participated in the ISPE. They agreed that they learned about the roles of other health care professionals (M = 5.24 on a six-point scale, SD = 1.27), and that they would recommend the ISPE to fellow students in their profession (M = 5.25, SD = 1.30). Discussion: Students appreciated the ability to observe learners from other health professions interacting with the SP, and how different perspectives and expertise were integrated to create a comprehensive care plan. The exercise can be adapted to accommodate local health professions learners.

Chinese Herb Use by Patients at a San Francisco Chinatown Public Health Center.

OBJECTIVES: Chinese herbal medicine (CHM) use has not been well characterized in persons living in the United States who receive care by Western-trained healthcare providers. The primary objective of this study was to characterize use of CHM taken in the last 12 months by patients seen at a Chinatown public health center. DESIGN: Convenience sample survey. SETTING: Data collection occurred over 3 months at a San Francisco Chinatown public health center. PARTICIPANTS: Adult patients visiting their primary care provider. INTERVENTIONS: Completion of a voluntary 24-question survey on CHM use. OUTCOME MEASURES: Prevalence, type, and indications for use. RESULTS: Survey response rate was 29% (50/170). Seventy percent (35/50) of respondents had used CHM in the last 12 months and 94% (33/35) were also taking prescription medicines. The three most commonly used CHM were goji berry (37%), Dioscorea (31%), and ginseng (23%). The most common indications for herbs used in the last 12 months were general wellness (34%), cold/flu (25%), and headache (6%). Sixty-four percent of respondents had used Western medicine in combination with CHM within the last 12 months. Sixty-nine percent of respondents who used CHM did not tell their Western provider about this use. No patient had CHM use documented in the electronic medical record. CONCLUSIONS: Patients seen at a Chinatown public health center frequently used CHM products in conjunction with Western prescription medicines. Providers should routinely enquire about CHM use for health as a soup, tea, food, or pill and document this use in the medical record.

Dietary supplement-related adverse events reported to the California Poison Control System.

PURPOSE: Dietary supplement (DS)-related adverse events (AEs) reported to the California Poison Control System (CPCS) were studied. METHODS: The CPCS database was used to search for all telephone calls from consumers concerning DS-related AEs received during the six-month period between April and September 2002. The calls were characterized according to the substance involved, the caller's age (adult or pediatric), and the type of ingestion (accidental or intentional). Each exposure in which symptoms were reported was categorized as involving an AE. Each AE was assessed for severity and causality. RESULTS: Data on a total of 1183 telephone calls were retrieved, of which 828 calls (70%) met the study's inclusion criteria. DS exposure occurred in 389 adults (47%) and 438 children (53%). DS ingestion was accidental in 360 patients (43%) and intentional in 467 patients (56%). Exposure resulted in an AE in 480 patients (58%). AEs were reported in 353 patients (74%) who ingested products containing ephedra; other exposures frequently involved zinc, kava, creatine, and valerian. AEs were classified as moderate in 198 patients (41%) who ingested a DS and as severe in 40 patients (8%). One patient had a fatal reaction. Among the 480 AEs in DS-exposed consumers, the DS was classified as the definite cause of 1 AE (<1%) and a probable cause of 237 (49.4%). The most frequently reported AE symptoms were increased heart rate (45%), agitation (30%), vomiting (30%), and nausea (15%). CONCLUSION: A majority of DS-related AEs reported by consumers to CPCS involved ephedra-containing products.

Perceptions and Cost-Analysis of a Multiple Mini-Interview in a Pharmacy School Admissions Process.

OBJECTIVE: To improve the quality of admissions interviews for a doctor of pharmacy program, using a multiple mini-interview (MMI) in place of the standard interview. METHODS: Stakeholders completed an anonymous web-based survey. This study characterized perceptions of the MMI format across 3 major stakeholders (candidates, interviewers, admissions committee members) and included comparative cost estimates.Costs were estimated using human and facility resources from the 2012 cycle (standard format) and the 2013 cycle (MMI format). RESULTS: Most candidates (65%), interviewers (86%), and admissions committee members (79%) perceived the MMI format as effective for evaluating applicants, and most (59% of candidates, 84% of interviewers, 77% of committee members) agreed that the MMI format should be continued. Cost per candidate interviewed was $136.34 (standard interview) vs $75.30 (MMI). CONCLUSION: Perceptions of the MMI process were favorable across stakeholder groups, and this format was less costly per candidate interviewed.

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

OBJECTIVE: This study examined the usage patterns of dietary supplements during menopause, providing information about type, prevalence, and rationale for use. METHODS: A survey instrument was distributed to self-identified peri- or postmenopausal women at a San Francisco women's health conference in March 2000. RESULTS: Of 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. CONCLUSIONS: Dietary 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.

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

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 Children's 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 institution's 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 patient's 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.

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.

The use of herbs by california midwives.

OBJECTIVE: To characterize herbal product use (prevalence, types, indications) among Certified Nurse Midwives/Certified Midwives (CNMs/CMs) and Licensed Midwives (LMs) practicing in the state of California and to describe formal education related to herbal products received by midwives during midwifery education. DESIGN/SETTING/PARTICIPANTS: Cross-sectional survey/California/Practicing midwives. METHODS: A list of LMs and CNMs/CMs practicing in California was obtained through the California Medical Board (CMB) and the American College of Nurse Midwives (ACNM), respectively. The survey was mailed to 343 CNMs/CMs (one third of the ACNM mailing list) and 157 LMs (the complete CMB mailing list). RESULTS: Of the 500 surveys mailed, 40 were undeliverable, 146 were returned, and 7 were excluded (30% response rate). Of the 139 completed surveys, 58/102 (57%) of CNMs/CMs and 35/37 (95%) of LMs used herbs, and LMs were more comfortable than CNMs/CMs in recommending herbs to their patients. A majority of LMs had >20 hours of midwifery education on herbs whereas a majority of CNMs/CMs received 0 to 5 hours. Some CNMs/CMs indicated that their practice site limited their ability to use herbs. Common conditions in which LMs and CNMs/CMs used herbs were nausea/vomiting (86% vs. 83%), labor induction (89% vs. 58%), and lactation (86% vs. 65%). Specific herbs for all indications are described. CONCLUSION: Licensed midwives were more likely than CNMs/CMs to use herbs in clinical practice. This trend was likely a reflection of the amount of education devoted to herbs as well as herbal use limitations that may be encountered in institutional facilities.

Characteristics of drug and dietary supplement inquiries by college athletes.

BACKGROUND: In the United States, the National Center for Drug Free Sport manages the drug-testing programs for athletes of the National Collegiate Athletic Association (NCAA). Through its Resource Exchange Center (REC), Drug Free Sport supports athletic staff and athletes with information regarding drugs and dietary supplements. PURPOSE: To characterize the types of drug-related and dietary supplement-related inquiries submitted to Drug Free Sport through the REC. STUDY DESIGN: Cross-sectional study. METHODS: All inquiries submitted to the REC for the period of September 1, 2005, through June 30, 2006, were reviewed. The data were categorized by the method of inquiry submission; the name of the substance in question; the sex, sport, and NCAA division of the athlete involved; the nature of the inquiry; and the response provided by the REC regarding the NCAA's status of the substance in question. RESULTS: Pseudoephedrine, acetaminophen/hydrocodone, and albuterol were the most commonly self-searched medications; stimulants accounted for the majority of banned medications. Dietary supplements accounted for 80% of all inquiries submitted to the REC via the Banned Drug Inquiry Form. Among all dietary supplements, creatine was the most commonly inquired. Banned substances accounted for 29% of all inquiries. CONCLUSIONS: There were more than 10 000 inquiries regarding the status of medications, dietary supplements, and other substances for NCAA athletes during the 2005-2006 academic year. It is helpful for athletes to have resources that help them navigate banned-substance lists and so avoid the inadvertent use of banned substances. CLINICAL RELEVANCE: Educating athletes regarding the stimulant content of various dietary supplements and addressing the lack of clinical trials to support stated claims and safety appear critical.

Improving the reporting of adverse drug reactions in the hospital setting.

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.

In vivo effect of I'm-Yunity on hepatic cytochrome P450 3A4.

The inhibition or induction of hepatic cytochrome P450 3A4 (CYP3A4) enzyme associated with herbal medicines such as I'm-Yunity (Coriolus versicolor) can result in clinically significant herb-drug interactions. The active ingredient of I'm-Yunity is believed to be polysaccharopeptide polymer (PSP). Drug interactions between I'm-Yunity and other medications or supplements are yet to be investigated. The objective of this single-treatment, one-period, three-phase, open-labeled study was to evaluate the ability of I'm-Yunity to inhibit or induce CYP3A4 in 12 healthy adult volunteers (8 women and 4 men) aged between 23 and 54 years through the use of a CYP3A4-specific assay, the erythromycin breath test (EBT). EBT measurements are reported as percentage of 14C-Erythromycin metabolized/hr. Participants were given a 14-day supply of I'm-Yunity and instructed to take 1200 mg, three times daily with meals. Comparisons of all subjects' mean CYP3A4 activities were performed with the EBT before and after taking I'm- Yunity. Results revealed a mean EBT change (SD) from baseline of 0.08% (0.56%) 14C-Erythromycin metabolized/hr, which was not significant (p = 0.63). Therefore, 14 days of exposure to I'm-Yunity was not associated with clinically significant CYP3A4 inhibition or induction, suggesting that short-term administration of I'm-Yunity with medications primarily metabolized by CYP3A4 is safe and not expected to be associated with significant herb-drug interactions. However, it is still unknown whether interactions exist between I'm-Yunity and other medications metabolized by other CYP450 isozymes or enzyme/transporter systems.