Erin M. Timpe

Comparing therapies for postmenopausal osteoporosis prevention and treatment

OBJECTIVE: To review the literature concerning the efficacy of calcium, hormone replacement therapy (HRT), bisphosphonates, selective estrogen receptor modulators, and calcitonin in the prevention and treatment of postmenopausal osteoporosis. DATA SOURCES: Articles were identified through searches of the MEDLINE (1966–July 2002), EMBASE (1980–July 2002), and International Pharmaceutical Abstracts (1970–July 2002) databases using the key words osteoporosis, postmenopausal, fracture, calcium, vitamin D, hormone replacement therapy, bisphosphonates, alendronate, risedronate, raloxifene, and calcitonin. Additional references were located through review of the bibliographies of the articles cited. Searches were not limited by time restriction, language, or human subject. STUDY SELECTION AND DATA EXTRACTION: Experimental and observational studies of the use of calcium and antiresorptive therapies for the prevention and treatment of postmenopausal osteoporosis were selected. Articles evaluating bone mineral density (BMD) or fracture efficacy were included in this review. DATA SYNTHESIS: HRT, bisphosphonates, raloxifene, and calcitonin have demonstrated stabilization of and improvement in BMD. Randomized clinical trials have shown fracture risk reduction with bisphosphonates, raloxifene, HRT, calcium, and calcitonin. The largest risk reductions have been reported with use of bisphosphonates in several trials. CONCLUSIONS: Several therapeutic options with well-documented improvements in BMD and reductions in fracture risk are available to women for the prevention and treatment of postmenopausal osteoporosis.

Bromocriptine Mesylate for Glycemic Management in Type 2 Diabetes Mellitus

Objective: To review the pharmacologic characteristics, safety, and efficacy of bromocriptine mesylate for glycemic control in patients with type 2 diabetes mellitus. Data Sources: A Scopus and MEDLINE search (1950–June 2010) was conducted using the key words bromocriptine, diabetes, and circadian rhythm. Data were also received from the manufacturer. Study Selection and Data Extraction: Available abstracts, studies, and review articles published in English with human data discussing bromocriptine treatment for type 2 diabetes mellitus were reviewed. Data Synthesis: Bromocriptine is an ergot derivative available for treatment of type 2 diabetes. The mechanism of action of this agent is unclear; however, activity as a dopamine D2 receptor agonist seems to provide the primary mechanism for utility in resetting the circadian rhythm in patients with type 2 diabetes. Other mechanisms, including α-1 antagonist, α-2 agonist, and serotonin and prolactin modulator, may also help to explain bromocriptines glucose-lowering effects. Studies with bromocriptine have included 4328 patients with type 2 diabetes. The majority of available trials conducted enrolled patients for a study duration of 6–24 weeks. One trial evaluating the safety and efficacy of bromocriptine concluded after 52 weeks of follow-up. Endpoints of hemoglobin A1c (A1C) reduction and plasma glucose concentrations were the primary focus of all studies, with statistically significant differences found. Bromocriptine use resulted in a mean A1C reduction of 0.27% (range 0.1–0.6), while placebo resulted in a mean A1C increase of 0.48% (range 0.3–1.1), Incidence of adverse effects of nausea, vomiting, headache, and rhinitis was greater than that of placebo in clinical trials. Cardiovascular endpoints did not differ from those of placebo. Conclusions: Bromocriptine has demonstrated efficacy as an adjunctive agent in the management of type 2 diabetes. Caution may be warranted in the elderly population or patients at risk for suspected drug-drug interactions. Further studies of longer duration may help to define the role of bromocriptine in the management of diabetes.

Urinary-Based Ovulation and Pregnancy: Point-of-Care Testing

OBJECTIVE To review the literature concerning ovulation prediction devices and pregnancy detection tests for home use. DATA SOURCES Articles were identified through searches of the MEDLINE (1966–May 2003), EMBASE (1980–May 2003), and International Pharmaceutical Abstracts (1970–May 2003) databases using the key words ovulation, ovulation detection, pregnancy test, diagnostic reagent kit, and diagnostic test. Additional references were located through review of the bibliographies of the articles found in the literature search. Searches were not limited by time restriction, language, or use of human or animal subjects. STUDY SELECTION AND DATA EXTRACTION Review articles, textbook chapters, and experimental and observational studies on home use ovulation and pregnancy tests were selected. DATA SYNTHESIS Luteinizing hormone (LH)-based ovulation tests have demonstrated accurate and superior ovulation detection when compared to basal body temperature charting, calendar calculation, salivary ferning, or observation of vaginal or cervical discharge changes. Systems using LH and estrone-3-glucuronide (E3G) have also demonstrated accurate detection of the fertile period. Literature evaluating home use of pregnancy tests has demonstrated accurate use by lay persons. CONCLUSIONS Urinary-based ovulation prediction and pregnancy detection tests available for use by nonprofessionals enable women and couples to take an active role in the family planning process. Numerous products are available at reasonable costs to the consumer.

Drug Information: From Education to Practice

Drug information is a specialty area within the realm of clinical pharmacy that has evolved as technology and clinical practice have changed. Drug information specialists are trained individuals who have clinical knowledge and skills that allow them to provide clear, concise, and accurate recommendations regarding drug use. The constant changing culture of drug information and health care in general has prompted the need for continual growth and refinement of the standards that govern drug information practice. This article outlines specific standards to help ensure that the education and practice of drug information will continue to meet the needs of the health care community. This opinion paper is divided into two sections: Education and Training, and Practice Areas. The Education and Training section is organized to describe the role of drug information and that of the drug information specialist in the training of all pharmacy students and advanced trainees, as well as to describe the role of focused training for those individuals wishing to specialize in drug information. This article also affirms the recommendations for the standards‐based approach to drug information education and specialty training. The Practice Areas section is organized to describe the role of the drug information specialist within various practice settings, to identify some of the challenges faced by the drug information specialist within those settings, and to provide recommendations for the different practice areas. The areas found within this section include academia, institutional health systems, managed care, industry, medical writing, and informatics.

Evaluation of Accuracy of Health Studies Reported in Mass Media

OBJECTIVE To evaluate communication of clinical research in the written media for completeness and accuracy. DESIGN Observational assessment. SETTING United States. PARTICIPANTS Not applicable. INTERVENTIONS Content of media articles discussing randomized controlled trials was assessed by three reviewers on the basis of the Consolidated Standards of Reporting Trials (CONSORT) criteria modified for the mass media. Reports from October 1 through December 31, 2002, published in the top two U.S. daily newspapers (USA Today and Wall Street Journal), weekly news magazines (Time and Newsweek), and daily news Web sources (CNN.com and MSNBC.com) and the corresponding published RCTs were analyzed. MAIN OUTCOME MEASURES Total score and score in 10 specific content areas, leading to classification of coverage as poor, fair, or excellent. RESULTS A total of 60 media reports discussing results of 25 RCTs appeared in these media during the study period. All reports were categorized as fair, and no content area was rated excellent. Several content areas received poor rankings in all and/or most media, including reporting of adverse effects, outcomes data, and statistical tests used. Media reports written by newswire services were rated more highly than were those prepared by nonnewswire services, but only 1 of 10 criteria had statistically significant differences. CONCLUSION Mass media reports of RCTs are often incomplete. This type of reporting may misinform the lay public and may lead to questions about the applicability of the results to individual patients.

Propofol-Related Infusion Syndrome in Critically Ill Pediatric Patients: Coincidence, Association, or Causation?

Over the past two decades numerous reports have described the development of a propofol-related infusion syndrome (PRIS) in critically ill adult and pediatric patients who received continuous infusion propofol for anesthesia or sedation. The syndrome is generally characterized by progressive metabolic acidosis, hemodynamic instability and bradyarrhythmias that are refractory to aggressive pharmacological treatments. PRIS may occur with or without the presence of hepatomegaly, rhabdomyolysis or lipemia. To date, the medical literature contains accounts of 20 deaths in critically ill pediatric patients who developed features consistent with PRIS. These reports have generated considerable discussion and debate regarding the relationship, if any, between propofol and a constellation of clinical symptoms and features that have been attributed to its use in critically ill pediatric patients. This paper reviews the literature concerning PRIS, its clinical presentation, proposed mechanisms for the syndrome, and potential management should the syndrome occur.

Nephrotoxicity with combination vancomycin-aminoglycoside therapy.

OBJECTIVES The purpose of this paper is to review the medical literature regarding vancomycinaminoglycoside induced nephrotoxicity in the pediatric population. METHODS MEDLINE: (1966 through June 2005), EMBASE (1980 through 1st quarter 2005), and International Pharmaceutical Abstracts databases were reviewed using appropriate search terms for articles related to nephrotoxicity with vancomycin and aminoglycoside use. Case reports, letters to editors, retrospective and prospective studies evaluating nephrotoxicity with the agents in pediatric patients were compiled and summarized. Studies in animals and adults were also briefly reviewed. RESULTS One case report, two letters to editors, one retrospective study, and two prospective studies evaluated the nephrotoxicity of combination aminoglycoside and vancomycin therapy in pediatric patients. The collective number of patients in the reports was 165. Patients ranged in age from 3 days to 19 years old. Four out of the six reports, including all of the prospective studies, concluded that combination therapy does not potentiate nephrotoxicity. CONCLUSIONS Although vancomycin and the aminoglycosides have been associated with drug induced nephrotoxicity, reports in the literature do not appear to support the idea that the combination of vancomycin and an aminoglycoside is more nephrotoxic than either medication alone.

Asenapine: A Novel Atypical Antipsychotic Agent for Schizophrenia and Bipolar I Disorder:

Objective: To review the literature regarding asenapine, a recently approved atypical antipsychotic, and to evaluate its safety and efficacy profile. Data Sources: Primary literature was identified by conducting a MEDLINE search (1950–June 2010). English-language articles were searched using the key words asenapine, Saphris, schizophrenia, and bipolar disorder. All data were reviewed for clinical trials evaluating the safety and efficacy of asenapine. Data were also obtained directly from the manufacturer. Study Selection and Data Extraction: English-language articles on studies conducted in humans were reviewed. Data Synthesis: Asenapine is a novel atypical antipsychotic agent available as a treatment option for patients with schizophrenia, as monotherapy for the acute treatment of bipolar I manic or mixed episodes, and as adjunctive therapy with either lithium or valproate for the acute treatment of bipolar I manic or mixed episodes. Compared with other atypical antipsychotic agents, asenapine has a favorable adverse effect profile in terms of weight gain and metabolic disorders. Multiple studies have established its efficacy and safety profile. Asenapine has been shown to be superior to placebo in 4 clinical trials in patients with schizophrenia and in 2 clinical trials in patients with bipolar I disorder. Two studies comparing asenapine with olanzapine found asenapine to be similar in efficacy, 1 found olanzapine to be more effective, and 1 trial found asenapine to be associated with more adverse effects than olanzapine. This new agent is formulated as a sublingual tablet and is administered at either 5 or 10 mg twice daily. Common adverse effects reported include extrapyramidal symptoms, somnolence, sedation, and dizziness. Conclusions: Asenapine offers a viable treatment option for the acute treatment of patients affected by schizophrenia and bipolar I disorder. Future studies are needed to compare asenapine directly against other atypical antipsychotics to determine its appropriate place in therapy.

Incorporating a Continuous Quality Improvement Process into Pharmacy Accreditation for Well-Established Programs

Svensson and colleagues advocated for an extended accreditation cycle for well-established pharmacy programs.1 They argued that the extensive time and resources necessary during the 12 to 18 months prior to reaccreditation as part of the self-study process may reduce or delay other important initiatives, including academic initiatives. Therefore, Svensson and colleagues suggested that the Accreditation Council for Pharmacy Education (ACPE) consider lengthening their customary 6-year accreditation cycle, especially for programs that have been successful through 3 or more continuous full-accreditation cycles.1,2 Subsequently, the ACPE Board of Directors approved an 8-year accreditation cycle for fully accredited programs seeking continuing accreditation at or after the January 2012 Board meeting.3 The ACPE will now reaffirm full accreditation status for a period of 8 years; however, it reserves the right to allow for shorter intervals.2 Between onsite evaluations, institutions must provide annual reviews, interim reports, reports of any substantive changes, and a full self-study immediately prior to an evaluation visit. The self-study is the most time-intensive part of the process and it is recommended that the college or school start it 18 to 24 months prior to the accreditation visit. The self-study is composed of a summary evaluation of each of the accreditation standards and guidelines and any progress and changes that have occurred since the last accreditation visit, with documentation, data, and descriptive text provided to support each.4 Based on findings from the self-study, the college or school notes whether its program is compliant, compliant with monitoring, partially compliant, or noncompliant with each accreditation standard. Ideally, the purpose of this process is to promote self-evaluation and continuous quality improvement in programs. However, it may be conducive for some programs to only think about quality improvement and self-evaluation during the time of the self-study. We would like to propose an alternative accreditation process that incorporates an alternative continuous quality improvement model. Our institution, Southern Illinois University Edwardsville, maintains accreditation through the Academic Quality Improvement Program (AQIP) of The Higher Learning Commission. This process requires that the institution provide evidence of continuous improvement through 7 core processes: strategy forum, action projects, annual update, systems portfolio, systems appraisal, quality checkup, and reaffirmation of accreditation.5 These processes are further described in Table 1. Each institution continually maintains 3 to 4 action projects related to continuous improvement efforts that should be completed within months to years depending on the scope of the project. Progress on the action projects is updated in the systems’ portfolio and feedback is given to the organization through the portfolio and strategy forum through a peer review process. Table 1. AQIP Core Processes5 and the Proposed ACPE-Continuous Quality Improvement Process Paradigm The AQIP process charges programs to continually assess and improve based on outcomes and requires constant resources to maintain the portfolio and work on action projects.5 While this process still includes a reaccreditation or reaffirmation process every 7 years, the process is much less time intensive during the time immediately prior to reaccreditation because of the continuous efforts throughout the accreditation cycle. Such an evidence-based approach requires significant dedication and infrastructure to support these institutional initiatives. Moreover, it encourages sustained attention and action from administrators, faculty members, and staff members, and facilitates the universitys achievement of its long-term goals. Arguably, this process helps foster a culture focused on continuous improvement, rather than focusing stakeholders’ attention on accountability in the short-term. The American Association of Colleges of Pharmacy (AACP) developed the Assessment and Accreditation Management System (AAMS) which is required for submission of accreditation documents to ACPE.6 The advantage of the AAMS is that data can be continuously compiled and updated. Interim reports that are submitted by schools during the accreditation cycle to address issues related to standards for which a college or school requires monitoring could serve as “action projects” in the continuous quality improvement process paradigm. “Annual updates” in this paradigm could be created from the continuously updated information in the AAMS. The regular updating of information for action projects and annual updates should greatly reduce the time and resource commitment before the comprehensive review. The systems appraisal process is already conducted by the ACPE staff when they review interim reports and determine if a focused visit is necessary. This would constitute a quality checkup in the continuous quality improvement process paradigm. Such focused visits, which are typically shorter than comprehensive visits, could serve the purpose of ensuring continuous quality improvement by a college or school. These focused visits would include faculty members at other colleges and schools of pharmacy in addition to ACPE staff members. The systems portfolio in the AQIP paradigm would constitute the comprehensive self-study. Because continuous annual updates and action project reports are reviewed during the accreditation cycle, the need for comprehensive site visits could be obviated. The “reaffirmation of accreditation” in the continuous quality improvement process paradigm could therefore be performed by ACPE staff members and volunteer faculty members at colleges and schools of pharmacy. The ACPE Board would make a decision about continued accreditation of a college or school at this point. To close the loop of the continuous quality improvement process, notable action projects and features of colleges and schools of pharmacy could be discussed at annual AACP meetings or ACPE workshops. This would be similar to the strategy forum in the continuous quality improvement process. The strategy forum would serve as a strategic planning meeting, allowing colleges and schools of pharmacy to review unit data and strategically prioritize continuous quality efforts for the upcoming accreditation cycle. This process would likely not be appropriate for every pharmacy program, but may be a realistic/viable alternative for established programs with sufficient resources and administrative support. This process could be used as a parallel method to the existing process as a means to enhance continuous quality improvement in colleges and schools of pharmacy. It would be fair for ACPE to consider the financial implications of the system proposed here. Appropriate adjustments in ACPE annual fees, focused visit fees, and reaffirmation of accreditation fees would be needed. A proposed ACPE process similar to the AQIP core process is presented in Table 1.5 We believe that this process would reduce the amount of time and resources that colleges and schools of pharmacy spend on compiling a comprehensive self-study document every 8 years and may assist schools in cultivating a continuous quality improvement focus.