Showing papers by "American Pharmacists Association published in 2008"

Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen)

Abstract: Allergic rhinitis is a symptomatic disorder of the nose induced after allergen exposure by an IgE-mediated inflammation of the membranes lining the nose. It is a global health problem that causes major illness and disability worldwide. Over 600 million patients from all countries, all ethnic groups and of all ages suffer from allergic rhinitis. It affects social life, sleep, school and work and its economic impact is substantial. Risk factors for allergic rhinitis are well identified. Indoor and outdoor allergens as well as occupational agents cause rhinitis and other allergic diseases. The role of indoor and outdoor pollution is probably very important, but has yet to be fully understood both for the occurrence of the disease and its manifestations. In 1999, during the Allergic Rhinitis and its Impact on Asthma (ARIA) WHO workshop, the expert panel proposed a new classification for allergic rhinitis which was subdivided into 'intermittent' or 'persistent' disease. This classification is now validated. The diagnosis of allergic rhinitis is often quite easy, but in some cases it may cause problems and many patients are still under-diagnosed, often because they do not perceive the symptoms of rhinitis as a disease impairing their social life, school and work. The management of allergic rhinitis is well established and the ARIA expert panel based its recommendations on evidence using an extensive review of the literature available up to December 1999. The statements of evidence for the development of these guidelines followed WHO rules and were based on those of Shekelle et al. A large number of papers have been published since 2000 and are extensively reviewed in the 2008 Update using the same evidence-based system. Recommendations for the management of allergic rhinitis are similar in both the ARIA workshop report and the 2008 Update. In the future, the GRADE approach will be used, but is not yet available. Another important aspect of the ARIA guidelines was to consider co-morbidities. Both allergic rhinitis and asthma are systemic inflammatory conditions and often co-exist in the same patients. In the 2008 Update, these links have been confirmed. The ARIA document is not intended to be a standard-of-care document for individual countries. It is provided as a basis for physicians, health care professionals and organizations involved in the treatment of allergic rhinitis and asthma in various countries to facilitate the development of relevant local standard-of-care documents for patients.

Understanding and Developing Strategic Corporate Social Responsibility

Abstract: Over the last decade, there has been considerable debate over whether organizations have a corporate social responsibility (CSR), as well as whether socially responsible initiatives predict subsequent financial performance. Business leaders are increasingly concerned with how their organizations can grow and thrive from addressing societal challenges. Strategic CSR can benefit organizations through growth in market share and organizational learning, as well as more committed and engaged employees, supportive external stakeholders, and positive investor relations. We discuss how organizations around the world are prospering by proactively engaging with social and environmental challenges. Seven strategic CSR principles, illustrated by 21 exemplars of strategic CSR initiatives, are outlined. These principles should not be interpreted as a checklist of best practices, but rather as a stimulus for designing financially viable and prudent CSR initiatives, given each organization's combination of mission, resources, challenges, and opportunities.

Assessment of Clinical Pharmacists' Interventions in French Hospitals: Results of a Multicenter Study:

Abstract: Background:The development of clinical pharmacy activities in most European countries is underway; however, data on these activities are still poorly reported. Multicenter studies are necessary to standardize and demonstrate the value of clinical pharmacy activities in these countries.Objective:To document clinical pharmacists' daily routine interventions (Pls) to identify trends of intervention, drugs, and situations most frequently associated with drug-related problems (DRPs) and to estimate physicians' acceptance of PI.Methods:A prospective study of Pls was conducted in 6 French hospitals. The sample consisted of 300 randomized Pls par hospital, recorded during the medication order validation process when a DRP was identified. We recorded patients' demographic characteristics, drugs involved, wards, DRP description, pharmacists' recommendations, and whether or not the recommendations were accepted by the physicians.Results:A total of 38, 626 medication orders were analyzed by 28 clinical pharmacists, l...

Efficacy of Memantine on Behavioral and Psychological Symptoms Related to Dementia: A Systematic Meta-Analysis:

Abstract: BACKGROUND: The behavioral and psychological symptoms related to dementia (BPSD) are difficult to manage and are associated with adverse patient outcomes. OBJECTIVE: To systematically analyze the data on memantine in the treatment of BPSD. METHODS: We searched MEDLINE, EMBASE, Pharm-line, the Cochrane Centre Collaboration, www.clinicaltrials.gov, www.controlled-trials.com, and PsycINFO (1966-July 2007). We contacted manufacturers and scrutinized the reference sections of articles identified in our search for further references, including conference proceedings. Two researchers (IM and CF) independently reviewed all studies identified by the search strategy. We included 6 randomized, parallel-group, double-blind studies that rated BPSD with the Neuropsychiatric Inventory (NPI) in our meta-analysis. Patients had probable Alzheimer's disease and received treatment with memantine for at least one month. Overall efficacy of memantine on the NPI was established with a t-test for the average difference between means across studies, using a random effects model. RESULTS: Five of the 6 studies identified had NPI outcome data. In these 5 studies, 868 patients were treated with memantine and 882 patients were treated with placebo. Patients on memantine improved by 1.99 on the NPI scale (95% Cl -0.08 to -3.91; p = 0.041) compared with the placebo group. CONCLUSIONS: Initial data appear to indicate that memantine decreases NPI scores and may have a role in managing BPSD. However, there are a number of limitations with the current data; the effect size was relatively small, and whether memantine produces significant clinical benefit is not clear.

Topical clobetasol in the treatment of atrophic-erosive oral lichen planus: a randomized controlled trial to compare two preparations with different concentrations.

Abstract: Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs. However, to date, the most commonly employed and useful agents for the treatment of LP are topical corticosteroids. A randomized, double-blind, placebo-controlled trial has been designed to compare the efficacy and safety of two different formulations of clobetasol, a very potent topical steroid, in the topical management of OLP and to evaluate which gives the longest remission from signs and symptoms. Thirty-five consecutive patients were divided into two groups: the first received clobetasol propionate 0.025% and the second was given clobetasol propionate 0.05%. Both drugs were placed in 4% hydroxyethyl cellulose bioadhesive gel. Anti-mycotic prophylaxis was also added. After the end of therapy, patients received a 2-month follow-up. In all, 14 of the 15 clobetasol 0.025% patients (93%) and 13 of the 15 clobetasol 0.05% patients (87%), had symptoms improvement after 2 months of therapy (P = 0.001 in both groups). Also, 13 of the 15 clobetasol 0.025% patients (87%) and 11 of the 15 clobetasol 0.05% patients (73%) had clinical improvement after 2 months of therapy (P < 0.05 in both groups). No statistical differences were found in comparing the two different formulations. A larger concentration of the active molecules cannot further improve the therapeutic findings or optimize the obtained results in a significant manner.

Mustard Gas: Imminent Danger or Eminent Threat?

Abstract: Objective:To increase awareness of the widespread environmental prevalence of the chemical warfare agent mustard gas, examine the acute and chronic toxic effects to exposed humans, and discuss medical treatment guidelines for mustard gas exposures.Data Sources:Literature retrieval of medical case reports and clinical studies was accomplished using PubMed and the Cochrane Database (1919–March 2007). Search terms included mustard, mustard gas, sulfur mustard, chemical warfare, blister agents, vesicants, and war gas. Historical information and current events were accessed through military field manuals and Internet searches.Study Selection and Data Extraction:All articles in English identified from the data sources were evaluated. Adult and pediatric populations were included in the review.Data Synthesis:Mustard gas and other chemical weapons are feared for their use as weapons of terror; however, the major threat of mustard gas lies elsewhere. Tons of this chemical agent were produced for war, then subseque...

Hypomania with Agitation Associated with Varenicline Use in Bipolar II Disorder

Abstract: TO THE EDITOR: Varenicline is an α4β2 nicotinic receptor partial agonist approved for smoking cessation.1 We report a case of probable hypomania due to initiation of varenicline therapy in a woman diagnosed with bipolar II disorder. Case Report. A 41-year-old white woman with a history of bipolar II disorder and polysubstance abuse presented to the hospital with irritability and suicidal ideation. She reported abstinence from alcohol for 3 months and from methamphetamine for 3 years. Her medications at the time of admission included bupropion XL 300 mg every morning, clonazepam 1 mg at bedtime, oxcarbazepine 150 mg every morning and 300 mg at bedtime, quetiapine 100 mg as needed for insomnia, montelukast 10 mg, and pantoprazole 40 mg every morning. With the exception of clonazepam, which had been started 5 months prior to her admission, she had taken these medications for more than a year. She was also taking varenicline 1 mg twice daily, started approximately 1 month prior. She smoked 2 packs of cigarettes per day and made several unsuccessful attempts to quit with nicotine replacement formulations and bupropion. The patient was otherwise healthy—all laboratory test results were within normal limits. Using the recommended titration schedule, the woman had found that, within 2 days of starting varenicline, cigarettes had begun to taste unpleasant, and she decreased her amount of smoking. However, she also reported that, after 3 days of taking varenicline, she became irritable, her “skin crawled,” and she felt “wacko.” At that point, she decided to discontinue taking the drug. She reported that upon discontinuation of varenicline, those symptoms resolved. A few days later, she developed a “head cold” which she treated with over-the-counter products, including vitamin C and Alka Seltzer Cold (which contains a decongestant and an antihistamine). When the cold reinforced her desire to quit smoking, she decided to restart varenicline. She became increasingly irritable and angry and was sleeping only about 2 hours a night. Her symptoms continued for several weeks, at which point she had a fight with her husband and made a suicidal gesture. She reported crying uncontrollably and feeling so tense that she felt that her “body was crawling”; she also scratched her arms and pulled clumps of hair from her head. At that point she was admitted to the hospital due to suicidal ideation, feelings of hopelessness and irritability, insomnia, agitation, and racing thoughts. Her psychiatrist, who had treated her for approximately 10 years, diagnosed a hypomanic episode with suicidal ideation. By the patient’s own report, she had experienced a similar episode 10 years prior to this. Varenicline was discontinued; quetiapine dosing was changed to 25 mg 3 times per day as needed for agitation and 50 mg at bedtime for sleep; guanfacine 1 mg every night was added for explosive anger. Her symptoms improved greatly and she was discharged 3 days later. Discussion. Alternatives to varenicline’s being the cause of the patient’s symptoms include (1) nonadherence to drug therapy (the patient asserted that she had been taking her medications as directed and nothing suggested otherwise), (2) illicit drug use (she reported abstinence from illicit drugs and alcohol; a urine drug screen was positive for cannabis, but she was discharged before the results were known and was unavailable to respond), and (3) nicotine withdrawal (the timing of the symptoms went beyond that expected if withdrawal were the culprit; nicotine withdrawal symptoms are generally short-lived and the patient’s symptoms lasted at least a month). The Naranjo criteria indicated a probable association of varenicline with this episode of hypomania.1 Psychiatric complaints such as insomnia (20.9–33.9%), irritability (21%), and abnormal dreams (11.6–19.4%) were reported as adverse events in clinical trials of varenicline, but those trials were conducted in nonpsychiatric populations.2,3 We identified one published case of a manic episode4 and another of an exacerbation of schizophrenia associated with varenicline.5 Recently, the Food and Drug Administration sent out a safety alert informing healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken varenicline.6 With the widespread use of smoking cessation products in psychiatric populations, it is important that providers be made aware of the potential for psychiatric adverse effects with this medication.

Promoting health communication between the community-dwelling well-elderly and pharmacists: The Ask Me 3 program

Abstract: Objective To describe readiness to use clear health communication principles with a pharmacist before and after participating in the Ask Me 3 (What is my main problem?, What do I need to do?, Why is it important for me to do this?) program. Design Modified, separate-sample, pretest–posttest study. Setting Senior centers in Polk County, IA, between March 2006 and February 2007. Participants 106 community-dwelling well-elderly. Intervention Information on demographic characteristics, regularity of health care and medication use, health literacy level, and a measurement of multidimensional health locus of control were collected from participants, who were then were randomly allocated to one of three assessment subgroups: (1) pretest–posttest, (2) pretest only, and (3) posttest only during each of 12 Ask Me 3 program educational sessions. Main outcome measure Readiness to use the seven principles of clear health communication described in the Ask Me 3 program. Results Participants were predominantly women and white, had a high school education or higher, had a yearly income of $25,000 or less, and had a mean age of 75.1 years. A majority reported good to excellent health status and visited their physician two or more times per year. All took medications regularly for a medical problem. A minority had inadequate to marginal health literacy. Before the Ask Me 3 program, a majority reported planning to or actively asking their pharmacist (1) for help with questions about their medications (88.2%), (2) to explain how to take their medication (82.6%), (3) to describe the main problem for which their medication is being prescribed (78.6%), and (4) to describe what can happen if they don't take their medication (74.3%). Approximately one-half of participants (55.2%) made a list of health or medication concerns to tell their pharmacist. A minority brought a list of current medications (47.8%) or brought a friend or family member to help when visiting their pharmacist (27.9%). A significantly higher proportion of participants reported planning to or actively bringing a list of current medications when visiting the pharmacist ( P ≤ 0.025) after participating in the Ask Me 3 program. Increases were not statistically significant for the remaining principles. Conclusion The Ask Me 3 program is a practical tool that creates awareness and reinforces principles of clear health communication. The Ask Me 3 program should be evaluated in diverse pharmacy and health care settings with patients at high risk for poor health communication.

Impact of quality circles for improvement of asthma care: results of a randomized controlled trial.

Abstract: Rationale and aims Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark. Methods Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs. Results A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and selfmanagement low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased ( P = 0.19), and asthma steps improved ( P = 0.02). Delivery of individual emergency plans increased ( P = 0.008), and unscheduled emergency visits decreased ( P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07‐0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5‐34.3) and emergency visits (OR 4.9; 95% CI 1.6‐14.7). There was no difference between traditional and benchmarking QCs. Conclusions Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the selfmanagement of asthma patients.

Cross-sectional survey of patients in receipt of long-term repeat prescriptions for antidepressant drugs in primary care

Abstract: This cross-sectional survey describes the clinical characteristics of 92 patients from across 12 general medical practices, in receipt of a long-term repeat prescription of an antidepressant for the treatment of depression. Psychiatric diagnoses were determined using the Schedule for Clinical Assessment in Neuropsychiatry. Fifty-three participants (57.6%) failed to meet criteria for any psychiatric diagnosis (95% confidence interval (CI): 47.5–67.7%). Independent clinical assessments based upon diagnoses and other clinical data indicated that 26 (31.0%) participants (95% CI: 28.9–49.7%) had no clear clinical reason for continued receipt of an antidepressant. Reasons for the continued use of antidepressants in this population require further investigation.

Möbius Syndrome in a Neonate After Mifepristone and Misoprostol Elective Abortion Failure

Abstract: Objective:To report a case of a child born with Mobius syndrome following exposure in utero to mifepristone and misoprostol for elective abortion.Case Summary:In the seventh week of pregnancy, a woman was administered mifepristone 600 mg and, 2 days later, misoprostol 400 μg for abortion. One month later, despite significant metrorrhagia, an ultrasound examination showed ongoing gestation. At 33 weeks and 3 days of gestation, the woman gave birth to a male with left facial palsy, microretrognathia, and axial hypotonia related to Mobius syndrome.Discussion:Mobius syndrome is characterized by unilateral or bilateral palsy of the abducens (VI) and facial (VII) cranial nerves. Other cranial nerves (eg, the hypoglossal [XII]), craniofacial or orofacial anomalies, and limb malformations are often associated. The etiology of the Mobius syndrome remains largely unknown and probably involves multiple factors. The most likely etiological hypothesis is disruption of the developing vascular system, with transient isc...

Optimizing clinical practice with case-based reasoning approach.

Abstract: Summary Rationale and aims Learning through experience is an important approach that humans employ to comprehend new problems. The knowledge of physicians does not only consist of rules, but of a mixture of textbook knowledge and experience. Medical treatment is facing a challenge of knowledge discovery from the growing volume of information. Method Case-based reasoning (CBR) matches the natural reasoning model of human. This approach is similar to that used by physicians when they are thinking: ‘I have seen a patient like this’, and provides instant recollection of past cases that may be relevant to the present case. In fact, CBR is an approach for solving problems based on solutions of similar past cases. Unlike other forms of reasoning such as rule-based reasoning, CBR does not draw conclusions by chaining together generalized rules. Conclusion The application of CBR to medical databases can be powerful techniques to aid physicians in making decisions about the management of their patients, in various types of medical units. CBR is an effective reasoning strategy for optimizing clinical practice.

Delirium and use of sedation agents in intensive care.

Abstract: Aim: The aim of the review was to consider the relationship between delirium and aspects of sedative and analgesic drug use in mechanically ventilated intensive care patients. The basis for routine delirium screening and the implications for nurses are discussed along with a brief outline of the treatment of delirium. Background and context: Delirium is common in intensive care patients and like other markers of organ failure is associated with worse outcomes. The risk of developing delirium is dependent on the patients’ individual vulnerability and on the burden of precipitating factors they are exposed to. Detection of delirium in intensive care patients is often difficult and requires the regular use of a validated screening tool. Intensive care patients are exposed to multiple delirium risk factors, and sedative and analgesic agents present an important subgroup, which we can attempt to control. Sedative and analgesic drug choice, their mode of administration, monitoring and titration have consequences for delirium development. Method: Literature review. Conclusions: Sedative and analgesic drugs have an important role in the prevention and treatment of delirium in intensive care patients. Routine delirium screening should be included as part of sedation monitoring practice. When detected, treatment is focused on the prompt correction of precipitating factors, non-pharmacological interventions and appropriate drug therapy for symptom control.

Model for medication therapy management in a university clinic.

Abstract: Purpose. Experience with a referral-based medication therapy management (MTM) clinic in a university medical center is described. Summary. The MTM clinic’s mission is to assist patients who take multiple medications due to multiple chronic conditions with the management of their drug therapy to improve or maintain their health and prevent or minimize drug-related problems. The clinical services provided at the clinic have evolved into a comprehensive program providing five distinct service areas: access, adherence, coordination of care, medication therapy review, and education. During initial visits, patient information is collected, patients are interviewed, medications are reconciled, and the pharmacist identifies and attempts to solve any immediate drug-related problems and concerns. Routine visits are scheduled monthly to coincide with a patient’s medication refills. On a typical day, a minimum of two MTM pharmacists and one pharmacy technician staff the clinic. On two days of the week, three MTM pharmacists are available in the clinic. The clinic averages 9–13 scheduled patient visits per day. The MTM clinic functions as a subset of the outpatient pharmacy and is merged financially in the general operational budget of the ambulatory care pharmacy. This model of MTM patient care is intensive and comprehensive and is significantly different from the majority of MTM models currently provided by Medicare Part D plans. Conclusion. A referral-based MTM clinic managed by pharmacists at a university medical center outpatient pharmacy provides care to patients with the goal of improving medication access, medication adherence, continuity of care, medication therapy management, and patient education.

Development and validation of a Spanish language patient satisfaction questionnaire with drug dispensing

Abstract: Objective: To develop and validate a specific questionnaire about patient satisfaction with drug dispensing at Spanish community pharmacies. Method: A self-administered semi-structured questionnaire was designed centered on the perception of the patients with the dispensing service. To validate this questionnaire, it was administered at Spanish community pharmacies, which voluntarily agreed to participate in the study for a period of 2 months (March and April 2006). Patients or caregivers who were able to read and write were included in the study. Main outcome measure: Scores of the items related to satisfaction with the dispensing service. Results: The questionnaire consisted of: an introduction, 10 closed questions in an interval scale of five points, an open section to express comments, and finally demographic data of the patients. Twenty-seven community pharmacies participated in the validation, and 561 questionnaires were obtained with a response percentage of 56.5%. A Cronbach’s α coefficient of 0.91 was obtained. The Kaiser–Meyer–Olkin coefficient was 0.92, and the extraction of the principal components revealed a unique component explaining 55.2% of the total variance. About 15.5% of patients made additional comments that praised the quality of attention received and other aspects of the service such as the amiability and friendliness shown by pharmacy staff. Conclusion: The questionnaire developed shows evidence of validity and reliability for evaluating patient satisfaction with the dispensing service in community Pharmacies in Spain.

Serotonin Syndrome Risks When Combining SSRI/SNRI Drugs and Triptans: is the FDA's Alert Warranted?

Abstract: In 2006 the Food and Drug Administration (FDA) issued an alert, based on 27 case reports gathered over a 5-year span, regarding serotonin syndrome resulting from concurrent use of either a selective serotonin-reuptake inhibitor (SSRI) or a selective serotonin/norepinephrine reuptake inhibitor (SNRI) with a triptan. These diagnoses have been subsequently challenged as not meeting validated criteria for serotonin syndrome, in part because the FDA has yet to publicly disseminate important case report data. As a result of the FDA's alert, some clinicians are reluctant or refuse to provide these drugs concomitantly to patients. We believe that withholding these medications due to fears of serotonin syndrome is difficult to justify. In contrast to the small number of case reports, research shows that approximately 700,000 patients annually take SSRIs or SNRIs with triptans and that this drug combination has been effectively used by millions of individuals over the past decade. We encourage healthcare professionals to familiarize themselves with data on serotonin syndrome and to administer SSRIs/SNRIs with triptans when clinically appropriate.

Intravenous Human Plasma-Derived Augmentation Therapy in α1-Antitrypsin Deficiency: From Pharmacokinetic Analysis to Individualizing Therapy

Abstract: Background:Severs forms of α1-antitrypsin (AAT) deficiency require augmentation therapy by intravenous administration of purified preparations of AAT concentrate. Although standard AAT treatment schedules are widely available, pharmacokinetic studies characterizing AAT serum decay are scarce, and data on the variability of individual patients are almost nonexistent.Objective:To establish individual AAT pharmacokinetics and develop a predictive model based on simple pharmacokinetic characterization that can be used to optimize Individual AAT dosing regimens.Methods:Seven patients with severe hereditary AAT deficiency (PI*ZZ phonotype) with serum AAT levels less than 0.50 g/L Initially received AAT 180 mg/kg every 3 weeks. At 7, 14, and 21 days after AAT administration, serum samples were taken for quantitative AAT analysis and further one-compartment pharmacokinetic analysis. Subsequently, patients were rescheduled (dose and dosing interval) according to their individual responses. The influence of baselin...

Conducting medication safety research projects in a primary care physician practice-based research network

Abstract: Objective To describe a roadmap for developing a practice-based research network (PBRN) through the experience of conducting medication safety research projects in a primary care physician PBRN. Setting Southern Primary-care Urban Research Network (SPUR-Net) in Houston, Tex., from 2000 to 2007. Practice Description SPUR-Net is a partnership of six health care organizations in Houston and includes 32 clinics with 313 primary care clinicians (50% family physicians, 25% general internists, and 25% pediatricians) who provide care for approximately 1 million patient encounters annually. Practice Innovation The pharmacist principal investigator collaborates with physicians and researchers in primary care clinics to investigate medication safety practice in SPUR-Net. Main Outcome Measures (1) A roadmap for PBRN research and (2) initiation of a research program focusing on medication safety through the PBRN. Results A roadmap with 10 steps for conducting practice-based research is recommended: (1) form collaborative partnership, (2) develop research infrastructure, (3) formulate research questions, (4) design study methods, (5) obtain funding support, (6) develop study instruments, (7) implement the study, (8) manage and analyze data, (9) disseminate results, and (10) translate research into practice. Four research projects focusing on medication safety were conducted in SPUR-Net from 2002 to 2007. Medication outcomes include improved medication use, increased awareness for medication counseling, decreased medication errors, and identification of best practices for medication reconciliation. Conclusion Practice-based research conducted in primary care settings identifies, studies, and evaluates common problems encountered in busy clinic practice. With feedback from stakeholders, best practices and improved practice can be identified and "translated" back to practice. Grant funding for research projects helps sustain PBRNs. The implementation of medication safety research projects has helped primary care clinics, clinicians, and patients increase appropriate medication use and explore ways to further improve medication safety.

Accuracy of a Provincial Prescription Database for Assessing Medication Adherence in Heart Failure Patients

Abstract: Background:British Columbia's central prescription database, PharmaNet, is often used for both clinical and research applications. However, PharmaNet details prescription transactions, not actual medication consumption, resulting in many potential sources of inaccuracy when the information is assumed to reflect population or individual drug utilization.Objective:To assess the accuracy of PharmaNet for adherence assessment in patients with heart failure who are taking β-blockers.Methods:A 6-month prospective, longitudinal assessment of adherence to the prescribed β-blocker regimen was carried out using both PharmaNet data and the Medication Event Monitoring System (MEMS) for each patient enrolled. The limit of agreement between the 2 adherence assessment methods was assessed using the Bland-Altman approach.Results:Fifteen of 58 patients initially enrolled in the study were excluded, most due to misuse of MEMS or failure to return the MEMS vial despite thorough follow-up. For the 43 patients included in the...

Bone and total alkaline phosphatase for screening skeletal metastasis in patients with solid tumours.

Abstract: Alkaline phosphatase (AP) has several isoforms including bone alkaline phosphatase (BAP). We evaluated BAP and AP for screening for bone metastasis (BM) in patients with solid tumours. This is a prospective non-blinded study conducted at ABC Foundation School of Medicine Oncology clinics. A total of 40 subjects without a history of cancer and 62 patients with various solid tumours referred for a bone scan had serum drawn for BAP and AP determination. Bone alkaline phosphatase and AP levels in patients with cancer and BM, without BM and with no cancer, were 70.32 +/- 3.65 and 310.21 +/- 16.87 U/L; 41.40 +/- 2.80 and 113.23 +/- 12.95 U/L; 21.19 +/- 2.76 and 148.05 +/- 12.79 U/L respectively (P < 0.0001 for both AP and BAP). For BAP and AP sensitivity, specificity, positive and negative predictive values were 0.86 and 0.52; 0.69 and 1; 0.45 and 1; 0.94 and 0.87 respectively. ROC AUC value for BAP was 0.89 and for AP was 0.93. We conclude that BAP is more sensitive than AP, whereas AP had a remarkable specificity of 100%. In screening for BM in patients with solid tumours, obtaining initially BAP and then selecting for further investigation only patients with an abnormal AP may be a cost and resource saving strategy.

Bio-availability and dissolution of three phenytoin preparations for children.

Abstract: A study of bio-availability of three drug companies' brands of phenytoin preparations (50mg capsule/tablets) was undertaken on 30 children with tonic-clonic or complex partial seizures. Eight children were excluded because of non-compliance and three because of abnormally high serum levels. Phenytoin capsules (Parke Davis) and tablets (Boots) produced significantly higher serum-level profiles than phenytoin tablets (Evans). Seizure frequencies did not differ significantly with the three brands of phenytoin. Dissolution of the three preparations tested in vitro was different. As a result of this study the authors recommend that children remain on the same manufacturer's brand of phenytoin throughout their treatment.

Multilevel factors affecting tuberculosis diagnosis and initial treatment.

Abstract: The study aims to assess provider adherence to national tuberculosis programme guidelines on diagnosis initial regimens and dosages and to examine independent effects of factors at patient staff and hospital levels influencing adherence. A review of 383 medical records of new tuberculosis (TB) patients and interviews with related staff were carried out. The study was conducted in 16 public hospitals of seven provinces of southern Thailand. The outcome variables were provider adherence to the guidelines on diagnostic procedure initial regimen and dosage. Independent variables consisted of patient staff and hospital factors. Multilevel logistic regression was used to identify factors associated with adherence. The proportions of adherence to the diagnostic procedure initial regimen and initial dosage prescribed were 70.0% 100.0% and 57.1% respectively. Most of diagnosis non-adherence was anti-TB drugs being prescribed for smear-negative patients without prior antibiotic trial (12.5%). The anti-TB drug with the highest percentages of patients receiving non-adhered dosage was ethambutol (33.6%). In contrast to single-level analysis which showed significant influence of up to five factors multilevel analysis confirmed only strong effect of male patients receiving better adhered diagnosis and of non-doctors and TB clinics providing better dosage adherence. Adherence to TB diagnostic procedures was not good and adherence to initial dosage especially for ethambutol was poor. TB clinics the key factor of adherence should be expanded. Female patients should be reviewed more carefully because they tend to receive poorer diagnosis adherence. (authors)

Hyperglycaemia upon onset of ICU-acquired bloodstream infection is associated with adverse outcome in a mixed ICU population.

Abstract: This study aimed to assess whether a relationship exists between hyperglycaemia and outcome in a mixed cohort of critically ill patients with nosocomial bloodstream infection (BSI), and to evaluate patterns of blood glucose levels between survivors and non-survivors. A historical observational cohort study was conducted in the intensive care unit (ICU) of a tertiary care referral centre. One-hundred-and-thirty patients with a microbiologically documented ICU-acquired BSI (period 2003 to 2004) were included. For the study, morning blood glucose levels were evaluated from one day prior until five days after onset of BSI. The contribution of hyperglycaemia, divided in three subgroups (>= 150 mg/dl, >= 175 mg/dl and >= 200 mg/dl), to in-hospital mortality was estimated by logistic regression. In-hospital mortality was 362%. Over the seven study days, no differences were found in daily morning blood glucose levels between survivors (n=83) and non-survivors (n=47). Nevertheless, the trend of blood glucose levels upon onset of BSI showed a remarkable increase in the non-survivors, whereas it decreased in the survivors. Hyperglycaemia (>= 175 mg/dl and >= 200 mg/dl) was observed more often among the non-survivors. Multivariate logistic regression showed that APACHE II (P=0.002), antibiotic resistance (P=0.004) and hyperglycaemia (>= 175 mg/dl) upon onset of BSI (P=0.017) were independently associated with in-hospital mortality, whereas a history of diabetes (P=0.041) was associated with better outcome. Hyperglycaemia (>= 175 mg/dl) upon onset of ICU-acquired BSI is associated with worse outcome in a heterogeneous ICU population. Patterns of morning blood glucose levels have only limited value in the prediction of the individual course.

Adaptación del "Cuestionario de Evaluación de la Adhesión al Tratamiento antirretroviral" (CEAT-VIH) para su uso en Perú

Abstract: Objective: To adapt and validate the “Assessment of Adherence to Antiretroviral Therapy Questionnary” “Cuestionariopara evaluar la adhesion al tratamiento antirretroviral” (CEAT-VIH) for use in Peru, in HIV-infected patients in highlyactive antiretroviral therapy (HAART).Method: Understanding of the questionnaire was evaluated as well as its psychometric properties in 41 HIV-infectedpatients; antiretroviral therapy for at least 3 months was required. Data was obtained between December 2005 andJanuary 2006. CEAT-VIH was carried out the day when sample for HIV viral load and CD4 cell count were taken.Reliability and validity related to two external criterions were evaluated.Results: CEAT-VIH showed appropriate reliability (α = 0,706) and adequate external criterion-related validity for CD4cell count (r = 0,439, p < 0.005), and for HIV viral load (r = - 0,548, p < 0, 005).Conclusions: CEAT-VIH has proved to be useful to assess the level of adherence and to identify the factors affectingpatient adherence to highly active antiretroviral therapy in Peru.

Poison Centers Detect an Unexpectedly Frequent Number of Adverse Drug Reactions to Lisdexamfetamine

Abstract: TOTHE EDITOR: In February 2007. the Food and Drug Administration (FDA)approved the release of lisdexamfetamine for the treatment of attention deficit/hyperactivity disorder (ADHD). Release and marketing of the drug began in the US in June of 2007. Lisdexamfetamine is a prodrug. with t.-lysine, an aminoacid. attached to dextroamphetamine, the dextroisomerof amphetamine. Onceabsorbed. the t-lysine is cleavedin the liver.releasingthe dextroamphetamine and making it availablefor distribution to the tissues.' Because of whatappeared to be a high rate of adversedrug reactions to lisdexamfetamine, we retrospectively reviewed the databases of 5 poisoncenters,covering 8 states,forall humancasesinvolving lisdexarnfetamine for the first IOmonths postmarketing (June I, 2007. through March31,2(08). During this period,81 cases of lisdexamfetamine ingestion.adversereactions werereportedin 28 (35%)patients.The first adversereactionto lisdexamfetamine was reportedon August8, 2007. approximately 2 monthsafter its releaseand marketing. In cases of adversereactions, a blindedcopy of the poisoncenterchart was reviewed by the primaryauthor (HAS)and all data reportedhere were collected fromthiscarefulreview. Table I lists the clinicaleffectsreportedin the adversedrug reaction group.Meanand median agesof thisgroupwere 11 and 8 years.respectively (range4-44). The adverse reactionoccurredon initial usage of lisdexamfetaminein 22 of the 28 (79%) patients and within the first weekof therapy in 24 (86%)patients.suggesting close association with the useof the drug.Thirteen of the28 (46%)had previously usedstimulant therapy for theirADHD.Twenty-five of the cases(89%)involved a singledrug (lisdexarnfetamine), with3 cases involving therapeutic polydrugexposure. The singlepatientwhoexperienced a seizure wasalsoreceiving trazodoneand imipramine therapy,but these therapieshad not changed sinceinitiation of lisdexarnfetarnine. Fifteen(54%)of thesepatientsreceived direct medical evaluation and care, with3 requiring hospitaladmission. The rateof adverse drugreactions wassignificantly elevated from rates previously reported to poison centers, which are approximately 2% of all exposures and were 3.1% for amphetamines specificallyf Approximately half of these cases have been reportedto theFDAMedWateh program. Importantlimitationsto this report are that no attempt was made to excludeotherdrugsor conditions thatmayhavehadan impacton theeffectsreported, although only 11% of patients reported usingothermedications,and spontaneous reporting by poison centersmay not be indicativeof the trueincidence of an event. In the fITSt 10monthsafter its release,casesof adversedrug reaction relatedto lisdexamfetamine were reportedat a rate more than IO times the previously reported mean rate for amphetamines.The majorityof theseeventsoccurred on initiation of therapy, suggesting thatgreaterpatientselection andeducation effortsregarding lisdexarnfetamine maybe warranted. Futuremonitoring by poison centersmaybe helpful as a'sentinel in postrnarketing of newdrugs. Director Kentucky RegionalPoisonCenter PO Box35070 Louisville, Kentucky 40232 fax 502/629-7277 Henry.spiller@nortonhealthcare.org

Choice of Comparator in Active Control Trials of New Drugs

Abstract: Background:When choosing the active control group in a randomized that, it is important to maintain standard treatment for the therapeutic indication for which a medicine is studied. This choice is relevant not only for demonstrating the efficacy and safety of a new drug, but also for assessing Its place in therapy in comparison with existing medicines. Comparative information is important for decisions on prescribing and reimbursement. However, choosing the most suitable comparator is difficult when recommendations on drugs of first choice vary depending on clinical settings and times.Objective:To evaluate the choice of comparator in premarketing randomized active control trials (RaCTs) in comparison with recommendations lor standard treatment.Methods:We evaluated drugs that were authorized for use in the European Union market between 1999 and 2005. Information on active comparators in RaCTs was extracted from the European Public Assessment Reports and information on recommendations regarding standard tr...

Establishing gold standard approaches to rapid tranquillisation: a review and discussion of the evidence on the safety and efficacy of medications currently used

Abstract: Background: Rapid tranquillisation is used when control of agitation, aggression or excitement is required. Throughout the UK there is no consensus over the choice of drugs to be used as first line treatment. The NICE guideline on the management of violent behaviour involving psychiatric inpatients conducted a systematic examination of the literature relating to the effectiveness and safety of rapid tranquillisation (NICE, 2005). This paper presents the key findings from that review and key guideline recommendations generated, and discusses the implications for practice of more recent research and information. Aims: To examine the evidence on the efficacy and safety of medications used for rapid tranquillisation in inpatient psychiatric settings. Method: Systematic review of current guidelines and phase III randomised, controlled trials of medication used for rapid tranquillisation. Formal consensus methods were used to generate clinically relevant recommendations to support safe and effective prescribing of rapid tranquillisation in the development of a NICE guideline. Findings: There is a lack of high quality clinical trial evidence in the UK and therefore a ‘gold standard’ medication regime for rapid tranquillisation has not been established. Rapid tranquillisation and clinical practice: The NICE guideline produced 35 recommendations on rapid tranquillisation practice for the UK, with the primary aim of calming the service user to enable the use of psychosocial techniques. Conclusions and implications for clinical practice: Further UK specific research is urgently needed that provides the clinician with a hierarchy of options for the clinical practice of rapid tranquillisation.

Email Medication Counseling Services Provided by Finnish Community Pharmacies

Abstract: Background:The importance of email as a mode of communication between medication users and pharmacists is likely to increase. However, little is known about the email medication counseling practices of community pharmacies.Objective:To determine the prevalence of email medication counseling services in Finland and to assess the accuracy and comprehensiveness of responses by pharmacies providing the opportunity for email medication counseling to inquiries related to use of antidepressants.Methods:An inventory was made of all Finnish community pharmacies that provided the opportunity for email medication counseling. Data related to the accuracy and comprehensiveness of responses were collected, using a virtual pseudo-customer method with 3 scenarios related to common concerns of patients on antidepressants. Two inquiries were emailed to each pharmacy that provided the opportunity for email medication counseling in January and February 2005. The responses were content analyzed by 2 researchers, using a prest...