Pharmacoepidemiology and Drug SafetyThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

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Pravastatin use and cancer risk: a meta-analysis of individual patient data from long-term prospective controlled trials in JapanEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To assess the influence of pravastatin therapy on cancer morbidity and mortality by a meta-analysis of individual patient data (IPD) from three independent Japanese large-scale clinical trials.We conducted a meta-analysis of IPD collected from three large-scale prospective studies, the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study, Kyushu Lipid Intervention Study (KLIS), and Hokuriku Lipid Coronary Heart Disease Study-Pravastatin Atherosclerosis Trial (Holicos-PAT), which compared cardiovascular outcomes with pravastatin therapy and non-statin therapy in Japanese patients...
Source: Pharmacoepidemiology and Drug Safety - October 26, 2009 Category: Drugs & Pharmacology Authors: Yasuyuki Matsushita, Masahiro Sugihara, Junpei Kaburagi, Masumi Ozawa, Mikio Iwashita, Sanae Yoshida, Hanako Saito, Yoko Hattori Source Type: journals

NSAID switching and short-term gastrointestinal outcome rates after the withdrawal of rofecoxibEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The consequences of the rofecoxib withdrawal on upper GI toxicity are largely unknown. We sought to estimate the effect of switching from selective Cox-2 inhibitors to non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) on the incidence of upper GI adverse events following the withdrawal of rofecoxib on 30 September 2004.We identified a cohort of 33 045 patients with arthritis and chronic use of any selective Cox-2 inhibitor during the 6 months before the withdrawal of rofecoxib in claims data from several US health plans. We calculated monthly rates of hospitalization for upper GI adverse events or upper GI end...
Source: Pharmacoepidemiology and Drug Safety - October 20, 2009 Category: Drugs & Pharmacology Authors: Sebastian Schneeweiss, Robert J. Glynn, Jerry Avorn, Muhammad Mamdani, Helen Mogun, Daniel H. Solomon Source Type: journals

Validation of diagnostic codes for outpatient-originating sudden cardiac death and ventricular arrhythmia in Medicaid and Medicare claims dataEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study examined the positive predictive value (PPV) of hospitalization and emergency department encounter diagnoses in identifying SD/VA events originating in the outpatient setting.We selected random samples of hospitalizations and emergency department claims with principal or first-listed discharge diagnosis codes indicative of SD/VA in individuals contributing at least 6 months of baseline time within 1999-2002 Medicaid and Medicare data from five large states. We then obtained and reviewed medical records corresponding to these events to serve as the reference standard.We identified 5239 inpatient and 29 135 emerge...
Source: Pharmacoepidemiology and Drug Safety - October 19, 2009 Category: Drugs & Pharmacology Authors: Sean Hennessy, Charles E. Leonard, Cristin P. Freeman, Rajat Deo, Craig Newcomb, Stephen E. Kimmel, Brian L. Strom, Warren B. Bilker Source Type: journals

Commentary on 'case series of liver failure associated with rosiglitazone and pioglitazone' by James Floyd et alEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - October 18, 2009 Category: Drugs & Pharmacology Authors: Annette B. Beiderbeck, Motonobu Sakaguchi Source Type: journals

Self-medication with antibiotics: questionnaire survey among primary care center attendantsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The aim of this study was to determine the frequency and reasons for self-medication with antibiotics within the last 12 months among primary healthcare center attendants aged 18 or over, in Ankara.A questionnaire was applied by face to face interview technique to 2696 subjects attending at five primary healthcare centers. Information on demographic characteristics, intention to self-medication with antibiotics and self-medication within last 12 months were collected.It was found that 28% of the subjects were storing antibiotics at home. The percentage of self-administering antibiotics was 19.1% in the last 12 months. The ...
Source: Pharmacoepidemiology and Drug Safety - October 13, 2009 Category: Drugs & Pharmacology Authors: Mustafa N. Ilhan, Elif Durukan, Sevil Özger Ilhan, F. Nur Aksakal, Seçil Özkan, Mehmet Ali Bumin Source Type: journals

Tramadol dependence: a survey of spontaneously reported cases in SwedenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol.The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug reactions.The Swedish database for spontaneously reported adverse drug reactions, Swedish Drug Information System (SweDIS), was searched for reports on tramadol dependence from 1 January 1995 until 31 December 2006. Selection was conducted based on the DSM-IV definition of dependence. Available information was scrutinised and regist...
Source: Pharmacoepidemiology and Drug Safety - October 12, 2009 Category: Drugs & Pharmacology Authors: Micaela Tjäderborn, Anna K Jönsson, Johan Ahlner, Staffan Hägg Source Type: journals

The identification of pregnancies within the general practice research databaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The United States is moving toward active drug safety surveillance using sources such as administrative claims and electronic medical records, but use of these data for studying teratogenicity has been challenging, as they typically do not allow for the easy identification of pregnancies. Our goal was to develop and validate an algorithm for the identification of pregnancies in the general practice research database (GPRD) that could be used to study pregnancy outcomes.The algorithm identified pregnancies in women 15-45-year-old that were pregnant between 1 January 1987 and 31 December 2006. We identified live births, stil...
Source: Pharmacoepidemiology and Drug Safety - October 12, 2009 Category: Drugs & Pharmacology Authors: Scott Devine, Suzanne West, Elizabeth Andrews, Pat Tennis, Tarek A. Hammad, Susan Eaton, John Thorp, Andrew Olshan Source Type: journals

Influence of genetic variation in CYP3A4 and ABCB1 on dose decrease or switching during simvastatin and atorvastatin therapyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Simvastatin and atorvastatin are metabolized by the CYP3A4 enzyme and transported by the ABCB1 transporter. We studied whether the polymorphism CYP3A4*1B and the polymorphisms C1236T, G2677A/T and C3435T in the ABCB1 gene were associated with a decrease of the prescribed dose or a switch to another cholesterol lowering drug during simvastatin and atorvastatin therapy. These events may indicate that statin plasma levels were too high and resulted in an adverse drug reaction or a too strong reduction in cholesterol level.We identified 1239 incident simvastatin and atorvastatin users in the Rotterdam Study, a population-based...
Source: Pharmacoepidemiology and Drug Safety - October 2, 2009 Category: Drugs & Pharmacology Authors: Matthijs L. Becker, Loes E. Visser, Ron H. N. van Schaik, Albert Hofman, André G. Uitterlinden, Bruno H. Ch. Stricker Source Type: journals

Antiepileptic drugs in Australia: 2002-2007Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We examined the trends in the prescribing of subsidised AEDs in the Australian population from 2002 to 2007.We analysed the Medicare Australia and Drug Utilisation Sub-Committee databases for script data for AEDs from 2002 to 2007 in 5-year age groups by gender and by class of prescriber. Scripts were converted to defined daily doses (DDDs)/1000/day using Australian Bureau of Statistics population data.Overall AED use (mainly valproate, lamotrigine and levetiracetam) increased progressively in 2002-2007 from 9.33 to 10.12 DDD/1000 population/day. Sodium valproate was the most widely used agent followed by carbamazepine the...
Source: Pharmacoepidemiology and Drug Safety - October 1, 2009 Category: Drugs & Pharmacology Authors: Samantha A Hollingworth, Mervyn J Eadie Source Type: journals

Should response rules be used to decide continued subsidy of very expensive drugs? A checklist for decision makersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We present a four-item checklist that may be used to help decision makers identify when a response rule is appropriate. As an example, we apply our checklist to the response rules used for tumour necrosis factor (TNF) inhibitors in rheumatoid arthritis. On the basis of the checklist we find that the response rules in both countries are inadequate and may cause therapy to be inappropriately ceased in some and continued in others. Careful assessment is needed before decision makers adopt a response rule as a way of increasing the cost effectiveness of therapy. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Pharmacoepidem...
Source: Pharmacoepidemiology and Drug Safety - October 1, 2009 Category: Drugs & Pharmacology Authors: Katy J. L. Bell, Les Irwig, Lyn M. March, Andrew Hayen, Petra Macaskill, Jonathan C. Craig Source Type: journals

Trends of the potentially inappropriate medication consumption over 10 years in older adults in the East of FranceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study shows a decrease in PIM consumption. Despite an increase of drug use in the elderly, an improving of the quality of this consumption remains possible. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - September 30, 2009 Category: Drugs & Pharmacology Authors: Bienvenu Bongue, Florence Naudin, Marie-Laure Laroche, Marie-Madeleine Galteau, Claire Guy, René Guéguen, Jean-Pierre Convers, Alain Colvez, Nabil Maarouf Source Type: journals

An application of propensity score methods to estimate the treatment effect of corticosteroids in patients with severe cutaneous adverse reactionsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To investigate whether propensity score (ps) methods could reasonably be applied to estimate the treatment effect on mortality, based on a comparatively small sample of patients with severe cutaneous adverse reactions (SCAR) and who come from different countries where physicians prefer different treatment schemes.Ps methods were applied to cope with confounding due to non-randomized treatment assignment for the analysis of the treatment data obtained in the case-control study EuroSCAR. For the study's purpose, the analysis focused on the comparison of the treatments: corticosteroids (STER) and supportive care only (SUPP).2...
Source: Pharmacoepidemiology and Drug Safety - September 29, 2009 Category: Drugs & Pharmacology Authors: P Sekula, A Caputo, A Dunant, J-C Roujeau, M Mockenhaupt, A Sidoroff, M Schumacher Source Type: journals

Polypharmacy in primary care practices: an analysis using a large health insurance databaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To ascertain the rate and range of continuous polypharmacy in German general practices and compare practice characteristics and prescribing profiles in practices with a high rate of polypharmacy patients (HPP) and a low rate of polypharmacy patients (LPP), respectively.This observational study used a database composed of prescription data from a large German statutory health insurance. We defined polypharmacy as the continuous prescription of five or more drugs and calculated the percentage of polypharmacy patients for each practice to identify HPP and LPP.A total of 136 521 patients in 730 general practices received conti...
Source: Pharmacoepidemiology and Drug Safety - September 29, 2009 Category: Drugs & Pharmacology Authors: Thomas Grimmsmann, Wolfgang Himmel Source Type: journals

Compliance with dosing recommendations from common references in prescribing antibiotics for preterm neonatesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study assesses the compliance rate with the common reference sources in antibiotic dosage prescribed for preterm infants in a neonatal intensive care unit (NICU).A retrospective study using chart review was conducted at a tertiary care medical center with university affiliation in Taiwan. Study subjects were preterm neonates admitted to the NICU of the medical center between 2000 and 2002 and prescribed at least one antibiotic during the stay. Recommendations from three commonly used reference sources (Pediatric Dosage Handbook, Neonatal Drug Formulary, and Neofax) were employed to evaluate the dosage compliance of th...
Source: Pharmacoepidemiology and Drug Safety - September 24, 2009 Category: Drugs & Pharmacology Authors: Ching-Lan Cheng, Yea-Huei Kao Yang, Swu-Jane Lin, Chyi-Her Lin, Yuh-Jyh Lin Source Type: journals

Effectiveness of rosuvastatin compared to other statins for the prevention of cardiovascular events - a cohort study in 395 039 patients from clinical practiceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study compared the effectiveness of rosuvastatin (RSV) to other statins prescribed in clinical practice in prevention of cardiovascular (CV) events.This longitudinal inception cohort study, using Thomson Healthcare's MarketScan databases, included patients aged [ge] 18 starting statin therapy during August 2003-December 2005. Patients were followed until 90 days after index statin monotherapy exposure, start of another lipid-lowering therapy, an event, end of eligibility, or end of study. The primary endpoint was a composite of CV death (in-hospital only), myocardial infarction, unstable angina, coronary revasculariza...
Source: Pharmacoepidemiology and Drug Safety - September 23, 2009 Category: Drugs & Pharmacology Authors: Stephen P. Motsko, Stefan Russmann, Eileen E. Ming, Varinder P. Singh, Ruby M. Vendiola, Judith K. Jones Source Type: journals

Prevalence and safety-relevance of drug-related problems in German community pharmaciesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this study was to assess prevalence and characteristics, including safety-relevance, of drug-related problems (DRPs) detectable in community pharmacy routine service, and to investigate the influence of relevant risk factors.Patients in 69 community pharmacies in Berlin were surveyed using a checklist for quality assurance of DRP detection in order to enable quantitative detection. An expert committee assessed the safety-relevance of detected DRPs by use of an algorithm. Logistic regression analysis was applied to investigate the influence of different risk factors.Of the 3040 surveyed patients, 638 (21.0%) ...
Source: Pharmacoepidemiology and Drug Safety - September 22, 2009 Category: Drugs & Pharmacology Authors: Daniel Lewinski, Stefan Wind, Christian Belgardt, Vanessa Plate, Christian Behles, Harald G. Schweim Source Type: journals

Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databasesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies.We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This s...
Source: Pharmacoepidemiology and Drug Safety - September 22, 2009 Category: Drugs & Pharmacology Authors: Marco Egbring, Gerd A. Kullak-Ublick, Stefan Russmann Source Type: journals

Factors associated with a continuous regular analgesic use - a population-based study of more than 45 000 Danish women and men 18-45 years of ageEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The objective of this study was to describe continuous regular analgesics use and examine factors associated with a continuous regular analgesic use.The study was based on data from two surveys and included a random sample of women and men aged 18-45 years from the general Danish population. Information on analgesics use, self-rated health, demographic and lifestyle factors was collected using a self-administered questionnaire. A total of 28 000 women and 33 000 men were invited to participate and 22 199 women (response-rate 81.4%) and 23 080 men (response-rate 71.0%), respectively, were included in the study. Data were an...
Source: Pharmacoepidemiology and Drug Safety - September 14, 2009 Category: Drugs & Pharmacology Authors: Marie Hargreave, Tina Veje Andersen, Ann Nielsen, Christian Munk, Kai-Li Liaw, Susanne K. Kjaer Source Type: journals

Calcium supplementation, cardiovascular disease and mortality in older womenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To investigate the long-term cumulative effect of calcium and vitamin D supplementation on cardiovascular outcomes and death in older women.We undertook an observational cohort study using UK electronic primary care records in the Doctor's Independent Network (DIN-LINK) database; 9910 women aged 60-89 who started calcium and vitamin D supplementation between 2000 and 2005, with no heart disease or stroke history and who survived disease free for 2 years after supplement initiation were studied. The main outcome was first occurrence of myocardial infarction (MI), stroke or death more than 2 years after initiation.In the per...
Source: Pharmacoepidemiology and Drug Safety - September 14, 2009 Category: Drugs & Pharmacology Authors: Sunil M. Shah, Iain M. Carey, Tess Harris, Stephen DeWilde, Derek G. Cook Source Type: journals

Confounder summary scores when comparing the effects of multiple drug exposuresEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Little information is available comparing methods to adjust for confounding when considering multiple drug exposures. We compared three analytic strategies to control for confounding based on measured variables: conventional multivariable, exposure propensity score (EPS), and disease risk score (DRS).Each method was applied to a dataset (2000-2006) recently used to examine the comparative effectiveness of four drugs. The relative effectiveness of risedronate, nasal calcitonin, and raloxifene in preventing non-vertebral fracture, were each compared to alendronate. EPSs were derived both by using multinomial logistic regress...
Source: Pharmacoepidemiology and Drug Safety - September 14, 2009 Category: Drugs & Pharmacology Authors: Suzanne M. Cadarette, Joshua J. Gagne, Daniel H. Solomon, Jeffrey N. Katz, Til Stürmer Source Type: journals

Systematic reviews of adverse effects of drug interventions: a survey of their conduct and reporting qualityEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
There is a need for high quality evidence on the adverse effects of medical interventions to inform policy, practice and research. Methods to systematically review adverse effects have not been fully developed. We aimed to assess the current methods and reporting used by such reviews.Survey of general medical, drug safety and pharmacology journals published in 2006. Methods including: searching, inclusion criteria, quality assessment and meta-analysis were assessed.Forty three systematic reviews from 2704 abstracts in 16 journals were included. The search strategy was not reported by 10 (23%) of reviews. The collection and...
Source: Pharmacoepidemiology and Drug Safety - September 14, 2009 Category: Drugs & Pharmacology Authors: V. R. Cornelius, M. J. Perrio, S. A.W. Shakir, L. A. Smith Source Type: journals

Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Data mining on electronic health records (EHRs) has emerged as a promising complementary method for post-marketing drug safety surveillance. The EU-ADR project, funded by the European Commission, is developing techniques that allow mining of EHRs for adverse drug events across different countries in Europe. Since mining on all possible events was considered to unduly increase the number of spurious signals, we wanted to create a ranked list of high-priority events.Scientific literature, medical textbooks, and websites of regulatory agencies were reviewed to create a preliminary list of events that are deemed important in p...
Source: Pharmacoepidemiology and Drug Safety - September 14, 2009 Category: Drugs & Pharmacology Authors: Gianluca Trifirò, Antoine Pariente, Preciosa M. Coloma, Jan A. Kors, Giovanni Polimeni, Ghada Miremont-Salamé, Maria Antonietta Catania, Francesco Salvo, Anaelle David, Nicholas Moore, Achille Patrizio Caputi, Miriam Sturkenboom, Mariam Molokhia, Julia Source Type: journals

Evaluating the positive predictive values of antidote signals to detect potential adverse drug reactions (ADRs) in the medical intensive care unit (ICU)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Signals are used to alert clinicians of potential ADRs. Positive predictive values (PPVs) of antidote signals in ICUs are unknown. The primary purpose was to determine PPVs of six signals. The secondary objective was to determine the sensitivity of various ADR detection strategies including manual chart review, administrative data review, and voluntary reporting at identifying the same ADRs discovered using antidotes as a signal.Adult patients admitted to a medical ICU from July 1, 2005 to June 30, 2006 who were prescribed select signals were eligible. Evaluated antidote signals included injectable diphenhydramine, protami...
Source: Pharmacoepidemiology and Drug Safety - September 1, 2009 Category: Drugs & Pharmacology Authors: Sandra L. Kane-Gill, Cassandra J. Bellamy, Margaret M. Verrico, Steven M. Handler, Robert J. Weber Source Type: journals

Using health information technology to improve drug monitoring: a systematic reviewEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To conduct a systematic review of current evidence regarding the use of health information technology (HIT) interventions to improve drug monitoring in ambulatory care.We searched PubMed, CINAHL, the Cochrane Library, and other computerized databases from 1 January 1998 to 30 June 2008 using the key words "drug monitoring," "medical records systems, computerized," "ambulatory care," and "outpatients." We manually reviewed reference lists of articles identified through computer searches and asked experts in the field to review our search strategy and results for completeness.Seven relevant studies were identified. Four of t...
Source: Pharmacoepidemiology and Drug Safety - August 31, 2009 Category: Drugs & Pharmacology Authors: Geoffrey L. Hayward, Aaron J. Parnes, Steven R. Simon Source Type: journals

The use of selective cyclooxygenase-2 inhibitors and the risk of acute myocardial infarction in Saskatchewan, CanadaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study showed a modest increased risk of AMI/CHD with various traditional NSAIDs and COX-2 inhibitors. Confidence intervals of estimated ORs included the null value for most comparisons. The study confirmed that the differentiation between traditional NSAIDs and COX-2 inhibitors is not a reliable tool for predicting cardiovascular risk associated with NSAIDs. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - August 28, 2009 Category: Drugs & Pharmacology Authors: Cristina Varas-Lorenzo, Jordi Castellsague, Mary Rose Stang, Susana Perez-Gutthann, Jaume Aguado, Luis Alberto García Rodriguez Source Type: journals

The effect of selected patient's characteristics on the choice of antihypertensive medication in the elderly in SlovakiaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The aim of the present study was to determine which patient-related characteristics influence the selection of the antihypertensive drug class in elderly patients in Slovakia.The sample for our study (n = 401) was selected from 1045 patients admitted to the Department of Internal Medicine of a general hospital during the period of 1 December 2003 - 31 March 2005. Patients aged 65 or more with documented arterial hypertension and treated with at least one antihypertensive drug were enrolled in our retrospective study. Specific socio-demographic and clinical characteristics as well as cardiovascular comorbid conditions were ...
Source: Pharmacoepidemiology and Drug Safety - August 27, 2009 Category: Drugs & Pharmacology Authors: Martin Wawruch, Andrej Dukat, Jan Murin, Ladislava Wsolova, Magdalena Kuzelova, Agata Macugova, Gejza Wimmer Jr, Rashmi Shah Source Type: journals

Trends in long-term opioid therapy for chronic non-cancer painEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To report trends and characteristics of long-term opioid use for non-cancer pain.CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult enrollees of two health plans serving over 1 per cent of the US population. Using automated data, we constructed episodes of opioid use between 1997 and 2005. We estimated age-sex standardized rates of opioid use episodes beginning in each year (incident) and on-going in each year (prevalent), and the per cent change in rates annualized (PCA) over the 9-year period. Long-term episodes were defined as > 90 days with 120+ days supply or 10+ opioid prescriptions in a given year....
Source: Pharmacoepidemiology and Drug Safety - August 27, 2009 Category: Drugs & Pharmacology Authors: Denise Boudreau, Michael Von Korff, Carolyn M. Rutter, Kathleen Saunders, G. Thomas Ray, Mark D. Sullivan, Cynthia I. Campbell, Joseph O. Merrill, Michael J. Silverberg, Caleb Banta-Green, Constance Weisner Source Type: journals

An algorithm to identify incident myocardial infarction using Medicaid dataEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Studies of non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular events using administrative data require identification of incident acute myocardial infarctions (AMIs) and information on whether confounders differ by NSAID status.We identified patients with a first AMI hospitalization from Tennessee Medicaid files as those with primary ICD-9 discharge diagnosis 410.x and hospitalization stay of > 2 calendar days. Eligible persons were non-institutionalized, aged 50-84 years between 1999-2004, had continuous enrollment and no AMI, stroke, or non-cardiovascular serious medical illness in the prior year. Of 5524 ...
Source: Pharmacoepidemiology and Drug Safety - August 27, 2009 Category: Drugs & Pharmacology Authors: Neesha N. Choma, Marie R. Griffin, Robert L. Huang, Edward F. Mitchel, Lisa A. Kaltenbach, Patricia Gideon, Shannon M. Stratton, Christianne L. Roumie Source Type: journals

Gender differences in the use of anxiolytics and antidepressants: a population based studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In the majority of studies on determinants of use of anxiolytics and antidepressants a substantially higher consumption is observed among women than among men. We investigated gender differences in the association between the use of anxiolytics and antidepressants and mental health and explored if there are indications of gender differences in inappropriate use of these medicines.Data were from the 2004 Belgian Health Interview Survey, a nationally representative sample of the Belgian population. The analysis was restricted to the population of 15 years and older (n = 11,220). The probability of use of anxiolytics and anti...
Source: Pharmacoepidemiology and Drug Safety - August 17, 2009 Category: Drugs & Pharmacology Authors: J.H.A. Van der Heyden, L. Gisle, E. Hesse, S. Demarest, S. Drieskens, J. Tafforeau Source Type: journals

U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national surveyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Food and Drug Administration (FDA) regulates prescription drug marketing, not prescribing. However, off-label use is common, often lacks supporting evidence, and may expose patients to unwarranted risk. We sought to determine physicians' knowledge of the FDA-approved indications of commonly prescribed drugs, and to assess whether physicians' belief that an indication is FDA-approved increases with level of evidence supporting such use.We conducted a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008. Physicians were presented with 14 drug-indication...
Source: Pharmacoepidemiology and Drug Safety - August 13, 2009 Category: Drugs & Pharmacology Authors: Donna T. Chen, Matthew K. Wynia, Rachael M. Moloney, G. Caleb Alexander Source Type: journals

Out-of-hospital medication errors: a 6-year analysis of the national poison data systemEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Previous research and reporting has focused on the incidence and prevention of medication errors in the hospital setting; however, no previous study has reported the frequencies, characteristics and outcomes of out-of-hospital medication (OHME) errors.Data from the National Poison Data System (NPDS) was collected for 2000-2005 and information regarding out-of-hospital medication errors reported to Poison Control Centers (PCC) was collected by a trained investigator.From 2000-2005 there were 1,166,116 OHME reported to PCC. Of these patients, 88,451 (7.5%) received medical evaluation by a healthcare provided and 229 (0.01%) ...
Source: Pharmacoepidemiology and Drug Safety - August 13, 2009 Category: Drugs & Pharmacology Authors: Kanan Shah, Kimberly A. Barker Source Type: journals

Validity of computerized diagnoses, procedures, and drugs for inflammatory bowel disease in a northern California managed care organizationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Resources for studying inflammatory bowel disease (IBD) are needed in evaluations of drug safety including traditional drugs and new biologics agents. We developed an IBD registry, with ascertainment from computerized visit information.We sought to characterize the positive predictive value (PPV) of IBD case-finding using computerized data compared with chart review.We identified 2906 persons aged 89 years or younger with one or more IBD diagnoses in computerized visit data during the period of 1996-2002. The diagnosis of IBD was confirmed through chart review. Adopting chart review as the gold standard, the validity of co...
Source: Pharmacoepidemiology and Drug Safety - August 11, 2009 Category: Drugs & Pharmacology Authors: Liyan Liu, James E. Allison, Lisa J. Herrinton Source Type: journals

Aspirin increases mortality in diabetic patients without cardiovascular disease: a Swedish record linkage studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Aspirin is effective in secondary prevention of cardiovascular disease. The results are less convincing when aspirin is used for primary prevention even in high-risk patients (i.e., patients with diabetes). We therefore analyzed the effect of aspirin on mortality and serious bleeding in diabetic patients with and without cardiovascular disease.We performed a record linkage study of the patient registry of the Västra Götaland region in south-western Sweden, the Swedish mortality register and the Swedish register of dispensed drugs. All diabetic patients (n = 58 465) from 1 July 2005 to 30 June 2006 were followed up with r...
Source: Pharmacoepidemiology and Drug Safety - August 10, 2009 Category: Drugs & Pharmacology Authors: Lennart Welin, Lars Wilhelmsen, Arne Björnberg, Anders Odén Source Type: journals

Prescription quality in an acute medical wardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study demonstrates a relatively acceptable level of prescription quality compared to the published literature. However, the number of DDIs and level of allergy documentation are of concern emphasising the need for continued education in this field. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - August 9, 2009 Category: Drugs & Pharmacology Authors: Nayef A. Alyamani, Yvonne Hopf, David J. Williams Source Type: journals

Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorderEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD).Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving ADT monotherapy and 366 patients receiving ADT and adjunctive aripiprazole (2-20 mg/day) were included. Efficacy measures included the Montgomery-Åsberg depression rating scale (MADRS) Total score response ([ge]50% reduction) and remission (response plus Total score [le] 10). Treatment-emergent adverse events were classified by s...
Source: Pharmacoepidemiology and Drug Safety - August 5, 2009 Category: Drugs & Pharmacology Authors: Stephen R. Wisniewski, PhD, Chi-Chang Chen, PhD, Edward Kim, MD, MBA, Hong J. Kan, PhD, Zhenchao Guo, PhD, Berit X. Carlson, PhD, Quynh-Van Tran, Pharm D, BCPP, Andrei Pikalov, MD, PhD Source Type: journals

Monitoring of drug-associated electrolyte disturbances in a hospitalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The aim of our study was to find drug-associated changes in serum levels of major electrolytes using clinical-event monitoring method.During 1-year period, electrolyte disturbances in serum samples from patients of Clinical Center Kragujevac, Serbia, were monitored in central biochemical facility. A sample of 982 patients was randomly selected from total population of 43 120 patients whose electrolyte serum levels were measured in the facility during the study period.Clinically important drug-associated electrolyte disturbances were detected in 181 patient. There were 25 significant associations between the drugs and elect...
Source: Pharmacoepidemiology and Drug Safety - August 4, 2009 Category: Drugs & Pharmacology Authors: Nenad Zornic, Danijela Jovanovic Radojevic, Slobodan Jankovic, Dusan Djuric, Mirjana Varjacic, Viktorija Dragojevic Simic, Dragan R. Milovanovic Source Type: journals

Temporal trends in anti-diabetes drug use in tricare following safety warnings in 2007 about rosiglitazoneEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To describe utilization patterns for anti-diabetes medications among a cohort of diabetes patients in the Military Health System (MHS) before and after warnings about rosiglitazone issued in May 2007.We used segmented regression analysis to compare changes in the level and trend of rosiglitazone utilization and use of other anti-diabetes therapies in the period prior to the drug warnings (between April 2006 and May 2007) and the period after the warnings were issued (between October 2007 and May 2008).The level and trend of rosiglitazone use changed after the highly publicized warnings. The number of prescriptions filled f...
Source: Pharmacoepidemiology and Drug Safety - August 3, 2009 Category: Drugs & Pharmacology Authors: Kate A. Stewart, Brenda M. Natzke, Thomas Williams, Elder Granger, S. Ward Casscells, Thomas W. Croghan Source Type: journals

Commentary on 'case series of liver failure associated with rosiglitazone and pioglitazone' by Floyd et al.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - August 3, 2009 Category: Drugs & Pharmacology Authors: Suzette Y Osei, Carol E Koro, Alexander R Cobitz, Nikheel S Kolatkar, Monika Stender Source Type: journals

Access to linked administrative healthcare utilization data for pharmacoepidemiology and pharmacoeconomics research in Canada: anti-viral drugs as an exampleEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Administrative healthcare utilization data from Canadian provinces have been used for pharmacoepidemiology and pharmacoeconomics research, but limited transparency exists about opportunities for data access, who can access them, and processes to obtain data. An attempt was made to obtain data from all 10 provinces to evaluate access and its complexity.An initial enquiry about the process and requirements to obtain data on individual, anonymized patients dispensed any of four anti-viral drugs in the ambulatory setting, linked with data from hospital and physician service claims, was sent to each province. Where a response w...
Source: Pharmacoepidemiology and Drug Safety - August 2, 2009 Category: Drugs & Pharmacology Authors: Nigel S. B. Rawson Source Type: journals

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in SwedenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We describe the pattern of spontaneously reported CAM related adverse reactions submitted to the Swedish Medical Products Agency (MPA) and highlight areas of safety concern.All adverse reactions spontaneously reported to MPA between 1987 and 2006, where at least one CAM substance was a suspected agent, were scrutinised. From each report information about the patient, adverse reaction/s, drug treatment/s, dosage, time relationship and outcome was retrieved.Among a total of 64 493 reports, 778 reports concerned 967 suspected adverse reactions related to 175 different CAM products. The main distribution of suspected adverse r...
Source: Pharmacoepidemiology and Drug Safety - August 2, 2009 Category: Drugs & Pharmacology Authors: Ingela Jacobsson, Anna K Jönsson, Barbro Gerdén, Staffan Hägg Source Type: journals

Highly active antiretroviral therapy adherence and its determinants in selected hospitals from south and central EthiopiaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To determine the adherence rate and its determinants among people living with HIV/AIDS on highly active antiretroviral therapy (HAART) in selected governmental hospitals from central and south Ethiopia.A cross-sectional study involving both qualitative and quantitative methods was conducted between August and October 2007 in Yirgalem, Hawassa, and Shashemene Hospitals. Quantitative data collection techniques include patient self-report and unannounced pill count and the qualitative methods employed were focus group discussions (FGDs), semi-structured interviews, and observations of health facilities.Whereas females account...
Source: Pharmacoepidemiology and Drug Safety - August 2, 2009 Category: Drugs & Pharmacology Authors: Kebede Abera Beyene, Teferi Gedif, Tsige Gebre-Mariam, Ephrem Engidawork Source Type: journals

Comparison of adverse events between oral and intravenous formulations of antimicrobial agents: a systematic review of the evidence from randomized trialsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Some clinicians may favor a strategy of early switch to oral antimicrobial therapy for patients responding to initial intravenous therapy. An important relevant consideration refers to the comparative safety and tolerability between oral and intravenous antimicrobial therapy.We sought to evaluate the above-mentioned issue by performing a systematic review of randomized studies comparing the occurrence of adverse events between oral and intravenous antimicrobial therapy with the same agents.Ten relevant studies (five randomized controlled trials, three randomized cross-over studies, and two randomized, placebo-controlled, p...
Source: Pharmacoepidemiology and Drug Safety - August 2, 2009 Category: Drugs & Pharmacology Authors: Vasilios D. Kouranos, Drosos E. Karageorgopoulos, George Peppas, Matthew E. Falagas Source Type: journals

Non-aspirin NSAIDs, cyclooxygenase-2 inhibitors and risk for cardiovascular events-stroke, acute myocardial infarction, and death from coronary heart diseaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To determine if certain non-steroidal anti-inflammatory drugs (NSAIDs) are associated with increased risk of cardiovascular events: acute myocardial infarction (AMI), stroke, and death from coronary heart disease (CHD).We conducted a retrospective cohort study of Tennessee Medicaid enrollees aged 35-94 years between 1 January 1999 and 31 December 2005. Eligible persons were non-institutionalized, had continuous enrollment, and had no serious illness prior to cohort entry. Exposure to celecoxib, rofecoxib, valdecoxib, ibuprofen, naproxen, diclofenac, and indomethacin was studied. The outcome was hospitalization for AMI, str...
Source: Pharmacoepidemiology and Drug Safety - July 27, 2009 Category: Drugs & Pharmacology Authors: Christianne L. Roumie, Neesha N. Choma, Lisa Kaltenbach, Edward F. Mitchel, Jr, Patrick G. Arbogast, Marie R. Griffin Source Type: journals

What do pregnant women know about non-steroidal anti-inflammatory drugs?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Non-steroidal anti-inflammatory drug (NSAID) use on late pregnancy can be associated with severe adverse neonatal outcomes. Some NSAIDs, available over the counter, can be purchased easily by pregnant women. The present study evaluates pregnant womens' knowledge about NSAID use in pregnancy.The survey includes 250 pregnant women in South-west France. Women have been interviewed about their knowledge on analgesic and NSAID use in pregnancy.A total of 2% pregnant women use aspirin or ibuprofen as self-medication. More than 10% of the women think that it is safe to take NSAIDs on late pregnancy. A majority of them thought tha...
Source: Pharmacoepidemiology and Drug Safety - July 23, 2009 Category: Drugs & Pharmacology Authors: Christine Damase-Michel, Julie Christaud, Alain Berrebi, Isabelle Lacroix, Jean-Louis Montastruc Source Type: journals

Methodological variability in detecting prescribing errors and consequences for the evaluation of interventionsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, each method predominantly identified different PE. A combination of methods may be required to understand the true effectiveness of different interventions. Copyright © 2009 John Wiley & Sons, Ltd. (Source: Pharmacoepidemiology and Drug Safety)
Source: Pharmacoepidemiology and Drug Safety - July 23, 2009 Category: Drugs & Pharmacology Authors: Bryony Dean Franklin, Sylvia Birch, Imogen Savage, Ian Wong, Maria Woloshynowych, Ann Jacklin, Nick Barber Source Type: journals

Increase in lipid-lowering treatment rates among TRICARE beneficiaries: a population-based studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To evaluate the use of lipid-lowering treatment (LLT) among patients at risk for cardiovascular disease (CVD) in the US Military Health System (MHS).The study examined healthcare service and prescription records among beneficiaries [ge]18 years for calendar years 2002, 2004, and 2006. Patients were categorized based on cardiovascular (CV) risk, with exposure to LLT defined as one or more prescriptions for lipid-lowering medication. Logistic regression models estimated odds of treatment in 2004 and 2006 relative to 2002 after adjustment for age, gender, and CV risk.The yearly unadjusted population prevalence of LLT increase...
Source: Pharmacoepidemiology and Drug Safety - July 23, 2009 Category: Drugs & Pharmacology Authors: Joshua Devine, Andrea Linton, Harsha Mistry, Josh Napier, Shana Trice, Thomas Bacon Source Type: journals

Case series of liver failure associated with rosiglitazone and pioglitazoneEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The thiazolidinedione drugs rosiglitazone and pioglitazone are not widely known to be hepatotoxic. We evaluated the FDA Adverse Event Reporting System (AERS) to determine the number of reported cases of liver failure associated with rosiglitazone and pioglitazone between 1997 and 2006, and described their clinical characteristics.Adverse event reports spontaneously submitted to the FDA AERS from 1997 to 2006 were examined. Liver failure associated with rosiglitazone or pioglitazone was defined as liver injury accompanied by hepatic encephalopathy, liver transplantation, placement on a liver transplant list, or death in whi...
Source: Pharmacoepidemiology and Drug Safety - July 21, 2009 Category: Drugs & Pharmacology Authors: James S. Floyd, Elizabeth Barbehenn, Peter Lurie, Sidney M. Wolfe Source Type: journals

Positive predictive value of computerized medical records for uncomplicated and complicated upper gastrointestinal ulcerEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Computerized databases can be an efficient resource to study the epidemiology of peptic ulcer (PU) and upper gastrointestinal complications (UGIC) if we achieve a high positive predictive value (PPV) of outcome definitions. We assessed the PPV of diagnosis codes in THIN, a primary-care medical-record database, to ascertain individuals with uncomplicated PU, and to identify UGIC and Helicobacter pylori infection status (HPIS) among these patients.We identified: (1) patients with codes suggesting a first episode of uncomplicated PU; (2) episodes of UGIC among them. The computerized profiles with free-text comments of these i...
Source: Pharmacoepidemiology and Drug Safety - July 21, 2009 Category: Drugs & Pharmacology Authors: Andrea V. Margulis, Luis A. García Rodríguez, Sonia Hernández-Díaz Source Type: journals

Local anaesthetic drugs: adverse effects as reported through the ADROIT system in the UKEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Adverse drug reactions (ADRs) to local anaesthetic drugs are reported voluntarily through the Adverse Drug Reporting On Line Tracking system (ADROIT). We aimed to determine hazards associated with drugs commonly used in anaesthesia including ropivacaine and levobupivacaine.The ADROIT database was queried for all ADRs to local anaesthetics used in anaesthesia and surgery between 1967 and 2005. Details of age, sex, suspect drug, date and reaction details were analysed.There were 985 reports analysed, 797 for lidocaine, 160 for bupivacaine, 16 for ropivacaine and 12 for levobupivacaine. The female to male ratio was 1.6:1 and ...
Source: Pharmacoepidemiology and Drug Safety - July 20, 2009 Category: Drugs & Pharmacology Authors: Muhummad Sohaib Nazir, Anita Holdcroft Source Type: journals

Comparison of sales and reimbursement data regarding outpatient antibiotic use in a northern Italian RegionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
To evaluate the accuracy of systemic antibiotic use statistics, based on the reimbursement data of the Emilia-Romagna Region (Italy), focusing on agents prescribed for urinary tract infections.Reimbursement data were obtained from the drug prescription database that includes all outpatient drug prescriptions reimbursed by the Regional Health Service in 2007. Reimbursements were compared to sales data, provided by International Medical Statistics (IMS) Health.The reimbursement data of the Emilia-Romagna Region significantly underestimates the actual use of systemic antibiotics when compared to sales. The overall underestima...
Source: Pharmacoepidemiology and Drug Safety - July 20, 2009 Category: Drugs & Pharmacology Authors: Carlo Gagliotti MD, Ilaria Mazzetti BS, Maria Luisa Moro MD Source Type: journals