Pharmacoepidemiology and Drug Safety

Publisher: International Society for Pharmacoepidemiology; International Society of Pharmacovigilance, John Wiley & Sons

Description

The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data methods and opinion in the emerging discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research invited reviews and a variety of guest editorials and commentaries embracing scientific medical statistical and legal aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Communication. Particular areas of interest include: design results analysis and interpretation of post-marketing surveillance and other studies looking at specific drugs populations and outcomes methods for detection and evaluation of drug-associated adverse events assessments of risk versus benefit ratios in drug therapy patterns of drug utilization relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines The Publishers recognize the need of journal users to access articles through a variety of channels and are committed to providing a wide range of options in the future. The Publishers are also aware that new communication media increase the threat to authors' own rights through unauthorized distribution alteration or attribution. To enable the Publishers to make the published version of articles available as widely as possible while protecting authors' rights to be associated with their work it is essential that a Copyright Transfer Agreement form is signed for every article which is to be considered for publication in the journal. The form can be photocopied from the journal or copies can be obtained on request from the Publisher or printed from this Web site. Inclusion of a signed form with the manuscript at the original submission stage will speed up processing and eventual publication of the article.

  • Impact factor
    2.90
  • 5-year impact
    2.91
  • Cited half-life
    4.70
  • Immediacy index
    1.30
  • Eigenfactor
    0.01
  • Article influence
    1.06
  • Website
    Pharmacoepidemiology and Drug Safety website
  • Other titles
    Pharmacoepidemiology and drug safety (Online), Pharmacoepidemiology and drug safety
  • ISSN
    1099-1557
  • OCLC
    44084438
  • Material type
    Document, Periodical, Internet resource
  • Document type
    Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

John Wiley & Sons

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author can archive a post-print version
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    • See Wiley-Blackwell entry for articles after February 2007
    • On personal web site or secure external website at authors institution
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    • JASIST authors may deposit in an institutional repository
    • Non-commercial
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    • Publisher's version/PDF cannot be used
    • Articles in some journals can be made Open Access on payment of additional charge
    • 'John Wiley and Sons' is an imprint of 'Wiley-Blackwell'
  • Classification
    ​ green

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Background and aimsDespite the use of administrative data to perform epidemiological and cost-effectiveness research on patients with hepatitis B or C virus (HBV, HCV), there are no data outside of the Veterans Health Administration validating whether International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes can accurately identify cirrhotic patients with HBV or HCV. The validation of such algorithms is necessary for future epidemiological studies.Methods We evaluated the positive predictive value (PPV) of ICD-9-CM codes for identifying chronic HBV or HCV among cirrhotic patients within the University of Pennsylvania Health System, a large network that includes a tertiary care referral center, a community-based hospital, and multiple outpatient practices across southeastern Pennsylvania and southern New Jersey. We reviewed a random sample of 200 cirrhotic patients with ICD-9-CM codes for HCV and 150 cirrhotic patients with ICD-9-CM codes for HBV.ResultsThe PPV of 1 inpatient or 2 outpatient HCV codes was 88.0% (168/191, 95% CI: 82.5–92.2%), while the PPV of 1 inpatient or 2 outpatient HBV codes was 81.3% (113/139, 95% CI: 73.8–87.4%). Several variations of the primary coding algorithm were evaluated to determine if different combinations of inpatient and/or outpatient ICD-9-CM codes could increase the PPV of the coding algorithm.ConclusionsICD-9-CM codes can identify chronic HBV or HCV in cirrhotic patients with a high PPV and can be used in future epidemiologic studies to examine disease burden and the proper allocation of resources. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 10/2014;
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    ABSTRACT: PurposeDays supply (prescription duration) values are commonly used to estimate drug exposure and quantify adherence to therapy, yet accuracy is not routinely assessed, and potential inaccurate reporting has been previously identified. We examined the impact of cleaning days supply values on the measurement of adherence to oral bisphosphonates.Methods We identified new users of oral bisphosphonates among Ontario seniors (April 2001–March 2011). Days supply values were examined by dose, and we identified misclassification by comparing observed values to dose-specific expected values. Days supply values not matching expected values were cleaned using dose-specific algorithms. One-year adherence to therapy was defined using measures of compliance (mean proportion of days covered [PDC], and categorized into high [PDC ≥ 80%], medium [50% < PDC < 80%], low [PDC ≤ 50%]) and persistence (30-day permissible gap). Estimates were compared using the observed and cleaned days supply values, stratified by site of patient residence (community or long-term care [LTC]).ResultsWe identified 337 729 (5% LTC) eligible new users. Among LTC patients, adherence estimates increased significantly following data cleaning: mean PDC (59 to 83%), proportion with high compliance (47 to 76%), and proportion persisting with therapy (62 to 78%). Modest increases were identified among community-dwelling patients following data cleaning (mean PDC, 71 to 74%; high compliance, 54 to 58%; and persistence, 56 to 61%).Conclusions Data cleaning to correct for exposure misclassification can influence estimates of adherence with oral bisphosphonate therapy, particularly in LTC. Results highlight the importance of developing data cleaning strategies to correct for exposure misclassification and improve transparency in pharmacoepidemiologic studies. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 10/2014;
  • Pharmacoepidemiology and Drug Safety 10/2014; 23(10):1107-9.
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    ABSTRACT: PurposeInfants and young children are at elevated risk of influenza-associated complications, but information on the safety of antiviral therapies is limited in this age group.Methods In this prospective open-label observational safety study, children aged ≤24 months with a clinical diagnosis of influenza in routine practice received either no antiviral treatment (‘unexposed’ group) or oseltamivir treatment or prophylaxis (‘exposed’ group), according to the physician's judgment. Patients were followed up for 30 days after the baseline visit.ResultsAdverse events (AEs) were analysed in 1065 patients; they were reported in 390/711 (54.9%) in the unexposed group, 167/340 (49.1%) patients in the exposed group, and 6/14 prophylaxis patients. Cough and rhinitis were the most common events, reported more often in unexposed children (22.9 and 20.3% respectively) than in exposed children (13.2 and 10.0%; p < 0.001); pyrexia, diarrhoea and vomiting were less common, occurring at similar rates in exposed and unexposed patients. Nasal congestion (3.5%), bronchitis (5.6%) and upper respiratory tract infection (1.5%) were reported more frequently in exposed patients than in unexposed patients (0.7, 2.7 and 0.1% respectively; p < 0.05). In the exposed group, 11.2% of patients (n = 38) experienced 41 AEs considered at least possibly related to oseltamivir, none being assessed as serious. Overall, there were 79 serious AEs in 59 patients. Eleven discontinued treatment because of an AE.Conclusions Oseltamivir has a good tolerability profile in infants and children aged ≤24 months. These findings contributed to the recent FDA approval of oseltamivir for treating infants aged 2–51 weeks. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 10/2014;
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    ABSTRACT: PurposeEstimating drug effectiveness and safety among older adults in population-based studies using administrative health care claims can be hampered by unmeasured confounding as a result of frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding control. Our objective was to develop an algorithm to predict dependency in activities of daily living (ADL) in a sample of Medicare beneficiaries.Methods Community-dwelling respondents to the 2006 Medicare Current Beneficiary Survey, >65 years old, with Medicare Part A, B, home health, and hospice claims were included. ADL dependency was defined as needing help with bathing, eating, walking, dressing, toileting, or transferring. Potential predictors were demographics, International Classification of Diseases, Ninth Revision Clinical Modification diagnosis/procedure and durable medical equipment codes for frailty-associated conditions. Multivariable logistic regression was used to predict ADL dependency. Cox models estimated hazard ratios for death as a function of observed and predicted ADL dependency.ResultsOf 6391 respondents, 57% were female, 88% white, and 38% were ≥80. The prevalence of ADL dependency was 9.5%. Strong predictors of ADL dependency were charges for a home hospital bed (OR = 5.44, 95%CI = 3.28–9.03) and wheelchair (OR = 3.91, 95%CI = 2.78–5.51). The c-statistic of the final model was 0.845. Model-predicted ADL dependency of 20% or greater was associated with a hazard ratio for death of 3.19 (95%CI: 2.78, 3.68).Conclusions An algorithm for predicting ADL dependency using health care claims was developed to measure some aspects of frailty. Accounting for variation in frailty among older adults could lead to more valid conclusions about treatment use, safety, and effectiveness. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 10/2014;
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    ABSTRACT: PurposeThe purpose of this study was to determine the continuation rates of new users of long-acting reversible contraceptive (LARC) methods in the UK, using data from general practice.Methods We conducted an observational study using a general practitioner (GP) database, The Health Improvement Network (THIN). The methods studied were copper intrauterine devices (Cu-IUDs), levonorgestrel-releasing intrauterine system (LNG-IUS), progestogen-only implants and progestogen-only injections. The study population comprised women in THIN aged 18–44 years during the period 2004–2009 who had been registered with their GP for at least 5 years, with a computerized prescription history of at least 1 year. Using computer algorithms, the database was searched for the Read and Multilex codes for each LARC method. New LARC users were identified and followed until there was a record indicating termination of use or the study period ended.ResultsThe proportion of women who discontinued use during the same year of administration was 7.5% for Cu-IUDs, 10.6% for LNG-IUS, 13.2% for progestogen-only implants and 54.4% for progestogen-only injections. By the end of the study, a higher proportion of Cu-IUD and LNG-IUS users (21.1 and 18.6%, respectively) undertook consecutive use of the same method than progestogen-only implant users (10.7%). Manual review of computerized profiles demonstrated the validity of this approach.Conclusions In the UK, the continuation rates of LARCs are high, and approximately one fifth of women chose to have a second intrauterine device fitted after expiry of the first device. A validation step demonstrated the reliability of the methodology and computer algorithms used. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: Background Epidemiologic studies using electronic healthcare data often define the presence or absence of binary clinical outcomes by using algorithms with imperfect specificity, sensitivity, and positive predictive value. This results in misclassification and bias in study results.Methods We describe and evaluate a new method called probabilistic outcome definition (POD) that uses logistic regression to estimate the probability of a clinical outcome using multiple potential algorithms and then uses multiple imputation to make valid inferences about the risk ratio or other epidemiologic parameters of interest. We conducted a simulation to evaluate the performance of the POD method with two variables that can predict the true outcome and compared the POD method with the conventional method.ResultsThe simulation results showed that when the true risk ratio is equal to 1.0 (null), the conventional method based on a binary outcome provides unbiased estimates. However, when the risk ratio is not equal to 1.0, the traditional method, either using one predictive variable or both predictive variables to define the outcome, is biased when the positive predictive value is <100%, and the bias is very severe when the sensitivity or positive predictive value is poor (less than 0.75 in our simulation). In contrast, the POD method provides unbiased estimates of the risk ratio both when this measure of effect is equal to 1.0 and not equal to 1.0. Even when the sensitivity and positive predictive value are low, the POD method continues to provide unbiased estimates of the risk ratio.Conclusions The POD method provides an improved way to define outcomes in database research. This method has a major advantage over the conventional method in that it provided unbiased estimates of risk ratios and it is easy to use. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: Keywords:safety surveillance;insurance claims;electronic medical records;pharmacoepidemiology
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeWe present a database of prescription drugs and international normalized ratio (INR) data and the applied methodology for its use to assess drug–drug interactions with vitamin K antagonists (VKAs). We use the putative interaction between VKAs and tramadol as a case study.Methods We used a self-controlled case series to estimate the incidence rate ratio (IRR) comparing the rate of INR measurements of ≥4.0 in concomitant tramadol and VKA-exposed periods to VKA-only-exposed periods. Secondary analyses considered specific subgroups, alternative exposure criteria, alternative outcome definitions, and other drugs.ResultsWe identified 513 VKA users with at least 1 INR measurement ≥4.0 and concomitant tramadol and VKA exposure during the observation period. The overall IRR was 1.80 (95% confidence interval [CI], 1.53–2.10), with a stronger association among users of phenprocoumon compared to warfarin (IRR, 3.37; 95%CI, 2.50–4.53 and IRR, 1.46; 95%CI, 1.20–1.76, respectively). We observed larger IRRs with stricter outcome definitions. Concomitant tramadol and VKA exposure was also associated with an increased rate of low INR measurements (i.e., <1.5; IRR, 1.70; 95%CI, 1.37–2.13). Morphine and, to some extent, oxycodone, penicillin, beta-blockers, and inhaled beta-agonists were associated with high INR.Conclusions The approach successfully identified an interaction between tramadol and VKA. However, associations observed for other drugs with no known VKA interaction suggest that the current approach may have too low specificity to be useful as a screening tool, at least for drugs for which time-varying confounding may be present. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: IntroductionThe incident user design is the preferred study design in comparative effectiveness (CER) research. Usually, 180–365 days of exposure free time is adequate to remove biases associated with inclusion of prevalent users. In HIV research, the use of antiretrovirals (ARVs) at any time in the past may influence future treatment choices and CER results; thus, identifying naive as opposed to incident users is of importance. We examined misclassification of antiretroviral naive status based on Medicaid administrative data through linkage to the UNC CFAR HIV Clinical Cohort (UCHCC).Methods We identified Medicaid patients with incident exposure to common first-line ARV regimens between 2002 and 2008 that were also patients enrolled in the UCHCC. We calculated the proportion of antiretroviral naive patients based on the UCHCC, among patients identified as having incident exposure in Medicaid and examined factors associated with being antiretroviral naive in both data sources using logistic regression to generate prevalence odds ratios and associated 95% confidence intervals.ResultsOf the 3500 Medicaid patients with incident antiretroviral (ARV) exposure, 1344 were also enrolled in the UCHCC. In this sample, 34% were antiretroviral naive at the time of first exposure in the Medicaid data based on the UCHCC. In multivariable models, higher CD4 cell counts and log HIV RNA values were associated with being antiretroviral naive in both data sources.Conclusions Administrative data are an important source of information related to HIV treatment. As the construction of a durable and long-lasting HIV treatment plan involves knowledge of current and past antiretroviral therapy, augmentation of this data with comprehensive clinical cohort information is necessary. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeType 2 diabetes mellitus has reached epidemic proportions worldwide. Many patients with type 2 diabetes mellitus will require insulin, and the evidence-based use of insulin is described in the prescription drug label. Product labels in different countries may provide inconsistent information. We evaluated the variability in drug label content for one brand of basal insulin across diverse settings.Methods We examined the drug label content pertinent to effective and safe use of insulin glargine across 17 countries: Abu Dhabi (United Arab Emirates), Argentina, Brazil, Canada, China, Germany, Israel, Italy, Japan, Mexico, Russia, Saudi Arabia, South Korea, Spain, Turkey, UK, and the USA. We compared label characteristics in settings where drug labels were governed by a local regulatory authority versus countries where labels were administered by a regional body or adopted from another locale.ResultsAll 17 labels cautioned that providers should consider age, illness, diet, and exercise when prescribing. Only two (12%) described care of the fasting patient. Caution was urged for patients with renal or hepatic impairment in 16 (94%) labels. Four (24%) did not describe responses to missed doses, and five (29%) failed to recommend patient counseling about the risk of hypoglycemia. Labels emerging from regional or adopted regulatory bodies reported fewer patients in efficacy studies than did labels from settings with their own drug regulatory agencies (365 ± 0 patients vs. 3560 ± 2938, p = 0.04).Conclusions There is substantial variation in the content of drug labels for glargine, which may lead to international inconsistency in quality of care for diabetic patients. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
  • Pharmacoepidemiology and Drug Safety 09/2014; 23(9).
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    ABSTRACT: PurposeCardiac glycosides affect several pathways central for tumor formation. We sought to evaluate the association between digoxin use and colorectal cancer (CRC) risk.Methods We conducted a nested case-control study using The Health Improvement Network (THIN), a medical record database representative of the broader UK population. Study cases were defined as those with a diagnostic code for CRC. Each case was matched to up to four eligible controls on age, sex, practice site, and duration of follow-up before index date using incidence density sampling. Exposure of interest was digoxin therapy before index date. The odds ratios (ORs) and 95% confidence intervals (CIs) for CRC associated with digoxin use were estimated using conditional logistic regression analysis, adjusted for BMI, alcoholism, smoking history, diabetes mellitus, heart disease, chronic NSAIDs use and previous screening colonoscopies.ResultsThe case-control analysis included 20 990 CRC patients and 82 054 controls whose mean follow-up time before index date was 6.5 years (SD 4.0). The adjusted OR for CRC among current digoxin users was increased compared with non-users with an adjusted ORs of 1.41 (95%CI 1.25–1.59, p < 0.0001), 1.45 (95%CI 1.22–1.72, p < 0.0001) and 1.41 (95%CI 1.00–1.99, p = 0.049) for first prescriptions 1–5 years, 5–10 years and more than 10 years before index date respectively. Similar results were observed when cumulative duration and number of digoxin prescriptions were analyzed. The risk was not elevated for past digoxin users.Conclusions Current digoxin use is associated with increased CRC risk. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposePharmacovigilance monitors the safety of drugs after their approval and marketing. Timely detection of adverse effects is important. The true relationship between time-varying drug use and the adverse event risk is typically unknown. Yet, most current pharmacovigilance studies rely on arbitrarily chosen exposure metrics such as current exposure or use in the past 3 months. The authors used simulations to assess the impact of a misspecified exposure model on the timeliness of adverse effect detection.Methods Prospective pharmacovigilance studies were simulated assuming different true relationships between time-varying drug use and the adverse event hazard. Simulated data were analyzed by fitting conventional parametric and more complex spline-based estimation models at multiple, pre-specified testing times. The ‘signal’ was generated on the basis of the corrected model-specific p-value selected to ensure a 5% probability of incorrectly rejecting the null hypothesis of no association.ResultsResults indicated that use of an estimation model that diverged substantially from the true underlying association-reduced sensitivity and increased the time to detection of a clinically important association.Conclusions Time to signal detection in pharmacovigilance may depend strongly on the method chosen to model the exposure. No single estimation model performed optimally across different simulated scenarios, suggesting the need for data-dependent criteria to select the model most appropriate for a given study. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeThe abuse and nonmedical use of prescription opioids and its subsequent consequences are an important public health concern. This phenomenon has paralleled the increase in the therapeutic use of opioids for pain management. There is thus a need to measure prescription opioid abuse to understand trends over time and to compare abuse of one product to another. The purpose of this review is to provide an overview of the strengths and weaknesses of frequently used numerators and denominators in “abuse ratios” (ARs).Methods For this review, we critically evaluated the various measures to quantify drug availability and the available data sources to measure prescription opioid abuse.ResultsThere are currently no commonly adopted metrics for measuring either the prevalence of opioid abuse, or abuse relative to drug availability. Because the settings, manifestations, and severity of abuse can vary from one person to the next, no one measure of abuse, abuse-related outcome, or drug exposure is ideal. Each measure of abuse captures a specific facet of abuse, but not the whole spectrum. Reliable estimation of population-adjusted or utilization-adjusted rates of abuse can be accomplished with a prescription opioid AR. This metric estimates the prevalence of abuse in a given population or abuse relative to how much drug is available, and, in certain cases, can be used to compare abuse among various opioid drugs. AR measurements in the literature vary in the inclusion of specific measures of abuse and availability, and there is little consensus in the field regarding which measures allow for the most appropriate approximation of the extent of abuse, and for comparisons among opioids. Crude numbers of outcomes related to abuse (e.g., emergency department visits, treatment admissions, and overdoses) cannot be properly understood without context as these may overestimate or underestimate the true scope and severity of prescription opioid abuse. They can, however, serve as numerators in properly constructed ARs. The denominator of the AR provides the necessary context by accounting for populations at risk or drug availability (e.g., prescriptions or tablets dispensed, unique recipients of dispensed drug, total patient days of therapy, or kilograms sold), and each comes with its own set of assumptions to consider.Conclusions Moving forward, it is important that there be a common understanding in the scientific community regarding how to select appropriate measures to serve as numerators and denominators in AR calculations, and how to interpret the resultant findings. There is no single best measure of abuse for use as a numerator in an AR, and each must be chosen and interpreted in the context of what it measures. For public health considerations, one must always look at both absolute numbers and adjusted numbers. When conducting multiple analyses using different measures of exposure as denominators, differences in ARs are not unexpected, but one should explore why there are differences and assess the appropriateness of each of the denominators. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeSome pregnant women use the internet to search for medical information. However, online information is not controlled. The objectives were to describe French online chats about drugs and pregnancy and evaluate the quality and reliability of information shared by internet users.Methods This French descriptive study was performed in November 2012. In order to identify drugs and pregnancy-related forum websites, we used three French key words: forum, pregnancy and drug. We explored the first 10 websites from the search result. Diseases were described using the International Classification of Diseases and drugs classified with the Anatomical Therapeutic Chemical codes and the FDA risk classification.ResultsWe selected 115 questions that were mainly posted by pregnant internet users in French forums. Drugs raising questions were mostly “nervous system,” “anti-infective for systemic use” and “respiratory system” drugs. The risk during pregnancy for nearly half of these drugs had not been evaluated properly. Health professionals were only involved in 7% of the 214 answers. Internet users advised to take a drug in 21% of their answers. Thirty-four percent of those recommended drugs had not been well-evaluated or were potentially at risk during pregnancy. Finally, 12% of the answers could be at risk for pregnant woman.Conclusions This study shows that information related to drugs and pregnancy in online chats could be at risk for pregnant women. Internet users must be aware that online forums are not reliable sources of information. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeNowadays, the development of antibiotic resistance represents one of the most important issues of the global public health. The incorrect use of antimicrobial drugs is recognized as one of the leading causes of antibiotic resistance. Therefore, a better understanding of the existing pieces of evidence pertaining knowledge and attitudes about antibiotic and antibiotic resistance in the general population worldwide is advisable.MethodsA systematic review and proportion meta-analyses were performed through PubMed and Scopus scientific databases. Cross-sectional studies published from January 2000 to November 2013 and investigating knowledge about antibiotic use and antibiotic resistance were included.ResultsOverall, 26 studies have been selected for the systematic review, and 24 of these were included in the meta-analyses. A lack of knowledge about antibiotics was detected. In particular, 33.7% (95%CI 25.2–42.8) of the sample did not know that antibiotics can treat bacterial infections, and 53.9% (95%CI 41.6–66.0) of them did not know that antibiotics are not useful against viruses. Besides, although 59.4% (95%CI 45.7–72.4) of the sample was aware of antibiotic resistance, 26.9% (95%CI 16.6–38.7) of them did not know that misuse of antibiotics can lead to this problem. Finally, 47.1% (95%CI 36.1–58.2) of the subjects stop taking antibiotics when they start feeling better.Conclusions It would be necessary to strengthen educational initiatives in the community and to push physicians to correctly inform patients in order to make them aware of the importance of a correct behavior concerning antibiotic consumption. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: Background The evidence to date on the relationship between antipsychotic drugs and the risk of venous thromboembolism (VTE) is limited.PurposeOur aim was to examine the association between the use of typical and atypical antipsychotics and risk of VTE and to assess the effects of dose and duration of use.Methods Among users of typical or atypical antipsychotics between 1998 and 2012 in the Clinical Practice Research Datalink, we identified all VTE cases aged 20–59 years with no major risk factors for VTE. From the same population, we randomly selected up to four controls for each case matched on age, sex, general practice, calendar time, and length of medical history. We estimated adjusted odds ratios (aORs) and 95% confidence intervals (CIs) of VTE for current and recent use of antipsychotics compared with non-use using conditional logistic regression.ResultWe identified 868 cases and 3158 matched controls. Compared with non-use, any current use of antipsychotics was associated with a marginally increased risk of VTE: aOR 1.26 (95%CI [0.97, 1.63]); for new users, the aOR was 3.21 (95%CI [1.64, 6.29]). Prochlorperazine and risperidone were associated with elevated risks of VTE (aORs 2.18, 95%CI [1.47, 3.25], and 1.83, 95%CI [0.88, 3.81], respectively).Conclusion The risk of VTE with typical and atypical antipsychotics varies with type of drug and is highest just after starting the drug. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeThe objectives of this study were to develop and validate algorithms to accurately identify patients with diverticulitis using electronic medical records (EMRs).Methods Using Kaiser Permanente Southern California's EMRs of adults (≥18 years) with International Classification of Diseases, Clinical Modifications, Ninth Revision diagnosis codes of diverticulitis (562.11, 562.13) between 1 January 2008 and 31 August 2009, we generated random samples for pilot (N = 692) and validation (N = 1502) respectively. Both samples were stratified by inpatient (IP), emergency department (ED), and outpatient (OP) care settings. We developed and validated several algorithms using EMR data on diverticulitis diagnosis code, antibiotics, computed tomography, diverticulosis history, pain medication and/or pain diagnosis, and excluding patients with infections and/or conditions that could mimic diverticulitis. Evidence of diverticulitis was confirmed through manual chart review. Agreement between EMR algorithm and manual chart confirmation was evaluated using sensitivity and positive predictive value (PPV).ResultsBoth samples were similar in socio-demographics and clinical symptoms. An algorithm based on diverticulitis diagnosis code with antibiotic prescription dispensed within 7 days of diagnosis date, performed well overall. In the validation sample, sensitivity and PPV were (84.6, 98.2%), (95.8, 98.1%), and (91.8, 82.6%) for OP, ED, and IP, respectively.Conclusion Using antibiotic prescriptions to supplement diagnostic codes improved the accuracy of case identification for diverticulitis, but results varied by care setting. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;
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    ABSTRACT: PurposeIn the 2004, FDA placed a black box warning on antidepressants for risk of suicidal thoughts and behavior in children and adolescents. The purpose of this paper is to examine the risk of suicide attempt and self-inflicted injury in depressed children ages 5–17 treated with antidepressants in two large observational datasets taking account time-varying confounding.METHODS We analyzed two large US medical claims databases (MarketScan and LifeLink) containing 221,028 youth (ages 5–17) with new episodes of depression, with and without antidepressant treatment during the period of 2004–2009. Subjects were followed for up to 180 days. Marginal structural models were used to adjust for time-dependent confounding.ResultsFor both datasets, significantly increased risk of suicide attempts and self-inflicted injury were seen during antidepressant treatment episodes in the unadjusted and simple covariate adjusted analyses. Marginal structural models revealed that the majority of the association is produced by dynamic confounding in the treatment selection process; estimated odds ratios were close to 1.0 consistent with the unadjusted and simple covariate adjusted association being a product of chance alone.Conclusions Our analysis suggests antidepressant treatment selection is a product of both static and dynamic patient characteristics. Lack of adjustment for treatment selection based on dynamic patient characteristics can lead to the appearance of an association between antidepressant treatment and suicide attempts and self-inflicted injury among youths in unadjusted and simple covariate adjusted analyses. Marginal structural models can be used to adjust for static and dynamic treatment selection processes such as that likely encountered in observational studies of associations between antidepressant treatment selection, suicide and related behaviors in youth. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014;