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

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    • 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
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    • Non-commercial
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    • 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: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. This retrospective cohort study used 1997-2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records). We compared the prevalence of OCs in infants of women exposed to TPM in the first trimester (TPM cohort) with the prevalence in infants of women formerly exposed to TPM or other antiepileptic drugs (formerly exposed [FE] cohort) and infants of women with similar medical profiles (SMPs) to the TPM cohort that were not exposed to TPM (SMP cohort). To control for confounding, we used stratification and standardization for individual variables and propensity score deciles. The birth prevalence of OCs was 0.36% (7/1945) in the TPM cohort, 0.14% (20/13 512) in the FE cohort, and 0.07% (9/13 614) in the SMP cohort. Standardized by site, the prevalence ratio (PR) for TPM versus FE was 2.5 (95% CI: 1.0-6.0) and for TPM versus SMP was 5.4 (95% CI: 2.0-14.6). Adjustment for covariates one at a time or by propensity score yielded similar results. Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 04/2014;
  • Pharmacoepidemiology and Drug Safety 04/2014; 23(4):435-6.
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    ABSTRACT: Purpose Given the metabolic and neurologic side effects of antipsychotics and concerns about the increased risks associated with concomitant use, antipsychotic polypharmacy is a quality concern. This study assessed the operating characteristics of a Medicaid claims-based measure of antipsychotic polypharmacy. Methods A random sample from 10 public mental health clinics and 312 patients met criteria for this study. Medical record extractors were blind to measure status. We examined the prevalence, sensitivity, specificity, and positive predictive value (PPV) in Medicaid claims, testing nine different definitions of antipsychotic polypharmacy, including >14, >60, or >90 days concurrent use of ≥2 antipsychotic agents, each with allowable gaps of up to 0, 14, or 32 days in days' supply of antipsychotic medications. Results All Medicaid claims measure definitions tested had excellent specificity and PPV (>91%). Good to excellent sensitivity was dependent upon use of a 32-day gap allowance, particularly as duration of concurrent antipsychotic use increased. The proposed claims-based measure (90-day concurrent use of ≥2 or more antipsychotics, allowing for a 32-day gap) had excellent specificity (99.1%, 95%CI: 98.2-99.6) and PPV (90.9%, 95%CI: 83.1-95.7) with good sensitivity (79.4%, 95%CI: 70.4-86.6). The overall level of concordance between claims and medical record-based categorization of antipsychotic polypharmacy was high (96.4%, n = 301/312 clients, Cohen's K = 84.7, 95%CI: 75.9-93.5). Discrepant cases were reviewed, and implications are discussed. Conclusions Administrative claims data can be used to construct valid measures of antipsychotic polypharmacy. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: Antihyperglycemic medication intensification practices among patients with incident diabetes are incompletely understood. We characterized the first intensification the year after oral antihyperglycemic medication initiation among incident diabetes patients. This retrospective cohort study across 11 US health systems included adults identified with incident diabetes between 2005 and 2009 who started oral antihyperglycemic monotherapy or combination therapy within 6 months after diabetes identification. We determined intensification, defined as increased index medication dosage, addition of another oral medication, or switch to/addition of insulin 31-365 days after initial antihyperglycemic dispensing. Cox regression was used to assess intensification for patient, temporal, and system covariates, adjusting for glycosylated hemoglobin (HbA1c) as a time-dependent variable. Among 41 233 patients, 33.5% and 45.3% had treatment intensified within 6 and 12 months, respectively. This first intensification was most often with increased index medication dosage (78%), least often with insulin (<1%). HbA1c% was strongly associated with intensification (adjusted hazard ratios [HR] 1.59, 3.62, 4.44, and 5.52 for HbA1c 6.5% to <7%, 7% to <7.5%, 7.5 to <8%, and ≥8%, respectively, all P < 0.001, compared with HbA1c < 6.5%). In patients initially on monotherapy, age modified the HbA1c effect: at HbA1c < 7%, the HR differed little between middle-aged and older patients; at HbA1c ≥ 7%, the HR decreased with older age (e.g., age 40-49 years and HbA1c ≥ 8%: HR 8.14; age ≥ 80 years and HbA1c ≥ 8%: HR 4.44; compared with age ≥ 80 years and HbA1c < 6.5%). Within 1 year, 84.3% achieved HbA1c < 8%; 65.1% achieved HbA1c < 7%. Clinicians appear to be applying treatment intensification guidelines and individualizing therapy by considering patient age, achieving glycemic control among most incident diabetes patients. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: To assess the long-term efficacy and safety of DPP-IV inhibitors therapy versus comparators in patients with T2DM. A comprehensive search for randomized controlled trials (RCTs; ≥24 weeks) was performed. RCTs had to compare DPP-IV inhibitors therapy with placebo, metformin and sulphonylureas + metformin. Inverse variance mean difference (IV-MD) with 95%CI was calculated for the mean HbA1c changes (%) from baseline to (imputed) endpoint. Mantel-Haenszel odds ratio (MH-OR) with 95%CI was calculated for side reactions. Twenty-three RCTs were included. The mean HbA1c changes (%) were as follows: IV-MD, 95%CI = -0.35 [-0.51, -0.19], p < 0.0001 for DPP-IV inhibitors therapy versus comparators, and IV-MD, 95%CI = 0.11 [0.04, 0.18], p = 0.002 for DPP-IV inhibitors + met versus su + met. For hypoglycaemia, MH-OR, 95%CI = 0.13 [0.09, 0.19], p < 0.00001(DPP-IV inhibitors + met vs. su + met). For diarrhoea, MH-OR, 95%CI = 0.77 [0.64, 0.93], p = 0.008 (DPP-IV inhibitors + met vs. met). By comparing DPP-IV inhibitors therapy with comparators, we found 95%CI = 0.00 [-0.01, 0.01], p = 0.49, for the upper respiratory tract infection MH-OR; 95%CI = 0.97 [0.70, 1.34], p = 0.83 for the urinary tract infection MH-OR; and 95%CI = 1.07 [0.94, 1.21], p = 0.30 for nasopharyngitis MH-OR. DPP-IV inhibitors could achieve a long-term effective and safe glycaemic control for use as monotherapy or in combination with metformin. They have low incidences of hypoglycaemia and gastrointestinal side effects. There is no evidence that DPP-IV inhibitors increase the risk of infections. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: Several clinical trials have shown that rhythm-control drugs have serious adverse events and no survival advantage over rate-control drugs in patients with atrial fibrillation. The objectives were to determine and explain the recent trends in outpatient prescribing of both drug classes. Data were obtained over 10 years from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. Visits by patients with atrial fibrillation were identified by ICD-9 diagnosis code 427.31. Trend lines were estimated for drug prescribing and comorbidities. A multinomial logistic model was estimated to predict treatment on the basis of visit characteristics. The percentage of visits mentioning only a rate-control medication trended upward (p = 0.07) from 41.9% in 2001 to 47.3% in 2010; the percentage mentioning both rhythm-control and rate-control drugs also had an upward trend (p < 0.05) from 3.1% to 12.5%; finally, the percentage mentioning rhythm-control drugs alone remained steady (p = 0.37). Consistent with the increase (p = 0.10) in the percentage of visits mentioning hypertension, there was a statistically significant (p < 0.01) rise in the prescribing of β-blockers from 20.5% to 43.4%. The odds that a patient aged 65 years or younger was prescribed a rhythm-control medication were significantly higher (p < 0.01) than those for a patient older than 65 years. The estimated odds that a diabetic patient was prescribed both rhythm-control and rate-control medications was only 0.269 (p < 0.05). This study documents change in the outpatient treatment of atrial fibrillation in the USA from 2001-2010. In clinical practice, there has been a growing reliance on rate-control medications. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
  • [show abstract] [hide abstract]
    ABSTRACT: This study aimed to describe the trends in use of Attention Deficit Hyperactivity Disorders (ADHD) medication during pregnancy in Denmark from 1999 to 2010, as well as to explore characteristics of women who use ADHD medication during pregnancy and whether exposure is associated with outcome of pregnancy. A linkage between various Danish national health registries was performed to identify all recorded pregnancies from 1999 to 2010. Use of ADHD medication was defined as a redeemed prescription on methylphenidate, modafinil, or atomoxetine from 28 days prior to the first day of the last menstrual period until the end of pregnancy. Of the 1 054 494 registered pregnancies, 480 were exposed to ADHD medication. From 2003 to the first quarter of 2010, use of ADHD medication during pregnancy increased from 5 to 533 per 100 000 person-years. A similar increase was observed among Danish women of childbearing age. Compared with unexposed, women who used ADHD medication during pregnancy were more often younger, single, lower educated, received social security benefits, and used other psychopharmaca. Exposed pregnancies were more likely to result in induced abortions on maternal request (odds ratio = 4.70, 95%CI = 3.77-5.85), induced abortions on special indication (odds ratio = 2.99, 95%CI = 1.34-6.67), and miscarriage (odds ratio = 2.07, 95%CI = 1.51-2.84) compared with unexposed pregnancies. The number of pregnancies exposed to ADHD medication has increased similarly to the increase in use of ADHD medication among women of childbearing age. Use of ADHD medication in pregnancy was associated with different indicators of maternal disadvantage and with increased risk of induced abortion and miscarriage. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
  • Pharmacoepidemiology and Drug Safety 03/2014;
  • [show abstract] [hide abstract]
    ABSTRACT: To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3 person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be 'ruled out'. It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined 'hypersensitivity', and the incidence was 0.9% (4/445) among abacavir naïve patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea. The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
  • [show abstract] [hide abstract]
    ABSTRACT: Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7 person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be "ruled out." It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were "hyperlipidemia," "nausea," "increased γ-glutamyltransferase level," "increased blood triglycerides," "abnormal hepatic function," and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion). During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
  • Pharmacoepidemiology and Drug Safety 03/2014; 23(3).
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    ABSTRACT: PurposeDrug-induced liver injury (DILI) is one of the primary targets for pharmacovigilance using medical information databases (MIDs). Because of diagnostic complexity, a standardized method for identifying DILI using MIDs has not yet been established. We applied the Digestive Disease Week Japan 2004 (DDW-J) scale, a Japanese clinical diagnostic criteria for DILI, to a DILI detection algorithm, and compared it with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) scale to confirm its consistency. Characteristics of DILI cases identified by the DDW-J algorithm were examined in two Japanese MIDs. Methods Using an MID from the Hamamatsu University Hospital, we constructed a DILI detection algorithm on the basis of the DDW-J scale. We then compared the findings between the DDW-J and CIOMS/RUCAM scales. We examined the characteristics of DILI after antibiotic treatment in the Hamamatsu population and a second population that included data from 124 hospitals, which was derived from an MID from the Medical Data Vision Co., Ltd. We performed a multivariate logistic regression analysis to assess the possible DILI risk factors. ResultsThe concordance rate was 79.4% between DILI patients identified by the DDW-J and CIOMS/RUCAM; the Spearman rank correlation coefficient was 0.952 (P < 0.0001). Men showed a significantly higher risk for DILI after antibiotic treatments in both MID populations. Conclusions The DDW-J and CIOMS/RUCAM algorithms were equivalent for identifying the DILI cases, confirming the utility of our DILI detection method using MIDs. This study provides evidence supporting the use of MID analyses to improve pharmacovigilance. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: PurposeNursing home residents are of particular interest for comparative effectiveness research given their susceptibility to adverse treatment effects and systematic exclusion from trials. However, the risk of residual confounding because of unmeasured markers of declining health using conventional analytic methods is high. We evaluated the validity of instrumental variable (IV) methods based on nursing home prescribing preference to mitigate such confounding, using psychotropic medications to manage behavioral problems in dementia as a case study.MethodsA cohort using linked data from Medicaid, Medicare, Minimum Data Set, and Online Survey, Certification and Reporting for 2001–2004 was established. Dual-eligible patients ≥65 years who initiated psychotropic medication use after admission were selected. Nursing home prescribing preference was characterized using mixed-effects logistic regression models. The plausibility of IV assumptions was explored, and the association between psychotropic medication class and 180-day mortality was estimated.ResultsHigh-prescribing and low-prescribing nursing homes differed by a factor of 2. Each preference-based IV measure described a substantial proportion of variation in psychotropic medication choice (β(IV → treatment): 0.22-0.36). Measured patient characteristics were well balanced across patient groups based on instrument status (52% average reduction in Mahalanobis distance). There was no evidence that instrument status was associated with markers of nursing home quality of care.Conclusion Findings indicate that IV analyses using nursing home prescribing preference may be a useful approach in comparative effectiveness studies, and should extend naturally to analyses including untreated comparison groups, which are of great scientific interest but subject to even stronger confounding. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: PurposeAssessing the safety and effectiveness of medical products with observational electronic medical record data is challenging when the treatment is time-varying. The objective of this paper is to develop a Cox model stratified by event times with stabilized weights (SWs) adjustment to examine the effect of time-varying treatment in observational studies. Methods Time-varying SWs are calculated at unique event times and are used in a Cox model stratified by event times to estimate the effect of time-varying treatment. We applied this method in examining the effect of an antiplatelet agent, clopidogrel, on events, including bleeding, myocardial infarction, and death after a drug-eluting stent was implanted in coronary artery. Clopidogrel use may change over time on the basis of patients' behavior (e.g., non-adherence) and physicians' recommendations (e.g., end of duration of therapy). We also compared the results with those from a Cox model for counting processes adjusting for all covariates used in creating SWs. ResultsWe demonstrate that the (i) results from the stratified Cox model without SWs adjustment and the Cox model for counting processes without covariate adjustment are identical in analyzing the clopidogrel data; and (ii) the effects of clopidogrel on bleeding, myocardial infarction, and death are larger in the stratified Cox model with SWs adjustment compared with those from the Cox model for counting processes with covariate adjustment. Conclusions The Cox model stratified by event times with time-varying SWs adjustment is useful in estimating the effect of time-varying treatments in observational studies while balancing for known confounders. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: PurposeThe aim of this study was to describe trends in attention deficit hyperactivity disorder (ADHD) drugs consumption in Israel (Ritalin, Concerta, Daytrana, Vyvanse, Focalin, and Adderall) over the 8 years, 2005–2012, and to explore explanations for changes in amounts and patterns of the utilization. Methods Data for the period from 2005 to 2012 were extracted from the database maintained by the Israel Ministry of Health's Pharmaceutical Administration. The data were converted into a defined daily dose (DDD) per 1000 inhabitants per day. ResultsConsumption of all ADHD drugs covered by Israel's national health care system doubled over the study period, from 4.02 DDD/1000 inhabitants/day in 2005 to 9.92 DDD/1000 inhabitants/day in 2012. This rise was largely due to a fivefold increase in Concerta consumption (from 0.46 DDD/1000 inhabitants/day in 2005 to 2.28 DDD/1000 inhabitants/day in 2012) and a threefold increase in Ritalin consumption (from 1.43 DDD/1000 inhabitants/day in 2005 to 4.84 DDD/1000 inhabitants/day in 2012). Adderall (amphetamine mixed salts) consumption rose by 30% for the same period. A substantial trend was noted for increased utilization of high-dose formulations together with proportional decline in low-dose consumption. In the same period, cost of the medications has been reduced an average by 20–25%. Conclusions There has been a drastic rise in ADHD drugs consumption in Israel over 2005–2012. This has been associated with substantial reduction in cost and changes in the pattern of prescribing that characterized by increased prescription of high-dose long-acting preparations of ADHD drugs and decreased prescription of their low-dose, short-acting formulations. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: PurposeDetermining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-dependent covariates. An important class of continuous time-dependent covariates is that denoting cumulative duration of exposure.Methods We used fractional polynomial methods to describe the association between cumulative duration of exposure and adverse outcomes. We applied these methods in a cohort study to examine the relationship between cumulative duration of use of the antiarrhythmic drug amiodarone and the risk of thyroid dysfunction. We also used these methods with a conditional logistic regression model in a nested case-control study to examine the relationship between cumulative duration of use of bisphosphonate medication and the risk of atypical femur fracture.ResultsUsing a cohort design and a Cox proportional hazards model, we found a non-linear relationship between cumulative duration of use of the antiarrhythmic drug amiodarone and the risk of thyroid dysfunction. The risk initially increased rapidly with increasing cumulative use. However, as cumulative duration of use increased, the rate of increase in risk attenuated and eventually levelled off. Using a nested case-control design and a conditional logistic regression model, we found evidence of a linear relationship between duration of use of bisphosphonate medication and risk of atypical femur fractures.Conclusions Fractional polynomials allow one to model the relationship between cumulative duration of medication use and adverse outcomes. © 2013 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
  • Pharmacoepidemiology and Drug Safety 03/2014; 23(3).
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    ABSTRACT: PurposeTo estimate prevalences of hospital admissions/visits associated with actual drug–drug interactions (DDIs) and examine the effect of study design (prospective vs. retrospective), population (all ages or adults), and method of detecting DDIs on reported prevalences. Methods PubMed, International Pharmaceutical Abstracts, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature plus, and the Cochrane Database of Systematic Reviews up to October 2013 were searched for observational studies examining actual DDIs, in any language. The outcomes in this study were DDI prevalence rates in total populations, DDI prevalence rates in total adverse drug reaction patients, and frequency (%) of each pair of DDIs. ResultsThirteen studies met our inclusion criteria. The median DDI prevalence rate for hospital admissions was 1.1% (367 DDI cases/47 976 patients, interquartile range [IQR] 0.4–2.4%). The median DDI prevalence rate for hospital visits was 0.1% (20 DDI cases/23 607 patients, IQR 0.0–0.3%). In adverse drug reaction patients, the median DDI prevalence rate for hospital admissions (308 DDI cases/1683 patients) and hospital visits (8 DDI cases/90 patients) were 22.2% (IQR 16.6–36.0%) and 8.9%, respectively. Medical record, interview, drug interaction screening program, adverse reaction report, and electronic medical record were identified as methods used for detecting DDIs. Non-steroidal anti-inflammatory drugs were most commonly involved in hospital admission associated DDIs, whereas warfarin was frequently involved in DDIs detected at hospital visits as outpatients/emergencies. Conclusions Drug–drug interactions are a significant cause of hospital admissions and hospital visits. Improved DDI information gathering could help to reduce such adverse effects from DDIs, especially for patients using non-steroidal anti-inflammatory drugs and warfarin. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;
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    ABSTRACT: PurposeWe aimed to identify modifiable, routinely available patient characteristics associated with adverse experiences potentially attributable to efavirenz-based regimens in patients in Botswana.MethodsHIV-infected treatment naïve individuals starting a standard antiretroviral regimen including two nucleoside analog reverse transcriptase inhibitors and efavirenz in Botswana were enrolled in a prospective cohort. Adverse experiences were measured at 1 and 6 months using the efavirenz checklist, a 35-item instrument developed by the AIDS Clinical Trials Group.ResultsWe enrolled 232 patients from 11 March 2010 to 17 March 2011. One hundred ninety-six were included in the month 1 analyses. Of the 196 included in the month 1 analyses, 157 (80%) completed the 6-month follow-up. Median efavirenz checklist score was 6 (interquartile range (IQR): 2–15) at month 1 and 1 (IQR: 0–5) at month 6. The median change in efavirenz checklist score from month 1–6 was −4 (IQR: −11 to −1), representing an improvement. Depressive symptoms, low CD4 count and less alcohol use were associated with improvement in adverse experiences over time. Low weight was associated with increased extent of adverse experiences at month 1 and 6. There was no confounding or effect modification.Conclusions Clinicians may want to consider more intensive and tailored adverse experience education and management in patients based on depressive symptoms, CD4 count, and weight. Further assessment of the mechanism of the effect of alcohol use on adverse experiences, including analysis of CYP2B6 genotype and plasma efavirenz concentrations, is warranted. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2014;

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