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
  • Conditions
    • See Wiley-Blackwell entry for articles after February 2007
    • On personal web site or secure external website at authors institution
    • Not allowed on institutional repository
    • JASIST authors may deposit in an institutional repository
    • Non-commercial
    • Pre-print must be accompanied with set phrase (see individual journal copyright transfer agreements)
    • Published source must be acknowledged with set phrase (see individual journal copyright transfer agreements)
    • 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: Studies on the safety of drugs used during pregnancy are necessary and important but prone to bias. Using cases as their own controls can reduce bias. We used a case-crossover design and a case-time-control design to estimate the risk of congenital malformation (CM) for children born to mothers who redeemed a trimethoprim prescription shortly before pregnancy.
    Pharmacoepidemiology and Drug Safety 08/2014;
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    ABSTRACT: Objective The goal of this study is to compare patient-reported quality of life (PRQOL) evolution between two groups of end-stage renal disease patients with secondary hyperparathyroidism (SHPT). The first with a cinacalcet prescription within 3 months after a diagnosis of SHPT (early group) and a second group of patients with a later or no cinacalcet prescription (nonearly group).Patients and methodsFrom 2009 to 2012, we conducted a multicenter pharmaco-epidemiologic study in Lorraine region (France) including all consecutive patients on maintenance dialysis for at least 3 months with a diagnosis of SHPT (PTH > 500 pg/ml or first cinacalcet prescription). PRQOL was estimated using the Kidney Disease Quality Of Life-Short Form questionnaire, at baseline and at 6 and 12 months follow-up. Change in PRQOL was compared between the groups and adjusted with a propensity score.ResultsWe included 124 patients: 44 in the early group and 80 in the nonearly group. The mental component summary score was lower in the early group, at baseline (43.6 ± 6.6 vs 46.6 ± 7.6; p = 0.030), and at the follow-up assessment (42.6 ± 6.9 vs 45.7 ± 7.9; p = 0.033). We found no difference between the groups in change in PRQOL, for all dimensions, even after adjustment with the propensity score. Mean serum alkaline phosphatase levels were normal in both groups at baseline (80.9 ± 32.5 vs 95.1 ± 39.6; p = 0.41).Conclusion Cinacalcet prescription immediately following diagnosis of SHPT does not seem to be associated with better PRQOL evolution at 1 year. Mean serum alkaline phosphatase levels suggest that physicians should consider waiting for another PTH assay result before starting cinacalcet in case of a PTH rise. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 08/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Keywords:Spontaneous reports;Drug withdrawal;Regulatory decision making;pharmacoepidemiology
    Pharmacoepidemiology and Drug Safety 08/2014;
  • Pharmacoepidemiology and Drug Safety 08/2014;
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    ABSTRACT: Background Animal studies have suggested that drugs inhibiting the enzyme histone deacetylase might have a beneficial effect on multiple sclerosis (MS). Valproic acid (VPA), an anti-epileptic drug, is the only widely used human drug with a histone deacetylase inhibitory effect.Objective The objective of this paper is to examine if VPA use is associated with a reduced risk of MS.Methods We conducted a propensity score-matched cohort study in the period 1997–2011 linking nationwide register data on filled VPA prescriptions, MS cases, and several covariates. The VPA users were matched on propensity scores in a 1:4 ratio with non-users of VPA. Incidence rates of MS were compared among VPA users and non-users of VPA using Cox regression to estimate hazard ratios (HRs).ResultsAmong 16 028 ever-users of VPA and 54 172 non-users, 18 and 26 cases of MS were identified, respectively. Neither current VPA users nor recent users of VPA, who had ceased VPA treatment within the last year, were at a reduced risk of MS compared with non-users of VPA (HR = 1.30 (95% confidence interval, 0.44–3.80), n = 4, and HR = 1.22 (0.28–5.32), n = 2, respectively). Similarly, in an intention-to-treat analysis, ever-users of VPA were not at reduced risk of MS (HR = 2.41 (1.32–4.43), n = 18).Conclusion In the first human study addressing a possible beneficial effect of VPA use on the risk of MS, we found no support for a protective effect. However, given the wide confidence intervals, only large effects can be ruled out with sufficient certainty. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 08/2014;
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    ABSTRACT: PurposeThis study estimates the prevalence in US counties of opioid patients who use large numbers of prescribers, the amounts of opioids they obtain, and the extent to which their prevalence is predicted by ecological attributes of counties, including general medical exposure to opioids.Methods Finite mixture models were used to estimate the size of an outlier subpopulation of patients with suspiciously large numbers of prescribers (probable doctor shoppers), using a sample of 146 million opioid prescriptions dispensed during 2008. Ordinary least squares regression models of county-level shopper rates included independent variables measuring ecological attributes of counties, including rates of patients prescribed opioids, socioeconomic characteristics of the resident population, supply of physicians, and measures of healthcare service utilization.ResultsThe prevalence of shoppers varied widely by county, with rates ranging between 0.6 and 2.5 per 1000 residents. Shopper prevalence was strongly correlated with opioid prescribing for the general population, accounting for 30% of observed county variation in shopper prevalence, after adjusting for physician supply, emergency department visits, in-patient hospital days, poverty rates, percent of county residents living in urban areas, and racial/ethnic composition of resident populations. Approximately 30% of shoppers obtained prescriptions in multiple states.Conclusions The correlation between prevalence of doctor shoppers and opioid patients in a county could indicate either that easy access to legitimate medical treatment raises the risk of abuse or that drug abusers take advantage of greater opportunities in places where access is easy. Approaches to preventing excessive use of different prescribers are discussed. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 08/2014;
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    ABSTRACT: PurposeThis study was performed to evaluate the change of prescribing patterns after the regulatory action regarding fluoroquinolones in pediatric patients.Methods We conducted a time series analysis using the Korea Health Insurance Review and Assessment Service National Patients Sample database. Study subjects consisted of pediatric patients under 18 years of age who were prescribed antibiotics at least once (ATC code, J01) before (January 2009–December 2009) and after implementation (January 2010–December 2011) of the regulation. The use of fluoroquinolones was defined as the use of the following antibiotics for at least once in pediatric patients: ofloxacin, ciprofloxacin, norfloxacin, lomefloxacin, levofloxacin, and gemifloxacin. We calculated the number of pediatric fluoroquinolone users for each month. The difference between proportions before and after the regulation was estimated as relative and absolute reduction of fluoroquinolone use. We calculated 95% confidence intervals (CI).ResultsWe identified 4, 945, 169 antibiotic prescriptions in 484, 914 pediatric patients. During the 12-month period before implementation, percentage of fluoroquinolone use was 4.81% (95% CI: 4.70–4.91%, N = 8001). We observed a rapid decrease in the monthly number of fluoroquinolone users in pediatric population after the implementation of regulatory action. In the year after regulatory action, the percentage of fluoroquinolone use was only 0.26% (95% CI: 0.24–0.28%, N = 834). Overall, there was a 94.55% relative reduction (95% CI: 88.02–101.56%) in the use of fluoroquinolones.Conclusion Korean regulatory actions regarding fluoroquinolones had an effect of reducing use in pediatric population. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 08/2014;
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    ABSTRACT: A growing number of patients today receive anticoagulants. These drugs can cause serious adverse reactions leading to patients' hospitalization. The present study aimed to assess the number of hospital admissions as a result of anticoagulant adverse reactions in Alsace, a French region of 1.8 million inhabitants, and to estimate the economic burden associated with their management.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: The aim of this study is to study the mortality rate in so-called "metformin-associated lactic acidosis" (MALA) from the 1960s to date and to establish whether the rate has changed over time.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: Little is known about the contribution of telephone-based prescribing on overall antibiotic utilization. The objective of this study was to determine the extent and characteristics of telephone-based antibiotic prescribing in teaching and non-teaching primary care practices.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: To compare cardiovascular and mortality risks in elderly patients treated with varenicline or bupropion for smoking cessation.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: PurposeTo enable easier access to triptans, the drug of choice for moderate to severe migraine, some countries have made triptans available without prescription, that is, over the counter (OTC). Concern has been raised about this. The aim of this study was to describe the utilization pattern of triptans in Sweden before and after the OTC switch.Methods Wholesaler and aggregated sales data from all Swedish pharmacies 1991 to 2011 and patient identity data on dispensed prescriptions 2007 and 2011 from the Swedish National Prescribed Drug Register were used to investigate volume and expenditure of triptans. The databases contain complete data for all drugs sold in Sweden or dispensed to all Swedish inhabitants (9.5 million in 2012).ResultsVolumes of triptans have increased to 7.0 million defined daily doses (DDD) on prescriptions and 0.7 million DDDs OTC in 2011. Prescriptions were dispensed to 10.0 and 10.1 per 1000 inhabitants in 2007 and 2011, respectively. Although half of those dispensed triptans in 2007 were not in 2011, the incidence remained stable at 2.8 patients per thousand person-years. In 2011, the 10% of the heaviest users accounted for 44% and 48% of dispensed triptans in women and men, respectively.Conclusions Triptans OTC and the volumes dispensed on prescription have increased as has the DDD per patient purchasing triptans on prescription. However, the number of patient's dispensed triptans on prescription has remained stable. A concern is that almost half of prescribed triptans are purchased by 10% of the users. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: PurposeThe goal of this study is to develop and validate an algorithm to identify Prolia® users within a health insurance claims database.Methods Patients with a denosumab-specific or nonspecific administration claim during the early period of Prolia availability in the USA (June 1, 2010 to March 31, 2012) were classified as definite, probable, possible, and nonusers of Prolia using an algorithm consisting of nine different components based on claims patterns consistent with Prolia use. Medical record review confirmed a sample of definite, probable, and possible users and the positive predictive value (PPV) was estimated.ResultsThe PPV of the claims-based algorithm components varied (17.8–95.8%). Requiring claims for a bone or cartilage disorder or osteoporotic fracture after excluding claims for cancer prior to a denosumab-specific administration code gave the highest PPV (95.8%), followed by requiring a Prolia National Drug Code on the same claim as a denosumab-specific or nonspecific administration code (88.2%). Among the 87 confirmed Prolia users, osteoporosis diagnoses were seen more frequently in the medical record than in claims (83% vs 62%).Conclusions Prolia users are most accurately identified with administration code claims in conjunction with claims for Prolia National Drug Code and bone disorder treatment and diagnosis codes. Osteoporosis diagnoses may be under-recorded in claims data. The algorithm may require reassessment as uptake for more recently approved indications increases. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: Background Several studies have indicated that statins may have anticarcinogenic effects. The aim of the present study was to investigate if statin treatment was associated with a reduced risk of hepatocellular carcinoma (HCC) or colon cancer.MethodsA nationwide case-control study was carried out in which all cases of HCC and colon cancer in the Swedish population above 40 years of age between 1 July 2006 and 31 December 2010 were identified in the Swedish Cancer Register. For every case, five controls were selected and matched on age and sex. Data on statin use was extracted from the Swedish Prescribed Drug Register. We estimated risks using conditional logistic regression and adjusted for educational level, concomitant medications and comorbidity.ResultsIdentified were 3994 cases of HCC and matched with 19.970 controls, and 21.143 cases of colon cancer were identified and matched with 105.715 controls. In the adjusted analysis, the odds ratio (OR) for HCC among statin users was 0.88 (95% confidence interval (CI) 0.81–0.96), and the OR for colon cancer was 1.04 (95%CI 1.00–1.08) compared with non-users.Conclusion Statin use was associated with a modest decreased risk of HCC but did not influence the risk of colon cancer. Future randomized placebo-controlled trials in HCC high-risk patients are warranted to further investigate the possible prophylactic effect of statins in HCC. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: PurposeThe aims of this study are to examine the validity of diagnostic codes for psoriatic arthritis in The Health Improvement Network (THIN) and to examine the agreement between General Practitioner (GP) report and prescription records for disease modifying antirheumatic drugs (DMARDs).Methods Questionnaires were sent to the GPs of 100 randomly selected patients with at least one medical record code for psoriatic arthritis. The positive predictive value (PPV) for a GP confirmed diagnosis was calculated, and alternative algorithms were examined to determine which method resulted in the highest PPV.ResultsThe PPV for a single code for psoriatic arthritis was 85% (95%CI: 75.8–91.7%). Adding a prescription for a DMARD increased the PPV to 91% but with a substantial loss in sensitivity. Agreement between GPs and prescription data for use of an oral DMARD was 69%.Conclusions The diagnosis codes for psoriatic arthritis used in THIN are valid. All prescriptions for DMARDs may not be accounted for in THIN. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: PurposeThe purpose of this study is to assess pregnancy outcomes of women treated with a novel neuraminidase inhibitor, laninamivir, during pregnancy.MethodsA retrospective review of pregnancy outcomes of 112 pregnant women who were given laninamivir for treatment of influenza was performed. Possible adverse events, including miscarriages, preterm birth, foetal malformation and any neonatal morbidity requiring treatment, were assessed.ResultsSeventeen, 39, 46 and 10 women were administered a single inhaled dose of 20 or 40 mg of laninamivir at gestational week (GW) 3–11, 12–21, 22–36 and 37 or more, respectively. One (1.8%) of 56 women with laninamivir at GW <22 experienced miscarriage at GW <12. The remaining 111 women gave birth to 111 viable infants but at preterm (GW <37) in nine (8.8%) of 102 women with laninamivir at GW <37. Three (2.7%) of the 111 newborns had malformations: forefoot varus deformity, foot polydactyly and cleft lip in one each born to a mother taking laninamivir at GW 6, 17 and 21, respectively. Five neonates (4.5%) were small for gestational age. Eleven (9.9%), five (4.5%) and no neonates required phototherapy for jaundice, transient respiratory supports for respiratory distress syndrome (n = 2) or transient tachypnoea of the newborn (n = 3), and glucose administration for hypoglycaemia, respectively.Conclusions Although this study included a small number of study women and no control women, the results suggested that maternal exposure to laninamivir did not increase the rate of adverse pregnancy and foetal outcomes. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;
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    ABSTRACT: PurposeThis study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information.Methods This retrospective study compared the reported information between 200 ADR reports of patients and HCPs. Reports were rendered anonymous and scored for the presence or absence of predefined elements of information. These elements can be objective (e.g. start date of the ADR) or subjective (e.g. the impact or severity of the ADR).A two-sided Pearson's Chi-square test was used to detect statistically significant differences in the reported information. A Bonferroni correction was used to correct for multiple comparisons. Correlation between the elements of information was explored using categorical principal components analysis (CATPCA).ResultsOverall, HCPs had a higher score for the presence of objective and patients for subjective elements of information. Elements that were statistically significant more often reported by patients are the impact of the ADR and the patient's weight and height. HCPs statistically significant more often reported the medical history and the route of administration of the drug. CATPCA showed four clusters of elements of information that have fair correlation.Conclusions This study demonstrates the differences in reported information between ADR reports of patients and HCPs. Patient reports are more focused on patient-related information and the impact of the reported ADRs, whereas reports from HCPs provide more clinically related information. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 07/2014;

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