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  • 1.
    Aagaard, Lise
    et al.
    University of So Denmark, Denmark FKL Research Centre Qual Medical Use, Denmark Danish Pharmacovigilance Research Project DANPREP, Denmark .
    Strandell, Johanna
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Melskens, Lars
    University of Copenhagen, Denmark .
    Petersen, Paw S. G.
    University of Copenhagen, Denmark .
    Holme Hansen, Ebba
    FKL Research Centre Qual Medical Use, Denmark Danish Pharmacovigilance Research Project DANPREP, Denmark University of Copenhagen, Denmark .
    Global Patterns of Adverse Drug Reactions Over a Decade Analyses of Spontaneous Reports to VigiBase (TM)2012In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 35, no 12, p. 1171-1182Article in journal (Refereed)
    Abstract [en]

    Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. Objective: The aim of the study was to characterize ADRs reported to the WHO-ADR database, VigiBase (TM), and to relate data to national income. Methods: We analysed ADR reports submitted to VigiBase (TM) from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. Reports were also analysed with respect to national income level, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high. Results: We analysed 1 359 067 ADR reports including 3 013 074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3-613 reports/million inhabitants/year) and low-income countries the lowest (range 0-21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was non-significant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. Conclusion: This study showed that high-income countries had the highest ADR reporting rates and low-income countries the lowest, with large variations across countries in each group. Significant differences in ADR reporting rates were only found for ADRs of the type skin and subcutaneous tissue disorders and for the therapeutic groups antiinfectives for systemic use and antineoplastic and immunomodulation agents. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large variations in ADR reporting rates within income groups.

  • 2.
    Alfredsson, Joakim
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Roe, Matthew T.
    Duke University of School Med, NC USA.
    Risks and Benefits of Triple Oral Anti-Thrombotic Therapies After Acute Coronary Syndromes and Percutaneous Coronary Intervention2015In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 38, no 5, p. 481-491Article, review/survey (Refereed)
    Abstract [en]

    The key pathophysiological process underlying symptomatic coronary artery disease, including acute coronary syndromes (ACS), is usually a rupture or an erosion of an atherosclerotic plaque, followed by platelet activation and subsequent thrombus formation. Early clinical trials showed benefit with long-term aspirin treatment, and later-based on large clinical trials-dual anti-platelet therapy (DAPT), initially with clopidogrel, and more recently with prasugrel or ticagrelor, has become the established treatment in the post-ACS setting and after percutaneous coronary intervention (PCI). Treatment with DAPT is recommended for both ST-elevation myocardial infarction and non-ST-elevation ACS, as well as after PCI with stenting, in American and European clinical guidelines. Notwithstanding the benefits observed with DAPT, including third-generation P2Y(12) receptor inhibitors plus aspirin, ACS patients remain at high risk for a recurrent cardiovascular event, suggesting that other treatment strategies, including the addition of a third oral anti-platelet agent or a novel oral anticoagulant (NOAC) to standard DAPT regimens, may provide additional benefit for post-ACS patients and for patients undergoing PCI. Adding a third anti-thrombotic agent to DAPT after an ACS event or a PCI procedure has been shown to have modest benefit in terms of ischemic event reduction, but has consistently been associated with increased bleeding complications. Therefore, the quest to optimize anti-thrombotic therapies post-ACS and post-PCI continues unabated but is tempered by the historical experiences to date that indicate that careful patient and dose selection will be critical features of future randomized trials.

  • 3.
    Gyllensten, Hanna
    et al.
    Nordic School of Public Health NHV, Gothenburg, Sweden.
    Jönsson, Anna K
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Diagnostics, Department of Clinical Pharmacology.
    Rehnberg, Clas
    Karolinska Institutet, Stockholm.
    Carlsten, Anders
    Nordic School of Public Health NHV, Gothenburg, Sweden,/Medical Products Agency, Uppsala, Sweden.
    How are the Costs of Drug-Related Morbidity Measured?: A Systematic Literature Review2012In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 35, no 3, p. 207-219Article, review/survey (Refereed)
    Abstract [en]

    Background: Drug-related morbidity has been associated with increased healthcare costs and has been suggested as one of the leading causes of death. Previous reviews have identified heterogeneity in research methods in studies measuring the cost of drug-related morbidity. To date, no attempt has been made to analyse different methods and cost sources used when estimating the costs of drug-related morbidity. Objective: The aim of this review was to evaluate and compare methods and data sources in cost estimates of drug-related morbidity. Methods: A literature search was conducted in three electronic databases (CINAHL, EMBASE and MEDLINE) to identify peer-reviewed articles written in English and published between January 1990 and November 2011. Articles were included if estimating the direct or indirect costs of drug-related morbidity based on clinical data from general patient groups. The general patient groups were defined as patients visiting, being admitted to, treated at or discharged from a general hospital, excluding studies from nursing homes or specialized hospitals. Study information was collected using a standardized data collection sheet. Studies were categorized according to the type of costs included in the cost analysis. Thereafter, the cost analyses of included studies were reviewed regarding viewpoint, costing methods and adjustments for timing of costs. Results: In total, 9569 articles were identified, of which 25 publications were included in this review, and four additional articles were identified from reference or citation lists of publications already included. Eighteen studies measured either the total or attributable costs of drug-related morbidity, while seven studies estimated the increased costs using matched controls or regression analyses. Six studies measured costs from a payer perspective, while the other 23 measured costs to the hospital. One study included costs resulting after discharge, and discounted future costs, while the remaining 28 studies measured costs during the initial admission only and involved no adjustment for timing of costs. Conclusions: The data sources and costs measured in the included studies varied considerably in terms of perspectives and use of data sources. Even though there is a trend towards more studies estimating costs from the payer perspective, the identified studies still focused on costs resulting from patients attending hospital, therefore underestimating the cost of drug-related morbidity. There is thus a need for more research on the costs of drug-related morbidity to providers other than hospitals, and costs occurring outside of hospitals and after the initial care episode. Such studies require clear descriptions of how the costs of drug-related morbidity are measured, and should adhere to published guidelines for observational studies and economic evaluation studies.

  • 4.
    Hakkarainen, Katja Marja
    et al.
    Nordic School of Public Health (NHV), Gothenburg, Sweden.
    Andersson Sundell, Karolina
    Nordic School of Public Health (NHV), Gothenburg, Sweden.
    Petzold, Max
    Nordic School of Public Health (NHV), Gothenburg, Sweden.
    Hägg, Staffan
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Diagnostics, Department of Clinical Pharmacology.
    Methods for assessing the preventability of adverse drug events: A systematic review2012In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 35, no 2, p. 105-126Article in journal (Refereed)
    Abstract [en]

    Background: Preventable adverse drug events (ADEs) are common in both outpatient and inpatient settings. However, the proportion of preventable ADEs varies considerably in different studies, even when conducted in the same setting, and methods for assessing the preventability of ADEs are diverse. Objective: The aim of this article is to identify and systematically evaluate methods for assessing the preventability of ADEs. Data sources: Seven databases (Cochrane, CINAHL, EMBASE, IPA, MEDLINE, PsycINFO and Web of Science) were searched in September 2010 utilizing the databases' index terms and other common terminology on preventable ADEs. No limits for the years of publication were set. Reference lists of included original articles and relevant review articles were also screened. Study selection: After applying predetermined inclusion and exclusion criteria on 4161 unique citations, 142 (3.4%) original research articles were included in the review. One additional article was included from reference lists. Outcome measures of included studies had to include the frequency of ADEs and the assessment of their preventability. Studies were excluded if they focused on individuals with one specific type of treatment, medical condition, medical procedure or ADE. Data extraction: Measurement instruments for determining the preventability of ADEs in each article were extracted and unique instruments were compared. The process of assessing the preventability of ADEs was described based on reported actions taken to standardize and conduct the assessment, and on information about the reliability and validity of the assessment. Data synthesis: Eighteen unique instruments for determining the preventability of ADEs were identified. They fell under the following four groups: (i) instruments using a definition of preventability only (n = 3); (ii) instruments with a definition of preventability and an assessment scale for determining preventability (n = 5); (iii) instruments with specific criteria for each preventability category (n = 3); and (iv) instruments with an algorithm for determining preventability (n = 7). Of actions to standardize the assessment process, performing a pilot study was reported in 21 (15%), and use of a standardized protocol was reported in 18 (13%), of the included 143 articles. Preventability was assessed by physicians in 86 (60%) articles and by pharmacists in 41 (29%) articles. In 29 (20%) articles, persons conducting the assessment were described as trained for or experienced in preventability assessment. In 94 (66%) articles, more than one person assessed the preventability of each case. Among these 94 articles, assessment was done independently in 73 (51%) articles. Procedures for managing conflicting assessments were diverse. The reliability of the preventability assessment was tested in 39 (27%) articles, and 16 (11%) articles referred to a previous reliability assessment. Reliability ranged from poor to excellent (kappa 0.19-0.98; overall agreement 26-97%). Four (3%) articles mentioned assessing validity, but no sensitivity or specificity analyses or negative or positive predictive values were presented. Conclusions: Instruments for assessing the preventability of ADEs vary from implicit instruments to explicit algorithms. There is limited evidence for the validity of the identified instruments, and instrument reliability varied significantly. The process of assessing the preventability of ADEs is also commonly imprecisely described, which hinders the interpretation and comparison of studies. For measuring the preventability of ADEs more accurately and precisely in future, we believe that existing instruments should be further studied and developed, or that one or more new instruments should be developed, and the validity and reliability of the existing and new instruments be established.

  • 5.
    Hägg, Staffan
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Clinical Pharmacology . Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Bate, Andrew
    Uppsala.
    Stahl, Malin
    Uppsala.
    Spigset, Olav
    Trondheim Norge.
    Associations between venous thromboembolism and antipsychotics: A study of the WHO database of adverse drug reactions2008In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 31, no 8, p. 685-694Article in journal (Refereed)
    Abstract [en]

    Background: Concern has been raised about the occurrence of venous thromboembolism (VTE) during treatment with antipsychotics. However, to date, clozapine is the only antipsychotic agent for which recurring evidence supports an association with VTE. Therefore, the aim of this study was to investigate the association between antipsychotic drugs, including clozapine and VTE. Study design and methods: Data mining of the WHO database of adverse drug reactions (ADRs) using Bayesian statistics is in routine use for early alerting to possible ADRs. An information component measure was used to investigate the association between antipsychotic drugs and VTE reactions in the database. Results: A total of 754 suspected cases of VTE related to treatment with antipsychotics had been reported. After excluding cases related to clozapine, 379 cases remained. A robust association was found for the second-generation antipsychotics group but not for the high-potency, first-generation antipsychotics group or the low-potency first-generation antipsychotics group. The individual compounds with statistically significant associations were olanzapine, sertindole and zuclopenthixol. A time-dependent analysis showed that the associations were positive for these drugs in 2002, 2001 and 2003, respectively. Case analyses were undertaken after excluding ten suspected duplicate reports. Of the remaining 369 cases, 91 cases were associated with olanzapine, 9 with zuclopenthixol and 6 with sertindole. Conclusions: VTE was more often reported with the antipsychotic drugs olanzapine, sertindole and zuclopenthixol than with other drugs in the WHO database. Further studies are warranted to explain this disproportional reporting. Since the associations found were based on incomplete clinical data, the results should be considered as preliminary and interpreted cautiously. © 2008 Adis Data Information BV. All rights reserved.

  • 6.
    Reichenpfader, Ursula
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences.
    Gartlehner, Gerald
    Danube University of Krems, Austria RTI Int, NC 27709 USA .
    Morgan, Laura C.
    RTI Int, NC 27709 USA .
    Greenblatt, Amy
    RTI Int, NC 27709 USA .
    Nussbaumer, Barbara
    Danube University of Krems, Austria .
    Hansen, Richard A.
    Auburn University, AL 36849 USA .
    Van Noord, Megan
    Danube University of Krems, Austria RTI Int, NC 27709 USA .
    Lux, Linda
    RTI Int, NC 27709 USA .
    Gaynes, Bradley N.
    University of N Carolina, NC 27599 USA .
    Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis2014In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 37, no 1, p. 19-31Article in journal (Refereed)
    Abstract [en]

    Sexual dysfunction (SD) is prevalent in patients with major depressive disorder (MDD) and is also associated with second-generation antidepressants (SGADs) that are commonly used to treat the condition. Evidence indicates under-reporting of SD in efficacy studies. SD associated with antidepressant treatment is a serious side effect that may lead to early termination of treatment and worsening of quality of life. Our objective was to systematically assess the harms of SD associated with SGADs in adult patients with MDD by drug type. We retrieved English-language abstracts from PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to October 2012 as well as from reference lists of pertinent review articles and grey literature searches. Two independent reviewers identified randomized controlled trials (RCTs) of at least 6 weeks duration and observational studies with at least 1,000 participants. Reviewers abstracted data on study design, conduct, participants, interventions, outcomes and method of SD ascertainment, and rated risk of bias. A senior reviewer checked and confirmed extracted data and risk-of-bias ratings. Random effects network meta-analysis using Bayesian methods for data from head-to-head trials and placebo-controlled comparisons; descriptive analyses calculating weighted mean rates from individual trials and observational studies. Data from 63 studies of low and moderate risk of bias (58 RCTs, five observational studies) with more than 26,000 patients treated with SGADs were included. Based on network meta-analyses of 66 pairwise comparisons from 37 RCTs, most comparisons showed a similar risk of SD among included SGADs. However, credible intervals were wide and included differences that would be considered clinically relevant. We observed three main patterns: bupropion had a statistically significantly lower risk of SD than some other SGADs, and both escitalopram and paroxetine showed a statistically significantly higher risk of SD than some other SGADs. We found reporting of harms related to SD inconsistent and insufficient in some trials. Most trials were conducted in highly selected populations. Search was restricted to English-language only. Because of the indirect nature of the comparisons, the often wide credible intervals, and the high variation in magnitude of outcome, we rated the overall strength of evidence with respect to our findings as low. The current degree of evidence does not allow a precise estimate of comparative risk of SD associated with a specific antidepressant. In the absence of such evidence, clinicians need to be aware of SD as a common adverse event and should discuss patients preferences before initiating antidepressant therapy.

  • 7.
    Strandell, Johanna
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Caster, Ola
    Uppsala Monitoring Centre, Uppsala Sweden. Department of Computer and Systems Sciences, Stockholm University, Stockholm, Sweden.
    Bate, Andrew
    Uppsala Monitoring Centre, Uppsala Sweden. School if Information Systems, Brunel University, London, UK.
    Norén, Niklas
    Uppsala Monitoring Centre, Uppsala Sweden. Department of Mathematics, Stockholm University, Stockholm, Sweden.
    Edwards, I Ralph
    Uppsala Monitoring Centre, Uppsala, Sweden.
    Reporting Patterns Indicative of Adverse Drug Interactions: A Systematic Evaluation in VigiBase.2011In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 34, no 3, p. 253-66Article in journal (Refereed)
    Abstract [en]

    Background: Adverse drug interaction surveillance in collections of Individual Case Safety Reports (ICSRs) remains underdeveloped. Most efforts to date have focused on disproportionality analysis, but the empirical support for its value is based on isolated examples. Additionally, too little attention has been given to the potential value of the detailed content of ICSRs for improved adverse drug interaction surveillance. Objective: The aim of the study was to identify reporting patterns indicative of suspected adverse drug interactions before the drug interactions are generally established. Methods: A reference set of known adverse drug interactions and drug pairs not known to interact was constructed from information added to Stockley's Drug Interactions Alerts between the first quarter of 2007 and the third quarter of 2009. The reference set was used to systematically study differences in reporting patterns between adverse drug interactions before they are generally established and adverse drug reactions (ADRs) to drug pairs that are not known to interact, in the WHO Global ICSR Database, VigiBase. The scope of the study included pharmacological properties such as common cytochrome P450 metabolism, explicit suspicions of drug interactions as noted by the reporter, clinical details such as dose and treatment overlap, and the lower limit of the 95% credibility interval of a three-way measure of disproportionality, Omega(025) (Ω(025)), based on the total number of reports on two drugs and one ADR together. Analyses were carried out including and excluding concomitant medicines. Results: Five reporting patterns were highlighted as particularly strong indicators of adverse drug interactions before they are known: suspicion of interactions as noted by the reporter in a case narrative, the assignment of the two drugs as interacting or through an ADR term; co-reporting of effect increased with the drug pair; and, finally, an excess total number of reports on the ADR together with the two drugs, as measured by Ω(025). Overall, the inclusion of concomitant medicines led to a larger number of true adverse drug interactions being highlighted, but at a substantial decrease in the strength of most indicators. Notably, the inclusion of concomitant medicines completely eliminated the value of Ω(025) as an indicator of adverse drug interactions, in this systematic evaluation. Conclusions: Reported suspicion of interactions as noted by the reporter in a case narrative, the assignment of the two drugs as interacting or through an ADR term; co-reporting of effect increased with the drug pair and by the Ω(025) each provide unique information to highlight adverse drug interactions before they become known in the literature. To our knowledge, this is the first systematic analysis demonstrating the value of disproportionality analysis for adverse drug interactions using a comprehensive reference set, and the first study to consider a broader basis including clinical information for systematic drug interaction surveillance.

  • 8.
    Strandell, Johanna
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. WHO Collaborating Centre Int Drug Monitoring, Sweden .
    Caster, Ola
    WHO Collaborating Centre Int Drug Monitoring, Sweden .
    Hopstadius, Johan
    WHO Collaborating Centre Int Drug Monitoring, Sweden .
    Edwards, Ralph I.
    WHO Collaborating Centre Int Drug Monitoring, Sweden .
    Noren, Niklas G.
    WHO Collaborating Centre Int Drug Monitoring, Sweden .
    The Development and Evaluation of Triage Algorithms for Early Discovery of Adverse Drug Interactions2013In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 36, no 5, p. 371-388Article in journal (Refereed)
    Abstract [en]

    Background Around 20 % of all adverse drug reactions (ADRs) are due to drug interactions. Some of these will only be detected in the postmarketing setting. Effective screening in large collections of individual case safety reports (ICSRs) requires automated triages to identify signals of adverse drug interactions. Research so far has focused on statistical measures, but clinical information and pharmacological characteristics are essential in the clinical assessment and may be of great value in first-pass filtering of potential adverse drug interaction signals. less thanbrgreater than less thanbrgreater thanObjective The aim of this study was to develop triages for adverse drug interaction surveillance, and to evaluate these prospectively relative to clinical assessment. less thanbrgreater than less thanbrgreater thanMethods A broad set of variables were considered for inclusion in the triages, including cytochrome P450 (CYP) activity, explicit suspicions of drug interactions as noted by the reporter, dose and treatment overlap, and a measure of interaction disproportionality. Their unique contributions in predicting signals of adverse drug interactions were determined through logistic regression. This was based on the reporting in the WHO global ICSR database, VigiBase (TM), for a set of known adverse drug interactions and corresponding negative controls. Three triages were developed, each producing an estimated probability that a given drug-drug-ADR triplet constitutes an adverse drug interaction signal. The triages were evaluated against two separate benchmarks derived from expert clinical assessment: adverse drug interactions known in the literature and prospective adverse drug interaction signals. For reference, the triages were compared with disproportionality analysis alone using the same benchmarks. less thanbrgreater than less thanbrgreater thanResults The following were identified as valuable predictors of adverse drug interaction signals: plausible CYP metabolism; notes of suspected interaction by the reporter; and reports of unexpected therapeutic response, altered therapeutic effect with dose information and altered therapeutic effect when only two drugs had been used. The new triages identified reporting patterns corresponding to both prospective signals of adverse drug interactions and already established ones. They perform better than disproportionality analysis alone relative to both benchmarks. less thanbrgreater than less thanbrgreater thanConclusions A range of predictors for adverse drug interaction signals have been identified. They substantially improve signal detection capacity compared with disproportionality analysis alone. The value of incorporating clinical and pharmacological information in first-pass screening is clear.

  • 9.
    Strandell, Johanna
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Noren, Niklas G
    WHO Collaborating Centre Int Drug Monitoring, Sweden .
    Hägg, Staffan
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Diagnostics, Department of Clinical Pharmacology.
    Key Elements in Adverse Drug Interaction Safety Signals An Assessment of Individual Case Safety Reports2013In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 36, no 1, p. 63-70Article in journal (Refereed)
    Abstract [en]

    Background A large proportion of potential drug interactions are known from pre-authorization studies, but adverse drug reactions (ADRs) due to interactions (adverse drug interactions) are often first detected through astute observation in clinical practice. Individual case safety reports (ICSRs) are collected from broad patient populations and allow for the identification of groups of similar reports. Systematic screening for adverse drug interactions in ICSRs will require an understanding of which information on these reports can be suggestive of adverse drug interactions. less thanbrgreater than less thanbrgreater thanObjective The aim of the study was to identify what reported information may support the identification of drug interaction safety signals in collections of ICSRs. less thanbrgreater than less thanbrgreater thanMethods Three previously published safety signals of suspected adverse drug interactions were re-evaluated. To this end, 137 reports related to these signals were retrieved from the WHO Global ICSR Database, VigiBase (TM), and corresponding original reports were obtained from national pharmacovigilance centres. Criteria from an operational score for causality analysis of drug interactions of clinical cases, the Drug Interaction Probability Scale (DIPS), were applied to each of these reports with the aim of identifying what supportive information tends to be available in ICSRs. For three DIPS elements (plausible time course, resolution of the ADR after terminating the drug inducing the interaction without changes in affected drug therapy (positive dechallenge) and alternative causes of the reaction) we also compared the amount of information in VigiBase (TM) and in original reports, and in free text and structured data. less thanbrgreater than less thanbrgreater thanResults Commonly fulfilled DIPS elements on reports supporting an adverse drug interaction signal were plausible time course (50 reports; 36 %) and positive dechallenge (8 reports; 6 %). Alternative causes for the observed adverse reaction were observed in 72 (53 %) reports. We found limited differences between VigiBase (TM) and original reports for the structured data, although a substantial amount of additional information was available in free text in original reports. less thanbrgreater than less thanbrgreater thanConclusions Information on plausible time courses and resolution of the adverse reaction upon withdrawal of the drug suspected to have induced the interaction may be a useful element in identifying suspected adverse drug interactions from ICSRs. Of these, plausible time course is by far the most commonly reported element in the three signals studied here. Our analysis also demonstrated the importance of sharing and analysing information available in free text where relevant clinical details are often available, such as those mentioned above, along with severity and dosage changes.

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