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Premedications for infliximab infusions do not impact the risk of acute adverse drug reactions.

ABSTRACT: The purpose of this study was to identify the association of premedication with the adverse drug reaction (ADR) rate in infliximab infusions.A retrospective chart review of 684 patients who received 4077 infusions in a network of community clinics over 16.5 months. Data collected included age, weight, sex, diagnosis, dose, premedications and ADR information, which was coded for time of onset, severity and outcome.Community infusion clinics located in Ontario, Canada.Patients aged 12-91 years who receive regular infliximab infusions to treat their autoimmune condition, mainly either Crohn's disease or rheumatoid arthritis.The number of infusions to the occurrence of an acute ADR by presence of premedication.ADRs are not significantly different (χ2(1, n=644, p=0.651)=0.204) between those who always received premedications and those who never did. When controlling for age, sex, weight and diagnosis, patients receiving premedications were just as likely to experience an ADR as patients who never received any (OR 1.1, 95% CI 0.7 to 1.9, p=0.5). When assessing the number of infusions to the occurrence of an ADR using the Kaplan-Meier method, no significant difference was found between the two groups.The use of premedications is not associated with a decreased risk of ADR in patients receiving infliximab. This held true for patients who had never had an ADR prior to receiving premedications and while controlling for age, sex, weight and diagnosis.

SUBMITTER: Ducharme J

PROVIDER: S-EPMC5517230 | biostudies-other | 2011 Oct

REPOSITORIES: biostudies-other

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Project description:BackgroundSpontaneous reports of adverse drug reactions (ADRs) form an essential component of both drug safety monitoring and patient safety initiatives. Pharmacists are well positioned to report ADRs, but many barriers exist to their doing so. Over the past decade, substantial changes have occurred with regard to drug regulations and medication safety initiatives, and it is possible that knowledge-based interventions may be needed to enhance ADR reporting by pharmacists.ObjectiveTo determine whether ADR reporting behaviours of pharmacists improved after release of a revised policy on the reporting of medication incidents.MethodsA telephone survey was administered to pharmacists practising in the Canadian Forces Health Services Group. Self-reported behaviours and perceived barriers related to ADR reporting were compared before and 3 months after the updated policy was released. Accuracy in participants' self-assessed ADR reporting was evaluated using independently derived workload statistics.ResultsDuring the second survey phase (after release of the revised policy), a greater proportion of respondents reported awareness of institutional policies on ADR reporting and declared that they were able to complete all necessary ADR reports during their assigned work hours. However, the number of ADR reports submitted did not increase. Participants' recall of their ADR reporting behaviour was corroborated by workload data. During the second survey phase, there was a noticeable reduction in the number of free-form comments mentioning lack of staff as a barrier to ADR reporting.ConclusionsRelease of a more comprehensive policy was not associated with an increase in the number of ADR reports generated by pharmacists in the study setting. Interventions to strengthen the organization's work processes for detection of ADRs and submission of individual ADR reports should be strongly considered, to reinforce and enhance existing ADR reporting behaviours among pharmacists.

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Premedications for infliximab infusions do not impact the risk of acute adverse drug reactions.

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