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A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.

ABSTRACT: Strengthening antenatal care as a platform for maternal immunization is a priority of the World Health Organization (WHO). Systematic surveillance for adverse events following immunization (AEFI) in pregnancy is needed to identify vaccine safety events. We sought to identify active and passive AEFI surveillance systems for pregnant women and infants. Representatives from all National Pharmacovigilance Centers and a convenience sample of vaccine safety experts were invited to complete a 14-item online survey in English, French or Spanish. The survey captured maternal immunization policies, and active and passive AEFI surveillance systems for pregnant women and infants in respondents' countries. The analysis was descriptive. We received responses from 51/185 (28%) invited persons from 47/148 (32%) countries representing all WHO regions, and low, middle and high-income countries. Thirty countries had national immunization policies targeting pregnant women. Eleven countries had active surveillance systems to detect serious AEFI in pregnant women and/or their infants, including six low and middle-income countries (LMIC). Thirty-nine countries had passive surveillance systems, including 23 LMIC. These active and passive surveillance programs cover approximately 8% and 56% of the worldwide annual birth cohort, respectively. Data from one active and four passive systems have been published. We identified 50 active and passive AEFI surveillance systems for pregnant women and infants, but few have published their findings. AEFI surveillance appears to be feasible in low and high resource settings. Further expansion of AEFI surveillance for pregnant women and sharing of vaccine safety information will provide additional evidence in support of maternal immunization policies.

SUBMITTER: Cassidy C

PROVIDER: S-EPMC4994761 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.

Cassidy Christine C MacDonald Noni E NE Steenbeek Audrey A Ortiz Justin R JR Zuber Patrick L F PL Top Karina A KA

Human vaccines & immunotherapeutics 20160509 8

Strengthening antenatal care as a platform for maternal immunization is a priority of the World Health Organization (WHO). Systematic surveillance for adverse events following immunization (AEFI) in pregnancy is needed to identify vaccine safety events. We sought to identify active and passive AEFI surveillance systems for pregnant women and infants. Representatives from all National Pharmacovigilance Centers and a convenience sample of vaccine safety experts were invited to complete a 14-item o ...[more]

PMID: 27159639

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Project description:BackgroundWith over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.MethodsA case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC's Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system's attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews.ResultsIn all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated "fear of being victimized" as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics.ConclusionThe AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.

Project description:BackgroundHepatitis B vaccine (HepB) has been routinely recommended as part of the immunization program in China and has had a satisfactory safety and effectiveness profile in protecting infants from hepatitis B virus infection. We evaluated the surveillance sensitivity and changes over time of AEFI reports related to HepB among infants based on the consistent national data before and after the introduction of vaccine administration law (LAW) from 2013 to 2020 in China.MethodsAEFI records were extracted from the Chinese National AEFI Surveillance System from 2013 to 2020. According to the proportion of different kinds of HepB vaccines distributed, the annual administration data of the most distributed HepB produced by Bio-Kangtai and its corresponding adverse reaction reports were collected and analyzed. We categorized the time interval into the pre-LAW period (2013 to 2017), transition period (2018 to 2019), and LAW period (2020) to demonstrate the impact of LAW on the surveillance patterns of AEFIs.ResultsThe annual AEFI rates increased from 3.1/100,000 to 14.8/100,000 over this period in total. The rate ratio for the post-LAW period and pre-LAW period was 2.19 (95%CI: 2.10, 2.29). Common reactions occupied 87.6% of the total reported AEFIs whose rate was recorded as 7.9/100,000. Rare reactions occupied 9.1% of the total AEFIs showing an average rate of 0.8/100,000, of which anaphylaxis accounted for over 80%, with the rate ratio of the transition period and LAW period as 1.36 (95%CI:1.22, 1.52) and 1.14 (95%CI:0.95, 1.35), respectively. Children receiving more than one vaccine showed a higher proportion of fever, anaphylaxis, and febrile convulsions, which were suggested to be a result of vaccine co-administration vaccines, such as the DPT and Polio vaccine.ConclusionMost reactions were mild and self-limited and the rates of rare more serious events remained stable. The LAW has largely increased the surveillance capability and sensitivity on AEFIs of HepB and also contributes to enhancing public confidence in HepB immunization. Hepatitis B vaccination is a safe and effective means of preventing the complications of hepatitis B disease and continuous standardized AEFI investigation and assessment of causal association should be maintained.

Project description:ImportanceMedical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection.ObjectiveTo compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports.Design, setting, and participantsWe conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; κ, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient.Main outcomes and measuresError and AE rates.ResultsOverall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates.Conclusions and relevanceFamilies provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.

Dataset Information

A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.

Publications

A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.

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