Immunisation provider experiences with an automated short message service-based active surveillance system for monitoring adverse events following immunisation: A qualitative descriptive study.
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ABSTRACT: Objective
Currently, active surveillance systems to monitor adverse events following immunisation are limited to hospitals, and medical and immunisation clinics. Globally, community pharmacies represent a significant destination for immunisation services. However, until recently, pharmacies lacked active surveillance systems. We therefore wished to explore pharmacists' experiences with SmartVax: an active surveillance system that has recently been integrated for use in Australian community pharmacies. Specifically, we wished to explore pharmacists' perceived (1) benefits of using SmartVax, (2) areas for improvement in the system, and (3) issues with future/ongoing access to the system.Methods
The present study forms the qualitative arm of a convergent mixed-methods pilot study. In the present study, we performed semi-structured interviews with pharmacist immunisers after a 21- to 22-week trial period with SmartVax. Thematic analysis of interview transcripts was performed independently by two researchers in QSR NVivo 12, using the framework method.Results
Fifteen participants completed the semi-structured interviews. A broad range of perceived benefits were cited by participants, including the usability of SmartVax, the ease of patient follow-up facilitated by the system, and enhancement to the patient-pharmacist relationship. Participants voiced a desire for the system to have more granularity and a faster response time in the report generated for pharmacies. When asked about issues with future/ongoing access to SmartVax, cost concerns of the system were the prevailing theme.Conclusions
The present study suggests that, among pharmacist immuniser end-users of SmartVax, the system is perceived to be easy-to-use, facilitates patient follow-up, and enhances the patient-pharmacist relationship.
SUBMITTER: Singh G
PROVIDER: S-EPMC8488908 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionCOVID-19 vaccines require enhanced safety monitoring after emergency approval. The Canadian National Vaccine Safety Network monitors the safety of COVID-19 vaccines and provides enhanced monitoring for healthy, auto-immune, immunocompromised, pregnant and breastfeeding populations and allows for the detection of safety signals.Methods and analysisOnline participant reporting of health events in vaccinated and unvaccinated individuals 12 years of age and older is captured in three surveys: 1 week after dose 1, 1 week after dose 2 and 7 months after dose 1. Medically attended events are followed up by telephone. The number, percentage, rate per 10 000 and incident rate ratios with 95% CIs are calculated by health event, vaccine type, sex and in 10-year age groups.Ethics and disseminationEach study site has Research Ethics Board approvals for the project (UBC Children's & Women's, CIUSSS de l'Estrie-CHUS, Health PEI, Conjoint Health Research Ethics Board, University of Calgary and Alberta Health Services, IWK Health, Unity Health Toronto and CHU de Québec-Université Laval Research Ethics Boards). Individuals are invited to participate in this active surveillance and electronic consent is given before proceeding to each survey. Weekly reports are shared with public health and posted on the study website. At least one peer-reviewed manuscript is produced.
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Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.
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Project description:The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.
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Project description:ObjectiveTo understand how the source of information affects different adverse event (AE) surveillance methods.DesignRetrospective analysis of inpatient adverse drug events (ADEs) and hospital-associated infections (HAIs) detected by either a computerized surveillance system (CSS) or manual chart review (MCR).MeasurementDescriptive analysis of events detected using the two methods by type of AE, type of information about the AE, and sources of the information.ResultsCSS detected more HAIs than MCR (92% vs 34%); however, a similar number of ADEs was detected by both systems (52% vs 51%). The agreement between systems was greater for HAIs than ADEs (26% vs 3%). The CSS missed events that did not have information in coded format or that were described only in physician narratives. The MCR detected events missed by CSS using information in physician narratives. Discharge summaries were more likely to contain information about AEs than any other type of physician narrative, followed by emergency department reports for HAIs and general consult notes for ADEs. Some ADEs found by MCR were detected by CSS but not verified by a clinician.LimitationsInability to distinguish between CSS false positives and suspected AEs for cases in which the clinician did not document their assessment in the CSS.ConclusionThe effect that information source has on different surveillance methods depends on the type of AE. Integrating information from physician narratives with CSS using natural language processing would improve the detection of ADEs more than HAIs.
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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.
| S-EPMC8887767 | biostudies-literature