Feb 01, 2013
By Jasmeen Gahunia, Bscn, RN , Mark Bigham, Md, Frcpc , Stephanie Konrad, M.sc. , M. Elizabeth Snow, Phd, Ce
Adverse Events Following Immunization Evaluating an Enhanced Nursing Role for PHNs
Maintaining confidence in vaccine safety is critical to successful public health immunization programs. Surveillance and assessment of adverse events following immunization (AEFIs) are important for maintaining vaccine safety. The authors describe the evaluation of an initiative at Fraser Health Authority designed to enhance the role of a communicable disease nurse coordinator (CDNC) in assessing AEFI reports, in collaboration with a designated medical health officer (MHO) as required, and providing recommendations to clients and immunization providers. Previously, only MHOs performed this role. This evaluation project demonstrates this initiative’s feasibility and provides a roadmap for health authorities interested in pursuing a similar model. MHOs, public health nurses and public health management expressed satisfaction with the process and the quality of the CDNC’s recommendations. There was no statistically significant difference in median turnaround time for AEFI reporting date and date of recommendation, indicating this work is completed in as timely a manner by the CDNC as by the MHO. This role provides opportunity for professional growth, facilitates nursing practice to full scope, enables acquisition of specialized knowledge and provides a platform to share nursing expertise at a provincial level.
Immunization programs are a cornerstone of communicable disease prevention and control. Maintaining confidence in the safety of vaccines is critical to the success of public health immunization programs. Public health nurses play a key role in maintaining public confidence in the safety of vaccines by providing clients with evidence-based information about the benefits and risks of vaccines (Public Health Agency of Canada, n.d.). Surveillance and assessment of adverse events following immunization (AEFIs) are important processes for maintaining vaccine safety. This article describes the evaluation of an initiative by B.C.’s Fraser Health Authority to enhance the role of a communicable disease nurse coordinator in assessing AEFI reports and providing recommendations to clients and to those who administer immunizations.
An important component of the Fraser Health immunization program, which is part of the Canadian Adverse Events Following Immunization Surveillance System, is a mechanism for reporting and assessing AEFIs and providing recommendations, in accordance with the B.C. immunization program. Included in this mechanism are a standardized report form, AEFI definitions and the integrated Public Health Information System (iPHIS) AEFI registry, an access-protected, Internet-based application used by public health in all but one of the province’s health authorities. Public health serves as the clearing house in B.C. for all AEFI reports, which originate from physicians, pharmacists, PHNs, occupational health nurses, midwives, travel clinic staff and clients themselves (or their parents/guardians). The reports are made by phone or are faxed to the local public health unit. A PHN reviews the information and enters it into the iPHIS AEFI registry, which contains standardized data entry fields, as well as a section for outlining the details of the event. Each new AEFI report is sent to a designated individual for review. For more serious AEFIs, additional documentation (e.g., reports from emergency departments or primary care physicians) may also be requested. The individual inserts comments about the AEFI in iPHIS and provides a recommendation, which could include, for example, continuing with the client’s immunization schedule without change, advising allergy testing or indicating that a certain vaccine may be contraindicated. The PHN (generally, the same PHN who initially received the AEFI report) conveys the recommendation to the client and, after obtaining consent, to his/her physician.
Fraser Health’s PHNs have the authority to assess AEFI reports and make followup recommendations. However, prior to April 2009, all reports were routinely directed to a medical health officer (MHO). In 2008, a number of concerns associated with this process were identified. First, PHNs and MHOs felt there was opportunity to engage PHNs more fully in AEFI followup, within their full scope of professional practice. Second, MHOs reported having difficulty at times in providing timely responses, sometimes resulting in avoidable delays in immunizations. Finally, respective PHN and MHO roles for AEFI followup were not clearly defined.
A new response policy
In response to these concerns, Fraser Health conducted a comprehensive consultation with management, PHNs, communicable disease nurse coordinators (CDNCs) — PHNS with additional expertise in communicable disease management — and MHOs. An AEFI response policy was adopted in April 2009, outlining a consistent process for reporting and managing AEFIs. PHN and MHO roles and responsibilities were clarified. In addition, a new part-time (two days per week) position for a CDNC was created. The individual in this position, the AEFI CDNC, would lead the new Fraser Health AEFI process.
The AEFI CDNC would operate in an independent capacity, utilizing the full scope of relevant nursing clinical assessment skills in evaluating each AEFI and collaborating with the designated MHO on more serious cases (e.g., those prompting emergency medical system activation or leading to hospital admission).
The new role would involve a number of functions:
- review and triage all reports and make recommendations
- consult with immunization providers from the perspective of a subject-matter expert and as manager of the AEFI process
- participate in and provide input to the B.C. Immunization Committee
- provide education and data on trends to PHNs, other MHOs and agencies involved in the provincial vaccine program
The objectives were to improve turnaround time, defined as the number of days between the date an AEFI is reported to a public health unit and the date a recommendation is forwarded to the immunization provider; reduce delays in immunization due to incomplete or delayed AEFI reports; improve communication among immunization providers; and better employ nursing knowledge, skills and leadership in AEFI management. It was also believed that this role would facilitate better clinical feedback to the health authority and other agencies.
- Vaccines used in Canada are very safe. They are developed in accordance with the highest standards and are continually monitored for safety and effectiveness. On average, it takes about 10 years of research and development before a vaccine is considered for approval by Health Canada. Following approval, the National Advisory Committee on Immunization (NACI) recommends how the vaccine should be used. (From Immunize Canada)
- Safety is monitored by the Public Health Agency of Canada (PHAC) through the Canadian Adverse Events Following Immunization Surveillance System(CAEFISS). This is a voluntary reporting system in which AEFI reports collected by provincial and/or territorial public health authorities are forwarded for collation into the national CAEFI database, which is overseen by PHAC’s Vaccine Safety Section within the Surveillance and Outbreak Response Division of the Centre for Immunization and Respiratory Infectious Diseases. While reporting nationally is voluntary, several provinces and territories have laws requiring that health-care professionals report AEFIs.
CAEFISS aims to continuously monitor the safety of marketed vaccines in Canada; to identify increases in the frequency or severity of previously identified vaccine-related reactions; to identify previously unknown AEFIs that could possibly be related to vaccine; to identify areas that require further investigation and/or research; and to provide timely information on AEFI reporting profiles for vaccines marketed in Canada that can help inform immunization-related decisions.
In addition to the voluntary reporting system, Canada has an active pediatric hospital-based surveillance program known as IMPACT (Immunization Monitoring Program ACTive) for selected serious AEFIs. IMPACT is operated through a contract with the Canadian Paediatric Society and includes 12 pediatric centres across Canada, which represent over 90 per cent of all pediatric tertiary care admissions. At each centre, a nurse monitor and clinical investigator perform active case-finding based on a regular review of admission records. They are assisted by a network that includes admitting department staff, infection control nurses, neurology ward staff and physicians, infectious diseases staff and medical records technicians. (From the Public Health Agency of Canada)
Our evaluation project focused on the impact of the CDNC on leading the program, by analyzing AEFIs reported from Jan. 1, 2007 to Dec. 31, 2011. The Fraser Health public health evaluation specialist developed and implemented the project with guidance from the CDNC and the MHO. Quantitative analysis was performed by a Fraser Health epidemiologist.
A search of MEDLINE-listed English-language literature revealed no publications that discussed a specialized nursing role in assessing reported AEFIs and providing recommendations for re-immunization. One publication from Brazil was found that described nurses’ role in managing specified reportable AEFIs but not in assessing and reviewing them, with respect to recommendations for followup or safety of re-immunization (Bisetto, Cubas, & Malucelli, 2011).
Analyzing the data
Our team analyzed 1,827 AEFIs. Descriptive statistics of AEFI cases and turnaround time were calculated using data extracted from iPHIS. AEFIs were coded into the following categories: mild, moderate, severe and unclassified. Because multiple reactions were a factor in most of the cases, each AEFI was categorized according to the most severe of the reactions. When the date of a recommendation did not appear in iPHIS, and thus a turnaround time could not be calculated, the case was excluded from the analysis (n = 86). The majority of these cases were from the earlier years in the time period examined. Including these data in the analysis would have biased the results by showing a longer turnaround time than may have actually occurred. An additional 30 cases for which the category of AEFI was presumably inadvertently omitted from iPHIS were included in the total count. These cases represented 1.7 per cent of the total count.
The MHO-era was defined as the period prior to the implementation of the CDNC position (i.e., Jan. 1, 2007 to March 31, 2009). The CDNC-era was set as Aug. 1, 2010 to Dec. 31, 2011. The intervening months (April 1, 2009 to July 31, 2010) were excluded from analysis for two reasons: first, to provide a “washout period” for the CDNC to clear a backlog of AEFI reports from the MHO-era but for which the MHOs had not provided a recommendation; and, second, in consideration of a disruption of normal public health workflow caused by response to the 2009 H1N1 influenza pandemic.
As turnaround times were not normally distributed, median turnaround times were used instead of means. The Mann-Whitney U Test was used to compare turnaround times for each category of AEFIs and for AEFIs overall. A significance level set at p < 0.05 was used in this analysis. A simple bootstrap sampling method was used to obtain robust 95 per cent confidence intervals for the medians.
To gain an understanding of how the AEFI CDNC role was perceived, the Fraser Health public health evaluation specialist conducted interviews and focus groups with PHNs, MHOs, CDNCs and the communicable disease public health manager. She determined themes from the data and summarized the findings. Although clients (or their parents/ guardians) were not included in these consultations, PHNs were considered to be appropriate surrogates because they discuss and review recommendations with the clients and thus are well positioned to know how well the recommendations are received and the degree to which they address clients’ concerns.
Results and discussion
The majority of the AEFI cases were either mild or moderate in severity. Of note, in November 2009 two classifications of mild AEFIs were removed from the provincial surveillance system, which resulted in lower numbers of mild cases reported in 2010 and 2011. Commonly reported reactions included extensive, prolonged or painful local reactions in an injection site limb (a mild AEFI) and allergic (non-anaphylactic) reactions (a moderate AEFI).
There were no statistically significant differences in turnaround time, though the decreased turnaround time for mild cases in the CDNC-era approached significance (p = 0.052). The median turnaround times for mild, moderate or severe reactions were either similar or better (i.e., within a more narrow range) during the CDNC-era. There was a wider range of turnaround times for severe cases in the MHO-era, with some cases involving delays of up to a few years, compared to the CDNC-era (data not shown due to space constraints). However, a wider range in turnaround time was not observed for the unclassified category, for which there were a small number of cases in the CDNC-era.
Figure 1 shows the median turnaround time and count of cases by month between January 2007 and December 2011. The 2009 H1N1 influenza pandemic resulted in public health capacity being redirected from non-emergency work to pandemic response. The effect on turnaround time during this time is evident in the graph.
With respect to the feedback collected, overall, having a PHN responsible for AEFI assessments and recommendations was viewed positively. The person in this role was seen as being accessible, responsive, adaptive, helpful and approachable. PHNs noted the benefits of this role, particularly at times when quick turnaround was required. They appreciated the concise, comprehensive and evidence-based recommendations, which provided them with appropriate information that thoroughly addressed clients’ concerns, and having a nursing colleague with whom to consult on this topic. The new process of AEFI reporting was also viewed as a positive by all, providing clearer understanding of roles and responsibilities and more consistent recommendations.
Taken together, the quantitative and qualitative findings demonstrate the value of the AEFI CDNC role. Moreover, the role provides opportunity for professional growth, facilitates nursing practice to full scope, enables acquisition of specialized knowledge in vaccine safety and provides a platform to share nursing expertise at a provincial level.
Implementing the position and transitioning to the new process proceeded relatively smoothly. Having all PHNs fully grasp the process change took time, a result, perhaps, of turnover of staff and the size of Fraser Health. Some PHNs were initially unfamiliar with the transition, and a few were concerned about whether the new role indeed fell within their scope of practice. Other PHNs had expressed frustration about not receiving up-to-date data on trends in AEFI numbers and categories and wanted more education on vaccine safety they could share with clients. Thus, as with any organizational change, it is important to clearly communicate the process and provide accurate, relevant and timely information to all those involved.
Some challenges remain. The two-day-per-week schedule of the AEFI CDNC affords limited time for providing education or for participating in related professional activities. In addition, maintaining organizational capacity to do this type of work when there is a single person filling this role is difficult. To partly address these gaps, another CDNC now “job swaps” once a month with her colleague to gain and maintain a baseline familiarity with the role and to provide back up.
Following up on the findings of this project, Fraser Health is developing an on-the-job training module for CDNCs to build team capacity. As well, it is exploring the feasibility of producing comprehensive reports for immunization providers at various points during the annual influenza immunization campaign or during public health outbreak control responses where a broad-based immunization intervention is undertaken. AEFI information is being profiled more actively in PHN education. The AEFI CDNC’s increasing proficiency and efficiency is allowing her to devote more attention to the broader scope of her role. Fraser Health is providing guidance to other regional health authorities that have expressed an interest in adopting this model.
A copy of the full evaluation report is available from the authors upon request.
Bisetto, L. H. L., Cubas, M. R., & Malucelli, A. (2011). Nursing practice in view of adverse events following vaccination. Revista da Escola de Enfermagem da USP, 45(5), 1128-1134.
Public Health Agency of Canada. (n.d.). Canadian immunization guide.