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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 17  |  Issue : 3  |  Page : 666-669

Adverse event following immunization surveillance and management: A case of two Districts in Madhya Pradesh


1 Public Health Foundation of India, Gandhinagar, Gujarat, India
2 Indian Institute of Public Health Gandhinagar, Gandhinagar, Gujarat, India
3 Government of Madhya Pradesh, India

Date of Submission25-Mar-2020
Date of Decision15-Dec-2020
Date of Acceptance04-Oct-2021
Date of Web Publication2-Nov-2022

Correspondence Address:
Dr. Snehal Parmar
Plot No- 135/1, Sector- 1/B. Gandhinagar, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdmimsu.jdmimsu_74_20

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  Abstract 


Background: Adverse event following immunization (AEFI) is defined as a medical incident that takes place after immunization, which is believed to be caused by the immunization. Health-care staff should be able to identify and report all serious and nonserious AEFI. Objective: The objective of this study is to analyze the reporting pattern of AEFI by grass-root health-care workers in Madhya Pradesh. Methods: Data related to AEFI were retrieved from three different reporting forms in Vidisha and Bhopal districts of Madhya Pradesh. Results: The results revealed gaps in the reporting patterns of health-care workers and limited understanding of reporting guidelines. AEFI surveillance and management are suboptimal, which can be strengthened with strategic actions. Conclusion: Robust AEFI surveillance and management are warranted. AEFI surveillance can potentially minimize the risk of serious adverse reactions, improve reporting and treatment, prevent any further complications which can overall reduce the negative impact on the immunization programme.

Keywords: Adverse event following immunization reporting, immunization, India, Madhya Pradesh


How to cite this article:
Parmar S, Puwar T, Saxena D, Shukla S, Pandya A. Adverse event following immunization surveillance and management: A case of two Districts in Madhya Pradesh. J Datta Meghe Inst Med Sci Univ 2022;17:666-9

How to cite this URL:
Parmar S, Puwar T, Saxena D, Shukla S, Pandya A. Adverse event following immunization surveillance and management: A case of two Districts in Madhya Pradesh. J Datta Meghe Inst Med Sci Univ [serial online] 2022 [cited 2023 Feb 4];17:666-9. Available from: http://www.journaldmims.com/text.asp?2022/17/3/666/360233




  Introduction Top


Although the vaccines are proven to be extremely safe, the potential risk of an adverse event following immunization (AEFI) is inevitable.[1] The health-care workers must be able to identify and report all serious and nonserious AEFI to determine whether immunization is responsible for the reported events and address the cases immediately to prevent serious illness[2] Serious AEFIs (such as death, disability, cluster, and hospitalization) need to be reported immediately, and investigated nonserious AEFI are reported monthly.[3] In India, all nonserious and serious AEFIs are reported by the community health worker, i. e., auxiliary nurse midwife (ANM) which is further verified by medical officer (MO) at the district level and reported at the State and National level through monthly progress reports.[4],[5]

Given that community health workers provide the majority of AEFI reports to surveillance systems, it is important to understand their AEFI reporting practices.[6] Setting up awareness on the importance and relevance of the reporting AEFI, AEFI surveillance system and the vaccine safety monitoring are important for sustaining NIP and increasing vaccine coverage.[1],[6]

The key elements of an effective surveillance system include rapid notification and effective evaluation of the basic information, rapid and effective response, ensuring the appropriate outcome of an action, and focused responsibility to avoid duplication of efforts.[7],[8] AEFI cases if reported properly will provide a better understanding of the safety issues around vaccines. It will help to counsel the parents of the children who had AEFI so that system can make them understand the reasons behind it. Discontinuation of further vaccination will help to improve immunization coverage.[1],[6],[9]


  Methods Top


The secondary data of total reported AEFI cases in Vidisha and Bhopal districts of Madhya Pradesh from January 2014 to December 2017 were collected from the Health and Family Welfare Department, Government of Madhya Pradesh. Data were fetched from three different reporting forms case-reporting forms (CRF), preliminary investigation forms, and final-case investigation forms which are used to report AEFI cases. A total of 60 cases of AEFI were reported during this period. Data were entered and analyzed using the Microsoft Excel.


  Ethical clearance Top


The Institutional Ethics Committee of Govt Medical College, Bhopal has approved the Research work proposed to be carried out at Govt Medical Collage, Bhopal, Madhya Pradesh, Date : 27th September 2018 with Reference no GMC/EIC/2018-19/471.


  Results Top


Observations are presented in the four subsections: age and sex of distribution cases, vaccines' collusion in developing AEFI, vaccine and symptom development, and outcome of patients and reporting by health workers

Age and gender distribution of reported cases

A total of 60 reported cases of AEFI were reported between 2014 and 2017. According to age distribution, 40% of children <2 months old, 47% of children between 2 and 10 months, and 13% children between 11–24 months experienced AEFI. Majority of children (87%) affected by AEFI before completing the full-immunization schedule. Male and female both were equally affected.

Vaccine's collusion in developing adverse event following immunization

Immunization services are provided at different governments' health-care facilities as well as at predetermined outreach locations. Vaccination is completed as per the government reference immunization schedule and vaccination schedule. Different combinations of vaccines exist under the immunization schedule. The following combinations and/or individual vaccines were administrated to the children before AEFI.

Five single doses and ten different combinations of vaccine doses were involved in the reported cases. Among them, birth dose (BCG, Hep-B, and OPV-0) had higher AEFI than other vaccines, 23.33% of all cases occurred due to birth dose. The second highest involvement of vaccine was a combination of OPV-2, PENTA-2 dose, which contained (18.33%) of all cases. The third highest involvement was measles 1st dose with 11.33%. Other vaccine impacts were as follows: BCG – 3.33%, BCG, OPV1st, PENTA 1st– 1.60%, Hep-B – 5%, BCG, OPV-1, PENTA-1, Rota-1-1.60%, OPV-1, PENTA-1, fIPV-1-8.33%, OPV-1, PENTA-1, ROTA-1-5%, OPV-3, PENTA-3, and fIPV-2-5%, OPV-3, PENTA-3, fIPV-2, and Rota-1-1.60%, measles 2nd dose, DPT-1st booster, and OPV booster – 6.66%, DPT-1st booster, and OPV booster– 5%, OPV booster– 1.60%, PENTA-1-1.60%.

Progression and symptom of adverse event following immunization

Duration between vaccination and developing symptoms

There is no pattern of a time lag between fixed timing of developing symptoms of an adverse event and the administration of vaccines. In half of the cases (52%), effect of adverse events were experienced on the same day of vaccination. In 23% of cases, symptoms were developed after 48 h of vaccination, whereas the rest cases (25%) experienced AEFI after 72 h or more.

Place of vaccination

A total of 47% of cases occurred after vaccination at outreach session sites, whereas 53% of cases occurred at a health-care facility.

Outcome status of patients

Once the symptoms of AEFI are developed, it is important to record its outcome to gauge its impact. In this study, 33% of cases were hospitalized who recovered completely; nonetheless, 17% of patients who were hospitalized, but the outcome of these patients was unknown due to the unavailability of data. Furthermore, there was not any case of disability due to AEFI, however, 15% of the total cases ended up in death. Out of those 15% cases, 10% of cases were hospitalized but still resulted in death. Outcome status of remaining 25% cases was, recovered and discharged with sequelae – 10%, not hospitalized – 11.66%, left against medical advice – 1.6%, and outcome status unknown – 1.6%.

Adverse event following immunization reporting and investigation mechanism

The AEFI reporting and investigation mechanism were reported in the study. The reporting chain begins with community health workers (ANM/ASHA) and passes through the checks and investigation at the primary health-care center and district levels. [Figure 2] presents the reporting and investigation mechanism captured from the study.
Figure 2: Adverse event following immunization reporting and investigation mechanism captured from the study sites

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Reporting of adverse event following immunization by the community-level health-care team

After vaccination, the follow-up of beneficiaries within 24 h is mandated in the National AEFI guideline.[10] However, such standard practice was recorded only in the 18% of AEFI cases. The delay in reporting of AEFI was apparent from the practice data. Nearly, a quarter 25% of cases were reported after 24 h, whereas half of AEFI cases (53%) were reported after 48 h of symptoms. In rest of the cases (3.3%), data were not available.

Investigation by medical officer

MOs are the first point of contact for the community level health-care workers for reporting of AEFI cases. Once MOs are notified, they are expected to investigate at the earliest. In the present study, 78% of MOs had commenced an investigation on the same day of notification. The rest cases were investigated within 1–3 days. Data were missing for 3.3% cases.

Reporting at the district health office

As per the National AEFI reporting guideline, CRF should be sent by MO to District Immunization Officer (DIO) within 24 h of notification. However, only 42% of CRF were shared with district authority. However, in 50% of cases, CRF was delayed to reach the district. The delay was ranged from 1 day, 2 days, or more. Data were missing in 8% of cases. Apart from CRF, preliminary-case investigation form (PCIF) and final-case investigation form (FCIF) are mandatory reporting formats. These help in assessing causality. While checking the availability of these reporting forms at the district level, CRF was available for 98% of total reported cases, whereas PCIF and FCIF were available for 87% of the total reported case. Further, many forms had incomplete details or missing information which highlights the shortcomings of the reporting system [Figure 1].
Figure 1: Vaccine's collusion in developing adverse event following immunization

Click here to view


Investigation by district immunization officer

DIOs are expected to investigate the case within 48 h of notification by MO. Half of the cases (52%) were investigated on the same day of notification, whereas 44% of cases were delayed ranging from 1 to more than 2 days. Data were not available on 4% cases.

Reporting from district to state level

The district health office is anticipated to send these three reporting forms to the State Health Office. In the present review, 67% of the CRF was timely reported to the state, whereas PCIF reporting was 63%. In the case of FCIF, 78% of the forms were timely reported. While reviewing the content of the forms, data mismatch was observed in 3% cases between three reporting formats, whereas 5% forms were incomplete.


  Discussion Top


The present study analyzed the gap in the secondary data. Nevertheless, the result of the study provides important information for AEFI monitoring actions and capacity building of community-level health workers.

Vaccination practice and standard guideline

Most of the children under 9 months who received vaccination have experienced the adverse events and birth dose have contributed to the highest number of AEFI cases. In some of the cases, it was observed that some combinations given to the children are not as per described schedule. This might be occurred due to delayed vaccination or missed dose due to any reason. However, the contribution of a single vaccine in developing AEFI could not be analyzed.

Adverse event following immunization reporting, investigation, and surveillance

The results suggest that in most of the cases reporting of the AEFI symptoms were delayed. MOs have done an investigation on time after getting notified, but they failed to send CRF on time as per the guidelines to the district level in the majority of the cases.[5] For a subject having an AEFI that comes to medical attention, careful medical evaluation is required to confirm the diagnosis, assess the probability that vaccines caused the AEFI, and assess the safety of future immunizations.[8]

Most of the patients who have experienced AEFI were hospitalized, took treatment and after complete recovery, they got discharged. Assessing the possibility of future immunizations in such cases is particularly very challenging as there is a lack of scientific data regarding the risk of recurrence of AEFI. Another group of patients who need expert medical advice are patients with underlying medical conditions that may alter the risk of an adverse event and/or lead to reduced vaccine effectiveness.

From this study, we could say that even if an AEFI would be detected, there are a few barriers to reporting.[6] However, despite the barriers of reporting, under-reporting might be attributed to their poor training status on reporting of AEFI. This decreases the awareness of health workers toward reporting AEFIs as they do not get training on a regular interval. Although the number of health-care professionals who fear personal consequences is low, this might be a factor that contributes to poor perception of AEFI surveillance. Strengthening reporting systems by increasing health-care provider participation and knowledge about AEFI can enhance surveillance efforts during real-time events, like mass immunization in a pandemic.[1],[3],[6],[7],[9]

Strengthening adverse event following immunization

AEFI surveillance can be a part of the medical and allied health sciences curriculum so that professionals are oriented on the importance of AEFI surveillance. Besides, AEFI should be taken up as continuing medical education/continuing professional education for practitioners working in this area. Training curriculum on AEFI should include immediate advancement of immunization, technology in vaccination management or surveillance, AEFI treatment and protocol, newer vaccines schedule.[6],[9],[10],[11],[12],[13],[14]

The WHO recommends training of all health workers on immunization safety to enable appropriate response at all levels in the system.[4],[7] Therefore, training should be planned timely and strategically. Training content and delivery should be aligned with the educational and professional background so make training impactful. Monitoring and supportive supervision need to be strengthened to minimize the unwanted occurrence of AEFI and facilitate immediate treatment actions. Training for ANMs should essentially comprise safe vaccine practices, case diagnosis, reporting, case referral, first-aid (use of adrenaline and hydrocortisone injection) while training of ASHA workers should emphasize follow-up of the infants and children, identification of illness among infants/children before vaccination.

In views of the study conducted by Yamoah Peter,[10] it is seen that parents and the community should be sensitized on AEFI to promote health-seeking behaviour, self-reporting of AEFIs to health workers, and reduce negative perception regarding vaccination. Such interventions might be integrated within the system of continuous educational programs for health-care workers and coordinated with national immunization program activities.


  Conclusion Top


The robust AEFI reporting mechanism is warranted. Monitoring and supportive supervision should focus on AEFI kit availability at the place of vaccination area, the expiry date of logistics related to immunization. AEFI should be included in the agenda of the monthly meeting held by PHC-MO. Experienced health workers can be promoted as a mentor for those who are new and facing challenges in AEFI surveillance and management which would promote the culture of peer-learning.

AEFI surveillance and management are sub-optimal which can be strengthened with strategic actions. Information Education and Communication Materials on AEFI practices for health workers (at state, district, PHC, and sub-center level) as well as materials for parents and community members on AEFI and its reporting can be useful. The digital reporting system can be useful where incomplete forms are not processed, and missing information is highlighted to reduce documentation error. An appropriate mechanism of reporting should be developed when staff is on leave. The innovative mechanism for notification or reporting by caretakers such as miss-call notification for AEFI can improve timely reporting and case-management.

Robust AEFI surveillance and management can potentially minimize the risk of serious adverse reactions, improve reporting and treatment, prevent any further complications which can overall reduce the negative impact on the immunization programme.

Acknowledgment

The authors would express deepest gratitude and warmest appreciation to the entire Immunization Cell at National Health Mission, Madhya Pradesh, India, for the support.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Chitkara AJ, Thacker N, Vashishtha VM, Bansal CP, Gupta SG. Adverse event following immunization (AEFI) surveillance in India, position paper of Indian Academy of Pediatrics, 2013. Indian Pediatr 2013;50:739-41.  Back to cited text no. 1
    
2.
WHO Library Cataloguing-in-Publication Data Global manual on Surveillance of Adverse Events Following Immunization; 2014. Available from: www.who.int. [last accessed on 2020 Mar 23].  Back to cited text no. 2
    
3.
Standard Operating Procedures (SOPs) Investigation of Adverse Events Following Immunization (AEFI). New Delhi: Ministry of Health and Family Welfare, Govt. of India; 2010. p. 1-40.  Back to cited text no. 3
    
4.
MODULE 3: Adverse Events Following Immunization. WHO, Vaccine Safety; Africa.  Back to cited text no. 4
    
5.
Immunization Handbook for Medical Officers. New Delhi: Ministry of Health and Family Welfare, Goverment of India; 2017. p. 1-346.  Back to cited text no. 5
    
6.
Mehmeti I, Nelaj E, Simaku A, Tomini E, Bino S. Knowledge, practice and approaches of health professionals to adverse events following immunization and their reporting in Albania. Heliyon 2017;3:e00331.  Back to cited text no. 6
    
7.
World Health Organization. Adverse Events Following Immunization (AEFI). Geneva: World Health Organization, Library Cataloguing. 2014. p. 1-109.  Back to cited text no. 7
    
8.
EMP. Causality Assessment of an Adverse Event Following Immunization (AEFI) User Manual for the Revised WHO Classification Department of Essential Medicines and Health Products (EMP); 2013.  Back to cited text no. 8
    
9.
Shen AK, Fields R, McQuestion M. The future of routine immunization in the developing world: Challenges and opportunities. Global Health Science and Practice. Vol. 2. Washington DC, USA: Johns Hopkins University Press; 2014. p. 381-94.  Back to cited text no. 9
    
10.
Yamoah Peter FO. AEFI surveillance and response operational guidelines. Glob J Health Sci 2018;10:1-11.  Back to cited text no. 10
    
11.
Masuka JT, Khoza S. Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): An analysis of spontaneous reports in Vigibase® from 1997 to 2017. BMC Public Health 2019;19:1166.  Back to cited text no. 11
    
12.
Meher BR. Vaccine pharmacovigilance in India: Current context and future perspective. Indian J Pharmacol 2019;51:243-7.  Back to cited text no. 12
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13.
Yamoah P, Bangalee V, Oosthuizen F. Knowledge and perceptions of adverse events following immunization among healthcare professionals in Africa: A Case Study from Ghana. Vaccines (Basel) 2019;7:1-15.  Back to cited text no. 13
    
14.
Masika CW, Atieli H, Were T. Knowledge, perceptions, and practice of nurses on surveillance of adverse events following childhood immunization in Nairobi, Kenya. Biomed Res Int 2016;2016:3745298.  Back to cited text no. 14
    


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