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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 13  |  Issue : 2  |  Page : 127-131

Pharmacist-led intervention on adverse events following immunization at a tertiary care hospital: A randomized controlled study


Department of Pharmacy Practice, KLE College of Pharmacy, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India

Date of Submission28-May-2019
Date of Acceptance14-Mar-2020
Date of Web Publication23-Jun-2020

Correspondence Address:
Prof. Shashikala Wali
Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi - 590 010, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/kleuhsj.kleuhsj_111_19

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  Abstract 


CONTEXT: An adverse event following immunization (AEFI) is defined as “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.” Pharmacists who do not administer vaccines also have a role in promoting the importance of immunization in other ways, which include: (1) history and screening of patients, (2) patient counseling, (3) documentation, (4) formulary management, (5) administrative measures, and (6) public education and awareness.
AIMS: This study aimed to assess AEFI and record and report AEFIs.
SUBJECTS AND METHODS: Forty-seven individuals were screened and randomized into two groups. One group received the conventional therapy, whereas the second group received pharmacist intervention. A comparison of the two groups gives an idea of how the objectives were fulfilled.
STATISTICAL ANALYSIS USED: Chi-square test and McNemar test were used for statistical analysis.
RESULTS: From the 47 individuals screened, 40 were selected and divided into two groups of 20 each: intervention and control groups. Of the two groups, 67.5% and 32.5% were male and female, respectively. A wide range of vaccines were administered, of which oral polio vaccine was the most administered, and typhoid, haemophilus influenzae type b, rotavirus, and Tdap were the least administered. Fever was the most commonly recorded AEFI, and loss of appetite was the least recorded.
CONCLUSION: The reporting rate of AEFI increases with the intervention of a clinical pharmacist.

Keywords: Adverse events following immunization reporting, oral polio vaccine, pharmacist intervention, vaccination


How to cite this article:
Menezes NB, Wali S, Ganachari MS. Pharmacist-led intervention on adverse events following immunization at a tertiary care hospital: A randomized controlled study. Indian J Health Sci Biomed Res 2020;13:127-31

How to cite this URL:
Menezes NB, Wali S, Ganachari MS. Pharmacist-led intervention on adverse events following immunization at a tertiary care hospital: A randomized controlled study. Indian J Health Sci Biomed Res [serial online] 2020 [cited 2020 Aug 3];13:127-31. Available from: http://www.ijournalhs.org/text.asp?2020/13/2/127/287408




  Introduction Top


National immunization programs (NIPs) make use of vaccines that are assumed to be efficacious and safe when used correctly[1] Vaccines are not risk free – adverse events post vaccination can occur. The trust of the public on vaccine safety is a factor which promotes vaccination programs and their success.[1],[2] Every year, 2.5 million child deaths globally are prevented by vaccines. Two million or more child deaths can be avoided yearly by immunizing with vaccines that are available currently.[3]

Vaccines are biological substances that enhance the immunity of a human subject to a specific vaccine preventable disease (VPD). One of the most effective (financially) public health interventions is immunization which protects an individual and public from VPDs and death, every year.[1],[2],[3],[4] Vaccines are administered to the healthy, including new born infants in large numbers. The role of vaccines in countries like India is significant – which can promote health, which, in turn, has a significant reach and an impact and reduces treatment cost.[5]

The failure of dealing quickly and effectively with vaccine-related adverse event allegations reduces the confidence of the general public on vaccines, which ultimately results in reduced coverage of immunization and increased incidence of diseases. Although vaccines used in NIPs are considered safe and effective, like alternative pharmaceutical products, they are not risk free and occasionally, adverse events will occur resulting from vaccinations.[1],[2],[3]

There is low tolerance to adverse events following vaccination by the general public due to the fact that vaccines are administered to healthy individuals to prevent the disease. Hence, high safety standards are expected from vaccines as compared to medications used to treat people that are sick.[6] The need to detect and investigate adverse events following immunization (AEFI) has resulted from the lowered tolerance for risks of vaccines compared to other pharmaceutical products.[3]

According to the World Health Organization (WHO), “an AEFI is defined as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.”[1]

AEFIs are categorized into five main categories:

  1. Vaccine product-related reactions
  2. Vaccine quality defect-related reactions
  3. Immunization error-related reactions
  4. Immunization anxiety-related reactions
  5. Coincidental events.[1],[2],[3]


Clinical pharmacists can be placed into the field of vaccination to help not only on the quality and quantity of vaccination services but also in the minimization of financial burden of the needy and increase in community awareness, participation, and education. Pharmacists are important in providing patient information and informed choices when it comes to immunization, as well as in benefit–risk comparison.

Pharmacists have the knowledge and the ability to determine and identify patients who fall in a particular target group for certain vaccinations. They can also ease the patients' fears by providing information and facts of risks related to not being immunized, thus leading to reduced hesitancy of vaccination.[7],[8]

In India, pharmacists do not receive certification required for the administration of vaccinations, but pharmacists who do not administer vaccines have a crucial role in other aspects, which include:

  • Screening of patients
  • History of patients
  • Patient counseling
  • Documentation
  • Formulary management
  • Administrative measures
  • Public education
  • Public awareness.[9],[10]



  Subjects and Methods Top


The study protocol was prepared and submitted to the Ethics Committee (KLECOP/665/2018-19), KLE Dr. Prabhakar Kore Charitable Hospital and Medical Research Centre. This was a randomized controlled study. Ethical approval was obtained from the Ethics Committee of KLE College of Pharmacy, KAHER, Belagavi.

The study was set to be carried out in the outpatient Department of Paediatrics at KLES Dr. Prabhakar Kore Hospital and MRC. The inclusion criteria included patients aged up to 18 years of either gender, outpatients for whom vaccination was given, and the parents/caretakers of the child who provide their willingness for informed consent form. The exclusion criteria included patients who were traveling.

Screening was done according to the eligibility criteria. Participants or the parents of the participants were provided and informed with the study details. Both were informed about the procedures in the work and the rights to withdraw from the study at any moment. Subject data regarding the reason of withdrawal from the study was registered and documented for statistical evaluation.

This randomized controlled study was carried out in the outpatient Department of Paediatrics in KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, which is a tertiary care hospital in North Karnataka. The study included forty children aged till 18 years with consent received from their parents/guardian. Approval of the Institutional Ethical Committee was obtained prior to the study. All details were recorded in a predefined pro forma which included personal information and vaccination details.

Other study materials such as patient profile forms (online), patient information leaflets, patient information sheet, informed consent forms, and questionnaires were prepared. The AEFI form prepared by the WHO was also used in the study.

Randomization was carried out by using online research randomization software. Follow-up was done telephonically/physically whenever applicable for the experiment group.


  Results Top


From the randomized participants that completed the study, twenty were divided into control group and twenty in the intervention group. The analysis was only performed for those participants that completed the study.

There was a total of 13 boys and 27 girls in the study. The control group consisted of 4 boys and 16 girls, making up 20% and 80% of the group, respectively. The intervention group consisted of 9 boys and 11 girls, making up 45% and 55% of the group, respectively. [Figure 1].
Figure 1: Comparison of control group and experiment group with age and gender

Click here to view


The mean age in years for the control group was 1.07 ± 1.08, whereas that of the intervention group was 0.67 ± 1.22.

There were a total of 13 boys and 27 girls in the study. The control group consisted of 4 boys and 16 girls, making up 20% and 80% of the group, respectively. The intervention group consisted of 9 boys and 11 girls, making up 45% and 55% of the group, respectively.

A large number of vaccines were administered. The most common vaccine administered was oral polio vaccine at twenty administrations, majority of which were in the control group (60%). Hepatitis B was the second most administered vaccine at 14 doses, of which majority were in the control group (8/14). Bacillus Calmette–Guérin and diphtheria, pertussis, and tetanus vaccines were followed at 12 doses and 11 doses, respectively [Figure 2].
Figure 2: Comparison of control group and experiment group with vaccination status

Click here to view


It was also observed that the least common vaccines administered were haemophilus influenza type b bacteria and rotavirus, which were at one dose each.

Fever was the most commonly reported AEFI with a total incidence of 23, of which 4 were reported by the control group and 19 were reported in the intervention group. The injection site reactions were in the second place at 13 reports, of which 2 were reported by the control group and 11 were recorded from the intervention group. [Figure 3].
Figure 3: Comparison of control group and experiment group with adverse events following immunization reported status

Click here to view


Five incidents of rashes were noticed on the body of a child in the intervention group.

There was only one report of loss of appetite in the intervention group, but it did not show relationship to the vaccine administered.

There were two cases of vomiting recorded in the intervention group.

There were five reports of AEFI in the control group. The association of AEFI with the number of vaccines taken was checked. It was found that participants that took more than one vaccine in the control group were more likely to have an AEFI. The highest number of reactions reported by an individual was two reactions. The recorded reactions were considered minor reactions that are not life threatening and can be prevented with appropriate therapy.


  Discussion Top


In a country like India, there is standing gender discrimination.[11] In a study carried out, it was found that females were less likely to get immunized, especially in the western parts of the country due to religious standings or financial standings of poor households. In our study, it was found that there was no such case. Both male and female participants received immunization. It was also found that more female children when compared to male children were taken for immunization. It may be due to the changing mindset of the parents and the acceptance that both genders are equal.

There were only five AEFIs reported in our study, namely fever, injection-site reactions, rash, vomiting, and loss of appetite. Twenty-three cases of fever, 13 cases of injection-site reactions, and 5 cases of rash were reported owing to vaccination. Vomiting and loss of appetite were not related to vaccination but were reported by the parents anyway. According to a study conducted, fever was a common reaction experienced by 158/396 participants enrolled, followed by injection-site reactions at 161/396 responses.[12] These reactions were considered to be nonserious events. Serious events for immunization are sepsis, encephalopathy, abscess, thrombocytopenia, anaphylaxis, and toxic shock syndrome. It is also known that a serious event is any event that is life threatening, persistent, or causes significant disability, hospitalization, or even death.

In a study conducted,[13] the authors showed that supervision is required to enhance AEFI reporting by patients. In their study, they tried short messaging service as a mode of communication with the patient to determine any AEFI. In our study, we conducted telephonic communication with the parents of the children that underwent immunization. In our study, it was apparent that the use of pharmaceutical care was necessary for enhanced AEFI reporting rates. The control group in our study showed a response of only five out of twenty participants, whereas our intervention group showed the entire twenty out of twenty reports though the reports were not necessarily related to AEFI. From this comparison, it is clear that there is a need for pharmacist intervention in the enhancement of AEFI reporting in parents of children undergoing immunization.

Through this study, it was identified that there is a need to invoke knowledge in the parents of children that undergo immunization, resulting in a better response rate. There is a need of a constant surveillance system to be incorporated into the health-care system for monitoring and reporting AEFI within the tertiary care hospital even though no serious reactions were observed. Pharmacists can help in the management of AEFI by providing information to the vaccine prescriber, administrator, and the patient/parent of the patient regarding the same.

Spontaneous reporting of parents or caretakers of the children who undergo immunization needs to be enhanced as it can play an integral part in vaccine safety surveillance and can help development at a national level. Provision of pharmaceutical care can advocate consumer reporting and can benefit by signal detection, improve consumer confidence in immunization, and also provide vaccine safety communication to health-care facilities and community.

Acknowledgement

I wish to express my gratitude to the Principal, KLE College of Pharmacy, Belagavi, for providing all facilities required for carrying out this project. I thank the MD of KLE's Dr. Prabhakar Kore Charitable Hospital and MRC for allowing me this opportunity to carry out my study within the hospital. My sincere thanks to Dr. (Mrs.) Sujata M. Jali, Head and Professor, Department of Pediatrics, KLE's Prabhakar Kore Charitable Hospital and MRC. I thank her for her help during this project work.


  Conclusion Top


Through this study, it was identified that there is a need of constant surveillance system to be incorporated into the health care system for monitoring AEFI within the tertiary care hospital even though there were no serious reactions that were observed. Provision of pharmaceutical care can advocate consumer reporting and can benefit by signal detection and improve the consumer confidence in immunization and also provide vaccine safety communication into healthcare facilities and the community.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
World Health Organization (WHO), United Nations Children's Fund (UNICEF), World Bank. State of the world's vaccines and immunization. 3rd ed. Geneva: WHO; 2009.  Back to cited text no. 1
    
2.
Global Manual on Surveillance of Adverse Events Following Immunization. World Health Organization 2014. Available from: http://www.who.int/vaccine_safety/publications/aefi_surveillance/en/. [Last accessed on 2018 Oct 06].  Back to cited text no. 2
    
3.
4.
Plotkin SL, Plotkin SA. A short history of vaccination. In: Plotkin S, Orenstein W, Offit PA, editors. Vaccines. 5th ed. Philadelphia: Saunders; 2008.  Back to cited text no. 4
    
5.
Immunization Coverage Fact sheed 2014. Available from: http://www. who. int/mediacentre/factsheets/fs378/en/. [Last accessed on 2018 Oct 06].  Back to cited text no. 5
    
6.
Vashishtha VM, Kumar P. 50 years of immunization in India: Progress and future. Indian Pediatr 2013;50:111-8.  Back to cited text no. 6
    
7.
Immunization. Available from: http://unicef.in/Whatwedo/3/Immunization. [Last accessed on 2018 Oct 06].  Back to cited text no. 7
    
8.
Vaccine Safety E-Learning Manual. World Health Organization 2013. Available from: http://www.who.int/vaccine_safety/initiative/tech_support/ebasic/en/. [Last accessed on 2018 Oct 06].  Back to cited text no. 8
    
9.
World Health Organization (WHO). Progress in Global Measles Control and Mortality reduction, 2000-2007. Weekly Epidemiological Record. Vol. 83. Geneva: WHO; 2009. p. 441-8.  Back to cited text no. 9
    
10.
Copenhagen Consensus 2008. Available from: http://www.copenhagenconsensus.com [Last accessed 2018 Oct 06].  Back to cited text no. 10
    
11.
Ranjan KP, Abhishek K. Socioeconomic Dynamics of Gender Disparity in Childhood Immunization in India, 1992–2006 PLos One. 2014;9: e 104598.  Back to cited text no. 11
    
12.
Deepika M, Aditi D, Jane C, Bronwen H, Rob M, Kristine M, Surveillance of Adverse Events Following Immunization in Australia Annual Report, 2013. CDI Vol39 No 3 2015.  Back to cited text no. 12
    
13.
Baron S, Goutard, Nguon K, Tarantola A, Eysenbach G. Use of a text message-based pharmacovigilance tool in Cambodia: pilot study. J M Int Res 2013; 15:1-; PMID:23591700; http://dx.doi. org/10.2196/jmir. 2477.  Back to cited text no. 13
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]



 

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