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ORIGINAL ARTICLE
Year : 2016  |  Volume : 60  |  Issue : 4  |  Page : 268-272  

Case profile, volume analysis, and dropout rate of antirabies vaccination regimens among animal bite victims in Gujarat


1 Assistant Professor, Department of Community Medicine, Shri M. P. Shah Govt. Medical College, Jamnagar, Gujarat, India
2 Associate Professor, Department of Community Medicine, Shri M. P. Shah Govt. Medical College, Jamnagar, Gujarat, India
3 Internee, Department of Community Medicine, Shri M. P. Shah Govt. Medical College, Jamnagar, Gujarat, India

Date of Web Publication15-Dec-2016

Correspondence Address:
Kishor M Dhaduk
Department of Community Medicine, Shri M. P. Shah Government Medical College, P N Marg, Jamnagar - 361 008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-557X.195855

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   Abstract 


Background: Rabies is a preventable neglected public health problem and associated with multiple cultural, religious, and social practices, myths in our country. There is a lack of organized surveillance system to measure the incidence of animal bite and human rabies as well as to evaluate cost-saving of different routes, regimen, and types of antirabies vaccines (ARV)/immunoglobulin available in India. Objectives: The objective of this study is to know dropout rate in intradermal (i.d.) ARV regimen among animal bite and to analyze the utilized volume of ARV by a different route of vaccine administration. Methods: A total of 250 animal bite victims were followed up at ARV Clinic (ARVC). Volume utilization of i.d. route over intramuscular (i.m.) route was analyzed among the patients who attended ARVC during the past 2 years. Total dropout and delayed compliance rates of ARV regimen among different group were compared by Chi-square test. Results: The i.d. route was about five times more volume and cost-saving than i.m. route. The majority of victims belonged to 15–30 years (27.60%) and children <15 years (26.40%) and had wound at their lower limbs (85%) mainly bitten by dogs (98%). Thirty-four percent total dropout and 31.5% delayed compliance observed particularly during the last dose of i.d. regimen. There was no significant difference in dropout rates among different demographic groups. Half of the victims practiced wound toilet on the same day of bite. Only 68% received the first dose of ARV within 24 h of the exposure. Conclusion: Children and young adults are at higher risk of having dog bite. I.d. ARV regimen is more volume and cost-saving than i.m. one and proper counseling and follow-up should be arranged to complete the vaccination schedule.

Keywords: Antirabies vaccine regimen, dropout rate, intradermal, vaccination schedule, volume analysis


How to cite this article:
Dhaduk KM, Unadkat SV, Katharotiya PR, Mer AR, Chaudhary MC, Prajapati MM. Case profile, volume analysis, and dropout rate of antirabies vaccination regimens among animal bite victims in Gujarat. Indian J Public Health 2016;60:268-72

How to cite this URL:
Dhaduk KM, Unadkat SV, Katharotiya PR, Mer AR, Chaudhary MC, Prajapati MM. Case profile, volume analysis, and dropout rate of antirabies vaccination regimens among animal bite victims in Gujarat. Indian J Public Health [serial online] 2016 [cited 2017 Feb 21];60:268-72. Available from: http://www.ijph.in/text.asp?2016/60/4/268/195855




   Introduction Top


Rabies in India has been a disease of low public health priority both in the medical and veterinary sectors, mostly affecting the poor, who are voiceless and disorganized.[1] Dog, the main biting animal to human and showing high positivity (48.4%) for disease virus, is not an animal of economic importance.[1] Still, it is an endemic lethal disease, even after 100 years of the invention of its vaccine by Louis Pasteur and Emile Roux in 1885.[2] More than 99% of all human rabies deaths occur in thedeveloping countries and lack of organized surveillance system is responsible for the absence of reliable data regarding rabies.[3],[4] According to the WHO (2002), India officially reported 30,000 human rabies deaths (an estimated figure, which has remained constant since 1990) and it accounts for 60% of the global report of 50,000 deaths annually.[1] Every year, approximately 1.1–1.5 million people receive postexposure treatment with rabies vaccine.[5] In the Association for Prevention and Control of Rabies in India (APCRI) (1992–2001) decadal survey from isolation hospital data, the majority of human rabies deaths occurred in adults (64.7%), males (71.1%) belonged to poor/low-income group (87.6%) and mainly was due to dog bite (96.2%).[1] About 79% of rabies victims did not receive any antirabies vaccination (ARV), and of those who took the vaccine (neural tissue vaccine/tissue culture vaccine), most of them did not complete the full course.[1]

The APCRI is in a hope of a coordinated “National Rabies Elimination Programme” to ensure a rabies free India by 2020.[1] For that, either all (100%) animal bite victims must be managed according to guideline and/or biting animals must be controlled adequately. However, due to various economic and political factors, multiple cultures, religious and social practices, multiples myths associated with rabies, and lack of accurate data, even though economic and effective control measures are available; the disease has not been brought under control.[4],[6] The present study was conducted to know dropout rate in updated Thai Red Cross intradermal (i.d.) ARV regimen among animal bite victims having different clinical and demographic profile presenting to ARV Clinic (ARVC). We also tried to analyze the utilized volume of ARV by a different route of vaccine administration in the previous years.


   Materials and Methods Top


The present follow-up study was conducted at ARVC after obtaining approval from the Institutional Review Board of Medical College Hospital of Jamnagar which provides 24 × 7 emergency medical care.

Sample size

For estimating a population proportion with specified relative precision, formula n = Z[2]1 − α/2 (1 − P) P[2] was used. Where n = Sample size, 1− α = confidence level, P = anticipated population proportion, ε = relative precision.[7]

In a study conducted at infectious disease hospital, Lucknow, complete vaccination was found in 65% of the animal bite victim.[8] At P = 0.65 (65%) and ε =10% of P, a sample size of 215 would be needed. To make the calculation of rates more convenient, sample size increased to 250.

To calculate vaccine volume utilization and wastage factor, total number of animal bite victims vaccinated during the period of last 2 years (2013 and 2014) was obtained from ARV registers.

Case profile and dropout rate were presented for patient attending the clinic from March 2015. Data were collected by personal interview of animal bite victims during each visit for vaccination using pretested structured questionnaire. First, 250 animal bite victims who consented to interview at ARVC were included in the study and each of them was followed up during their each visit till 30 days from the first dose of ARV or till completion of full course ARV regimen, whichever was late. We collected various information regarding their sociodemographical and clinical profile; i.e. age and sex of the victim, time, site, type (domestic/wild) and profile (provoked/unprovoked) of animal, longevity of animal after bite, type of first aid treatment taken before reporting to the hospital, time-lapse between animal bite and first dose of vaccine, severity of wound, timing, route and schedule of ARV/immunoglobulin doses, injection tetanus toxoid, and their adherence to prescribed antirabies management protocol. Patient adherence was evaluated according to the national guideline on rabies prophylaxis.[9]

Those who had taken at least one dose of ARV after animal bite but not completed all prescribed doses of ARV regimen were taken as complete dropout, while those who had completed all doses but come on a later date to complete the ARV course were considered as delayed compliance.

Statistical analysis of data was done using Epi Info, version 3.5.4, CDC, Atlanta, GA.


   Results Top


In the present study, 14750 and 18697 animal bite victims were vaccinated during the year 2013 and 2014, respectively. In 2014, due to shortage of i.d. syringe, 1631 of 18697 were vaccinated by Essen intramuscular (i.m.) regimen (1 ml of rabies vaccine administered intramuscularly on days 0, 3, 7, 14, and 28), while rest of all vaccinated by two site 0.1 ml Modified Updated Thai Red Cross Intradermal Regimen (“2-2-2-0-2”). The i.d. route was more volume and cost-saving than i.m. route because it utilized 0.21 ml of vaccine per victim per visit for total four visits against 1 ml per victim per visit for total five visits by i.m. route [Table 1].
Table 1: Calculation of vaccine volume utilization and wastage in different route of administration

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The most common age groups injured by animal bite were 15–30 years (27.60%) and children <15 years (26.40%), followed by 33–45 years (19.20%), 45–60 years (14.40%), and >60 years (12.40%). Most of the victims were male in each age group and of the urban residential area (overall male: female ratio = 3:1) [Table 2].
Table 2: Distribution of animal bite victims according to age, sex, and residence (n=250)

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The overall complete coverage to full course of ARV by i.d. route was found to be as low as 66%. The dropout for the last (28 days) dose of 34% was higher compared to the previous doses [Table 3]. As per the WHO classification of animal bite wound, 81% of the victims had Category II bite wound and 19% had Category III bite wound.[9] There was no statistically significant difference observed in dropout rate among victims belonging to different category of bite wound (P = 0.17 at df = 2 and χ[2] = 3.49), residential area (P = 0.36 at df = 2 and χ[2] = 2.05), and sex group (P = 0.9 at df = 1 and χ[2] = 0.01) [Table 3].
Table 3: Comparison of dropout rate of updated Thai Red Cross antirabies vaccine regimen among different groups

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The main biting animal in the study was dog (98.8%), while cat and kitten were responsible for bite in 2 (0.8%) and 1 (0.4%) cases, respectively. The majority of the bites were on lower limb (64%) followed by foot (15%), hand (7%), upper limb (6%), gluteal region (6%), face (1.2%), and abdomen (0.8%). More than half of the victims (54.4%) had not taken household first aid, i.e., thorough wound toilet with soap and water on the day of biting. 68% of the victims had received ARV on the day of biting while as much as 27% of them received it on the 2nd or 3rd day of bite. 5% of the victims received it still later, i.e., after the 3rd day of bite [Table 4].
Table 4: Wound toilet, initiation and completion of antirabies vaccine dose(s) from the day of animal bite (n=250)

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Sixty-eight percent of the victims who completed the full course of ARV schedule completed the regimen within 28 days from the day of bite, while 25% and 7% of the same were considered as delayed compliance because they had taken 29–30 days and 36 days, respectively, to complete the ARV schedule [Table 4].


   Discussion Top


Cell culture vaccine by two-site i.d. route was recommended for use in the government sector in 2006. The present study was planned to assess the dropout among updated Thai Red Cross regimen (2”-2”-2”-0”-2”) in a tertiary care medical college hospital.

I.d. route of ARV was found to be more volume and cost-saving than i.m. route as it requires less volume than i.m. route. Similar finding was demonstrated in a study of Aggarwal et al.[10]

In this study, majority victims were male (male: female = 3:1); among them, children <15-year group (26%) and youth 15–30-year group (28%) were affected more as reported by similar studies.[6],[8],[11],[12],[13] Most probably because they are highly kinetic and they are mostly engaged in outdoor activity without proper precaution. The main biting animal was dog, and this observation is seen uniformly in other studies too.[6],[8],[11],[12],[13] In the study, majority (60%) of the victims were from urban area while 17% and 22% of the victims were from rural and slum background, respectively, corresponding to the finding of Sahu et al.[8]

Rabies is 100% fatal disease only preventable by antirabies prophylaxis. Completeness of postexposure vaccination is crucial to achieve optimum level of antibody titers (0.5 IU/ml of serum).[9] Completion of full course of vaccination was poor (66.0%) when it should be 100% and this is similar to finding of Sahu et al. and Aggarwal et al.[8],[10] Shankaraiah et al., in their study on compliance to ARV, reported 60% adherence to i.m. and 77% adherence to i.d. ARV regimen,[11] while Biswas et al., in their study conducted at a medical college hospital, reported only 9.4% overall dropout to ARV regimen.[14] In the present study, dropout was most commonly encountered, between the third dose (completed by 96.3% of total victims) and the fourth dose (completed by 66% of total victims), while Biswas et al. reported 41.2% dropout in the third dose [14] [Table 3].

The majority of the victim had Category II bite wound in the studies conducted by Aggarwal et al. (Solapur, Maharashtra 72.02%), Sahu et al. (Lucknow, Uttar Pradesh 88.2%), and Umarigar et al. (Surat, Gujarat 73.6%) which corresponds to our findings.[8],[10],[13] A study by Biswas et al. reported more dropout among victims having wound Category II (8.8%) than among wound Category III (5.1%), and a study by Aggarwal et al. reported statistically significant adherence among males (65.52%) as compared to females (58.25%), while in the present study, we did not find any statistically significant difference in dropout/adherence rate among animal bite victims belonging to different categories, sex, and residential groups.[14]

Appreciable similarity of wound location (lower limb 80%–90% cases, upper limb around 10%–20% cases) was observed in different studies conducted at different locations in India.[6],[8],[11],[12],[13] The practice of wound toilet on the same day bite was poor (<50%) and uniform in different areas of India.[6],[11],[12],[13]

Antirabies prophylaxis should be administered preferably within 24 h of the bite exposure,[9] while only 68% of the victims in the present study had received it within prescribed time limit. Similar low coverage of ARV first dose within 24 h of exposure was reported by other studies (50% by Ichhpujani et al., 75% by Sahu et al., 14% by Abhay et al., 74% by Umarigar et al.).[6],[8],[12],[13]

Only 66% of the victims had completed full course regimen, 31.5% of them but (52/165) did not complete within prescribed time limit. Hence, they were considered as delayed compliance. Similarly, Biswas et al. reported 77.5% delayed compliance in their study.[14]


   Conclusion Top


Adherence and full course completion to updated Thai Red Cross ARV regimen among animal bite victims are poor without significant variation among urban, rural, and slum region victims. However, i.d. ARV regimen is well compliant and more volume and cost-saving than i.m. one because it requires one-fifth volume in comparison to i.m. regimen. The dogs were the main biting animal affecting mostly male children and youth. Lower limb was the most common site and Category II exposure was the most common. More than half of the bite victims did not do proper wound care. There is a need of new molecular vaccine which would be more potent than currently available vaccines so that total duration of full course vaccination and total number of injection can be reduced.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
World Health Organization. WHO Sponsored National Multi-Centric Rabies Survey 2003: Assessing Burden of Rabies in India. APCRI [Final Report]; May, 2004. Available from: http://www.rabies.org.in/rabies/wp-content/uploads/2009/11/whosurvey.pdf. [Last accessed on 2015 Mar 11].  Back to cited text no. 1
    
2.
Maurya I, Vagholkar K, Patel B, Siddiqui M, Tiwari S, Maurya P. State of globe: Rabies: The lethality since antiquity! J Glob Infect Dis 2015;7:1-2.  Back to cited text no. 2
    
3.
WHO Expert Consultation on Rabies:First Report; 2004. Available from: http://www.whqlibdoc.who.int/trs/WHO_TRS_931_eng.pdf. [Last accessed on 2012 Nov 22].  Back to cited text no. 3
    
4.
Ichhpujani RL, Bhardwaj M, Mala C, Datta KK. Rabies in India. Country Report, 4th International Symposium on Rabies Control in Asia, Vietnam; March, 2001. p. 35.  Back to cited text no. 4
    
5.
World Health Organization. WHO Technical Report Series 931: WHO Expert Consultation on Rabies;First Report. Geneva, Switzerland: WHO; 2005. p. 13.  Back to cited text no. 5
    
6.
Ichhpujani RL, Mala C, Veena M, Singh J, Bhardwaj M, Bhattacharya D, et al. Epidemiology of animal bites and rabies cases in India. A multicentric study. J Commun Dis 2008;40:27-36.  Back to cited text no. 6
    
7.
World Health Organization, Lwanga SK, Lemeshow S. Sample Size Determination in Health Studies – A Practical Manual. Geneva: WHO; 1991. p. 1-27.  Back to cited text no. 7
    
8.
Sahu KK, Manar MK, Singh SK, Singh H. Epidemiological characteristics of patients attending for rabies post-exposure prophylaxis at the infectious diseases hospital of Lucknow, India. J Glob Infect Dis 2015;7:30-2.  Back to cited text no. 8
    
9.
National Center for Disease Control. Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. National Guideline for Rabies Prophylaxis. New Delhi; 2013. p. 1-23.  Back to cited text no. 9
    
10.
Aggarwal S, Chaugule R, Haralkar S, Aswar NR, Khandare K, Kumavat AP. A cross sectional study-intradermal vs. intramuscular anti rabies prophylaxis. J Res Med Dent Sci 2015;3:31-4.  Back to cited text no. 10
    
11.
Shankaraiah RH, Rajashekar RA, Veena V, Hanumanthaiah AN. Compliance to anti-rabies vaccination in post-exposure prophylaxis. Indian J Public Health 2015;59:58-60.  Back to cited text no. 11
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12.
Abhay K, Rishabh KR, Sunil K, Veena R, Roy C. Factors influencing animal bite cases and practices among the cases attending the anti-rabies clinic DMCH, Darbhanga (Bihar). Int J Recent Trends Sci Technol 2013;6:94-7.  Back to cited text no. 12
    
13.
Umarigar P, Parmar G, Patel PB, Bansal RK. Profile of animal bite cases attending urban health centres in Surat city: A cross-sectional study. Natl J Community Med 2012;3:631-5.  Back to cited text no. 13
    
14.
Biswas M, Kar K, Satpathy DM, Giri PP. A study on drop out among animal bite cases (provoked versus unprovoked) attending the ARV clinic SCB Medical College, Cuttack. APCRI J 2014;15:21-3.  Back to cited text no. 14
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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