PHARMACOVIGILANCE ON RABIES

IMMUNOGLOBULINS

ADMINISTRATION By Rajan H.

Under the guidance ofSudharshan M.K., Mahendra B.J., Githa Kishore, Meera N.K.

Department of Pharmacy Practice Department of Pharmacy Practice

Visveswarapura Institute of Pharmaceutical SciencesVisveswarapura Institute of Pharmaceutical SciencesBangaloreBangalore

INTRODUCTION

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

• Rabies is essentially a zoonotic disease with man being the dead-end host.

• Annual number of deaths caused by rabies worldwide as estimated by WHO accounts for 55,000 and mostly in the rural areas of Africa and Asia.

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

• Post-exposure prophylaxis adequately applied after exposure to a rabid animal is highly effective in prevention of human disease.

• Adverse reactions after vaccination are considered as an important practical problem.

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

• Identification of adverse reactions during post-exposure prophylaxis of rabies immunoglobulins would be helpful in improving the quality of life of the recipient and to prevent further hospitalization.

• This study is a small step in this direction.

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

OBJECTIVE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

• To find out the various adverse reactions during post-exposure prophylaxis of rabies immunoglobulins.

• To find out the sociodemographic details of the host as well as the carriers.

METHODOLOGY

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

METHODOLOGY

• A retrospective study was conducted in 1000-bed tertiary care teaching hospital, in Rabies Preventive Medicine Department, KIMS, Bangalore.

• The data was collected for a period of two and a half years from June 2003 to December 2005 based on the records and data stored in the department.

RESULTS

AND

DISCUSSIONS

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

• Overall 1316 cases were analyzed.

Gender

889, 68%

427, 32%

male

female

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

RESULTS AND DISCUSSIONS

Female Patients

19, 4%

408, 96%

pregnant female

non pregnant

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

RESULTS AND DISCUSSIONS

Residence

341, 26%

975, 74%

rural

urban

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Occupation

209, 12%

1107, 61%

499, 27%

un employed

employed

students

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Educational Qualification

288

429

250

7 295

223

0100200300400500

illitera

te

prima

rysch

ool

seco

ndary

schoo

l

sslc

diplom

a puc

degre

e

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Monthly Income

178

864

117 157

0100200300400500600700800900

1000

poor

(<100

0)

low

inco

me(1

001

-50

00)

mid

dle

inco

me(5

001

-10

000)

uppe

r(>

1000

0)

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Time of Bite

337, 26%

979, 74%

night

day

Place of Bite

375, 28%

941, 72%

house

on road

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Nature of Bite

506, 38%

795, 61%

15, 1%

provoked

unprovoked

cant say

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Biting Animal

3 1 27 4 2

1231

3 19 4 220

500

1000

1500

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Nature of Biting Animal

22

375

906

130

200

400

600

800

1000

human pet stray wild

Pet:Stray Ratio is : 1:2.5

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Vaccination Status Of Biting Animal

78, 6% 108, 8%

1130, 86%

fully vaccinated

partiallyvaccinated

unvaccinated

DEPARTMENT OF PHARMACY PRACTICE – VIPS, BANGALORE

Place of Biting

774, 58%

520, 40%

22, 2%

over bareskinoverclothingboth

DEPARTMENT OF PHARMACY PRACTICE - VIPS, BANGALORE

Type of Wound

296, 22%

303, 23%242, 18%

393, 31%

82, 6%

abrations

lacerations

mixed(abrations+lacerations)punture wound

scratch

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Wound Washed

87, 7%

25, 2%

403, 31%

71, 5%616, 46%

114, 9%

antiseptic only

water andantiseptic

water andsoapwater only

water+soap+antiseptic

not done

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Fate of Dog

5126

536

197

422

300

100200300400500600

aliv

e

dead

heal

thy

and

aliv

e

kille

d

not

trace

able sick

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Conformation of Rabid Animal

41244

822

209

0200400600800

1000

confirmedrabid

not rabid probablyrabid

suspectrabid

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Dressing of Wound

1117

1168

300

200400600800

100012001400

dressed notapplicable

nothingdone

sutured

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Age of Subjects Bitten

176

343412

15037

196

0100200300400500

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Rig Administered

1237, 94%

79, 6%

ERIG

HRIG

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Occurence of Reaction

126, 10%

1190, 90%

yes

no

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

VaccineLocalPain Others No Reaction Total p-value

ERIG 147 7 1083 1237

0.015012HRIG 18 0 61 79

Total 165 7 1144 1316  

Chi – Square Test For Immediate Reactions

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Immediate reactions ERIG (n=1237) HRIG(n=79) p-value

Local Pain 147 18 0.0005

Others 7 0 0.503

No reaction 1083 61 0.008

Z Test For Proportions

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Chi – Square Test For Delayed Reactions

Vaccine FeverLocal Pain

Urticaria Others No reaction Total p-value

ERIG 6 4 5 4 1218 1237

<0.001HRIG 3 3 0 2 71 79

Total 9 7 5 6 1289 1316  

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

Late reaction ERIG (n=1237) HRIG(n=79) p-value

Fever 6 3 0.013

Local Pain 4 3 <0.001

Urticaria 5 0 0.571

Others 4 2 0.005

No reaction 1218 71 <0.001

Z Test For Proportions

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

CONCLUSION

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

• The study helps to identify the adverse reactions of rabies immunoglobulins so that further precautions can be taken by giving proper counseling and treatment to improve the quality of life of the recipient.

• Since P value is <0.05, we can conclude that there is a significant relationship between the type of vaccines and the immediate reaction.

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE

CONCLUSION

• Since the pet:stray dog ratio is more ie 1:2.5, the stray dog population should be controlled.

THANK YOU

DEPARTMENT OF PHARMACY PRACTICE VIPS BANGALORE