The document provides information about the Department of Pharmacology at SMS Medical College in Jaipur, India. It introduces the faculty members and describes the department's undergraduate and postgraduate curriculum, ongoing research projects, administrative work, integrated teaching initiatives, guest lectures, and awards. It also summarizes the department's introduction of an Adverse Drug Reaction Monitoring Centre for pharmacovigilance, including details about awareness programs, training initiatives, and the number of ADR reports submitted annually.

1. CPC By Department of Pharmacology SMS
Medical College, Jaipur
Dr. Jyotsna Bhargava
Dr. Abhimanyu
Dr. Lokendra Sharma
Dr. Rupa Kapadia
Dr. Monika Jain
Presented by:

2. SMSMC-CPC:
The TEAM
• DR. U.S. AGARWAL, Principal & Controller
• DR. HEMANT MALHOTRA, CONVENER (9829062040,
drmalhotrahemant@gmail.com)
• DR. PUNEET SAXENA, Dept. of Medicine (9414079182,
puneetsaxena96@yahoo.co.in)
• DR. ARADHANA SINGH, Dept. of Medicine (9166916692,
aradhanas610@yahoo.com)
• DR. MONICA JAIN, Dept. of Pharmacology (9828786533,
monicajain07@yahoo.com)

3. DEPARTMENT OF PHARMACOLOGY
Dr. Jyotsna Bhargawa
Dr. Monica Jain
Dr. Rupa Kapadia
Dr. Monika Mishra
Dr. Lokendra Sharma
Dr. Chetana Meena
Dr. Alka Bansal
Dr. Charu Jain
Dr Uma Advani
Dr. Shivankan Kakkar
Dr. Neha Sharma
Dr. Kopal Sharma

6. COMPUTER SIMULATION CUM
PHARMACY LAB

7. MUSEUM

8. EXPERIMENTAL PHARMACOLOGY LAB

10. Dr. Abhimanyu
8/25/2018 CPC 10

11. Evaluation of the effects of β- Agonist Isoprenaline
on human ureter motility – an Ex- vivo study.
Abhimanyu Anat, Sher Singh Yadav, Monica Jain, Vinay Tomar

12. AIM AND OBJECTIVES
• Aim: To conduct an interventional study
recording the direct effects of Isoprenaline
instillation on the motility of human ureter
segments in an ex-vivo setting.
• Objective: To record various variables e.g-
length and caliber of the ureter; frequency
and amplitude of the ureteric contractions-
both pre and post drug instillation

13. Material & Methods

16. Bar chart comparing the inhibitory
effect of Isoprenaline vs control.
0
10
20
30
40
50
60
70
Amplitude
Frequency
% inhibition control
% inhibition ISO

17. RESULTS
• 40 cases, including 36 Donor nephrectomies, 4
Radical Cystectomy have been evaluated .
• There was a 65.2 ± 6% (mean ± SEM) amplitude
reduction post ISO compared to 9.6 ± 4% with
control (p <0.0001).
• ISO decreased the (mean ± SEM) contraction
frequency by 32.1± 16.9% vs 5.4 ± 1.9% with
control (p < 0.0002).

18. CONCLUSION
• Isoprenaline instillation causes a potent yet
reversible inhibition of human ureteric
contractions resulting in ureteric relaxation.

20. UG Curriculum
• Meticulous one and half year course has been framed
and uploaded on website.
• Innovative teaching
1. Student centric activities
2. Seminars
3. Tutorials
4. Self directed learning
5. Skill based learning
6. MCQ tests
7. Integrated teaching- DM, Angina pectoris
Arrhythmia, Hypertension, Malaria, Tuberculosis.
8/25/2018 CPC 20

21. PG Curriculum
• 3 years PG curriculum – have been laid down as per MCI
norms.
• 5 days Teaching programme with Log book maintenance.
• Regular Assessment now every 3 months and student
evaluation sheet is incorporated.
• Students are encouraged for paper presentation and
research work.
• Invited guest lectures. Inter department posting will also be
held from this year.
8/25/2018 CPC 21

22. Ongoing Research Projects
• MD Dissertation titles :
- A descriptive analysis of prescribing
pattern of drugs in chronic kidney disease
patients on maintenance hemodialysis in
SMS hospital Jaipur
- A cross sectional study to assess various
drug treatment and adherence in type II
DM outpatients in SMS hospital Jaipur.
• PhD thesis titles :
- A Comparative Study of Two Descriptive Drug
Surveillance Methods for Reporting ADR in
Tuberculosis Patients.
- Descriptive analysis of adverse drug reactions to
antiretroviral therapy: Causality, severity and
preventability assessment in a tertiary care
teaching hospital.
- Pharmacoepidemiological study of oral and
oropharyngeal cancers in Jaipur city
- Assessment and monitoring of ‘adverse drug
reactions’ (adrs) in the hospitalized patients of
rukmani devi beni prasad jaipuria hospital in
Jaipur, Rajasthan
- Cross-Sectional descriptive analysis of Non-
Steroidal Anti-Inflammatory Drugs-associated
Gastrointestinal complications in a Tertiary care
hospital of Rajasthan
- To study the effectiveness of add on acupressure
therapy to the conventional therapy in
management of chronic pain in patients of
osteoarthritis of the knee in SMS Medical College,
Jaipur

23. Other Administrative Work of Faculty Members
• Drug Therapeutic and Safety Committee members
• Human Ethics Committee members
• Institutional Animal Ethical Committee members
• Clinical Trial Screening Committee members
• Online Counseling
• Medical Education Unit
• Foundation Course
• Curriculum Planning of MBBS Couse

24. Other Administrative Work
• Inspection of Upcoming College: Medical &
Pharmacy College
• Additional post of Assistant warden
• Drug auditing committee members
• Duties in Directorate
• As a representative in Court
• Physical Verification of various departments in
college

25. INTEGRATED TEACHING
Movement from traditional teaching

26. GUEST LECTURES BY
FACULTIES FROM DIFFERENT STATES

27. Mental Health Training by
International Faculty
Workshop(Psychiatry)
National Programme for
mental health Care of
Elderly

28. Pharmacovigilance
Sensitization in School
Deworming by Albendazole in
school
Skill Training of Trainers
To Enhance students Caliber

29. Safe Medication & CPR
Training
Workshop for BSF Doctors
Research methodology Workshop

30. Clinical Research Poster April 2011

31. Book /Chapter of Medical Education
Research Work
1. Dr. Lokendra Sharma
2. Dr. Uma Advani

32. Conference participation of the faculty
Poster presented in IPS
Conference AIIMS
Invited speaker in XII annual conference
of society of pharmacovigilance of India
Paper presented in IPS
Conference , Mumbai
WPC 2018
Kyoto Japan

33. Awards and Achievements
• Department hosted National Conference in
2006
• CME
• Various Pharmacovigilance Programme
8/25/2018 CPC 33

34. AWARDS AND ACHIEVEMENTS OF DEPARTMENT
• Dr. Monica Jain
•Dr. Rupa Kapadia
• Dr. Lokendra Sharma
•Dr. Uma Advani
•Dr. Shivankan Kakkar

35. Departmental Projects under pipeline
• Pattern of mobile phone usage amongst medical students and its correlation with their
academic performance.
• A comparative study to determine the beneficial effect of calcium-channel and alpha-1-
adrenoceptor antagonism on human ureteric activity in vitro.
• Pharmacogenetics study of Vitamin K antagonists in CTVS Department of SMS Medical
College.
• Item analysis for quality of multiple choice question for undergraduate MBBS students.
• Awareness and sensitization of general public regarding safe use of drugs by using board
game.
• A comparative evaluation of different integrated teaching and learning methods among
medical students to improve the knowledge of pharmacology.
• Informed consent and the prescription of non-steroidal anti-inflammatory drugs in different
departments of S.M.S. Medical College, Jaipur

36. Introduction of Adverse Drug Reaction Monitoring Centre
Pharmacovigilance Committee
.
Dr. Lokendra Sharma
Dr. Monika Jain
Dr. Rupa Kapadia
Dr. Monika Mishra

37. INTRODUCTION
• In July 2010, Ministry of Health & Family welfare,
Government of India launched Pharmacovigilance
Programme of India (PvPI) with the AllMS, New Delhi as
National Co-ordination Centre (NCC).
• In April 2011, it was shifted from AIIMS, New Delhi to Indian
Pharmacopoeia Commission, Ghaziabad.
• The first Adverse Drug Reactions Monitoring Centre (AMC) in
Rajasthan was started functioning in the Department of
Pharmacology, SMS Medical College, Jaipur in 2011.

38. PRESENT PHARMACOVIGILANCE COMMITTEE
• Dr. Rupa Kapadia : Member Secretary
• Dr. Lokendra Sharma : Coordinator
• Dr. Monica Jain : Assistant Co-ordinator
• Dr. Monika Mishra Member
• Chaitanya Prakash : Pharmacovigilance Associate
• There are also 28 co-opting Pharmacovigilance members from
13 Departments of SMS Medical College & Hospital, Jaipur.

39. Causality assessment committee
• Dr.Lokendra Sharma: Chairman
• Dr.Monika Mishra : Member
• Dr. Srikant Sharma: Member
8/25/2018 CPC 39

40. ADR MONITORING CENTRES
6. J.L.N. Medical College, Ajmer
7. Institute of Respiratory Diseases,
Sashtri Nagar, Jaipur
8. AIIMS, Jodhpur
9. Geetanjali Medical College,
Udaipur
10. NIMS Medical College, Jaipur
1. S.M.S. Medical College, Jaipur
2. S. P. Medical College, Bikaner
3. R.N.T. Medical College, Udaipur
4. Dr. S. N. Medical College, Jodhpur
5. Government Medical College, Kota
Total number of Adverse Drug Reaction
Monitoring Centres in India : 250
(till Dec-2017)
Total number of Adverse Drug Reaction
Monitoring Centres in Rajasthan : 10
(till Dec-2017)

41. PROGRAMMES FOR PATIENT SAFETY IN INDIA
• Pharmacovigilance programme in India
• Materiovigilance programme of India
• Haemovigilance Programme of India
• Adverse Event Following Immunization

42. ADR REPORTING STATUS
• In the Year-2017 : 327 ADR reports were sent
• From January to June-2018 : 161 ADR reports have been sent.
• From January-2011 to June-2018 : More than 2000 ADR
reports have been sent to National coordination Centre-
Pharmacovigilance Programme of India.

43. CMES AND SEMINAR ORGANIZED BY AMC
• CME on “Pharmacovigilance and it’s relevance in current
Medical Practice” was organized on 23/09/2011 at RUHS,
Jaipur.
• Seminar on “Pharmacovigilance” was held on 17/09/2012 at
SMS Medical College, Jaipur.
• CME on “Pharmacovigilance” with the technical support of
PGIMER, Chandigarh, was organized on 08th May, 2015 at SMS
Medical College, Jaipur.

44. CME ORGANIZED ON 8TH MAY 2015

45. AWARENESS PROGRAMMES AND PV TRAININGS
• More than 35 awareness programmes and trainings on
pharmacovigilance have been conducted by AMC in the
various Clinical Departments of SMS Medical College and
Attached hospitals to sensitize the faculty and PG students.
• More than 2700 healthcare professionals and students have
been sensitized through these programs and trainings.

47. POSTER PUBLICATIONS
• A poster on “Awareness on Pharmacovigilance and ADR reporting”
in Hindi was launched on 01/07/2017 by Dr. U. S. Agarwal,
Principal & Controller, SMS Medical College, Jaipur.
• The poster was placed in various Clinical Departments of SMS
Medical College & attached hospitals.

48. LAUNCHING OF PHARMACOVIGILANCE POSTER ON 1ST JULY, 2017

49. PHARMACOVIGILANCE POSTER

50. ACTIVITIES IN THE SCIENCE OF LIFE EXHIBITION ORGANIZED
FROM 15TH FEB, 2018 TO 25TH FEB, 2018 AT
SMS MEDICAL COLLEGE, JAIPUR.

51. APPRECIATION NOTE BY PRINCIPAL SIR FOR OUR STALL

52. WORKSHOP CUM TRAINING ON PHARMACOVIGILANCE FOR NABH
ACCREDITED HOSPITALS FOR RAJASTHAN STATE
• One day Workshop-cum-
Training programme was
organized on 20th June
2018 at Santokba Durlabhji
Memorial Hospital, Jaipur
to train NABH-Accredited
Hospitals staff on
Pharmacovigilance.
• 54 healthcare
professionals participated
in the Workshop.

54. Health Care
Professionals
Consumer
NCC-PvPI
IPC, Ghaziabad AMCs
Industry
REPORTING OF ADRS

55. HOW & WHOM TO REPORT ?
• Use the ‘Suspected Adverse Drug Reaction Reporting Form/
Medicine side effect Reporting form available on official website
of IPC (www.ipc.gov.in).
• Fill the form and submit it to the nearest ADR Monitoring Centre
or directly to the National Coordination Centre,
Pharmacovigilance Programme of India, IPC, Ghaziabad.
ADR Monitoring Centre, SMS Medical College, Jaipur
Contact Number: 9414048334, 7727017839, 0141-2518682
Email ID: drlokendra29@gmail.com, pchaitanya84@gmail.com

56. A reporter can also report ADR via Toll Free-Helpline
Number of PvPI.
1800 -180 -3024
(Monday to Friday 9:00AM to 5:30 PM)
ADR REPORTING HELPLINE NUMBER

58. Please inform ADRAll PHODs are requested-
• To send the information on adverse drug reactions
occurred in the patients of their respective
Departments.
• To incorporate Pharmacovigilance and ADR reporting
in the curriculum of PG students.

59. • Department of Skin & V.D.
• Department of Chest & T.B.
• Department of Psychiatric
• Department of Allergy and Pulmonary Medicine
• Anti Retroviral Therapy (ART) Centre
for their kind cooperation in Pharmacovigilance
programme and regular reporting of ADRs to our
AMC.
APPRECATION AND SINCERE THANKS TO

60. CASE 1
By
Dr. Prashant
Resident,
Department of Medicine

61. CHIEF COMPLAINTS
• A 20 yrs old, right handed Hindu female,
student, resident of Churu, was admitted in
SMS hospital on 29/11/17 with complaints of
fever since 7 days
Throat pain since 7 days
Shortness of breath since 2 days
Cough with expectoration since 2 days

62. HISTORY OF PRESENTING ILLNESS
The patient was apparently asymptomatic 7
days back when the complaints started
Fever was high grade associated with chills
and rigors
No diurnal variations and continuous
Associated with sore throat with pain on
swallowing solids

63. Also had complaints of cough with shortness
of breath
Cough was productive with mucoid and foul
smelling expectoration
no diurnal and postural variations
no history of hemoptysis either
Dyspnoea was sudden in onset and not
associated with exertion
No progression and patient able to do her
activities

64. PAST HISTORY
• k/c/o Hyperthyroidism since 1.5 year
On treatment
Taking Carbimazole 20mg bd
• no other significant medical/surgical history
•PERSONAL HISTORY NAD
•FAMILY HISTORY

65. GPE
• Patient was conscious, oriented to time,
person and place.
• Vitals
BP=110/70
P=110/min
SpO2=95% on room air
RR=18/min
 Note is made of posterior Pharyngeal wall and
tonsillar pillar inflammation with whitish
membrane

66. SYSTEMIC EXAMINATION
 Respiratory system
bilateral normo-vesicular breath sounds
present
bilateral infra-scapular crepitations present
Rest NAD
 Cardiovascular system
S1 S2 heard
no additional sounds or mumurs

67.  Gastrointestinal system
Abdomen: Soft, non tender
No organomegaly present.
Bowel sounds present.
 CNS
Within normal limits

68. CASE SUMMARY
• A 20 year old female known case of
hyperthyroidism on anti-thyroid drug
presented with acute febrile illness with acute
pharyngitis with ? LRTI

69. INVESTIGATIONS
• CBC
• Hb - 10.3 (14-18 g/dl)
• TRBC- 3.71 / mm
3
(3.8-4.8)
• HCT- 30.5 (36-46 <F>)
• TLC - .43 *1000/mm
3
• DLC- NOT POSSIBLE DUE TO LOW COUNT
• MCV- 82.3fl (70 to 99)
• MCHC- 33.8g/dl (32-35)
• Platelet-2.65 lac/mm3
• ESR-64 mm/1st hr

70. • Urea - 26
• Creatinine - .70
• Na - 148
• K - 3.9
• Cl - 102
• Ca - 8.6
• P - 3.1
• Uric acid - 3.8
• Triglycerides - 126
• Total cholesterol - 113
• HDL - 39
• LDL - 64
• CPK -MB - 24

71.  S.Bilirubin
Total - 0.9(up to 1.0mg/dl)
Direct - 0.4(0.1-0.3 mg/dl)
Indirect - 0.5(0.2-0.7 mg/dl)
 SGOT - 24U/L
(up to 40U/L)
 SGPT - 28U/L
(up to 50U/L)
 Alkaline phosphate - 11 IU/L
(normal<130IU/L)
 GGT - 13 U/L (<55U/L)
 INR - 1.34

72. • HBsAg - Negative
• Anti HCV - Negative
• HIV - Negative
• MP - Negative
• Dengue - Negative

73. • CRP-Positive
• RF -Negative
• ANA-Negative
• Scrub Typhus IgM-Negative
• Widal –Negative
• T3-1.34 pg/mL(2.3-4.2)
• T4-8.80 mcg/mL(0.66-1.76)
• TSH-0.01 mIU/mL(0.35-4.5)
• Procalcitonin-0.47 ng/mL(<0.5)
• FDP/D-Dimer—Negative

74. • Blood culture and sensitivity-- Sterile
• Urine culture and sensitivity--Sterile
• Throat swab culture and sensitivity—
Streptococcus viridans(alpha hemolytic and
non pathogenic)
• Sputum culture and sensitivity– Streptococcus
species

75. Sputum
AFB- negative
KOH- Occasional budding yeast with
pseudohyphae seen
GRAM STAIN - few polymorphs , few epithelial
cells , gram positive cocci ++

76. • Peripheral Blood Film
Peripheral smear showed normocytic
normochromic anaemia.
Leucopenia with no atypical cells.
Adequate platlets count .

77. BONE MARROW
• Bone marrow biopsy
Shows reduction in granulocytic
precursors with normal erythropoiesis
and megakaryocyte proliferation.
no atypical cells noted

78. Now what can be the diagnosis
?

79. DIFFERENTIAL DIAGNOSIS
Carbimazole induced agranulocytosis
HIV
Viral infections(hepatitis, EBV)
Hematologic malignancies(LGL, hairy cell
leukemia, MDS)
Aplastic anemia
PNH
Rheumatologic disorders
Familial neutropenia

80. NEUTROPENIA SECONDARY TO SEPSIS
 IN FAVOUR
• History of fever
• Chest finding
 AGAINST
• No evidence of any
organ damage
• Bone marrow report
• Procalcitonin is not
too high
• FDP/D-DIMER
negative
• Platlets count
normal

81. Myelodysplastic syndrome and other
blood dyscrasia
 IN FAVOUR
• Mostly MDS Present
with neutropenia
 AGAINST
• No blast cells in
bone marrow
report

82. Auto immune disorder
 IN FAVOUR
h/o fever
neutropenia
elevated ESR
 AGAINST
no h/o joint pain
no h/o rashes
no h/o alopecia
ANA negative

83. HIV-AIDS
 IN FAVOUR
fever
neutropenia
 AGAINST
HIV negative

84. Carbimazole induced agranulocytosis
 IN FAVOUR
• Classical presentation
with fever and sore
throat
• Grade 2 goiter
• Cbc and bone marrow
report
 AGAINST
• None

85. What next?

86. ADVERSE DRUG REACTION
• ADR FORM

87. CAUSALITY ASSESSMENT
Causality assessment is defined as “the evaluation of
the likelihood that a medicine or drug was the
causative agent of an observed adverse reaction”.

88. Types of Algorithms Method
• Karch and Lasagna algorithm (1977):three tables
• Beguad algorithm 1977 French criteria:three
stages
• Jones algorithm 1979
• Kramer 1979 : 56 questions
• Naranjo’s 1981:10 questions
• WHO-UMC : Grades of certainty
• Thia

89. WHO-UMC CAUSALITY ASSESSMENT SYSTEM
This method includes the following 4 criteria:
1. Time relationships between the drug use and the adverse
event.
2. Presence/Absence of other competing causes (medications,
disease process itself).
3. Response to drug withdrawal or dose reduction (de-
challenge).
4. Response to drug readministration (re-challenge).

90. CRITERION OF WHO SCALE
• CERTAIN- GOOD TIMING,NO OTHER CAUSE, WITHDRAWL
RESPONSE PLAUSIBLE, RECHALLANGE DEFINITIVE
• PROBABLE/ LIKELY-GOOD TIMING, OTHER CAUSES
UNLIKELY,WITHDRAWL POSITIVE
• POSSIBLE-GOOD TIMING, OTHER CAUSES POSSIBLE
• UNLIKELY-POOR TIMING ,OTHER CAUSES MORE LIKELY
• UNASSESSABLE/UNCLASSIFIABLE- INFORMATION
INSUFFICIENT

91. • Event or laboratory test abnormality,
with reasonable time relationship to
drug intake.
• Unlikely to be attributed to disease or
other drugs.
• Response to withdrawal clinically
reasonable.
• Rechallenge not required
PROBABLE/ LIKELY
Causality assessment of the Case

92. ADR Data entry through Vigiflow
• ADRs reports (Individual Case
Safety Report) are processed
through VigiFlow to NCC,
Ghaziabad.
• At NCC, the Signal Review
Panel, Quality Review Panel
evaluate the ICSR and send the
regulatory recommendations
to the CDSCO, New Delhi.

93. • Drug safety alerts for October and December
2017 as per the latest was the news letter of
PvPi
• Amikacin –SJS
• Allopurinol –uveitis
• Quetiapine –gynaecomastia
• Ceftriaxone –palpitations
• Fluoxetine- urinary incontinence

95. TREATMENT GIVEN
• Stop Carbimazole
• Tab. Lithium carbonate
• I.V. antibiotic (empirically)
• G-csf
• Supportive management

98. Antithyroid Drug-Induced
Agranulocytosis
• Hyperthyroidism is a common endocrine disorder
which affects mainly women with a prevalence of 2%.
• Anti-thyroid drug therapy is the main treatment for this
condition.
• A serious rare side effect of carbimazole is
agranulocytosis. Others include pruritic or urticarial
rash. There may be vasculitis, arthralgia, cholestatic
jaundice and lupus like reaction.
• This drug- induced agranulocytosis is a lethal condition
but reversible if recognized and treated
early.

99. • The incidence of Carbimazole induced
agranulocytosis is 0.3–0.6% and has got a
mortality rate of 21.5%.
• Drug- induced agranulocytosis occurs within
1–2 months of taking the anti-thyroid
medication but the onset can get delayed.

100. • Methimazole in higher doses of 30 mg/day at
age of 40 years or above caused greater risk
for the development of
agranulocytosis.(Cooper et al 1983)

101. DRUGS CAUSING AGRANULOCYTOSIS
• Methimazole
• Carbimazole
• Propylthiouracil
• Clozapine
• Dapsone
• Dipyrone
• Penicillin G
• Procainamide
• Rituximab
• Sulfasalazine
• Ticlopidine

102. Epidemiology
• The mean age of onset is fifth decade.
• Females were more affected than males (6.3 :
1 ratio)

103. PATHOPHYSIOLOGY
• Two mechanisms are there to explain why
ATD-induced agranulocytosis develops
• Firstly- Some drugs have the potential to be
oxidized to reactive metabolites by
neutrophils inducing an immune
response by activating inflammasomes
thus destroying neutrophils-direct toxicity.
• These reactions are mediated by
myeloperoxidase and cytochrome P450

104. • Secondly Circulating antibodies against
differentiated granulocytes can cause
agranulocytosis rendering this process immune
mediated .
• These antibodies, which can be anti-neutrophil
cytoplasmic antibodies (ANCA) react against
specific granules inside the neutrophils.
• These antibodies can also react with myeloid
progenitor cells and induce opsonization of
neutrophils.

106. A cross-reaction between Carbimazole and
Propylthiouracil was observed in 15.2% of
patients .
• Therefore surgery or radioactive iodine seem
to be effective options to restore an euthyroid
state.
• Radioactive iodine was demonstrated as a
successful option, with 88.8% of patients
experiencing euthyroidism after treatment.

107. TAKE HOME MESSAGE
• Agranulocytosis occurs in 0.2–0.5% of patients
with Graves’ disease receiving antithyroid
drugs.
• High fever and sore throat are the most
common presenting signs.
• Patient’s should be warned about this side
effect.

108. CASE 2
By
Dr. Taniya Mehta
Senior Resident
Department of Dermatology, Venereology & Leprosy

109. CHIEF COMPLAINTS
A 40 years old male resident of Alwar, Rajasthan was
admitted in SMS hospital on 18/06/2018 with
complaints of
 Multiple fluid filled lesions over palms and sole
since 2 days
 Crusting over lips since 2 days

110. HISTORY OF PRESENTING ILLNESS
Patient was asymptomatic 2 days back then he
developed fluid filled lesion over palm and soles which
were acute in onset (4 hrs after tablet Ofloxacin
ingestion for URTI starting from soles involving palms
with pain and fever).
Then the patient also developed crusting over lips with
difficulty and pain during mouth opening.

111. PAST HISTORY
k/c/o Schizophrenia and was on medication since
8-10 years by a local practitioner & non compliance
(on & off) : treatment history unavailable.
No h/o Tuberculosis, Diabetes Mellitus, hypertension,
COPD, asthma and epilepsy.

112. PERSONAL HISTORY
• Smoker: Bidi smoker, 1 bundle/day since 10 yr
• Tobacco chewing: 3-4 packets/day since 4 yr
• Alcoholic: Occasionally
• Mixed diet

113. FAMILY HISTORY
• No significant family history

114. GENERAL PHYSICAL EXAMINATION
• Patient was conscious , cooperative, well oriented
with time, place and person.
• Vitals:
 Pulse: 100/min, regular, normal volume ,no radio-
radial and radio-femoral delay.
 Blood pressure: 94/60 mm of Hg in right arm supine
position

115. • Cyanosis: absent
• Pallor: absent
• Icterus: absent
• Clubbing: absent
• Lymph node: not palpable

116. CUTANEOUS EXAMINATION
 Multiple fluid filled bullae which were well defined, discrete,
size ranging from 1cm to 6cm present over palm and soles.
 Multiple hyperpigmented macular lesions, well-defined,
discrete present over abdomen of size 1-2 cm.
 Mucocutaneous examination- hemorrhagic crusting over lips.

117. CASE SUMMARY
• A 40 years old male, presented with multiple fluid
filled lesions over palms and sole since two days and
Crusting over lips since two days with history of
Schizophrenia and was on medication since 8-10
years by a local doctor with poor compliance.

118. CBC
• Hb - 15.3 (14-18 g/dl)
• TRBC- 5.16 / mm
3
(3.8-4.8)
• TLC – 11.40*1000/mm
3
• MCV- 86.2fl (70 to 99)
• MCHC- 34.4g/dl (32-35)
• Platelet-1.96lac/mm3

119.  S.Bilirubin
Total - 0.5(up to 1.0mg/dl)
Direct - 0.2(0.1-0.3 mg/dl)
Indirect - 0.3(0.2-0.7 mg/dl)
 SGOT - 21U/L (up to 40U/L)
 SGPT - 23U/L (up to 50U/L)
 Alkaline phosphate - 92 IU/L
(normal<130IU/L)

120. Now what diagnosis comes to your mind
?

121. Probable diagnosis
• Generalised bullous Fixed drug eruption
• Steven-Johnson’s syndrome
• Erythema multiforme

122. Generalised bullous FDE
• Points in favour:
1. Dusky macules on abdomen
2. Limited lesions on palms, soles and lips
3. General condition good

123. Erythema multiforme
Points in favour:
1. Palms, soles and lips involved.
Points against:
1. No target lesions

124. Steven Johnson’s syndrome
• Point in favor:
1. Bullous lesions on palms and soles
2. Haemorrhagic crusting of lips.
Points against:
1. Lesions limited.
2. Rest of mucosae spared.
3. General condition and investigations: normal

125. TREATMENT GIVEN
• Injection Dexamethasone 1 cc IV OD
• Injection Pantoprazole IV OD
• Betadine gargles

126. What next?

127. ADVERSE DRUG REACTION
• ADR FORM

128. • Event or laboratory test abnormality,
with reasonable time relationship to
drug intake.
• Unlikely to be attributed to disease or
other drugs.
• Response to withdrawal clinically
reasonable.
• Rechallenge not required
PROBABLE/ LIKELY
Causality assessment of the Case

129. ADR Data entry through Vigiflow

130. FIXED DRUG ERUPTION
• Analgesics
• Anticonvulsants
• Sedatives
• Antifungal
• Antibiotics –trimethoprim/sulphamethoxazole
Tetracyclines and rarely floroquinolones
Fixed drug eruption account for about 16-21 %of
cutaneous drug reactions

131. Mechanism of FDE
• Delayed type of hypersensitivity mediated by
CD*8 T-cell
• Also IgE mediated hypersensitivity reaction

132. ADVERSE DRUG REACTIONS-
OFLOXACIN
1. Diarrhea that is watery or bloody;
2. Seizure (convulsions);
3. Confusion, hallucinations, anxiety, feeling restless, tremors, insomnia,
nightmares, unusual thoughts or behavior, feeling light-headed;
4. Severe dizziness, fainting, fast or pounding heartbeat;
5. Sudden pain, snapping or popping sound, bruising, swelling, tenderness,
stiffness, or loss of movement in any of joints;
6. Easy bruising or bleeding;
7. Fever, swollen glands, general ill feeling;
8. Urinating less than usual or not at all;
9. Numbness, burning pain, or tingly feeling in hands or feet;
10. Pale skin, dark colored urine, fever, weakness, jaundice (yellowing of the skin or
eyes);
11. The first sign of any skin rash, no matter how mild; or severe skin reaction --
fever, sore throat, swelling on face or tongue, burning in eyes, skin pain, followed
by a red or purple skin rash that spreads (especially in the face or upper body)
and causes blistering and peeling.

134. SJS/TEN

136. FIXED DRUG ERUPTIONS

137. Times of India News
Sushmi Dey, TNN, Jul 12, 2018: Fluoroquinolone, a commonly
used antibiotic in India for the treatment of a
range of bacterial infection, has come under
USFDA lens for it on mental health and low
blood sugar adverse reactions effect

138. We look forward for collaboration with
clinical, pre clinical and para clinical
departments for:-
• Integrated teaching for both UG and PG
• Research projects
• Adverse Drug Reporting
• Non invasive animal experiments
• Computer simulation experiments

139. Thank You