CLERKSHIP PROJECT

1. INTRODUCTION
ADR(Adverse Drug Reaction):
• Adverse drug reaction (ADR) is noxious and unintended response
that occurs at normal doses used in humans for the prophylaxis,
diagnosis, treatment or modification of physiological function.
ADRs spontaneous reporting system:
• ADRs Spontaneous reporting system is considered the main
mechanism in the pharmacovigilance system by which the ADRs are
identified after the drug is released into the market.
• Unfortunately, the spontaneous ADR reporting system is affected by
a number of weaknesses, the most noticeable of these being the
phenomena of ADRs under reporting from healthcare professionals.
1

2. LITERATURE REVIEW
STUDY 1
• Author: LiQ*, Zhang SM
• Study: Conducted a study to identify reasons for under reporting and
to investigate the awareness and attitudes of health care professionals
towards the ADR system in Wuhan, China. A questionnaire survey of
a stratified random sample of approximately 15% of health care
professionals in each selected hospital was conducted during
February - March 2003.
• Results: 89.2% of health care professionals had encountered ADRs.
However, only 28.5% of doctors, 22.8% of nurses and 29.7% of
administrators actually submitted a report. Healthcare professionals
in Wuhan, China have little basic knowledge of ADR and of the
voluntary reporting system. The main reasons for under reporting
were lack of basic knowledge of ADRs and the voluntary reporting
procedure. Education and training of health care professionals is
needed to improve the current ADR reporting system.
2

3. STUDY 2
• Author: Marco Cosentino*, Olivia Leoni
• Study: Conducted a study to investigate spontaneous ADR reporting
among all the National Health Service (NHS) doctors operating in
the territory of the area health authority Italy, to assess their
awareness of the reporting system and to identify reasons for under
reporting. Three hundred and fifty doctors were sent questionnaires
and 207 (59.1%) were returned completed.
• Results: More than 77% of the responders stated to have noticed
ADRs. Fifty per cent did not report ADRs to anyone. NHS doctors in
this district have little information concerning ADR reporting
systems. Provision of guidelines for ADR spontaneous reporting can
be one effective measure to improve the situation.
3

4. STUDY 3
• Author: M. Backstrom*, Elisabet Ekman
• Study: Conducted a study to investigate whether, after a short
special education period, nurses could be a useful resource for
improving the reporting rate of ADRs in Sweden. The study assessed
the ADR reports from the participating nurses regarding quality and
seriousness of reported reactions. The nurses were encouraged and
allowed to report ADRs after the first educational session and during
the following 12 months (October 2003 to September 2004). Fifty-
four nurses participated in the study.
• Results: During the study period, a total number of 23 reports with
39 ADRs were sent to the regional centres by the nurses. At the end
of the study, the nurses thought that they had enough knowledge to
report ADRs. Sixty-eight percent of the physicians did not object to
nurses being included as reporters of suspected ADRs. Adverse drug
reaction reporting by nurses could improve the overall safety of
drugs.
4

5. STUDY 4
• Author: Sathisha aithal*, Tanuja V hooli
• Study: Conducted a cross sectional study on doctors working at a
tertiary care hospital, Davangere, Karnataka using a standardized
questionnaire to assess the knowledge, attitude and practice about
adverse drug reaction reporting. The total number of participants
who voluntarily participated in the study was 42.
• Results: Only 38% of study participants were aware of ADR
reporting centre in their institution The most factors for discouraging
reporting of ADR was non-availability of reporting form (47%)
followed by lack of time (42%). The most common factors
encouraging reporting of an ADR included seriousness of the event
(95%). The result of the study indicates that there is a need to create
awareness about ADR reporting among doctors.
5

6. STUDY 5
• Author: Suresh chenchu*, Dr. Mohan raj rathinavelu
• Study: Conducted a prospective observational study of six-month
duration from April to September 2014 in a tertiary care hospital
located at Anantapur, Andhra Pradesh for evaluating the knowledge,
attitude and practice among doctors, nurses, and pharmacists
working towards ADRs and pharmacovigilance. A questionnaire
which was suitable for assessing the basic knowledge, attitude and
practice (KAP) of pharmacovigilance was designed and distributed
among health-care professionals. Among the total 220 health-care
professionals working in the hospital only 75% (n=165) provided
their responses.
• Results: The study showed that the knowledge of health care
professionals in general was less about the national
pharmacovigilance Program, international centre and the WHO
online data base of monitoring and reporting ADRs. The findings of
the study suggest that there is a need for continuous educational
initiatives for the doctors, nurses and the pharmacists.
6

7. RATIONALE FOR THE STUDY
• From the literature survey it was observed that many studies have
been published in India and abroad on monitoring ADR reporting in
different health care settings.
• Our findings from the literature review are ADRs are under reported
in general in all the institutions studied. In order to deal with the
current scenario of under reporting, it is important to identify the
barriers for under reporting and to overcome it by improving the
knowledge, attitude, practices of healthcare professionals regarding
ADR and its reporting.
• This made us to study ADR reporting rate and patterns in our
hospital ICU settings.
• Our study not only focuses on ADR reporting rates but to identify the
barriers for under reporting and methods to overcome them.
7

8. STUDY MATERIALS AND
METHODOLOGY
STUDY OBJECTIVE:
• To study the practice and patterns of ADR reporting by healthcare
professionals in ICU settings and measures to improve ADR
reporting.
METHODOLOGY:
• Study period: The study was conducted over a period of 6 months
(Jan,2019 to June,2019).
• Sample size: Proposed sample size was 50 cases.
• Selection of subjects:
Inclusion criteria:The retrospective and prospective ADR data was
collected from all adult ICU settings of both genders who
experience ADR during their hospital admission.
Exclusion criteria:All Paediatric patients were excluded.
• Study design: The study was a combination of both retrospective
and prospective studies.
8

9. • A Retrospective study was conducted for 2 months (Jan-Feb 2019)
to review ICU patient’s discharge files for 3 months retrospectively
(Oct 2018 – Dec 2018) in MRD.
• For the next 1 month (March-2019), the compliance for ADR
reporting was studied and the barriers in ADR reporting process were
identified through a well-designed questionnaire.
• All the health care professionals who are eligible to report an ADRs
were included to know their knowledge and awareness on ADR
reporting and to educate them through an ADR brochure(hand out).
• A Prospective study was conducted for next 3 months (April-June
2019) to study ADR reporting in ICU patients and the results
obtained were compared with the above retrospective study for
improvement in ADR reporting.
9

10. DATA COLLECTION PROCEDURE:
• Data on demographic details for patient profile (age and sex),
medications prescribed (generic name of the medicine, dose
frequency, strength), description of the adverse event, onset and end
of the adverse event, severity of the event.
• The tracking of an adverse event was done based on the tracer drugs
prescribed.
• Tracer drugs used to identify ADRs are
Anti-histamines(Pheniramine maleate, Diphenhydramine)
Corticosteroids(Methyl prednisolone, Hydrocortisone)
Antidotes-Protamine sulphate , Vitamin K, Dextrose 50% solution ,
Calcium gluconate , Ion exchange resins , Insulin.
10

11. STUDY OUTCOMES:
• Identifying ADR reporting rate and pattern of reporting.
• Improvement in reporting rate due to the increased awareness.
DATA HANDLING AND MANAGEMENT:
• Data collection form is enclosed. MS excel format was used for
collecting data. Patients were assigned a specific case number along
with their initials, and this form was used while collecting relevant
information. Their names were kept confidential. Strict privacy and
confidentiality were maintained during data collection and
throughout the study.
11

12. STATISTICALANALYSIS:
• Data was analyzed by Microsoft Excel. Data was summarised by
percentages for categorical data. The comparison between
retrospective reports and prospective reports was done by Fischer’s
Exact test. All ‘p’ values less than 0.05 was considered as statistically
significant.
PUBLICATION POLICY:
• The findings of the study will be submitted to peer-reviewed
scientific journals with due acknowledgement of all candidates,
supervisors and institution. Details of Patients, Doctors, other Health
care staff and organisation who participated will be kept confidential
12

13. RESULTS AND DISCUSSION
13
General Description about ADRs through Retrospective study
(14 ADRs are detected)
S. No DRUGS ADVERSE DRUG
REACTION
SEVERITY
1 T.SODIUM VALPROATE Itching & puffiness of
face
Mild
2 INJ.CEFTAZIDIME Shivering Mild
3 INJ.NITROGLYCERINE Chills with shivering Mild
4 INJ.VORICONAZOLE Derranged LFT’s Moderate
5 INJ.FUROSEMIDE Hypokalemia Moderate
6 T. DIGOXIN Junctional rhythm Severe
7 INJ.DOBUTAMINE Hypokalemia Moderate
8 INJ.LINEZOLID Hypotension Moderate

14. 9 INJ.NITROGLYCERINE Bradycardia&Hypotension Moderate
10 T. CARNITINE Itching Mild
11 INJ.NITROGLYCERINE Bradycardia Moderate
12 INJ.CEFTRIAXONE Increased transaminase Moderate
13 T. HYDROCLORTHIAZIDE Metabolic alkalosis Moderate
14 INJ.AMPHOTERICIN Hypomagnesemia Moderate
14

15. 15
Severity assessment using Modified Hartwig and Siegel’s scale
(Retrospective study)
Severity of ADRs No. of ADRs (n)
Mild 4
Moderate 9
Severe 1

16. Causality assessment using Naranjo ADR probability scale
16
Causality No of ADRs (n)
Certain 0
Probable 13
Possible 1
Unlikely 0
Conditional/unclassified 0
ADRs REPORTED DURING RETROSPECTIVE STUDY
ADRs REPORTED
ADRs Identified ‘n’ 14
ADRs reported ‘n’ (%) 8 (57.14)

17. A well designed questionnaire was given to the health care professionals to
assess their knowledge, attitude and practice (KAP) on ADR reporting.
17
a) Knowledge of study group towards ADR reporting
S. No QUESTIONS YES
‘n’ (%)
NO
‘n’ (%)
NO
ANSWER
‘n’ (%)
1 Are you familiar with term Pharmacovigilance 13 (43) 17 (57) 0
2 Pharmacovigilance is the study that relates to
ADRs
12 (40) 3 (10) 15 (50)
3 Do you believe all the drugs available in
market are safe
0 30(100) 0
4 Do you think both ADR and ADE are same 6 (20) 24 (80) 0
5 The Health care professionals are responsible
for reporting ADRs in a hospital
30(100) 0 0

18. 6 In India CDSCO is responsible for
monitoring ADRs
11(37) 4 (13) 15(50)
7 Is there any nearby ADR reporting and
monitoring center in your knowledge
10 (33) 20(67) 0
8 Do you know regarding the existence of
Pharmacovigilance Program in India
15 (50) 15(50) 0
9 Vigibase is the WHO online database for
reporting ADRs
9 (30) 3(10) 18(60)
10 Side effects like nausea, vomiting and
headache should not be reported
3 (10) 27(90) 0
18

19. b) Attitude of Study group towards ADR reporting
19
S. No QUESTIONS YES
‘n’ (%)
NO
‘n’ (%)
NO
ANSWER
‘n’ (%)
11 Do you feel that ADR reporting is a time-
consuming activity with no outcome
1 (3) 29 (97) 0
12 Do you think reporting adverse drug
reaction will increase patient safety
30(100) 0 0
13 Do you think it is necessary to report
only serious and unexpected reactions
3 (10) 27 (90) 0
14 Do you think Pharmacovigilance should be
taught in detail to healthcare professionals
30(100) 0 0
15 Do you think ADR reporting is important 30(100) 0 0

20. c)
20
Practice of Study group towards ADR reporting
S. No QUESTIONS YES
‘n’ (%)
NO
‘n’ (%)
NO
ANSWER
‘n’ (%)
16 Have you ever been trained on how
to report ADRs
17(57) 13(43) 0
17 Have you ever experienced ADR in
patients during your practice
20(70) 10(30) 0
18 Have you ever reported ADR to the PV
centre
8 (27) 20(67) 2 (6)
19 Have you ever counseled patients
regarding ADRs
27(90) 3 (10) 0
20 Do you think ADR form is complex to
fill
5 (15) 12(41) 13(44)

21. Reasons for under reporting of ADRs
21
S. No Barriers to reporting of ADRs
1. Low awareness and poor understanding about reporting of
ADRs and Pharmacovigilance activities.
2. Busy nature of work and less free time
3. ADR form is complex to fill
4. Lack of training on ADR reporting
5. ADRs considered not serious enough to report
6. Inability to establish Drug-Symptom relation

22. General Description about ADRs through Prospective study (11 ADRs are
detected)
22
S.NO DRUGS ADVERSE DRUG REACTION SEVERITY
1 INJ.FOSFOMYCIN Hypernatremia and
Hypokalemia
Moderate
2 INJ.COLISTIN Increased serum creatinine Moderate
3 NEB.BUDESONIDE Chills Mild
4 T. DUTASTERIDE Hyponatremia Moderate
5 T. DIGOXIN Multiple ectopics Severe
6 INJ.AMPHOTERICIN Hypomagnesemia Moderate
7 T. CLOPIDROGREL Hematuria Moderate
8 INJ.METRONIDAZOLE Rashes Mild
9 INJ.TEICOPLANIN Hypokalemia Moderate
10 INJ.COLISTIN Increased serum creatinine Moderate
11 INJ.CARBAPLATIN
&INJ.PACLITAXEL
Neutropenia Moderate

23. Severity assessment using Modified Hartwig and Siegel’s scale
(Prospective study)
23
Severity of ADRs No of ADRs (n)
Mild 2
Moderate 8
Severe 1

24. Causality assessment using Naranjo ADR probability scale
Causality No of ADRs (n)
Certain 0
Probable 10
Possible 1
Unlikely 0
Conditional/unclassified 0
24
ADRs REPORTED DURING PROSPECTIVE STUDY
(After education)
ADRs REPORTED
ADRs Identified ‘n’ 11
ADRs Reported ‘n’ (%) 8 (72.72)

25. EVALUATION OF ADR REPORTING RATE
25
ADR REPORTING RATE
Retrospective Study 57.14%
Prospective Study 72.72%
IMPROVEMENT IN ADR REPORTING RATE AFTER EDUCATING
HEALTHCARE PROFESSIONALS
IMPROVEMENT IN ADR REPORTING RATE
Retrospective study 57.14%
Prospective study (After
Education)
72.72%
Improvement in ADR reporting
rate
21.4%*

26. 26
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
Retrospective Prospective(After
Education)
ADR reporting rate

27. LIMITATIONS
• Time limitations
• Access to patient file was limited
• Getting reports from IT department was not easy
27

28. CONCLUSION
• We found that rate of Adverse drug reaction reporting was not
optimal during Retrospective study due to various barriers which we
have recognized through our questionnaire study. After educating
healthcare professionals knowledge and attitude were improved. This
led to a moderate increase in the reporting rate during Prospective
study period.
• Clinical pharmacist has an important role in identifying barriers,
educating health care professionals, designing strategies to improve
ADR reporting rate.
• Number of training sessions and workshops must be conducted in
hospitals to healthcare professionals in order to improve their
knowledge on Pharmacovigilance, filling the spontaneous ADR
reporting forms and mode of reporting criteria.
• By continuous efforts to promote the ADR reporting we can
definitely achieve better results in the near future.
• Under reporting of ADRs is a common problem in
Pharmacovigilance program. So, the ADR reporting should be made
an integral part of the clinical activities in order to improve the
patient safety.
28

29. REFERENCES
• G.Parthasarthi , A Text book of clinical pharmacy practice: Second
edition, Pg.No :105-107,111-113.
• Edwards I.R, Olsson S et al, The WHO International Drug
Monitoring Programme, in Side Effects of Drugs, Annual 25, J.K.
Aronson, Editor. 2002, Elsevier Science B.V. pg. 589-598.
• Belton et al., 1995 - Belton KJ, Lewis SC, Payne S, et al. Attitudinal
survey of adverse drug reaction reporting by medical practitioners in
the United Kingdom. Br J Clin Pharmacol,1995; 39: 223-6.
• LiQ, Zhang SM, Awareness and attitudes of healthcare professionals
in Wuhan, China to the reporting of adverse drug reactions, China
Medical Journal English. 2004 Jun;117(6):856-61.
• Marco Cosentino, Olivia Leoni, Attitudes to Adverse drug reaction
reporting by medical practitioners in a Northern Italian District, The
Italian Pharmacological Society, Pharmacological Research Volume
35,Issue 2, February 1997, Pages 85-88.
29

30. • M. Backstrom, Elisabet Ekman, Adverse drug reaction reporting by
nurses in Sweden, European Journal of Clinical Pharmacology
63(6):613-8, June 2007.
• Sathisha Aithal, Tanuja, "Knowledge and Attitude about Adverse
drug reaction reporting among doctors at a Tertiary Care Hospital",
International Journal of Pharma and Bio Sciences; Pharmacology
;2014 Jan; 5(1): (P) 108 – 113.
• Suresh Chenchu, Dr. Mohan raj Rathinavelu, Healthcare
Professionals Knowledge Attitude and Practices towards
Pharmacovigilance and Adverse Drug Reactions (ADRS) in India;
International Journal of Science and Research (IJSR); Volume 3
Issue 10, October 2014.
30

31. Thank you
31