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Abstract:
Pharmacovigilance is ‘’the science and activities concerned with the detection, assessment, understanding and
prevention of adverse reactions or any other drug related problems to medicines’’.‖Pharmacovigilance plays an
important role in ensuring patients safety. The main aim of the study is the role of clinical pharmacist in
pharmacovigilance and drug safety in Teritiary care teaching hospital. The patients were included based upon the
inclusion and exclusion criteria. The Adverse reactions were assessed by using different scales and the assessed
adverse reactions was reported to the pharmacovigilance centres. The study reveals that majority of the
females(57%), younger age people (30%) and illiterates(57%) are affected with the drug related problems. Here by
we conclude that clinical pharmacists could offer effective patient care by means of their intervention in
pharmaceutical care and hence improved therapeutic outcome could be reached.
Key Words: Pharmacovigilance, Adverse Drug Reactions (ADR), Clinical Pharmacist.
Corresponding Author:
Dr. Madan Mohan Rao, QR code
Associate Professor ,
Rajiv Gandhi Institute Of Medical Sciences,
Kadapa.
Email.ID :- vamsiveera81@gmail.com
Phone:- 8019877715
Please cite this article in press Madan Mohan Rao et al., The Role of Clinical Pharmacist in Pharmacovigilance
and Drug Safety in Teritiary Care Teaching Hospital, Indo Am. J. P. Sci, 2018; 05(04).
was evaluated by Schumock scale. The founded period of 6 months .A total of 60 patients were
ADRs were reported in ADR reporting form to recruited under inclusion criteria.
peripheral pharmacovigilance centres. PATIENT DISTRIBUTION BASED ON
GENDER:
RESULTS AND DISCUSSION: In our study we screened 60 cases. Out of 60 patients
A prospective observational study was conduct in 26 (43%) were male, 34(57%) were female.
south Indian tertiary care hospital RIMS (Rajiv
Gandhi institute of medical science), Kadapa for a
ADVERSE DRUG REACTION BASED ON THE diabetic, diuretic, DMARD, Hematinic, Anti
THERAPEUTIC CLASS OF THE DRUG: platelet,Anti protozoal, Anti acne ,Anti depression,
Therapeutic group of the drugs associated with the Immuno suppressants, 2(3.33%) were anti histamines
adverse drug reactions. Out of 60 adverse reactions ,GABA inhibitor,Anti viral;3(5%) were anti epileptic,
observed during study period, 8(13.33%) were Cardiac glycoside, Anti ulcer, Bronchodilator;
corticosteroids and anti psychotics, anti 6(10%) antibiotic.
hypertensive,1(1.67%) were anti inflammatory, anti
Table 05: Based On Therapeutic Class of The Drug
THERAPEUTIC NUMBER OF PERCENTAGE(%)
CLASS ADRs
CORTICOSTERIOD 8 13.33
ANTI PSYCHOTICS 8 13.33
ANTI 8 13.33
HYPERTENSIVES
ANTI INFLAMATORY 1 1.67
ANTIDIABETIC 1 1.67
DIURETIC 1 1.67
DMARD 1 1.67
HEMATINIC 1 1.67
ANTI PLATELET 1 1.67
ANTI PROTOZOAL 1 1.67
ANTI ACNE 1 1.67
ANTI DEPRESSION 1 1.67
IMMUNOSUPRESSANT 1 1.67
ANTI HISTAMINES 2 3.33
GABA INHIBITOR 2 3.33
ANTI VIRAL 2 3.33
ANTI EPILEPTIC 3 5.00
CARDIAC GLYCOSIDE 3 5.00
ANTI ULCER 3 5.00
BRONCHO DILATOR 3 5.00
ANTIBIOTICS 6 10.00
TOTAL 60 100.00
ASSESSMENT OF ADRs BASED ON scale Majority of adverse drug reactions were rated
CAUSALITY SCALE: certain 9(15%), probable/likely 14(23%), possible
The suspected adverse drug reactions were assessed 31(52%), unlikely 0(0%), Conditional 6 (10%),
by using WHO scale of assessment for causality Unassessible 0(0%).
assessment scale. According to the WHO causality
Table 6: Based On Causality Scale
CAUSALITY NUMBER OF ADRs PERCENTAGE
CERTAIN 9 15
POSSIBLE 31 52
PROBABLE 14 23
CONDITIONAL 6 10
UNLIKELY 0 0
UNASSESSIBLE 0 0
TOTAL 60 100
CONCLUSION:
The most of the observed results were comparable to incidences of adverse drug reaction and also
the literature reviews. . decreases the economic burden on health care
All most all ADRs were reported to peripheral system.
pharmacovigilance centers. Causality of the ADRs The number of ADRs reported during study period
was probable for most cases according to Naranjo’s were good but still it requires continuous education
scale and possible according to WHO-UMC criteria. on pharmacovigilance programme of India and to
Severity of the ADRs was mild according to Hartwig increase awareness and knowledge of the health care
and Siegel severity assessment scale. Majority of professionals.
ADRs were probably preventable according to Clinical pharmacists are the upcoming breed of
Schumock and Thornton scale. The number of ADRs pharmacists in our country. Clinical pharmacists can
reported during study period were good but still it contribute improved patients outcomes by monitoring
requires continuous education on pharmacovigilance the drug therapy and can also promote rational use of
programme of India and to increase awareness and drugs. Contribution of clinical pharmacists in
knowledge of the health care professionals. identifying , monitoring, reporting of suspected
Clinical pharmacists are the upcoming breed of adverse drug reactions and by effective utilizing the
pharmacists in our country. Clinical pharmacists can knowledge of clinical pharmacist by clinicians will
contribute improved patients outcomes by monitoring increases the patient care and not only reduces the
the drug therapy and can also promote rational use of incidences of adverse drug reaction and also
drugs. Contribution of clinical pharmacists in decreases the economic burden on health care
identifying , monitoring, reporting of suspected system.
adverse drug reactions and by effective utilizing the
knowledge of clinical pharmacist by clinicians will CONFLICTS OF INTEREST: We do not have any
increases the patient care and not only reduces the conflict of interest.