Research Article Open Access
Khoda et al., J Pharmacovigilance 2014, 2:3
DOI: 10.4172/2329-6887.1000128
Research Article Open Access
Volume 2 • Issue 3 • 1000128
J Pharmacovigilance
ISSN: 2329-6887 JP, an open access journal
Keywords: Adverse drug events; Antipsychotics; Extra pyramidal
side efects; Pharmacovigilance
Abbreviations: ADE: Adverse Drug Event; WHO: World Health
Organization; IEC: Institutional Ethics Committee
Introduction
Drugs are used for the well-being of an individual but apart from
its efectiveness many side efects are observed. Te Harward Medical
Practice Study was one such study which showed that the incidence
of iatrogenic injury in hospitals and medicines were the main cause
of injury to the patients. In United States approx 98,000 patients per
year sufered from medical errors [1]. In Britan, it was seen that more
than 10,000 patients per year were dying because of the bad reactions
of the drugs [2]. Te side efects seen from Drugs and their use are
in general termed as ‘Adverse drug reactions’ (ADRs). World Health
Organization (WHO) describes adverse drug reactions as a “Response
that is noxious or unintended, and that occurs at doses normally used
in humans for the prophylaxis, diagnosis, or therapy of a disease, or for
the modifcation of physiological function” and an ‘Adverse Drug Event’
(ADE) is defned as “an injury resulting from the use of a drug.”
It is well known that 30% of the documented adverse drug reactions
are neuropsychiatric and such drugs can cause depression, insomnia,
memory impairment, self-harming, aggression, mania and suicidal
ideation. Cessation of drug therapy can abort these symptoms, but they
trigger them too [3]. Antipsychotics are the mainstay of treatment for
psychotic disorders. Newer atypical antipsychotics and their traditional
counter parts are more prone to drug- drug interactions within
themselves and other agents used concomitantly in the treatment of
various ailments. Most of the frst generation and to a lesser degree
second generation antipsychotic agents are associated with adverse
drug events like extra pyramidal symptoms (EPS), sedation, anti-
cholinergic side efects and various metabolic disorders [4].
Most of the data available on adverse drug events addresses to
patients of out setting departments, surgery wards, medicine wards
and every few towards psychiatric in-patients; where the patient’s life
is on continuous alteration of doses and outcome of which at times is
seen as an adverse event. A MEDLINE search using the terms adverse
drug reactions, hospital, psychiatry in patients showed a great paucity
of literature (1950-december 2009) [5].
Psychiatry patients are on a regimen of more than 3 to 4 drugs
in their daily routine; with the increasing number of drugs, increases
the chances of drug interactions. In general, drug interactions are
known to occur with many agents used commonly in conjunction with
many antipsychotics such as anti-cholinergic, anti-convulsants, anti-
depressants, anxiolytics and lithium. Most of the data on anti-psychotic
interactions has been extracted from case reports. It is quite difcult to
derive inferences from available data due to lack of well documented
studies [4].
*Corresponding author: Disha A Khoda, Paddm-Kunj Apartments, 4842A/39A,
2nd main 2nd cross, Sadashivnagar, Belgaum, Karnataka, India, Tel: +91-
9916251092; E-mail: dishakhoda@gmail.com
Received March 14, 2014; Accepted March 10, 2014; Published March 17, 2014
Citation: Khoda DA, Ganachari MS, Wadhwa T, Walli S, Parihar B, et al. (2014) Clinical
Pharmacist Driven Impact towards Intensive Monitoring and Reporting of Adverse
Drug Events in Psychiatric Patients. J Pharmacovigilance 2: 128. doi:10.4172/2329-
6887.1000128
Copyright: © 2014 Khoda DA, et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
source are credited.
Clinical Pharmacist Driven Impact towards Intensive Monitoring and
Reporting of Adverse Drug Events in Psychiatric Patients
Disha A Khoda
1
*, Madiwalayya S Ganachari
1
, Tarun Wadhwa
2
, Shashikala Walli
1
, Bhupendra Parihar
1
and Atul Aggarwal
1
1
KLE University, Belgaum, Karnataka, India
2
RAK College of Pharamceutical Sciences, UAE
Abstract
Background: Drugs are used for the well-being of an individual but apart from its effectiveness many adverse
effects are observed. Antipsychotics are the mainstay of treatment for psychotic disorders. Most of the frst generation
and to a lesser degree second generation antipsychotic agents are associated with ADEs like extra pyramidal
symptoms (EPS), sedation and anti-cholinergic side effects.
Method: This study was conducted at a tertiary care hospital. Informed consent was obtained from patients
care takers. Patients aged ≥18 years of either gender admitted to psychiatry department were included in the study.
Patients on OPD basis, emergency, ICUs and special population were excluded. The main objective of the study
was to estimate the incidence of ADEs and evaluate ADEs based on various parameters like demographics, drug
class implicated, individual drug implicated, organ system affected, and analysis of ADEs (causality, severity and
preventability).
Result: A total of 58 patients were enrolled into the study. Out of them, 32 patients experienced 90 ADEs.
The incidence rate was found to be 55.17%. Male (65.51%) preponderance was observed over females (34.48%).
Benzodiazepine was reported to be one of the major drug class implicated in which Lorazepam accounted for
36.51% ADEs. CNS was one of the most prominent systems affected due to ADEs.
Conclusion: The fact goes undenied, psychiatric patients are prone towards adverse events, the only good that
could be done to these subjects is try avoiding and minimizing the events. This could be possible only by thorough
monitoring of such cases. Our results showed incidence rate of 79.31%. This incidence rate could be minimized by
the presence of a clinical Pharmacist for better treatment and creating awareness of the medicines to the patients.
Journal of Pharmacovigilance
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ISSN: 2329-6887