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Economic impact and severity of
adverse drug reactions in patients
with mental illness: A prospective
observational study
Website:
www.ijhas.in Jisha M Lucca, Niphy Annie Varghese, Madhan Ramesh, Dushad Ram1
DOI:
10.4103/ijhas.IJHAS_191_15
Abstract:
INTRODUCTION: Psychotropic medications are the mainstay in the management of psychiatric
disorders but they are not devoid of side effects. The occurrence of adverse drug reactions (ADRs)
in Indian psychiatry populace varies from 5.9% to 45%. The cost associated with the management
of ADRs in general settings ranges from Rs. 412.76 to 1080/‑ per ADR.
MATERIALS AND METHODS: A prospective observational study was conducted for a period of
1 year. The ADRs were assessed for causality by the World Health Organization probability scale
and severity by modified Hartwig and Siegel scale. The direct costs in the management of ADRs
were calculated.
RESULTS: A  total of 494 ADRs were reported and evaluated from 300 patients. Of the total
reported ADRs, 3.44% (n  =  17) lead to hospital admissions and 2.83%  (n  =  14) prolonged the
hospital stay. The gastrointestinal system 25.10% (n  =  125) and central and peripheral nervous
system 20.64% (n = 102) were the most common system organ class affected by ADRs. The drug
classes mainly implicated with ADRs were antipsychotics 53.03% (n = 262) and antidepressants
23.88% (n  =  118). Majority  (24.29%) of the reactions that lead to cost impact was moderate in
severity. Total cost incurred for the management of 131 reported ADRs was Rs. 57,891.33/‑ with an
average cost of Rs. 117.18/‑ per ADR.
CONCLUSION: In 131 cost impact ADRs, 114 patients had a cost impact of Rs. 57,891.33/‑.
A directly proportionate relationship was observed between the severity and cost incurred for the
management of ADRs. Hence, it is necessary to identify and prevent these reactions as they cause
burden to the patients.
Keywords:
Adverse drug reactions, cost, psychiatry

Introduction drug related, out of which 4.9% were due to

ADRs and it calculated a cost of more than

Department of Pharmacy
Practice, JSS College of
A dverse drug reactions (ADRs) have
been reported with significant impact
on morbidity, mortality, quality of life, and
€ 2 million per patient.[1] A study conducted
in Germany estimated that direct cost
associated with ADRs was 0.4 billion dollars
Pharmacy, 1Department of health‑care cost. It has been estimated that annually.[2] United States study[3] revealed
Psychiatry, JSS Medical approximately 2.9%–5.6% of all hospital
College and Hospital, that the cost of ADRs per patient was in
Mysore, Karnataka, India admissions are caused by ADRs and as many the range of US $2000–US $4000. In India,
as 35% of hospitalized patients experience Ramesh et al. estimated the cost associated
Address for an ADR during their hospital stay.[1‑3] In an in treating all reported ADRs to be US $1595,
correspondence: Australian study, 5.7% of all admissions were
Dr. Jisha M Lucca, with the average US $15 per ADR.[4]
Department of
Pharmacy Practice, This is an open access article distributed under the terms of the Creative
How to cite this article: Lucca JM, Varghese NA,
JSS College of Pharmacy, Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which
Ramesh M, Ram D. Economic impact and severity of
Mysore ‑ 570 015, allows others to remix, tweak, and build upon the work non‑commercially,
as long as the author is credited and the new creations are licensed under adverse drug reactions in patients with mental illness:
Karnataka, India. A prospective observational study. Int J Health Allied
the identical terms.
E-mail: jishajojo06@ Sci 2017;6:93-8.
yahoo.co.in For reprints contact: reprints@medknow.com

© 2017 International Journal of Health & Allied Sciences | Published by Wolters Kluwer ‑ Medknow 93

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Lucca, et al.: Economic impact and severity of ADRs in psychiatry
Global prevalence of ADRs in the psychiatric department
varies from 3.6% to 91%.[5‑10] The rate of ADRs during
hospitalization is 4.2%–75%[5‑10] and it was the root cause
of 10/1000 patient days in a psychiatric hospital.[11] A
recently published database study reports that nearly 1
in 10 of all adverse drug events visiting the emergency
department was due to psychiatric drugs[12] and 9% of the
patients from the psychiatric ward were transferred to
the general wards due to ADRs.[13] ADRs were the reason
for 7.5% of hospitalization in acute psychiatric ward,
and 25% of the admitting diagnoses were drug‑induced
psychiatric conditions.[14‑16] ADRs in Indian psychiatric
populace vary from 5.9% to 45%,[16‑22] and they extend
hospital stay and add to the health‑care expenditure.
Studies on economic impact for the management of
ADRs are plenty full in number and carried out in
Western settings. The data obtained from the developed
countries appear far less compared with the reports
from our country due to the differences in per capita
expenditure. The components that were responsible
for the cost involved changes from country to country.
The search on PubMed and Ovid reveals that studies
on economic impact of ADRs in psychiatric practice
are limited and no data are available in the Indian
population. Hence, we aim to study the cost associated
with reported ADRs in psychiatric department of tertiary
care hospital.
Materials and Methods
Study design and study period
This prospective observational study was conducted in
the mental health department of a tertiary care hospital
in South India over a period of 1 year.
Study patients
All patients of either gender and of any age that visited
or admitted to the psychiatric department as per the
International Classification of Diseases‑10 psychiatric
diagnosis were reviewed and the patients who
experienced an adverse event (AE) were included in
the study. AEs due to overdose, suicidal or accidental
intake of drugs, substance abuse, and another system
of medicines (Ayurveda, Unani) were excluded
from the study. The patients who were treated in
other departments or in consultation‑liaison with the
psychiatric department were exempted, for the want
of complete medical information. All the necessary and
relevant information about the patient, medications, and
the ADRs were collected from doctor’s notes, treatment
charts, laboratory reports, outpatient department (OPD)
cards, and patient–reporter interviews. Hospital and
pharmacy bills were the source documents to determine
the cost of hospitalization and cost associated with the
management of ADRs.
94 International Journal of Health & Allied Sciences - Volume 6, Issue 2, April‑June 2017
Study procedure
The patients were intensively monitored by interview
and chart review, to detect any symptom that might
be related to an AE. All the patients admitted to the
psychiatric ward were closely monitored from the day
of admission till the day of discharge, whereas the
outpatients were randomly reviewed on their visits to
the OPD. Any reaction noted by the study pharmacist
was brought into the notice of the concerned psychiatrist.
The patient details, medication intake, ADR details, and
other relevant data were collected and documented in
a suitably designed data collection forms. ADRs with
probable, possible, and certain causality relationship
with drug intake were included in the study, and
various ADR management strategies such as types of
medications, hospitalization and medication charges,
duration of stay, consultation fees, and other charges
were assessed. The severity of ADRs was assessed using
modified Hartwig and Siegel scale into mild, moderate,
and severe (level 1–7). Direct cost was calculated,
documented, and subjected for analysis.
Ethical considerations
The study protocol was reviewed and approved by
the Institutional Ethics Committee, and permission
was obtained from the hospital authority before the
commencement of the study.
Results
During the study period, a total of 505 ADRs were reported
from 309 patients, in which 11 ADRs from 9 patients were
not considered for further evaluation due to lack of data.
Of the 300 patients, 45.3% (n = 136) and 54.6% (n = 164)
were male and female, respectively. The mean age of
the patients was 34 ± 12 (range, 13–79). Mood (affective)
disorders (n = 154 [51.3%]) were the most common
diagnosis and 23.3% (n = 70) of patients presented
with at least a comorbid medical condition [Table 1].
The gastrointestinal system (n = 125 [25.10%]) was
the most common system organ class affected with
ADRs followed by the central and peripheral nervous
system (n = 102 [20.64%]) [Figure 1]. Antipsychotic
medications accounted for 53.03% (n = 262) of ADRs
followed by antidepressants (n = 118 [23.88%]).
Nonpsychotropic medications implicated for
4.04% (n = 20) of adverse reactions [Figure 2].
Out of 494 reported ADRs, 131 (26.51%) ADRs had a
direct cost impact. The total cost incurred in managing
all reported ADRs was Rs. 57,891.33/‑. Of the total
direct cost incurred for the management of ADRs,
medicines cost accounted for Rs. 21,661.33/‑ followed
by the hospital bed charges (Rs. 21,000/‑) [Table 2].
The most frequently reported reaction with cost impact
was extrapyramidal side effects (n = 29 [22.13%]) which
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Lucca, et al.: Economic impact and severity of ADRs in psychiatry

Figure 2: Drug classes associated with adverse drug reactions (n = 494)

“mild,” “moderate,” and “severe” reactions was Rs.

Figure 1: System organ classification affected by adverse drug reactions (n = 494) 58.58/‑, Rs. 361.30/‑, and Rs. 7457.665/‑, respectively.
The average cost involved in treating each ADR was
Table 1: Demographic details of the study patients found to be Rs. 441.91/‑ (10‑9201/‑ INR) [Table 4].
Characteristics Number of Number of
patients (300) ADRs (494)
Discussion
Gender (%)
Male 136 (45.3) 207 (41.9)
In psychiatry, the frequency and severity of ADRs play
Female 164 (54.6) 287 (58.09)
an important role in effectiveness and tolerability of the
Age (%)
drugs and are the major contributors for noncompliances
Pediatrics 5 (1.6) 10 (2.02)
and reduction of quality of life.[23,24] It is clear that ADRs
Adults 283 (94.3) 462 (93.5)
Geriatrics 12 (4) 22 (4.45)
are a source of economic burden on patients, their
Diagnosis* (%)
caregivers, and health‑care system that treats them.
F01-F09 10 (3.33) 15 (3.03) The incidence rate of ADRs in this study was found to
F10-F19 10 (3.33) 10 (2.02) be 34.24%, which is similar to the other studies where it
F20-F29 53 (17.6) 90 (18.21) ranges from 3.6% to 91%.[17‑21] A total of 66 different types
F30-F39 154 (51.3) 254 (51.41) of ADRs were observed in this study.
F40-F49 48 (16) 70 (14.17)
F50-F59 14 (4.66) 30 (6.07) In 54 cases, ADRs were the reason for either hospital
F60-F69 4 (1.33) 12 (2.42) visits (n = 37) or admission (n = 17). Approximately 50%
F70-F79 5 (1.66) 10 (2.02) of ADR‑related hospital admissions were drug‑induced
F80-F89 1 (0.33) 1 (0.20) psychiatric conditions (such as psychosis, mania,
F90-F99 1 (0.33) 2 (0.40) and depression) while 14 cases of ADRs resulted in
*Organic, including symptomatic, mental disorders (F01-F09), mental prolongation of hospital stay and development of
and behavioral disorders due to psychoactive substance use (F10-F19),
schizophrenia, schizotypal, and delusional disorders (F20-F29), mood
extra pyramidal symptoms (EPS), and pruritus and
(affective) disorders (F30-F39), neurotic, stress‑related, and somatoform hyponatremia were the common reasons for increased
disorders (F40-F49), behavioral syndromes associated with physiological length of stay. A major portion of the drug‑induced
disturbances and physical factors (F50-F59), disorders of adult personality and
behavior (F60-F69), mental retardation (F70-F79), disorders of psychological hospital visits was due to adverse reactions such as
development (F80-F89), and behavioral and emotional disorders with onset diabetes mellitus, hypothyroidism, and galactorrhea.
usually occurring in childhood and adolescence  (F90-F99). ADRs=Adverse
drug reactions
It is well reported that ADRs are more common
in females, [25‑28] and the present study showed no
Table 2: The direct costs incurred in managing
adverse drug reaction discrepancy with this regard (54.6%). The reasons for
Direct cost Number Cost (Rs.) Percentage
a higher risk in females may be multicausal including
of ADRs gender‑related differences in pharmacokinetics,
Medicines 100 21,661.33 37.41 pharmacodynamics, pharmacogenetics, immunological
Laboratory investigations 19 10,780 18.62 and hormonal factors as well as differences in the use
Hospital beds 32 21,000 36.27 of medications (contraceptives) by women compared
Consultation 19 950 1.64 with men.[25‑28] Previous studies have shown a larger
Others 21 3500 6.04 percentage of ADRs in geriatric patients when compared
ADRs=Adverse drug reactions to adult population. However, in this study adult (93.5%),
predominance is observed as the psychiatrist possibly
accounted for a total of Rs. 15,342/‑. ADRs with highest consider the elderly and pediatric patients and monitor
cost impact were observed in a case of quetiapine‑induced them more intensively, prescribe lower dosages, or
bradycardia and QT prolongation which amounted for avoid high‑risk drugs and dangerous combinations, thus
Rs. 9201/‑ [Table 3]. The average cost incurred in each reduces the risks of ADRs in these populations.
International Journal of Health & Allied Sciences - Volume 6, Issue 2, April‑June 2017 95
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Lucca, et al.: Economic impact and severity of ADRs in psychiatry

Table 3: Common adverse drug reactions that resulted in increased cost

Drugs implicated Individual ADRs (n=131)
Risperidone EPS (7), anemia (1), rash (1), acne (1), vomiting (1), acidity (1), excessive salivation (1), pancytopenia (1)
Quetiapine Gastritis (1), EPS (8), constipation (1), bradycardia and QT prolongation (1), metabolic syndrome (1)
Olanzapine EPS (6), acne (1), gastritis (1), constipation (1), gastritis incontinence (1), myalgia (1), drooling (1)
Haloperidol EPS (1), thrombophlebitis (9), vomiting (1), constipation (1)
Valproic acid Thrombocytopenia (2), gastritis (1), DM (1), hypothyroidism (1), metabolic syndrome (1), vomiting (1),
gastritis (1), edema (1), hyperammonemia (1)
Amisulpride EPS (4), galactorrhea (2), gastritis (1), acne (1)
Escitalopram Gastritis (1), constipation (1), mania (2), hyponatremia (2) vomiting (1)
Clomipramine Myalgia (1), constipation (1), hypomania (2), acne (1), pruritus (1)
Desvenlafaxine Constipation (1), mania (2), acidity (1), myalgia (1), headache (1)
Prednisolone Psychosis (4), osteoporosis (1)
Flupentixol Gastritis (2), EPS (2)
Antitubercular Psychosis (2), depression (2)
Paroxetine Constipation (1), erectile dysfunction (2)
Clozapine Drooling (2), thrombocytopenia (1)
Amitriptyline Gastritis (1), constipation (1), EPS (1)
Carbamazepine Abdominal pain (2)
Dexamethasone Psychosis (2)
Trihexyphenidyl Constipation (1), delirium (1)
Lorazepam Delirium (1), thrombophlebitis (1)
Clonazepam Ataxia (1), myalgia (1)
Atorvastatin Myalgia (2)
Chlordiazepoxide Erectile dysfunction (1), imbalance (1)
Sertraline Arthralgia (1)
Nimodipine PME (1)
Fluvoxamine Increased TG (1)
Lithium Gastritis (1)
Cefixime Diarrhea (1)
Efavirenz Depression (1)
Isotretinoin Psychosis (1)
Aspirin Epistasis (1)
EPS=Extra pyramidal symptoms, PME=Premature ejaculation, TG=Triglyceride, ADRs=Adverse drug reactions, DM=Diabetes mellitus

Table 4: Comparison between cost and severity of the adverse drug reactions
Level of severity Total number of Number of ADRs with Total cost incurred Average cost per ADR
reactions (494) cost impact (131)
Mild (%) 372 (75.3) 12 (9.16) 703 (1.21) 58.58
Moderate (%) 120 (24.29) 117 (89.31) 42,273 (73.02) 361.30
Severe (%) 2 (0.40) 2 (1.52) 14,915.33 (25.7) 7457.66
Total 494 131 57,891.33 441.91
ADRs=Adverse drug reactions

One‑fourth of the adverse reactions were affected
with the gastrointestinal system. This is in link with
most of the studies.[20‑22] In this study, antipsychotic
medications (53.03%) were the most commonly
implicated class of drugs which is in concordance with
the results of Iuppa et al.,[12] while it contradicts with the
findings of the study conducted by  Thomas et al.,[15] where
nonpsychotic medications were responsible for 53% of
ADRs.
Severe reactions were those which required intensive
medical care, permanent harm, or leading to death
directly or indirectly though no fatality was observed
in the study. They required advanced treatment
96 International Journal of Health & Allied Sciences - Volume 6, Issue 2, April‑June 2017
procedures and greater financial expenditure from
the patients, but the reported adverse reactions were
less (n = 02). Approximately three‑fourth of the reactions
were moderate (89.31%) as it did require immediate
cessation of the causative drug therapy, substitution
with alternative drug, and also treatment to the reaction.
The average cost (INR 441.91) for the management of
each adverse reaction was lower than reported by other
studies. This can be attributed to the fact that this study
included both inpatient and outpatients, thus leading
to reduced cost. The cost of ADRs observed in the
study reflects psychiatry department in a tertiary care
hospital perspective. The cost of treatment generally
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Lucca, et al.: Economic impact and severity of ADRs in psychiatry
varies from hospital to hospital depending on the level
of sophistication and type of hospital. Usually, the
charity trusts hospitals charge lower fees than private
corporate hospitals. Thus, results of the present study
might reflect the economic burden of ADRs in similar
types of hospitals across the country.
The components that were accountable for the cost
involved were medicines, bed/hospital stay, laboratory
investigations, consultation, and others charges such
as administrative and nursing charges. It was found
that cost of medications was the major contributor of
expenses (Rs. 21,661.33). However, in Rajakannan et al.[29]
study, higher charges in managing the adverse reactions
were reported with laboratory investigations. One of
the reasons was that in this study, majority of the ADRs
reported was hepatocellular damage.
The average cost of treating a “mild” reaction was Rs.
58.58 while that of treating a “moderate” reaction was
Rs. 361.30. An amount of Rs. 7457.66 was incurred in
treating “severe” reactions. One hundred and nineteen
patients incurred some cost in managing their ADR. Of
the total cost (Rs. 57891.33) spent by them, the minimum
cost incurred in a single patient was Rs. 10 while the
maximum cost incurred was Rs. 9201. It was seen that
as the severity of ADRs increased, the cost incurred in
their management also increased.
Conclusion
The incidence of ADR in the present study was 34.24%.
The total cost for the management of ADR was found
to be Rs. 57,891.33/‑. It was seen that as the severity of
ADRs increased, the cost incurred in their management
also increased. Hence, it is very important to identify and
prevent these reactions as they cause greater suffering to
the patient and involve higher health‑care cost in their
management.
Acknowledgment
The authors gratefully acknowledge JSS University, JSS
College of Pharmacy, and Psychiatric Department of
JSS Hospital, Mysore, for their help in conducting this
prospective observational study.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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