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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 6  |  Issue : 2  |  Page : 93-98

Economic impact and severity of adverse drug reactions in patients with mental illness: A prospective observational study


1 Department of Pharmacy Practice, JSS College of Pharmacy, Mysore, Karnataka, India
2 Department of Psychiatry, JSS Medical College and Hospital, Mysore, Karnataka, India

Date of Web Publication18-May-2017

Correspondence Address:
Jisha M Lucca
Department of Pharmacy Practice, JSS College of Pharmacy, Mysore - 570 015, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijhas.IJHAS_191_15

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  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


How to cite this article:
Lucca JM, Varghese NA, Ramesh M, Ram D. Economic impact and severity of adverse drug reactions in patients with mental illness: A prospective observational study. Int J Health Allied Sci 2017;6:93-8

How to cite this URL:
Lucca JM, Varghese NA, Ramesh M, Ram D. Economic impact and severity of adverse drug reactions in patients with mental illness: A prospective observational study. Int J Health Allied Sci [serial online] 2017 [cited 2019 Sep 17];6:93-8. Available from: http://www.ijhas.in/text.asp?2017/6/2/93/206423


  Introduction Top


Adverse drug reactions (ADRs) have been reported with significant impact on morbidity, mortality, quality of life, and health-care cost. It has been estimated that approximately 2.9%–5.6% of all hospital admissions are caused by ADRs and as many as 35% of hospitalized patients experience an ADR during their hospital stay.[1],[2],[3] In an Australian study, 5.7% of all admissions were drug related, out of which 4.9% were due to ADRs and it calculated a cost of more than € 2 million per patient.[1] A study conducted in Germany estimated that direct cost associated with ADRs was 0.4 billion dollars annually.[2] United States study [3] revealed that the cost of ADRs per patient was in the range of US $2000–US $4000. In India, Ramesh et al. estimated the cost associated in treating all reported ADRs to be US $1595, with the average US $15 per ADR.[4]

Global prevalence of ADRs in the psychiatric department varies from 3.6% to 91%.[5],[6],[7],[8],[9],[10] The rate of ADRs during hospitalization is 4.2%–75%[5],[6],[7],[8],[9],[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],[15],[16] ADRs in Indian psychiatric populace vary from 5.9% to 45%,[16],[17],[18],[19],[20],[21],[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 Top


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.

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 Top


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].
Table 1: Demographic details of the study patients

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Figure 1: System organ classification affected by adverse drug reactions (n = 494)

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

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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 accounted for a total of Rs. 15,342/- ADRs with highest cost impact were observed in a case of quetiapine-induced bradycardia and QT prolongation which amounted for Rs. 9201/- [Table 3]. The average cost incurred in each “mild,” “moderate,” and “severe” reactions was Rs. 58.58/-, Rs. 361.30/-, and Rs. 7457.665/-, respectively. The average cost involved in treating each ADR was found to be Rs. 441.91/- (10-9201/- INR) [Table 4].
Table 2: The direct costs incurred in managing adverse drug reaction

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

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Table 4: Comparison between cost and severity of the adverse drug reactions

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  Discussion Top


In psychiatry, the frequency and severity of ADRs play an important role in effectiveness and tolerability of the drugs and are the major contributors for noncompliances and reduction of quality of life.[23],[24] It is clear that ADRs are a source of economic burden on patients, their caregivers, and health-care system that treats them. The incidence rate of ADRs in this study was found to be 34.24%, which is similar to the other studies where it ranges from 3.6% to 91%.[17],[18],[19],[20],[21] A total of 66 different types of ADRs were observed in this study.

In 54 cases, ADRs were the reason for either hospital visits (n = 37) or admission (n = 17). Approximately 50% of ADR-related hospital admissions were drug-induced psychiatric conditions (such as psychosis, mania, and depression) while 14 cases of ADRs resulted in prolongation of hospital stay and development of extra pyramidal symptoms (EPS), and pruritus and hyponatremia were the common reasons for increased length of stay. A major portion of the drug-induced hospital visits was due to adverse reactions such as diabetes mellitus, hypothyroidism, and galactorrhea.

It is well reported that ADRs are more common in females,[25],[26],[27],[28] and the present study showed no discrepancy with this regard (54.6%). The reasons for a higher risk in females may be multicausal including gender-related differences in pharmacokinetics, pharmacodynamics, pharmacogenetics, immunological and hormonal factors as well as differences in the use of medications (contraceptives) by women compared with men.[25],[26],[27],[28] Previous studies have shown a larger percentage of ADRs in geriatric patients when compared to adult population. However, in this study adult (93.5%), predominance is observed as the psychiatrist possibly consider the elderly and pediatric patients and monitor them more intensively, prescribe lower dosages, or avoid high-risk drugs and dangerous combinations, thus reduces the risks of ADRs in these populations.

One-fourth of the adverse reactions were affected with the gastrointestinal system. This is in link with most of the studies.[20],[21],[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 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 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 Top


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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