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ORIGINAL ARTICLE
Year : 2020  |  Volume : 10  |  Issue : 3  |  Page : 144-148

Prevalence and Severity of Adverse Drug Reactions Among Patients Receiving Antipsychotic Drugs in a Tertiary Care Hospital


Department of Pharmacology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, Karnataka, India

Date of Submission31-Jan-2020
Date of Decision10-Feb-2020
Date of Acceptance07-Mar-2020
Date of Web Publication20-Aug-2020

Correspondence Address:
Assistant Professor Netravathi Basavaraj Angadi
Department of Pharmacology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, Nehru Nagar, Belagavi – 590010
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijnpnd.ijnpnd_9_20

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   Abstract 


Aims: Adverse drug reactions are usually dose dependent and can be influenced by patient characteristics including age and gender and these confounding factors should be considered in clinical practice and in the interpretation of research data. This study was planned to evaluate the profile of adverse drug reactions among patients receiving antipsychotic drugs in a tertiary care hospital and to assess the severity of adverse drug reactions. Methods: It was a hospital-based cross-sectional study, conducted in Department of Psychiatry in a tertiary care hospital. An assessment of severity was done using modified Hartwig and Siegel scale. Categorical variables were summarized as percentages. Chi-square test was used to test for independence of two categorical variables. P < 0.05 was considered as statistically significant. Results: The overall prevalence of ADRs in the study population was found to be 51.9%. When the percentage of individual ADRs was taken into consideration, the most common ADR was increase in weight (15.7%) followed by sedation (9.6%), increased appetite (7.8%), Rigidity (6.8%) and akathesia (5.1%) As per modified Hartwig and Siegel scale for assessing the severity of ADRs, 34(63.0%) ADRs were mild in severity and 20 (37.0%) ADRs were moderate in severity. Conclusion: ADRs occur quite frequently in these patients receiving antipsychotic drugs, which are often mild in nature Thus, the recognition of these side-effects and their management can ensure optimal care for the patient.

Keywords: Antipsychotic drugs, ADR prevalence, modified Hartwig and Siegel scale


How to cite this article:
Angadi NB, Mathur C. Prevalence and Severity of Adverse Drug Reactions Among Patients Receiving Antipsychotic Drugs in a Tertiary Care Hospital. Int J Nutr Pharmacol Neurol Dis 2020;10:144-8

How to cite this URL:
Angadi NB, Mathur C. Prevalence and Severity of Adverse Drug Reactions Among Patients Receiving Antipsychotic Drugs in a Tertiary Care Hospital. Int J Nutr Pharmacol Neurol Dis [serial online] 2020 [cited 2020 Oct 31];10:144-8. Available from: https://www.ijnpnd.com/text.asp?2020/10/3/144/292694




   Introduction Top


According to WHO, adverse drug reaction (ADRs) is defined as “Any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”[1] ADRs are known to be the significant cause of morbidity and mortality both inpatients and outpatients settings.[2] ADRs are recognized to be one the significant cause of hospital admissions and the incidence varied from 0.2% to 41.3%.[3]

Antipsychotic drugs are considered the cornerstone for the treatment of schizophrenia and other psychotic disorders.[4] Earlier conventional antipsychotics were used, with the introduction of atypical antipsychotics use of conventional ones has come down. Data from the various studies have indicated that atypical antipsychotic drugs are superior in efficacy to conventional antipsychotic drugs.[5] Though the symptoms will be resolved with long-term medication, non-adherence, adverse reactions and drug interactions are major complications in the pathway. Antipsychotics produce their own spectrum of adverse drug effects including extra-pyramidal effects, weight gain, seizures, hypotension, hyperlipidemia and increased risk of diabetes mellitus [6] Over the last few years, atypical antipsychotics have been increasingly used in the pharmacological treatment of schizophrenia and other related psychotic disorders. These agents improve quality of life, have better medication compliance, and also decrease suicidal tendencies and depression in these patients.[7] Atypical antipsychotics differ from conventional agents in that they have lower risk of EPS and significantly reduce both positive and negative symptoms of schizophrenia. Although the atypical antipsychotics have lower risk of extrapyramidal side effects, these agents present their own spectrum of adverse effects including hypotension, seizures, weight gain, increased risk of diabetes mellitus and hyperlipidemia.[8] Therefore, there is growing concern among the healthcare personnel to assess the ADRs of atypical antipsychotics, which have an impact on long-term compliance and achieving successful treatment.

There have been few studies in this regard, a study on metabolic syndrome in outpatients receiving antipsychotic therapy by Mainara et al.[9] has shown that prevalence of metabolic syndrome was significantly higher in subjects on antipsychotics (27.0%) and elevated body mass index was seen in 33.40% of them. A study done by Simpson et al.[10] has shown that treatment with atypical antipsychotics was associated with more weight gain than treatment with typical antipsychotics. Few studies have shown that typical antipsychotics like haloperidol and flupenthixol have been known to cause ADRs in 19% and 7% of the patients[7],[11]. Pharmacovigilance (PV) is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug-related problem[12] It is a key component of effective drug regulation systems, clinical practice and public health programs.

The national pharmacovigilance centres have become a significant influence on the drug regulatory authorities, at a time when drug safety concerns have become increasingly important in public health and clinical practice.[12] Pharmacovigilance highly essential in developing countries where there is lack of adequate safety-related data for drugs in general and psychotropic agents in particular.[13]

In India, pharmacovigilance studies are still at fledgling stage and there are very fewer reports accessible on the ADR profile of antipsychotic agents inaccurate.

This study was planned to evaluate the profile of ADRs among patients receiving antipsychotic drugs in a tertiary care hospital and to assess the severity of ADRs using modified Hartwig and Seigel scale.


   Materials and Methods Top


This study was carried after obtaining Ethical clearance was obtained from the Institutional Ethics committee for conduct of research in humans. It was a hospital-based cross-sectional study conducted in Department of Psychiatry in a tertiary care hospital. All the in-patients in the psychiatry ward of either sex in the age group 18–65 years who were receiving antipsychotic drugs for more than 6 weeks were included in the study by universal sampling method. Data was collected after taking written informed consent from the patients. The data collection instrument included a pretested questionnaire, including demographic information, brief history of the disease, the medication history, information on development of any ADRs during the course of treatment and its profile was collected.

Proforma also included name, dose, route and frequency of antipsychotics and other co-prescribed drugs given. Blood pressure, pulse rate, body weight in kilograms (kgs), height in centimetres and random blood sugar (RBS) were measured. Body mass index of all the patients was calculated using the formula, BMI= weight in kgs/ Height in meter2 The patients were grouped into categories of normal weight, overweight and obese based on consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management.[14] Normal BMI: 18.0-22.9 kg/m2, Overweight: 23.0-24.9 kg/m2, Obesity: >25 kg/m2. The details about the various ADRs were recorded viz, the presence or absence of adverse effects like drowsiness, giddiness, pedal oedema, urinary retention, altered appetite, insomnia, weight gain, constipation, hyper salivation, extrapyramidal symptoms like tremor, rigidity, akathisia, tardive dyskinesia and perioral tremor, irregular menstrual cycles and galactorrhea in female patients. All these data were obtained by questioning the patients and the accompanying person. Any other adverse reaction was also noted down.

Modified Hartwig criteria were followed for assessing the severity of ADR, based on this severity assessment scale, adverse reactions were categorized broadly into mild, moderate and severe.[15]

Statistical Analysis

Categorical variables were summarized as percentages. Chi-square test was used to test for independence of two categorical variables. P < 0.05 was considered as statistically significant.


   Results Top


Out of total 104 patients enrolled for the study, 48(46.2%) were constituted by males and 56(58.3%) of the study population were females. Out of the total study population, 54 patients reported at least one or more ADRs out of which 29 were females and 25 were males. However there was no statistically significant relationship of ADRs with age or gender of the study population [Table 1].
Table 1 Prevalence of ADR among the study participants

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Out of 104 patients, 58 patients had obesity. 41(70.6%) had their BMI in the range of 25–29.9 and 17 had their BMI > 30. Among the antipsychotics prescribed Olanzapine, risperidone and clozapine the prevalence of obesity with maximum with olanzapine.

Most frequently prescribed drugs were olanzapine, trifluperazine and paroxetine in with their frequency of 26.9%, 14.4% and 13.5% respectively and the other drugs used included either clozapine alone or the combination of various antipsychotics.

The overall prevalence of ADRs in the study population was found to be 51.9% [Table 1] and [Table 2]. When the percentage of individual ADRs was taken into consideration, the most common ADR was increase in weight (15.7%) followed by sedation (9.6%), increased appetite (7.8%), rigidity (6.8%) and akathesia (5.1%) Out of 104 cases, 16 cases (15.7 %) had documented weight gain. The mean percentage of weight gain was 11.3%.
Table 2 Prevalence of ADR in study participants according to the drug used

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When the percentage of individual ADRs was taken into consideration according to the drug used, the most common drug showing ADR was olanzapine(60.8%) followed by trifluperazine, paroxetine and others [Table 2]. Among atypical antipsychotics, olanzapine was most commonly associated with ADRs followed by trifluperazine [Table 3].
Table 3 The antipsychotic drugs commonly implicated in the most common ADRs

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As per modified Hartwig and Siegel scale for assessing the severity of ADRs, 34(63.0%) ADRs were mild in severity and 20 (37.0%) ADRs were moderate in severity. None of the reported ADRs belonged to the ‘severe’ or ‘lethal’ category [Figure 1], [Table 4].
Figure 1 Severity of ADR in the study population according to the modified Hartwig and Siegel scale.

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Table 4 Severity of ADR in the study population according to the modified Hartwig and Siegel scale

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   Discussion Top


Atypical antipsychotics are now considered as first line agents based on treatment efficacy, better tolerability and reduced risk of extra-pyramidal symptoms.[4],[5] Knowledge about the association of various ADRs with various antipsychotics can prevent their frequency as well as the severity when various factors influencing the same are taken into consideration. So the present study was conducted to know the prevalence of ADRs and severity assessment was done using the modified Hartwig and Siegel scale. The results were compared with the studies conducted earlier and we also tried to determine their relationship with age and sex of the patients. In the present study, the participants were in the young and middle age groups and the female to male ratio was 1.16. However there was no significant relationship of ADR with age or sex of the enrolled patients. The proportion of patients with at least one ADR was found to be (51.9%) and most of them being mild in severity. The number of females showing ADRs was more as compared to the males It is also evident from the previous studies that the prevalence of ADRs is more in case of females than the males.[16]Increase in weight, sedation, increased appetite, and akathesia were the most common ADRs observed in our study population in decreasing order of their occurrence. When compared to other studies conducted earlier, weight gain was reported as the most common ADR where as tremor was the most common ADR followed by weight gain. This difference may be attributed to a different patient population group used by Sengupta et al and Prajapati et al. [6],[17],[18] It is also worth to mention that these studies reported ADRs in a population of patients on psychotropic drugs whereas in our study, the patients were receiving only antipsychotics among psychotropic drugs. Since the most frequently drugs prescribed in the present study were olanzapine, trifluperazine, Paroxetine and quietapine and as such more patients showing adverse effects related to them were seen while as the percentage of patients showing adverse effects to clozapine and the combination of various antipsychotics very less and thus needs evaluation through further research. Due to the ADRs faced by patients, they tend to discontinue their prescribed medicine once their symptoms start to disappear. This often causes the symptoms to reappear. To prevent this from happening and to give the patients better advice, an understanding of these ADRs is important. Documentation of these ADRs and interactions may serve as a database that could provide warning signals for early prevention of such episodes in future.


   Conclusion Top


From this study, we can conclude that ADRs occur quite frequently in these patients receiving antipsychotic drugs, which are often mild in nature Thus, the recognition of these side-effects and their management can ensure optimal care for the patient. Such prospective studies conducted across multiple hospitals through active collaboration of psychiatrists and pharmacologists can be helpful in building up a database for ADRs occurring due to psychotropic drugs.

Financial support and sponsorship

Funded by Indian Council of Medical Research (ICMR), New Delhi.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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2.
Hakkarainen KM, Hedna K, Petzold M, Hägg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions − a meta-analysis. PloS One 2012;7:e33236.  Back to cited text no. 2
    
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Beijer HJ, De Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharmacy World and Science 2002;24:46-54.  Back to cited text no. 3
    
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Tripathi KD. Essentials of Medical Pharmacology. 8th ed. New Delhi: JAYPEE Brothers Medical Publishers (P) Limited; 2018.  Back to cited text no. 4
    
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Sengupta G, Bhowmick B, Hazra A, Datta A, Rahaman M. Adverse drug reaction monitoring in psychiatry outpatient department of an Indian teaching hospital. IJP 2011;43:36-39.  Back to cited text no. 6
    
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Sicras-Mainar A, Blanca-Tamayo M, Rejas-Gutiérrez J, Navarro-Artieda R. Metabolic syndrome in outpatients receiving antipsychotic therapy in routine clinical practice: a cross-sectional assessment of a primary health care database. Eur Psychiatry 2008;23:100-8.  Back to cited text no. 9
    
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Simpson MM, Goetz RR, Devlin MJ, Goetz SA, Walsh BT. Weight gain and antipsychotic medication: differences between antipsychotic-free and treatment periods. J Clin Psychiatry 2001;62:694-700.  Back to cited text no. 10
    
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World Health Organization (WHO). The Importance of pharmacovigilance: safety monitoring of medicinal products. WHO, Geneva, 2002.  Back to cited text no. 12
    
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Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India 2009;57:163-70.  Back to cited text no. 14
    
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Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:22  Back to cited text no. 15
    
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Afkat A, Arshad H, Samina F, Shagufta P, Vineeta S, Zubair A. Prevalence and Severity of Adverse Drug Reactions (ADRs) in patients subjected to different Anti-psychotic drugs in an Out-Patient Department of a Psychiatry Hospital in Kashmir; a prospective observational study. Int J Pharmacol and Clin Sci 2016;5(1):12-16.  Back to cited text no. 16
    
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Chakravarty P, Neog P, Dewan B. Study of adverse drug reactions of atypical antipsychotic drugs in the department of psychiatry in a tertiary care hospital of Assam. Open J Psychiatry Allied Sci 2017;8:24-8.  Back to cited text no. 17
    
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Prajapati K, Desai M, Shah S, Panchal J, Kapadia J, Dikshit R. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. Perspect Clin Res 2016;7(4):181-6.  Back to cited text no. 18
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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