INTRODUCTION:

Psychiatric disorders are considered as the most common amongst all human illness that can alter or destroy a person’s feeling and thinking ability which may disrupt their daily functioning^[1,2]. In moderate to severe psychiatric diseases, psychotropic medications contribute a major role in their management.Due to the differences in the parameters like pharmacokinetics and pharmacodynamics, an individual’s response to a specific treatment may vary^[3].

Psychotropic agents are prescribed based on the patient’s needs, target symptoms and side effect profile^[4]. Being on complex regimens and multiple medications, psychiatric patients are at a greater risk compared to other age matched patients, which makes them liable to adverse drug reactions^[5]. The most commonly occurring drug related problem across the world is an adverse drug reaction^[6]. These effects tend to worsen the patient’s mental and physical well-being and thereby make them non-adherent to therapy^[7]. According to World Health Organisation (WHO), an adverse drug reaction is defined as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of a disease, or for the modification of physiological function”^[8]. ADR monitoring is important in a hospital setting so that the patients who are at high risk for developing ADRs can be identified and also the incidence and nature of identified ADRs can be assessed. Thus ADR monitoring helps to develop proper strategies for preventing, managing and reducing the risk of developing ADRs and thereby minimizing healthcare cost^[9]. Proper management of these undesired side effects of psychotropic medications has the potential to improve patient compliance, prognosis and treatment outcome and also the quality of life^[5]. With this background, the study aims to identify and analyse the extent of occurrence of ADRs, its causality, severity, preventability and their management.

METHODS:

A prospective observational study was conducted in the inpatients of psychiatry department of a multi-speciality teaching hospital. This study was approved by the Institutional Ethics Committee and the duration of the study was for 6 months. The sample size included during the study was 200 patients. In-patients of both gender and patients prescribed with at least 1 psychotropic drug were included in the study. Subjects being treated as out-patients and patients under de-addiction therapy were excluded.

Information such as age, gender, complaints on admission, medical history, medication history, allergies, laboratory investigations, treatment given to the patient including drug(s) prescribed, dose, frequency and duration of therapy were obtained from the patient’s clinical record. All the patients were followed on daily basis for the identification of suspected ADRs. Identified ADRs were evaluated using various scales. Causality of ADRs was analysed using Naranjo’s scale^[10] and WHO probability scale^[11]. Severity assessment was done using Hartwig and Siegel scale ^[12]. Preventability assessment was carried out by Modified Schumock and Thornton scale Strategies used for the management of ADRs and the patient outcomes after the management of ADRs were analysed.

Frequency and percentage was used to summarize the categorical variables like age, gender, number of drugs prescribed and frequency of ADRs. Descriptive statistics was applied for evaluating identified ADRs and analysis was carried out by applying SPSS software.

RESULTS:

A total of 200 patients with different types of psychiatric illness receiving psychotropic drugs during the study period were monitored. Out of 200 patients, 79 ADRs were identified from 56 patients. The overall incidence of ADRs during the study was found to be 28%.

Gender wise distribution of the patients with the incidence of ADR:

Among the enrolled patients, 134 were males and 66 were females. The occurrences of ADRs were found to be higher in females (33.33%) when compared to males (25.37%). The details are depicted in Table 1.

Table 1: Gender wise distribution of the patients with the incidence of ADR

Gender

Total number of patients (n=200)

Number of patients with ADRs

(n=56)

Percentage

Male

134 (67%)

25.37%

Female

66 (33%)

33.33%

Age wise distribution with the incidence of ADR:

In the study, higher incidence of ADRs was seen in the age group of 31-40 years (34.28%) compared to other age groups. Table 2 shows age wise distribution of patients with the incidence of ADRs.

Table 2: Age wise distribution of the patients with the incidence of ADR

Age group (years)	Total number of patients (n=200)	Number of patients with ADRs (n=56)	Percentage
11-20	13 (6.5%)	01	07.69 %
21-30	63 (31.5%)	17	26.98 %
31-40	35 (17.5%)	12	34.28 %
41-50	49 (24.5)	15	30.6 1%
51-60	27 (13.5%)	08	29.62 %
61-70	12 (6%)	03	25.00 %
71-80	1 (0.5%)	-	-

Psychiatric diagnosis in patients with the incidence of ADR:

Out of 200 patients monitored, Bipolar Affective Disorder (37.50%) and Schizophrenia (32%) were the most common psychiatric illness. Higher incidence of ADR was seen in patients diagnosed with Schizophrenia (39.06%) followed by BPAD (29.33%) when compared with other psychiatric illness. Table 3 presents the patients with various psychiatric illnesses and the incidence of ADRs identified during the course of therapy.

Classes of psychotropic drugs associated with adverse drug reactions:

Out of 79 ADRs identified, antipsychotics drugs caused maximum number of ADRs (83.27%) followed by anxiolytics, antiepileptics, mood stabilizers and antidepressants. Figure 1 illustrates the classes of drugs and the occurrence of ADRs related to it.

Individual psychotropic drugs associated with the incidence of ADRs:

Among the identified 79 ADRs, olanzapine caused maximum number of ADRs (29.11%) followed by clozapine (12.65%) and quetiapine (12.65%). Different psychotropic drugs associated with the ADRs are shown in Table 5.

Table 5: Different psychotropic drugs associated with the incidence of ADRs

Sl No.	Drugs	Number of ADRs (n=79)	Percentage
1	Olanzapine	23	29.11 %
2	Clozapine	10	12.65 %
3	Quetiapine	10	12.65 %
4	Risperidone	09	11.39 %
5	Sodium valproate	05	06.32 %
6	Lorazepam	04	05.06 %
7	Amisulpride	04	05.06 %
8	Aripiprazole	03	03.79 %
9	Chlorpromazine	03	03.79 %
10	Haloperidol	02	02.53 %
11	Lithium	02	02.53 %
12	Trifluperazine	02	02.53%
13	Fluoxetine	01	01.26 %
14	Venlafaxine	01	01.26 %

Prescribed number of drugs per patient:

In the study, patients prescribed with more than 5 numbers of drugs showed maximum number of ADRs (50%). The number of drugs prescribed per patient is summarised in Table 6.

Table 6: Prescribed number of drugs associated with the incidence of ADRs

Number of drugs prescribed	Total number of patients (n=200)	Number of patients with ADRs	Percentage
1-2	86	17	19.76 %
3-4	94	29	30.85 %
>5	20	10	50.00 %

Occurrences of ADRs among individual patients:

Among 56 patients who developed ADRs, 78.57% of patients were reported to have a single ADR. The rest of the patients were presented with two and more ADRs during the course of drug therapy. The detailed list is presented in Table 7.

Table 7: Occurrences of ADRs per patient

Number of occurrences of ADRs per patient	Number of patient (n=56)	Percentage
1	44	78.57 %
2	04	07.14 %
3	06	10.71 %
4	01	01.78 %
5	01	01.78 %

Causality, Severity, Preventability assessment of ADRs:

The causality of suspected ADRs was analysed using World Health Organisation probability scale and Naranjo’s scale. According to World Health Organisation probability scale, most of the ADRs were considered as probable (62.02%) and possible (37.97%). According to Naranjo’s scale, majority of the ADRs fall under the criteria probable (77.21%) and possible (22.78%). Table 8 and table 9 shows causality assessment of ADRs using different scales.

Table 8: Causality assessment of using WHO-Probability Scale

Category	Number of ADRs (n=79)	Percentage
Certain	-	-
Probable	49	62.02 %
Possible	30	37.97 %
Unlikely	-	-
Unclassifiable	-	-
Conditional	-	-

Table 9: Causality assessment of using Naranjo Scale

Category	Number of ADRs (n=79)	Percentage
Definite	-	-
Probable	61	77.21 %
Possible	18	22.78 %
Unlikely	-	-

Severity assessment of ADRs:

Severity assessment of ADRs was analysed using Hartwig and Siegel scale. As per the scale, majority of the ADRs were considered to be moderate (54.42%) and the rest were considered as mild (45.56%). Table 10 shows the severity assessment of ADRs.

Table 10: Hartwig and Siegel severity assessment of ADRs

Severity		Number of ADRs (n=79)	Percentage
Mild	Level 1	05	06.32 %	45.56 %
Mild	Level 2	31	39.24 %	45.56 %
Moderate	Level 3	35	44.30 %	54.42 %
Moderate	Level 4	08	10.12 %	54.42 %
Severe	Level 5	-	-	-
	Level 6	-	-
	Level 7	-	-

Preventability assessment of ADRs:

Preventability assessment of ADRs was analysed using Schumock and Thornton scale. As per the preventability assessment most of the ADRs were found to be definitely preventable (48.10%) and probably preventable (44.30 %). Preventability assessment of ADRs is shown in Table 11.

Table 11: Preventability assessments of ADRs

Preventability	Number of ADRs (n=79)	Percentage
Definitely Preventable	38	48.10 %
Probably Preventable	34	43.03 %
Not Preventable	6	7.59 %

Spectrum of Adverse Drug Reaction and drugs implicated:

Among the identified ADRs, the most frequent ADRs were found to be tremor (18.98%) where the causative agent was Olanzapine, Clozapine, etc. The second commonly observed ADR was drowsiness (17.72%) followed by constipation, insomnia, etc. Table 12 shows the different types of ADRs and drug(s) implicated.

Table 12: Types of ADRs and drug(s) implicated

Types of ADRs	Number of ADRs (n=79)	Percentage (%)	Drug(s) implicated
Tremor	15	18.98 %	Olanzapine (5), Clozapine (3), Trifluperazine (2), Risperidone (2), Amisulpride (1), Aripiprazole (1), Fluoxetine (1).
Drowsiness	14	17.72 %	Olanzapine (5), Lorazepam (2), Chlorpromazine (2), Clozapine (1), Sodium valproate (1), Venlafaxine (1), Amisulpride (1), Quetiapine (1).
Constipation	09	11.39 %	Quetiapine (4), Risperidone (2), Clozapine (1), Chlorpromazine (1), Amisulpride (1).
Insomnia	07	08.86 %	Risperidone (2), Olanzapine (1), Quetiapine (1), Sodium valproate (1), Aripiprazole (1), Amisulpride (1).
Weight gain	05	06.32 %	Olanzapine (4), Clozapine (1)
Dystonia	04	05.06 %	Haloperidol (2), Quetiapine (2).
Hypersalivation	03	03.79 %	Olanzapine (2), Clozapine (1).
Sedation	03	03.79 %	Olanzapine (1), Clozapine (1), Lorazepam (1).
Vomiting	03	03.79%	Risperidone (2), Sodium valproate (1).
Xerostomia	02	02.53 %	Olanzapine (2).
Tachycardia	02	02.53 %	Clozapine (2).
Hypothyroidism	02	02.53 %	Lithium (2).
Dyskinesia	01	01.26 %	Quetiapine (1).
Pseudo parkinsonism	01	01.26 %	Quetiapine (1).
Diabetic mellitus	01	01.26 %	Olanzapine (1).
Somnolence	01	01.26 %	Chlorpromazine (1).
Dizziness	01	01.26 %	Olanzapine (1).
Headache	01	01.26 %	Lorazepam (1).
Nausea	01	01.26 %	Aripiprazole (1).
Abdominal discomfort	01	01.26 %	Risperidone (1)
Anorexia	01	01.26 %	Sodium valproate (1)
Dysphagia	01	01.26 %	Sodium valproate (1)

Strategies applied in the management of Adverse Drug Reaction:

Out 79 number of ADRs identified, 17.72% of the ADRs where managed by withdrawal of the suspected drug and 46.83% of ADRs were managed by alteration of dose of the suspected drug. Table 13 shows different strategies applied for management of ADRs.

Table 13: Management of ADRs

Category	Number of ADRs (n=79)	Percentage
Drug withdrawn	14	17.72 %
Dose altered	37	46.83 %
No change	28	35.44 %

De-challenge on suspected drugs that caused ADRs:

In this study, 51 suspected drugs were de-challenged out of which 50.63% of ADRs showed definite improvement. Details on the pattern of patient outcome based on de-challenging the suspected drug are illustrated in the Table 14.

Table 14: Outcome on de-challenge of suspected drugs that caused the ADRs

Category	Number of ADRs (n=79)	Percentage
Definite improvement	40	50.63%
No improvement	08	10.12%
Unknown	03	03.79%
No de-challenge	28	35.44%

Re-challenge on suspected drugs that caused ADRs:

Among the 7 drugs re-challenged, 6.32% of the drug related ADRs was found to have recurred. Table 15 summarises the details on the pattern of patient outcome based on re-challenging the suspected drug.

Table 15: Outcome on re-challenge of suspected drugs that caused ADRs

Category	Number of ADRs (n=79)	Percentage
Recurrence of symptoms	05	06.32 %
No occurrence of symptoms	00	0 %
Unknown	02	02.53 %
No re-challenge	72	91.13 %

Treatment approach for the management of ADRs

In this study specific treatment was given to most of the patients identified with ADR(s) (46.83%) and symptomatic treatment was given to 22.78% of patients. Table 16 shows the treatment given for the management of ADRs

Table 16: Treatment approach for the management of ADRs

Category	Number of ADRs (n=79)	Percentage
Specific	37	46.83 %
Symptomatic	18	22.78 %
Nil	24	30.37 %

Patient outcomes after the management of ADRs:

The patient outcomes were studied once the ADRs were managed based on its nature. 70.88% of the ADRs identified among the patients were resolved completely. 6.32% of ADRs were not resolved or continuing despite its management. Table 17 shows the various treatment outcomes on the patients

Table 17: Outcome of the patient

Category	Number of ADRs (n=79)	Percentage
Fatal	-	-
Recovery	56	70.88 %
Continuing	05	06.32 %
Unknown	18	22.78 %
Other	-	-

DISCUSSION:

Assessment on the adverse drug reactions associated with psychotropic drug use in hospitalized patients of Psychiatry department was carried out. A total of 200 patients were enrolled, among them 79 different ADRs were identified from 56 patients. The overall incidence of psychotropic drug induced ADRs was 28%. In a similar study conducted by Sengupta G et al., the incidence of psychotropic drugs induced ADRs was 21.45%^[14]. Another study conducted by Murthy MK et al., reports an incidence of 31.13%^[15]and a study conducted by Nalini R et al., reports the incidence of 21.34%^[16].

In this study, patients in the age group 31-40 were more prone to develop ADRs (34.28%). Similar results were observed in a study conducted by Mukherjee S et al., where the maximum number of ADRs was found in the age group 30-39 (36.84%) years^[3]. In a study conducted by Gawali UP et al., 31-40 (31.16%) was the age group that experienced more number of ADRs^[6]. All the study result’ s showed a high incidence of ADRs in 31-40 age group, so it is learnt that young adult population is more commonly affected with psychiatric disorders and prescribed with psychotropic drugs which in turn leads to develop more ADRs.

The study reports that, females (33.33%) were predominant in the occurrence of ADRs compared to males (25.37%). Comparable results were seen in a study conducted by Singh H, where females (55.66%) showed more number of ADRs compared to males (44.33%)^[16].A study conducted Hotha PP et al. showed contradictory results where males (68%) were more affected by ADRs than females (32%)^[16].

In the present study, the highest number of ADRs was found in patients treated for schizophrenia (39.06%) followed by bipolar disorder (29.33%). Comparable results were found in studies conducted by Singh H et al., Lakshmi P et al., and Hotha PP et al., where patients diagnosed with schizophrenia developed maximum number of ADRs (25.47%), (34.72%), (46.5%) respectively^[6,17,18]. Schizophrenia is a psychiatric disorder where the patient needs long term treatment with high dose of antipsychotics or multiple antipsychotics which can lead into more possible adverse drug reactions.

Analysis on ADRs among all the psychotropic drugs prescribed reveals that atypical antipsychotics (74.63%) caused most number of ADRs. In a study conducted by Sridhar SB et al., similar result was seen where atypical antipsychotics was the drug class implicated with most of the ADRs^[9]. Another study conducted by Harichandran DT et al., also describes atypical antipsychotics as the most common class of drug implicated with ADRs^[19]. It is believed that conventional antipsychotics are replaced with atypical antipsychotics and are most commonly prescribed. This may be the reason that ADRs are more prominent with atypical antipsychotics.

The study also evaluated the individual drugs that are responsible for ADRs. Notably, Olanzapine (29.11%) was the drug that caused maximum number of ADRs. Comparable results were observed in a study conducted by Lucca JM et al., Senguptha G et al., Harichandran DT et al. where olanzapine was the drug that caused more number of ADRs (31.83%), (31.82%), (29%) respectively^[5,14,19]. Olanzapine is often the preferred antipsychotic in the management of psychiatric disorders. Therefore more utilisation of the drug can be a cause for higher chance of ADRs.

The study analysed the incidence of ADRs in association with the number of drugs prescribed. It was observed that the patients who received more than 5 drugs n=20 shows the higher incidence of ADRs (50%) in 10 patients. Similar result was found in a study conducted by Lucca JM where more number of ADRs (43.33%) was reported in patients prescribed with more than 5 drugs^[5].Polypharmacy is known to be associated with increased risk of ADRs.

In this study, the highest reported ADR was found to be tremor (18.98%) where the commonest causative agents were Olanzapine and Clozapine. Similar result was found in a study conducted by Senguptha G et al., where tremor (19.60%) was found to be the most commonly reported ADR^[14].Study conducted by Gawali UP et al., also reported tremor (13.04%) as the most common ADR in their study^[20]. Based on these studies tremor can be considered as one of the most possible ADRs associated with the psychotropic drugs.

The analysis on the reported ADRs revealed that most of patients experienced a single ADR (78.57%). In a similar study conducted by Sridhar SB et al., 63% of patients reported only a single ADR^[9]. Another study conducted by Lakshmi P et al., also shows a similar result where, 37% of patients experienced a single ADR^[18].

The causality assessment was carried out to assess the reported ADRs. These assessments categorize the cause of the ADRs. Based on WHO-UMC scale, most of the ADRs were categorized under the criteria probable (62.02%) followed by possible (37.97%). These results are comparable to the study conducted by Gawali UP et al., where most of the ADRs were categorized under probable (71.73%) and possible (28.26%)^[20].Similar result was seen in another study conducted by Nalini R et al., where most of the ADRs were probable (15.69%) and possible (5.65%)^[16].

Another causality assessment that was carried out based on Naranjo’s scale reveals that, 77.21% of ADRs were categorized under the criteria probable and 22.78% were possible. Similar result was seen in a study conducted by Chakravarty P where, most of the ADRs were probable (51.2%) and possible (48.79%)^[21]. Contradictory results were observed in a study conducted by Sridhar SB et al., in UAE population were most of the ADRs were possible (53.5%) followed by probable (34%)^[9].

In this study, severity of the identified ADRs was assessed by Hartwig and Siegel scale. As per the assessment, the severity of the ADRs was categorized as moderate (54.42%) and mild (45.56%). Similar results were found in a study conducted by Gummadi T where most of the ADRs were moderately severe (67.64%)^[3]. Contradictory result was found in a study conducted by Munoli S et al., where most of the ADRs were mild (57.5%) and moderately severe (33.33%)^[22].

According to preventability assessment using Schumock and Thornton scale, most of the ADRs were categorized as definitely preventable (48.10%) and probably preventable (44.30%). Similar result was found in a study conducted by Hotha PP in which the result shows most of the ADRs were categorized as definitely preventable (10.52%) followed by probably preventable (8%)^[17]. Contradictory result was found in a study conducted by Shah A where most of the ADRs were not preventable (64.29%)^[23].

In the present study, dose alteration and drug withdrawal was done in 46.83% and 17.72% cases respectively. Whereas in a study conducted by Lakshmi P et al., reports that 20.25% of drugs were withdrawn and dose of 7.59% of drugs were altered ^[18]. In another study conducted by Sridhar SB et al., the results tells that drug withdrawal and dose alteration was done in 41.1% and 25.9% respectively^[9].

In the present study, 51 of the suspected drugs that caused ADRs were de-challenged. The patient outcome on de-challenging of these drugs were analysed and it was observed that 50.63% of ADRs shown definite improvement and 10.12% found no improvement in de-challenging the drug. Comparable results were found in a study conducted by Sridhar SB et al., where out of the 53 drugs that are de-challenged, 39.2% showed definite improvement and 4.5% showed no improvement^[9].

It was also noticed that some of the suspected drugs that caused ADRs in 7 patients were re-challenged. The outcome measures on re-challenging these drugs reveal that 6.32% of the similar symptoms reoccurred. A study conducted by Sridhar SB et al. showed comparable results were out of 8 drugs re-challenged, 7.1% of similar reactions reoccurred^[9].

Overall, the approach in the management of adverse drug reactions varied from individual patients. In this study, specific and symptomatic way of management was indicated to 46.83% and 22.78% of ADRs respectively. 70.88% of the ADRs resolved completely based on specific treatment approach. A study conducted by Sridhar SB et al., says that most of the ADRs were treated symptomatically (40.2%) and specific treatment was given to 27.7% of ADRs. They also mentioned the recovery rate as 46.5%^[9].

CONCLUSION:

The study establishes the pattern of adverse drug reactions that are likely to be associated with psychotropic drugs. The incidence of drug induced ADRs were found to be 28%. Patients diagnosed with schizophrenia developed maximum number of ADRs and majority of these ADRs were associated with atypical antipsychotics, which includes Olanzapine, Clozapine, Quetiapine and Risperidone. Majority of the ADRs were found to be moderately severe. Majority of the patients recovered from the adverse effects based on specific and symptomatic treatment approach. Study reveals the role of clinical pharmacist in the identification, analysis and reporting of ADRs. Monitoring drugs that are at high risk of developing ADRs could have a remarkable influence on reducing the symptoms which are preventable. The study result firmly suggests that Pharmacovigilance plays an important role in the detection of ADRs that is essential for improving the safe and effective use of psychotropic drugs.

LIMITATIONS OF THE STUDY:

The study was carried out in the psychiatric department of a single hospital, multicentre studies will have more impact on this area of specification

AUTHOR CONTRIBUTIONS:

All the authors have contributed equally throughout the study.

CONFLICT OF INTEREST:

The authors proclaim that there is no conflict of interest.

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Received on 31.01.2019 Modified on 20.02.2019

Research J. Pharm. and Tech. 2019; 12(7):3455-3461.

DOI: 10.5958/0974-360X.2019.00585.7

Psychiatric conditions	Total number of patients (n=200)	Number of patients with ADR (n=56)	Percentage
Schizophrenia	64 (32%)	25	39.06 %
Bipolar Affective Disorder	75 (37.50%)	22	29.33 %
Other psychotic disorders	31 (15.50%)	03	09.67 %
Depression	17 (8.50%)	04	23.52 %
Mania	6 (3%)	01	16.66 %
Obsessive Compulsive Disorder	1 (0.5%)	-	-
Attention Deficit Hyperactivity Disorder	4 (2%)	01	25.00 %
Delusional disorder	2 (1%)	-	-

Class of drugs		Number of ADRs (n=79)	Percentage
Antipsychotics	Atypical antipsychotics	59	74.63 %	83.27%
Antipsychotics	Typical antipsychotics	7	8.86 %	83.27%
Antidepressants	Selective serotonin reuptake inhibitors	1	1.26 %	2.52%
Antidepressants	Selective non epinephrine reuptake inhibitors	1	1.26 %	2.52%
Antiepileptics	CNS depressants	5	6.32 %	6.32%
Anxiolytics	Benzodiazepines	4	5.06 %	5.06%
Mood stabilizers	Antimanic	2	2.53 %	2.53%