Usage and cost-effectiveness of anti-psychotics in psychiatry OPD among various clinical A prospective observational study in a tertiary care center

Authors: Reshabh Saini, Chandrasekaran Dhinakaran, Rohit Raina, Ramanathan Gandhibabu, Kathiresan Krishnasamy

Abstract

Background:

Aims and Objective:

This study attempts to collect the demographic details of the outpatient in the psychiatric department and to describe the usage, prescribing trends and cost-effectiveness of antipsychotics in psychiatry OPD among various clinical conditions to older and younger patients with psychiatry disorders.

Material and Methods:

Observation and Results:

A total number of 150 cases were enrolled in this study. All psychiatric OPD cases were studied and the results were taken. Based on the inclusion and exclusion criteria, 93 were the anti-psychotics prescribed cases and 57 were the non-anti-psychotics prescribed cases. Out of 93 patients, 69.89% (65 patients) were male and 30.10% (28 patients) were female. Out of non-psychotic 57 patients, 27 were male patients and 30 were female patients. Out of the 93 OPD patients, 40% of the patients have psychological based symptoms followed by 17% of patients have behavioral symptoms. 86.02% of patients received atypical antipsychotic medications in comparison with 36.55% of patients received the typical antipsychotic medications.

Conclusion:

In this study, we had observed the usage and types of anti-psychotic drugs to control and minimize the different psychotic symptoms among the OPD patients. Maximum antipsychotics studied were cost-effective and cheaper in Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) as compared to Intas, Torrent, Sun, Linux, Cipla, Abbott, Alkem, and Sanofi.

INTRODUCTION

Psychotropic medications are prescription drugs that are commonly used to control some symptoms associated with many different types of mental ill health. Although they cannot cure a patient illness, they can assist with the management of some extremely distressing symptoms and this in turn can facilitate individuals in leading a more fulfilled life. A psychological disorder is a condition where disturbances do not reflect expected or culturally approved responses to certain events. Common symptoms include feeling sad or down, confused thinking or reduced ability to concentrate, suicidal thinking. Conceptions about mental health and disease are profoundly influenced by social and cultural norms and stigma.[1] The prevalence rates for psychiatric disorders varying from 9.5 to 370/1000 population in India. Despite variations in the design of studies, available data from the Indian studies suggests that about 20% of the adult population in the community is affected with one or the other psychiatric disorder.[2]

Each mentally ill patient requires Rs. 500 per month for mental health care. This includes medication cost, doctor’s fees, and travelling cost to meet the doctor. Then, the approximate total cost required per month will be Rs. 10,000 crores. Many of these disorders if not detected early and treated, may become chronic, and require medication for life. If we do not address this issue, then the indirect costs in terms of loss of wages, disability, absenteeism, and substance use are unimaginable.[2] The history of antipsychotic drug development has had a long and torturous course. The introduction of clozapine treatment in the United States in 1990 opened the era of “atypical” antipsychotic drugs.[3] The first of “atypical” antipsychotic drugs, risperidone, was approved in 1994, olanzapine in 1996, sertindole in 1997 (in some countries outside of the United States), and quetiapine in 1997. Due to cardiac safety concerns raised by the FDA, the manufacturer of sertindole has abandoned an effort to seek a US marketing license.[3] Psychiatric NHS bed numbers have fallen markedly, from a high of 150,000 in the 1950s to <30,000 currently. Traditionally, most were occupied by long-stay patients with schizophrenia, and although a number of factors contributed to the shift to community care, the role of antipsychotics drugs and its evolution in psychiatric disorders was crucial.[4]

The anti-psychotics are used in various neuropsychiatric conditions. These include attention-deficit hyperactivity disorder (ADHD), behavioral disturbances in dementia, geriatric agitation, depression, eating disorders, personality disorders, insomnia, generalized anxiety disorder, obsessive–compulsive disorder, post-traumatic stress disorder (PTSD), and substance use and dependence disorders. Antipsychotic drugs do not cure psychosis, but they can help to reduce and control many psychotic symptoms, taking antipsychotics can also reduce the risk of these symptoms returning in future (relapse).[5] Post-90s, atypical, novel, 2^nd^ generation modeled on 5-HT2/D2 antagonism had less severe neuromuscular and sexual side effects, but more metabolic effects like weight gain and diabetes. For people with moderate or severe depression, we provide a combination of antidepressant medication and a high-intensity psychological intervention cognitive behavioral therapy (CBT), interpersonal therapy (IPT), mindfulness-based cognitive therapy (MBCT) and PsychoDynamic therapy (PDT).[6]

MATERIAL AND METHODS

This study was a prospective observational study, conducted over a period of 6 months from November 2021 to April 2022 in the Department of Psychiatry, Chidambaram Government Medical College and Hospital, a 1400 bedded multi-specialty tertiary care teaching hospital, Tamil Nadu, and Dr. M.G.R. Medical University Chennai, Tamil Nadu. The data required for the study were collected from prescription (outpatients) and personal interactions with the patients and/or their care takers. The recruitment of subjects was carried out with the help the physicians who had the knowledge of patient’s history and caregivers consenting to the study protocol and patients with case sheets carrying antipsychotics prescription. Suicidal attempt counseling patients, patients who were not willing to participate in the study, not coming for follow-up in-patients, referral patients and seriously ill patients, and child speech therapy patients were excluded. Demographic data, medical history, family history, examination, diagnosis, and drug therapy used in the management of psychiatric disorder of the patient were collected on a specially designed proforma. Approval from Institutional Human Ethics committee is obtained vide number- IHEC/887/2022 with 25/05/2022 being the date of approval.

OBSERVATION AND RESULTS

A total number of 150 cases were enrolled in this study. All psychiatric OPD cases were studied, and the results were taken. Based on the inclusion and exclusion criteria, 93 were the anti-psychotics prescribed cases and 57 were the non-anti-psychotics prescribed cases.

AGE AND GENDER-WISE DISTRIBUTION

Gender-wise distribution of anti-psychotic patients shows that 69.89% (65 patients) were male and 30.10% (28 patients) were female. Out of 93 patients, 35.48% (33 patients) were between the age group of 26–35, 27.95% (26 patients) were between the age group of 36–45, 12.9% (12 patients) were between the age group of 18–25, 9.67% (9 patients) were between the age group of 56–65, 8.6% (8 patients) were between the age group of 46–55, 4.3% (4 patients) were between the age group of 66–75, and 1.07% (1 patient) were between the age group of 76–85. The study included a total of 93 psychiatric patients aged in between 18 and 85 years. When categorizing age group with gender, 26.88% of male and 8.60% of female was found in age group of between 26 and 35, which is significantly higher. 20.43% of male and 7.52% of female was found in age group of 36–45. 8.60% of male was found in age group of 18–25; then, 7.52% was found in age group of 36–45 in female. 6.45% was found in age group of 56–65 in male. 5.37% female was found in age group between 46 and 55. 3.22% was found in both age groups of males between 46 and 55 and 66 and 75; then, the 3.22% was also found in female age group between age 56 and 65. Then, finally, 1.07% was found in both genders, and for male, it is between the age 76 and 85, and for female, it is between 66 and 75 ages. This observation revealed that psychotic disorders were more prevalent in age groups 26–35 years, followed by 36–45 years [Table 1].

CHIEF COMPLAINT-WISE DISTRIBUTION

Out of these 93 anti-psychotic patients, they may experience psychotic symptoms based on behavioral, cognitive, mood, psychological, speech related, and other common symptoms as shown in Figure 1. OPD patients were diagnosed with suitable diagnostic tools to identify the symptoms of the patients, it shows that the psychological based symptoms were predominantly seen in patients, that is, out of the 93 OPD patients, 40% of the patients have psychological-based symptoms followed by 17% of patients have behavioral symptoms, 16% of the patients have cognitive based symptoms, 15% of the patients may have mood-based symptoms, 8% of the patients have speech-based psychotic symptoms, and 4% of the patients may have other common symptoms like increase appetite, weight gain, excessive sleep like that. Most of the patients, that is, almost 30% of the patients, may experience sleeping disturbances, and it involves the patients have problems with the quality, timing, and amount of sleep, sometimes sleep weakness. Followed by 23.65% of the patients may experience hearing voices. Out of 57 nonpsychotic patients, 27 were male patients and 30 were female patients. The most commonly affected disease among the patients other than anti-psychotics is depression disorder; that is, 24 patients (42.10%) patients were affected by depression followed by 26.31% of the patients affected by seizure disorder, followed by 15.78% other disorders, and then 8.77% of the patients affected by BPAD and 7.01% of the patients affected by alcohol dependence syndrome as shown in Figure 2.

Figure 1: Percentage-wise distribution of psychotic symptoms

Figure 2: Diagnosis-wise distribution of non-anti-psychotic patients

Most of OPD patients received atypical antipsychotics over the typical antipsychotics. In other words, out of 93 patients, about 86.02% of patients received atypical antipsychotic medications in comparison with 36.55% of patients received the typical antipsychotic medications. Out of the 93 anti-psychotic prescriptions, 50.53% of the prescription contains 2–4 medications, 29.03% of the prescription contains 5 or more medications, and 20.43% of the prescription contains 1–2 medications. 75.26% of the prescription contains single antipsychotic medication, followed by 23.65% of the prescription contains two antipsychotics (combined) medications prescribed. 60.21% of anti-epileptic drugs prescribed along with antipsychotic medications to the psychiatric patients, followed by 33.33% of anxiolytics prescribed, 34.40% of benzodiazapines, 9.67% proton pump inhibitors, 4.30% H2 blockers, 41.93% vitamins, 19.35% anticholinergics, 12.90% anti-convulsant, 2.15% SNRIs, 3.22% choline esterase inhibitors, and each 1.07% for tranquilizers, anti-emetic, anti-maniac, and anti-depressant. From the above data, more than 60% of anti-epileptics (sodium valproate, encorate 500, valance syrup, dicorate ER 250 mg, oxetol 300 mg, divalin 500 mg) being prescribed along with antipsychotic medications.

From the results, we observed that 26.88% of the patients affected with BPAD mania. Followed by 17.20% of the patients affected by paranoid schizophrenia, 7.52% of the patients affected with behavioral disorder, 6.45% of the patients affected by BPAD mania under remission, 5.37% of the patients affected with BPAD mania with psychotic symptoms. 4.30% of the patients affected with Schizophrenia.

Then, each 3.22% of the patients affected with (alcohol induced psychosis, depression with psychotic symptoms, undifferentiated schizophrenia, each 2.15% of the patients diagnosed with (behavioral disorder, bpad mania with depression, polysubstance abuse). Then, each 1.07% of the patients was diagnosed with other disorders mentioned above.

Regarding antipsychotic medications, 24.73% of the patients received either Riscure LS alone or combined with other antipsychotic medication, followed by 21.50% of the patients received either Riscure plus alone or combined with other antipsychotic medication, then same 21.50% of the patients received either haloperidol 5 mg alone or combined with other antipsychotic medications. 17.20% of the patients received olanzapine 5 mg either alone or combined with other antipsychotic medication. 8.60% of the patients received chlorpromazine 100 mg alone or with other antipsychotic medication. 5.37% of the patients received risperidone 2 mg either alone or combined with other antipsychotic medication. 4.30% of the patients received quetiapine 50 mg combined with other antipsychotic medication. 3.22% of the patients received Riscure 1 mg either alone or combined with other antipsychotic medication. Another same 3.22% of the patients received chlorpromazine 50% either alone or combined with other antipsychotic medication. 2.15% of the patients received lurasidone 40 mg as generic drug as well as brand drug. Then, another 2.15% of the patients received amisulpride 50 combined with other antipsychotic medication. Then, remaining each 1.07% of the patients received according to their needs either alone or combined with other antipsychotic medication. From the above, it clear that out of 93 patients, 24.76% (23 patients) were received mostly Riscure LS (risperidone 2 mg + trihexyphenidyl 2 mg) medication either alone or with other antipsychotic medication according to the patient conditions and needs.

Cost-effective comparison analysis

Amisulpride 50 mg is available in above-mentioned brands in market with same composition and dose, but the price is differed in each brand and prescribed drug cost is Rs 94, that is, prescribed sun pharma brand is cost-effective when compared to Sanofi but less cost-effective than other above-mentioned brands. On other hand, PMBJP Generic is very cheaper cost only. Rs 29 for 10 tablets in comparison with branded drugs. So, if patient brought PMBJP Generic drug, it will very cost-effective treatment as shown in Figure 3.

Figure 3: Cost-effective comparison analysis of amisulphride 50

Quetiapine 25 mg is available in above-mentioned brand in market with same composition and dose, but the price is differed in each brand and prescribed drug (sun pharma drug) cost is Rs 40. This shows that that the prescribed brand is more costlier when compared to other above-mentioned brands like Cipla, Abbott, etc., and on the other hand, PMBJP Generic is very cheaper cost only Rs 10 for 10 Tablets in comparison with branded drugs. So, if patient brought PMBJP Generic drug, it will very cost-effective treatment as shown in Figure 4.

Figure 4: Cost-effective comparison analysis of quetipine 25

Chlorpromazine 50 mg is available in above-mentioned brand in market with same composition and dose, but the price is differed in each brand and prescribed sun pharma drug cost is Rs 6.9, which is cost-effective when compared to Abbott brand drug but less cost effective when compared to other above-mentioned drugs. On the other hand, PMBJP Generic is cheaper cost only Rs 5 for 10 Tablets in comparison with branded drugs. So, if patient brought PMBJP Generic drug, it will very cost-effective treatment as shown in Figure 5.

Figure 5: Cost-effective comparison analysis of chlorpromazine 50

Olanzapine 5 mg is available in above-mentioned brand in market with same composition and dose, but the price is differed in each brand and prescribed drug (linux pharma) and cost is Rs 36. It is cost-effective when compared to sun pharma brand drug but less cost effective when compared to other above-mentioned brand drugs. On the other hand, PMBJP Generic is very cheaper cost only Rs 6 for 10 Tablets in comparison with branded drugs. So if patient brought PMBJP Generic drug, it will very cost-effective treatment as in Figure 6.

Figure 6: Cost-effective comparison analysis of olanzapine 5

Risperidone 1 is available in above-mentioned brand in market with same composition and dose, but the price is differed in each brand and prescribed drug (linux) and cost is Rs 34.3. It is less cost-effective when compared to other above-mentioned brands. On the other hand, PMBJP Generic is very cheaper cost only Rs 8 for 10 Tablets in comparison with branded drugs. So, if patient brought PMBJP Generic drug, it will very cost-effective treatment as in Figure 7.

Figure 7: Cost-effective comparison analysis of risperidone 1

Hence, maximum antipsychotics studied were cost-effective and cheaper in PMBJP as compared to Intas, Torrent, Sun, Linux, Cipla, Abbott, Alkem, and Sanofi.

DISCUSSION

There were several studies done in the past on use of antipsychotics and their cost-effectiveness in relation to clinical utility in various psychiatric disorders. Yazici E et al. did a study to investigate the antipsychotic use patterns of patients with schizophrenia and its correlations in their daily drug use patterns.[7] From our study among 150 patients, the 93 patients where anti-psychotic prescribed patients other 57 patients were non-antipsychotic patients. It was evident that 69.89% male patients were mostly affected by psychotic disorder. The age group of people between 26 and 35 was most commonly affected by psychotic disorder. Garcia-Ruiz AJ et al. did a study on cost-effectiveness analysis of antipsychotics in reducing schizophrenia relapses in Spain, 2012. The aim of this study was to assess the efficiency of the antipsychotics used in Spain in reducing schizophrenia relapses under the Spanish Health System perspective.[8] O’Day K et al. evaluated the long-term cost-effectiveness (including hospitalizations and cardiometabolic consequences) of atypical antipsychotics among adults with schizophrenia.[9] Obradovic M et al. evaluated the cost-effectiveness of alternative treatments for outpatients with chronic schizophrenia from the healthcare payer’s perspective.[5]

Our study reveals that the psychological-based symptoms were predominantly seen in psychotic patients; that is, 40% of the patients had psychological-based symptoms. Park T et al. developed a Markov model to estimate the costs and quality-adjusted life-years (QALYs) for different sequences of treatments for 40-year-old patients with schizophrenia.[10] Lahon K et al. obtained that the second-generation antipsychotics olanzapine, risperidone, and aripiprazole were the most commonly prescribed antipsychotics.[11] Furiak NM et al. compared the cost-effectiveness of oral olanzapine, oral risperidone (at generic cost, primary comparator), quetiapine, ziprasidone, and aripiprazole in the treatment of patients with schizophrenia from the perspective of third-party payers in the U.S. healthcare system.[12] Nicholls CJ et al. did a study, which compared the treatment costs of amisulpride (including drug costs, hospital costs, and costs of clinician and nurse visits) with those of risperidone over a 6-month treatment period, from the perspective of the UK National Health Service.[13] Thakkar KB et al. conducted the study to delineate the various drugs used in psychiatric disorders, to find discrepancies, if any, between the actual and the ideal prescribing pattern of psychotropic drugs.[14]

The chief complaints according to the patients revealed that sleep disturbances were the most common symptoms the affected psychotic patients were facing compared to other symptoms. Findling RL et al. obtained that atypical anti-psychotic, which are effective in adults with schizophrenia and mania and are associated with lower risk of EPS and tardive dyskinesia in adults, has changed the landscape of psychopharmacology.[15] Alexopoulos GS et al. conducted study to identify the antipsychotic use in older patients (65 years of age or older) for recommendations concerning indications for antipsychotics.[16]

Then, for the non-psychotic patients, 52.36% of female patients were mostly affected when compared to male patients. The most common disorder among the female patients was the depressive disorder (depression); that is, 42.10% of the female patients were affected by depression. Tap A et al. concluded that combination antipsychotic therapy is clinically beneficial and provided guidelines on when and for whom antipsychotic polypharmacy should be considered.[17] Hartlz AL et al. identified qualitative themes on barriers affecting implementation and design opportunities to optimize workflow among youths.[18]

When comes to drugs category, around 86.02% of the patients were received atypical antipsychotics over the typical antipsychotics. The number of average medications contains per prescription was about 2-4; that is, more than 50% of the prescriptions contains 2-4 medications. Then, about 75.26% of the prescription contains single anti-psychotic drug. Pappadopulus E et al. developed treatment recommendations for the use of antipsychotic medications for children and adolescents with serious psychiatric disorders and externalizing behavioral problems.[19]

The most of the OPD patients were diagnosed with the BPAD MANIA; that is, 26.88% of the patients were diagnosed as BPAD MANIA. The other medications prescribed along with anti-psychotic medications were anti-epileptics, and 60.21% of the anti-epileptic drugs were prescribed along with anti-psychotic medications to control the psychotic symptoms to the patients. Watts V et al. showed that after one year of treatment, participants who received the daily oral form of risperidone had a 33 percent relapse rate, compared with 5 percent in those treated biweekly with LAI risperidone. The medications prescribed which was used to control the psychotic symptoms were mostly atypical antipsychotics when compared to the typical anti-psychotics.[20] Pillarella J et al. examined trends in the use of second-generation antipsychotics for the treatment of bipolar disorder before and after the USFDA’s approval in 2000 of olanzapine for use in treating acute manic episodes of bipolar disorder. Atypical anti-psychotics are the most effective and safest one when compared to typical antipsychotics for most cases.[21] Polsky D et al. analyzed the cost-effectiveness of second-generation antipsychotics relative to first-generation antipsychotics in individuals with schizophrenia disorders.[22]

Our study also shows that about 24.73% of the patients were received Riscure LS drug (risperidone 2 mg + trihexyphenidyl 2 mg) either alone or combine with other medications to control the psychotic symptoms. Then, we compared the different brands of the drugs and we found out which one is cost-effective when used for longer days to control the psychotic symptoms by patients. The use of PMBJP drug of same composition compared to prescribed one is cost-effective for the patients who needs to take the medications for more than years.

CONCLUSION

In this study, we had observed the usage and types of anti-psychotic drugs to control and minimize the different psychotic symptoms among the OPD patients. From our study, we observed that the patients affected with psychotic disorder had mostly psychological based symptoms 39.78%, followed by behavioral symptoms 17.20%, followed by cognitive based symptoms 16.20%, and followed by others.

The patients those who were affected by psychotic disorders mostly had sleeping disturbances as the major chief complaints; that is, 27.95% of our observed OPD patients were experienced sleeping disturbances as the primary complaint followed by 23.655 was experienced hearing voices and followed by other complaints. Most of the patients who came to the OPD were diagnosed as BPAD MANIA; that is, 26.88% of the patients were diagnosed as BPAD MANIA followed by 17.20% of the patients who were paranoid schizophrenia, and followed by others, we had to use the anti-psychotic drugs to control and minimize these symptoms. For that, we used atypical anti-psychotics over the typical anti-psychotics because atypical antipsychotics had lower risks of extrapyramidal and endocrine symptoms with lower reported cases of parkinsonism.

So, we used risperidone as mostly to control the psychotic symptoms. Risperidone was the atypical anti-psychotic drug, which has more safety and efficacy, and it has been used as a monotherapy and combination therapy for the control of psychotic symptoms to the patients. It was used for both acute and long-term maintenance of the psychotic symptoms.

Then, we compared the cost of the prescribed brand with other brands and to conclude that which one is cost effective for the patients those who needs to use as long-term treatment. For this, we taken different brands of prescribed drugs with same composition and compared each other and obtained the results. Mostly, the PMBJP drug of same composition with the prescribed drug was most cost-effective for the patients who needs to take the medications for more than one year.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Usage and cost-effectiveness of anti-psychotics in psychiatry OPD among various clinical conditions: A prospective observational study in a tertiary care center