A study on prescription patterns, adverse drug reactions and medication awareness in Schizophrenia patients

Completed

Conditions: Schizophrenia, unspecified,

Registration Number: CTRI/2018/03/012533

Lead Sponsor: Seth GS Medcial College and KEM Hospital

Brief Summary: Schizophrenia is a chronic and complex mental illness consisting of a heterogeneous group of symptoms. It is associated with high relapse rates and medication adherence is found to be one of the contributing factor towards relapse. Since medication adherence and treatment awareness are found to be linked to each other, an alarming need was felt to evaluate the level of drug treatment awareness in patients suffering from schizophrenia. Based on the chronicity and debilitating nature of the disease, patients suffering from schizophrenia are often dependent on their caregivers. Hence, the role of caregivers cannot be disregarded and the need to assess treatment awareness among caregivers was also found to be important.

Prescription pattern studies conducted in schizophrenia have shown a variability in utilization of antipsychotics based on the geographical location of the study setting. Some settings prefer the use of typical antipsychotics while some preferred atypical antipsychotics. We felt that there was a need to study the prescription patterns in our setting. To add to this, we found that there were only a sparse number of studies which were specifically related to adverse drug reactions in schizophrenia. Adverse drug reactions due to antipsychotics can be deleterious for the patients thereby warranting a continuous surveillance so that precautionary measures can be taken to prevent their occurrence. Moreover, adverse drug reaction assessment would be of help to gauge the incidence as well as types of reactions specific to the study setting.

Taking this into consideration, the current study was conceptualised to conduct a thorough evaluation of all these three factors in the very same study setting i.e., drug treatment awareness, prescription patterns and adverse drug reactions in schizophrenia patients. The study was also planned to evaluate the drug treatment awareness in caregivers of the patients undergoing treatment for schizophrenia. Patients who were diagnosed to have schizophrenia as per the DSM-V criteria and who were on antipsychotic medications for at least 3 monthsâ€™ duration, were included. A total of 250 and 157 caregivers were recruited in the study over a duration of 18 months.

Majority of the patients (66 %) and caregivers (65 %) enrolled in this study were males. 166 patients had good insight and were administered the patient drug awareness questionnaire. Maximum percentage of correct responses (~93 %) on the patient drug awareness questionnaire were obtained in the domains related to the importance of preserving past prescriptions and importance of doctor-patient interaction. Minimum percentage of correct responses were seen in the side effects domain (52.41 %) and in the current prescription domain (66.42 %) and in synchrony with the % of correct responses, minimum awareness was seen in these two domains. The overall drug treatment awareness score in patients was found to be 12.57 Â±1.81 out of a maximum possible score of 17. Patient age, gender, socio-economic status and duration of disease did not show a statistically significant correlation with drug awareness scores. A weak positive correlation was found between the patient education status and drug awareness scores. However, this weak correlation cannot be considered as clinically significant. Similar results were seen with caregivers where again the maximum awareness and maximum percentage of correct responses were obtained in the domains related to the importance of preserving past prescriptions (98.73 %) and importance of doctor-patient interaction (93 %). The percentage of caregivers aware and answering correctly were minimum in side effects domain (~58 %) and in current prescription domain (~65 %). The overall drug treatment awareness score in caregivers was found to be 12.84 Â± 1.91 out of a maximum of 17. Age and gender of caregivers did not show a statistically significant correlation with drug awareness scores. A weak positive correlation was found between caregiver drug awareness scores and their socio-economic status as well as education status. However, this weak correlation cannot be considered as clinically significant. No statistically significant difference (at p<0.05) was found between the domain wise and overall awareness scores of patients and caregivers.

Prescription pattern analysis showed that the average number of drugs per encounter were 3.11 while the average number of antipsychotics per encounter were 1.44. % prescriptions that were found to be complete were 88.54 %. Almost 89 % of the prescriptions were found to be complete. Risperidone and olanzapine were the most commonly prescribed antipsychotic drugs while trihexyphenidyl was the most frequently prescribed concomitant medication. A total of 67 cases of adverse events were recorded and on conducting a causality assessment, 37 were found to be causally related. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation and weight gain were found to be the most common. Majority of ADRs (23 cases) were attributable to risperidone. Maximum proportion of the ADRs were possibly related to the medication and were of mild severity in addition to being non-preventable.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 360

Inclusion Criteria

Inclusion Criteria for patients: 1.
Male or female patients with age 18-65 years, attending Psychiatry OPD for existing Schizophrenia diagnosed as per DSM-V Criteria 2.
Patients carrying treatment records prescribed at Psychiatry OPD of KEM Hospital, containing antipsychotic medication regimen for at least 3 months 3.
For patients who will be given the drug awareness questionnaire, insight score equal to or above 9 on Birchwood insight scale thereby suggesting that patient has good insight Inclusion criteria for the caregivers: 1.Primary caregivers of the patient.
Those who give written informed consent.

Exclusion Criteria

Exclusion Criteria for patients: 1.Patients admitted to psychiatry IPD and emergency department as well as referred patients 2.
Newly diagnosed and treatment-naive patients 3.Patients with a history of Substance dependence or abuse at the current visit.
4.Patients with other Neurological disorders (dementia, delirium, and other cognitive disorders), seizure disorders, with sensory impairment and other psychiatric disorders such as mood disorders, and anxiety disorders.
5.Critically ill patients requiring urgent attention to medical problems Exclusion criteria for the caregivers: 1.
Those with age < 18 years and > 65 years 2.
Those having neurological disorders such as dementia, delirium and other cognitive disorders.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the awareness of drug treatment in Schizophrenic patients having insight	Single point (cross sectional study), 18 months duration

Secondary Outcome Measures

Name	Time	Method
To study the awareness of drug treatment in Schizophrenic patients having insight	Single point (cross sectional study), 18 months duration

Trial Locations

Locations (1): Seth GS Medical College and KEM Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Seth GS Medical College and KEM Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raakhi Tripathi
Principal investigator
9821724700
lookon@rediffmail.com