Medication errors and adverse drug reactions in psychiatry department: A prospective observational study

The study was aimed to analyse the pattern of medication errors and drug interaction induced adverse drug reactions in the psychiatry department of a tertiary care hospital. A Prospective observational study being conducted in the inpatient and outpatient department of psychiatry in a tertiary care hospital, Erode, Tamil Nadu for over six months. A total of 80 prescriptions with psychiatric illness and 174 medication errors were observed. Of the 174 medication errors observed, 132(75.8%) were incomplete prescriptions making the highest number of medication errors. The highest number of errors occurred due to Prescription error 156(89.0%), followed by administration error 8(4.5%). According to the NCCMERP classi(cid:976)ication, the majority of medication errors were coming under category B 120(68.9%) but there is no harm. The demographic reports of outpatients in the present study showed a higher incidence of medication errors in patients with the age group of 31-40 years 25(36.7%). Considering the factors contributing to a medication error, refusal of the patient to take the drug 27(39.7%) followed by forgetting 13(19.1%) due to the vulnerable characteristics of the patient was more signi(cid:976)icant. Although there is a general lack of awareness, many patients and bystanders are unaware of their diagnosis and medications. It is, therefore, a crucial step to educate and make them aware of the correct use of medicine.

Administration Error, Error Classi ication, Drug Interaction, Omission Errors, Prescription Error, Psychiatric Population A The study was aimed to analyse the pattern of medication errors and drug interaction induced adverse drug reactions in the psychiatry department of a tertiary care hospital. A Prospective observational study being conducted in the inpatient and outpatient department of psychiatry in a tertiary care hospital, Erode, Tamil Nadu for over six months. A total of 80 prescriptions with psychiatric illness and 174 medication errors were observed. Of the 174 medication errors observed, 132(75.8%) were incomplete prescriptions making the highest number of medication errors. The highest number of errors occurred due to Prescription error 156(89.0%), followed by administration error 8(4.5%). According to the NCCMERP classi ication, the majority of medication errors were coming under category B 120(68.9%) but there is no harm. The demographic reports of outpatients in the present study showed a higher incidence of medication errors in patients with the age group of 31-40 years 25(36.7%). Considering the factors contributing to a medication error, refusal of the patient to take the drug 27(39.7%) followed by forgetting 13(19.1%) due to the vulnerable characteristics of the patient was more signi icant. Although there is a general lack of awareness, many patients and bystanders are unaware of their diagnosis and medications. It is, therefore, a crucial step to educate and make them aware of the correct use of medicine.

INTRODUCTION
The prevalence of psychiatric illness has shown a growing trend, with the overall rate rising from 10% in the last decade to 30% (Neong and Rashid, 2018). According to the reports revealed by WHO, states that at least 6.5% of the Indian population suffers from some form of the serious mental disorders. Over the past six decades, antipsychotic drugs have revolutionized the treatment of many psychiatric disorders (Ambwani et al., 2019). Medication error rates may vary from 4.4% to 59.1% worldwide and 5.2 million medication errors have been reported annually in India (Ayani et al., 2016). Most researches in the area of psychiatry has tend to focus on medication errors in inpatient settings whereas there is a dearth in outpatients (Lucca et al., 2014). The psychiatric population is much more likely to experience medication errors due to individual and organizational factors. The individual factors contribute the most. Since the psychiatric patients may be non-complaint, resist medication administration and even be violent Demler (2012) Caregiving is dif icult and demanding since psychiatric patients with impaired cognition are less likely to follow their behaviours and take less care, which increases the risk of medication errors (Neong and Rashid, 2018).
There are only a few studies conducted in India, analysing the incidence of medication errors in the psychiatric population. Although psychiatric medication errors were studied almost solely in the clinical setting, little is known about the incidence and signi icance in outpatient and community settings (Susan, 2008) Outpatient care is dif icult and challenging and can in luence the physical and mental well-being of caregivers (Anandhasayanam et al., 2016). This study is likely to have an impact on analysing the incidence, predictors of medication errors and drug interactions, also relay the emphasis on caregivers and factors that contribute to medication errors in outpatients.

Design And Settings
The prospective observational study was carried out in the inpatient and outpatient department of a Tertiary Care Hospital Erode, Tamil Nadu over 6 months from January 2019 to June 2019. The study protocol was reviewed and approved by the Institutional Ethics Committee before the commencement of the study. All the participants were provided with informed consent to enrolment into the study.

Inclusion criteria
1. All the participants were provided with the informed consent to enrolment into the study.
2. All Patients of either gender and any age groups are admitted to the psychiatric department.
3. The patients who were registered in the psychiatry outpatient during the study period.

Pregnant and lactating women
Study Procedure

Sampling technique
The prescription was collected by using simple random sampling technique because random sampling minimizes bias. The prescription was collected randomly by using computer software's that generates numbers.

Data collection procedure
The patients admitted to the psychiatric ward were intensively monitored from the day of admission to the day of discharge, whereas outpatients were randomly reviewed on their visits to the outpatient department. 100 prescriptions were collected randomly by using a computer program that generates numbers. The data collection forms were separately designed based on the general information of patients age, gender, diagnosis, drug categories, current medical history, prescribed medication details, laboratory data and other information such as type, causes, stages and various level of medication errors and Drug interactions by MICROMEDEX software. The errors were categorized according to the National Coordination Council for Medication Error Reporting and Prevention (NCCMERP) for categorizing the medication errors based on severity.
Of the 22 Drug-Drug interactions, 14(63.6%) were major, 5(22.7%) were moderate and the remaining 3(13.6%) were minor. Trihexyphenidyl an anticholinergic drug when interacts with haloperidol and promethazine leads to pharmacodynamic and pharmacokinetic effects which may result in excessive anticholinergic effect (dry mouth, constipation). Also Fluoxetine and Alprazolam can cause a pharmacokinetic effect which may result in increased extrapyramidal symptoms. The pharmacokinetic interaction of Trihexphenidyl and Promethazine may result in decrease phenothiazine serum concentrations, decreased phenothiazine effectiveness and enhanced anticholinergic effects. The probable mechanism behind the interaction includes decreased absorption, delayed gastric emptying and increased gut wall metabolism of  The highest number of errors occurred due to Prescription error 156(89.0%), followed by administration error 8(4.5%), monitoring error 8(4.5%) and dispensing error 2(1.1%). On classifying medication errors according to the profession related to the occurrence of medication errors, it was found that physician-related errors 156(89.6%) were more as when compared to nurses related errors 18(10.3%) (Figure 1).

Figure 1: Errors in various stages
While observing the medication errors in outpatients, spouse 32(47.0%) had contributed the highest medication errors followed by parents 24(35.2%), son/daughter 9(13.2%) and others 3(4.4%) in relation to patient. It was observed that the education status of most of the caregivers who got primary education 41(60.2%) made the high number of medication errors followed by illiterate 15(22.0%), secondary 6(8.8%), higher secondary 4(5.8%) and Graduate 2(2.9%). Considering the factors contributing to a medication error, refusal of the patient to take the drug 27(39.7%) followed by forgetting 13(19.1%) due to the vulnerable characteristics of the patient was more signi icant.

DISCUSSION
This study was an attempt to ind out the pattern of medication errors and drug interaction induced adverse drug reactions in psychiatric populations. Medication errors are any barriers that prevent the right patient from receiving the right drug at the right dose at the right time through the right route of administration, at any stage in the medication use process, with or without the occurrence of adverse drug events (ADEs) (Lucca et al., 2014).
It was observed that 132 (75.8%) of the 174 medication errors were incomplete prescriptions making the highest number of medication errors. Although incomplete prescription itself is an error, it can cause both prescribing and administration errors including dose missing and frequency missing followed by Drug-drug interactions 22(12.6.%), monitoring errors 8(4.5%). Omission errors and Wrong dose errors constitute 4(2.2%). The factors that may contribute to medication errors were increased workload of both the physician and nurses, inadequate number of staff in the department, unavailability of medicine and miscommunication. The majority of the prescriptions containing more than one error includes abbreviations instead of full names and illegible handwriting. A study conducted by Sinha et al. (2016) in the department of general medicine, reported that more number of errors were due to omission error 12(42.9%) followed by wrong time error 8(28.6%) and others.
Of the 22 Drug-Drug interactions, 14(63.6%) were major, 5(22.7%) were moderate and the remaining 3(13.6%) were minor. Studies reporting on the utilization of psychotropics in managing patients with mental illness vary considerably from that of psychiatrists, demonstrating an increased need in clarifying the use of psychotropics in primary care patients. The major error types in prescription include the omission of the drug name, drug formulation, its route, dose, dosing regimen, date, and signature.
The factors contributing to prescription errors were due to inappropriate drug selection, dose, and route of administration, illegible handwriting, inappropriate dosage interval, and inadequate patient-speci ic information. Similarly, the study conducted by Nair and Srivastava (2013) shows prescription error 39% followed by administration error 38% and dispensing error 12%. These may due to the pressure of work, lack of familiarity with the patient, dosage calculations and simple carelessness.
On classifying medication errors according to the profession related to the occurrence of medication errors, we found that physician-related errors 156(89.6%) were more as when compared to nurses related errors 18(10.3%). This may be due to heavy patient load, stressful environment, emergencies, and distractions. In the present study, we observed that incomplete prescription errors, drug interactions, and wrong frequency errors contribute to physician related errors. Omission error, Wrong dose error, Wrong time error, monitoring errors are the most frequently occurring errors that contribute to nurse's related medication errors. A study conducted by Ayani et al. (2016) showed that the majority of errors occurred in the monitoring and ordering stages (39 % and 34%).
According to the NCCMERP classi ication, the majority of medication errors were coming under category B 120(68.9%) but there is no harm. The highest number of medication errors was coming under category B this may due to an environment that is susceptible to medication errors. Approximately half of the reported incidents can cause an error. A similar study conducted by Ganeshan et al. (2015) reported that the category Error, No Harm which comes under subcategory B contributes the highest and they stated this was because of the carelessness of health care professionals working in the department.
The demographic reports of outpatients in present study showed higher incidence of medication errors in patients with the age group of 31-40 years 25(36.7%) followed by 21-30 years 17(25.0%), 10-20 years 15(22.0%), and 41-50 years 6(8.8%) and 51-60 years 4(5.8%) shows the same number of medication errors followed by 61-70 years 1(1.4%). Considering the factors contributing to a medication error, refusal of a patient to take the drug 27(39.7%) followed by forgetting 13(19.1%) due to the vulnerable characteristics of the patient was more signi icant. Refusal of the patient to the drug was due to multiple factors like strong displeasure, temperament, sickness and becoming discourteous. They showed evidence of higher mood elevation and had a less positive attitude towards treatment.
All of these factors lead to poor medication adherence. Adelugba et al. (2016) conducted the study of reasons of psychotropic medication refusal and patient's perception at a psychiatric treatment center revealed that the main reasons for medication refusal among all patients were an inconvenience (38%), side effects (21%) and ineffectiveness of medication (18%)( Table 2).

Limitations
The study has its limitations. First, the duration of our study was too short to identify all types of medication errors that could occur in the hospital setting. Second, due to the vulnerable characteristics of psychiatric patients, many of them showed no response to the treatment.

CONCLUSIONS
Studies on medication errors in mental health are limited. Errors can always occur due to recti iable errors by various experts under varying conditions, making needed measures can decrease the incidence of medication errors. Although the lack of awareness is common, most of the patients and bystanders were unaware of their diagnosis and medications. So educating and making them aware of the proper use of medication is a crucial step. The clinical pharmacist can play a major role in the early detection and prevention of medication errors and the quality of care to patients.