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 Table of Contents  
Year : 2016  |  Volume : 3  |  Issue : 2  |  Page : 77-80

Adverse drug reactions among hospitalized patients in Psychiatry Department in a Tertiary Care Hospital

1 Department of Pharmacology, Government Medical College, Thrissur, India
2 Department of Pharmacology, SUT Medical College, Thiruvananthapuram, Kerala, India
3 Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kulasekaram, Kanyakumari, Tamil Nadu, India

Date of Web Publication17-Jun-2016

Correspondence Address:
Dhanya Thirookaran Harichandran
Thirookaran House, Manaparambu, Veluthur PO, Thrissur - 680 012, Kerala
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2394-2010.184243

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Background: Adverse drug reactions (ADRs) to psychotropic drugs are common. There are very few reports of ADR profile of psychotropic drugs. Pharmacovigilance of psychotropic drugs is essential to improve patient care and create awareness among physicians. Objective: To study the pattern of ADRs among hospitalized patients in the Department of Psychiatry of Tertiary Care Hospital. Materials and Methods: This prospective study was conducted at a Tertiary Care Teaching Hospital and all the patients who developed ADR to psychotropic drugs formed the study population. Details were documented on an ADR reporting form of Central Drugs Standard Control Organization and Causality assessment was done based on Naranjo algorithm. Data were subjected to descriptive analysis. Results: During the study period, 31 patients developed a total of 53 ADRs. Polypharmacy was seen in 39% of patients who developed ADR. Based on causality assessment in these cases as per Naranjo algorithm, all were judged as probable, except one as possible. The most common ADRs observed were extrapyramidal symptoms. Antipsychotics are the most common group of drugs found responsible for most of the ADRs; olanzapine being the individual drug which caused the maximum number of ADRs. Conclusion: Active surveillance from the part of clinicians and pharmacologists will help build a database for ADRs in Indian setting.

Keywords: Adverse drug reactions, causality assessment, psychotropic drugs

How to cite this article:
Harichandran DT, Viswanathan MT, Gangadhar R. Adverse drug reactions among hospitalized patients in Psychiatry Department in a Tertiary Care Hospital. J Health Res Rev 2016;3:77-80

How to cite this URL:
Harichandran DT, Viswanathan MT, Gangadhar R. Adverse drug reactions among hospitalized patients in Psychiatry Department in a Tertiary Care Hospital. J Health Res Rev [serial online] 2016 [cited 2021 Apr 19];3:77-80. Available from: https://www.jhrr.org/text.asp?2016/3/2/77/184243

  Introduction Top

Drugs are administered to patients after careful screening, various toxicity studies, and regulatory and legislative activities. However, at a "dose normally used in man," many patients experience an adverse effect. [1]

Pharmacotherapy for psychiatric disorders is frequently associated with adverse drug reactions (ADRs). Different drugs may need to be tried in a patient to control the symptoms, which increases the risk of ADR. Almost all the psychiatric diseases have temporary cure and the treatment is lifelong. In published trials, ADR is not reliably reported. Hence, psychiatrists need to be informed the concept of identification and reporting of potential ADRs. Reported ADRs can form a "signal" which when reviewed systematically form a guide in clinical practice. [2]

ADRs to psychotropic drugs are common. [3] Noncompliance is common with prolonged treatment. This can lead to discontinuation of therapy, impairment of quality of life, stigma, and physical morbidity. Most of the ADRs are dose dependent and are influenced by patient characteristics. Prevalence and severity of ADRs vary for different antipsychotics. [4]

Polypharmacy is one of the leading causes for ADR in psychiatric patients. Pharmacovigilance in India is still in infancy and ADR reporting rates is below 1% and requires more data. There are very few reports of ADR profile of psychotropic drugs. [5] Pharmacovigilance of psychotropic drugs is essential to improve patient care. [6] Monitoring and evaluation of prescribing practices are essential to understand rationality of medical care and to communicate the message to the prescriber and regulatory authorities. [7] Hence, this study was undertaken to evaluate the pattern of ADRs among hospitalized patients in Psychiatry Department of a Tertiary Care Hospital.

  Materials and methods Top

Inpatients of the Department of Psychiatry in a Tertiary Care Hospital, who developed ADR to psychotropic drugs, formed the study population. All patients who developed ADR during the study period were enrolled in the study. A prospective study was done over 5 months. Diagnosis of psychiatric ADRs was done by a consultant psychiatrist. All ADRs were documented on an ADR reporting form of the Central Drugs Standard Control Organization by active surveillance. Causality assessment was done in patients who developed adverse reaction to a single drug based on Naranjo algorithm. Clearance for the study was obtained from the Ethics Committee of the institution.

Statistical analysis

Data were subjected to descriptive analysis.

  Observations and results Top

Of 31 patients who developed a total of 53 ADRs, a maximum of 15 (48.38%) were in the age group of 15-29, followed by 12 (38.7%) in 30-44, 3 (9.67%) in 45-60, and one case was that of a 65-year-old. Male predominance was observed (53%). Sixty-one percent of the patients developed ADR to a single drug and 39% to multiple drugs. Based on causality assessment in these cases, as per Naranjo algorithm, all were judged as probable, except one as possible. None was labeled certain as rechallenge was not performed. All reactions except one were of Type A. The organ system most affected was central nervous system. Extrapyramidal symptoms (EPSs) such as Parkinsonism and tremor were the most common ADRs [Figure 1]. The individual drug class responsible for most of the ADRs was atypical antipsychotics; the individual drug which caused highest ADR is olanzapine [Figure 2].
Figure 1: Spectrum of adverse drug reaction to psychotropic drugs in the study population. NMS: Neuroleptic malignant syndrome

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Figure 2: Psychotropic drugs causing adverse drug reaction in the study population. Li: Lithium

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  Discussion Top

The study was conducted to evaluate pattern of ADRs to psychotropic drugs in the Psychiatry Department of a Tertiary Care Hospital. Incidence of ADR was found to be more in males when compared to females. There was polypharmacy in prescription; around 39% of the patients who developed ADR were on multiple drugs which was similar to the study by Solanke et al. [5]

Among all the ADRs reported, maximum number of ADRs was seen in patients who were on antipsychotic drugs which were comparable to the study by Sengupta et al., [8] Rothschild et al. [9] and Jayanthi et al. [10] Atypical antipsychotic drugs formed the main class of drugs as they were most frequently prescribed in the hospital. Over the last few years, atypical antipsychotics (e.g., clozapine, olanzapine) have been increasingly prescribed in the treatment of schizophrenia and other related psychotic disorders because they significantly reduce both positive and negative symptoms of schizophrenia.

Even though EPS is observed less frequently with atypical antipsychotics, metabolic complications such as dyslipidemia and diabetes are more observed. [11],[12] In the present study, olanzapine was the most common drug causing ADR and this finding was similar to the studies of Sengupta et al., [8] Jayanthi et al., [10] Prajapati et al., [4] and Farhat et al. [13] Risperidone and clozapine were the next common drugs causing ADRs. Quetiapine was the most common drug causing ADR in the study by Sandiya et al. [3] In a retrospective study by Iuppa et al., [14] mood stabilizers formed the major medications causing ADRs. Shah and MD [15] reported antidepressants as a major group of drugs causing ADRs.

Common adverse effects observed with antipsychotics drugs were Parkinsonism, tachycardia, and tremor. Tremor and extrapyramidal reactions were also reported as common ADRs by Prajapati et al. [4] and Jayanthi et al. [10] In the present study, weight gain was reported with olanzapine. Based on causality assessment, using Naranjo algorithm, all ADRs are probable which is similar to the study by Prajapati et al. [4] Rechallenge was not attempted in any patient.

As per Maudsley, there are certain points to be noted when prescribing drugs in psychiatry which will help reduce ADR. It is recommended that single drug should be used in lowest possible dose as far as possible. Use of more than one drug is advised only when single drug is demonstrably inadequate. When a drug is administered, target symptoms should be clearly demonstrated and side effects should be clearly documented. Antipsychotics should not be used as sedatives. Response to drugs should be assessed using recognized rating scale to reduce drug dosage. Close monitoring of physical health such as monitoring blood pressure, baseline blood investigations, and electrocardiogram should be done. Selection of drug should be patient specific, example in patients with cardiac disease avoid cardiotoxic drugs. This helps prevent the incidence of ADR.

Antidotes can be combined with drugs with established ADR such as anticholinergics to treat extrapyramidal side effects caused by antipsychotics. Nonpharmacological management such as electroconvulsive therapy (ECT), behavioral therapy, and supportive psychotherapy to patients and bystanders can be combined with drug therapy. ECT and repeated transcranial magnetic stimulation is also useful in managing extrapyramidal side effects. Sudden stoppage of a drug or restarting a drug in high dosage is not recommended. Close monitoring of blood count when clozapine is prescribed and monitoring of serum levels for optimizing the dosage when lithium is used is needed to reduce ADR. Specific investigations to look for metabolic and other ADR should be done according to the drugs prescribed. Probiotics such as fish liver oil and thyroxine have been found to increase the efficacy of clozapine. Fish liver oil helps reduce dose of clozapine and also improve physical health and reduce ADR. [16]

The American Diabetes Association and the American Psychiatric Association have published a metabolic monitoring protocol for adults on second generation antipsychotic medication. Weight (body mass index) and waist circumference need to be assessed before starting medication followed by assessment every month, for 4 months and then reassessed every 3 months. Blood pressure and fasting glucose need to be assessed before starting medication followed by assessment in the 3 rd and 4 th month and then reassessed every 3 months for 1 year then annually. Fasting lipid profile needs to be assessed before starting medication followed by assessment in the 3 rd month and then reassessed annually. [17]

Thomas et al. have mentioned that knowledge about most common preventable ADR help develop targeted patient safety initiatives such as medication management systems. They have enlisted certain preventability factors such as medication not appropriate for patient's condition, inappropriate dose, route, and frequency of administration for the patient's age, weight, and disease state, history of allergy or previous reaction to the drug, drug-drug interaction, therapeutic drug monitoring not performed, and poor compliance involved in the reaction, which help in identifying high-risk areas of medication use specific to psychiatric inpatients. [18],[19]

Monitoring cardiometabolic risk in patients on antipsychotics should start immediately after they have started the drugs, then every 3 months during the 1 st year and every 6 months after that. To promote adherence, patient counseling should be a mainstay of all interventions offered to patients with metabolic comorbidity. [20]

Polymorphisms present in genes are a cause of ADRs due to psychotropic medications and are responsible for most of the variations. Pharmacokinetics and pharmacodynamics pathways candidate gene approaches have identified several genetic factors influencing treatment response. Psychotropic drug prescribers need to consider treatment-resistant patients as potential abnormal metabolisers. One of the aims of personalized medicine is prevention of ADR. Implementation of pharmacogenetics in patient care promises not only better and safer treatments for patients but also potentially lowering overall healthcare costs. [21]

  Conclusion Top

This study among psychiatric inpatients showed that majority of the ADRs that occurred were of Type A, meaning most of them are dose-dependent and predictable. A considerable number of patients who developed ADRs were on multiple psychotropic drugs. Maximum number of ADRs was seen in patients who were on antipsychotic drugs, the most common adverse effect observed being EPSs. Olanzapine was the most common drug causing ADR.

ADRs go hand in hand with drugs in the treatment of psychiatric illnesses due to chronicity of the disease and long duration of treatment process. Atypical antipsychotics are the drugs commonly prescribed these days as patients with psychosis formed the major group among hospitalized individuals in Psychiatry Department.

Polypharmacy is commonly observed in psychiatric clinical practice which may contribute to poor drug compliance and also form a basis for drug interaction. Hence, active surveillance from the part of clinicians and pharmacologists will help build a database for ADRs in Indian setting. Awareness and early detection of ADRs will help the consulting psychiatrist to make the necessary alterations in the drugs prescribed or addition of newer drugs to reduce the symptoms of ADR, which will in turn improve patient care and compliance.

Systematic review about factors affecting the development of ADRs addresses that some factors can be changed such as smoking or alcohol intake and others cannot be changed such as age, presence of other diseases, or genetic factors. Knowledge about ADRs helps in choosing appropriate drug treatment to patients. Pharmacogenomics emphasizes the genetic predisposition of ADRs and helps in choosing right drug. [22]

The Health Information Technology for Economic and the Clinical Health Act in the United States allocate hospitals of electronic health records with computerized provider order entry. This is said to reduce patient injuries caused by medication errors (preventable adverse drug events) by 50%. There is a decrease in medication errors which will benefit public health. [23]

As per a study by Weinstock et al., cardiometabolic illness was associated with increased total number of medications prescribed. Hence, reducing the number of prescribed medication will help reduce the incidence of ADR. [24]

A systematic review to identify the prevalence and management strategies of nine clinically important categories of antipsychotic adverse effects such as EPSs, sedation, weight gain, Type II diabetes, hyperprolactinemia, metabolic syndrome, dyslipidemia, sexual dysfunction, and cardiovascular effects was done and it was found that documentation of baseline monitoring is found to be very low. Hence, measures to collect evidence from management strategies need to be strengthened. [25]

Information regarding ADR can be obtained from preclinical evaluation and different phases of clinical trials, but the real life situation can be observed only in clinical practice. Hence, this study was intended to create awareness among psychiatrists to identify and report ADRs and actively participate in pharmacovigilance. The data received can be conveyed to drug regulatory authorities who can assess the drug information for safe and judicious use. All health professionals and other trained personnel along with patients should be educated on the importance and benefit of ADR reporting and encouraged to report any suspected ADR and respect the confidentiality of the patient. Drug interactions are a major contributor to ADR; hence, polypharmacy should be prevented as far as possible. [25],[26]

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Conflicts of interest

There are no conflicts of interest.

  References Top

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  [Figure 1], [Figure 2]


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