Evaluation of adverse drug reactions in patients of schizophrenia in tertiary care teaching hospitals in Central India

Background: For decades, it has been observed that mental health is shrouded in stigma and discrimination. The scope, severity, and expense of impairment and costs to people, families, and societies are staggering. Mental illnesses are among the most frequent illnesses, affecting over a quarter of the population in any given year. According to national institute of mental health and neurosciences, Bangalore, the prevalence of schizophrenia has been considered as 4/1000 for all ages and both sexes. Aim and Objectives: The objectives of this study were to as follows: (1) To evaluate adverse drug reactions (ADRs) in patients with schizophrenia who received antipsychotic treatment and (2) to compare ADRs in typical versus atypical antipsychotic agents in schizophrenic patients. Materials and Methods: A total of 50 schizophrenic patients were enrolled for evaluating adverse effects to antipsychotic drugs. During the research, all ethical precautions were taken. All patients were followed up by medical history, history of drugs, and any severity of adverse drug reaction. Causality assessment was graded by Naranjo scale. Result: Among all of the antipsychotic drugs, risperidone (05%), quetiapine (04%), and aripiprazole (04%) have shown lowest propensity to cause serious adverse event. These drugs are most commonly prescribed drugs and are least likely to affect quality of life of patient. However, the risk of extrapyramidal symptoms is lower with olanzapine (05%) than haloperidol (34%) and even in case with risperidone at higher dose (20%). Although atypical antipsychotics such as olanzapine (46%) have shown maximum potential to produce metabolic side effect such as dyslipidemia and hyperglycemia compared to that of other antipsychotics. Conclusion: The most common adverse effects were found with typical and atypical antipsychotics such as weight gain, drowsiness, constipation, sedation, dyslipidemia, and hypotension.

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Background: Pharmacovigilance is the science which deals with adverse drug reactions (ADRs) appear after long and short drug treatment. ADRs monitoring is essential to gain knowledge of drugs reaction for betterment of mankind. In the present study, observation of ADRs in Type II diabetic patients was conducted in tertiary care hospitals, Bhopal. ADRs reported in the present study were diarrhea, myalgia, flatulence, palpitations, rash, itching, etc., in patients receiving oral hypoglycemic agents. So through this observation, we want to acknowledge the various adverse effects occurred by oral hypoglycemic agents for reduction of morbidity and mortality in Type II Diabetic patients. Aims and Objectives: (1) The objectives of the study were to ADRs monitoring in Type II Diabetic patients receiving oral anti-diabetic agents and (2) to compare ADRs in conventional versus newer anti-diabetic agents therapies in Type II Diabetic patients. Materials and Methods: 150 patients were enrolled for evaluating adverse effects with oral antidiabetic agents. All patients were followed up by medical history, history of drugs, and any severity of ADR. Causality was graded by Naranjo scale. Results: 45 patients (30%) with mean age of 64.6 year (SD = 2.41) complained adverse effects and out of which 17 (11.3%) patients were reported to the physician. The most common adverse effect was found with sulfonylureas, biguanides, and thiazolidinediones such as hypoglycemia, weight gain, gastrointestinal (GI) disturbances allergic reactions, and dizziness probability of adverse effects more common in females (64.17%) in comparison to male (35.29%) patients. Conclusion: In Type II Diabetic patients receiving oral antidiabetic agents provides a fruitful information about a ADRs and enhance knowledge about pharmacovigilance to health-care providers. However, predominance of adverse effects in female diabetic patients was reported. Hypoglycemia, weight gain, and GI tract disturbances were observed frequently with oral antidiabetic agent in middle age diabetic patients. By this information, we can prevent drug related complications and improve quality of life of a person

Study of pattern & distribution of adverse drug reactions in acute coronary syndrome patients in a tertiary care hospital

Background & objectives: With the availability of a wide range of drugs to treat patients with acute coronary syndrome (ACS), adverse drug reactions (ADRs) have become inevitable in clinical practice. Thorough knowledge of such reactions is essential for the treating physician for optimal treatment and better outcomes. There are many scales to define, measure and assess the ADRs, but there is a dearth of data available on such drug reactions among ACS patients. Hence, this study attempted to analyze the pattern, causality, severity, predictability and preventability of ADRs in ACS patients. All the ADRs reported during the study period were analyzed for causality by the World Health Organization–Uppsala Monitoring Centre (WHO-UMC), Naranjo’s and Karch and Lasagna scales; severity by modified Hartwig and Siegel scale; predictability by Rawlins and Thompson criterion and preventability by Schumock and Thornton scale. Methods: A single-centre, record-based analysis for the occurrence of ADRs was done among ACS patients admitted to the department of Cardiology between January and October 2017. Demographic data, comorbid conditions, reported ADRs and ADR assessment details were noted from the hospital case records and ADR monitoring centre (AMC) records. The data were analyzed and presented in a descriptive manner using percentages, mean and standard deviation. The Pearson’s chi-squared test was used to ascertain the significance of the association between different groups. Results: Out of 324 patients under evaluation, 67 had developed one or more ADRs. There were 30 different types of ADRs reported, headache being the most common. Among the drugs, heparin was the most common factor, causing 27 per cent of ADRs. Definite causality of a suspected drug causing ADRs was seen in 11.9 (n=8), nine (n=6) and 7.5 (n=5) per cent cases as per WHO-UMC, Naranjo (Naranjo algorithm) and Karch and Lasagna scales, respectively. In the severity of ADRs, the most severe reactions according to the modified Hartwig-Siegel scale (level 4a in our study) were seen in 17.5 (n=12) per cent of patients, and the rest were either level 2 or 3 reactions. Nearly 92.5 (n=62) per cent of reactions were predictable according to the Rawlins and Thompson criterion. Application of the modified Schumock-Thornton scale showed that 22.4 per cent of ACS patients had preventable reactions, and the rest were not preventable.Interpretation & conclusions: The study results suggest that ADRs are relatively common among ACS patients. Most of these can be identified and assessed for causality, severity, predictability and preventability using various available scales. Diligent pharmacovigilance for identifying and assessing ADRs may help manage and mitigate morbidity associated with these in high-risk ACS patients.

Effectiveness And Safety Assessment Of Fixed Dose Combination Of Non-Steroidal Antiinflammatory Drugs Prescribed For Orthopedic Patients

Objective: Many Fix Dose Combinations (FDCs) being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, pediatric formulations of nimesulide+paracetamol. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. The aim of the present work was to evaluate the efficacy and safety of FDCs in non-steroidal anti-inflammatory drugs in the orthopedic department at a tertiary care teaching hospital. To study the effectiveness and safety parameters of fixed-dose combinations of Non-Steroidal Anti-inflammatory Drugs. Methods: This prospective, observational study was conducted among 150 out-patients of the orthopedic ward over a period of July 2013 to December 2013(Each combination with 50 patients). Three fixed-dose combinations utilized were paracetamol+diclofenac, paracetamol+ibuprofen and paracetamol+nimesulide. The effectiveness was analyzed by using Visual Analogue Scale (VAS) and Disease Activity Scale (DAS) and the safety criteria were analyzed by using the WHO probability scale and Naranjo scale. 150 orthopedic patients attending Out Patient Department were included. 50 participants for each of the combinations of fixed-dose combination (FDCs) of NSAIDs. Results: Out of 150 patients 33 patients developed adverse effects, and 17(51.51%) adverse effects due to the combination of Paracetmol+Nimuselide, 11(33.34%) adverse effects due to the Paracetamol+Ibuprofen and 5 (15.15%) were due to the combination of Paracetamol+Diclofenac. The maximum effectiveness (3.55±0.208) showed in the combination of paracetamol+diclofenac compared to the other two combinations. Conclusion: It was concluded from this study that the effectiveness and safety profile of PCM+DICLO is better than the other two FDCs.

A study of adverse drug reaction profile of tuberculosis patients attending DOTS center at Dr. Bhim Rao Ambedkar memorial hospital, Raipur, Chhattisgarh, India

Background: Tuberculosis is second leading cause of death in the world. The causative organism is Mycobacterium tuberculosis. The objective was to study the adverse reactions of the patients attending the DOTS center and to assess their causality and severity of reported ADRs.Methods: Present study was a prospective observational study carried at the DOTS center of Dr. Bhim Rao Ambedkar Memorial Hospital, Raipur, Chhattisgarh, India between August 2011 to July 2012 (One year). The patients were monitored for adverse drug reactions. The assessment of ADRs were based upon the WHO assessment scale, Naranjo scale, European A.B.O scale.Results: Total number of patients attending DOTS center was 816. The number of males (428) exceeded that of females (388). Majority of patients in this study belonged to 21-30 years (26.96%) next 31-40 years (25.24%) and 41-50 years (16.5%) of age group. Prevalence of ADRs were more in males (57%) than in females 32 (43%). Majority of ADRs reported were moderate 33 (35.22%) followed by 29 (46,77%) were mild, no severe ADRs reported. According to severity of ADRs seen were gastritis 28 (45%) followed by 10 (16% ) rashes , 10 (16,12%) of arthralgia, 3 (4.83%) of hepatitis, 6 (9.7%) of peripheral neuropathy, 2 (3%) onsets of ADRs after starting anti-tubercular drug were 12 (19.35%) in 0-1 week followed by 19 (30%) ADRs showed onset in 1-2 week and 2-3 week, 8 (13%) in 3-4 week 3 (5%) in 4-5 week and 1 (2%) in 5-6 week.Conclusions: The casual link between the ADRs and the suspected anti-tubercular drug by Naranjo scale definitely relationship was established between the anti-tubercular drug and ADRs in 7 (11.25%) patient while 22 (35.45%) probable and 33 (53.22%) ADRs were categorized as possible.

An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.

Pattern and incidence of adverse drug reactions observed in cardiac clinic of tertiary hospital, Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard, New Delhi.

Background: The aim of the present study was to monitor the incidence and pattern of adverse drug reactions (ADRs) in cardiac care unit at Hakeem Abdul Hameed (HAH) Centenary Hospital. Methods: Study was conducted with the permission of Institutional Ethics Committee. Patients visiting medicine outpatient department, cardiac clinic, medical ward, and emergency departments over a period of 15 months were recruited. ADRs were recorded on the prescribed form. Causality assessment was done using Naranjo probability scale. 223 patients of hypertension and stable coronary artery disease were enrolled of which 48.9% were males and 51.1% females. The most common prescribed drugs were ace-inhibitors, angiotensin receptor blocker, and beta-blockers. Other prescribed drugs were calcium channel blockers, statins, nitrates, and antiplatelets. Results: A total of 44 ADRs were recorded. 26 ADRs were seen in females and 18 in males. Statins were the commonest drug associated with ADRs (29.5%) in our study. The most common organ system associated with ADRs in the present study was central nervous system followed by skin 15.9% each. The incidence of ADRs was about 20% of which 20% ADRs were probable, and 80% were possible. Maximum ADRs occurred in patients prescribed statins followed by beta-blockers and angiotensin receptor blockers. Conclusion: There is a need for conducting such studies in more and more patients to see the pattern of ADRs in cardiac patients. More information will help in reducing the ADR occurrence and making drug use more rational and safe for patients.

Ciprofloxacin induced erythema multiforme: a case report.

Erythema multiforme (EM) is an acute, self-limited, and sometimes recurring skin condition that is considered to be a type IV hypersensitivity reaction associated with certain infections, medications, and other various triggers like flavorings and preservatives, such as benzoic acid and cinnamon, immunologic disorders, such as transient selective C4 deficiency of infancy, collagen diseases, vasculitides, sarcoidosis, non-Hodgkin lymphoma, leukemia, multiple myeloma, myeloid metaplasia, and polycythemia, physical or mechanical factors, such as tattooing, radiotherapy, cold, and sunlight, foods, including salmon berries and margarine, malignancy, and hormonal. EM may be present within a wide spectrum of severity. EM minor represents a localized eruption of the skin with minimal or no mucosal involvement. According to a consensus definition, Stevens-Johnson syndrome (SJS) was separated from the EM spectrum and added to toxic epidermal necrolysis (TEN). The two spectra are now divided into the following: (1) EM consisting of erythema minor and major and (2) SJS/TEN. Ciprofloxacin is a second generation fluoroquinolone. Fluoroquinolones are rapidly bactericidal in vitro and are considerably potent against Escherichia coli and various species of Salmonella, Shigella, Enterobacter, Campylobacter, and Neisseria. Mainly used in urinary tract infections, prostatitis, sexually transmitted diseases, gastrointestinal and abdominal infections, respiratory tract infections, bone-joint and soft tissue infections. Metronidazole is a nitroimidazole antimicrobial medication used particularly for anaerobic bacteria and protozoa. It is on the World Health Organizations list of essential medicines, a list of the most important medications needed in a basic health system. Here we report the case of a 39-year-old male patient who presented with EM to the dermatology outpatient department, Adichunchanagiri Hospital and Research Centre. The patient gave a history of taking antimicrobials ciprofloxacin and metronidazole for the treatment of a non-healing wound on the right leg which he sustained in a road traffic accident. The review of the literature has revealed very rare associations of metronidazole and pantoprazole with EM, but cases of ciprofloxacininduced EM have been reported. Hence, the reported adverse drug reaction has been attributed to ciprofloxacin. In this event, casualty assessment using Naranjo’s scale revealed that ciprofloxacin was a probable cause for the adverse drug reaction.

To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital.

Adverse drug reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. Adverse Drug Reactions result in increased healthcare cost due to the need of some interventions and increased hospital stay. The study was undertaken to monitor the adverse drug reactions to medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital, to establish ten most commonly prescribed medicines in this unit that gave maximum adverse drug reactions and to determine the list of commonly affected organ systems and assess their causality. In this Retrospective, non-interventional study a total of 63 adverse drug reaction reports were collected from 249 patients. The most common medicine that caused maximum ADRs was Oxytocin 10 (15.87%). Other frequently used drugs were Amikacin, Methylergometrine, Mifepristone+Misoprostol, Levonorgestrel+Ethinylestradiol, Cefotaxim+sulbactam, Cefixime+Ofloxacin, Mifepristone alone, Clomifene citrate, Tramadol. The most commonly affected organ system was cardio-vascular system 12 (19.04%).The assessment by Naranjo’s scale showed that out of 63 ADRs, 41 (65.07%) ADRs were probably related to drugs, 21 (33.33%) ADRs were possibly related to drugs and 1 (1.58%) ADR was doubtful. WHO causality assessment scale revealed that out of 63 ADRs, 51(80.95%) ADRs were probable or likely, 12(19.04%) ADRs were possible. It was observed that safe medicines were prescribed in obstetrics and gynaecology department as per FDA category A with no banned drugs .However, there is a need to sensitize the doctors to prescribe rationally and emphasize this aspect in under and post graduate medical teaching as well. The health system needs to promote spontaneous reporting of Adverse Drug Reactions from all health care professionals and the public at large in a well structured programme to build synergies for monitoring ADR in the country. Also proper documentation and periodic reporting to regional pharmacovigilance centres should be encouraged to arrive at meaningful conclusion on safety issue of medicines and thereby reduce considerably social and economic consequences of ADRs.