Siegel Scale Research Articles

A retrospective study of adverse drug reactions in a tertiary care center

Background: Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hubballi, Karnataka, India.Methods: This was a retrospective observational study, extending over 6 months (May 2019 to October 2019). A total of 124 cases comprising patients of either sex and age group ranging from 1month to 72 years were studied. The data was collected using CDSCO ADR reporting form. “Naranjo’s Assessment Scale” was used for causality assessment and severity assessment was done in accordance with “Hartwig and Siegel scale”.Results: The study showed majority of ADRs were from General Medicine department and affected skin and appendages (59%). Skin rashes 44 (31.7%) were found to be the most commonly reported ADRs most of them were with antimicrobials 67 (54%). After causality assessment 83 (66.9%) of the cases were classified as probable and 41 (33.1%) were classified as possible. Majority of serious ADRs were not preventable in our study.Conclusions: ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended.

Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital

Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type “A” reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

Isoniazid-Induced Systemic Lupus Erythematosus: A Case Report.

Systemic lupus erythematosus (SLE) can be induced by various medications, such as hydralazine, procainamide, isoniazid, methyldopa, chlorpromazine, quinidine, and minocycline. A patient was admitted complaining of fever with chills and rigor. After being diagnosed with tuberculous meningitis, the patient was given antituberculosis treatment. As the patient did not improve, detailed investigations were conducted, and elevated antinuclear antibody levels were found. The consulting physician diagnosed that the patient was suffering from SLE. As isoniazid is associated with an increased risk of developing SLE, it was suspected as the culprit drug. After withdrawing isoniazid from the antituberculosis treatment regimen, the patient improved and was discharged. Based on the WHO-UMC and Naranjo’s causality assessment criteria, an association between the reaction and isoniazid was deemed probable. The reaction was moderately severe (level 4b) according to the modified Hartwig and Siegel scale.

Adverse Drug Reactions Affiliated with Atypical Antipsychotics in Patients with Schizophrenia

: An Adverse drug reaction cannot be avoided especially with drugs like antipsychotics which are the mainstay for the treatment of schizophrenia, a chronic disease, as well for the treatment of psychosis. Hence monitoring of adverse drug reactions is the key factor in ensuring patient compliance and safety. This study was a prospective, descriptive, follow up study. The reported ADRs were assessed for causality using both WHO causality assessment scale and Naranjo’s algorithm. The severity of the reported reactions was assessed using Modified Hartwig and Siegel scale. The predictability and preventability of the reported ADRs was assessed using developed criteria for determining predictability of an ADR and Modified Schumock and Thornton scale respectively. A total of one hundred and forty three adverse drug reactions were observed from One hundred and two patients that were recruited. ADR’s were noted and the majority of these adverse reactions was seen with Olanzapine and Risperidone. These include weight gain, sedation, tremors, drug induced parkinsonism and disturbances in menstrual cycle. Mild ADR’s using Hartwig scale were fatigue, dry mouth, insomnia, weight gain and GI disturbances. Moderate ADR’s were tardive dyskinesia, pill rolling movements, drug induced parkinsonism and hyper salivation. Severe reactions included disturbances in lipid profile, delirium, menstrual disturbances and hypertension Of the ADR’s, 92% were predictable and 7.4% unpredictable. 67.8% ADR’s were not preventable, 29.6% ADR’s were definitely preventable and 3.70% probably preventable. WHO causality assessment revealed 55.5% ADR’s to be certain, 29.6% to be probable and 14.8% to be possible. Need of the hour is active surveillance of adverse drug reaction with an efficient pharmacovigilance centre in every established hospital.Key words: Adverse drug reaction, World Health Organization, Pharmacovigillance, Atypical antipsychotics, Schizophrenia.

PREDICTORS ASSOCIATED WITH ADVERSE DRUG REACTIONS AMONG GERIATRIC PATIENTS IN AN OUTPATIENT CLINIC

Objective: The process of aging involves an individual’s structural and functional depravity of their organ systems often results in compromised pharmacological principles of the prescribed drugs. Multimorbidity and polypharmacy along with change in pharmacokinetic and pharmacodynamic responses of drugs predispose the elderly to adverse drug reactions (ADRs). The present study was aimed to identify and report the characteristics and incidence of ADRs among geriatrics in an outpatient clinic.
 Methods: This was a 6-month prospective hospital-based observational study among patients of either sex aged 60 years and above visiting an outpatient clinic at the study site. The suspected ADRs were categorized according to the Will’s and Brown classification system. Causality of these ADRs was verified by applying the WHO-UMC criteria and the Naranjo’s scale. Severity and preventability of the ADRs were classified using the modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. Multivariate logistic regression was used to determine the risk factors for developing ADRs.
 Results: Among the 365 patients monitored, 57 (15%) patients experienced 60 ADRs. Therapeutic classes of drugs frequently associated with ADRs were the drugs used in hypertension (27 [45%]). Patients presenting with amlodipine (9 [15%]) induced pedal edema were observed with the highest frequency of ADRs. Polypharmacy (OR: 1.619, 95% confidence interval: 0.957−2.741, p=0.021) was observed as the influential risk factor for ADRs.
 Conclusion: Pharmacist’s services and involvement in geriatric patient’s centered care can be associated with their improved health, quality of life and economic outcomes, a reduction in medicine-related adverse events, and limiting the morbidity and mortality in this age band.

A Case Report on Linezolid and Cefuroxime Induced Leucocytoclastic Vasculitis

A 65-year-old female diabetic patient with wet gangrene on left great toe developed skin eruptions and blebs over her limbs and lower abdomen after receiving three doses of tablet linezolid + cefuroxime (600mg+500 mg). The skin eruptions and blebs completely resolved fourteen days after discontinuation of tablet Linezolid + Cefuroxime. Based on her presentation (Skin eruptions and blebs), we consider that the condition was a result of linezolid+ cefuroxime administration. While the pathophysiology of these cutaneous reactions is not completely understood, clinicians should be vigilant to allow early detection of these problems. The causality of this adverse reaction was determined by using Naranjo’s criteria and World Health Organization Probability scale and was found to be possible and the severity of this reaction was determined by using the Modified Hartwig and Siegel scale and was found to be moderate (Level 3b) reaction. Although, Linezolid is known to cause dermatological reactions like rashes but the reports of leucocytoclastic vasculitis are rare. Thus, our case report of linezolid + cefuroxime induced leucocytoclastic vasculitis add newer information. Physician should be vigilant for the potential of drug to cause some rare side-effect like leucocytoclastic vasculitis on similar age groups, so that a safer alternative treatment can be started. Key words: Linezolid, Cefuroxime, Cutaneous reaction, Diabetes, Wet gangrene.

Assessment of adverse drug reaction profile of the disease-modifying anti-rheumatic drugs at the department of orthopaedics in a tertiary care hospital, Silchar, Assam, India

Background: The mainstay of treatment of Rheumatoid Arthritis (RA) is the use of the disease-modifying anti-rheumatic drugs (DMARDs). Methotrexate, sulfasalazine and hydroxychloroquine are some of the DMARDs which are used in combination for the treatment of RA. The current study was undertaken to assess the adverse drug reactions (ADRs) of DMARDs that are commonly encountered with the treatment of RA.Methods: The present study was designed as a prospective, observational study on newly diagnosed patients with RA. Patients diagnosed with RA above 18 years (excluding pregnant women) of either sex who were prescribed DMARDs in combination were included. ADRs reported spontaneously by the patients and also responses obtained in a questionnaire related to likely ADRs from the patients was recorded in the case record form. Statistical analysis was done using graph pad and p value <0.05 was considered to be statistically significant.Results: A total of 47 patients attending the Outpatient Department of Orthopaedics, Silchar Medical College and Hospital, Silchar, Assam, India were screened for the study. ADRs were monitored up to the last visit on 41 patients excluding the patients who were lost and who were not able to adhere to the treatment. A total of 27 ADRs were reported from 19 ADR forms. Gastrointestinal manifestations were the most common adverse effects of combination DMARDs seen in 10 patients (24.39%). Severity assessment done using modified Hartwig and Siegel scale that showed majority of the ADRs were mild (74.07%).Conclusions: Present study showed that DMARDs are well-tolerated and have an acceptable toxicity profile as majority of ADRs seen were mild. It was however difficult to prevent the occurrence of ADRs. Proper monitoring of therapy is needed for early recognition of ADRs.

Valproic Acid Induced Pancreatitis in an Arab Male

Valproate, a commonly used antiepileptic, is known to cause pancreatitis, which may present days to years after initiation of therapy. A 20-year-old Arab male patient with electroencephalogram (EEG) confirmed epileptiform activity over the left posterior head region was initiated with tablet carbamazepine 400 mg twice daily in the year 2015 and based on subsequent EEG findings (suggestive of more of generalized myoclonic seizure) carbamazepine was withdrawn gradually and started with sodium valproate 500 mg twice daily and levetiracetam 1 g twice daily. During treatment, the patient had status epileptics, treated with diazepam and lamotrigine 50 mg was added. Laboratory data indicated low valproate level, 47 μg/mL (normal range: 50–125 μg/mL) resulting in two episodes of myoclonic jerks necessitating lamotrigine dose escalation (100 mg twice daily). A month later, the patient developed nystagmus and tremors, and lamotrigine dose was deescalated to 75 mg twice daily. Patient was brought to the emergency with severe abdominal pain and vomiting since the day before and valproate level was 179 μg/mL (>150 μg/mL μg/mL is considered toxic), a diagnosis of acute pancreatitis due to valproate was made and the patient was treated in the intensive care unit. The causality assessment of the adverse drug reaction was “probable” (Naranjo score 8), and severity was “Severe” (Level 5; Modified Hartwig and Siegel scale), and the adverse reaction was “Not preventable” (Modified Schumock and Thornton scale). This report suggests the need for constant clinical monitoring and the need for therapeutic drug monitoring for patients undergoing valproate therapy.

Clinical profile and comparison of causality assessment tools in cutaneous adverse drug reactions

Background:Cutaneous adverse drug reactions (CADRs) are probably the most frequent of all manifestations of drug sensitivity. As a considerable number of new drugs are periodically introduced into the market, the incidence of CADR is likely to increase. The pattern of CADR and the causative drugs is likely to change accordingly. There is no uniformly accepted and reliable method of objectively assessing the causal link between drug and adverse reaction.Aim:To study the clinical patterns and causative drugs and compare causality assessment [World Health Organization (WHO) and Naranjo algorithm] of CADR among patients attending the dermatology department.Materials and Methods:This is a cross-sectional hospital-based study in which all patients with suspected CADR attending the dermatology department of a tertiary care center over a 9-month period were evaluated using the causality assessment criteria recommended by the WHO-Uppsala Monitoring Centre (UMC) and Naranjo scale. The severity of the reaction was assessed using Adverse Drug Reaction Severity Assessment Scale (modified Hartwig and Siegel scale).Results:A total of 200 consecutive patients with CADR were evaluated. The causality assessment for a drug as per WHO scale yielded 63 (31.5%) cases as certain, 12 (6%) as probable, and 125 (62.5%) as possible, whereas Naranjo scale showed 26 (13%) cases to be definite, 138 (69%) as probable, and 36 (18%) as possible. There was poor agreement between the two scales. Fixed drug eruption was the most common pattern of CADR (82.41%). The average number of drugs received by patients was 2.09. The most common suspected drug group was antimicrobials (n = 170; 40.5%), followed by nonsteroidal anti-inflammatory drugs (n = 148; 35.3%) and antiretroviral drugs (n = 41; 9.7%). Fixed drug eruption was most commonly caused by paracetamol. Antiepileptics and antimicrobials were the most common suspects among severe cutaneous adverse reactions.Limitations:Multiple concomitant drug usage by patients and inability to provoke all patients/measure drug levels in blood resulted in higher number of drugs with causal association as probable/possible.Conclusion:WHO-UMC scale was found to be easier to apply and evaluate, with greater practical utility. Poor agreement between the two commonly used scales emphasizes the need for a consistent and uniform causality assessment tool.

Evaluation of adverse drug reactions in dermatology department of a charitable hospital in India

Background: Adverse drug reactions (ADRs) can be confined to either skin or be a part of systemic reaction such as drug hypersensitivity syndrome or toxic epidermal necrolysis. Objective: The objective is to evaluate the incidence, causality, severity, preventability, and risk factors of ADRs in the dermatology department of a charitable hospital in India. Patients and Methods: A prospective observational study was carried out over a period of 8 months in the dermatology department. The WHO and Naranjo's scales evaluated the suspected ADRs for causality assessment, severity by Hartwig and Siegel Scale, and preventability by modified Schumock and Thornton Scale. Results: A total number of 200 eligible patients were enrolled in the study. Out of 200, 18 patients developed ADRs. The incidence of dermatological ADRs in the study was 9%. The most commonly manifested ADRs were Stevens–Johnson syndrome (SJS) (22.2%) followed by skin rashes (16.7%) and others. The maximum number of ADRs were observed with antibiotics (33.5%), followed by antiepileptic drugs (16.7%) and nonsteroidal anti-inflammatory drugs (NSAIDs) (16.7%). According to the WHO and Naranjo's scales, most of the reactions were probable with 61.1% and 55.6%, respectively. Most of the ADRs were moderately severe (66.6%) and were not preventable (55.6%). Conclusions: SJS and rashes were the most commonly observed clinical pattern of ADRs. The most common drug class responsible for ADRs was antibiotics, followed by antiepileptic drug and NSAID's. Dermatological ADRs varied in their causality, severity, and preventability.

Individual case safety reports by nursing staff: a retrospective pharmacovigilance analysis

Background: The burden of adverse drug reactions is high and accounts for considerable morbidity which can be prevented if healthcare professionals have proper knowledge. Early and spontaneous reporting of ADRs is the mainstay of pharmacovigilance program. Since staff nurses are closely involved in direct patient care, they can easily identify ADRs in the early stage. This study was done to assess the extent of participation of nurses in pharmacovigilance program in our institution.Methods: Retrospective observational study was conducted by analyzing the 210 Individual Case Safety Reports (ICSR) of 2years duration. Causality assessment in the ICSR was analyzed. Severity of the reactions was categorized into mild, moderate and severe according to Modified Hartwig and Siegel scale. Descriptive statistics were used.Results: There were 177 cases reported by faculties and 33 were by the staff nurses.19 nurses reported 33 adverse effects (1:1.7) whereas 41 faculties 177 events (1:4). On analyzing the severity of reactions, 188 cases were categorized as moderate (89.5%), 20 mild (9.5%) and 2 severe (1%). In moderate category of 188 reports, 82 % reporting was by faculties and 18% by staff nurses. All the 33 reports by nurses were of moderate category (100%). In the mild and severe category, 100% reporting was by faculties. Causality analysis showed that 194 were classified as probable (92%), 14 as Possible (7%) and 2as certain (1%). In probable category 85% of reporting was by faculties and 15% by nurses, in possible group 71 % by faculties and 29% by nurses and 100% by faculties in severe category.Conclusions: Training and dedicated participation of nurses can improve reporting of ICSR.

PATTERN OF ADVERSE DRUG REACTIONS AND ITS MANAGEMENT IN FEMALE CANCER PATIENTS IN A PRIVATE HOSPITAL IN TELANGANA, INDIA

ABSTRACT
 Chemotherapy and radiation are one of the important components of treatment for many cancers. Anti-neoplastic agents are used with caution due to their high toxicity and narrow therapeutic window. Studies describing pattern of adverse drug reactions in cancer chemotherapy and radiation therapy patients are less in India. This study aims to evaluate the pattern of ADR’s due to cancer chemotherapy and radiation therapy in hospitalized patients and to assess the causality and severity of these reactions in Telangana state, India. This was a prospective observational study conducted in a private hospital in Telangana region from January to august. Two thousand three hundred and forty two ADR’s were recorded from 254 patients. Most common ADR’s were vomiting (10.7 %), nausea (10.7 %) and fatigue (10.7 %). Majority of the ADR’s (53.5 %) were affecting the Gastro-intestinal system. Naranjo scale for causality assessment showed 54.3 % of the reaction to be “definite”, 36.8 % to be “probable”. Modified Hartwig and Siegel scale for severity showed most reaction (84.1 %) to be of “moderate level”, while 13.3 % of reactions were of “mild level”. There is an immediate need to create awareness among health care professionals regarding the importance of the pharmacovigilance system. Use of preventive measures is to be enhanced in order to reduce the incidence and severity of ADR’s. This study showed most ADR’s are preventable with effective ADR monitoring.
 Keywords: Adverse drug reaction (ADR), ADR monitoring, Pharmacovigilance, chemotherapy, radiation therapy.

A study of pattern of adverse drug reactions in inpatients department of medicine of tertiary care hospital in Madhya Pradesh, India

Background: Adverse Drug Reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. The main aim of the study was to detect and analyze Adverse Drug Reactions in inpatients of medicine department in tertiarycare hospital. The study assesses the incidence and pattern of ADRs, identifying co-morbidities, past and present illness, assess causality and the offending drugs, monitoring and documenting suspected adverse drug reactions.Methods: A prospective study was conducted over a period of 6 months. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using WHO probability scale. The severity of each ADR was assessed by using modified Hartwig et al, and Siegel scale.Results: A total 58 ADR were reported during study period out of which 28 (48.27%) were male and 30 (51.72%) were female patients. The assessment by WHO probability scale showed that out of 58 ADR 22 (37.93%) were probable and 17 (29.31%) were possible and 6 (10.34%) were certain. Most commonly involved system was gastrointestinal system with 24 (41.37%) ADRs. Severity assessment by modified Hartwig and Siegel scale showed that 22 (37.93%) were moderate, 32 (55.17%) were mild and 4 (6.89%) were severe ADRs. No lethal effects were observed or produced.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased health care cost due to need of some interventions and increased length of hospital stay. The health system should promote the reporting of Adverse Drug Reactions, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

Collection and analysis of adverse drug reactions of antiretroviral therapy in a tertiary care hospital in central India

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

Antituberculosis Drug-Induced Fixed Drug Eruption: A Case Report.

Fixed drug eruption (FDE) was caused by fixed-dose combination (FDC) of antituberculosis drugs in the form of tablet Forecox® (rifampicin [rifampin] 225 mg + isoniazid 150 mg + pyrazinamide 750 mg + ethambutol 400 mg) in a 40-year-old male patient with a history of drug allergy. The patient developed FDE after taking the third dose of tablet Forecox® for pulmonary tuberculosis. Tablet Forecox® was withdrawn and the patient recovered from the reaction after 15 days of treatment for FDE. As per World Health Organization–Uppsala Monitoring Centre (WHO-UMC) and Naranjo causality assessment criteria, the association between the reaction and tablet Forecox® was possible and probable, respectively. The reaction was moderately (Level 4b) severe according to the Modified Hartwig and Siegel scale. As there is an increased risk of allergic reaction in patients with a history of drug allergy, FDCs should not be used in order to avoid complexity in identifying the culprit drug.

A study of serious adverse drug reactions with antiepileptic drugs: a pharmacovigilance study

Background: Approximately 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. There are currently more than 25 drugs in the market for the treatment of epilepsy, many of which have similar efficacy but differ in their tolerability profile. Besides unmatched beneficial potential of antiepileptic drugs, it is associated with many adverse reactions too. This study aims to identify the serious adverse reactions caused by prescribed antiepileptics, reported at the pharmacovigilance centre of government tertiary care centre.Methods: This is a retrospective, pharmacovigilance study of the antiepileptic drugs adverse reactions reported over a period of 1 year at a tertiary care centre.Results: A total of 120 ADRs of antiepileptic drugs were reported and collected at the pharmacovigilance centre. According to the WHO-ART system organ classification of ADRs, 78% of ADRs belonged to skin and appendages disorder. Based on the modified Hartwig and Siegel scale of severity, 60.8% ADRs were mild, 18.5% were moderate and 20.8 % were severe ADRs. The severe ADRs included: Steven-Johnson syndrome, Toxic epidermal necrolysis, Erythroderma, DRESS syndrome and Acute pancreatitis. Phenytoin has been found to be the antiepileptic drug causing the most number of severe ADRs amongst the prescribed antiepileptics. According to the modified Schumock and Thornton criteria most of the severe ADRs were not preventable.Conclusions: This study analyses the ADRs associated with antiepileptics reported at the pharmacovigilance centre. 20.8% ADRS were severe, this indicates that the epileptic patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of ADRs would help physicians to identify patients with greater risk of ADRs and therefore, might benefit from ADRs monitoring and reporting programmes.

Assessment of causality and severity of various reported adverse drug reactions by different classes of anti-cancer drugs

Background: Chemotherapy involves highly complex regimens and hence accounts to high susceptibility towards Adverse Drug Reactions. All antineoplastic drugs have potential to cause one or more Adverse Drug Reactions which may vary from mild to severe form. So the aim of this study was to determine the prevalence of Adverse Drug Reactions in patients treated with chemotherapy.Methods: After getting approval from the Institutional Ethical Committee, the prospective observational study was conducted in the Department of Pharmacology in association with Department of Radiation Oncology and Department of Medicine, Government Medical College, Srinagar between April 2015 to October 2016. All patients of either sex and any age receiving anti-cancer drugs in the inpatient department of radiation oncology were included. The mean age of the study population was 51 years and 53.9% of them were males and 46.1% of them were females. The WHO-UMC system was used for assessment of case programme and case reports. The severity of adverse drug reactions was determined by using modified Hart wig and Siegel scale.Results: Most of the reported ADR’s were moderate to mild in severity according to modified Hart wig and Siegel scale. Most of the frequent ADR’s were certain followed by probable and possible according to WHO-UMC causality assessment.Conclusions: Antineoplastic drugs have a narrow therapeutic index and the dosage needed to achieve a therapeutic response usually proves toxic to the body’s rapidly proliferating cells. Measures need to be put into place to reduce the physical, emotional and economic burden on the patient due to adverse drug reactions. Therefore, there is a need for vigilant ADR monitoring to decrease morbidity and mortality due to ADR’s which require further studies on large populations.

A study to analyze the pattern, causality, severity, predictability, and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital

Background: Adverse drug reactions (ADRs) in women demand a special care due to altered physiology. Despite lingering safety questions, studies on vulnerable groups such as pregnancy, lactation, peri- and post-menopausal women are lacking. Hence, the assessment of ADRs is essential for early risk detection and its management. Aims and Objectives: To analyze the pattern, causality, severity, predictability and preventability of occurrence of ADRs in the Obstetrics and Gynecology (OBG) Department. Materials and Methods: An observational study was conducted from June 2012 to 2016 to analyze the ADRs reported spontaneously from the Department of OBG to ADR Monitoring Center, Bangalore Medical College and Research Institute. Causality of each ADR was assessed by the WHO-ADR scale, severity by Hartwig and Siegel scale and preventability by modified Schumock and Thornton scale. Results: A total of 100 ADRs were reported over 48 months; a maximum number of ADRs were observed in the age group of 21–40 years (81%) and majority of them during pregnancy (62%). The highest number of ADRs was associated with iron therapy (42%) followed by antimicrobials (31%). Gastrointestinal system (51%) was affected predominantly. Gastritis (25%) followed by allergic reactions (18%) was most commonly observed ADRs. The WHO-UMC criteria showed that 61% were “probable” and 57% were “mild” in nature. Preventability assessment showed that 56% were “probably preventable” ADRs. Furthermore, 72% of the ADRs were predictable in nature. 43% of the ADRs required additional medical treatment, while causative drug was withdrawn in 44% of cases. Conclusion: This study provides a database of ADRs in the OBG Department and most of the ADRs were predictable and probably preventable with no severe ADRs, which highlights the appropriate management of ADRs at our center.

A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients.

Background:Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART).Materials and Methods:All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale). Comparison was done between (tenofovir + lamivudine + efavirenz [TLE]) and (zidovudine + lamivudine + nevirapine [ZLN]) regimens.Results:During a study period, 2983 patients were on ART. The most common drug regimen prescribed was TLE (1805) followed by ZLN (326). A total of 325 (10.89%) ADRs were reported in which 150 ADRs were reported in TLE regimens (46%) and 130 in ZLN regimens (40%). The mean age of patients with ADRs was 40 ± 12.56 years and men (58.1%) were more affected than women (41.8%). The most common system organ involved in ZLN regimen was blood (50, 39%) and skin (35, 27%), while it was neurological (63, 42%) and renal disorder (27, 18%) in TLE regimen. Most of ADRs were observed after 1 month of therapy (79.5%) and showed possible causal relation with drug therapy (78.15%). Majority of ADRs were mild in nature (86.7%). The serious ADRs were reported more in ZLN (18%) regimen as compared to TLE (9%) (P < 0.05).Conclusion:Both ART regimens are associated with ADRs affecting all body system; however, the frequency and severity of ADR are high with ZLN regimen.