Hartwig's Severity Assessment Scale Research Articles

Evaluation of medical adherence, adverse drug reactions, and quality of life in post tubercular obstructive airway disease.

Increasing incidence of tuberculosis is intensifying the posttubercular obstructive airway disease (PTOAD) in developing countries. Currently, there are no standard treatment guidelines for the management of PTOAD patients. The present study aims to evaluate the prescribing pattern, adherence, adverse drug reactions (ADRs), and quality of life (QoL) in PTOAD patients. A prospective observational study was conducted to evaluate the prescriptions of PTOAD patients, estimating the medical adherence using Morisky 8-Item Medication Adherence Questionnaire, assessing ADRs using Hartwig's Severity Assessment Scale and assessing QoL using St. George's respiratory Questionnaire. Chi-square test, analysis of variance, paired t-test were used to compare the data. The significance of change in adherence status was assessed by Wilcoxon signed-rank test. A total of 94 prescriptions of PTOAD were analyzed. Inhaled long-acting muscarinic antagonist was prescribed to 31.9% of patients. The most common inhaled fixed dose combination was long-acting beta-2 agonist with corticosteroid, prescribed to 52.1% of patients. At final follow-up, maximum percentage of patients were found to be highly adherent, i.e. 56.4%. Overall, 34% of patients have complained about mild category of ADRs. A significant improvement in QoL was observed. At baseline, mean forced expiratory volume in 1 (FEV1) was 64.66% ±23.61%, which increased significantly to 73.34% ±21.60% on final follow-up (P < 0.001). Bronchodilators are the mainstay of treatment of PTOAD patients, since both the QoL and FEV1 were improved with treatments. However, to have good treatment outcome, strict adherence along with safety of the medications must be assured.

Leukopenia Related to Haloperidol in a Case of Chronic Untreated Schizophrenia

Haloperidol is a commonly prescribed first-generation antipsychotic drug in psychiatric practice. It is usually well tolerated and presents with few side effects such as sedation, antiparkinsonian features, and hypotension. Few cases have been reported on leukopenia with haloperidol, none from India. We present a case where a patient with untreated schizophrenia for 9 years developed leukopenia (total leukocyte count [TLC] = 2800 cells/mm3) at 20 mg of oral haloperidol, in our inpatient setting. He chiefly presented with fever. The causality of adverse drug reaction (ADR) was attributed to haloperidol and using the Naranjo algorithm, the score recorded was 8, suggesting probable causal association. Hartwig's Severity Assessment Scale showed the severity of the ADR to be Level 4 (moderate severity). There was prompt reversal after drug discontinuation (TLC = 7000 cells/mm3 at discharge). Risk factors, possible mechanisms, and role of monitoring are discussed.

An epidemiological and clinical analysis of cutaneous drug eruption: A cohort of 164 patients

Aim: Drug reactions are important and frequent complications of medical treatments. In this study we aimed to investigate the patients hospitalized with a diagnosis of cutaneous drug eruptions, implicated drugs, and related skin manifestations considering the literature. Methods: This retrospective cohort study was performed in Haydarpaşa Numune Training and Research Hospital, Dermatology and Venereology Department. The study comprised 164 patients that were diagnosed with cutaneous drug eruption between January 2010 and December 2016. Some parameters, such as demographic characteristics, type of the reaction, culprit drug groups, multiple drug usage, time between the onset of the drug intake and beginning of the eruption were recorded. Age, gender, symptoms, laboratory tests, diagnosis and treatment information were obtained through patient files. Causal relationship was assessed by Naranjo algorithm. Adverse drug reactions were categorized as definite, probable, possible, and absent. All values were expressed in percentages. The severity of the reaction caused by the drug was assessed with Hartwig's Severity Assessment Scale. Results: Among 164 patients, there were 104 females and 60 males with a mean age of 46.3 (18.8) years. The most commonly encountered type of drug reactions were urticaria and angioedema (42.1 %), followed by morbilliform drug eruption (31.7%). More cutaneous reactions were noted with NSAIDs (18.9%), antibiotics (15.2%) and the combination of NSAIDs and antimicrobial agents (9.8%). Time between the onset of eruption and the intake of the drug varied by hours to months. Some of these patients also described similar reactions related to drugs in the past. Conclusion: Knowledge of these drug eruptions, the causative drugs and the prognostic factors is important for clinicians. It is recommended to advise patients to carry a list in their wallets indicating their drug allergies and/or intolerances, especially if they had a severe reaction before. We conclude that a careful follow-up should be performed with NSAIDs, antibiotics and anti-epileptics. The combination of drugs, including NSAIDs and antibiotics should be avoided as much as possible.

ADVERSE DRUG REACTION MONITORING OF FLUCONAZOLE IN A TERTIARY CARE HOSPITAL

Objective: To study the incidence and pattern of adverse effects of Antifungal drug Fluconazole and to assess the severity of its adverse effects.&#x0D; Methodology: The study was approved by Institutional ethics committee and informed consent was obtained from all willing participants. Patients fulfilling inclusion and exclusion criteria were enrolled. Age sex, diagnosis, dose and duration of treatment were recorded. 2ml of blood was collected for liver function test. The adverse drug reaction (ADR) was documented. The causality assessment was done by WHO assessment scale and severity assessment by using modified Hartwig severity assessment scale.&#x0D; Results: In this study, most of the patients were in 31-40 years age group. Among the 100 patients who were on Fluconazole 58 developed adverse drug reactions. 64 percentage of ADRs were reported in patients with treatment duration of more than 12 weeks. The most common adverse drug effect documented was abdominal pain followed by headache. Increase in serum transaminases was noted in 7 percentage of patients who were taking Fluconazole for more than 12 weeks, which did not require treatment termination or dosage alteration. Most of the ADRs were in possible category of causality assessment scale. In severity assessment most of the ADRs were in mild category.&#x0D; Conclusion: Adverse drug reaction to Fluconazole was mostly noted in patients who were on treatment for more than12 weeks of which elevated serum transaminases were observed in 8 patients. Hence regular liver function monitoring is advised in all patients receiving Fluconazole for more than 12 weeks to prevent further liver damage.&#x0D; Keywords: Adverse drug reaction, Fluconazole

Adverse drug reactions of anti-tuberculosis treatment among children with tuberculosis.

The frequency, severity, and the nature of anti-tuberculosis (TB)-induced adverse drug reactions (ADRs) have always been the matter of concern. The present study was, therefore, aimed to study the incidence, risk factors, and effect of anti-tuberculosis treatment (ATT) among TB children. A prospective longitudinal study was conducted in the Sindh province, Pakistan. A total of 508 TB children in multicenter hospitals under ATT were assessed for ADRs. Naranjo Causality Assessment and Hartwig's Severity Assessment Scale were used. A total of 105 ADRs were reported in 67 (13.2%) of 508 patients. Gastrointestinal disorders were the most frequently observed ADRs (65.7%), followed by arthralgia (24.8%). Around 65 (61.9%) of ADRs were identified as probable and 78 (74.3%) as mild severe ADRs during the study. A total of four cases of mild hepatotoxicity were observed among children. On multivariate analysis, the independent variables which had statistically significant positive association with ADRs were female (OR; 2.66, P = 0.004), retreatment (OR; 22.32, P = ≤ 0.001), and absence of BCG scar (OR; 17.84, P = 0.001). The finding of the current study suggests that close monitoring of females, patients with previous TB treatment, and those without BCG is warranted at the study site.

Fluconazole-induced hepatotoxicity in a tertiary care hospital among patients with dermatophytosis

Background: Fluconazole is being used commonly to treat onychomycosis. Although the risk of liver injury is comparatively less with fluconazole, the severity among immunocompromised individuals is high. There are only a few studies available regarding fluconazole-induced drug-induced liver injury for Indian population. The purpose of this study is to investigate the incidence rate of fluconazole-induced liver injury among general population and to identify other adverse drug reaction (ADR) associated with the use of fluconazole in dermatophytosis. Aims and Objectives: This study aims to study the incidence and severity of liver injury caused by fluconazole and to assess the other adverse effects. Materials and Methods: After obtaining the Institutional Ethical Committee clearance, this study was conducted at the Outpatient Department of Dermatology, RGGH, Chennai. One hundred patients with dermatophytosis, on oral fluconazole 150 mg, biweekly were included and data were collected regarding duration of therapy and adverse effects. The causality assessment was done by the World Health Organization assessment scale and severity assessment using modified Hartwig severity assessment scale. Results: Of the 100 patients, 58% developed ADR. About 64% of patients had ADR and they were on therapy for more than 12 weeks. Increase in serum transaminases was noted in 8% of patients. Abdominal pain was the most common adverse drug effect documented followed by headache. Most of the ADRs were in possible category of causality assessment scale. In severity assessment, most of the ADRs were in mild category. Conclusion: From this study, we conclude that asymptomatic elevations of liver enzymes were observed in patients on fluconazole therapy for more than 12 weeks duration. Liver functions are to be monitored periodically among the patients taking fluconazole for longer periods so that we can avoid the unwanted effects.

A STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL OF PUNE

A STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL OF PUNE Dr. Steffi Jerry Mammen Inamdar Multispecialty Hospital, Pune, India ABSTRACT To study the adverse drug reactions reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hart wig severity assessment scale and the outcomes were studied. This observational and cross-sectional study was conducted for 6 months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. Patients of all age groups and either sex were included in this study. The adverse drug reactions were checked for their causality and severity by performing the Naranjo’s algorithm scale and Hart wig’s scale respectively. Data analysis was done by descriptive statistics. Total 50 adverse drug reactions were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most common organ affected is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hart wig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period. Study was conducted only in wards and critical units not in all departments of the hospital. Keywords: Adverse Drug Reactions, Pharmacovigilance, Naranjo, Hart wig, Suspected Drugs, Tertiary Care Hospital. Full Text Article

A Study of Adverse Drug Reactions in a Tertiary care Hospital of Pune

Purpose: To study the adverse drug reactions (ADR’s) reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hartwig severity assessment scale and the outcomes were studied.Methods: This observational and cross-sectional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. The data collection was done only in wards and critical units. Patients of all age groups and either sex were included in this study. The adverse drug reactions were assessed for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. The outcomes were studied. Data analysis was done by descriptive statistics. Result: Total 50 adverse drug reactions were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most commonly affected organ is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period.Limitations: Study was conducted only in wards and critical units not in all departments of the hospital. Some of the ADR’s have gone un-reported by Resident Medical Officer (RMO) due to increased work pressure, lack of awareness or busy environment.

Mobile App Design, Development, and Publication for Adverse Drug Reaction Assessments of Causality, Severity, and Preventability.

BackgroundAdverse drug reactions (ADRs) cause significant morbidity and mortality. Improved assessment of ADRs to identify the causal relationship, the severity, and the preventability will aid ADRs prevention or reduce patient burden.ObjectiveThe aim of this study was to develop mobile apps in assisting clinical decision in ADR assessments of causality, severity, and preventability using validated tools. The usability of the apps was assessed.MethodsWe designed mobile apps using validated assessment tools for ADRs. They are the Liverpool ADRs Causality Assessment Tool, Hartwig’s Severity Assessment Scale, and the Modified Schumock and Thronton Preventability Scale. The apps were named “Adverse Drug ReactionCausality,” “Adverse Drug ReactionSeverity,” and “Adverse Drug RxnPreventability.” A survey was conducted using the System Usability Scale (SUS) to assess the usability of the developed apps among health care professionals.ResultsThese apps are available for download through Google Play Store for free since January 2015. From the survey, the mean SUS score was 70.9 based on 26 responses from the pediatric ward of Hospital Ampang, Malaysia.ConclusionsThe developed apps received an overall acceptable usability among health care professionals. The usage of these apps will improve detection, assessment, and avoidance of future ADRs. They will also contribute to future research on ADRs, thus increasing drug safety.

Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy.

Introduction:Adverse drug reactions can cause increased morbidity and mortality, and therefore information needs to be studied systematically. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system.Methods:This was a prospective, observational, 1-year, real-life study about the pharmacotherapy of a sample of 390 chronic obstructive pulmonary disease patients. Prescribed medicines were systematized and national pharmacovigilance databases were searched for reported adverse drug reactions. The expectedness was evaluated through the review of the summary of product characteristics, the seriousness was evaluated by the clinicians based on the life threatening nature of the adverse drug reactions, and the severity was evaluated through Hartwig’s Severity Assessment Scale. Descriptive statistics of the reported adverse drug reactions was performed and the relative risk of developing an adverse drug reaction with all international non-proprietary names included in the analysis was calculated.Results:Results confirm that the chronic obstructive pulmonary disease is a disease with high appearance of adverse drug reactions, and causes many additional costs to the healthcare system. Unexpected and severe adverse drug reactions are frequent. A total of 4.8% of adverse drug reactions were evaluated as life threatening. Majority of adverse drug reactions are classified in Levels 1 (32.6%), 2 (26.4%) and 3 (19%) according to Hartwig’s Severity Assessment Scale. Approximately 22% of reported adverse drug reactions affect people’s everyday life to a greater extent and require additional therapy which might further increase the risk. The relative risk of developing an adverse drug reaction was highest for novphyllin (relative risk = 0.65), followed by aclidinium bromide (relative risk = 0.09). Both indacaterol and salbutamol are with a relative risk of 0.07.Conclusion:In conclusion, the medicines for chronic obstructive pulmonary disease cause many serious adverse drug reactions, most of them were unexpected, lacking in the short product characteristics. Appropriate reporting of adverse drug reactions is necessary to decrease the risk of patients and healthcare system.

A retrospective study on the incidences of adverse drug events and analysis of the contributing trigger factors.

Objectives:To retrospectively determine the extent and types of adverse drug events (ADEs) from the patient cases sheets and identify the contributing factors of medication errors. To assess causality and severity using the World Health Organization (WHO) probability scale and Hartwig's scale, respectively.Methods:Hundred patient case sheets were randomly selected, modified version of the Institute for Healthcare Improvement (IHI) Global Trigger Tool was utilized to identify the ADEs; causality and severity were calculated utilizing the WHO probability scale and Hartwig's severity assessment scale, respectively.Results:In total, 153 adverse events (AEs) were identified using the IHI Global Trigger Tool. Majority of the AEs are due to medication errors (46.41%) followed by 60 adverse drug reactions (ADRs), 15 therapeutic failure incidents, and 7 over-dose cases. Out of the 153 AEs, 60 are due to ADRs such as rashes, nausea, and vomiting. Therapeutic failure contributes 9.80% of the AEs, while overdose contributes to 4.58% of the total 153 AEs. Using the trigger tools, we were able to detect 45 positive triggers in 36 patient records. Among it, 19 AEs were identified in 15 patient records. The percentage of AE/100 patients is 17%. The average ADEs/1000 doses is 2.03% (calculated).Conclusion:The IHI Global Trigger Tool is an effective method to aid provisionally-registered pharmacists to identify ADEs quicker.