Clinical Pattern and Causality Assessment of Drug-induced Cutaneous Reactions in a Tertiary Care hospital in India – A Prospective Study

2021 ◽  
Vol 16 ◽  
Author(s):  
Jerin James ◽  
Althab Begum M. ◽  
Syed Hussain F. ◽  
Jamuna Rani ◽  
Sathyanarayanan Varadarajan
Keyword(s):  
Adverse Drug Reactions ◽  
Tamil Nadu ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Care Hospital ◽  
Drug Reactions ◽  
Self Administration ◽  
Drug Induced ◽  
Clinical Pattern

Background: Cutaneous Adverse Drug Reactions (ADRs) are very common and is an important challenge to the physician especially in situations of multiple comorbidities of the patient, polypharmacy and self-administration of over-the-counter medications. Objective: To analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo’s scale and severity of the reactions were determined by Hartwig scale. Method: This was conducted as a prospective observational study in patients admitted in SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance, of all adverse drug reactions reported at the hospital. Results: Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drug which produced cutaneous adverse reaction were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18 % (82) as probable and 14.85 % (15) as possible whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82 % as moderate. Conclusion: It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve outcome of the treatment.

scholarly journals ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

2018 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Organ Systems ◽  
A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

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

2018 ◽  
Vol 7 (7) ◽  
pp. 1326
Author(s):  
Sandeep Kumar Adwal ◽  
B. L. Bamboria ◽  
Ashutosh Chourishi ◽  
Aditya Bamboria
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Prospective Observational Study ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Central India ◽  
Treatment Interruption ◽  
Care Hospital ◽  
Drug Reactions ◽  
The Common

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.

scholarly journals Pharmacovigilance study in geriatric patients of a tertiary care hospital

2021 ◽  
Vol 2 (2) ◽  
pp. 33-38
Author(s):  
Rajalakshmi Rukmangathen ◽  
Vasundara Devi Brahmanapalli
Keyword(s):  
Adverse Drug Reactions ◽  
Geriatric Patients ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Organ Systems

Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital.  Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.

scholarly journals A Prospective Study on Adverse Drug Reactions in Inpatients of General Medicine Department in a Tertiary Care Hospital- A clinical Pharmacist-led Study

2021 ◽  
pp. 111-122
Author(s):  
Shereen Hassan ◽  
U. Ujwal Kumar ◽  
Venessa Mascarenhas ◽  
G. Suresh ◽  
K. C. Bharath Raj ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Data Gathering ◽  
Drug Effects ◽  
General Medicine ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Medicine Department

The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.

scholarly journals Causality assessment and pattern of adverse drug reactions in a tertiary care hospital

2018 ◽  
Vol 7 (2) ◽  
pp. 210
Author(s):  
Dinesh K. Badyal ◽  
Bimal Kanish ◽  
Gaurav Gulrez
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Study Results ◽  
Set Up ◽  
Definition Of ◽  
Almost All

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

scholarly journals A COMPARISON OF CAUSALITY ASSESSMENT TOOLS FOR SUSPECTED ADVERSE DRUG REACTIONS IN HOSPITALIZED PATIENTS AT A TERTIARY CARE HOSPITAL

2020 ◽  
pp. 176-181
Author(s):  
PARIKH CD ◽  
DESAI CK ◽  
KAPADIA JD ◽  
SHAH MK
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Hospitalized Patients ◽  
Assessment Tools ◽  
Care Hospital ◽  
Drug Reactions ◽  
Substantial Agreement ◽  
Suspected Adverse Drug Reactions

Objective: The objective of the study was to compare six causality assessment (CA) tools for suspected adverse drug reactions (ADRs) reported in hospitalized patients at a tertiary care hospital in India. Methods: Intensive ADR monitoring was performed in indoor patients of two randomly selected medicine units. A detailed case report of each suspected ADR (n=120) was provided to six independent experts for CA using either visual analog scale (VAS) or WHO-UMC scale. Investigator assessed causality using Naranjo’s scale, Koh et al. scale, the French method, and Karch and Lasagna scale. Similar causality categories from these scales were coded for correlation. Agreement among experts and that between various CA tools were analyzed using Cohen’s kappa and Fleiss kappa. Reasons for disagreements among different scales were evaluated. Results: A variation was observed in the total number of drugs suspected to cause ADR by experts and investigator. “Likely” and “Plausible” causality were suggested frequently by experts using VAS whereas “Possible” causal association was frequent according to experts using the WHO-UMC scale and also by the investigator using algorithms except Koh et al. scale. None to the slight agreement was observed among experts who used VAS (k=0.117), whereas a substantial agreement was observed among experts using the WHO-UMC scale (k=0.707). A substantial agreement was observed between Karch and Lasagna scale and the French method (k=0.740). Both scales demonstrated moderate agreement with Naranjo’s scale. Disagreement among the WHO-UMC scale, the French method, and Karch and Lasagna scale were associated with polypharmacy, serious ADRs, non-availability of laboratory data, and skin and subcutaneous tissue ADRs. Conclusion: A higher inter-rater agreement with the WHO-UMC scale suggests its utility for CA of suspected ADRs in indoor patients. The French method and Karch and Lasagna scale can be used for CA in hospitalized patients as an adjunct to Naranjo’s scale. Factors associated with disagreement should be considered at the time of reporting ADRs and evaluating causality.

scholarly journals Assessment of adverse drug reactions to antituberculosis regimen in a tertiary care hospital

2019 ◽  
Vol 8 (10) ◽  
pp. 2202
Author(s):  
Sanitha Kuriachan ◽  
Prakash Krishnan ◽  
Bharti Chogtu ◽  
Manu Mathew George
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Patient Adherence ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Antitubercular Treatment ◽  
Improve Patient

Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.

scholarly journals Comparative study of adverse drug reaction pattern of two anti-asthma groups of drugs in a tertiary care hospital

2019 ◽  
Vol 8 (4) ◽  
pp. 788
Author(s):  
Narendra Babu S. ◽  
Vinoth Kumar C. ◽  
Nandini R.
Keyword(s):  
Bronchial Asthma ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Bronchial Tree ◽  
Vital Role ◽  
Care Hospital ◽  
Drug Reactions ◽  
Beta 2 ◽  
Madras Medical College

Background: Bronchial Asthma is one of the worldwide health problems associated with increased morbidity and also mortality. Bronchial Asthma is a disease of airways that is characterized by increased responsiveness of the trachea-bronchial tree. Anti asthmatic drugs are associated with adverse effects which can affect the compliance and course of treatment. Monitoring adverse drug reactions in asthma will play a vital role in alerting physicians about the possibility and circumstances of such events, thereby protecting the user population from avoidable harm.Methods: The study was conducted in 500 bronchial asthma patients (250 patients in Beta 2 agonist group (Salbutamol) and 250 patients in Methylxanthine group (Deriphyllin) who fulfilled the study criteria and were observed for three months at Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai. Their prescriptions were collected and analysed. Adverse drug reactions(ADRs) in each group were collected and evaluated. The causality assessment was done by WHO-UMC assessment scale and severity by using Modified Hartwig-Seigel severity assessment scale.Results: Total 38% of patients taking anti-asthma drugs were encountered adverse drug reactions and were more common in elderly females (61 to 70 years). Adverse Drug Reactions were more common in Methylxanthine group (48%) compared to Beta 2 agonist group (28%). Headache (38%) was the commonest ADR in Methylxanthine group and Tremors (31%) in Beta 2 agonist group. Most of ADRs were mild (95 %), manageable and comes under possible (60 %) category of WHO causality assessment scale.Conclusions: Treatment of Bronchial Asthma is mainly based on Beta 2 agonist and Methylxanthine group. So, occurrence of ADR is much common. Our study offers a representative idea of the ADR profile of anti asthmatic drugs. Constant vigil in detecting ADRs and subsequent dose adjustments can make therapy with anti asthmatic drugs safer and more effective. This, in turn, will improve compliance.

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

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2669-2674
Author(s):  
Dona Thomas ◽  
Sharon Thomas ◽  
Venkateswaramurthy N ◽  
Sambathkumar R
Keyword(s):  
Observational Study ◽  
Medication Errors ◽  
Adverse Drug Reactions ◽  
Tamil Nadu ◽  
Prospective Observational Study ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Psychiatry Department

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

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

2020 ◽  
Vol 9 (4) ◽  
pp. 611
Author(s):  
Ankitha L. ◽  
Ramesh H.
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Causality Assessment ◽  
Care Center ◽  
Tertiary Care ◽  
General Medicine ◽  
Accurate Estimate ◽  
Care Hospital ◽  
Drug Reactions

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.

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