scholarly journals Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reactions Found in a Tertiary Care Teaching Hospital

2018 ◽  
Author(s):  
Siraj Sundaran ◽  
Anjali Udayan ◽  
Keerthi Hareendranath ◽  
Basil Eliyas ◽  
Babu Ganesan ◽  
...  
Keyword(s):  
Healthcare Professionals ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Hospital Setting ◽  
Common Type ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Reporting Programs ◽  
Monitoring Service ◽  
Assessment Scales

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of drugs. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The drugs most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer drug use. Similar ADR reporting programs are necessary to educate and to improve awareness among the healthcare professionals in developing countries.

scholarly journals Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients

Pharmacy ◽  
2018 ◽  
Vol 6 (4) ◽  
pp. 108 ◽  
Author(s):  
Siraj Sundaran ◽  
Anjali Udayan ◽  
Keerthi Hareendranath ◽  
Basil Eliyas ◽  
Babu Ganesan ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Causality Assessment ◽  
Hospital Setting ◽  
Adr Reporting ◽  
Reporting Programs ◽  
Monitoring Service ◽  
Assessment Scales

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries.

scholarly journals A survey of knowledge, attitude and practice of adverse drug reaction monitoring among doctors in Western Odisha region

2018 ◽  
Vol 7 (11) ◽  
pp. 2234
Author(s):  
Kaustav Saha ◽  
Bhabagrahi Rath ◽  
Ratna Agrawal
Keyword(s):  
Healthcare Professionals ◽  
Tertiary Care ◽  
Reaction Monitoring ◽  
Drug Reactions ◽  
Voluntary Reporting ◽  
Adverse Drug Reaction Monitoring ◽  
Adr Reporting ◽  
Attitude And Practice ◽  
Almost All ◽  
Knowledge Attitude And Practice

Background: Adverse drug reactions (ADRs) are the major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an important role in the reduction of ADRs. Voluntary reporting of ADRs by healthcare professionals is an important tool in the success of pharmacovigilance program, but the same are scantly reported due to lack of awareness and knowledge among the physicians. So, the present study was conducted to evaluate the knowledge, attitude and practice (KAP) regarding ADR reporting among healthcare professionals at a tertiary care hospital.Methods: A questionnaire-based study containing 25 questions (knowledge- 18, attitude -2 and practice- 5) was conducted in 70 prescribers and time allotted to complete it was 1 week. Statistical analysis was done by using Graph Pad Prism version 6.01.Results: Out of 70 prescribers, only 50 (71.43%) responded. ADR reporting was considered very important by almost all of them, but actual practice was lacking as only 36% of consultants had reported any ADR. The higher grading was given to causes most important for reporting were patient safety, to identify safe drug and new ADRs. The main reasons for under-reporting were unavailability of reporting forms when needed, uncertain association and lack of knowledge about reporting procedure.Conclusions: The prescribers are aware of the importance of ADR reporting, but lack of awareness and knowledge are most common cause of under-reporting. So, there is need of pharmacovigilance awareness program to improve voluntary reporting of ADRs.

scholarly journals A qualitative study to analyse adverse drug reaction reporting forms

2016 ◽  
Vol 4 (2) ◽  
pp. 208
Author(s):  
Thamizhvani D ◽  
Keerthana Brattiya. R ◽  
Ramachandra Bhat.C ◽  
Stalin C
Keyword(s):  
Adverse Reactions ◽  
Hospital Admissions ◽  
Causality Assessment ◽  
Adverse Drug Reaction Reporting ◽  
Pharmacovigilance Centre ◽  
Adr Reporting ◽  
Clinical Events ◽  
Incomplete Filling ◽  
Financial Burdens ◽  
Assessment Scales

Introduction: Adverse reactions to drugs cause increase in the hospital admissions. They also cause increased financial burdens to the patients. They can be reduced by increasing the awareness about adverse drug reactions. ADR reporting can create a database help in this regard. To make ADR reporting effective, good ADR reporting form is needed. This study was started to analyse the existing ADR forms of different countries and identify the possible improvements that can be made.Material and methods: ADR Reporting forms submitted to the Regional Pharmacovigilance Centre were analysed to identify the difficulties faced by the reporters while filling them. ADR reporting forms of different countries were also collected and analysed. Adequacies of these forms were analysed. Based on this qualitative analysis, areas for improvement were identified.Results: Use of generic names, use of abbreviations and incomplete filling up of the details were observed. Options for causality assessment scales, colouring of mandatory details, categorising ADRs as new or old, dates of intake of concomitant drugs were identified as items to be included in the ADR reporting forms in future.Conclusion: As per the study’s findings and other similar studies , dates of the concomitant drugs, categorisation of ADRs (as known or new ), different colours for the mandatory fields, options for causality assessment scales , whether the ADR is medically confirmed , exact chronology of clinical events are the items which can be included in ADR reporting forms in future. Need for more training for primary reporters in filling up of the ADR reporting form is recognized in this study.

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 Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

2018 ◽  
Vol 7 (7) ◽  
pp. 1345
Author(s):  
Kabilan K. ◽  
Sathyanarayanan V. ◽  
R. Jammuna Rani
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Type A ◽  
Drug Reactions ◽  
Male Predominance ◽  
Organ Systems ◽  
A Prospective Study

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

scholarly journals Analysis of spontaneously reported adverse drug reactions to pharmacovigilance cell of a tertiary care hospital

2018 ◽  
Vol 7 (8) ◽  
pp. 1551
Author(s):  
Kaksha J. Patel ◽  
Ashwin K. Panchasara ◽  
Manish J. Barvaliya ◽  
C. B. Tripathi
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Geriatric Patients ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Common Group ◽  
Selection Of

Background: The objective of the study was to study the clinical patterns, causality and severity of adverse drug reactions in a tertiary care hospital.Methods: Total 131 ADR forms were collected from January 2012 to December 2012 and evaluated. Patient’s characteristics, ADR and drug characteristics, causality, severity and preventability of collected ADR were analyzed.Results: Total 131 ADR forms were evaluated. Male patient experiencing ADR were more (73, 55.7%) than female (58, 44.2%). Adult patients (12-60 years) experienced 110 (84%) ADR followed by pediatric patients (< 12 years) 11 (8.4%) and geriatric patients (>60 years) 10 (7.63%). Antimicrobial were the most common group of drugs responsible for ADR followed by NSAIDs and antipsychotic group.Conclusions: Present study shows lack of awareness among health care professionals for reporting of an ADR. Training and collaboration of health care professionals are needed for improvement in ADR reporting. Appropriate feedback from ADR reporting will help in selection of drug and promotes safer use of drugs.

scholarly journals Patterns and Causality Assessment of Adverse Drug Reactions in Inpatients of a Tertiary Care Hospital, Nepal

2020 ◽  
Vol 42 (3) ◽  
pp. 97-101
Author(s):  
Anish Mudvari ◽  
Dipendra Yadav ◽  
Rakesh Ghimire ◽  
Pravin Prasad
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Exposure ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
University Teaching ◽  
Care Hospital ◽  
Drug Reactions ◽  
Clinical Events ◽  
The World

Introduction Adverse drug reaction (ADR) is a leading cause of morbidity and mortality around the world. Causality assessment is done to establish relation of drug exposure with undesired clinical events. This study conducted in tertiary care hospital was undertaken to evaluate the patterns of ADR and causality assessment using Naranjo causality algorithm. MethodsData on suspected ADR cases were collected retrospectively from Medicine and Dermatology wards of Tribhuvan University Teaching Hospital, Kathmandu from April 2018 to April 2019. Naranjo causality assessment was performed. Statistical analysis was done using SPSS version 18. ResultsOf 34 suspected ADR, occurrence of ADR was more in females (18) as compared to males (16). Skin and integumentary system was the most common organ affected (35.29%). Pyrazinamide induced hepatitis was found to be the most common suspected ADR. Causality assessment was performed and ADRs were categorized as possible 17 (50%), probable 16 (47.06%) and definite 1 (2.94%). ConclusionThe patients are commonly admitted at the hospital due to suspected ADRs. Pyrazinamide induced hepatitis was the most common suspected ADR.

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 Knowledge, attitude and practice towards adverse drug reactions reporting in post graduate students of a tertiary care hospital

2019 ◽  
Vol 8 (6) ◽  
pp. 1320
Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Adr Reporting ◽  
Microsoft Office ◽  
Knowledge Attitude And Practice

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.

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.

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