scholarly journals Causality assessment and the severity of the adverse drug reactions in tertiary care hospital: a pharmacovigilance study

2017 ◽  
Vol 6 (12) ◽  
pp. 2800
Author(s):  
S. G. S. Rajeshreddy V. ◽  
Lokesh V. Patil
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Clinical Problem ◽  
Care Hospital ◽  
Drug Reactions ◽  
Number Of Patients ◽  
Care Costs

Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health care costs. To study the adverse drug reactions reported in a tertiary care hospital and study of causality assessment and severity of adverse drug reaction (ADR) cases reported.Methods: A prospective observational study was conducted as part of pharmacovigilance program over 12months between September 2015 and August 2016. Adverse drug reactions reported from hospital were filled into Suspected ADR - CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo’s algorithm and WHO - UMC causality scale. The severity of each ADR was assessed using Modified Hartwig and Siegel scale.Results: Total 120 cases were reported over 12 months. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by haematinics (12%) and anti-epileptics (10%). Maximum number of patients (30.25%) reported with dermatological manifestations. Highest number of ADRs was reported from the department of medicine (45%). As per Naranjo’s scale, 54% reports were assessed as probable and 46% classified as possible. Majority of cases were mild to moderate in severity.Conclusions: The pattern of ADRs reported in our hospital is similar with the pattern of studies conducted in other hospitals elsewhere. This study provides a database of ADRs due to commonly used drugs in our hospital, which will help clinicians for their optimum and safe use. Hence effective pharmacovigilance is required for the use of these drugs and their safety assessment.

scholarly journals A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India

2018 ◽  
Vol 7 (7) ◽  
pp. 1257
Author(s):  
Hemavathy G. ◽  
Jeyalalitha Rathinam ◽  
Preethi A. ◽  
Divakar R.
Keyword(s):  
Retrospective Analysis ◽  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Antihypertensive Drugs ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions

Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.

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 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 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 Antibiotic-Related Adverse Drug Reactions at a Tertiary Care Hospital in South Korea

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
In Young Jung ◽  
Jung Ju Kim ◽  
Se Ju Lee ◽  
Jinnam Kim ◽  
Hye Seong ◽  
...  
Keyword(s):  
South Korea ◽  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Clinical Information ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Manifestations

Background. Adverse drug reactions (ADRs) are any unwanted/uncomfortable effects from medication resulting in physical, mental, and functional injuries. Antibiotics account for up to 40.9% of ADRs and are associated with several serious outcomes. However, few reports on ADRs have evaluated only antimicrobial agents. In this study, we investigated antibiotic-related ADRs at a tertiary care hospital in South Korea.Methods. This is a retrospective cohort study that evaluated ADRs to antibiotics that were reported at a 2400-bed tertiary care hospital in 2015. ADRs reported by physicians, pharmacists, and nurses were reviewed. Clinical information reported ADRs, type of antibiotic, causality assessment, and complications were evaluated.Results. 1,277 (62.8%) patients were considered antibiotic-related ADRs based on the World Health Organization-Uppsala Monitoring Center criteria (certain, 2.2%; probable, 35.7%; and possible, 62.1%). Totally, 44 (3.4%) patients experienced serious ADRs. Penicillin and quinolones were the most common drugs reported to induce ADRs (both 16.0%), followed by third-generation cephalosporins (14.9%). The most frequently experienced side effects were skin manifestations (45.1%) followed by gastrointestinal disorders (32.6%).Conclusion. Penicillin and quinolones are the most common causative antibiotics for ADRs and skin manifestations were the most frequently experienced symptom.

scholarly journals A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA

2019 ◽  
pp. 89-92
Author(s):  
JERIN JAMES ◽  
JAMUNA RANI
Keyword(s):  
Adverse Drug Reactions ◽  
South India ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Negative Impact ◽  
Tertiary Care ◽  
Laboratory Data ◽  
Health Concern ◽  
Care Hospital ◽  
Drug Reactions

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale. Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail. Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole. Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.

scholarly journals Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

2018 ◽  
Vol 7 (2) ◽  
pp. 303
Author(s):  
Manodeep Sen ◽  
Arpita Singh ◽  
Mukul Misra
Keyword(s):  
Health Care ◽  
Retrospective Analysis ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Antimicrobial Agents ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.

Pattern, severity, and outcome of adverse drug reactions in a tertiary care hospital: an evidence from a cross-sectional study

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Manik Chhabra ◽  
Manjeet Singh Jangra ◽  
Muhammed Rashid ◽  
Puneet Sharma ◽  
Kota Vidyasagar
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Significant Risk ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Medicine Department ◽  
Number Of Patients

Abstract Objectives Study aim to describe the spontaneous reporting of the adverse drug reactions (ADRs) among the patients admitted to medicine department of a tertiary care hospital. Methods A prospective observational study was conducted over a period of four months at the medicine department. On the daily basis, all the patients aged >18 years admitted to the internal medicine department were followed and analyzed for occurrence of ADRs. Naranjo scale was used to determine causal relationship between the ADRs and suspected drugs. The nature of ADRs and its severity was assessed using the Hartwig scale. Results A total of 4,530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were type A (augmented). The least number of ADRs were observed in the age group of 31–40 years. Furthermore, the more significant number of male patients suffered from a severe type of ADRs as compared to females. Sixteen ADRs were of the mucocutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs was in the age group 41–60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups. Conclusions There is a strong need to extend the monitoring and reporting of the ADRs to ensure the patient safety. However, the overall incidence of ADRs appeared to be less in our study, highlighting the need for strengthening reporting system of ADRs. The results indicate that elderly patients are at significant risk of developing ADRs.

Sign in / Sign up

Export Citation Format

Share Document