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 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 Evaluation of adverse drug reactions of anti-tubercular drugs in the treatment of tuberculosis in tertiary care hospital

2020 ◽  
Vol 9 (9) ◽  
pp. 1430
Author(s):  
Krishnakanth K. ◽  
Jagadeesh A. ◽  
Swetha T. D.
Keyword(s):  
Adverse Drug Reaction ◽  
Adverse Drug Reactions ◽  
Adverse Drug Events ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Medicine Department ◽  
Study Results

Background: Adverse drug reactions are very common among patients on anti-tubercular treatment. Hence, the current study was done to evaluate the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT).Methods: A 6 months prospective, cross-sectional observational study was performed in collaboration with Pulmonology Medicine department. WHO-UMC scale and Naranjo scale was used to evaluate the ADRs.Results: Ninety-two patients receiving ATT presented with 113 adverse drug events (ADE). Males were more affected than females. DOTS category-1 regimen was mostly responsible for ADE. Addition of drugs for the management of ADR events was done.Conclusions: The study results show more ADRs related to ATT demanding increased collaboration between NTEP 2020 and Pharmacovigilance Programme of India to enhance drug safety in this field.

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

2019 ◽  
Vol 8 (11) ◽  
pp. 2423
Author(s):  
S. Sre Akshaya Kalyani ◽  
Pendota Srihitha ◽  
Katnapally Abhinay Sharma ◽  
Porandla Dharanija ◽  
Sandeep Kumar Bheemreddy
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Observational Study ◽  
Health Care Professionals ◽  
Prospective Observational Study ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adr Reporting

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.

scholarly journals An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

2019 ◽  
Vol 7 (3) ◽  
pp. 687
Author(s):  
Preet Lakhani ◽  
Divya Singh ◽  
Shireen Barua ◽  
Suchi Jain ◽  
Surya Kant ◽  
...  
Keyword(s):  
Observational Study ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Multidrug Resistant ◽  
Predisposing Factors ◽  
Care Hospital ◽  
Drug Reactions ◽  
Resistant Tuberculosis ◽  
Previously Treated

Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.

scholarly journals Causality assessment of adverse drug reaction in Pulmonology Department of a Tertiary Care Hospital

2015 ◽  
Vol 6 (3) ◽  
pp. 84 ◽  
Author(s):  
Amer Khan ◽  
MirS Adil ◽  
K Nematullah ◽  
S Ihtisham ◽  
K Aamer ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital

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.

Surveillance of adverse drug reactions and drug–drug interactions with pediatric oncology patients in a south Indian tertiary care hospital

2019 ◽  
Vol 26 (5) ◽  
pp. 1103-1109
Author(s):  
Bency Joseph ◽  
Julius X Scott ◽  
M G Rajanandh
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Interaction ◽  
Adverse Drug Reactions ◽  
Pediatric Oncology ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Drug Interaction

Objective The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug–drug interaction in a pediatric oncology unit of a tertiary care hospital. Methods A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug–drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug–drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. Results Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are “probable” (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug–drug interaction, 38.13% of the prescription needs to be monitored and 10 drug–drug interactions were under the risk category of “X.” The majority of the adverse drug reaction was moderately severe in nature and those were preventable. Conclusion Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug–drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

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.

Sign in / Sign up

Export Citation Format

Share Document