scholarly journals ANALYSIS OF THE ADVERSE DRUG REACTIONS COLLECTED THROUGH ACTIVE SURVEILLANCE IN THE PHARMACOVIGILANCE UNIT OF A TERTIARY CARE HOSPITAL

2018 ◽  
Vol 11 (8) ◽  
pp. 383
Author(s):  
Anand M Ingale ◽  
Pratibha Nadig ◽  
Ananya Chakraborty
Keyword(s):  
Active Surveillance ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Organ System ◽  
Research Centre ◽  
Care Hospital ◽  
Drug Reactions ◽  
Comorbid Conditions ◽  
Medical Sciences ◽  
Cross Sectional

Objectives: The objectives of the study were to analyze the various adverse drug reactions (ADRs) collected in the Pharmacovigilance Unit of Vydehi Institute of Medical Sciences and Research Centre with respect to their causality, severity, and preventability and also to identify the various risk factors, concomitant medications, and comorbid conditions with the occurrence of these events.Methods: A prospective, non-interventional, observational, and cross-sectional study was carried out in the various clinical departments of Vydehi Institute of Medical Sciences and Research Centre from June 2014 to May 2015. The Classes of drugs, Organ system involved, Comorbid conditions associated and Concomitant drugs involved in causing ADRs were looked into. The assessment for causality and severity was determined by Naranjo and Modified Hartwig and Siegel scales, respectively. The data were compiled and subjected to descriptive statistical analysis.Results: A total of 433 patients developing ADR reports were analyzed during our study period. Of these, 53.59% were females. 75% of them were of adult age group. Antimicrobials and chemotherapy group showed the maximum ADRs. The skin and appendages (27.6%) were the most affected organ system followed by the gastrointestinal system (22.8%). Comorbid conditions were found in 76 (20.1%) reports; of which diabetes (28.9%) and hypertension (26.3%) were maximum. 74 were serious reports. Maximum reports were probable and of mild severity.Conclusion: Through active surveillance of the ADRs helps in early detection and prevention of all the possible adverse events associated with the usage of drugs and thereby provides a better health-care treatment to the patients. 

scholarly journals An observational study of adverse drug reactions reported in a rural tertiary care hospital

2019 ◽  
Vol 8 (11) ◽  
pp. 2367
Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Unintended Effects ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Physician Visits ◽  
Medical College

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

scholarly journals An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study

2018 ◽  
Vol 7 (9) ◽  
pp. 1715
Author(s):  
Abdul Aslam P. ◽  
Sangeetha Purushothaman ◽  
Jihana Shajahan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Important Concern ◽  
Post Marketing ◽  
The Individual ◽  
Prolonged Hospital ◽  
Sectional Analysis

Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.

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 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.

PATTERN OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL – A CROSS-SECTIONAL STUDY

2021 ◽  
pp. 51-53
Author(s):  
LIMA KORUTHARA MOHANAN ◽  
DHANYA THIROOKARAN HARICHANDRAN ◽  
SANALKUMAR KB
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Antineoplastic Drugs ◽  
Care Hospital ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Suspected Adverse Drug Reactions

Objective: The objective of the study was to study the pattern of suspected adverse drug reactions (ADRs) in a tertiary care hospital. Methods: This is a cross-sectional study conducted in the Department of Pharmacology of a Tertiary Care Teaching Hospital, Kerala. As part of pharmacovigilance activities, the ADRs were collected in Central Drug Standard Control Organization Suspected ADR reporting form from various departments during a period of 3 months and recorded in Pharmacovigilance register maintained by the pharmacology department. As part of our study, we collected the details such as patient’s initials, age, gender, reporting department of hospital, description of the ADR, duration of the reaction, name of suspected ADRs, and outcome from the Pharmacovigilance register. Descriptive statistics will be used for data analysis by statistical package for the social science for windows 16. Results: Two hundred and twenty-two ADR from 141 patients obtained during a period of 3 months. The maximum ADR reports were in age group more than 50 years of age. The skin and appendages were most affected followed by gastrointestinal tract. Antineoplastic drugs accounted for 59.7% of drug class suspected for ADRs followed by use of more than one drug (14.1%). Among antineoplastic drugs, cyclophosphamide and carboplatin accounted for majority causes of ADR. The antibiotics accounted for 12.7% of all drugs. Among the antibiotics penicillin and cephalosporins caused most of the ADRs. Conclusion: The maximum number of ADR reported in our study was with the use of antineoplastic drugs and most common ADR reported was alopecia.

scholarly journals Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital

2017 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
B. Janardhan ◽  
D. Shailendra
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Clinical Manifestations ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Female Ratio ◽  
The Mean ◽  
Cutaneous Drug Reactions

<p class="abstract"><strong>Background:</strong> An adverse cutaneous drug reaction (ACDR) is defined as an undesirable clinical manifestation resulting from administration of a particular drug. With an ever increasing number of drugs and varied formulations being continuously made available it is important that a close watch on the risks of adverse drug reactions is looked for, to ensure safe use of medicines in the interest of the patient. In the present study our aim is to study the prevalence &amp; pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> All suspected cutaneous adverse drug reactions reported to the department of dermatology at MediCiti Institute of Medical Sciences during the two year period from January 2013 to December 2014 were included in this study. A thorough clinical examination of all these cases &amp; details related to the drug use and clinical manifestations of the cutaneous adverse drug reaction were documented using a structured proforma. Naranjo scale was used to assess causality in all the causes of cutaneous adverse drug reactions.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients was 42 years (age range: 1-64 years). Most of them were in the age group of 30-39 years. The male to female ratio was 1.78:1. The most common type of skin eruptions observed were maculopapular rash (35.55%), urticaria (26.19%) and fixed drug eruption (17.87%). The mean duration between drug intake and appearance of rash was 4 days (range: 1-120 days)<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> The pattern of ACDRs and the drugs causing them in this study were similar to that reported in other studies both in terms of disease burden and clinical pattern. Knowledge of adverse cutaneous drug reactions will help to identify common medications contributing to dermatological reactions, so as to anticipate, prevent and limit their undue consequences<span lang="EN-IN">.</span></p>

scholarly journals Dermatological adverse drug reactions in tertiary care hospital: an analysis of causality and severity

2018 ◽  
Vol 7 (8) ◽  
pp. 1620
Author(s):  
Kalpana R. Bharani ◽  
Nitibhushansingh R. Chandel ◽  
Chhaya A. Goyal
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Age Distribution ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions ◽  
Morphological Pattern ◽  
Cross Sectional ◽  
Moderate Severity

Background: Dermatological adverse drug reactions (ADRs) are easily detected by patients and that precludes further usage of drugs. So, decided to study the pattern, causative drugs, severity of adverse drug reactions and their causality in tertiary care hospital.Methods: It was prospective non inventional cross sectional study. Patients attending OPD or admitted to IPD of all age group and both gender with suspected dermatological ADRs following drug intake were included and the ADRS were recorded on CDSCO’s Pharmacovigilance form. Collected data was analyzed for assessment of causality using WHO-UMC scale, for severity by using Modified Hartwig and Siegel. Morphological pattern, drug groups, gender and age distribution was analyzed.Results: 231 dermatological ADRs were recorded and analyzed. Maximum cases were found in 21-30 years age group (74 cases). Dermatological ADRs were found in 143 females and in 88 males. Three major classes of drugs found responsible for causing dermatological ADRs were -oral Antimicrobials-41 (17.75%) and Injectable Antimicrobials-40 (17.32%), NSAID's-40 (17.32%.) and Topical Betnovate-36 (15.58%.). Regarding the type, 95 cases were of maculopapular rashes (41.12%), steroid damaged face in 42 (18.18%) andacute urticaria in 20 (8.65%). In terms of Severity assessment, authors found 23 cases (9.95%) as Mild, 176 cases (76.19%) of moderate severity and 32 cases (13.85%) of Severe category. In terms of causality assessment: 3 cases as Certain, 68 cases as Probable and 160 cases as Possible.Conclusions: From this study, it was found maximum Dermatological ADRs of moderate severity and few cases of causality category as “Certain”.

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