scholarly journals A Profile of Adverse Drug Reactions in a Teritiary Care Teaching Hospital and Associated Factors

2021 ◽  
Vol 14 (1) ◽  
pp. 367-371
Author(s):  
Sree Sudha TY ◽  
Yakaiah Vangoori ◽  
Anjaly Mary Varghese
Keyword(s):  
Adverse Effects ◽  
Adverse Drug Reactions ◽  
Hospital Admissions ◽  
Causality Assessment ◽  
Improve Patient Safety ◽  
Financial Burden ◽  
Drug Reactions ◽  
Related Factors ◽  
Organ Systems ◽  
History Of

Objective: The present study was conducted to identify, analyze the causality, and severity of adverse drug reactions and to find out the factors associated with ADR related factors. Adverse effects of drugs are identified as one of the main reason for increasing in-patient number in the hospital. This has become financial burden and also rise in mortality rate in society. The main purpose of the pharmacovigilance program is to identify the risks linked with the use of drugs. This study may be useful to identify and prevent adverse effects caused by drugs to increase the quality of life and ability of doctors to treat consequences of ADRs more effectively. The main aim of the present study was to explore and identify adverse effects caused by drugs and to improve patient safety with pharmacovigilance activities. Method: An observational study was conducted as part of Pharmacovigilance program for 14 months (January 2018 - Feb 2019). ADRs reported from hospital were filled into Suspected ADR forms - CDSCO forms. Causality assessment was done based on WHO- UMC causality scale and severity was assessed using Hartwig-Siegel scale. By taking history of the patient, and by regular monitoring of the inpatients, the causative factors for ADR related hospital admissions were evaluated. Results: Total 145 ADR reports were analyzed. Most of the ADRs were observed in females (60%). Majority of ADRs were caused by NSAIDs (32.4%), followed by antimicrobials (20%). Most common organ systems involved was skin (38%). Causality assessment showed 85.5% ADRs as probable. 18.6% of ADRs were of severe type and 51% moderate. ADR related hospital admissions were found in 53 cases (36.5%) and 92 cases of ADRs occurred during hospitalization (63.4%). Conclusion: The study generated a data of ADRs that is useful to the clinicians for optimum and safe use of drugs in day to day practice and help in creating ‘P’ drug list. The major reasons for ADR related hospital admissions are OTC and non-compliance. Hence a constructive Pharmacovigilance to minimize ADR related hospitalization, treatment cost, morbidity and mortalities are the need of the hour.

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.

The role of electronic records in reporting adverse drug reactions.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 309-309
Author(s):  
Alanna M. Poirier ◽  
Paul Nachowicz ◽  
Subhasis Misra
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Drug Reactions ◽  
Improve Patient Safety ◽  
Cancer Center ◽  
Health Record ◽  
Drug Reactions ◽  
History Of ◽  
Electronic Health

309 Background: The Pharmacy and Therapeutics committee at a regional cancer center is responsible to report and trend existing adverse drug reactions. The electronic health record did not have an option to document the history of an event or have an alert function if a medication was re-ordered. The frequency of documented adverse drug reactions did not correlate to what was being observed on the units with the use of a paper document. Methods: InAugust 2010 a Lean Six Sigma project was initiated to improve adverse drug reaction reporting. An adverse drug reaction document along with standard work instructions was completed by March 2011. A report was built in the electronic health record and a computer based learning module was created and rolled out to clinical staff by October 2011. Results: The turn-around time in days to document an adverse drug reaction in the patients chart decreased from 6.8 days to 0.7 days. The documented adverse drug reactions increased by 37%; verified by the use of supportive medications. Conclusions: The root cause for under-reporting was attributed to lack of knowledge, process, and automation. The history of an adverse drug reaction can now be viewed and an automatic alert is produced requiring physician acknowledgement decreasing the chance of repeated discomfort or harm to the patient. Adverse drug reaction documentation can be retrieved within 24 hours, analyzed, trended, and used for educational purposes to improve patient safety. [Table: see text]

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 Pharmacovigilance in cancer chemotherapy in regional cancer center of Eastern India: prospective observational study

2017 ◽  
Vol 6 (8) ◽  
pp. 1910 ◽  
Author(s):  
Anima Rout ◽  
Rajendra K. Panda ◽  
Vedvyas Mishra ◽  
Prasant Parida ◽  
Srikant Mohanty
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Cancer Chemotherapy ◽  
Prospective Observational Study ◽  
Causality Assessment ◽  
Financial Burden ◽  
Morbidity And Mortality ◽  
Cancer Center ◽  
Platinum Compound ◽  
Drug Reactions

Background: Globally cancer is the leading cause of morbidity and mortality with annual death rate of 12%. According Indian Council of Medical Research, more than 1300 Indians die every day due to cancer. Chemotherapy is one of the multimodal approaches for treatment of cancer and regimens are much complex and cancer patients are more susceptible to adverse drug reaction with little tolerance due to diminished immunity. The present study was done to evaluate the prevalence of various adverse drug reactions with different cancer chemotherapy regimens, their nature and severity as well as their causality assessment as per WHO scale.Methods: This prospective observational study was conducted from July 2015 to June 2016. Patients receiving cancer chemotherapy from regional cancer centre, Cuttack were observed during the study period for the adverse drug reactions. Those ADRs were analysed for causality assessment, severity and preventability.Results: It was observed that after the initiation of chemotherapy, ADRs were observed in 92 (88.46%) patients. Among these 329 observed ADRs, during the study period, female predominance was observed in the age group 51-60yrs. Most common ADRs observed were nausea and vomiting 57 (17.37%), alopecia 46 (13.98%) and neutropenia 38 (11.55%). ADRs were most commonly seen with the haematological systems (37.68%) followed by gastrointestinal system amounting 25.22% of the total ADRs. Platinum Compound (58.35%), followed by antibiotics, antimetabolites, were the most common group of drugs causing different adverse drug reactions. On causality assessment, as per WHO-UMC criteria 68.38% were probable and 31.62% ADRs were possible. Severity assessment showed majority of the ADRs were moderate 228 (69.31%) followed by mild 67 (20.36%) and severe 34 (10.33%). It was observed that majority 212 (64.45%) of the ADRs were not preventable, 72 (21.88%) were definitely preventable and 45 (13.67%) were probably preventable.Conclusions: Cancer chemotherapy has definitely improved the quality of life, but associated ADRs need early diagnosis, prompt management and routine reporting. Thus, pharmacovigilance will definitely reduce morbidity and mortality, so also the financial burden for the patients and society.

scholarly journals Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

2021 ◽  
Author(s):  
Malahat Khalili ◽  
Hamid Sharifi ◽  
Bita Mesgarpour ◽  
Fatemeh Dabaghzadeh ◽  
Ali Akbar Haghdoost
Keyword(s):  
Hospital Stay ◽  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Economic Burden ◽  
Hospital Admissions ◽  
Improve Patient Safety ◽  
Healthcare Delivery ◽  
Drug Reactions ◽  
Drug Safety Issue ◽  
Tertiary Hospitals

Abstract Background: Monitoring and detecting adverse drug reactions (ADRs) in hospitals is crucial to improving drug safety and healthcare delivery quality. Nevertheless, there was not enough information on ADR incidence and its figure in Iran. Aim: this study aimed to determine the incidence of ADRs in hospitalized patients and investigate their characteristics in Iran.Methods: We conducted a three-month prospective study in two tertiary hospitals in 2019. All admitted patients were intensively monitored for all suspected ADRs through daily visiting hospital wards and soliciting information from physicians, nurses and interviewing suspicious patients. We calculated the incidence of ADRs, and 95% confidence intervals (95% CI). Poisson regression was used to evaluate risk factors for ADR incidence. Results: Among 13,613 admitted patients, we detected 115 ADRs in 114 patients. The incidence of ADR was 8.4 per 1000 admissions (95% CI: 7.0-10.1), and 13.9% of them were ADR-related hospital admissions. The risk of ADRs was significantly predicted by age, length of hospital stay, patients’ diagnostics, number of drug usage, and using respiratory system agents and anti-infectives for systemic use. The most common ADRs were skin and subcutaneous manifestations (52.2%), and 62.6% of ADRs were caused by anti-infectives (commonly vancomycin, ceftriaxone, and ciprofloxacin). Conclusion: This study indicated that ADRs occurrence during the hospital stay or resulting in hospital admissions are considerable. Given that ADR occurrence could be associated with increased morbidity, mortality, and economic burden, constant intensive monitoring is required to address the drug safety issue and promote actions to improve patient safety and reduce the health and economic burden.

ADRs Causing Hospital Admissions; A Reader's Tale of Serotonin Syndrome; Adverse Effects of Laxatives; Oxcarbazepine-Induced SIADH; Two Problems with Fluoroquinolones

2002 ◽  
Vol 37 (11) ◽  
pp. 1143-1146 ◽  
Author(s):  
Joel Shuster
Keyword(s):  
Adverse Effects ◽  
Adverse Drug Reactions ◽  
Serotonin Syndrome ◽  
Hospital Admissions ◽  
Drug Reactions

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

scholarly journals Adverse drug reactions in hospitalized patients in a tertiary care teaching hospital: analysis of the reported cases

2018 ◽  
Vol 7 (7) ◽  
pp. 1377
Author(s):  
Althab Begum M. ◽  
Satyajit Mohapatra ◽  
R. Jamuna Rani
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
General Medicine ◽  
Drug Reactions ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching ◽  
Organ Systems

Background: Adverse Drug Reactions (ADR’s) contributes to the burden of drug-related morbidity and mortality. ADRs are seen frequently in hospitals due to a variety of factors like complexity of diseases, drug interactions, polypharmacy, and possible negligence. The purpose of the study was to identify and assess ADR in various departments of a tertiary care teaching hospital.Methods: A prospective spontaneous reporting was carried out in a tertiary care teaching hospital during a period of four months from November 2016 to February 2017. All suspected spontaneous ADRs were assessed and the information was collected and analyzed by the pharmacologists for causality assessment using the Naranjo’s causality assessment scale.Results: A total of 30 ADRs were reported with female preponderance (70%). Majority of ADRs were from General Medicine and Oncology departments. The most affected organ systems were skin (80%) followed by the gastrointestinal system (13.3%). The most frequent drugs causing ADRs were antibiotics (56.3%) in which type B reactions were more compared to type A and followed by anticancer drugs (10%). The severity assessment showed that most of them were mild reactions (76.6%). Causality assessment revealed that 90% of the reactions were probable, 10% were possible and no reactions were unlikely.Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to increased hospital stay. The reporting of the ADRs to regional Pharmacovigilance centers should be encouraged to ensure drug safety.

scholarly journals Adverse Drug Reactions in Norway: A Systematic Review

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 102 ◽  
Author(s):  
Vaismoradi ◽  
Logan ◽  
Jordan ◽  
Sletvold
Keyword(s):  
Systematic Review ◽  
Healthcare System ◽  
Adverse Drug Reactions ◽  
Hospital Admissions ◽  
Financial Burden ◽  
Healthcare Providers ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Psychotropic Medicines ◽  
Comprehensive Picture

Prescription medicines aim to relieve patients’ suffering but they can be associated with adverse side effects or adverse drug reactions (ADRs). ADRs are an important cause of hospital admissions and a financial burden on healthcare systems across the globe. There is little integrative and collective knowledge on ADR reporting and monitoring in the Norwegian healthcare system. Accordingly, this systematic review aims to investigate the current trends in ADR reporting, monitoring, and handling in the Norwegian healthcare system and describe related interventions. Appropriate keywords, with regard to ADRs in both English and Norwegian languages, were used to retrieve articles published from 2010 to 2019. Six articles met the inclusion criteria. The findings offer a comprehensive picture of ADR reporting and monitoring in the Norwegian healthcare system. Psychotropic medicines were most commonly implicated by patients, while professionals most commonly reported ADRs associated with anticoagulants. The current ADR systems were compiled with the involvement of both patients and healthcare providers to record all types of drugs and ADRs of various severities, and aimed at improving ADR tracking. However, there is a need to improve current initiatives in terms of feedback and quality, and more studies are needed to explore how ADR profiles, and the associated vigilance, can improve the safety of medicines management in Norway.

scholarly journals A study on prospective monitoring of adverse drug reactions associated with hematinics at a tertiary care teaching hospital

2021 ◽  
Vol 2 (1) ◽  
pp. 16-21
Author(s):  
P. Vinay ◽  
P. Venkata Ramana ◽  
B. Jaya Kiran ◽  
K. Meghana ◽  
N. Vineetha
Keyword(s):  
Adverse Drug Reactions ◽  
Prospective Observational Study ◽  
Adverse Reactions ◽  
Causality Assessment ◽  
Tertiary Care ◽  
General Medicine ◽  
Care Hospital ◽  
Drug Reactions ◽  
Organ Systems ◽  
Prospective Monitoring

Introduction: Adverse reactions are the documented hazards of drug treatment and they can happen with any class of drugs and several studies exposed that the incidence is increasing with blood and blood products. Objectives: The main aim of this study is to identify and analyze Adverse Drug Reactions with Hematinics in a tertiary care hospital. Methods: This prospective observational study was conducted for a period of 6 months. Results: A total of 29 ADRs were reported during the study period with a female high proportion (79.31%), more amounts of ADRs were from Obstetrics & Gynecology and General Medicine in which the mainly affected organ systems were the skin (86.20%) and the GIT (13.79%). The hematinics mostly accounted were Iron sucrose (44.82%) followed by ferric carboxy maltose (37.93%) and Iron dextran (17.24%) in which type B reactions were more compared to type A and 72.41% of them were unpredictable. The severity assessment revealed that the majority of them were moderate reactions (62.06%). Out of the reported reactions, 58.62% were definitely preventable and a causality assessment was done which showed that 68.96% of the reactions were probable, possible (20.68%) and conditional (10.34%). Most of the patients (65.51%) were treated with Antihistamines & corticosteroids, with only anti-histamines (24.13%) and no treatment (10.34%). Conclusions: The study concludes that Adverse Drug Reactions with Hematinics are increasing in recent days. Better vigilance is necessary for the implementation of safe and effective treatment with hematinics for each and individual patient.

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