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.

The feasibility and potential role of pharmacogenetics to improve drug safety in patients with advanced cancers.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e22522-e22522
Author(s):  
Sourat Darabi ◽  
Chelsey Weatherill ◽  
Valentina Dalili-Shoaie ◽  
Burton Larry Eisenberg ◽  
Michael J. Demeure
Keyword(s):  
Drug Metabolism ◽  
Drug Interactions ◽  
Advanced Cancer ◽  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Genetic Variants ◽  
Improve Patient Safety ◽  
Observation Interval ◽  
Clinical Effects ◽  
Drug Reactions

e22522 Background: Pharmacogenetics is the study of genetic variants that define drug metabolism and dosing requirements, response or toxicity. Knowledge regarding drug-drug interactions and individual variations in genes involved in drug metabolism is increasing. Since patients with cancer often take several drugs (polypharmacy), they have a higher risk of severe drug interactions. The FDA lists several pharmacogenetic biomarkers in drug labeling, including genetic variants that impact how certain medications are prescribed. The drugs listed span multiple medical applications, including but not limited to oncology, primary care, psychiatry, neurology, cardiology, and many more. Adverse drug reactions are a significant cause of morbidity and mortality, yet the use of pharmacogenetic testing has not yet become established as a routine in clinical practice. Herein we sought to study the feasibility of applied pharmacogenetics in a pilot drug safety program in patients with advanced cancer. Methods: We enrolled patients in a prospective single-center IRB approved study. Patients with advanced cancer on three or more drugs about to begin chemotherapy at the Hoag Family Cancer Institute were eligible. Informed consent was obtained from the study participants, and their samples were sent to a CLIA laboratory to conduct a 25-gene pharmacogenetics testing panel, which includes “major drug-metabolizing enzymes” CYP2D6, CYP2C19, CYP2C9, CYP3A4, and CYP3A5 as well as other genes with known drug implications. We recorded patients’ demographics and clinical information. In addition, participant’s drug lists were assessed for potential polypharmacy interactions. Results: We analyzed the results from 36 patients, 20 females and 16 males, enrolled between December 2017 and June 2020. Pharmacogenetics results from these patients showed that 61% (22 patients) had a variant with gene drug interaction indication. The most common variants were identified in the CYP2D6 gene, followed by CYP2C19, CYP3A4, and CYP3A5. Of these 22 patients, seven patients had at least one major criterion (drug interactions may lead to severe clinical effects), and eight patients with reported moderate criteria (may lead to substantial clinical effects). Additionally, seven patients had variants with both major and moderate criteria. Patients were taking an average of 10 medications per person ranging from 3-19 drugs. No patient, however, experienced significant drug toxicity during the observation interval. Conclusions: Patients with advanced cancer are at particular risk for polypharmacy and adverse drug reactions. Our data report supports pharmacogenetics testing as being feasible for oncology patients. Therefore, programs to prevent or limit the frequency and severity of drug reactions warrant further exploration as they offer the potential to improve patient safety and decrease healthcare costs.

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.

METHODOLOGIES FOR ASSESSING DRUG SAFETY, EFFECTIVENESS AND ADVERSE DRUG REACTIONS

2018 ◽  
Vol 20 (3) ◽  
pp. 112-117
Author(s):  
O.I. Slyusar ◽  
◽  
A.B. Kachalov ◽  
M.V. Ryzhkova ◽  
I.В. Slyusar ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Drug Reactions ◽  
Safety Effectiveness

Adverse Drug Reactions in Children Leading to Hospital Admission

PEDIATRICS ◽  
1988 ◽  
Vol 82 (1) ◽  
pp. 24-29
Author(s):  
Allen A. Mitchell ◽  
Peter G. Lacouture ◽  
Jane E. Sheehan ◽  
Ralph E. Kauffman ◽  
Samuel Shapiro
Keyword(s):  
Adverse Drug Reactions ◽  
Neonatal Intensive Care ◽  
Hospital Admissions ◽  
Teaching Hospitals ◽  
Surveillance Program ◽  
Pediatric Hospital ◽  
Drug Reactions ◽  
Drug Surveillance ◽  
Community Hospitals ◽  
Tetanus Vaccine

To provide information regarding pediatric hospital admissions prompted by adverse drug reactions, data were reviewed from an intensive drug surveillance program in which 10,297 patients admitted to diverse pediatric wards at four teaching and three community hospitals were systematically monitored. Among 3,026 neonatal intensive care unit admissions, 0.2% were prompted by adverse drug reactions; among 725 children with cancer, 22% of admissions were prompted by adverse drug reactions. Among 6,546 children with other conditions monitored on general medical and specialty wards at two teaching hospitals and on general pediatric wards at three community hospitals, 2% (131) of admissions were prompted by adverse drug reactions. Two patients (0.03%) died because of their reactions. The proportion of admissions prompted by drug reactions increased between infancy and 5 years of age and tended to be relatively stable thereafter. The drugs most commonly implicated in the admissions were phenobarbital, aspirin, phenytoin, ampicillin/amoxicillin, theophylline/aminophylline, trimethoprim-sulfamethoxazole, and diphtheria-pertussis-tetanus vaccine. Similar proportions of admissions were prompted by adverse drug reactions in teaching hospitals (2.1%) and in community hospitals (1.8%), and the drug groups implicated in these admissions were generally similar in the two settings. In contrast to adult populations, children with adverse drug reactions account for a small proportion of hospital admissions. Findings from this large, systematic study of pediatric admissions to teaching and community hospitals may serve as a baseline to which other pediatric facilities can compare their experience.

scholarly journals Operation Save the World from Adverse Drug Reactions: findings from a drug safety surveillance programme in Nigeria

2019 ◽  
Vol 7 ◽  
pp. S46 ◽  
Author(s):  
Yohanna Kambai Avong ◽  
Bolajoko Jatau ◽  
Gbenga Ayodele Kayode ◽  
Blessing Ukpabi ◽  
Eunice Bosede Avong ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Drug Reactions ◽  
Surveillance Programme ◽  
Safety Surveillance ◽  
Drug Safety Surveillance ◽  
The World
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