scholarly journals Can Active Surveillance Improve Reporting of Serious and Life-Threatening Adverse Drug Reactions? — The CPSP Experience

2011 ◽  
Vol 16 (9) ◽  
pp. 532-534 ◽  
Author(s):  
Margaret Zimmerman ◽  
Danielle Grenier ◽  
Miriam Levitt

2007 ◽  
Vol 33 (12) ◽  
pp. 2150-2157 ◽  
Author(s):  
Marieke Grenouillet-Delacre ◽  
Hélène Verdoux ◽  
Nicholas Moore ◽  
Françoise Haramburu ◽  
Ghada Miremont-Salamé ◽  
...  

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Wen-Lang Fan ◽  
Meng-Shin Shiao ◽  
Rosaline Chung-Yee Hui ◽  
Shih-Chi Su ◽  
Chuang-Wei Wang ◽  
...  

Adverse drug reactions (ADRs) remain a common and major problem in healthcare. Severe cutaneous adverse drug reactions (SCARs), such as Stevens–Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) with mortality rate ranges from 10% to more than 30%, can be life threatening. A number of recent studies demonstrated that ADRs possess strong genetic predisposition. ADRs induced by several drugs have been shown to have significant associations with specific alleles of human leukocyte antigen (HLA) genes. For example, hypersensitivity to abacavir, a drug used for treating of human immunodeficiency virus (HIV) infection, has been proposed to be associated with allele 57:01 of HLA-B gene (terms HLA-B∗57:01). The incidences of abacavir hypersensitivity are much higher in Caucasians compared to other populations due to various allele frequencies in different ethnic populations. The antithyroid drug- (ATDs- ) induced agranulocytosis are strongly associated with two alleles: HLA-B∗38:02 and HLA-DRB1∗08:03. In addition, HLA-B∗15:02 allele was reported to be related to carbamazepine-induced SJS/TEN, and HLA-B∗57:01 in abacavir hypersensitivity and flucloxacillin induced drug-induced liver injury (DILI). In this review, we summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.


2012 ◽  
Vol 25 (1) ◽  
pp. 22-29 ◽  
Author(s):  
James O’Donnell

Anticoagulants are powerful and unavoidably dangerous drugs that must be carefully selected, monitored, and evaluated. Every patient undergoing treatment is at risk of excess bleeding, since the primary purpose of this class of drugs is to decrease clotting through a variety of biochemical and pharmacological mechanisms. Under the best of circumstances, significant numbers of patients (∼10%) experience toxicity on traditional warfarin oral anticoagulants. Beyond the obvious type A pharmacological toxicity, heparin products carry a seemingly paradoxical/novel risk of increased coagulopathy with limb- and life-threatening thromboembolic injuries (heparin-induced thrombocytopenia [HIT]). As a result of the great toxicity risk, many patients suffer injuries, and litigation is threatened or initiated, frequently against pharmacists and their employers. This article reviews the therapeutic use of old and novel anticoagulants, lists the types of litigation related thereto, and discusses the HIT risk associated with heparin products treatment. Litigation can result from adverse drug reactions and toxicity from anticoagulants.


1985 ◽  
Vol 6 (10) ◽  
pp. 297-303
Author(s):  
N. J. Braden ◽  
Philip D. Walson

An adverse drug reaction can be a life-threatening, irreversible event that could have been prevented. The physician is responsible for protecting the patient and the public by avoiding adverse drug reactions whenever possible, and by suspecting, diagnosing, and treating them promptly. Documentation of adverse drug reactions protects the individual from future exposure, and reported experience may protect others. Reactions to recently introduced products are especially important. Rational therapeutic practices depend on knowledge (including continual education about drug effects), logic, clinical acumen, and vigilance. Any therapeutic maneuver, no matter how apparently benign, requires a careful risk-benefit assessment because of potentially devastating consequences.


2012 ◽  
Vol 97 (8) ◽  
pp. 761-762
Author(s):  
Desiree Kunac ◽  
Michael V Tatley ◽  
Keith Grimwood ◽  
David M Reith

Author(s):  
Anand M Ingale ◽  
Pratibha Nadig ◽  
Ananya Chakraborty

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. 


2012 ◽  
Vol 02 (02) ◽  
pp. 111-117 ◽  
Author(s):  
Mariapina Gallo ◽  
Antonio Clavenna ◽  
Maurizio Bonati ◽  
Paolo Siani ◽  
Antonio Irpino ◽  
...  

Author(s):  
Prashant P. Shivgunde ◽  
Ganesh Ashok Chepuri

Background: Iohexol is widely used radiocontrast media in the radiology departments for the diagnostic imaging purpose. As very few studies are carried out focusing on safety profiles of this contrast media. This study was conducted to know the profile of adverse drug reactions (ADRs) induced by Iohexol in patients who are undergoing the contrast-enhanced computed tomography (CECT) examination.Methods: Total 106 patients from CT unit of radiology department were observed for adverse drug reactions from Iohexol contrast media in 2 months duration. Acute ADRs were recorded immediately after contrast media administration by observation and personal interviews and delayed ADRs are recorded by follow up after 24hrs.Results: Total 23 out of 106 patients who had undergone CT imaging investigations by Iohexol contrast media had developed ADRs. Total 29 ADRs were developed in 23 patients. Out of these, 22 ADRs were acute and 7 ADRs were delayed reactions. All acute ADRs were of “probable” category and all delayed ADRs were of “possible” category according to WHO-UMC and Naranjo’s causality assessment scales. All ADRs were at Level-1 according to Modified Hartwig and Siegel severity scale. Preventability assessment of ADRs using Modified Schumock and Thornton preventability scale showed that all the ADRs were of “not preventable” class. All 29 ADRs were of TYPE U (Unclassified) as per the Wills and Brown method.Conclusions: All reactions are physiologic and are mild in nature. No life-threatening reactions are observed during the entire study period. Development of ADRs in female patients seen higher than male patients. So, this population requires a special attention for any serious contrast media reactions.


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