Myopathy with Ezetimibe Monotherapy; Statin-Associated Pancreatitis; Linezolid Associated Toxic Optic Neuropathy; Hiccups and Dopamine Agonists; SIADH and Seizures in a Patient Treated with Duloxetine; Prevention of a Well-Known Adverse Drug Reaction

2006 ◽  
Vol 41 (5) ◽  
pp. 408-488
Author(s):  
Joel Shuster

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and 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.

2018 ◽  
Vol 25 (4) ◽  
pp. 1768-1778 ◽  
Author(s):  
Sara Santiso ◽  
Arantza Casillas ◽  
Alicia Pérez

This work focuses on adverse drug reaction extraction tackling the class imbalance problem. Adverse drug reactions are infrequent events in electronic health records, nevertheless, it is compulsory to get them documented. Text mining techniques can help to retrieve this kind of valuable information from text. The class imbalance was tackled using different sampling methods, cost-sensitive learning, ensemble learning and one-class classification and the Random Forest classifier was used. The adverse drug reaction extraction model was inferred from a dataset that comprises real electronic health records with an imbalance ratio of 1:222, this means that for each drug–disease pair that is an adverse drug reaction, there are approximately 222 that are not adverse drug reactions. The application of a sampling technique before using cost-sensitive learning offered the best result. On the test set, the f-measure was 0.121 for the minority class and 0.996 for the majority class.


2018 ◽  
Author(s):  
Neil H. Shear ◽  
Sandra Knowles ◽  
Lori Shapiro

An adverse drug reaction is defined as any noxious, unintended, and undesired effect of a drug that occurs at doses used in humans for prophylaxis, diagnosis, or therapy. A cutaneous eruption is one of the most common manifestations of an adverse drug reaction. This chapter reviews the epidemiology, etiology, diagnosis, clinical manifestations, and differential diagnosis of adverse drug reactions, as well as laboratory tests for them. Also discussed are the types of cutaneous eruption: exanthematous eruption, urticarial eruption, blistering eruption, pustular eruption, and others. The simple and complex forms of each type of eruption are reviewed. The chapter includes 4 tables and 12 figures. Tables present the warning signs of a serious drug eruption, clinical features of hypersensitivity syndrome reaction and serum sickness-like reaction, characteristics of Stevens-Johnson Syndrome and toxic epidermal necrolysis, and clinical pearls to identify anticoagulant-induced skin necrosis. Figures illustrate hypersensitivity syndrome reaction, a fixed drug eruption from tetracycline, pseudoporphyria from naproxen, linear immunoglobulin A disease induced by vancomycin, pemphigus foliaceus from taking enalapril, pemphigus vulgaris from taking penicillamine, toxic epidermal necrolysis after starting phenytoin therapy, acneiform drug eruption due to gefitinib, acute generalized exanthematous pustulosis from cloxacillin, coumarin-induced skin necrosis, a lichenoid drug eruption associated with ramipril, and leukocytoclastic vasculitis from hydrochlorothiazide. This chapter contains 106 references.


2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Ricardo Cruz-Correia

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Lense Temesgen Gurmesa ◽  
Mohammed Gebre Dedefo

Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%), 56 (42.1%), and 13 (9.8%) health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.


2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 309-309
Author(s):  
Alanna M. Poirier ◽  
Paul Nachowicz ◽  
Subhasis Misra

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]


2021 ◽  
Vol 9 ◽  
pp. 205031212110390
Author(s):  
Tadele Mekuriya Yadesa ◽  
Freddy Eric Kitutu ◽  
Serawit Deyno ◽  
Patrick Engeu Ogwang ◽  
Robert Tamukong ◽  
...  

Background: Occurrence of adverse drug reactions is a major global health problem mostly affecting older adults. Identifying the magnitude and predictors of adverse drug reactions is crucial to developing strategies to mitigate the burden of adverse drug reactions. This study’s objectives were to estimate and compare the prevalences of adverse drug reactions, to characterize them and to identify the predictors among hospitalized older adults. Methods: A comprehensive systematic literature search including both prevalence and risk factors of adverse drug reactions in hospitalized older adults was conducted using PubMed, Scopus and Google Scholar, involving all articles published in English. Descriptive statistics and comparison of means was performed using SPSS version 20.0 and metaprop command was performed in STATA version 13.0. Heterogeneity was assessed using I2 statistic. Results: A total of 18 studies, involving 80,695 participants with a median age of 77 years, were included in this study. The pooled prevalence of adverse drug reaction was 22% (95% confidence interval: 17%, 28%; I2 = 99.23%). Among high-income countries, the prevalence of adverse drug reactions was 29% (95% confidence interval: 16%, 42%) as compared to 19% (95% confidence interval: 14%–25%) in low and middle-income countries ( p value = 0.176). Of the 620 adverse drug reactions categorized, most were type A (89%), which are generally predictable and preventable. Two-thirds (795, 67%) of the adverse drug reactions were probable and most (1194, 69%) were mild or moderate. The majority (60%) of the categorized adverse drug reactions were preventable and less than one-third (31%) were severe. The most consistently reported predictors of adverse drug reactions in hospitalized older patients were medication-related factors, including polypharmacy and potentially inappropriate medications followed by disease-related factors—renal failure, complex comorbidity, heart failure and liver failure. Conclusion: Almost one-quarter of all hospitalized older adults experienced at least one adverse drug reaction during their hospital stay. The majority of the adverse drug reactions were preventable. Medication-related factors were the most consistently reported predictors of adverse drug reactions followed by disease-related factors.


2021 ◽  
Author(s):  
Milad Besharatifard ◽  
Zahra Ghorbanali ◽  
Fatemeh Zare-Mirakabad

Identifying and controlling adverse drug reactions is a complex problem in the pharmacological field. Despite the studies done in different laboratory stages, some adverse drug reactions are recognized after being released, such as Rosiglitazone. Due to such experiences, pharmacists are now more interested in using computational methods to predict adverse drug reactions. In computational methods, finding and representing appropriate drug and adverse reaction features are one of the most critical challenges. Here, we assess fingerprint and target as drug features; and phenotype and unified medical language system as adverse reaction features to predict adverse drug reaction. Meanwhile, we show that drug and adverse reaction features represented by similarity vectors can improve adverse drug prediction. In this regard, we propose four frameworks. Two frameworks are based on random forest classification and neural networks as machine learning methods called F_RF and F_NN, respectively. The rest of them improve two state-of-art matrix factorization models, CS and TMF, by considering target as a drug feature and phenotype as an adverse reaction feature. However, machine learning frameworks with fewer drug and adverse reaction features are more accurate than matrix factorization frameworks. In addition, the F_RF framework performs significantly better than F_NN with ACC = %89.15, AUC = %96.14 and AUPRC = %92.9. Next, we contrast F_RF with some well-known models designed based on similarity vectors of drug and adverse reaction features. Unlike other methods, we do not remove rare reactions from the data set in our frameworks. The data and implementation of proposed frameworks are available at http://bioinformatics.aut.ac.ir/ADRP-ML-NMF/.


2021 ◽  
Author(s):  
Apichaya Thontham ◽  
Rapin Polsook

Background: Patients with newly diagnosed pulmonary tuberculosis often suffer from adverse drug reaction symptoms, which leads to the automatic discontinuation of anti-tuberculosis drugs. Thus, understanding symptom experience of adverse drug reactions is necessary.Objective: This study aimed to examine differences in symptoms experienced in four dimensions: presence, frequency, severity, and distress of adverse drug reactions, between male and female patients.Methods: This was a quantitative survey with a cross-sectional design, with data collected between January and April 2020. A total of 394 patients with newly diagnosed pulmonary tuberculosis was selected through a purposive sampling technique. The symptom experiences of adverse drug reactions were measured using a validated instrument. Data were analyzed using mean, standard deviation, and independent t-test.Results: The most commonly reported symptom was itchiness (24.1% in males and 34.9% in females). Vomiting occurred as the most frequent symptom among males (x̅ ± SD = 2.73 ± .88), and fatigue was found to be the most severe and distressing symptom across male patients (x̅ ± SD = 2.50 ± 1.61 and 2.06 ± 1.30, respectively). In contrast, yellowing of the eyes and skin was most frequent and severe among females (x̅ ± SD = 3.17 ± .75 and 3.83 ± 1.47, respectively). In addition, flu-like symptoms were evaluated as the most distressing symptom for female patients (x̅ ± SD = 2.80 ± 1.09). The symptom burdens of the females ranged significantly and reached higher than those of the male patients at a p-value of .05 (t = 3.33).Conclusion: Females taking anti-tuberculosis drugs should be carefully monitored to deal with adverse drug reaction symptoms. This finding would help to decrease the severity of disease and improve their quality of life.Funding: This study received funding from the Ratchadaphiseksomphot Endowment Fund, Chulalongkorn University, Bangkok, Thailand (GCUGR1125633058M).


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