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 The class imbalance problem detecting adverse drug reactions in electronic health records

2018 ◽  
Vol 25 (4) ◽  
pp. 1768-1778 ◽  
Author(s):  
Sara Santiso ◽  
Arantza Casillas ◽  
Alicia Pérez
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Records ◽  
Adverse Drug Reactions ◽  
Class Imbalance ◽  
Drug Reactions ◽  
Class Imbalance Problem ◽  
Health Records ◽  
Imbalance Problem ◽  
Electronic Health

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.

scholarly journals Standard-based comprehensive detection of adverse drug reaction signals from nursing statements and laboratory results in electronic health records

2017 ◽  
Vol 24 (4) ◽  
pp. 697-708 ◽  
Author(s):  
Suehyun Lee ◽  
Jiyeob Choi ◽  
Hun-Sung Kim ◽  
Grace Juyun Kim ◽  
Kye Hwa Lee ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Event Reporting System ◽  
Drug Event ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Laboratory Test Results ◽  
Electronic Health ◽  
Medical Dictionary

Abstract Objective. We propose 2 Medical Dictionary for Regulatory Activities–enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. Matrials and methods. This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)–based pharmacovigilance method, called CLEAR. Adverse drug reaction (ADR) signals from 117 laboratory abnormalities and 1357 standard nursing statements for all precautionary drugs (n  = 101) were comprehensively detected and validated against SIDER (Side Effect Resource) by MetaLAB and MetaNurse against 11 817 and 76 457 drug-ADR pairs, respectively. Results. We demonstrate that MetaLAB (area under the curve, AUC = 0.61 ± 0.18) outperformed CLEAR (AUC = 0.55 ± 0.06) when we applied the same 470 drug-event pairs as the gold standard, as in our previous research. Receiver operating characteristic curves for 101 precautionary terms in the Medical Dictionary for Regulatory Activities Preferred Terms were obtained for MetaLAB and MetaNurse (0.69 ± 0.11; 0.62 ± 0.07), which complemented each other in terms of ADR signal coverage. Novel ADR signals discovered by MetaLAB and MetaNurse were successfully validated against spontaneous reports in the US Food and Drug Administration Adverse Event Reporting System database. Discussion. The present study demonstrates the symbiosis of laboratory test results and nursing statements for ADR signal detection in terms of their system organ class coverage and performance profiles. Conclusion. Systematic discovery and evaluation of the wide spectrum of ADR signals using standard-based observational electronic health record data across many institutions will affect drug development and use, as well as postmarketing surveillance and regulation.

Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance

Drug Safety ◽  
2019 ◽  
Vol 42 (5) ◽  
pp. 657-670 ◽  
Author(s):  
Suehyun Lee ◽  
Jongsoo Han ◽  
Rae Woong Park ◽  
Grace Juyun Kim ◽  
John Hoon Rim ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Controlled Vocabulary ◽  
Health Record ◽  
Electronic Health

scholarly journals Pharmacovigilance study in psychiatry out-patient department of a tertiary care teaching hospital

2017 ◽  
Vol 6 (10) ◽  
pp. 2375
Author(s):  
Nalini R.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Psychotropic Drugs ◽  
Tertiary Care ◽  
Outpatient Department ◽  
Drug Reactions ◽  
Active Monitoring ◽  
History Of ◽  
Sedative Hypnotics

Background: Adverse drug reactions are important in psychiatry practice like any other branch of medicine. Adverse drug reactions associated with psychotropic drugs causes either noncompliance or at times discontinuation of therapy. The objective of the study was to evaluate the incidence and nature of adverse drug reactions in psychiatry outpatient department and to assess the causality and severity of the documented adverse drug reactions.Methods: Prospective observational study was done in the psychiatry outpatient department. All the patients were interviewed for basic details, history of medications and relevant history for adverse drug reactions. The causality, severity and modes of management assessment of the documented adverse drug reactions were done.Results: 2,727 patients attended psychiatry outpatient department, of which 582 patients developed at least one adverse drug reaction. The incidence of adverse drug reaction observed to psychotropic drugs was 21.34%. Majority of adverse drug reactions were seen with antidepressants 298 (10.93%) followed by antipsychotics 187 (6.86%), sedative hypnotics, anticonvulsants and antimanics. The most common adverse drug reactions were sedation 3.44%, weight gain 3.04%, and extrapyramidal symptoms 2.79%. Reported adverse drug reactions were assessed for causality and maximum belonged to probable (15.6 9%). The severity assessment of the reported adverse drug reactions revealed that most of the adverse drug reactions were mild (16.83%) in nature and majority of patients were made to continue the same treatment.Conclusions: Active monitoring of adverse drug reactions in psychiatry outpatient department can help in early detection and management of adverse drug reactions.

Cutaneous Adverse Drug Reactions

2018 ◽  
Author(s):  
Neil H. Shear ◽  
Sandra Knowles ◽  
Lori Shapiro
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Toxic Epidermal Necrolysis ◽  
Adverse Drug Reactions ◽  
Skin Necrosis ◽  
Drug Eruption ◽  
Hypersensitivity Syndrome ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Cutaneous Eruption

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.

scholarly journals Care-paradigm shift promoting smoking cessation treatment among cancer center patients via a low-burden strategy, Electronic Health Record-Enabled Evidence-Based Smoking Cessation Treatment

2019 ◽  
Author(s):  
Alex T Ramsey ◽  
Ami Chiu ◽  
Timothy Baker ◽  
Nina Smock ◽  
Jingling Chen ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Electronic Health Record ◽  
Paradigm Shift ◽  
Point Of Care ◽  
Cancer Center ◽  
Evidence Based ◽  
Health Record ◽  
Smoking Cessation Treatment ◽  
Cessation Treatment ◽  
Electronic Health

Abstract Tobacco smoking is an important risk factor for cancer incidence, an effect modifier for cancer treatment, and a negative prognostic factor for disease outcomes. Inadequate implementation of evidence-based smoking cessation treatment in cancer centers, a consequence of numerous patient-, provider-, and system-level barriers, contributes to tobacco-related morbidity and mortality. This study provides data for a paradigm shift from a frequently used specialist referral model to a point-of-care treatment model for tobacco use assessment and cessation treatment for outpatients at a large cancer center. The point-of-care model is enabled by a low-burden strategy, the Electronic Health Record-Enabled Evidence-Based Smoking Cessation Treatment program, which was implemented in the cancer center clinics on June 2, 2018. Five-month pre- and post-implementation data from the electronic health record (EHR) were analyzed. The percentage of cancer patients assessed for tobacco use significantly increased from 48% to 90% (z = 126.57, p < .001), the percentage of smokers referred for cessation counseling increased from 0.72% to 1.91% (z = 3.81, p < .001), and the percentage of smokers with cessation medication significantly increased from 3% to 17% (z = 17.20, p < .001). EHR functionalities may significantly address barriers to point-of-care treatment delivery, improving its consistent implementation and thereby increasing access to and quality of smoking cessation care for cancer center patients.

scholarly journals Promoting adverse drug reaction reporting: comparison of different approaches

2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Ricardo Cruz-Correia
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Cost Effectiveness ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Educational Approach ◽  
Reaction Reporting

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.

scholarly journals Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Lense Temesgen Gurmesa ◽  
Mohammed Gebre Dedefo
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Drug Reactions ◽  
Reaction Reporting ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

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.

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