A curated and standardized adverse drug event resource to accelerate drug safety research

Objective: To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. Data Sources: This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. Study Selection: The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. Data Synthesis: The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Conclusions: Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

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Best Paper Selection

Yearbook of Medical Informatics ◽

10.1055/s-0038-1641125 ◽

2017 ◽

Vol 26 (01) ◽

pp. e13-e14

Keyword(s):

Rare Diseases ◽

Adverse Drug Event ◽

Medical Data ◽

Drug Event ◽

Data Repository ◽

Common Disease ◽

Target Validation ◽

Genetic Determinants ◽

Safety Research ◽

Phenotype Similarity

Banda JM, Evans L, Vanguri RS, Tatonetti NP, Ryan PB, Shah NH. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data 2016;3:160026 https://www.nature.com/articles/sdata201626 Bauer CR, Ganslandt T, Baum B, Christoph J, Engel I, Lobe M, Mate S, Staubert S, Drepper J, Prokosch HU, Winter A, Sax U. Integrated Data Repository Toolkit (IDRT). A Suite of Programs to Facilitate Health Analytics on Heterogeneous Medical Data. Methods Inf Med 2016;55(2):125-35 https://methods.schattauer.de/en/contents/archivestandard/issue/2324/manuscript/25160.html Greene D, NIHR BioResource, Richardson S, Turro E. Phenotype Similarity Regression for Identifying the Genetic Determinants of Rare Diseases. Am J Hum Genet 2016;98(3):490-9 https://linkinghub.elsevier.com/retrieve/pii/S0002-9297(16)00014-8 Sarntivijai S, Vasant D, Jupp S, Saunders G, Bento AP, Gonzalez D, Betts J, Hasan S, Koscielny G, Dunham I, Parkinson H, Malone J. Linking rare and common disease: mapping clinical diseasephenotypes to ontologies in therapeutic target validation. J Biomed Semantics 2016;7-8 https://jbiomedsem.biomedcentral.com/articles/10.1186/s13326-016-0051-7

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Best Paper Selection

Yearbook of Medical Informatics ◽

10.1055/s-0037-1606521 ◽

2017 ◽

Vol 26 (01) ◽

pp. 151-151

Keyword(s):

Rare Diseases ◽

Adverse Drug Event ◽

Medical Data ◽

Drug Event ◽

Data Repository ◽

Common Disease ◽

Target Validation ◽

Genetic Determinants ◽

Safety Research ◽

Phenotype Similarity

Banda JM, Evans L, Vanguri RS, Tatonetti NP, Ryan PB, Shah NH. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data 2016;3:160026 https://www.nature.com/articles/sdata201626 Bauer CR, Ganslandt T, Baum B, Christoph J, Engel I, Lobe M, Mate S, Staubert S, Drepper J, Prokosch HU, Winter A, Sax U. Integrated Data Repository Toolkit (IDRT). A Suite of Programs to Facilitate Health Analytics on Heterogeneous Medical Data. Methods Inf Med 2016;55(2):125-35 https://methods.schattauer.de/en/contents/archivestandard/issue/2324/manuscript/25160.html Greene D, NIHR BioResource, Richardson S, Turro E. Phenotype Similarity Regression for Identifying the Genetic Determinants of Rare Diseases. Am J Hum Genet 2016;98(3):490-9 https://linkinghub.elsevier.com/retrieve/pii/S0002-9297(16)00014-8 Sarntivijai S, Vasant D, Jupp S, Saunders G, Bento AP, Gonzalez D, Betts J, Hasan S, Koscielny G, Dunham I, Parkinson H, Malone J. Linking rare and common disease: mapping clinical diseasephenotypes to ontologies in therapeutic target validation. J Biomed Semantics 2016;7-8 https://jbiomedsem.biomedcentral.com/articles/10.1186/s13326-016-0051-7

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Why Clinicians Don�t Report Adverse Drug Events: Qualitative Study (Preprint)

10.2196/preprints.9282 ◽

2017 ◽

Author(s):

Corinne M Hohl ◽

Serena S Small ◽

David Peddie ◽

Katherin Badke ◽

Chantelle Bailey ◽

...

Keyword(s):

Qualitative Study ◽

Adverse Drug Event ◽

Adverse Drug Events ◽

Community Pharmacists ◽

Care Quality ◽

Drug Event ◽

Complex Nature ◽

Safety Research ◽

Patient Care Quality ◽

Field Notes

BACKGROUND Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. OBJECTIVE Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. RESULTS We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. CONCLUSIONS Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.

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Adverse Drug Event-Related Emergency Department Visits Associated With Complex Chronic Conditions

PEDIATRICS ◽

10.1542/peds.2013-3060d ◽

2014 ◽

Vol 133 (6) ◽

pp. X25-X25

Keyword(s):

Emergency Department ◽

Adverse Drug Event ◽

Chronic Conditions ◽

Emergency Department Visits ◽

Drug Event ◽

Complex Chronic Conditions

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Adverse drug event-related mortality in Japan

Reactions Weekly ◽

10.1007/s40278-021-94096-4 ◽

2021 ◽

Vol 1851 (1) ◽

pp. 6-6

Keyword(s):

Adverse Drug Event ◽

Drug Event ◽

Related Mortality

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Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05061-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jeffrey P. Hau ◽

Penelope M. A. Brasher ◽

Amber Cragg ◽

Serena Small ◽

Maeve Wickham ◽

...

Keyword(s):

Health Information ◽

Adverse Drug Event ◽

Primary Outcome ◽

Adverse Drug Events ◽

Primary Objective ◽

Drug Event ◽

Controlled Trials ◽

Drug Reactions ◽

Main Trial ◽

Randomized Controlled

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

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