Quantifying the severity of adverse drug reactions using social media

AbstractAdverse drug reactions (ADRs) impact the health of 100,000s of individuals annually in the United States with associated costs in the hundreds of billions. The monitoring and analysis of the severity of adverse drug reactions is limited by the current qualitative and categorical system of severity classifications. Previous efforts have generated quantitative estimates for a subset of ADRs, but were limited in scope due to the time and costs associated with the efforts. We present a semi-supervised approach that estimates ADR severity by using a lexical network of ADR word embeddings and label propagation. We use this method to estimate the severity of 28,113 ADRs, representing 12,198 unique ADR concepts from MedDRA. Our Severity of Adverse Events Derived from Reddit (Saedr) scores have good correlations with real-world outcomes. Saedr scores had Spearman correlations with ADR case outcomes in FAERS of 0.595, 0.633, and −0.748 for death, serious outcome, and no outcome, respectively. We investigate different methods for defining initial seed term sets and evaluate their impact on severity estimates. We analyzed severity distributions for ADRs based on their appearance in Boxed Warning drug label sections, as well as ADRs with sex-specific associations. We find that ADRs discovered postmarket have significantly greater severity compared to those discovered in the clinical trial. We create quantitative Drug RIsk Profile (Drip) scores for 968 drugs that have a Spearman correlation of 0.377 with drugs ranked by FAERS cases resulting in death, where the given drug was the primary suspect. We make the Saedr and Drip scores publicly available in order to enable more quantitative analysis of pharmacovigilance data.

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A Microcomputer-Based Data Entry System for Reporting Adverse Drug Reactions in the United States

Drug Information Journal ◽

10.1177/009286158802200110 ◽

1988 ◽

Vol 22 (1) ◽

pp. 61-70 ◽

Cited By ~ 1

Author(s):

Michael H. Dong ◽

Charles Anello ◽

John P. Juergens ◽

Wayne M. Turner ◽

Alan Gelberg ◽

...

Keyword(s):

United States ◽

Adverse Drug Reactions ◽

Data Entry ◽

The United States ◽

Drug Reactions ◽

Data Entry System

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Pharmacovigilance with Transformers: A Framework to Detect Adverse Drug Reactions Using BERT Fine-Tuned with FARM

Computational and Mathematical Methods in Medicine ◽

10.1155/2021/5589829 ◽

2021 ◽

Vol 2021 ◽

pp. 1-12

Author(s):

Sajid Hussain ◽

Hammad Afzal ◽

Ramsha Saeed ◽

Naima Iltaf ◽

Mir Yasir Umair

Keyword(s):

Adverse Drug Reactions ◽

Text Classification ◽

Pharmacological Action ◽

Fine Tuning ◽

Testing Time ◽

Drug Reactions ◽

Training Time ◽

Proposed Model ◽

End To End ◽

The Given

Adverse drug reactions (ADRs) are the undesirable effects associated with the use of a drug due to some pharmacological action of the drug. During the last few years, social media has become a popular platform where people discuss their health problems and, therefore, has become a popular source to share information related to ADR in the natural language. This paper presents an end-to-end system for modelling ADR detection from the given text by fine-tuning BERT with a highly modular Framework for Adapting Representation Models (FARM). BERT overcame the predominant neural networks bringing remarkable performance gains. However, training BERT is a computationally expensive task which limits its usage for production environments and makes it difficult to determine the most important hyperparameters for the downstream task. Furthermore, developing an end-to-end ADR extraction system comprising two downstream tasks, i.e., text classification for filtering text containing ADRs and extracting ADR mentions from the classified text, is also challenging. The framework used in this work, FARM-BERT, provides support for multitask learning by combining multiple prediction heads which makes training of the end-to-end systems easier and computationally faster. In the proposed model, one prediction head is used for text classification and the other is used for ADR sequence labeling. Experiments are performed on Twitter, PubMed, TwiMed-Twitter, and TwiMed-PubMed datasets. The proposed model is compared with the baseline models and state-of-the-art techniques, and it is shown that it yields better results for the given task with the F -scores of 89.6%, 97.6%, 84.9%, and 95.9% on Twitter, PubMed, TwiMed-Twitter, and TwiMed-PubMed datasets, respectively. Moreover, training time and testing time of the proposed model are compared with BERT’s, and it is shown that the proposed model is computationally faster than BERT.

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An opportunity for clinical pharmacology trained physicians to improve patient drug safety: A retrospective analysis of adverse drug reactions in teenagers

F1000Research ◽

10.12688/f1000research.14970.2 ◽

2018 ◽

Vol 7 ◽

pp. 677 ◽

Cited By ~ 3

Author(s):

Andy R. Eugene ◽

Beata Eugene

Keyword(s):

Clinical Pharmacology ◽

Drug Interactions ◽

Adverse Drug Reactions ◽

Hospital Admissions ◽

The United States ◽

Drug Reactions ◽

The Third ◽

Data Limitations ◽

Ondansetron Hydrochloride ◽

Improve Patient

Background: Adverse drug reactions (ADRs) are a major cause of hospital admissions, prolonged hospital stays, morbidity, and drug-related mortality. In this study, we sought to identify the most frequently reported medications and associated side effects in adolescent-aged patients in an effort to prioritize clinical pharmacology consultation efforts for hospitals seeking to improve patient safety. Methods: Quarterly reported data were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 and ending in the third quarter of 2017. We then used the GeneCards database to map the pharmacogenomic biomarkers associated with the most reported FAERS drugs. Data homogenization and statistics analysis were all conducted in R for statistical programming. Results: We identified risperidone (10.64%) as the compound with the most reported ADRs from all reported cases. Males represented 90.1% of reported risperidone cases with gynecomastia being the most reported ADR. Ibuprofen OR=188 (95% CI, 105.00 – 335.00) and quetiapine fumarate OR=116 (95% CI, 48.40 – 278.00) were associated with the highest odds of completed suicide in teenagers. Ondansetron hydrochloride OR=7.12 (95% CI, 1.59 – 31.9) resulted in the highest odds of pneumothorax. Lastly, olanzapine (8.96%) represented the compound with the most reported drug-drug interactions cases, while valproic acid OR=221 (95% CI, 93.900 – 522.00) was associated with the highest odds of drug-drug interactions. Conclusion: Despite any data limitations, physicians prescribing risperidone in males should be aware of the high rates of adverse drug events and an alternative psychotropic should be considered in male patients. Further, patients with a history of pneumothorax or genetically predisposed to pneumothorax should be considered for an alternative antiemetic to ondansetron hydrochloride, due to increased odds associated with the drug and adverse event.

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Opportunities to improve the electronic reporting system for adverse drug reactions in Mexico: A comparative evaluation with the United States of America and the European Union

Pharmacoepidemiology and Drug Safety ◽

10.1002/pds.5092 ◽

2020 ◽

Vol 29 (11) ◽

pp. 1523-1526

Author(s):

Miguel Á. Cano‐Sandoval ◽

Gabriela C. López‐Armas ◽

Yocanxóchitl Perfecto‐Avalos ◽

Alan O. Vázquez‐Alvarez ◽

Lorena M. Brennan‐Bourdon

Keyword(s):

United States ◽

European Union ◽

Adverse Drug Reactions ◽

United States Of America ◽

Comparative Evaluation ◽

Reporting System ◽

The United States ◽

The European Union ◽

Drug Reactions ◽

Electronic Reporting

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Risk Analysis of Lurasidone in Patients with Schizophrenia and Bipolar Depression

CNS & Neurological Disorders - Drug Targets ◽

10.2174/1871527319666200303120147 ◽

2020 ◽

Vol 19 (2) ◽

pp. 109-114

Author(s):

Harika Modugula ◽

Anoop Kumar

Keyword(s):

Adverse Drug Reactions ◽

Causality Assessment ◽

Bipolar Depression ◽

Large Population ◽

The United States ◽

Drug Reactions ◽

Restless Leg Syndrome ◽

Exclusion Criteria ◽

United States Food ◽

States Food

Lurasidone was approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia, as well as for the treatment of bipolar depression. However, emerging reports have indicated various adverse drug reactions with the use of lurasidone. Thus, in this article, we have analyzed the risk profile of lurasidone in the established therapeutic indication. A total of 419 studies were published from October 2010-July 2019 regarding lurasidone. After the inclusion and exclusion criteria, 17 studies were selected for the analysis of risk. The adverse drug reactions (ADRs) of these studies were categorized as per the innovator summary of product characteristics (SmPC). Finally, the unlisted ADRs were analyzed by using the Naranjo probability algorithm. Telogen effluvium, thrombocytopenia, restless leg syndrome and hypersexuality were found with the use of lurasidone and fall under the unlisted category. The causality assessment has shown a probable correlation of lurasidone with hypersexuality, restless leg syndrome, thrombocytopenia and possible relation with telogen effluvium. In conclusion, lurasidone is a novel and efficacious pharmacological treatment for bipolar depression and schizophrenia. However, more data regarding the safety of this drug in a large population is needed.

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Surveillance of Adverse Drug Reactions in the United States

Neuropsychopharmacology ◽

10.1007/978-3-642-74034-3_60 ◽

1990 ◽

pp. 617-622

Author(s):

R. S. K. Young

Keyword(s):

United States ◽

Adverse Drug Reactions ◽

The United States ◽

Drug Reactions

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604. Factors Associated with Adverse Drug Reactions Leading to Discontinuation of Vancomycin in Outpatient Parenteral Antimicrobial Therapy

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.798 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S364-S364

Author(s):

Josh McDonald ◽

Russell J Benefield ◽

Laura Certain

Keyword(s):

Adverse Drug Reactions ◽

Antimicrobial Therapy ◽

Plasma Concentrations ◽

The United States ◽

High Rate ◽

Unplanned Readmission ◽

Drug Reactions ◽

Research Support ◽

Outpatient Parenteral Antimicrobial Therapy

Abstract Background Over 250,000 patients receive outpatient parenteral antimicrobial therapy (OPAT) in the United States each year. Vancomycin is commonly used in OPAT but has a high rate of discontinuations due to adverse drug reactions (ADRs). Being able to predict the occurrence of these ADRs and assess their impact could improve the overall quality of OPAT services when utilizing vancomycin. Methods This was a retrospective chart review of all adult University of Utah Health (UUH) patients who received vancomycin OPAT and had planned follow-up with UUH infectious disease (ID) providers between October 25, 2018 and July 31, 2019. Patients were excluded if they were less than 18 years of age, pregnant, did not have planned follow up with UUH ID physicians, or were on any form of renal replacement therapy. The primary outcome assessed was discontinuation of vancomycin due to ADR, as documented by the ID provider. Type of ADR leading to discontinuation and 30-day unplanned readmission were also assessed. Results One hundred fifty-eight patients met inclusion criteria (n=158). The mean age of patients was 55 years with a median Charlson comorbidity score of 3. Most patients utilized a non-UUH infusion service (116, 73% vs 42, 27%) and utilized vancomycin as their sole antibiotic (83, 53%). The majority of patients were being treated for orthopedic infections (78, 49%). Twenty-eight patients discontinued vancomycin OPAT due to an ADR (18%). The most common ADR leading to discontinuation was acute kidney injury (10, 36%). Variables associated with ADRs leading to discontinuation included utilization of UUH home infusion services (54% vs 21%, P < 0.001) and initial vancomycin plasma concentrations obtained less than 7 days after discharge (92% vs 71%, P < 0.001). The overall 30 day readmission rate was 10% and the rate among patients who experienced an ADR leading to discontinuation was higher than those who did not (25% vs 8%, P < 0.001). Conclusion The overall rate of discontinuation of vancomycin OPAT due to ADR in the UUH population is similar to what has been described in previous literature. The higher rate of unplanned readmission in the population of patients who experienced ADRs warrants further study. The results of this study will be utilized for future quality improvement interventions at our institution. Disclosures Russell J. Benefield, PharmD, Merck and Co (Grant/Research Support)Paratek Pharmaceuticals (Grant/Research Support)Rempex Pharmaceuticals (Grant/Research Support)

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Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i46a32867 ◽

2021 ◽

pp. 276-288

Author(s):

S. Narmada ◽

M. P. Gowrav ◽

Akhilesh Akki ◽

Vishakharaju Motupalli ◽

V. Balamuralidhara ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Adverse Reactions ◽

Healthcare Providers ◽

The United States ◽

Reporting Rate ◽

Global Perspective ◽

Drug Reactions ◽

Paediatric Patients ◽

Post Marketing Surveillance ◽

Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

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ADVERSE DRUG REACTIONS: AN OVERVIEW OF THE OLD AND CONTINUOUS CHALLENGE TO DRUG THERAPY AND DEVELOPMENT

The Libyan Journal of Pharmacy and Clinical Pharmacology ◽

10.5542/ljpcp.v3i0.v1i0.571902 ◽

2012 ◽

Vol 1 ◽

Author(s):

Abdelbaset A Elzagallaai

Keyword(s):

Drug Therapy ◽

Drug Development ◽

Adverse Drug Reactions ◽

Hospital Admissions ◽

Current Knowledge ◽

The United States ◽

World Health ◽

Drug Reactions ◽

Major Health Problem ◽

Health Organization

Adverse drug reactions (ADRs) represent a major health problem worldwide and constitute a big challengeto drug therapy and the drug development process. ADRs are responsible for 3% of total hospital admissions and occur in 10 to 20% of hospitalized patients. It has been estimated that ADRs account for at least 100,000 deaths annually in the United States alone ranking them as the fifth leading cause of death. According to the World Health Organization definition an ADR is a noxious and unintended response to a drug that occurs at a dose normally used in man for prophylaxis, diagnosis or therapy. This commonly used definition, however, excludes other drug therapy consequences such as drug abuse, accidental and inadvertent drug overdose and therapeutic failure. ADRs are classified into two main groups: Type A, which are predictable from the drugs’ normal pharmacological actions and are dose dependent and Type B, which are unpredictable, unrelated to the drugs’ pharmacology and do not have clear dose dependency. This is an overview of the currently used definitions and classifications of ADRs in clinical pharmacology and toxicology. Specific relevant examples are cited and some important points are discussed in the light of current knowledge. A special emphasis is made on the importance of ADRs in clinical drug therapy and drug development, which are the areas where ADRs play the most significant role.

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