The Complete Guide to GVP Module IX for Signal Management

This guide is intended to provide a comprehensive overview of GVP IX and discuss how Evidex Signal Management, a next generation pharmacovigilance workflow platform can help organizations detect, track, and resolve safety signal and inquiries in compliance with GVP IX.

White Paper: Pharmacovigilance Software in 2021

Analysis of the PV software market in 2021 and beyond, including trends and comparisons between legacy vs. next generation software.

Pharmacovigilance Best Practices for Clinical and Early Post-Approval Biopharma

The idea of selecting, implementing, and deploying pharmacovigilance software is overwhelming for smaller companies. Smaller clinical and early post-approval stage biopharma companies have to make do with significantly fewer resources and they are understandably quick to look for outside help.

Analysis of Post-Marketing Safety Signals for COVID-19 Therapies

Advera Health reviewed the top 6 most widely used COVID-19 treatments using Q2 2020 FAERS data. The report includes new potential safety signals, dechallenge and rechallenge data, detailed signal analysis and ROR forest plots, and top 10 highest reported adverse event tables for each product.

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug–AE pairs to analyze, the issue of focus is daunting.

Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events.

Hoffman, K. B., Overstreet, B. M., & Doraiswamy, P. M. (2013). Drugs and Therapy Studies, 3(1), e4-e4.

The Weber Effect and FAERS: Analysis of Sixty-Two Drugs Approved from 2006 to 2010

Most of the modern adverse event reporting into FAERS does not follow the pattern described by the ‘Weber Effect'. Modern FAERS reporting has improved greatly over the last decade and will be an increasingly important factor in determining the overall safety profile of FDA approved prescription drugs

Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

“Stimulated reporting,” is the concept that public disclosure of a safety issue by the issuance of an FDA alert or warning, or the clustering of adverse event reports triggered by consumer-based “support group” and/or litigation, will result in substantially increased reporting rates for the affected drug. This publication refutes this widely held assumption

Neuropsychiatric adverse effectsof oseltamivir in the FDA Adverse Event Report System, 1999-2012

Publications from Roche and a case-control study suggest that there is no evidence, or plausible mechanism of action, to link neuropsychiatric adverseeventst oTamiflu (oseltamivir). Cochrane Collaborators, the BMJ ,and others,however, contend that many of Roche’s data remain unavailable.

A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the Statin drug class

Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class.

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors

A systematic review of FAERS found elevated reporting for both tofacitinib and ruxolitinib for certain thromboembolic adverse events

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System.

Duprey, M. S., Al-Qadheeb, N. S., O’Donnell, N., Hoffman, K. B., Weinstock, J., Madias, C., ... & Devlin, J. W. (2019). Drugs-Real World Outcomes, 6(3), 141.

Amyotrophic lateral sclerosis associated with statin use: a disproportionality analysis of the FDA’s Adverse Event Reporting System.

Golomb, B. A., Verden, A., Messner, A. K., Koslik, H. J., & Hoffman, K. B. (2018). Drug safety, 41(4), 403-413.

A drug safety rating system based on postmarketing costs associated with adverse events and patient outcomes.

Hoffman, K. B., Dimbil, M., Kyle, R. F., Tatonetti, N. P., Erdman, C. B., Demakas, A., ... & Overstreet, B. M. (2015). Journal of managed care & specialty pharmacy, 21(12), 1134-1143c.

Post-approval adverse events of new and old anticoagulants.

Hoffman, K. B., Demakas, A., Erdman, C. B., & Dimbil, M. (2014). BMJ (Clinical research ed.), 348, g1859.

PAINWeek 2020: Adverse Events Associated with Analgesics Used for Osteoarthritis Pain: Analysis of Post-Marketing Data

Bannuru, R.R., Dimbil, M., Wei, W., Colilla, S., Huyghues-Despointes, C., Nettleship, J.E., Iyer, R. (2020, September). Adverse Events Associated with Analgesics Used for Osteoarthritis Pain: Analysis of Post-Marketing Data. Poster presented at PAINWeek 2020 National Conference on Pain Management.

AMCP 2017: FAERS Data as Proxy to Determine Total Medical Costs for TNF-α Inhibitors

Hoffman, K., Dimbil, M., Lukazewski, A., Keeser, H., Carter, J., Bartholow, T., & Goetz, E. (2017, March). FAERS Data as Proxy to Determine Total Medical Costs for TNF-α Inhibitors. Poster presented at the Academy of Managed Care Pharmacy (AMCP) Meeting, Denver, CO.

AMCP 2017: Adverse Drug Event Reporting Rates: Comparing FAERS to Clinical Trials

Compares the rate of adverse drug events (ADEs) for individual drugs from pre-approval clinical trials to post-approval reporting to FDA’s Adverse Event Reporting System (FAERS).

EHDN 2016: Post-Marketing Adverse Events Associated with Tetrabenazine: Findings Using the FDA Adverse Event Reporting System

Classen, D.O., Iyer, R., Dimbil, M., Giron, A., De Boer, L.M., Gandhi, S., & Hoffman, K.B. (2016, September). Post-Marketing Adverse Events Associated with Tetrabenazine: Findings Using the FDA Adverse Event Reporting System. Poster presented at the 9th European Huntington's Disease Network (EHDN) Plenary Meeting, The Hague, The Netherlands.

ISPOR 2016: Hepatitis C Medications: Analysis of Adverse Drug Events and Poor Patient Outcomes

Hoffman, K.B., Dimbil, M., Giron, A., Erdman, C.B., Chen, D., & Kyle, R.F. (2016, May). Hepatitis C Medications: Analysis of Adverse Drug Events and Poor Patient Outcomes. Poster presented at ISPOR, Washington, DC.

AMCP April 2016: Predicting FDA Safety Alerts: A Pharmacovigilance Signaling System Based on Past Regulatory Action

Hoffman, K.B., Dimbil, M., Erdman, C.B., Giron, A., Chen, D., Tatonetti, N.P., & Kyle, R.F. (2016, April). Predicting FDA Safety Alerts: A Pharmacovigilance Signaling based on Past Regulatory Action. Poster presented at the Academy of Managed Care Pharmacy (AMCP) Meeting, San Francisco, CA.

ASHP Midyear 2015: Direct Medical Costs from Post-Marketing Adverse Drug Reactions: Focus on GLP-1, DPP-4 & SGLT2 Type 2 Diabetes Medications

Hoffman, K.B., Giron, A., & Dimbil, M. (2015, December). Direct Medical Costs from Post-Marketing Adverse Drug Reactions: Focus on GLP-1, DPP-4, & SGLT2 Type 2 Diabetes Medications. Poster presented at ASHP Midyear Clinal Meeting and Exhibition, New Orleans, LA.

AMCP Nexus October 2015: Burden of Adverse Events for Atypical Antipsychotics: an Analysis of the Food and Drug Administration Adverse Event Reporting System

Francois, C., Harty A., Kamat, S.A., Dimbil, M., & Hoffman, K.B. (2015, October). Burden of Adverse Events for Atypical Antipsychotics: An Analysis of the Food and Drug Administration Adverse Event Reporting System. Poster presented at the Academy of Managed Care Pharmacy (AMCP) Nexus Meeting, Orlando, FL.

AMCP Nexus October 2015: A Drug Safety Rating System Based on Post-Marketing Costs associated with Adverse Events and Patient Outcomes

Hoffman, K.B., Dimbil, M., Kyle, R.F., Tatonetti, N.P., Erdman, C.B., Demakas, A., Chen, D., & Overstreet, B.M. (2015, October). A Drug Safety Rating System Based on Post-Marketing Costs associated with Adverse Events and Patient Outcomes. Poster presented at the Academy of Managed Care Pharmacy (AMCP) Nexus Meeting, Orlando, FL.

AMCP April 2015: Determining the Cost of Adverse Drug Reactions from FDA-approved Medications: Implications for Outcomes Research and Formulary Decisions

Hoffman, K.B., Dimbil, M., & Giron, A. (2015, April). Determining the Cost of Adverse Drug Reactions from FDA-approved Medications: Implications for Outcomes Research and Formulary Decisions. Poster presented at the Academy of Managed Care Pharmacy (AMCP) Meeting, San Diego, CA.

ISPOR 2015: MS Drugs: Calculating the Costs of Adverse Drug Reactions from Post-Marketing Data: Implications for Outcomes Research

Hoffman, K.B., Dimbil, M., & Giron, A. (2015, May). MS Drugs: Calculating the Costs of Adverse Drug Reactions from Post-Marketing Data: Implications for Outcomes Research. Poster presented at ISPOR, Philadelphia, PA.

Anticoagulation Forum: The Post-Marketing Costs of Adverse Drug Reactions Associated with Major Anticoagulants

Hoffman, K.B., Dimbil, M., & Giron, A. The Post-Marketing Costs of Adverse Drug Reactions Associated with Major Anticoagulants. Poster presented at the Anticoagulation Forum.

ASHP 2015: Post-Marketing Adverse Drug Reactions Associated with Major Bisphosphonate Medications: Calculating Downstream Costs

Hoffman, K.B., Silva, N.R., & Dimbil, M. (2015, June). Post-Marketing Adverse Drug Reactions Associated with Major Bisphosphonate Medications: Calculating Downstream Costs. Poster presented at ASHP Summer Meeting and Exhibition, Denver, CO.