Case Studies & Publications

The results of large population-based survey in Germany 2005-2007

HER2-Testing and Treatment Reality outside Clinical Studies in Germany

Ergebnisse einer repräsentativen nationalen Erhebung

Trends in der Diagnose und in der Therapie in Deutschland (2006-2009)

First Results from a Representative Multicentre Treatment Survey

First Results from a Representative Multicentre Treatment Survey in Germany

Ergebnisse einer repräsentativen multizentrischen Erhebung 2006

‘Real-world’ data from representative multicentre treatment surveys in Germany between 2008 and 2011

Analysis of a nationwide, multi-institutional survey

Analysis of a Multi-National Survey

To evaluate the current state of EHR-based medication safety signal identification, we conducted a scoping literature
review of studies aimed at identifying safety signals from routinely collected patient-level EHR data. We extracted
information on study design, EHR data elements utilized, analytic methods employed, drugs and outcomes evaluated, and
key statistical and data analysis choices.

Our main objective is to investigate whether an EHR-based data network can be used in pharmacovigilance investigations to calculate background rates, using rates of anemia in non-small cell lung cancer (NSCLC) patients and an illustrative use case.

Our objective in this study was to investigate using TreeScan on a federated EHR network by implementing an exposure-based and an outcome-based analysis focusing on previously identified associations.

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.

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

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” 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.

Cholesterol management drugs known as statins are widely used and usually 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.

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

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.