Discovery, development, regulation and marketing of the medications that are used in health care and the economics of the pharmaceutical industry.

FDA Restrictions on Mifepristone: Time for a Change?

Issue Brief
Sep. 10, 2020

Mifepristone, a drug used to manage early miscarriage or end an early pregnancy, carries unique restrictions imposed by the U.S. Food and Drug Administration (FDA). Patients are required to pick up the drug in person
from a doctor or a clinic, even though they can take the drug at home. In July, a federal court ruled that the FDA must suspend these restrictions during the COVID-19 pandemic, for patients seeking an early abortion,
although the ruling did not apply to women with an early pregnancy loss. But the challenges to FDA restrictions on mifepristone predate the pandemic. This Issue Brief provides the context for this ongoing controversy, and
reviews recent evidence on the clinical and cost effectiveness of mifepristone for the medical management of first trimester miscarriage.

Impact Of Hospitalization And Medication Switching On Post-Discharge Adherence To Oral Anticoagulants In Atrial Fibrillation Patients

Allison Willis, MD
Sep. 1, 2020

Thanh Phuong Pham Nguyen, Yong Chen, Dylan Thibault, Charles E. Leonard, Sean Hennessy, Allison Willis

Abstract [from journal

Background: Adherence to chronic medications remains poor in practice. There is limited evidence on how hospitalization affects post-discharge adherence to oral anticoagulants (OACs) in individuals with atrial fibrillation (AF). The aim of this study is to examine the impact of hospitalization and medication switching on post-discharge adherence to OACs in the AF population.

Methods: A quasi-experimental pre-post observational study was conducted using United States commercial insurance


Olaparib And Durvalumab In Patients With Germline BRCA-Mutated Metastatic Breast Cancer (MEDIOLA): An Open-Label, Multicentre, Phase 1/2, Basket Study

Aug. 6, 2020

Susan M. Domchek, Sophie Postel-Vinay, Seock-Ah Im, Yeon Hee Park, Jean-Pierre Delord, Antoine Italiano, Jerome Alexandre, Benoit You, Sara Bastian, Matthew G. Krebs, Ding Wang, Saiama N. Waqar, Mark Lanasa, Joon Rhee, Haiyan Gao, Vidalba Rocher-Ros, Emma V. Jones, Sakshi Gulati...

Abstract [from journal]

Background: Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.

Methods: The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial


Trends in Muscle Relaxant Prescribing

Jul. 21, 2020

As the opioid epidemic rages on, clinicians are looking towards safer medication alternatives for patients with acute and chronic pain. Skeletal Muscle Relaxers (SMRs) are a common opioid substitute for patients with musculoskeletal conditions. Although their use has grown at a rate similar to that of opioids, little is known about their safety and efficacy in treating long-term, chronic pain, particularly for older patients and patients with simultaneous opioid use.

Treatments Administered To The First 9152 Reported Cases Of COVID-19: A Systematic Review

May. 27, 2020

David C. Fajgenbaum, Johnson S. Khor, Alexander Gorzewski, Mark-Avery Tamakloe, Victoria Powers, Joseph J. Kakkis, Mileva Repasky, Anne Taylor, Alexander Beschloss, Laura Hernandez-Miyares, Beatrice Go, Vivek Nimgaonkar, Madison S. McCarthy, Casey J. Kim, Ruth-Anne Langan Pai, ...

Abstract [from journal]

The emergence of SARS-CoV-2/2019 novel coronavirus (COVID-19) has created a global pandemic with no approved treatments or vaccines. Many treatments have already been administered to COVID-19 patients but have not been systematically evaluated. We performed a systematic literature review to identify all treatments reported to be administered to COVID-19 patients and to assess time to clinically meaningful response for treatments with sufficient data. We searched PubMed, BioRxiv, MedRxiv, and ChinaXiv for articles reporting treatments


Sulfonylureas and Metformin were not Associated with an Increased Rate of Serious Bleeding in Warfarin Users: A Self-Controlled Case Series Study

Sean Hennessy
May. 11, 2020

Young Hee Nam, Xu Han, Colleen M. Brensinger, Warren B. Bilker, Charles E. Leonard, Sean Hennessy

Abstract [from journal]

Drug interactions between warfarin and sulfonylureas are suggested by pharmacokinetic information and prior studies. However, clinical evidence on the association of such interactions and the risk of bleeding is lacking. Using health care claims data from five US Medicaid programs from 1999-2011 and a self-controlled case series design with warfarin as an object drug, we examined confounder-adjusted rate ratios (RRs) for three outcomes separately: 1) serious bleeding as a composite outcome of gastrointestinal bleeding (GIB) and non-traumatic


Nudging Clinicians Toward Higher-Value Cancer Care

May. 5, 2020

In a new study published in JAMA Oncology, my colleagues and I find that behavioral nudges can promote high-value, evidence-based prescribing of specialty drugs in cancer care. For patients with breast, lung, and prostate cancer with bone metastases, clinicians face a decision between two therapies of comparable effectiveness but dramatically different cost.

Opioid Fills for Lumbar Facet Radiofrequency Ablation Associated with New Persistent Opioid Use

May. 1, 2020

Daniel L. Southren, Stephanie Moser, Hasan Abu-Amara, Paul Lin, Amanda A. Schack, Vidhya Gunaseelan, Jennifer F. Waljee, Chad M. Brummett

Abstract [from journal]

Background: Zygapophyseal (facet) joint interventions are the second most common interventional procedure in pain medicine. Opioid exposure after surgery is a significant risk factor for chronic opioid use. The aim of this study was to determine the incidence of new persistent use of opioids after lumbar facet radiofrequency ablation and to assess the effect of postprocedural opioid prescribing on the development of new persistent opioid use.


Management of Early Pregnancy Loss with Mifepristone and Misoprostol: Clinical Predictors of Success from a Randomized Trial

Apr. 16, 2020

Sarita Sonalkar, Nathanael Koelper, Mitchell D. Creinin, Jessica M. Atrio, Mary D. Sammel, Arden McAllister, Courtney A. Schreiber

Abstract [from journal]

Background: Early pregnancy loss (EPL) is a common event in the first trimester, occurring in 15-20% of recognized pregnancies. A common evidence-based medical regimen for EPL management uses the prostaglandin E1 analogue misoprostol 800 mcg self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in women with a closed cervical os, with 29% of women with EPL requiring a second dose after three days, and 16% eventually requiring a uterine aspiration procedure.



Brief Report: Biosimilar Uptake in the Academic and Veterans Health Administration Settings: Influence of Institutional Incentives

Apr. 6, 2020

Joshua F. Baker, Charles E. Leonard, Vincent Lo Re III, Michael H. Weisman, Michael D. George, Jonathan Kay

Abstract [from journal]

Objective: To compare uptake in the ordering of biosimilars at a Veterans' Affairs medical center (VAMC) to that at an academic medical center, where institutional incentives for infused medications differ.

Methods: We performed a cross-sectional study of medical record data and estimated institutional financial incentives at two medical centers in Philadelphia: 1) the University of Pennsylvania Health System (UPHS) and 2) the local VAMC. All ordering events for filgrastim or infliximab products were quantified