Pharmacies Must Disclose Opioid Dispensing Data Since 2006 Per Order from MDL Judge

On December 30, Judge Dan Aaron Polster of the Northern District of Ohio ordered the release of nearly a decade-and-a-half worth of pharmacy data related to opioid prescriptions by many of the nation’s largest pharmacy retail chains. Dating back to 2006, impacted companies will have to share, as part of the ongoing multidistrict litigation, the number of customers receiving opioids from their pharmacies along with existing safeguards to ensure patient safety and compliance with the law. The initial request made by the plaintiffs initially looked to recover data dating back to 1996 and the initial launch of OxyContin. The order specifies that data specific to two Ohio counties – Cuyahoga and Summit – are to be released first, followed by data for the entire state of Ohio, Kentucky and West Virginia.

Articles & Resources

Bloomberg Law – Walmart, CVS, Walgreens Must Disclose 14 Years of Opioid Data

Law360 – Pharmacies Must Produce 14 Years of Opioid Records in MDL


Report Highlights Ineffectiveness of FDA’s REMS Program for ER/LA Opioids

Researchers from Johns Hopkins Bloomberg School of Public Health published a comprehensive review of FDA’s extended-release/long-acting opioid Risk Evaluation and Mitigation Strategy (REMS) program in JAMA Internal Medicine this week that found implementation of the program could not demonstrate reduced prescribing habits or improve patient outcomes. Launched first in 2012, the purpose of the REMS program was to improve prescriber awareness around risks and adverse events associated with the inappropriate prescribing of ER/LA opioids. However, several years into the program, it’s been noted that serious flaws exist which impact the ability for the Food and Drug Administration to effectively educate prescribers and track outcomes from these continuing education programs.

Articles & Resources

Journal of the American Medical Association – Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration

New York Times – As Tens of Thousands Died, FDA Failed to Police Opioids

CNN – The FDA Can’t Prove It’s Opioid Strategy Actually Worked, Study Says


Review Highlights Ties Between Economic Hardship and Proliferation of Overdose Deaths

In search of answers regarding the proliferation of “deaths of despair,” researchers from the University of Pennsylvania, Massachusetts General Hospital, Yale University and Harvard Medical School published research in JAMA Internal Medicine this week highlighting the correlation between automobile plant closures and opioid-related overdose death rates from 1999-2016. As compared to counties that did not experience a plant closure, those who saw individuals laid off experienced a nearly two-fold increase in overdose death rates. While not itself a leading indicator for opioid misuse or abuse, researchers do believe that this could serve as a proxy for broader implications of decreased economic opportunities and increased hardships. It is suggested that these findings be used in conjunction with existing interventions to combat the nation’s opioid crisis perhaps with particular focus placed on areas of the country hit hardest with economic challenges.

Articles & Resources

Journal of the American Medical Association – Association Between Automotive Assembly Plant Closures and Opioid Overdose Mortality in the United States: A Difference-in-Difference Analysis

New York Times – Opioid Deaths Rise When Auto Plants Close, Study Shows

Washington Post – Counties Where Auto Plants Close See Higher Rates of Opioid Overdose Deaths, New Research Finds

Los Angeles Times – Factory Closures May Have Helped Fuel the Opioid Crisis. Here’s How.


What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

The Atlantic – The True Cause of the Opioid Epidemic

NPR – In Rural Areas Without Pain or Addiction Specialists, Family Doctors Fill In The Gaps

NPR – Effort to Control Opioids in ER Leaves Some Sickle Cell Patients in Pain

STAT News – This Mental Health Advocates Wants to Make Addiction and Behavioral Health a 2020 Election Issue

Annals of Internal Medicine – Unwanted Medication Disposal: Audit of California Pharmacy

CNN – Not Sure How to Get Rid of Extra Opioids or Antibiotics? The Pharmacy May Not Know, Either

Office of the New York Attorney General – AG James Facilitates Access to life-Saving Opioid Overdose Drug

New York State Department of Financial Services – Governor Cuomo Details New Health Insurance Requirements to Support New Yorkers Seeking Treatment for Mental Health Conditions and Addiction

Office of the Washington State Attorney General – AG Ferguson Sues Opioid Manufacturer Johnson & Johnson Over State’s Opioid Epidemic

CMS Center for Medicaid & CHIP Services – Guidance to State Medicaid Agencies on Dually Eligible Beneficiaries Receiving Medicare Opioid Treatment Services Effective January 1, 2020

U.S. Attorney for the Eastern District of Pennsylvania – Bucks County Dentist to Pay $150,000, Cease Prescribing Schedule II Opioids for Four Years, to Resolve Allegations of Opioid-Mishandling and Diversion for Personal Use


This Week’s Calendar – Welcome to 2020!

Good morning all and welcome to the first iteration of the CEPOP Weekly Opioid Policy Report for 2020! The House and Senate return from a short, two- week recess but have not noticed any opioid-related hearings or events for the week of January 6, 2020.


Questions about the above content can be directed to Matthew.Rubin@FaegreBD.com.