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Barbara McAneny, president of the American Medical Association, recently described a patient with metastatic prostate cancer who tried to kill himself after he could not get the medication he was prescribed for bone pain because...his insurer...denied coverage...my patient nearly died of an underdose...McAneny was talking about the suffering caused by government pressure to reduce opioid prescriptions, which has led to denials of treatment and arbitrary dose reductions...A Medicare rule that take effect on January 1 will compound that problem...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

A report from the majority staff of the House Energy and Commerce Committee found that distributors, which fulfill orders for prescription drugs to pharmacies, failed to conduct proper oversight of their customers by not questioning suspicious activity and not properly monitoring the quantity of painkillers that were being shipped to individual pharmacies...The committee also found that the DEA did not properly use a database that aims to monitor the flow of powerful prescription painkillers from manufacturers to sellers, something that could have allowed federal agents — in real time —...The agency also curtailed enforcement of distributors...and infighting inside the agency affected the way cases were handled...

FYI

Industry wisdom is that there is nothing new to learn about tablet making. Drugmakers have been doing it essentially the same way for more than 100 years. But that idiom was turned on its head this year when the FDA learned suspected carcinogens could be formed in “sartan” drugs from a specific sequence of manufacturing steps and chemical reactions—and that the U.S. drug supply had been riddled with them for years...The initial discovery of one of the impurities, N-nitrosodimethylamine, came this summer at a U.S. drug manufacturer that had used valsartan API from China’s Zhejiang Huahai Pharmaceutical...the FDA has since learned that the impurities were found in the APIs of other drugmakers, including Aurobindo and Mylan, and in finished products from Sandoz, Teva and others...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The Food and Drug Administration...issued a reminder to drug manufacturers that data integrity remains high on the regulator's agenda of Good Manufacturing Practice-related concerns, publishing new guidance aimed at helping drugmakers meet its standards...The document, which updates a 2016 version, lays out a series of questions and answers for drugmakers explaining how companies can ensure manufacturing data sets are complete, consistent and accurate. While a technical concern, the FDA makes clear that data errors carry real risk to patient health...Guidance isn't the only lever the FDA can pull to help companies comply. In recent years, the agency has flagged data integrity issues in numerous warning letters following inspections and pre-approval assessments.

A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals...A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals...The shutdown included AHRQ’s National Quality Measures Clearinghouse...The new nonprofit, The Alliance for the Implementation of Clinical Practice Guidelines, said recently it was launching Guideline Clearinghouse 2.0. AiCPG said it was created for the “charitable, educational and scientific purposes of freely disseminating evidence-based clinical practice guidelines information to the healthcare community in order to educate clinicians to improve patient care...A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals.

An advisory panel to the Food and Drug Administration....recommended prescribing the opioid overdose reversal drug, naloxone, along with addictive painkillers...The recommendation of the panel underscores concerns about the growing opioid overdose epidemic...FDA studies found that co-prescribing naloxone to all patients who are prescribed painkillers could increase annual healthcare costs by $63.9 billion to $580.8 billion...I think co-prescribing is an expensive way to saturate the population with naloxone. The at-risk population is not necessarily the ones that are being prescribed new narcotics...

...Senators Richard Blumenthal, D-Connecticut, Kamala Harris, D-California, Amy Klobuchar, D-Minnesota, and Jeff Merkley, D-Oregon, introduced a bill on the Senate floor, S. 3754, that would allow HHS to block drug price increases that it deems as “excessive.”...The bill, dubbed “A bill to prohibit price gouging in the sale of drugs,” is just the latest in a series of actions that Congressmen and the government alike have taken to address high drug prices.