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In new comments to the US government, several pharmacy groups say that mergers of major companies, such as CVS Health and Aetna, have had significant anticompetitive effects without improving the cost and quality of health care...The Alliance for Pharmacy Compounding, American Pharmacists Association, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, and National Community Pharmacists Association collectively urged for antitrust policy reform in a joint comment to the Federal Trade Commission and the Department of Justice Antitrust Division...READ MORE

A Florida law restricting the quantity of opioids a doctor can prescribe for acute pain to three days’ worth may have led to overall reductions in opioids dispensed to patients in the state,..After the law was passed in July 2018, doctors wrote fewer and shorter prescriptions for opioids...“The policy was intended to reduce the quantity prescribed but it was not expected to decrease opioid use overall,” said study coauthor Dr. Juan Hincapie-Castillo of the University of Florida College of Pharmacy...“But fewer people were getting opioids. That means the law led not only to a reduction in the quantity dispensed, but also to a reduction in the initial decision to prescribe.”...READ MORE

Despite increased access to naloxone, many individuals in rural communities continue to face barriers to obtaining the medication…However, informed pharmacists can serve as an educational resource, even if their pharmacies do not have the medication in stock...Ongoing efforts to expand prescribing methods through the United States have helped to improve naloxone accessibility. In Georgia, specifically, a standing order decrees that any individual may obtain naloxone from a licensed pharmacy without a prescription. Despite the standing order, pharmacies have been slow to adopt stocking naloxone and dispensing the medication…READ MORE

Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses...Purdue is seeking authorization for a development agreement between its affiliate, Greenfield Bioventures, and an unnamed pharmaceutical company. The proposed agreement would allow Purdue to grant intellectual property related to the nalmefene injectable to its unnamed partner, which in turn, would license its autoinjector technology to Purdue...READ MORE

The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market...The final rule clears the way for the agency’s March 23 transition of filings for chemically synthesized polypeptides, including insulin products, from new drug applications to biologics license applications...The FDA anticipates that the change will add more choices for patients and potentially reduce insulin prices. The final rule “will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition,” said FDA Commissioner Stephen Hahn.

The U.S. Food and Drug Administration said it has been alerted to the first manufacturing shortage of an unnamed drug due to the deadly novel coronavirus outbreak that began in China and has now reached the U.S...FDA Commissioner Stephen Hahn said the agency has been "closely monitoring" the medical product supply chain "with the expectation" that the outbreak of the novel coronavirus would "likely" have an impact..."A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list," Hahn said in a statement Thursday night. "The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug."...READ MORE

Although drug shortages due to the novel coronavirus disease outbreak haven’t occurred yet, the FDA and pharmacists are closely watching for potential shortages. Separately, pharmacists should urge Americans to get flu vaccinations and take a cautious approach with coronavirus…“While our primary concern is the health and safety of those affected by the virus, ASHP is concerned with the vulnerability of the pharmaceutical supply chain to threats like the coronavirus outbreak,” Michael Ganio, PharmD, BCPS, director of pharmacy practice and quality at ASHP...An estimated 80% of active pharmaceutical ingredient used in the US market comes from foreign sources. In addition, the FDA has recalled inspectors from China due to the outbreak, which could possibly lead to delays in manufacturing...READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network

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.

Opioid makers and distributors who proposed paying almost $50 billion to resolve U.S. lawsuits over the addictive drugs are drawing more support from states, including California and New York, as pressure mounts for a deal before a trial starts next month...But nearly two dozen states and most of the cities and counties suing to hold the industry responsible for the havoc and high costs of the opioid epidemic say the terms still aren’t good enough...READ MORE