FDA approves Perrigo’s Exalgo extended-release generic
SILVER SPRING, Md. — Perrigo is adding to its portfolio of opioid generics. The Food and Drug Administration has approved the company’s generic of Exalgo (hydromorphone HCL, 32 mg) extended-release tablets.
The drug is an opioid indicated to manage moderate to severe pain in patients requiring continuous around-the-clock pain opioid analgesia for an extended period of time. Perrigo said it planned to make the generic available by the end of September.
The drug had brand and generic sales of $35 million for the 12 months ended July 2017, the company said.
Bringing big data to bear on the opioid crisis
As the Centers for Disease Control and Prevention project that more than 1,000 people are treated everyday as a result of prescription opioid misuse, and the New York Times reports that drug overdose becomes the leading cause of death of Americans younger than 50 years of age, research from CVS Health Research Institute and Johns Hopkins University is looking at how algorithms can be used to help identify signs of patients misusing and abusing opioids.
The study looked at 15 algorithms that use e-prescriptions and/or medical claims to assess and track habits associated with patients who are pharmacy or doctor shopping, or those who seek prescriptions that aren’t medically necessary. The results, published in the Journal of American Medical Informatics, concluded that using these algorithms can help single out both patients and providers that require additional screening or pharmacy-based interventions for further evaluation of prescription drug misuse.
“As healthcare payers seek to both improve patients’ health and minimize fraud and waste, these data-driven approaches are applicable and beneficial to real-world, population-level surveillance. [They are] critical to targeting patient outreach and intervention, as well as minimizing provider fraud,” said Dr. Troyen Brennan, CVS Health chief medical officer and co-author of the study.
CVS Health unveils new PBM, pharmacy efforts to curb opioid abuse
WOONSOCKET, R.I. — CVS Health is continuing its fight against prescription drug misuse and abuse with efforts across its businesses. The company on Thursday announced enhanced enterprise-wide efforts to support drug disposal, manage pain medications and fund treatment and recovery programs.
“As America’s front door to health care with a presence in nearly 10,000 communities across the country, we see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” CVS Health president and CEO Larry Merlo said. “Today we are announcing an expansion of our enterprise initiatives to fight the opioid abuse epidemic that leverages CVS Pharmacy’s national presence with the capabilities of CVS Caremark, which manages medications for nearly 90 million plan members.”
Starting Feb. 1, 2018, CVS Health’s pharmacy benefits manager CVS Caremark will be implementing an enhanced opioid utilization management approach that will include limiting the supply of opioids for certain acute prescriptions to seven days for patients that are new to therapy. Other features of the initiative include limited the daily dosage of opioids dispensed based on the drug’s strength and requiring the use of immediate-release formulations before extended-release opioids are dispensed.
CVS Pharmacy locations will roll out a more robust patient counseling program for patients filling an opioid prescription, including an education program that will highlight opioid safety and the potential for addiction. The program will educate patients about prescribing guidelines from the Centers for Disease Control and Prevention encouraging the use of the lowest effective dose for the shortest time possible. They also will share with patients the importance of keeping medications secure at home and how to properly dispose of unused medication.
“Without a doubt, addressing our nation’s opioid crisis calls for a multipronged effort involving many health care stakeholders — from doctors, dentists and pharmaceutical companies to pharmacies and government officials,” Merlo said. “With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.”
CVS Health also will add in-store disposal units at 750 CVS pharmacy locations, bringing the total number of in-store units to 1,550. Such states as Florida, Massachusetts, North Carolina, Pennsylvania, South Carolina and the District of Columbia will begin seeing these in the fall. Besides providing the in-store disposal units, CVS Health has donated more than 800 medication disposal units to community police departments in the past several years. In the past two years, more than 100 metric tons of medication has been collected through the program.
“Everyone has a role to play in addressing the opioid epidemic, and CVS Health is showing how the private sector can help,” acting director of the Office of National Drug Control Policy Richard Baum said. “Making sure people can safely dispose of unwanted medications is a key part of preventing opioid misuse and abuse, and CVS Health has taken this important step which will support the health of communities across the country.”
Also as part of CVS Health’s expanded efforts, the CVS Health Foundation is adding $2 million to its commitment to mitigating prescription drug abuse through support for federally qualified community health centers that provide access to treatment and recovery services. Alongside the National Association of Community Health Centers, the foundation brought together a panel of experts to develop a protocol for best practices in community health centers on prescribing guidelines, medication-assisted treatment, behavioral health and community collaboration.
“Community health centers have the unique ability to leverage their care teams, health information technology systems and quality infrastructure to support drug abuse control in their communities,” NACHC president and CEO Tom Van Coverden said. “Through the Innovative Approaches for Prescription Drug Abuse Management and Prevention program, we hope to build capacity for providing integrated behavioral health services in communities with high incidence of substance use and abuse with the goal of implementing innovative, collaborative, and community‐based models that result in safe prescribing practices, care coordination, strengthened partnerships and non-judgmental environments for all patients.”
And CVS Health is expanding its Pharmacists Teach program’s audience with a new focus on parents. With its focus on teens, it has educated more than 295,000 students about prescription drug abuse. These efforts are in addition to CVS Pharmacy locations in 43 states offering prescription-free naloxone, and CVS Health’s advocacy for improving such tools as prescription drug monitoring programs.