#1 FDA advisory panel votes to co-prescribe Naloxone with opioids
An FDA advisory panel concluded a two-day discussion on December 18, 2018 by voting 12-11 in favor of labeling changes recommending co-prescribing the overdose antidote for opioids for high risk patients.
The incremental healthcare costs associated with implementing the recommendation are under debate. Current FDA studies show costs being upwards of $63.9 billion but Emergent Biosolutions who recently acquired the Narcan naloxone nasal spray product has pushed back estimating the costs to be around $115 million.
A dose of generic naloxone is estimated to cost $40. A two-pack of the Narcan nasal spray is $125. Kaleo’s Evzio naloxone autoinjector retails at over $4,000 and has resulted in the company getting heat from Congress. The company recently announced a generic version of Evzio being available for $178 for two doses.
Several states already require co-prescribing naloxone with certain opioids prescriptions and several more are anticipated to adopt this measure across the next few months.
#2 Ohio judge rules for federal court cases to continue against manufacturers and distributors
U.S. District Judge Dan Aaron Polster for the U.S. District Court for the Northern District of Ohio in Cleveland allowed the bulk of the claims to go forward in the landmark against the manufacturers, distributors and retailers of the prescription painkillers over what he called “a man-made plague.”
In the December 19, 2018 order, Judge Polster noted – “It is accurate to describe the opioid epidemic as a man-made plague, twenty years in the making. The pain, death, and heartache it has wrought cannot be overstated. As this Court has previously stated, it is hard to find anyone in Ohio who does not have a family member, a friend, a parent of a friend, or a child of a friend who has not been affected.”
More than 1,500 cities, counties, and states have their lawsuits rolled into this multidistrict litigation being led for the plaintiffs by attorneys Paul Farrell of Greene, Ketchum, Farrell, Bailey & Tweel in Huntington, West Virginia, Paul Hanly of Simmons Hanly Conroy in New York, and Joseph Rice of Motley Rice in Mount Pleasant, South Carolina.
Manufacturing defendants include Janssen, Purdue Pharma, Mallinckrodt, Insys Therapeutics, Noramco, Endo Pharmaceuticals, Allergan, and Teva. Distributors include McKesson, AmerisourceBergen, and Cardinal Health. Retailers include CVS, Rite Aid, Walgreen, and Walmart.
#3 Opioid overdose deaths high among Native Americans
A CDC Mortality and Morbidity Weekly Report published on December 21, 2018 with corrected data from the Washington State Center for Health Statistics show much higher overdose death rates for American Indian and Alaska Native populations than previously thought. Due to misclassification of the AI/AN race on death certificates, overdose deaths were underreported by 40%.
The study data covered the 2013 to 2015 timeframe and shows that the overdose death rate for American Indians and Alaska Natives was 2.7 times higher for total drug and opioids and 4.1 times higher for heroin than for white non-hispanic Washington state residents.
For more information review the published study: Joshi S, Weiser T, Warren-Mears V. Drug, Opioid-Involved, and Heroin-Involved Overdose Deaths Among American Indians and Alaska Natives — Washington, 1999–2015. MMWR Morb Mortal Wkly Rep 2018;67:1384–1387.
#4 New York state’s opioid tax blocked by federal judge
A federal court judge in Manhattan on December 19, 2018 blocked New York state from collecting an opioid surcharge set to begin on January 1, 2019. saying it infringes on federal interstate commerce laws because it could lead drug companies to pass on the cost of the surcharge to other states’ consumers and manufacturers.
U.S. District Judge Katherine Polk Failla ruled that the Opioid Stewardship Act, “is not a tax, but is rather a regulatory penalty on opioid manufacturers and distributors. And as currently structured, it improperly burdens interstate commerce.”
Statement on the New York State Department of Health website along with further information:
Effective July 1, 2018, all manufacturers, distributors, and importers licensed in New York State (NYS) as of January 1, 2017, must report transaction information for all opioids sold or distributed to or within NYS to the NYS Department of Health’s Bureau of Narcotic Enforcement as mandated under the Opioid Stewardship Act (OSA). The Department will calculate ratable shares of an assessment based on the reported data, and will issue invoices for the ratable shares of the assessment to each licensee by October 15, 2018. Payments of the invoices are due on January 1, 2019. The Department will provide guidance on when subsequent reports and payments are due for future years.
#5 Baltimore ranks city hospitals on best practices for addressing opioid use disorder
Baltimore city released a ranking of the city’s 11 hospitals on December 19, 2018 on best practices to address opioid use disorder using the Levels of Care framework introduced earlier this year in April for public comment and finalized in August.
|Level III||Level II||
Level I – Highest Rating
|Ø Bon Secours Hospital
Ø Sinai Hospital
Ø Mercy Medical Center
Ø Saint Agnes Hospital
|Ø Johns Hopkins Hospital
Ø Johns Hopkins Bayview Medical Center
Ø MedStar Good Samaritan Hospital
Ø MedStar Harbor Hospital
Ø MedStar Union Memorial Hospital
|Ø University of Maryland Medical Center
Ø University of Maryland Medical Center-Midtown
1) Screens ED patients for at-risk substance use and substance use disorder
2) Has an ED discharge protocol (as required by state law) that includes a referral to community-based treatment for patients with substance use disorder
3) Prescribes Naloxone to emergency patients at high risk for opioid overdose
4) Maintains capacity to initiate treatment for opioid use disorder for emergency department patients
5) Promulgates guidelines for judicious prescribing of opioid analgesics across the hospital system
6) Provides information about safe storage and disposal to patients who are prescribed opioids
|All of Level III
7) Offers peer recovery specialist services or similar support services to ED patients
8) Screens directly admitted patients for at-risk substance use and substance use disorder
9) Prescribes Naloxone to admitted patients at high risk for opioid overdose
10) Maintains capacity to initiate treatment for opioid use disorder for admitted patients with opioid use disorder
11) Monitors fidelity to prescribing guidelines and addresses cases of injudicious prescribing
|All of Level II
12) Maintains capacity to initiate treatment for opioid use disorder for admitted patients with at least one formulation of each medication approved by the FDA for that purpose
13) Offers peer recovery support services or similar support services to admitted patients
14) Dispenses Naloxone to ED patients and admitted patients at high risk for opioid overdose
15) Screens patients in hospital campus outpatient clinics for at-risk substance use and substance use disorder
16) Offers ongoing treatment in appropriate hospital campus outpatient clinics, including clinics that do not specialize in the treatment of substance use disorder