Becker's Clinical Quality & Infection Control

57 OPIOIDS FDA to change how it evaluates addiction drugs By Harrison Cook T he FDA on Aug. 6 shared a new dra guidance to promote the creation and more widespread use of medication-assisted therapies to treat opioid use disorder, according to STAT. e dra guidance seeks to reframe how the agency will evaluate new treat- ments for opioid addiction. Instead of only assessing whether a treatment lowers opioid use, the agency will now analyze whether the medication could help lower overdose rates or limit spread of infectious diseases. "We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission," Scott Gottlieb, FDA com- missioner, said in a statement. Medication-assisted treatment paired with psychosocial counseling is consid- ered the standard of care for treating opioid use disorder. ree drugs cleared for MAT are buprenorphine, methadone, and naltrexone. However, patients oen demonstrate poor adherence to the drugs, which addiction treatment ex- perts say are greatly underutized in today's healthcare settings. e FDA seeks to expand and development more drugs beyond these three medications. "e FDA's new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery," HHS Secretary Alex Azar, told STAT. e Senate also plans to further incorporate MAT as a key element in re- sponding to the opioid epidemic. n Meet the West Virginia lawyer overseeing 400+ opioid lawsuits against drugmakers, distributors By Harrison Cook P aul Farrell, an attorney from Huntington, W.Va., is leading one of the largest lawsuits in modern U.S. history, representing more than half of the 800 suits cities and counties nationwide have filed against drug manufacturers and distributors, according to Bloomberg. Here are six things to know: 1. Mr. Farrell is one of the lead attorneys for this case, working alongside Joe Rice and Paul Hanly, who served as litigators for a $246 billion deal with the tobacco industry in 1998 — the largest corporate settlement in U.S. history, according to Bloomberg. 2. Mr. Farrell heads up a five-lawyer firm and legal consortium, which represents more than half of the municipalities suing drugmakers and distributors. 3. He grew up in West Virginia and watched his community transform into what Bloomberg called "the opioid capital of the world." "I have people my age that I know that are ad- dicted to opioids," Mr. Farrell told Bloomberg. "I know people that have children in their early 20s that they have lost." 4. Mr. Farrell's argument for the lawsuit rests on a West Virginia public nuisance law meant to address complaints over common community issues like landfills or environmental waste. However, he is arguing opioid makers and wholesalers created a public nuisance with the opioid epidemic, and now local governments must spend millions of dollars to address it. 5. If the local cities, states and counties win the suit against the drug industry, they could receive up to $50 billion, according to one esti- mate cited by Bloomberg. Twenty-five percent of that would go the law firms — including Mr. Farrell's — representing the cases. 6. Mr. Farrell did not share an estimate for a settlement amount, as the judge overseeing the case issued a gag order barring all lawyers from disclosing specific negotiation details. n Johns Hopkins creates opioid guidelines for 20 common surgeries By Harrison Cook A panel of healthcare providers and patients from Baltimore-based Johns Hopkins Medicine developed the country's first set of opioid prescription guidelines for 20 common surgeries. The researchers outlined their process for creating the guidelines in a study published Aug. 14 in the Journal of the American College of Surgeons. The panel included 30 healthcare professionals from the Johns Hopkins Health System, including surgeons, pain specialists, outpatient surgical nurse practitioners, surgical residents, patients and pharmacists. The procedures included a combination of invasive and noninvasive surgeries across eight specialties, including thoracic, orthopedic and cardiac surgery. The panel recommends patients use over-the-counter painkillers before asking their physicians for opioids. When opioids are necessary, the panel recommends physicians prescribe one to 15 opioids tablets for 11 of the 20 procedures, 16 to 20 tables for six of the 20 procedures and zero tablets for three of the 20 procedures. "Prescriptions for pain meds after surgery should be custom tailored to the operation and a patient's needs and goals, but the hope is that these guidelines will help reset 'defaults' that have been dangerously high for too long," said lead author Martin Makary, MD, professor of surgery at Baltimore based-Johns Hopkins University School of Medicine. n

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