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Drug News

ARTIFICIAL INTELLIGENCE UBROGEPANT Machine learning helps New approval for acute treatment reduce drug errors he FDA has approved ubrogepant (Ubrelvy) tablets for the acute treatment of T migraine with or without aura in adults. It is not indicated for the preventive treatment linical decision support (CDS) of migraine. Ubrogepant is the first drug in the class of oral gene-related C alerting tools can identify and receptor antagonists approved for the acute treatment of migraine. reduce errors, but they In two randomized, double-blind, placebo-controlled trials of 1,439 adult patients with typically identify only errors previ- a history of migraine (with and without aura), patients received the approved doses of ously programmed into their alerting ubrogepant to treat an ongoing migraine. In both studies, the percentages of patients logic. New research indicates that achieving freedom from pain and other symptoms such as within 2 hours was machine learning systems can gener- significantly greater than for those receiving placebo. Patients were allowed to take their ate clinically valid alerts that CDS usual acute treatment of migraine at least 2 hours after taking ubrogepant and 23% of systems may miss. An application of patients were taking a preventive medication for migraine. The most common adverse re- actions were nausea, fatigue, and dry mouth. Ubrogepant should not be used concurrent- artificial intelligence, machine learn- ly with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin. ing gives a system the ability to auto- The FDA describes ubrogepant as a novel treatment that represents “an important matically learn and improve from new option for the acute treatment of migraine in adults.” In the US, migraine affects an experience rather than from explicit estimated 37 million people. programming. Source: US Food and Drug Administration. FDA approves new treatment for adults with migraine. News release. In the study, over 10,600 alerts December 23, 2019. were generated on outpatient data from two academic medical centers HIV INFECTION However, the researchers found that between 2009 and 2013. When Response to early ART in the rates of achieving and sustaining alerts generated by the machine viral suppression were similar among learning system were compared with neonates investigated infants who initiated ART within less those generated by an existing CDS ome adults with HIV infection who than 2 days of birth (51%) and within system, researchers found that over Sstart antiretroviral therapy (ART) 2 to 14 days of birth (54%), suggest- 68% of machine learning alerts soon after infection have achieved periods ing that starting ART immediately after would not have been generated by of remission when ART is withdrawn. birth is not essential for a good result. the CDS system. Based on a random A study was conducted to determine “Our results should be reassuring sample of the chart-reviewed alerts, whether HIV-infected neonates who for clinicians that speed is not every- 92% of these alerts were accurate initiate ART within 14 days of birth thing,” said lead researcher Louise and nearly 80% were clinically valid. and are maintained on ART would Kuhn, PhD, MPH, in an interview. The estimated cost of adverse events also be able to maintain viral sup- “Although undue delay should not be potentially prevented was more than pression when ART was withdrawn. introduced, good outcomes for neo- $60 per drug alert. Seventy-three HIV-infected neo- nates with HIV can be obtained if ART Although these results are promis- nates at one hospital in Johannesburg, is started in the first 2 weeks of life.” ing, machine learning also has risks South Africa, were initiated on ART Sources: Kuhn L, Strehlau R, Shiau S, et al. Early antiretroviral treatment of infants to attain HIV remission. and drawbacks. For example, due to within 14 days of birth and main- EClinicalMedicine. [e-pub January 2020] Outcomes the complexity of how the system tained on ART while viral load decline similar among infants who start ART at 2 vs. 14 days. Healio.com. January 8, 2020. arrives at a decision to generate an and immune recovery were tracked. alert, clinicians may misinterpret an In 46 infants, ART was initiated with- alert’s significance. The authors write in less than 2 days of birth; in the re- ADMINISTRATION that “the true value of such alerts is maining 27 infants, ART was initiated Customizable dosage highly contingent on whether and between 2 and 14 days of birth. how clinicians respond to such alerts Three infants died and nine were controller approved and their potential to prevent actual lost to follow-up before age 48 weeks. n interoperable automated glyce- patient harm.” Of the remaining infants, too few met Amic controller device, the Tandem Source: Rozenblum R, Rodriguez-Monguio R, Volk LA, et eligibility requirements for proceed- Diabetes Care Control-IQ Technology, al. Using a machine learning system to identify and prevent medication prescribing errors: a clinical and cost analysis ing with the proposed interruption is the first insulin controller that can evaluation. Jt Comm J Qual Patient Saf. 2020;46(1):3-10. of treatment as originally planned. be used with other diabetes devices www.Nursing2020.com March l Nursing2020 l 11

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that are meant to be integrated into a and fail-safe modes. However, de- based addiction treatment, defined as diabetes management system for auto- spite these assessments, a risk for a claim for behavioral health services; mated insulin delivery. The device delayed insulin delivery still exists. for buprenorphine, methadone, or automatically adjusts insulin delivery The FDA also cautions that loss of naltrexone prescription or adminis- through connection to an alternate communication between connected tration; or for both behavioral health controller-enabled insulin pump (ACE devices or from cybersecurity is- services and pharmacotherapy within pump) and integrated continuous sues could also cause delays. 30 days of overdose. About 29% glucose monitor (iCGM). Patients Source: US Food and Drug Administration. FDA received only behavioral therapy and authorizes marketing of automated insulin dosing with type 1 diabetes can use the new controller. News release. December 19, 2019. 69% received no therapy at all. Less controller with compatible iCGMs than 2% received pharmacotherapy and ACE pumps to automatically in- with buprenorphine, naltrexone, crease, decrease, and suspend delivery OPIOID EPIDEMIC or methadone. Youths with heroin of basal insulin based on insulin deliv- Few teens receive drug overdose were significantly less ery history, iCGM readings, and pre- likely than those who overdosed on dicted glucose values. The controller therapy after overdose other opioids to receive any treat- can also automatically deliver insulin n a cohort study of 4,039,216 ment. “Interventions are urgently when the glucose value is predicted to I Medicaid-enrolled adolescents and needed to link youths to treatment exceed a predefined number. young adults ages 13 to 22 (median after overdose, with priority placed The device was shown to be safe age, 18), 3,791 experienced a non- on improving access to pharma- and effective in a of 168 fatal opioid-related overdose. Of 3,606 cotherapy,” the authors write. ■ patients with type 1 diabetes. It was youths with opioid-related overdose Source: Alinsky RH, Zima BT, Rodean J, et al. Receipt of addiction treatment after opioid overdose among also assessed for its ability to com- and continuous enrollment for at Medicaid-enrolled adolescents and young adults. JAMA municate with the entire system with least 30 days after overdose, less than Pediatr. [e-pub Jan. 6, 2020] appropriate reliability, cybersecurity, a third received timely, evidence- DOI-10.1097/01.NURSE.0000654080.98025.1b

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