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Cracking down on kratom

The FDA is warning unscrupulous vendors that selling unapproved kratom products with fraudulent claims that they can treat opioid withdrawal, addiction, and other medical conditions is a violation of federal law. Derived from Mitragyna speciosa, a plant native to Asia, kratom contains opioid substances that may have a potential for abuse.


Kratom is promoted as a dietary supplement and is often marketed as a treatment for opioid use disorder (OUD). However, no scientific research supports its safety and effectiveness for OUD or any other disorder, and no studies have been published on potential adverse reactions or its ability to interact with other drugs or substances. In addition, kratom was linked to an outbreak of salmonellosis from a rare strain of Salmonella earlier this year.


In a statement, FDA Commissioner Scott Gottlieb, MD, pledged that the FDA will continue to promote innovation and access to approved treatments for OUD. "In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their healthcare provider."


Sources: Statement from FDA Commissioner Scott Gottlieb, MD, on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency's ongoing concerns about kratom. U.S. Food & Drug Administration. Press Announcement. September 11, 2018. In the news: kratom (Mitragyna speciosa). National Center for Complimentary and Integrative health. Update June 29, 2018. https://nccih.nih.gov/news/kratom.



Shorter visits impede antibiotic stewardship

Although frequently prescribed, antibiotics are rarely indicated to treat outpatient respiratory tract infections (RTIs). In a direct-to-consumer telemedicine setting, RTIs are the predominant reason patients seek care. In a recently reported observational study, shorter encounters between patients and providers in telemedicine settings correlate with more antibiotic prescriptions for RTIs.


Each prescription outcome was categorized as none, antibiotic, or nonantibiotic for each encounter. RTIs were categorized as sinusitis, pharyngitis, bronchitis, and other RTIs. Over 13,400 encounters were included in the study.


Findings showed that providers prescribed antibiotics in 67% of encounters for RTIs. Nonantibiotics were prescribed in 13% of encounters, and nothing was prescribed in 20% of encounters. Rates varied by type of RTI, from 91% for sinusitis to 15% for RTIs in the "other" category. Encounters that resulted in nothing being prescribed were 0.33 minutes longer than those resulting in antibiotic prescriptions. Encounters resulting in a nonantibiotic prescription were 1.12 minutes longer.


The authors suggest that in a telemedicine setting, where short patient encounters are encouraged, providers may be more inclined to prescribe an antibiotic than to take the time to explain why prescribing an antibiotic is inappropriate for most RTIs. "Because telemedicine encounters are short and physicians are often reimbursed by encounter volume, antibiotic stewardship efforts that lengthen visits even slightly may be challenging to implement," the authors write.


Sources: Martinez KA, Rood M, Jhangiani N, Boissy A, Rothberg MB. Antibiotic prescribing for respiratory tract infections and encounter length: an observational study of telemedicine. Ann Intern Med. [e-pub October 2, 2018]. Telemedicine RTI visits shorter when antibiotic prescribed. HealthDay News. October 2, 2018.



Opioid-related problems on the rise

Data from the Agency for Healthcare Research and Quality indicate that rates of opioid-related prescriptions and healthcare utilization are rising among older adults. The rate of opioid-related inpatient stays in patients age 65 and older increased by about 34% between 2010 and 2015, despite a 17% decrease in nonopioid-related stays during the same period. Similarly, the data revealed a 74% increase in the rate of opioid-related ED visits, compared with just a 17% increase in nonopioid-related visits. Compared with nonopioid-related stays in 2015, opioid-related stays were associated with higher inpatient costs and ED charges, more patients discharged against medical advice, and a higher proportion of patients with multiple chronic conditions.


"Opioid misuse in older adults is an underappreciated and growing problem," the investigators say, noting that the rate of opioid misuse among older adults nearly doubled between 2002 and 2014.


Sources: Weiss AJ, Heslin KC, Barrett ML, Izar R, Bierman AS. Opioid-related inpatient stays and emergency department visits among patients aged 65 years and older, 2010 and 2015. Healthcare Cost of Utilization Project. Statistical brief #244. September 2018. Opioid-related hospital use up in elderly adults. HealthDay News. October 3, 2018.



Facilitating weight loss to lower diabetes risk

A selective serotonin 2C receptor agonist, lorcaserin suppresses appetite and has been shown to facilitate sustained weight loss in obese or overweight patients. A direct relationship has been shown between excess bodyweight and risk of type 2 diabetes. To determine if long-term lorcaserin use is effective for diabetes prevention and remission, investigators conducted a randomized, double-blind, placebo-controlled trial in eight countries involving about 12,000 overweight or obese patients (body mass index 27 kg/m2 or higher) with or at high risk for atherosclerotic vascular disease. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or placebo. All patients also had access to a standardized weight management program based on lifestyle modification.


At 1 year, patients treated with lorcaserin had a net weight loss beyond placebo of 2.6 kg (patients with diabetes), 2.8 kg (patients with prediabetes), and 3.3 kg (patients with normoglycemia). Lorcaserin reduced the risk of incident diabetes by 19% in patients with prediabetes and 23% in patients without diabetes. The authors conclude, "Lorcaserin decreases risk for incident diabetes, induces remission of hyperglycemia, and reduces the risk of microvascular complications in obese and overweight patients, supporting the role of lorcaserin as an adjunct to lifestyle modification for chronic management of weight and metabolic health."


This study was funded by Eisai, which manufactures lorcaserin.


Source: Bohula EA, Scirica BM, Inzucchi SE, et al. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomized, placebo-controlled trial. Lancet. [e-pub October 4, 2018].



Hospitals mark up drugs by nearly 500%

A recent analysis of a full year of cost data from hospitals in 49 states and the District of Columbia shows that on average, hospitals mark up the cost of drugs by 479%. Over 80% of hospitals charge patients and insurers more than double their acquisition cost. A smaller share of hospitals (17%) charge 7 times the acquisition cost and about 10% of hospitals charge 10 times the cost.


The report, conducted by The Moran Company, was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA). Stephen J. Ubl, president and CEO of PhRMA, said in a statement, "In order to make medicines more affordable for patients, we must address the role hospital markups play in driving up medicine costs."


Sources: The Moran Company. Hospital Charges and Reimbursement for Medicines: Analysis of Cost-to-Charge Ratios. September 2018. Hospitals charge 479 percent of cost of drugs on average. HealthDay News. September 20, 2018.