Issue link: https://beckershealthcare.uberflip.com/i/821337
74 CMO / CARE DELIVERY Sepsis Drug Shortage Linked to Increase in Patient Deaths By Mackenzie Bean S eptic shock patients treated at a hospital with an insufficient supply of the drug norepinephrine were more likely to die than those treated at a hospital not experienc- ing the effects of the 2011 norepinephrine drug shortage, according to a study published in the Journal of the American Medical Association. Here are seven things to know. 1. e Food and Drug Administration an- nounced a severe shortage of the drug — which raises blood pressure by activating blood ves- sels to constrict — in February 2011. e shortage lasted a year and stemmed from pro- duction issues at three manufacturing sites. 2. For the study, researchers examined data on 27,835 septic shock patients treated at 26 hos- pitals between 2008 and 2013. 3. Prior to the shortage, about 60 percent of the hospitals used norepinephrine to treat septic shock. Researchers defined any hospital whose use of the drug decreased more than 20 percent in three months as experiencing a shortage. 4. Researchers found norepinephrine was used in about 77 percent of septic shock pa- tients at the hospitals included in the study. By the second quarter of 2011, usage dropped to about 56 percent, according to the report. 5. Septic shock patients had about a 40 percent risk of death during the shortage. Individuals treated at a hospital not experiencing a short- age only had a 36 percent risk. Researchers believe this four-percentage point difference accounts for hundreds of additional deaths among patients with septic shock. 6. While researchers could not confidently con- clude why a risk of death was related to the drug shortage, they said it might be related to the drugs physicians used as a replacement for norepineph- rine. Furthermore, some patients who were treat- ed with norepinephrine during the shortage may have had to wait longer to receive it. "You can't come to the firm conclusion that the alternative vasopressor was the problem, but it does point to problems in the system when there are shortages of medications like that," senior author Hannah Wunsch, MD, of Sunnybrook Health Sciences Center in Toronto, told Reuters. 7. Julie Donohue, PhD, and Derek Angus, MD, researchers at the University of Pitts- burgh discussed the shortage and share five broad solutions to stopping drug shortages in an accompanying editorial. eir suggestions included establishing early warning systems, implementing professional guidelines about drug alternatives and requiring drug manu- facturers to produce specific volumes of drugs aer they are approved by the FDA. n Jury Sides With Heart Surgeon in $6.4M Defamation Lawsuit Against Memorial Hermann By Emily Rappleye A Texas jury found Houston-based Memorial Hermann Health System guilty of gaming its own peer-review process for financial gain, according to a report in the Houston Chronicle. Here are five things to know about the lawsuit and the verdict. 1. The jury found Memorial Hermann guilty of defama- tion and awarded Miguel Gomez, MD, with $6.4 million in damages, according to the report. Health system offi- cials told the Houston Chronicle they believe the state dis- trict judge will reduce the award. 2. Dr. Gomez sued the health system five years ago, al- leging it misused the peer review process and falsified data to harm his practice after he tried to move it to an- other hospital, according to the report. Dr. Gomez was a top cardiovascular surgeon who had admitting privileges at Memorial Hermann, but after he decided to move his practice to Houston Methodist West, he alleged Memorial Hermann sought to damage his reputation to retain his pa- tients, according to the report. 3. The jury found Memorial Hermann made false statements about Dr. Gomez's competence and sur- gical mortality rates, according to the report. The jury also found Memorial Hermann further defamed the surgeon by sharing manipulated peer review data with referring cardiologists. However, the jury did clear the health system of allegations that it stifled the Houston healthcare market in its actions against Dr. Gomez, ac- cording to the report. 4. The verdict is extremely unusual. Typically, defamation cases are solved outside of courts, especially because it is difficult for physicians to prove the peer review process was used in a detrimental way, as is necessary in Texas for phy- sicians to access the otherwise confidential data, according to the report. 5. Memorial Hermann said it is still evaluating an appeal, according to the report. In a statement to the newspaper, Memorial Hermann affirmed its physician review process is in place to improve patient safety. n Septic shock patients had about a 40 percent risk of death during the norepinephrine shortage.