CDC Releases Ventilator-Associated Events Criteria

A new term has been coined by the CDC, ventilator-associated events (VAEs) (1). In 2011, the CDC convened a working group composed of members of several stakeholder organizations to address the limitations of the definition of ventilator-associated pneumonia (VAP) definition (2). The organizations represented in the Working Group include: the Critical Care Societies Collaborative (the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society for Critical Care Medicine); the American Association for Respiratory Care; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America.

VAEs are defined by an increase oxygen (>0.2 in FiO2) or positive end-expiratory pressure (PEEP) (≥3 cm H2O), after a previous stable baseline of at least 2 days. There are three definition tiers within the VAE algorithm: 1) Ventilator-Associated Condition (VAC); 2) Infection-related Ventilator-Associated Complication (IVAC); and 3) Possible VAP (PVAP) (2). There are also many other criteria to classify a VAE into the CDC’s tiers which are omitted for brevity. These definitions have been implemented in the National Healthcare Safety Network (NHSN) and according to the CDC are easily implemented, can make use of electronic health record systems to automate event detection, and identify events that are clinically important and associated with outcomes such as ICU and hospital length of stay and mortality. According to the CDC most VACs are due to pneumonia, ARDS, atelectasis, and pulmonary edema which “are significant clinical conditions that may be preventable”.

The CDC says "the VAE definition algorithm is for use in surveillance; it is not a clinical definition algorithm and is not intended for use in the clinical management of patients”. Based on the experience with the hospital acquired infections program this seems unlikely. What seems more likely is that hospitals will be measured on VAE rates with financial or public relations consequences shortly to follow.

The best evidence suggests that the VAE concept is not useful for guiding clinical decisions in the moment (1). Its performance characteristics as a screening test appear to be terrible, with poor sensitivity (~32%) for detecting VAP in the one of the only prospective studies. This is because clinically insignificant fluctuations in oxygenation/PEEP status are often recorded as VAEs, diluting signal with noise. Numerous retrospective reviews supporting the VAE concept listed on CDC's website strongly link VAEs with morbidity and mortality. However, these observations could be true of many events and may be very different from showing that a prospective (intervention-based) approach is helpful. Pulmonologist Dr. Richard Wunderink from Northwestern commented that “the central hypothesis of the VAE criteria—that VAP and other potentially preventable complications of mechanical ventilation can consistently be detected by worsening gas exchange—is clearly not true”.

The problems with VAE appear much the same as the problems with VAP. Neither is strongly evidence-based and neither has been shown to be helpful in patient care. Furthermore, it might be possible to “game” the numbers by adjusting PEEP, expiratory time, and FiO2 within the defined limits.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Pulm/CCM. What are ventilator-associated events (and why should you care)? Available at: http://pulmccm.org/main/2014/review-articles/ventilator-associated-events-care/?utm_source=Email+Updates+from+PulmCCM&utm_campaign=b1ee59472e-USP_mar_24_2014&utm_medium=email&utm_term=0_e9d9e09c7c-b1ee59472e-312029025 (accessed 1/24/17).
2. CDC. Ventilator-associated event (VAE). January 2017. Available at: https://www.cdc.gov/nhsn/pdfs/pscManual/10-VAE_FINAL.pdf (accessed 1/24/17).

Cite as: Robbins RA. CDC releases ventilator-associated events criteria. Southwest J Pulm Crit Care. 2017:14(1):40-1. doi: https://doi.org/10.13175/swjpcc009-17 PDF 

Medicare Bundled Payment Initiative Did Not Reduce COPD Readmissions

Implementation of the Medicare bundled payments for care improvement initiative has failed to cut readmission rates following hospitalization for acute exacerbation of chronic obstructive pulmonary disease (COPD), according to a study published in the Annals of the American Thoracic Society (1).

Bhatt and colleagues (1) from the University of Alabama at Birmingham enrolled 78 consecutive Medicare patients in 2014 compared to 109 patients in the historic group from 2012. They found that patients from 2014 were more likely to have compliance with the bundled care payment requirements. However, there was no difference in all-cause readmission rates at 30 days (15.4% vs.17.4%; p=.711), and 90 days (26.9% vs 33.9%; p=.306).

The bundled care requirements include regular follow-up phone calls, pneumococcal and influenza vaccines, home health care, durable medical equipment, pulmonary rehabilitation, and to attend pulmonary clinic which were significantly increased after implementation of the bundled care requirements. However, these COPD interventions were implemented despite having not been shown to decrease COPD readmissions (2). Furthermore, Shah et al. (3) have reported that only 27.6% of COPD hospital readmissions are for COPD making these COPD interventions even less likely to reduce readmissions.

References

1. Bhatt SP, Wells JM, Iyer AS, et al. Results of a Medicare Bundled Payments for Care Improvement Initiative for COPD Readmissions. Ann Am Thorac Soc. 2016 Dec 22 [Epub ahead of print]. [CrossRef] [PubMed]
2. Robbins RA, Wesselius LJ. Reducing readmissions after a COPD exacerbation: a brief review. Southwest J Pulm Crit Care. 2015;11(1):19-24. [CrossRef]
3. Shah T, Churpek MM, Coca Perraillon M, Konetzka RT. Understanding why patients with COPD get readmitted: a large national study to delineate the medicare population for the readmissions penalty expansion. Chest. 2015;147(5):1219-26. [CrossRef] [PubMed]

Cite as: Robbins RA. Medicare bundled payment initiative did not reduce COPD readmissions. Southwest J Pulm Crit Care. 2016;14(1):26. doi: https://doi.org/10.13175/swjpcc104-17 PDF

Younger Smokers Continue to Smoke as Adults: Implications for Raising the Smoking Age to 21

A review article published in Pediatrics assesses the evidence that smoking is particularly harmful the younger a smoker begins (1). Not only do youths tend to accumulate more pack-years but they have more difficulty quitting. The recent shift in smoking trends from tobacco cigarettes to e-cigarettes may not be helpful since both contain the addictive component, nicotine. Although e-cigarettes are marketed as a smoking cessation tool, there is no strong evidence to support these claims, the authors report.

"I think most people realize nicotine is addictive, but I don't know if there's an understanding of just how addictive it is – particularly for youths," said Lorena M. Siqueira, MD, MSPH, lead author of the report (2).

Evidence shows that the earlier in life a person is exposed to nicotine, the more likely they will consume greater quantities and the less likely they will be able to quit (1,2). The vast majority of tobacco-dependent adults (>99%) started smoking before age 26 years. Approximately two thirds of children who smoke in sixth grade, become regular smokers as adults. In comparison, 46% of youth who begin smoking in the eleventh grade go on to become regular smokers as adults. Youths require more attempts to quit smoking before being successful compared to adults. Only about 4% of smokers aged 12 to 19 years have been shown to successfully quit each year.

"There are now seven published longitudinal studies showing that youths who initiate smoking with e-cigarettes are about three times more likely to be smoking conventional cigarettes a year later," said Stanton A. Glantz, PhD, of the Center for Tobacco Research and Education at the University of California and a coauthor of the review (2). Instead of making quitting easier, e-cigarettes make it harder, Dr. Glantz added.

An Institute of Medicine report notes that the age of initiation of smoking is critical (3). The report estimates that that raising the minimum age for the sale of tobacco products to 21 will, over time, reduce the smoking rate by about 12 percent. This reduction is estimated to result in reducing smoking-related deaths by 10 percent, which translates into 223,000 fewer premature deaths, 50,000 fewer deaths from lung cancer, and 4.2 million fewer years of life lost (3).

These data may prove valuable in evaluating the potential health impact of this legislation.  California became the second state to raise the tobacco sale age to 21 in 2016, joining Hawaii (3). At least 210 localities have raised the tobacco age to 21, including New York City, Chicago, Boston, Cleveland, Kansas City and Cottonwood, Arizona. Statewide legislation to do so is being considered in several other states and will probably be introduced in Arizona during this legislative session.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Siqueira LM; Committee on Substance Use and Prevention. Nicotine and tobacco as substances of abuse in children and adolescents. Pediatrics. 2017 Jan;139(1):e20163436. [CrossRef] [PubMed]
2. Melville NA. Nicotine's highly addictive impact on youth underestimated. Medscape. January 3, 2017. Available at: http://www.medscape.com/viewarticle/873955?nlid=111769_2863&src=wnl_dne_170104_mscpedit&uac=9273DT&impID=1266832&faf=1 (accessed 1/5/17).
3. Campaign for Tobacco Free Kids. Increasing the minimum legal sale age for tobacco products to 21. Available at: https://www.tobaccofreekids.org/research/factsheets/pdf/0376.pdf (accessed 1/5/17).

Cite as: Robbins RA. Younger smokers continue to smoke as adults: implications for raising the smoking age to 21. Southwest J Pulm Crit Care. 2017;14(1):24-5. doi: https://doi.org/10.13175/swjpcc002-17 PDF

Most Drug Overdose Deaths from Nonprescription Opioids

The Centers for Disease Control (CDC) is reporting in Morbidity and Mortality Weekly that the number of people dying from an opioid overdose rose 15.5% from 2014 to 2015, but the increase had little to do with prescription painkillers such as oxycodone or hydrocodone (1). Roughly 52,000 people died from drug overdoses in 2015 and of those deaths 33,091 involved an opioid. The increases in “death rates were driven by synthetic opioids other than methadone (72.2%), most likely illicitly-manufactured fentanyl, and heroin (20.6%)”. Deaths from methadone, which is usually prescribed by physicians, decreased 9.1%.

The largest increase in deaths occurred in the South and Northeast with 3% and 24% increases in deaths from synthetic opioids from 2014 to 2015. In the Midwest and West, there were more modest 17% and 9% increases during the same period. States in the Southwest with “good” to “excellent” reporting included Colorado, Nevada, and New Mexico which showed 33%, 14% and 30% decreases respectively.

Earlier this year, CDC Director Tom Frieden, MD, MPH, said "The prescription overdose epidemic is doctor-driven…It can be reversed in part by doctors' actions” (2). That characterization has rung in some physicians' ears as blame for the entire opioid crisis, including deaths from heroin and illegal fentanyl. The data in the present article suggests that characterization is inaccurate and that efforts by a number of State Boards to limit physician opioid prescribing may be marginally or non-effective in reducing overdose deaths.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 16;65. Published on-line. [CrossRef]
2. Lowes R. CDC issues opioid guidelines for 'doctor-driven' epidemic. Medscape. March 15, 2016. Available at: http://www.medscape.com/viewarticle/860452 (accessed 12/21/16).

Cite as: Robbins RA. Most drug overdose deaths from nonprescription opioids. Southwest J Pulm Crit Care. 2016;13(6):316. doi: https://doi.org/10.13175/swjpcc145-16 PDF

Lawsuits Allege Price Fixing by Generic Drug Makers

Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1). The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit.

The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of sharply rising drug prices led to Congressional hearings. "We believe that this is the tip of the iceberg," Connecticut Attorney General George Jepsen told Reuters in an interview. "Price fixing in the generic industry is widespread and pervasive, and it involves many other drugs and a number of other companies."

Both former Heritage CEO Jeffrey Glazer and former Heritage Vice President of Commercial Operations Jason Malek are expected to plead guilty. According to Reuters, it is typical for the Justice Department to file one lawsuit about an ongoing issue and use evidence from those defendants to build subsequent cases against others. Several companies have publicly disclosed receiving subpoenas from the Justice Department related to generic drug pricing including Mylan, Allergan, Lannett, Impax, Par, Sun and Mayne.

The drugs involved in the Justice Department lawsuit include two older drugs, doxycycline hyclate and glyburide. Doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014.

Richard A. Robbins, MD

Editor, SWJPCC

Reference

1. Bartz D, Lynch SN. U.S. states sue Mylan, Teva, others for fixing drug prices. Reuters. December 16, 2016. Available at: http://www.reuters.com/article/us-usa-drugpricing-idUSKBN14420C (accessed 12/17/16).

Cite as: Robbins RA. Lawsuits allege price fixing by generic drug makers. Southwest J Pulm Crit Care. 2016;13(6):313. doi: https://doi.org/10.13175/swjpcc142-16 PDF