News Continued from page 442
risk of developing it, assigning some to receive products known to pose a higher cardiovascular risk than naproxen would be unethical. Moreover, Mosholder has argued, if PRECISION is allowed to continue, patients need to be told about the meta-analysis’s findings about celecoxib, ibuprofen, and naproxen and given the opportunity to either consent to continue participating or withdraw. FDA’s assembled advisers voiced no need for the PRECISION investigators to obtain patients’ informed consent again. “It would really be a shame to stop it early,” noted Donald R. Miller, a rheumatology expert at the North Dakota State University College of Pharmacy, Nursing, and Allied Sciences in Fargo. Available information. Miller, who did not think the available data support the conclusion that naproxen poses a lower cardiovascular thrombotic event risk than the other NSAIDs, said evidence supports reconsideration of FDA’s advice regarding the risk’s onset. “In my opinion,” he said, “the risk does occur early and that should be clarified” in the labeling. Thirteen of the other advisers likewise wanted FDA to reconsider its current labeling advice on risk onset, which states, “This risk may increase with duration of use.” Full-text reports of the 639-study metaanalysis and the Danish registries study are available online without charge. The meta-analysis, by the Coxib and traditional NSAID Trialists’ Collaboration, is at www.thelancet.com/journals/ lancet/article/PIIS0140-6736(13)60900-9/ fulltext. The registries study is at http://circ.aha journals.org/content/123/20/2226.full. The 25 advisers who attended FDA’s February 10–11 meeting in Maryland were members or temporary members of the advisory committees on arthritis and drug safety. —Cheryl A. Thompson DOI 10.2146/news140021
444
ICU infection-prevention efforts could be better, study finds
P
olicies for preventing health care– associated infections in intensive care units (ICUs) are often incomplete and not consistently followed at the bedside, according to data from hospitals that participate in a national surveillance program. The findings, reported in the February issue of the American Journal of Infection Control, indicated that efforts to prevent catheter-associated urinary tract infections (CAUTIs) are most in need of improvement. The implementation of policies to prevent central line–associated bloodstream infections (CLABSIs) and ventilator–associated pneumonia (VAP) were more in line with federal recommendations but could also stand improvement, according to the report. The study involved the use of an online survey to assess adherence to 16 evidence-based infection-prevention practices in 1534 ICUs at 975 hospitals that participate in the National Healthcare Safety Network (NHSN). Only adult ICUs were surveyed. For the six CLABSI-prevention practices examined in the survey, the proportions of respondents reporting a policy in place at their institution ranged from 87% to 97%; for the six VAP-prevention strategies, the figures ranged from 69% to 91%, and for the four CAUTI-prevention practices, the range was 27–68%. Observed adherence to the policies was highest for the six CLABSI-prevention practices, ranging from 37 to 71%. For VAP, policy adherence was 45–55%, and for CAUTI, adherence was 6–27%. The authors noted that the CAUTI findings are particularly worrisome, since this is the most common health care–associated infection. According to the Centers for Disease Control and Prevention (CDC), urinary tract infections account for 15% of all health care–associated infections, and virtually all of them are caused by catheter use.
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
CDC uses data from NHSN to track CAUTI, CLABSI, and VAP rates, and the agency assisted with hospital recruitment for the aforementioned surveillance study. The infection-prevention practices examined in the study are included in CDC guidelines for reducing infections. Practices examined in the study that may directly involve pharmacists include deep vein thrombosis prophylaxis, stomach ulcer prevention, and sedation vacations for VAP prevention. But ICU pharmacists can be involved in broader efforts to prevent all three types of infections. “It’s important for pharmacists to be at the table when these policies are developed” at a hospital, said Kristen E. Holt, assistant director of quality improvement and regulatory affairs for the department of pharmacy at The Johns Hopkins Hospital in Baltimore. The practices examined in the study also relate to quality reporting initiatives from the Joint Commission and the Centers for Medicare and Medicare Services that can affect hospitals’ accreditation and reimbursement status. Holt said pharmacists should examine existing and proposed quality measures for infection control and determine where the profession can add value and accountability to the process. “Pharmacists really should be knowledgeable of what’s going on with the measures and demonstrate that pharmacists can contribute in a significant way” to improve patient care and further the profession, she said. Ryan Servais, critical care clinical pharmacist at 711-bed Aurora St. Luke’s Medical Center in Milwaukee, said the hospital’s infection-prevention practices for VAP, CLABSI, and CAUTI are specified in checklists, bundles, guidelines, and best practices but are not, to his knowledge, part of official policies. Continued on page 446
News Continued from page 444
“I believe it would be helpful to spell out some of these strategies in policy,” Servais said. He said pharmacists can contribute every day to infection-prevention efforts by educating other caregivers and recommending interventions during multidisciplinary rounds. And, he said, pharmacists “can have an overarching impact through protocol creation, policy development, or implementation of best practices” and work with quality–management or infection– prevention staff to collect and analyze data and then rapidly implement and adopt changes in response to their findings. To help prevent VAP, he said, ICU pharmacists at Aurora St. Luke’s “work to minimize sedation as much as possible to ensure patients are able to be extubated in a timely fashion.” Other VAP-prevention efforts that involve pharmacists include daily sedation interruption, participation in nursing education, and daily multidisciplinary rounds during which pharmacists promote appropriate pain control and as-needed use of sedatives, including shorter-acting agents, Servais said. “Further, the hospital has a VAP bundle that includes elevating the head of the bed, oral care, and other evidence-based practices to reduce development of VAP,” Servais said. For CLABSI prevention, pharmacists at the hospital “have the ability, per our pharmacy and therapeutics committee, to convert many medications from intravenous to oral when patients qualify. This allows for lines to be removed as soon as no longer needed,” Servais said. He added that discussions about which central lines may no longer be needed occur during daily rounds. He said CAUTI prevention is addressed by the health care team as a whole. “My experience is in the cardiovascular intensive care unit, where all patients come out of surgery with a urinary catheter,” Servais said. “Our goal is to have this out by postoperative day 2 unless a specific indication exists to keep it in.”
446
He said this goal is discussed and enforced during multidisciplinary rounds. “Our pharmacists are currently in the process of education and establishing appropriate treatment strategies for UTIs, including curbing fluoroquinolone use. This is not preventing CAUTI but helping with appropriate treatment,” Servais added. Data at Medicare’s Hospital Compare website indicates that Aurora St. Luke’s exceeds the national benchmark for CLABSI prevention and meets the benchmark for CAUTI prevention. VAP-prevention data aren’t available at Hospital Compare. Another issue that relates more broadly to infection control was recently addressed in guidelines developed by members of the guidelines committee of the Society for Healthcare Epidemiology of America and published in the February issue of Infection Control and Hospital Epidemiology.
These guidelines address health care attire outside of operating rooms and recognize hospitals’ desire to balance professional appearance and infection prevention. According to the guidelines, hospitals that recommend the wearing of white coats for patient care staff should make sure that each wearer has at least two coats to alternate and access to free or low-cost laundering. To limit patient contact with potentially contaminated coats, coat hooks should be located in areas that promote removal of the coat before the wearer provides direct patient care. The guidelines did not find sufficient evidence to support limiting the use of neckties and other apparel, but the document recommends that neckties be secured in a way that prevents patient contact. —Kate Traynor DOI 10.2146/news140022
Stakeholders discuss biosimilar naming, substitution
B
iosimilars don’t yet exist in the United States, but the battle to control the market for these potentially lucrative products was on display February 4 during a public workshop convened in Washington, D.C., by the Federal Trade Commission (FTC). FTC sponsored the daylong event to obtain feedback on how states’ substitution laws and FDA’s terminology for biosimilars will affect competition among the products. Workshop presenters fell generally into two camps—those who said that unique nonproprietary names for biosimilars and state substitution laws will improve pharmacovigilance and patient safety, and those who called substitution laws and unique naming proposals scare
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
tactics intended to prevent biosimilars from taking market share from innovator products. At issue, ultimately, is whether the advent of biosimilars will introduce price competition into the U.S. marketplace and help reduce health care costs. Harry Travis, pharmacist and vice president of Aetna Specialty and Home Delivery Pharmacy, said the stakes are high. He said specialty products, 75% of which are biological agents, last year accounted for 1% of all dispensed prescriptions but half of all prescription costs and 10% of the total health spend among the company’s fully insured customers. Travis said Aetna’s specialty pharmacy spending is growing at an unsustainable 15%-per-year rate. He said part of the
risk of developing it, assigning some to receive products known to pose a higher cardiovascular risk than naproxen would be unethical. Moreover, Mosholder has argued, if PRECISION is allowed to continue, patients need to be told about the meta-analysis’s findings about celecoxib, ibuprofen, and naproxen and given the opportunity to either consent to continue participating or withdraw. FDA’s assembled advisers voiced no need for the PRECISION investigators to obtain patients’ informed consent again. “It would really be a shame to stop it early,” noted Donald R. Miller, a rheumatology expert at the North Dakota State University College of Pharmacy, Nursing, and Allied Sciences in Fargo. Available information. Miller, who did not think the available data support the conclusion that naproxen poses a lower cardiovascular thrombotic event risk than the other NSAIDs, said evidence supports reconsideration of FDA’s advice regarding the risk’s onset. “In my opinion,” he said, “the risk does occur early and that should be clarified” in the labeling. Thirteen of the other advisers likewise wanted FDA to reconsider its current labeling advice on risk onset, which states, “This risk may increase with duration of use.” Full-text reports of the 639-study metaanalysis and the Danish registries study are available online without charge. The meta-analysis, by the Coxib and traditional NSAID Trialists’ Collaboration, is at www.thelancet.com/journals/ lancet/article/PIIS0140-6736(13)60900-9/ fulltext. The registries study is at http://circ.aha journals.org/content/123/20/2226.full. The 25 advisers who attended FDA’s February 10–11 meeting in Maryland were members or temporary members of the advisory committees on arthritis and drug safety. —Cheryl A. Thompson DOI 10.2146/news140021
444
ICU infection-prevention efforts could be better, study finds
P
olicies for preventing health care– associated infections in intensive care units (ICUs) are often incomplete and not consistently followed at the bedside, according to data from hospitals that participate in a national surveillance program. The findings, reported in the February issue of the American Journal of Infection Control, indicated that efforts to prevent catheter-associated urinary tract infections (CAUTIs) are most in need of improvement. The implementation of policies to prevent central line–associated bloodstream infections (CLABSIs) and ventilator–associated pneumonia (VAP) were more in line with federal recommendations but could also stand improvement, according to the report. The study involved the use of an online survey to assess adherence to 16 evidence-based infection-prevention practices in 1534 ICUs at 975 hospitals that participate in the National Healthcare Safety Network (NHSN). Only adult ICUs were surveyed. For the six CLABSI-prevention practices examined in the survey, the proportions of respondents reporting a policy in place at their institution ranged from 87% to 97%; for the six VAP-prevention strategies, the figures ranged from 69% to 91%, and for the four CAUTI-prevention practices, the range was 27–68%. Observed adherence to the policies was highest for the six CLABSI-prevention practices, ranging from 37 to 71%. For VAP, policy adherence was 45–55%, and for CAUTI, adherence was 6–27%. The authors noted that the CAUTI findings are particularly worrisome, since this is the most common health care–associated infection. According to the Centers for Disease Control and Prevention (CDC), urinary tract infections account for 15% of all health care–associated infections, and virtually all of them are caused by catheter use.
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
CDC uses data from NHSN to track CAUTI, CLABSI, and VAP rates, and the agency assisted with hospital recruitment for the aforementioned surveillance study. The infection-prevention practices examined in the study are included in CDC guidelines for reducing infections. Practices examined in the study that may directly involve pharmacists include deep vein thrombosis prophylaxis, stomach ulcer prevention, and sedation vacations for VAP prevention. But ICU pharmacists can be involved in broader efforts to prevent all three types of infections. “It’s important for pharmacists to be at the table when these policies are developed” at a hospital, said Kristen E. Holt, assistant director of quality improvement and regulatory affairs for the department of pharmacy at The Johns Hopkins Hospital in Baltimore. The practices examined in the study also relate to quality reporting initiatives from the Joint Commission and the Centers for Medicare and Medicare Services that can affect hospitals’ accreditation and reimbursement status. Holt said pharmacists should examine existing and proposed quality measures for infection control and determine where the profession can add value and accountability to the process. “Pharmacists really should be knowledgeable of what’s going on with the measures and demonstrate that pharmacists can contribute in a significant way” to improve patient care and further the profession, she said. Ryan Servais, critical care clinical pharmacist at 711-bed Aurora St. Luke’s Medical Center in Milwaukee, said the hospital’s infection-prevention practices for VAP, CLABSI, and CAUTI are specified in checklists, bundles, guidelines, and best practices but are not, to his knowledge, part of official policies. Continued on page 446
News Continued from page 444
“I believe it would be helpful to spell out some of these strategies in policy,” Servais said. He said pharmacists can contribute every day to infection-prevention efforts by educating other caregivers and recommending interventions during multidisciplinary rounds. And, he said, pharmacists “can have an overarching impact through protocol creation, policy development, or implementation of best practices” and work with quality–management or infection– prevention staff to collect and analyze data and then rapidly implement and adopt changes in response to their findings. To help prevent VAP, he said, ICU pharmacists at Aurora St. Luke’s “work to minimize sedation as much as possible to ensure patients are able to be extubated in a timely fashion.” Other VAP-prevention efforts that involve pharmacists include daily sedation interruption, participation in nursing education, and daily multidisciplinary rounds during which pharmacists promote appropriate pain control and as-needed use of sedatives, including shorter-acting agents, Servais said. “Further, the hospital has a VAP bundle that includes elevating the head of the bed, oral care, and other evidence-based practices to reduce development of VAP,” Servais said. For CLABSI prevention, pharmacists at the hospital “have the ability, per our pharmacy and therapeutics committee, to convert many medications from intravenous to oral when patients qualify. This allows for lines to be removed as soon as no longer needed,” Servais said. He added that discussions about which central lines may no longer be needed occur during daily rounds. He said CAUTI prevention is addressed by the health care team as a whole. “My experience is in the cardiovascular intensive care unit, where all patients come out of surgery with a urinary catheter,” Servais said. “Our goal is to have this out by postoperative day 2 unless a specific indication exists to keep it in.”
446
He said this goal is discussed and enforced during multidisciplinary rounds. “Our pharmacists are currently in the process of education and establishing appropriate treatment strategies for UTIs, including curbing fluoroquinolone use. This is not preventing CAUTI but helping with appropriate treatment,” Servais added. Data at Medicare’s Hospital Compare website indicates that Aurora St. Luke’s exceeds the national benchmark for CLABSI prevention and meets the benchmark for CAUTI prevention. VAP-prevention data aren’t available at Hospital Compare. Another issue that relates more broadly to infection control was recently addressed in guidelines developed by members of the guidelines committee of the Society for Healthcare Epidemiology of America and published in the February issue of Infection Control and Hospital Epidemiology.
These guidelines address health care attire outside of operating rooms and recognize hospitals’ desire to balance professional appearance and infection prevention. According to the guidelines, hospitals that recommend the wearing of white coats for patient care staff should make sure that each wearer has at least two coats to alternate and access to free or low-cost laundering. To limit patient contact with potentially contaminated coats, coat hooks should be located in areas that promote removal of the coat before the wearer provides direct patient care. The guidelines did not find sufficient evidence to support limiting the use of neckties and other apparel, but the document recommends that neckties be secured in a way that prevents patient contact. —Kate Traynor DOI 10.2146/news140022
Stakeholders discuss biosimilar naming, substitution
B
iosimilars don’t yet exist in the United States, but the battle to control the market for these potentially lucrative products was on display February 4 during a public workshop convened in Washington, D.C., by the Federal Trade Commission (FTC). FTC sponsored the daylong event to obtain feedback on how states’ substitution laws and FDA’s terminology for biosimilars will affect competition among the products. Workshop presenters fell generally into two camps—those who said that unique nonproprietary names for biosimilars and state substitution laws will improve pharmacovigilance and patient safety, and those who called substitution laws and unique naming proposals scare
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
tactics intended to prevent biosimilars from taking market share from innovator products. At issue, ultimately, is whether the advent of biosimilars will introduce price competition into the U.S. marketplace and help reduce health care costs. Harry Travis, pharmacist and vice president of Aetna Specialty and Home Delivery Pharmacy, said the stakes are high. He said specialty products, 75% of which are biological agents, last year accounted for 1% of all dispensed prescriptions but half of all prescription costs and 10% of the total health spend among the company’s fully insured customers. Travis said Aetna’s specialty pharmacy spending is growing at an unsustainable 15%-per-year rate. He said part of the
