News
N e ws White House forum spotlights collaboration on antimicrobial stewardship
D
uring the June 2 antimicrobial stewardship forum convened by the White House, Department of Health and Human Services (HHS) Secretary Sylvia Burwell hinted that hospitals will soon be required to improve the way they use antimicrobial drugs. “We’re working to create regulations for antibiotic stewardship programs for
New drugs and dosage forms Albendazole chewable tablets (Albenza, Amedra Pharmaceuticals): A new chewable tablet, with wild berry flavoring, is indicated for patients who need the anthelmintic drug but may have difficulty swallowing a whole tablet. Glucagon for injection (no brand name, Fresenius Kabi): The new product, produced by solid-phase peptide synthesis, is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. The package label states that this product is for diagnostic use only. The prescribing information states that the product is not indicated for the emergency treatment of hypoglycemia because the vial is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. Moxifloxacin injection (no brand name, Fresenius Kabi): The new product, which is not a generic drug product, is indicated in adults for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, complicated intraabdominal infections, and skin and skin structure infections caused by susceptible bacteria. The ready-to-use sterile solution contains 400 mg of the antibacterial drug and 1207 mg of sodium in 250 mL and has a pH of 5–6.
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acute care and critical access hospitals as well as long-term [care] facilities,” Burwell said. “When in place, what these regulations will do is reduce harm that might arise from overtreatment with antibiotics while enabling patients to receive effective antibiotics for illnesses from bacteria.” Burwell and Centers for Disease Control and Prevention (CDC) Director Thomas Frieden were among the Obama administration officials who made public comments during the daylong event. The forum was the latest component of a comprehensive national effort to reduce the threat posed by antimicrobialresistant bacteria, which federal officials blamed for two million infections and 23,000 deaths in the United States each year. Forum attendees included ASHP Chief Executive Officer Paul W. Abramowitz and other leaders representing healthcare organizations, animal health groups, livestock and poultry producers, drug makers, and other entities involved in antimicrobial development and use. “ASHP applauds President Obama for making antibiotic stewardship a national priority and for recognizing the essential roles pharmacists play in improving stewardship and antibiotic use,” Abramowitz said. “It was a pleasure to be there representing ASHP members and the patients they serve. We look forward to working with the White House, CDC, and other stakeholders to address this important public health issue.” The White House in March announced a 2020 target date for achieving
Am J Health-Syst Pharm—Vol 72 Jul 15, 2015
several goals in the multiyear initiative to combat increasing antimicrobial resistance. One goal is to establish antimicrobial stewardship programs in all U.S. acute care hospitals and to improve stewardship in all healthcare settings. Another goal is to reduce the inappropriate use of antimicrobials by 20% in inpatient settings and 50% in outpatient settings. A third goal is to have 95% of all “Medicare-eligible” hospitals routinely report antimicrobial use and resistance data to CDC’s National Health Safety Network. These and other goals were developed as part of the national strategy for combatting antimicrobial-resistant bacteria, which the White House released last September. The June forum was convened to bring together leaders in human and animal health to identify barriers to antimicrobial stewardship activities and find ways to overcome those problems. Each of the more than 150 organizations represented at the forum had formally committed to adopt strategies to help reduce antimicrobial resistance. ASHP pledged to help develop standardized pharmacy metrics for stewardship programs and to promote education, research, and interprofessional collaboration aimed at finding solutions to the growing problem of antimicrobial resistance. According to ASHP’s 2013 national survey of pharmacy practice, 63% of hospitals had an antimicrobial stewardship program. These hospitals most commonly assessed the effect of their stewardship program by evaluating antimicrobial-use patterns. The Joint Commission stated that it will review 16 existing accreditation standards and one National Patient Safety Goal that contain stewardship elements
News
and develop new standards if they are needed to improve the judicious use of antimicrobials. Carolinas Medical Center pledged to implement antimicrobial stewardship programs at all of the health system’s inpatient facilities within three years. Ascension Health, the nation’s largest nonprofit hospital network, pledged to establish in each of its hospitals an antimicrobial stewardship program aligned with core elements established by CDC. Roy Guharoy, vice president and chief pharmacy officer at Ascension, said antimicrobial stewardship was declared a systemwide priority about two years ago, and standardized stewardship programs are now being rolled out at Ascension facilities across the country. “Our goal is to close the gaps and connect the dots so that we have continuity in antimicrobial stewardship programs and we can reduce antibiotic usage,” Guharoy said. He said this will lead to fewer instances of Clostridium difficile infections and other adverse events associated with the overuse of antimicrobials. In fact, Guharoy said, a previous initiative demonstrated that improvements in antimicrobial use at several Ascension hospitals with initially high rates of C. difficile infection cut those rates significantly. And he said antimicrobial-use guidelines that are being implemented across the organization have, within the past year, reduced daptomycin use by 14%, linezolid use by 43%, tigecycline use by 24%, and cefazolin use by 12%. Guharoy said the ongoing implementation of a real-time, integrated clinical decision support system is a critical component of Ascension’s stewardship efforts. The system allows pharmacists to monitor patients’ health status and intervene when necessary. Interventions include recommending the discontinuation of inappropriate medications, matching drug therapy to culture test results, switching patients from i.v. to oral therapy when possible, and ensuring that therapy is of the optimal dosage and duration. “Pharmacists play a most important role in this process,” Guharoy said. “Good
outcomes . . . can only be accomplished if we have prospective monitoring, meaning that antibiotics are reviewed and monitored clinically every day. And that’s a role no one really can do except the pharmacist.” But Guharoy emphasized that stewardship overall is a team effort that requires the participation of physicians, nurses, pharmacists, nonclinical staff, and hospital leaders. “I’m sure all the hospitals across the United States have some activities related to antimicrobial stewardship,” Guharoy noted. “But to accomplish a true antimicrobial stewardship program, you need to have all the elements in place, and that’s very complex.” According to CDC, research suggests that 30–50% of antimicrobial use in hospitals is inappropriate and contributes to the spread of potentially deadly infections with drug-resistant bacteria. CDC Director Thomas Frieden predicted during the June forum that if effective stewardship policies are adopted in all sectors across the nation, more than a half million drug-resistant infections can be prevented.
But failure to act now, he said, risks undermining “much of our ability to care and cure.” “We risk turning back the clock to when simple infections can kill,” he said. Frieden said that tension about antimicrobial use has traditionally existed between patient-focused healthcare providers and professionals who address population health. But he said that has changed. “It’s now clear that the interests are truly aligned,” he said. “What’s best for my patient is the same as what’s best for the community—not the most antibiotics, not the most wide–spectrum antibiotics, but the right drug at the right time in the right patients so they can have them when they need them.” CDC recommends that all hospitals create stewardship programs with specific elements, one of which is to designate a single pharmacist leader who is responsible for working to improve antibiotic use. —Kate Traynor DOI 10.2146/news150046
Pharmacists mull high-dose flu vaccine for seniors
P
harmacists say a recent analysis of Medicare claims data from the 2012–13 flu season helps make the case that for seniors, high-dose influenza virus vaccine leads to better clinical outcomes than standard-dose vaccine. The retrospective cohort study of Medicare claims data for about 930,000 recipients of high-dose influenza vaccine and 1.6 million recipients of a standard formulation found 22% reductions in probable flu infections and flu-related hospitalizations among high-dose vaccine recipients.
The study was a collaborative effort among researchers at FDA, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention (CDC), and Acumen LLC, a consulting firm. The results were published this March in the journal Lancet Infectious Diseases. “To my knowledge, this was the first study that showed a clinical benefit and real clinical outcomes with reducing hospitalizations,” said Christopher J. Edwards, clinical pharmacy specialist and emergency medicine clinical as-
Am J Health-Syst Pharm—Vol 72 Jul 15, 2015
1163
N e ws White House forum spotlights collaboration on antimicrobial stewardship
D
uring the June 2 antimicrobial stewardship forum convened by the White House, Department of Health and Human Services (HHS) Secretary Sylvia Burwell hinted that hospitals will soon be required to improve the way they use antimicrobial drugs. “We’re working to create regulations for antibiotic stewardship programs for
New drugs and dosage forms Albendazole chewable tablets (Albenza, Amedra Pharmaceuticals): A new chewable tablet, with wild berry flavoring, is indicated for patients who need the anthelmintic drug but may have difficulty swallowing a whole tablet. Glucagon for injection (no brand name, Fresenius Kabi): The new product, produced by solid-phase peptide synthesis, is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. The package label states that this product is for diagnostic use only. The prescribing information states that the product is not indicated for the emergency treatment of hypoglycemia because the vial is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. Moxifloxacin injection (no brand name, Fresenius Kabi): The new product, which is not a generic drug product, is indicated in adults for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, complicated intraabdominal infections, and skin and skin structure infections caused by susceptible bacteria. The ready-to-use sterile solution contains 400 mg of the antibacterial drug and 1207 mg of sodium in 250 mL and has a pH of 5–6.
1162
acute care and critical access hospitals as well as long-term [care] facilities,” Burwell said. “When in place, what these regulations will do is reduce harm that might arise from overtreatment with antibiotics while enabling patients to receive effective antibiotics for illnesses from bacteria.” Burwell and Centers for Disease Control and Prevention (CDC) Director Thomas Frieden were among the Obama administration officials who made public comments during the daylong event. The forum was the latest component of a comprehensive national effort to reduce the threat posed by antimicrobialresistant bacteria, which federal officials blamed for two million infections and 23,000 deaths in the United States each year. Forum attendees included ASHP Chief Executive Officer Paul W. Abramowitz and other leaders representing healthcare organizations, animal health groups, livestock and poultry producers, drug makers, and other entities involved in antimicrobial development and use. “ASHP applauds President Obama for making antibiotic stewardship a national priority and for recognizing the essential roles pharmacists play in improving stewardship and antibiotic use,” Abramowitz said. “It was a pleasure to be there representing ASHP members and the patients they serve. We look forward to working with the White House, CDC, and other stakeholders to address this important public health issue.” The White House in March announced a 2020 target date for achieving
Am J Health-Syst Pharm—Vol 72 Jul 15, 2015
several goals in the multiyear initiative to combat increasing antimicrobial resistance. One goal is to establish antimicrobial stewardship programs in all U.S. acute care hospitals and to improve stewardship in all healthcare settings. Another goal is to reduce the inappropriate use of antimicrobials by 20% in inpatient settings and 50% in outpatient settings. A third goal is to have 95% of all “Medicare-eligible” hospitals routinely report antimicrobial use and resistance data to CDC’s National Health Safety Network. These and other goals were developed as part of the national strategy for combatting antimicrobial-resistant bacteria, which the White House released last September. The June forum was convened to bring together leaders in human and animal health to identify barriers to antimicrobial stewardship activities and find ways to overcome those problems. Each of the more than 150 organizations represented at the forum had formally committed to adopt strategies to help reduce antimicrobial resistance. ASHP pledged to help develop standardized pharmacy metrics for stewardship programs and to promote education, research, and interprofessional collaboration aimed at finding solutions to the growing problem of antimicrobial resistance. According to ASHP’s 2013 national survey of pharmacy practice, 63% of hospitals had an antimicrobial stewardship program. These hospitals most commonly assessed the effect of their stewardship program by evaluating antimicrobial-use patterns. The Joint Commission stated that it will review 16 existing accreditation standards and one National Patient Safety Goal that contain stewardship elements
News
and develop new standards if they are needed to improve the judicious use of antimicrobials. Carolinas Medical Center pledged to implement antimicrobial stewardship programs at all of the health system’s inpatient facilities within three years. Ascension Health, the nation’s largest nonprofit hospital network, pledged to establish in each of its hospitals an antimicrobial stewardship program aligned with core elements established by CDC. Roy Guharoy, vice president and chief pharmacy officer at Ascension, said antimicrobial stewardship was declared a systemwide priority about two years ago, and standardized stewardship programs are now being rolled out at Ascension facilities across the country. “Our goal is to close the gaps and connect the dots so that we have continuity in antimicrobial stewardship programs and we can reduce antibiotic usage,” Guharoy said. He said this will lead to fewer instances of Clostridium difficile infections and other adverse events associated with the overuse of antimicrobials. In fact, Guharoy said, a previous initiative demonstrated that improvements in antimicrobial use at several Ascension hospitals with initially high rates of C. difficile infection cut those rates significantly. And he said antimicrobial-use guidelines that are being implemented across the organization have, within the past year, reduced daptomycin use by 14%, linezolid use by 43%, tigecycline use by 24%, and cefazolin use by 12%. Guharoy said the ongoing implementation of a real-time, integrated clinical decision support system is a critical component of Ascension’s stewardship efforts. The system allows pharmacists to monitor patients’ health status and intervene when necessary. Interventions include recommending the discontinuation of inappropriate medications, matching drug therapy to culture test results, switching patients from i.v. to oral therapy when possible, and ensuring that therapy is of the optimal dosage and duration. “Pharmacists play a most important role in this process,” Guharoy said. “Good
outcomes . . . can only be accomplished if we have prospective monitoring, meaning that antibiotics are reviewed and monitored clinically every day. And that’s a role no one really can do except the pharmacist.” But Guharoy emphasized that stewardship overall is a team effort that requires the participation of physicians, nurses, pharmacists, nonclinical staff, and hospital leaders. “I’m sure all the hospitals across the United States have some activities related to antimicrobial stewardship,” Guharoy noted. “But to accomplish a true antimicrobial stewardship program, you need to have all the elements in place, and that’s very complex.” According to CDC, research suggests that 30–50% of antimicrobial use in hospitals is inappropriate and contributes to the spread of potentially deadly infections with drug-resistant bacteria. CDC Director Thomas Frieden predicted during the June forum that if effective stewardship policies are adopted in all sectors across the nation, more than a half million drug-resistant infections can be prevented.
But failure to act now, he said, risks undermining “much of our ability to care and cure.” “We risk turning back the clock to when simple infections can kill,” he said. Frieden said that tension about antimicrobial use has traditionally existed between patient-focused healthcare providers and professionals who address population health. But he said that has changed. “It’s now clear that the interests are truly aligned,” he said. “What’s best for my patient is the same as what’s best for the community—not the most antibiotics, not the most wide–spectrum antibiotics, but the right drug at the right time in the right patients so they can have them when they need them.” CDC recommends that all hospitals create stewardship programs with specific elements, one of which is to designate a single pharmacist leader who is responsible for working to improve antibiotic use. —Kate Traynor DOI 10.2146/news150046
Pharmacists mull high-dose flu vaccine for seniors
P
harmacists say a recent analysis of Medicare claims data from the 2012–13 flu season helps make the case that for seniors, high-dose influenza virus vaccine leads to better clinical outcomes than standard-dose vaccine. The retrospective cohort study of Medicare claims data for about 930,000 recipients of high-dose influenza vaccine and 1.6 million recipients of a standard formulation found 22% reductions in probable flu infections and flu-related hospitalizations among high-dose vaccine recipients.
The study was a collaborative effort among researchers at FDA, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention (CDC), and Acumen LLC, a consulting firm. The results were published this March in the journal Lancet Infectious Diseases. “To my knowledge, this was the first study that showed a clinical benefit and real clinical outcomes with reducing hospitalizations,” said Christopher J. Edwards, clinical pharmacy specialist and emergency medicine clinical as-
Am J Health-Syst Pharm—Vol 72 Jul 15, 2015
1163
