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
News
increase has been offset by cost savings from using generic, rather than brandname, small-molecule drugs. But that savings mechanism is diminishing because many high-cost blockbuster drugs have already lost patent protection or soon will. “That benefit is pretty much over in about two years,” he said, adding that the cost of biologicals remains an elephant in the room that the nation must soon grapple with. Biosimilars have been available in the European Union for several years. Acceptance of the products varies among countries but is expected by some analysts to increase as pressure mounts to curb spending on medications. Biosimilars. The Biologics Price Competition and Innovation Act (BPCIA), signed into law in 2010, required FDA to create an approval process for two types of what the agency sometimes calls followon biologicals: those that are biosimilar, and those that are interchangeable. FDA defines a biosimilar product as one that is highly similar to an already approved biological except for minor differences in clinically inactive components. Biosimilars must lack clinically meaningful differences relative to the safety, purity, and potency of the reference product. Interchangeable biological agents must, in addition, be expected to confer the same clinical benefits as the reference product and pose no additional safety or diminished–efficacy risks for patients who alternate between the interchangeable and reference products. Under the BPCIA, an interchangeable product, by definition, “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Despite the apparent federal intent to freely substitute interchangeable biologicals, legislation was enacted in 5 states last year that requires the prescriber to be notified whenever a pharmacist substitutes a biosimilar product for the agent that was prescribed. In all, 28 bills
related to biosimilars substitution were introduced in 18 states last year, said Jessica Mazer, assistant vice president for state affairs at the Pharmaceutical Care Management Association (PCMA). Mazer said PCMA believes that if FDA classifies one biological as interchangeable with another, substitution should be allowed without the interference of “onerous” state requirements. Bruce Leichner, senior vice president and general counsel for Momenta Pharmaceuticals, likewise urged FTC to “encourage FDA to adopt a preemption policy with respect to state substitution laws for biosimilars, because interchangeables are meant by statute to be substituted.” PCMA represents pharmacy benefits managers, and Momenta is developing both innovator biologicals and biosimilars. Leichner said state substitution laws are the result of a campaign to convince the public and prescribers that biosimilars are meaningfully different from brand-name products and that such products should be viewed with suspicion. Groups that favor state substitution laws include the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America [see May 15, 2013, AJHP News]. Geoffrey Eich, executive director of research and development policy at Amgen, said prescribers must be informed about substitutions to ensure that patients’ medical records are accurate and to facilitate adverse-event reporting. But several presenters noted that pharmacy records already have sufficient information to identify any biological dispensed to a patient, and physicians have access to this information if they want it. Some speakers also questioned whether physicians will really want to receive these communications from pharmacists. Naming. Meeting attendees who supported state substitution laws generally also supported the creation of unique nonproprietary names for all biosimilar products. This practice would set biosimilars apart from small-molecule
generics, which have the same nonproprietary names as their reference products. Gino Grampp, director of research and development policy at Amgen, said biologicals “should not be treated as generics for the purpose of naming.” He said that the products are complex, and different versions from different manufacturers could have clinically different characteristics arising from the different processes used to make the products. These factors, he said support the need for distinct nonproprietary names for biosimilars. Mark McCamish, global head of biopharmaceutical development for Sandoz, countered that batch-to-batch variability is inherent in the production of all biological agents, and manufacturers routinely test their products to ensure that they fall within predetermined specifications. Biosimilars, he said, would likewise be required to meet specifications and need not have a unique nonproprietary name to distinguish them from reference products. Grampp also said that having unique nonproprietary names for biosimilars will help improve the accuracy of adverse-event reports, which are sometimes attributed to the wrong version of a drug. FDA, by requiring the addition of three-letter prefixes to the nonproprietary names of some biologicals (tbofilgrastim, ziv-aflibercept, and adotrastuzumab) has indicated a preference for unique nonproprietary names. These products are not considered biosimilars because they were licensed through FDA’s traditional pathway for biologicals. FDA has not yet finalized its policies for approving biosimilar products, and FTC did not indicate during the February meeting which naming and substitution policies it will support. —Kate Traynor DOI 10.2146/news140023 Continued on page 448
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
447
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
“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
News
increase has been offset by cost savings from using generic, rather than brandname, small-molecule drugs. But that savings mechanism is diminishing because many high-cost blockbuster drugs have already lost patent protection or soon will. “That benefit is pretty much over in about two years,” he said, adding that the cost of biologicals remains an elephant in the room that the nation must soon grapple with. Biosimilars have been available in the European Union for several years. Acceptance of the products varies among countries but is expected by some analysts to increase as pressure mounts to curb spending on medications. Biosimilars. The Biologics Price Competition and Innovation Act (BPCIA), signed into law in 2010, required FDA to create an approval process for two types of what the agency sometimes calls followon biologicals: those that are biosimilar, and those that are interchangeable. FDA defines a biosimilar product as one that is highly similar to an already approved biological except for minor differences in clinically inactive components. Biosimilars must lack clinically meaningful differences relative to the safety, purity, and potency of the reference product. Interchangeable biological agents must, in addition, be expected to confer the same clinical benefits as the reference product and pose no additional safety or diminished–efficacy risks for patients who alternate between the interchangeable and reference products. Under the BPCIA, an interchangeable product, by definition, “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Despite the apparent federal intent to freely substitute interchangeable biologicals, legislation was enacted in 5 states last year that requires the prescriber to be notified whenever a pharmacist substitutes a biosimilar product for the agent that was prescribed. In all, 28 bills
related to biosimilars substitution were introduced in 18 states last year, said Jessica Mazer, assistant vice president for state affairs at the Pharmaceutical Care Management Association (PCMA). Mazer said PCMA believes that if FDA classifies one biological as interchangeable with another, substitution should be allowed without the interference of “onerous” state requirements. Bruce Leichner, senior vice president and general counsel for Momenta Pharmaceuticals, likewise urged FTC to “encourage FDA to adopt a preemption policy with respect to state substitution laws for biosimilars, because interchangeables are meant by statute to be substituted.” PCMA represents pharmacy benefits managers, and Momenta is developing both innovator biologicals and biosimilars. Leichner said state substitution laws are the result of a campaign to convince the public and prescribers that biosimilars are meaningfully different from brand-name products and that such products should be viewed with suspicion. Groups that favor state substitution laws include the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America [see May 15, 2013, AJHP News]. Geoffrey Eich, executive director of research and development policy at Amgen, said prescribers must be informed about substitutions to ensure that patients’ medical records are accurate and to facilitate adverse-event reporting. But several presenters noted that pharmacy records already have sufficient information to identify any biological dispensed to a patient, and physicians have access to this information if they want it. Some speakers also questioned whether physicians will really want to receive these communications from pharmacists. Naming. Meeting attendees who supported state substitution laws generally also supported the creation of unique nonproprietary names for all biosimilar products. This practice would set biosimilars apart from small-molecule
generics, which have the same nonproprietary names as their reference products. Gino Grampp, director of research and development policy at Amgen, said biologicals “should not be treated as generics for the purpose of naming.” He said that the products are complex, and different versions from different manufacturers could have clinically different characteristics arising from the different processes used to make the products. These factors, he said support the need for distinct nonproprietary names for biosimilars. Mark McCamish, global head of biopharmaceutical development for Sandoz, countered that batch-to-batch variability is inherent in the production of all biological agents, and manufacturers routinely test their products to ensure that they fall within predetermined specifications. Biosimilars, he said, would likewise be required to meet specifications and need not have a unique nonproprietary name to distinguish them from reference products. Grampp also said that having unique nonproprietary names for biosimilars will help improve the accuracy of adverse-event reports, which are sometimes attributed to the wrong version of a drug. FDA, by requiring the addition of three-letter prefixes to the nonproprietary names of some biologicals (tbofilgrastim, ziv-aflibercept, and adotrastuzumab) has indicated a preference for unique nonproprietary names. These products are not considered biosimilars because they were licensed through FDA’s traditional pathway for biologicals. FDA has not yet finalized its policies for approving biosimilar products, and FTC did not indicate during the February meeting which naming and substitution policies it will support. —Kate Traynor DOI 10.2146/news140023 Continued on page 448
Am J Health-Syst Pharm—Vol 71 Mar 15, 2014
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Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
