News
N e ws Privileging expands pharmacists’ role
H
ospitals that have a strong clinical pharmacy presence are turning to their institutional privileging programs to expand the high-level patient care services that pharmacists can provide.
New drugs and dosage forms Apremilast tablets (Otezla, Celgene): The phosphodiesterase-4 inhibitor is indicated for the treatment of adults with active psoriatic arthritis. Coagulation factor IX Fc fusion protein, recombinant, for i.v. injection (Alprolix, Biogen Idec): The recombinant DNA-derived coagulation factor is indicated for adults and children with hemophilia B for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Florbetaben F18 injection (Neuraceq, Piramal Imaging): The radioactive diagnostic agent is indicated for use during positron emission tomography imaging of the brain to estimate the density of amyloid plaques in adults with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Metronidazole vaginal gel (no brand name, Valeant Pharmaceuticals): The 1.3% antimicrobial product, intended for one-time use at bedtime, is indicated for the treatment of bacterial vaginosis in women who are not pregnant. Miltefosine capsules (Impavido, Paladin Therapeutics): The drug is indicated for the treatment of visceral leishmaniasis due to Leishmania donovani, cutaneous leishmaniasis due to L. braziliensis, L. guyanensis, or L. panamensis, and mucosal leishmaniasis due to L. braziliensis in patients at least 12 years of age and weighing at least 30 kg. The drug is subject to FDA Medication Guide requirements.
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At The Johns Hopkins Hospital in Baltimore, a recently approved program will allow certain ward-based pharmacists to prescribe medications to inpatients. “It’s about empowering some of our folks to practice at the top of their license and the top of what their knowledge base allows them to do,” said John J. Lewin III, division director of critical care and surgery pharmacy at Johns Hopkins. “That’s going to be good for patients in terms of efficiency, and accuracy, and care, and medication John Lewin safety and its related outcomes.” Lewin expects the pilot program to begin this summer in the hospital’s surgical ICU, where clinical pharmacists are fully integrated into the multiprofessional team and work there daily. Under Maryland law, pharmacists can manage medication therapy by protocol, under the terms of a drug therapy management agreement between pharmacists and physicians. “Our pharmacists do make the interventions now, but they’re not allowed to write medication orders,” Lewin said. Under the current system, any changes to the medication regimen must be performed by a resident, attending physician, or other prescriber. “What we really heard from our physicians was, basically, ‘Why can’t you write the orders for this? You guys are the medication experts, and it would be good for patient care,” Lewin said. He said allowing pharmacists to enter medication orders into the computer system will decrease the administrative burden on physicians and allow them to make better use of their time.
Am J Health-Syst Pharm—Vol 71 May 1, 2014
Ultimately, he said, about 20–30 unitbased pharmacists are expected to be granted prescribing authority. He said the expanded scope of practice will be available to clinical pharmacy specialists who have a Pharm.D. degree and postgraduate year 2 (PGY2) residency training or equivalent experience. Lewin said hospital decision-makers concluded that modifying drug therapy is akin to prescribing, and that the hospital’s governing board should be responsible for assigning privileges to clinical pharmacists to encompass this work. The same process is used to permit physicians, nurse practitioners, and other qualified health care providers to order medications. Lewin expects the pilot program to focus on renal dosage-adjustment protocols. He said the protocols are designed to comply with state law and will allow pharmacists to use their professional judgment to make clinical decisions about drug therapy. He noted that different units will use different protocols that take into account the individual needs of the entire health care team and its patients. A similar privileging process is used at Fort Belvoir Community Hospital in Virginia, said U.S. Army Lieutenant Colonel Eric Maroyka, director of pharmacy for the joint services military treatment facility. Maroyka said all hospital pharmacists are “core privileged” to perform routine tasks at the hospital. But about a dozen clinical Eric Maroyka pharmacy specialists with advanced training have been granted additional privileges that include the ability to prescribe medications in specific settings. “We’re really mirroring what physicians and other midlevel practitioner
News
providers do for their privileging,” Maroyka said. For example, he said, one pharmacist in a patient-centered medical home setting specializes in diabetes care and is able to prescribe medications, monitor patients, and educate them about their drug therapy. “She handles newly diagnosed diabetics and type 2 diabetics without complications,” Maroyka said. “If it’s more complex, like they need to be set up on [an insulin] pump or some other advanced regimen, then they would see the endocrinologist.” Maroyka said credentials for supplemental privileges may include PGY2 residency training or the completion of a fellowship or other recognized educational activity. For one pharmacist, he said, completion of the ASHP Research and Education Foundation’s three-part traineeship program in pain management and palliative care supported the attainment of advanced privileges to treat patients in need of such services. The Council on Credentialing in Pharmacy, a coalition consisting of ASHP and nine other national pharmacy organizations, recognizes several groups that may credential or certify pharmacists in advanced practice areas. These include the Board of Pharmacy Specialties, the National Asthma Educator Certification Board, the American Heart Association, the National Certification Board for Diabetes Educators, the Commission for Certification in Geriatric Pharmacy, the American Academy of HIV Medicine, and the American Board of Applied Toxicology. Resources that describe credentialing opportunities and related documentation are available at the council’s website, www.pharmacycredentialing.org. William Greene, chief pharmaceutical officer at St. Jude Children’s Research Hospital in Memphis, Tennessee, said 11 clinical pharmacists have been granted advanced privi- William Greene leges by the St. Jude governing board.
“These individuals have the authority to order and monitor laboratory tests and other items related to medication therapy and to adjust medication therapy [for] a broad number of medications,” Greene said. He said most pharmacists practicing at this level have completed a PGY2 residency program and are board certified in oncology pharmacy. But he said the system includes enough flexibility to allow some highly qualified, experienced pharmacists who lack those credentials to perform advanced functions. Greene said the decision to privilege pharmacists through the medical staffing process grew out of his concern that an auditor could potentially decide that clinical pharmacists were providing medication therapy services without a valid medication order. The problem, he said, is that although Tennessee’s pharmacy practice act allows pharmacists and physicians to establish patient care relationships, the act doesn’t define collaborative drug therapy management. Greene said that the hospital’s medical executive committee determined
that clinical pharmacists are functioning as “midlevel practitioners” and should be credentialed and privileged as such. He noted that the determination coincided with the Centers for Medicare and Medicaid Services 2012 revision of its conditions of participation that allowed pharmacists to be considered part of a hospital’s medical staff. “It was perfect timing,” Greene said. ASHP’s Council on Education and Workforce Development recently recommended that the Society support the use of postlicensure credentialing, privileging, and competency assessment to establish qualifications for providing direct care to patients. The council agreed that credentialing programs should meet guiding principles established by the Council on Credentialing in Pharmacy. ASHP’s House of Delegates, when it meets this summer, will consider these positions for adoption as an official ASHP policy. —Kate Traynor DOI 10.2146/news140031
Specialty pharmacy presents opportunities for hospitals, health systems
A
s the nation’s spend on specialty medications continues to grow, hospitals and health systems are pursuing the patient care and revenue opportunities that come from integrating a specialty pharmacy. Kevin Colgan, corporate director of pharmacy for Rush University Medical Center in Chicago, gives partial credit to accountable care organizations. Kevin Colgan
“It’s not only the big financial opportunity,” he said of specialty pharmacy’s appeal to hospitals and health systems. A health care organization that operates a specialty pharmacy, Colgan explained, can collect robust data and determine which of the expensive medications work best. “That would be a game-changer for an accountable care organization,” he predicted.
Am J Health-Syst Pharm—Vol 71 May 1, 2014
687
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.
N e ws Privileging expands pharmacists’ role
H
ospitals that have a strong clinical pharmacy presence are turning to their institutional privileging programs to expand the high-level patient care services that pharmacists can provide.
New drugs and dosage forms Apremilast tablets (Otezla, Celgene): The phosphodiesterase-4 inhibitor is indicated for the treatment of adults with active psoriatic arthritis. Coagulation factor IX Fc fusion protein, recombinant, for i.v. injection (Alprolix, Biogen Idec): The recombinant DNA-derived coagulation factor is indicated for adults and children with hemophilia B for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Florbetaben F18 injection (Neuraceq, Piramal Imaging): The radioactive diagnostic agent is indicated for use during positron emission tomography imaging of the brain to estimate the density of amyloid plaques in adults with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Metronidazole vaginal gel (no brand name, Valeant Pharmaceuticals): The 1.3% antimicrobial product, intended for one-time use at bedtime, is indicated for the treatment of bacterial vaginosis in women who are not pregnant. Miltefosine capsules (Impavido, Paladin Therapeutics): The drug is indicated for the treatment of visceral leishmaniasis due to Leishmania donovani, cutaneous leishmaniasis due to L. braziliensis, L. guyanensis, or L. panamensis, and mucosal leishmaniasis due to L. braziliensis in patients at least 12 years of age and weighing at least 30 kg. The drug is subject to FDA Medication Guide requirements.
686
At The Johns Hopkins Hospital in Baltimore, a recently approved program will allow certain ward-based pharmacists to prescribe medications to inpatients. “It’s about empowering some of our folks to practice at the top of their license and the top of what their knowledge base allows them to do,” said John J. Lewin III, division director of critical care and surgery pharmacy at Johns Hopkins. “That’s going to be good for patients in terms of efficiency, and accuracy, and care, and medication John Lewin safety and its related outcomes.” Lewin expects the pilot program to begin this summer in the hospital’s surgical ICU, where clinical pharmacists are fully integrated into the multiprofessional team and work there daily. Under Maryland law, pharmacists can manage medication therapy by protocol, under the terms of a drug therapy management agreement between pharmacists and physicians. “Our pharmacists do make the interventions now, but they’re not allowed to write medication orders,” Lewin said. Under the current system, any changes to the medication regimen must be performed by a resident, attending physician, or other prescriber. “What we really heard from our physicians was, basically, ‘Why can’t you write the orders for this? You guys are the medication experts, and it would be good for patient care,” Lewin said. He said allowing pharmacists to enter medication orders into the computer system will decrease the administrative burden on physicians and allow them to make better use of their time.
Am J Health-Syst Pharm—Vol 71 May 1, 2014
Ultimately, he said, about 20–30 unitbased pharmacists are expected to be granted prescribing authority. He said the expanded scope of practice will be available to clinical pharmacy specialists who have a Pharm.D. degree and postgraduate year 2 (PGY2) residency training or equivalent experience. Lewin said hospital decision-makers concluded that modifying drug therapy is akin to prescribing, and that the hospital’s governing board should be responsible for assigning privileges to clinical pharmacists to encompass this work. The same process is used to permit physicians, nurse practitioners, and other qualified health care providers to order medications. Lewin expects the pilot program to focus on renal dosage-adjustment protocols. He said the protocols are designed to comply with state law and will allow pharmacists to use their professional judgment to make clinical decisions about drug therapy. He noted that different units will use different protocols that take into account the individual needs of the entire health care team and its patients. A similar privileging process is used at Fort Belvoir Community Hospital in Virginia, said U.S. Army Lieutenant Colonel Eric Maroyka, director of pharmacy for the joint services military treatment facility. Maroyka said all hospital pharmacists are “core privileged” to perform routine tasks at the hospital. But about a dozen clinical Eric Maroyka pharmacy specialists with advanced training have been granted additional privileges that include the ability to prescribe medications in specific settings. “We’re really mirroring what physicians and other midlevel practitioner
News
providers do for their privileging,” Maroyka said. For example, he said, one pharmacist in a patient-centered medical home setting specializes in diabetes care and is able to prescribe medications, monitor patients, and educate them about their drug therapy. “She handles newly diagnosed diabetics and type 2 diabetics without complications,” Maroyka said. “If it’s more complex, like they need to be set up on [an insulin] pump or some other advanced regimen, then they would see the endocrinologist.” Maroyka said credentials for supplemental privileges may include PGY2 residency training or the completion of a fellowship or other recognized educational activity. For one pharmacist, he said, completion of the ASHP Research and Education Foundation’s three-part traineeship program in pain management and palliative care supported the attainment of advanced privileges to treat patients in need of such services. The Council on Credentialing in Pharmacy, a coalition consisting of ASHP and nine other national pharmacy organizations, recognizes several groups that may credential or certify pharmacists in advanced practice areas. These include the Board of Pharmacy Specialties, the National Asthma Educator Certification Board, the American Heart Association, the National Certification Board for Diabetes Educators, the Commission for Certification in Geriatric Pharmacy, the American Academy of HIV Medicine, and the American Board of Applied Toxicology. Resources that describe credentialing opportunities and related documentation are available at the council’s website, www.pharmacycredentialing.org. William Greene, chief pharmaceutical officer at St. Jude Children’s Research Hospital in Memphis, Tennessee, said 11 clinical pharmacists have been granted advanced privi- William Greene leges by the St. Jude governing board.
“These individuals have the authority to order and monitor laboratory tests and other items related to medication therapy and to adjust medication therapy [for] a broad number of medications,” Greene said. He said most pharmacists practicing at this level have completed a PGY2 residency program and are board certified in oncology pharmacy. But he said the system includes enough flexibility to allow some highly qualified, experienced pharmacists who lack those credentials to perform advanced functions. Greene said the decision to privilege pharmacists through the medical staffing process grew out of his concern that an auditor could potentially decide that clinical pharmacists were providing medication therapy services without a valid medication order. The problem, he said, is that although Tennessee’s pharmacy practice act allows pharmacists and physicians to establish patient care relationships, the act doesn’t define collaborative drug therapy management. Greene said that the hospital’s medical executive committee determined
that clinical pharmacists are functioning as “midlevel practitioners” and should be credentialed and privileged as such. He noted that the determination coincided with the Centers for Medicare and Medicaid Services 2012 revision of its conditions of participation that allowed pharmacists to be considered part of a hospital’s medical staff. “It was perfect timing,” Greene said. ASHP’s Council on Education and Workforce Development recently recommended that the Society support the use of postlicensure credentialing, privileging, and competency assessment to establish qualifications for providing direct care to patients. The council agreed that credentialing programs should meet guiding principles established by the Council on Credentialing in Pharmacy. ASHP’s House of Delegates, when it meets this summer, will consider these positions for adoption as an official ASHP policy. —Kate Traynor DOI 10.2146/news140031
Specialty pharmacy presents opportunities for hospitals, health systems
A
s the nation’s spend on specialty medications continues to grow, hospitals and health systems are pursuing the patient care and revenue opportunities that come from integrating a specialty pharmacy. Kevin Colgan, corporate director of pharmacy for Rush University Medical Center in Chicago, gives partial credit to accountable care organizations. Kevin Colgan
“It’s not only the big financial opportunity,” he said of specialty pharmacy’s appeal to hospitals and health systems. A health care organization that operates a specialty pharmacy, Colgan explained, can collect robust data and determine which of the expensive medications work best. “That would be a game-changer for an accountable care organization,” he predicted.
Am J Health-Syst Pharm—Vol 71 May 1, 2014
687
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.
