Provider status gains steam at 2021 ASHP Midyear Meeting

The ASHP 2021 Midyear Clinical Meeting and Exhibition

All articles by Karen Blum, Gina Shaw and David Wild

‘Exciting Progress’ On Provider Status Cited During Town Hall

Governments at the state, local and national levels are increasingly recognizing the roles that pharmacists can play and contribute to health care. Gains in practice made during the COVID-19 pandemic can serve as a precedent to keep pushing the boundaries.

“We’re still working away at full provider status and, ultimately, recognition in the Medicare program,” said Tom Kraus, JD, MHS, ASHP’s vice president of government relations, during a town hall meeting on pharmacist provider status. “But we’re making exciting progress, and we’ve seen an acceleration over the past two years.”

During the pandemic, some governors used their emergency authority to expand

For an exclusive video on provider status with Tom Kraus, JD, MHS, ASHP’s vice president of government relations, visit bit.ly/3t5iyEo.

see LATE BREAKERS, page 4

Important Safety Information

ALBUTEIN® 25% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, adult respiratory distress syndrome (ARDS), and prevention of central volume depletion after paracentesis due to cirrhotic ascites. ALBUTEIN® 5% (albumin [human] U.S.P.) is indicated for: hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia, and plasma exchange. ALBUTEIN 5% and 25% are contraindicated in patients with a history of hypersensitivity to albumin preparations or to any of the excipients, and in patients with severe anemia or cardiac failure with normal or increased intravascular volume. Allergic or anaphylactic reactions require immediate discontinuation of the infusion and implementation of appropriate medical treatment.

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of fluid overload, the infusion must be slowed or stopped immediately. Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. The colloid-osmotic effect of human albumin 25% is approximately five times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Patients with marked dehydration require administration of additional fluids.

Concentrated (20% - 25%) human albumin solutions are relatively low in electrolytes compared to 4% - 5% human albumin solutions. Regularly monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance when albumin is administered. Regular monitoring of coagulation and hematology parameters is necessary if comparatively large volumes are to be replaced. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes). Regularly monitor hemodynamic parameters during administration of ALBUTEIN® 5% and 25% (albumin [human] U.S.P.). ALBUTEIN 5% and 25% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for ALBUTEIN 5% or 25%.

The most serious adverse reactions with use of albumin are anaphylactic shock, heart failure and pulmonary edema. The most common adverse reactions are anaphylactoid type reactions. Adverse reactions to ALBUTEIN normally resolve when the infusion rate is slowed or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment initiated.

Please see brief summaries of full Prescribing Information for ALBUTEIN FlexBag 5% and 25%.

LATE BREAKERS

continued from page 3

access to care, including services provided by pharmacists, Mr. Kraus said. Some states authorized pharmacists to provide access to testing and vaccinations.

“There’s been this recognition that we need access to pharmacist services and that is an important driver of care and value in communities,” he said.

Emergency orders happened on a national level, too, Mr. Kraus noted. The federal government used authority under the public health emergency to expand access to pharmacist services nationwide. It was the first time the federal government asked states to permit pharmacists to provide services such as testing, vaccinations and now COVID-19 treatment. “That’s a huge step,” he said.

Some states have taken additional measures to authorize payment for pharmacist services. About 40 states now recognize pharmacists as providers and reimburse at least some level of pharmacist services, Mr. Kraus said. Now, attention should be placed on how flexibilities allowed during the pandemic can become permanent, especially as new therapies such as antivirals emerge for the treatment of COVID-19, he said.

The demonstration that pharmacists are capable of providing direct patient care services during COVID-19, and ordering and administering therapeutics, is something that can be used as a precedent to further promote pharmacists’ involvement in helping manage other public health burdens, such as HIV and influenza, Mr. Kraus said.

“Policymakers can’t put that back in the bottle if you’ve already demonstrated that pharmacists are a great access point for care,” he stressed.

State legislatures still control scope-ofpractice issues. Over the past couple of years, some states expanded the scope of practice for pharmacists. Although it may be frustrating when progress is incremental, Mr. Kraus said, “every incremental win is an opportunity to celebrate a recognition of the role of pharmacists in providing access to care. The reality is that incremental progress is only going in one direction—toward expansion of pharmacists’ scope of practice.”

Sen. Charles “Chuck” Grassley (R-Iowa) also addressed meeting attendees in a recorded message, thanking pharmacists for being on the front lines of the pandemic. He is a sponsor of the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S. 1362), a bipartisan bill to amend Section 1861(s)(2) of the Social Security Act to include pharmacists on the list of recognized health care providers in medically underserved areas.

“This bill will let pharmacists offer health care services to their patients that they’re trained and licensed to perform,” Sen. Grassley said, and to be reimbursed by Medicare. “Eligible services would include point-of-care testing for infectious diseases, wellness screenings, diabetes management, vaccinations and more.”

ALBUTEIN

FlexBag 5% (albumin [human] U.S.P.) 5% solution

These highlights do not include all the information needed to use ALBUTEIN FlexBag 5% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 5%. ALBUTEIN FlexBag 5% (albumin [human] U.S.P.) 5% solution Initial U.S. Approval: 1978 ------------------------------------------INDICATIONS AND USAGE ------------------------------------------

ALBUTEIN 5% is an albumin solution indicated for: • Hypovolemia. • Cardiopulmonary bypass procedures. • Hypoalbuminemia. • Plasma exchange.

--------------------------------------DOSAGE AND ADMINISTRATION-------------------------------------For Intravenous Use Only

Dosage and infusion rate should be adjusted to the patient’s individual requirements.

Indication Dose

Hypovolemia

Cardiopulmonary bypass procedures Adults: Initial dose of 20 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g.

Adults: Initial dose of 25 g.

Hypoalbuminemia

Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. Plasma exchange The dose required depends on the volume of plasma removed during the procedure. Do not dilute with sterile water for injection as this may cause hemolysis in recipients.

------------------------------------DOSAGE FORMS AND STRENGTHS ------------------------------------

ALBUTEIN 5% is a solution containing 50 g per L of total protein of which at least 95% is human albumin.

---------------------------------------------CONTRAINDICATIONS---------------------------------------------

• Hypersensitivity to albumin preparations or to any of the excipients. • Severe anemia or cardiac failure with normal or increased intravascular volume.

--------------------------------------WARNINGS AND PRECAUTIONS --------------------------------------

• Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. • Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. • Monitor electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is given. • Do not dilute with sterile water for injection. • This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

--------------------------------------------ADVERSE REACTIONS --------------------------------------------

The most common adverse reactions are anaphylactoid type reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -------------------------------------USE IN SPECIFIC POPULATIONS -------------------------------------

• Pregnancy: No human or animal data. Use only if clearly needed.

Revised: 07/2021

Manufactured by:

Grifols Biologicals LLC

5555 Valley Boulevard Los Angeles, CA 90032, U.S.A. U.S. License No. 1694 3061038

ALBUTEIN

FlexBag 25% (albumin [human] U.S.P.) 25% solution

These highlights do not include all the information needed to use ALBUTEIN FlexBag 25% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 25%. ALBUTEIN FlexBag 25% (albumin [human] U.S.P.) 25% solution Initial U.S. Approval: 1978 ------------------------------------------INDICATIONS AND USAGE ------------------------------------------

ALBUTEIN 25% is an albumin solution indicated for: • Hypovolemia. • Cardiopulmonary bypass procedures. • Acute nephrosis. • Hypoalbuminemia. • Ovarian hyperstimulation syndrome. • Neonatal hyperbilirubinemia. • Adult respiratory distress syndrome (ARDS). • Prevention of central volume depletion after paracentesis due to cirrhotic ascites.

--------------------------------------DOSAGE AND ADMINISTRATION-------------------------------------For Intravenous Use Only

Dosage and infusion rate should be adjusted to the patient’s individual requirements.

Indication Dose

Hypovolemia

Cardiopulmonary bypass procedures Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g.

Adults: Initial dose of 25 g.

Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary.

Indication Dose

Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion.

Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.

Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed. Do not dilute with sterile water for injection as this may cause hemolysis in recipients.

------------------------------------DOSAGE FORMS AND STRENGTHS ------------------------------------

ALBUTEIN 25% is a solution containing 250 g per L of total protein of which at least 95% is human albumin.

---------------------------------------------CONTRAINDICATIONS---------------------------------------------

• Hypersensitivity to albumin preparations or to any of the excipients. • Severe anemia or cardiac failure with normal or increased intravascular volume.

--------------------------------------WARNINGS AND PRECAUTIONS --------------------------------------

• Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. • Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. • When concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. • Monitor electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered. • Do not dilute with sterile water for injection. • This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

--------------------------------------------ADVERSE REACTIONS --------------------------------------------

The most common adverse reactions are anaphylactoid type reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -------------------------------------USE IN SPECIFIC POPULATIONS -------------------------------------

• Pregnancy: No human or animal data. Use only if clearly needed.

Opioid Stewardship Programs Led by Pharmacists Proliferating

More and more hospital pharmacies are developing opioid stewardship programs and reducing the risk for related overdoses, experts noted during a press conference at the Midyear Clinical Meeting.

Anna Legreid Dopp, PharmD, the senior director of clinical guidelines and quality improvement at ASHP, said the group surveyed thousands of hospitals across the country and found the percentage ofinstitutions with opioid stewardship programs rose from 40.9% in 2018to about 47.3% in 2019, with programs with pharmacists in leadership

positions growing from 54.8% to 64.8% over the same period (Am J Health Syst Pharm 2020;77[13]:1026-1050)

“We’ve seen opioid stewardship programs follow a similar trajectory as with the growth in antimicrobial stewardship programs over the last 10 to 15 years, and we expect that this pattern will continue,” Dr. Legreid Dopp said.

Kings County Hospital, NYC Health + Hospitals, recently added a pharmacistguided opioid stewardship programs. Lisa Yamagishi, PharmD, is a clinical pharmacist for opioid stewardship at the institution. During the press conference, she said spearheading the establishment of the program, in 2020, “was a unique opportunity, given pharmacists’ expertise in medications and in determining whether or not patients have tolerance to opioids, doing conversion calculations and developing appropriate nonopioid analgesic pain management strategies.”

One opportunity Dr. Yamagishi and her colleagues identified while surveying their institution’s needs regarding better opioid management was being able to offer naloxone to inpatients at high risk for opioid overdose, she said. She noted that the practice was already in place for emergency department patients.

“Since the opioid stewardship program was monitoring high-risk inpatients already—determining risk based on their morphine milligram equivalents used per day, history of opioid use disorder and chronic pain medication regimens—we were able to recommend which patients should be provided with naloxone kits upon discharge,” Dr. Yamagishi said.

During the six months after implementing an inpatient naloxone dispensing initiative in October 2020, Dr. Yamagishi and her team identified 71 inpatients as being at high risk for opioid overdose; 75% of these patients were prescribed naloxone kits at discharge, according to data she presented at the meeting. In contrast, between June and September 2020, 18% of high-risk inpatients were prescribed naloxone kits.

“Providing this many naloxone kits was an extremely great accomplishment for us,” she stressed.

Dr. Yamagishi said these encounters also provided an opportunity to educate physicians on the pharmacist-driven naloxone distribution program and to counsel high-risk inpatients and their families and caregivers on naloxone use and overdose risk reduction strategies.

Dr. Yamagishi’s program “really highlights the importance of thinking about every setting in which you might see patients and taking every opportunity to make a difference,” said Elizabeth Bentley, PharmD, the director of clinical pharmacy services, Northwest Region, Kaiser Permanente, in Portland, Ore., who also spoke during the press conference.

Gender-Affirming Hormone Therapy: A Pharmacist’s Guide

Gender-affirming hormone therapy (GAHT) is an emerging area of clinical pharmacy, and pharmacists have a significant opportunity to contribute to patient care, said Karen M. Gunning, PharmD, the associate dean of community engagement at the University of Utah College of Pharmacy, in Salt Lake City.

“It’s important to understand the limitations and the value of the available evidence,” Dr. Gunning said at a session on caring for transgender people. “While there are guidelines and recommendations galore, there is relatively little that we would consider high-quality, evidence-based medicine in the field of transgender care and GAHT.”

She recommended three core resources that provide a good foundation for clinical pharmacists who are interested in learning more about GAHT: 1. The University of California, San

Francisco (UCSF) “Guidelines for the Primary and Gender-Affirming

Care of Transgender and Gender

Nonbinary People,” an expert consensus document with peer review, released in 2016: transcare.ucsf.edu/ guidelines 2. The Endocrine Society’s clinical practice guideline, “Endocrine

Treatment of Gender-Dysphoric/

Gender-Incongruent Persons,” evidence-based to the extent possible with a systematic review using the

GRADE approach and published in 2017: academic.oup.com/jcem/ article/102/11/3869/4157558 3. The World Professional Association for Transgender Health’s

“Standards of Care for the Health of Transsexual, Transgender, and

Gender Nonconforming People,” published in 2012, based on what it cites as “the best available science and expert consensus”: www.wpath. org/publications/soc

However, there are a lot of resources out there that don’t fit the description, including many single-creator “guidelines” and Reddit discussions that patients may encounter, Dr. Gunning cautioned. “Do not trust everything you read. But ‘Dr. Google’ can actually be helpful for understanding what your patient is asking you about and what they are seeing, hearing and reading about in their communities.” Despite progress, local and regional access gaps in GAHT continue. “At the University of Utah, we see a large number of patients coming to us from states where there is less ability to access this type of care,” Dr. Gunning noted. “For many of these people, there are significant safety concerns as they seek help on the internet or through do-it-yourself hormone therapy. Where care may be available for GAHT, there often is not primary careintegrated GAHT.”

She encouraged clinical pharmacists to promote the integration of GAHT into supportive primary care for transgender people in their clinics. “These individuals have many of the same health concerns as our other patients. They need you to answer questions about their diabetes and hypertension, and also about hormone therapy. What all patients need is care. If you can champion primary careintegrated GAHT at your institution, that would serve a significant need.”

Biosimilars Positioned For Continued Growth

With 31 biosimilar products approved by the FDA in the United States to date, the agents are slowly gaining a foothold. But challenges remain.

“Biosimilars offer high-quality treatment alternatives at a fraction of the cost,” thus offering “a strong value proposition,” said Jorge Garcia, PharmD, MBA, the assistant vice president of the system oncology pharmacy service line, at Baptist Health South Florida in Miami. “Unfortunately, we see that many pre- and postmarketing implementation barriers still exist in the marketplace today.”

Health care professionals, he noted, are “uniquely positioned to promote the evaluation of the growing body of evidence associated with biosimilars,” Dr. Garcia continued. “Where there is evidence to support safety and efficacy, it is our role to enable that process.”

The cost of biologics has reached an all-time high, he said. In 2019, biologics represented just 2% of U.S. prescription drug utilization, but 43% of the $493 billion drug spend, he said, citing a 2020 report from IQVIA (bit.ly/ 3IPpoDo). These costs could continue to grow, as cancer drugs alone are increasing at twice the rate of general health care costs, he said.

One hot topic affecting biosimilars is switching and interchangeability, Dr. Garcia said. Switching refers to the exchange of one medicine for another with the same therapeutic intent. It presents no greater safety or efficacy risk than continuous treatment with the reference product. Interchangeability, the use of a biological product as a substitute for a reference product, is determined by FDA guidelines, while switching is regulated at the state level. At least 45 states and Puerto Rico permit pharmacists to switch a biosimilar if it is considered interchangeable and covered under the payor’s pharmacy benefit.

Pharmacists in health-system settings generally, through institutional policy, are able to interchange these products, Dr. Garcia said. “The reality is that many payors are treating these products as interchangeable, because their benefit designs tell us not to use product A but to use product B,” he said. “Those are across reference and biosimilar options.”

In July, the FDA issued its first interchangeability designation to insulin glargine-yfgn (Semglee, Viatris), stating it is biosimilar to, and interchangeable with, the reference product insulin glargine (Lantus, Sanofi). The product is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. “This is very exciting because it really impacts a large patient population,” Dr. Garcia said. “This product has [Medicare] Part D or pharmacy benefits, which brings us a step closer to potentially seeing a more sustainable pharmacoeconomic model behind biosimilars.”

For up-to-date information on approved biosimilars, check the FDA website (bit.ly/30go5vN) or the Purple Book (bit.ly/3lQADBl).

Dr. Collins reported a fi nancial relationship with ASHP Consulting. Dr. Garcia reported no relevant fi nancial disclosures. The remaining sources reported no relevant fi nancial disclosures.