T
he return of COVID-19 symptoms or a positive test after treatment with nirmatrelvir+ritonavir (Paxlovid, Pfizer) remains a rare and mild phenomenon that should not dissuade clinicians from recommending the potentially lifesaving drug combination, according to specialists, the CDC and the FDA.
TheClinic-EmbeddedPharmacistsBridgeBiosimilarsGapByKarenBlum
Specifically, patients who were managed by a provider with a pharmacist affiliation were 39% more likely to use a biosimilar than those who weren’t, said lead study author Erin Connolly, PharmD, a PGY-2 ambulatory care pharmacy resident at the hospital.
pharmacypracticenews.com The Best-Read Pharmacist’s News Source Volume 49 • Number 9 • September 2022 Continued on page 9Continued on page 11 Continued on page 8Continued on page 3 OPERATIONS & MGMT The case for health-system specialty pharmacy 4 CLINICAL ISMP issues peri-op med safety guidelines 12 Weight control among benefits of diabetes Rx 18 WEB ONLY One health system’s experience navigating monkeypox supply chain challenges PharmacyPracticeNews.comREVIEWARTICLEPracticalConsiderationsForImplementingBiosimilarsinOncologyPractice See page 14. Accompanies this issue.
Patients seen by a pharmacist for type 2 diabetes management during the study were three times as likely to be prescribed an SGLT2 inhibitor or a GLP-1 RA as those managed
In fact, based on the results of a retrospective study involving the health records of 13,644 people, the odds of both President Joe Biden and Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, developing COVID-19 rebound after treatment with nirmatrelvir+ritonavir were astonishingly long. Only 3.53% of patients
By Dan Hurley
PHOENIX—Safer use of oxytocin, barcode verification beyond inpatient units and prevention strategies to reduce harm from highalert medications are the subjects of three new targeted medication safety best practices for hospitals from the Institute for Safe Medication Practices (ISMP). These updates for 2022-2023 were presented at the 2022 ASHP Summer Meetings and Exhibition. The new best practices are as follows:
By Karen Blum
Primary Care Setting
ISMP Canada reviewed 144 oxytocinrelated events reported to its database in 2019. Most events occurred during administration, but issues also were found around preparation and storage, IV administration, and communication and documentation, Ms. Michalek said. Following suit, ISMP conducted its own review in 2020, analyzing 54
PHOENIX— Although biosimilars have been available for infliximab (Remicade, Janssen) for approximately five years, uptake across the country has been slow, partly due to provider hesitancy, according to researchers at Rhode Island Hospital, in Providence. But by adding pharmacists into the management mix, use of biosimilars can be significantly increased, they reported at the 2022 ASHP Summer Meetings and Exhibition (poster 41M).
Triples Use of 2 New Diabetes Rx Classes
PHOENIX—Pharmacists can significantly increase the use of guideline-recommended sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and bolster clinical outcomes in diabetes, according to a study presented at the 2022 ASHP Summer Meetings and Exhibition.
ISMP Releases 3 Best Practices For Ensuring Safe Use of Meds
Fauci and Biden
By Karen Blum and David Bronstein
Aside, Rebound After Paxlovid Rare
1. Safeguard against oxytocin errors. Oxytocin and its analogs are commonly administered for induction and augmentation of labor as well as to prevent and treat
postpartum bleeding, said Christina Michalek, RPh, the administrative coordinator for ISMP’s Medication Safety Officers Society. When prescribed improperly, it can cause hyperstimulation of the uterus, potentially resulting in fetal distress and the need for an emergency cesarean delivery, she said.
Unit DoneUnitDoneDoseRightDoseRight Unit Dose,Bar NursingNursingPharmacyCoding,&SupplyExperts!UnitDose,BarCoding,Pharmacy&SupplyExperts!Cold Tamper-EvidentSealMoistureResistantUltravioletInhibitantReducesCrossContaminationIdealforMedsCoveredbyUSP 800 6 and 12-month Beyond-Use Dating 1-D and 2-D Bar Coding Flexible Label and Report Formatting Multiple Sizes and Shapes to Fit Your Meds & Storage Needs 800.523.8966MediDose.com Scan QR Code for more information and pricing. Brightly Colored Labels Call Attention to Meds Requiring Special Handling Simple. Reliable.
especially as some insurers are mandating them and evolving evidence continues to support that biosimilars do not negatively affect patient outcomes. But some patients who do well on the reference product and then are being told to switch are still hesitant, so improving patient education is necessary.
“As more high-cost specialty drugs lose patent exclusivity, pharmacist
continued from page 1 THE McMAHON GROUP, LLC McMAHON PUBLISHING, McMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036 Telephone: (212) 957-5300 CT Office: 83 Peaceable Street, Redding, CT 06896 Copyright © 2022 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News (ISSN 0886-988x) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information. WANT TO SUBSCRIBE? CHANGE YOUR ADDRESS? HERE’S HOW Selected U.S. hospital pharmacists and health care personnel receive Pharmacy Practice News free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address or make your address change directly with Pharmacy Practice News Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (815) 366–8297, or send it via email, circulation@mcmahonmed.com. If you are not a hospital pharmacist but would like to receive Pharmacy Practice News, please send a check for $105.00
is
Dr. Bhat reported that she is a consultant to Bristol Myers Squibb and Prometheus Labs. Dr. Connolly reported no relevant financial disclosures.
Operations & Management 3 A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.
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One limitation is the investigators were unable to account for insurance formulary product requirements as a potential confounder.
Founded in McMahon Publishing a family-owned medical
‘Pharmacists are really well positioned to help take ownership of the process and successfully navigate biosimilar implementation and adoption from beginning to end.’
integration into clinic spaces will be an important cost-savings tool in growing provider comfort with and utilization of biosimilar agents,” Dr. Connolly and colleagues wrote.
A total of 998 patients were included in the study, 498 of whom were managed by providers practicing in clinics with pharmacist involvement. Patients were 46 years of age on average; 57% were female. Only 395 patients (39.6%) received biosimilars during the study period. Of these, 231 (58%) were at pharmacist-affiliated clinics and 164 were at unaffiliated clinics. All but one patient who received a biosimilar received infliximab-dyyb; that last patient received infliximab-abda.
publisher of clinical newspapers and specialty periodicals, and creates continuing medical education programs and custom publications.
The findings are not surprising, because biosimilar implementation and adoption is a very complex process involving formulary addition, electronic health record integration, patient and provider education, insurance coordination, and additional coordination when transitioning patients between medications, commented Shubha Bhat, PharmD, a clinical pharmacy specialist in gastroenterology at Cleveland Clinic. Therefore, she said, “pharmacists are really well positioned to help take ownership of the process and successfully navigate biosimilar implementation and adoption from beginning to end.”
“Overall, we found there’s still a lot of brand-name utilization, which shows there may not be as much comfort with biosimilars among providers,” said Dr. Connolly, who presented the results. She stressed that pharmacists “have a baseline understanding” of biosimilars that enables them to address and in many cases overcome prescriber hesitancy. “Having pharmacists [with] this influence in these clinic spaces is really significant,” she said.
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Researchers performed a retrospective cohort study using electronic health record data from April 2016 through August 2021 to identify patients aged 18 years and older who were managed either on the originator infliximab or the biosimilar product and who received their infusions at facilities affiliated with a large academic medical center. Infliximab products included in the study were Remicade, infliximab-abda (Renflexis, Organon), infliximab-axxq (Avsola, Amgen) and infliximab-dyyb (Inflectra,InvestigatorsPfizer).looked at infliximab prescription orders, the prescriber National Provider Identifier (NPI) number, and patient age, sex, diagnosis codes and insurance coverage. The primary outcome was whether patients managed on
originator infliximab were switched to a biosimilar during the study.
‘Philllliid
1972,
Biosimilars
Among patients managed by pharmacist-involved clinics, 266 (53.4%) received the reference product only, 179 (35.9%) received the biosimilar only and 53 (10.6%) were switched to a biosimilar. By contrast, 335 (67%) patients managed by clinics without pharmacist involvement received the reference product only, 120 (24%) received the biosimilar only and 45 (9%) were switched to a biosimilar.
Providers are getting more comfortable with biosimilars, Dr. Bhat said,
Formulary and EHR Issues Can Be a Challenge
“I want to commend Dr. Connolly for doing this study,” she said. One area still to watch is what will happen when adalimumab (Humira, AbbVie) biosimilars become available next year. An interchangeability designation for biosimilars means that, depending on state laws, pharmacists may be able to substitute biosimilars for the reference product without having to get a provider’s approval, Dr. Bhat noted. She added that such a scenario could potentially help increase biosimilar adoption and use in the United States.
—Shubha Bhat, PharmD
Closing Biosimilars Gap (U.S.)
Pharmacy Practice News • September 2022
‘We want totoandpharmacistsourprovidersbeableseehowpatientsaredoingontheirspecialtytherapies, and the best way to do that is to provide the specialty drugs ourselves.’
“Health-system specialty pharmacies still sometimes struggle to gain access to limited distribution drugs,” said Thom Platt, PharmD, the associate director of quality and outcomes at the University of Kentucky (UK) HealthCare, in Lexington.
The Growing Case for HS Specialty Pharmacies
ealth-system leaders say delivering specialized medications under their unique practice model is the best way to ensure optimal patient care. Whether that model is superior to traditional stand-alone specialty pharmacies may be debated. But what’s not in question is the ever-larger share of available medications being launched as specialty drugs. Indeed, more than 50% of
This disconnection can be a problem because specialty pharmacies that are not housed within health systems do not have ready access
Anecdotal reports from health systems around the country describe this lockout effect, in which providers in those facilities write the prescriptions but pharmacists are unable to dispense the drug. That task falls to a specialty pharmacy outside the health system.
Free CE/CME now available! Safe Opioid Prescribing A Patient-Centered Approach to the FDA Blueprint A 3-Part Series RELEASE DATE: OCTOBER 27, 2021 EXPIRATION DATE: DECEMBER 31, 2022 CharlesCHAIR E. Argoff, MD YvonneFACULTYM.D’Arcy, CRNP, CNS Marc R. Gerber, MD Courtney M. Kominek, PharmD, BCPS, CPE Bill H. McCarberg, MD, FABM INDEPENDENT REVIEWER Michael Clark This activity is jointly provided by Global Education Group and Applied Clinical Education. These activities are supported by an independent educational grant from the Opioid Analgesic REMS Program Companies. Please see https://opioidanalgesicrems.com/Resources/Docs/List_of_RPC_Companies.pdfforalistingofREMSProgramCompanies. This activity is intended to be fully compliant with the Opioid Analgesic REMS education requirements issued by the U.S. Food and Drug Administration (FDA). Distributed by CMEZone.com 1.0 AMA PRA Category 1 Credit ™1.0 AANP credit1.0 ACPE credit1.0 ANCC credit Access today at www.cmezone.com/SY212 Pharmacy Practice News • September 2022 Specialty Pharmacy 4 Operations & Management
Many health systems decided to get into specialty when they realized that many specialty medications are only available through limited distribution networks. The idea behind these networks is to route drugs through specialty pharmacies, where expert pharmacists can better monitor side effects and ensure patients remain adherent to treatment. Limited distribution models also help manufacturers control their costs, but this restriction often left pharmacists at health systems on the outside looking in.
—Thom Platt, PharmD
new FDA drug approvals each year are for medications that treat rare diseases, which is a subset of the specialty pharmacy market. And this year, for the first time, specialty drugs are projected to account for more than half of drug spending in the United States, according to health plans and pharmacy benefit managers who spoke at the 2022 Asembia Specialty Pharmacy Summit in Las Vegas (bit.ly/3CfZYxY).
Autumn Zuckerman, PharmD, the director of health outcomes and research at Vanderbilt Specialty Pharmacy, in Nashville, Tenn., feels strongly that health systems are best positioned to manage this growing medication class.
to the patient’s
H
“We’ve shown that health systemintegrated specialty pharmacy services can improve medication adherence, which in turn helps patients manage their disease,” Dr. Zuckerman said. “Our copays are rarely more than $5,” she added, thanks to the extensive efforts by her team to find financing that makes otherwise expensive medications affordable to patients.
The Value Proposition
By Marcus A. Banks
many limited distribution plans, argues that their model will save more than a half-billion dollars in specialty drug spend this decade, and that the specialty pharmacies they support are equally as
Autumn Zuckerman, PharmD
Documenting the Benefits
Her research team also has determined that providers are more satisfied with their interactions with healthsystem specialty pharmacists than with pharmacists in other settings (AJHP 2021;78[11]:962-971).
Against Antimicrobial
FIGHT BACK Resistance with Integrated Diagnostic and Stewardship Solutions
The Other Side
—Autumn Zuckerman, PharmD
Arguing that health systems should be the preferred specialty trade channel is all well and good, but do the data support it? Dr. Zuckerman acknowledged there are few studies that directly compare health-system specialty pharmacy models with others. However, some comparative data are beginning to emerge. She has reported, for example, that pharmacies such as Vanderbilt’s can dispense oral oncolytic therapies more quickly than specialty pharmacies that aren’t part of a health system (J Hematol Oncol Pharm 2020;10[4]:198-205).
Specifically, the mean score for overall satisfaction with integrated specialty pharmacies was significantly higher than the score for satisfaction with external specialty pharmacies (4.72 [0.58] versus 2.97 [1.20]; 95% CI, 1.64-1.87; P<0.001). Provider ratings of the integrated specialty pharmacy model were also higher for all 10 items evaluating the quality of services (P<0.05 for all comparisons).Moreover,a February 2022 study referenced by Dr. Platt found that overall health costs were lower when drugs were dispensed through health-system specialty pharmacies than through other models (J Manag Care Spec Pharm 2022;28[2]:244-254). During the 2018 baseline period of observation, total healthcare costs and utilization were similar ($9,520 among health-system specialty pharmacy users; $8,691 among the provider benchmark group; $9,510 among the network benchmark group) but lower in 2019, when a health-system specialty pharmacist was part of the patient care team ($7,060, $7,683 and $8,152, respectively).
FIND OUT HOW Pharmacy Practice News • September 2022 Specialty Pharmacy Operations & Management 5
The specialty pharmacy division of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers that negotiate
electronic health record or their interactions with other providers in a health system, Dr. Platt noted, thus making their knowledge of the patient’s health incomplete.“Wewant our pharmacists and providers to be able to see how patients are doing on their specialty therapies, and the best way to do that is to provide the specialty drugs ourselves,” Dr. Platt added. This level of oversight is impossible if a patient must get a specialty drug from outside the network, he noted. In that case, the patient’s experience on the drug is invisible to Kentucky pharmacists and providers, unless the patient takes it upon themselves to keep their pharmacists and providers informed. Drs. Platt and Zuckerman want to reduce the frequency of this occurrence to zero.
‘How can we show not only that our specialty pharmacy model reduces healthcare utilization, but also improves everyday quality of life? That’s our goal going forward.’
Dr. Platt reported no relevant financial disclosures. Dr. Zuckerman reported grant funding from AstraZeneca and Pfizer to Vanderbilt University Medical Center.
high-touch and effective as those within healthAmidsystems.thisdebate, Dr. Zuckerman presses on. “How can we show not only that our specialty pharmacy model reduces healthcare utilization, but also improves everyday quality of life?” she asked. “That’s our goal going forward.”
ONTRUZANT is an FDA-approved biosimilar to Herceptin (trastuzumab)
l As part of a treatment regimen with docetaxel and carboplatin
l In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
l As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
• Evaluate cardiac function prior to and during treatment. Discontinue ONTRUZANT treatment for cardiomyopathy.
• Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
POWER FOR THE
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
BREAST CANCER 2+ more
organonconnect.com/ontruzantat
SELECTED SAFETY INFORMATION
Learn
l As a single agent following multi-modality anthracyclinebased therapy
for injection, for intravenous use 21 mg/mL
Same Indications and Usage as with Herceptin
• Administration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed congestive heart failure (CHF) died of cardiomyopathy.
• Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
l As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
Adjuvant Breast Cancer
ONTRUZANT is indicated:
Metastatic Breast Cancer
ONTRUZANT is indicated for adjuvant treatment of HER2overexpressing node-positive or node-negative (ER/PRnegative or with one high-risk feature) breast cancer:
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
• The most common adverse reactions associated with trastuzumab products were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
• Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.
• Leveraging market proximity strategies to minimize transportation time
• Utilizing multi-sourcing strategies during the manufacturing stage
Scan the QR code and request a callback from an Account Representative today
We work with manufacturersa that take steps to help maintain a continuous supply of ONTRUZANT, such as1:
ManufacturingSupply
• Verify the pregnancy status of females of reproductive potential prior to the initiation of ONTRUZANT. Advise pregnant women and females of reproductive potential that exposure to ONTRUZANT during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of ONTRUZANT.
© 2022 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. US-SBF-115290 08/22
SELECTED SAFETY INFORMATION (continued)
Our dedicated team of biosimilar experts is committed to supporting you as you make decisions about biosimilars at your health care system.
aSamsung Bioepis and their associated contract manufacturing organizations.
ER, estrogen receptor; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; PR, progesterone receptor.
Brands mentioned are trademarks of their respective owners.
• Detection of HER2 protein overexpression is necessary for selection of patients appropriate for ONTRUZANT therapy.
Reference: 1. Data available on request from Organon Professional Services-DAP, 30 Hudson Street, Jersey City, NJ 07302. Please specify information package US-NON-110225.
Request a callback from a representative
• Establishing the appropriate manufacturing capacity
ONTRUZANT: The power to help your HER2+ patients fight At Organon Biosimilars, we have an unwavering commitment to supporting you.
ONTRUZANT is manufactured in FDA-licensed facilities that employ a range of quality control principles to help monitor product quality and consistency1
Before prescribing ONTRUZANT, please read the accompanying Prescribing Information, including the Boxed Warning about cardiomyopathy, infusion reactions (pulmonary toxicity), and embryo-fetal toxicity.
• Exacerbation of chemotherapy-induced neutropenia has also occurred.
Dr. Smith, who is also the protocol co-chair of the ACTIV-2 trial that is testing the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2, said even the definition of COVID-19 rebound is in flux.
Despite that caution, when Dr. Fauci reported on June 30 that he had suffered a rebound of COVID-19 after taking nirmatrelvir+ritonavir, he revealed that his doctors had, in fact, prescribed a second course of the antiviral medicine.
“Patients might intuitively expect it to have antibioticlike efficacy,” Dr. Gallagher said. “It’s just not there. Paxlovid’s job is to keep you from going to the hospital and keep you alive. It’s been shown to do that for highrisk people. It has not been shown to make your symptoms better or improve your overall course.”
—Jason Gallagher, PharmD
“The truth is we don’t really know how common it is,” he said. “People are still struggling with the definition. Some patients test negative and then test positive without having symptoms. Some develop symptoms a second time but continue to test negative. It’s a complicated situation.”
The retrospective cohort study of COVID-19 rebound cases was published as a preprint on June 22, comparing their frequency following nirmatrelvir+ritonavir versus another antiviral approved for treating COVID-19, molnupiravir (Lagevrio, Merck). Between Jan. 1 and June 8, 2022, the study identified 11,270 cases in which nirmatrelvir+ritonavir had been prescribed, and 2,374 cases treated with molnupiravir.
sources reported no relevant financial disclosures.
Once a patient no longer has symptoms, he said, he does not recommend continued testing.
developed the condition within seven days of taking the two-drug combination, the study found.
Patients who are concerned about the risk for rebound after treatment with nirmatrelvir+ritonavir should be reminded that antivirals do not have the same overnight effect on symptoms as antibiotics.
‘The [incidence of rebound in] the clinical trial was about 2%, … both in the Paxlovid … [and placebo groups]. But that was with different strains … currently circulating. Anecdotally, I have a hard time believing it isn’t higher than 2%.’
The CDC’s Initial Response
The CDC issued a health advisory on May 24 to address the growing number of reports of COVID-19
“Most people should not take a second course,” Dr. Smith said. “It’s not necessarily the most benign drug. It doesn’t taste well, and it has lots of drug–drug interactions. Only with someone at high risk for [progression to severe disease] who develops significant symptoms after the first course of treatment would I treat with Paxlovid a second time.”
8.21% for COVID-19 symptoms, and 0.84% and 1.39% forPatientshospitalizations.whoexperienced rebound had a significantly higher prevalence of underlying medical conditions than those without such conditions, the study noted.
Jason Gallagher, PharmD, FCCP, RIDP, FIDSA, a clinical specialist of infectious diseases at Temple University Hospital, in Philadelphia, said he agreed that it’s impossible to know exactly how common nirmatrelvir+ritonavir rebound is, but that it’s likely higher than seen in the clinical trial that led to the FDA’s emergency use authorization of the medicine in December 2021.
Pharmacy Practice News • September 2022 Medication Safety 8 Clinical
Clinical Recommendations
Dr. Smith said he agrees with the CDC’s advice that a second course of treatment with nirmatrelvir+ritonavir after rebound is generally not warranted, except in cases such as Dr. Fauci’s in which symptoms become relatively severe.
rebound cases. Despite those reports, it said, “Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.” Cases of rebound, it said, had so far involved only mild disease.
The seven- and 30-day rebound rate after nirmatrelvir+ritonavir treatment was 3.53% and 5.40% for COVID-19 infection, 2.31% and 5.87% for COVID-19 symptoms, and 0.44% and 0.77% for hospitalizations.Thecomparable seven- and 30-day rates for molnupiravir were slightly higher, but not significantly so: 5.86% and 8.59% for COVID-19 infection, 3.75% and
President Biden’s rebound was far less severe. After testing negative on July 26 through 29, he tested positive again on July 30, according to Kevin C. O’Connor, DO, the White House physician to the president. “The President has experienced no reemergence of symptoms,” Dr. Connor stated in a news release, “and continues to feel quite well. This being the case, there is no reason to reinitiate treatment at this time.”
continued from page 1
“There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARSCoV-2 therapies in cases where COVID-19 rebound is suspected,” the CDC stated.
“The thing I’m worried about is people hearing about Paxlovid rebound and deciding not to take it,” said Davey Smith, MD, the head of the Division of Infectious Diseases and Global Public Health at the University of California, San Diego. “We know that people who take Paxlovid have a greatly reduced risk of needing hospitalization or of dying. So I’m concerned that people will [reject Paxlovid] due to unfounded fears.”
Paxlovid Rebound
“I started to feel really poorly, much worse than in the first go-around,” Dr. Fauci said. “I went back on Paxlovid, and right now I am on my fourth day of a five-day course of my second course of Paxlovid. Fortunately, I feel reasonably good.”
“The number from the clinical trial was about 2% of people, both in the Paxlovid group and in the placebo group,” Dr. Gallagher said. “But that was with different strains than we have currently circulating. Anecdotally, I have a hard time believing it isn’t higher thanWhatever2%.” the true number might be, Dr. Gallagher said, “I don’t know of any cases of people rebounding and then getting so sick they have to go to the hospital. The role of the therapy is to keep you from getting seriously ill, to the point that you have to be hospitalized. That’s what it’s been shown to do.”
“If you feel fine, I don’t think there’s a reason to test again,” he said.
The
blister-pack configurations, wit different dosing a a specific blister pack for patients who have modera renal impairment
continued from page 1 see BEST PRACTICES, page 10
Pharmacy Practice News • September 2022 Medication Safety Clinical 9
• Don’t skimp on education. For example, talk with prescribers about the reduced-dose blister package for patients with moderate renal impairment and who should receive it.
high-alert medication-related errors continue to occur, she said. That’s often because low-leverage risk reduction strategies such as increasing awareness, or medium-leverage strategies such as requiring independent double checks, have been employed. “Very rarely are strategies implemented that span the entire medication-use process,” she said.
ISMP Issues Warning About Renal Dosing, Other Paxlovid Risks
• Check and confirm renal function, and use the FDA’s screening checklist to identify significant drug interactions.
‘There’s about six premixed concentrations of [oxytocin] on the market, which is a recipe for confusion; it’s way too easy for someone to pick an unintended concentration and cause a potential medication error.’
• Provide clinical decision support. Prescribing systems should include guidance for nirmatrelvir+ritonavir, if possible, such as an order sentence with dosing for patients with moderate renal impairment.
The sources reported no relevant financial disclosures.
Other prescribing errors included not checking or asking patients about renal function or concomitant drug use to avoid drug–drug interactions.
been used often in inpatient settings and is proven to prevent errors, “it’s really falling short in some of the limited patient stay areas like the emergency department (ED), ambulatory care clinics and dialysis centers,” she said.
contains four nirmatrelvir tablets (150 mg each) and two ritonavir tablets (100 mg each). Patients should take two tablets of nirmatrelvir (150 mg each, 300 mg total) and one tablet of ritonavir (100 mg) in the morning, and the same doses in theForevening.patients with moderate renal function, who must take only one tablet of nirmatrelvir (150 mg) along with one tablet of ritonavir (100 mg) together, twice daily, special reduced-dose blister packages are available. (Patients with severe renal impairment should not be prescribed this drug.)
daily-doseblistercardsEachblistcard
ISMP’s New Best Practices
—Mary Ann Kliethermes, BS, PharmD
Dr. Jew also suggested highlighting any serious errors averted by barcode verification to gain buy-in from staff for the process.
This ISMP best practice incorporates five parts, including the goal of standardizing the approach to labor induction/ augmentation and control of postpartum bleeding (Table). Using standardized order sets for both can eliminate some issues, Ms. Michalek said.
3. Layer numerous strategies throughout the medication-use process to improve safety with high-alert medications. High-alert medications are those that bear a heightened risk for causing significant patient harm if there is a related error, Dr. Jew said. Despite recommendations by ISMP and agencies such as the Joint Commission,
umerous wrong-dose errors involving nirmatrelvir+ritonavir (Paxlovid, Pfizer) have been reported to the Institute for Safe Medication Practices (ISMP) over the past several months, with many of the errors involving confusion over renal dosing, according to a new ISMP alert.
Prior to April 2022, only the standard packaging was available, and pharmacy staff were asked to remove one of the nirmatrelvir tablets for each dose on all five blister cards, and apply manufacturer-supplied stickers to alert patients with moderate renal impairment to the removal of the unneeded tablets.
• Check the electronic health record configuration. Ensure it is intuitive to select two of the 150-mg nirmatrelvir tablets to make up a 300-mg dose.
This best practice has six recommendations, with an emphasis on including higher-level efforts, such as forcing functions through which a hard stop is implemented to prevent people from making errors. These are the hardest to implement, Dr. Jew acknowledged.
For patients with normal renal function the drug comes in a carton holding 30 tablets contained in five
Beginning in April 2022, nirmatrelvir+ritonavir became available in tablet form in two normalrenalconfigurations,blister-packwithdifferentdosingandwhohavemoderateimpairment.Forpatientswithrenalfunction,blistercards.Eachblister
2. Maximize the use of barcode verification prior to medication and vaccine administration by expanding use beyond inpatient care areas. Look-alike packages and labels are a common contributing factor to medication safety, said Rita K. Jew, PharmD, MBA, BCPPS, the ISMP president. While barcode verification of both patients and medications prior to administration has
By Gina Shaw
To avoid errors, ISMP recommends the following:
• Be careful with blister packs. Specifically, when educating patients about how to take the drug, avoid communicating the dose by tablet or blister color, which can cause confusion. Instead, show them how it is labeled on the blister pack, and make sure they know which tablets to take at what time.
“ISMP is emphasizing the need to educate patients using the teach-back method, since blister-pack instructions can be quite confusing,” said ISMP President Rita K. Jew, PharmD, MBA, in a statement. “Providing patients with the Paxlovid Fact Sheet for Patients, Parents, and Caregivers (www.fda.gov/media/155051/ download) is a requirement and provides printed instructions to follow; if patients have questions, they should contact their pharmacist.”
N
The two main recommendations within this best practice involve targeting clinical areas with increased likelihood of a short or limited patient stay, such as the ED, perioperative area, infusion clinics, dialysis centers, radiology department, labor and delivery areas, and the cardiac catheterization laboratory.Mosthospitals monitor scanning rates for medication, Dr. Jew noted, but she advised attendees to take an additional step, visiting patient care areas to observe what’s happening in practice. It’s not uncommon for nurses or other providers to develop workarounds, she said, such as scanning medication after it’s administered, which may not
reported events. In total, 44% of errors were in the dispensing phase, 23% in administration and 13% in prescribing. Forty percent of reporters noted some concern with look-alike vials, and 25% of events resulted in maternal, fetal or neonatal harm, she said.
The ISMP alert noted that many recently reported errors have involved patient self-administration, such as taking the wrong tablets or the entire day’s dose at one time. Others have been dispensing errors, many involving renal dosing modifications— even with the availability of the new reduced-dose blister“Dispensingpackages.errors involved providing the carton with reduced-dose blister packages intended for patients with moderate renal impairment to patients with normal renal function or mild renal impairment, or vice versa,” the ISMP alert stated. “Several of the reported errors involved improper renal dosing, such as prescribing or dispensing Paxlovid to patients with severe renal impairment.”
prevent errors even if the scan rate is very high. Seeing what is really going on can help medication safety officers prevent serious errors.
1. Target clinical areas with increased likelihood of a short or limited patient stay, such as the ED, perioperative area, infusion clinics, dialysis centers, radiology department, labor and delivery areas, and the cardiac catheterization laboratory.
She added that extending medication safety systems beyond to radiology and other decentralized areas is a long-standing need in health-systems. “There’s a reason why so many of us refer to ambulatory care areas as the wild, Wild West,” she said. The care teams involved “need to benefit from our expertise as medication safety specialists, but to do that, we need to maximize barcoding and other safety tools in place to [bolster] medication safety.”
errors with oxytocin use
3. Avoid reliance on low-leverage risk reduction strategies; bundle these with mid- and high-leverage strategies. Mid-leverage strategies include warnings, alerts, checklists, standardization and protocols. High-leverage strategies include forcing functions through which a hard stop is implemented to prevent people from making errors.
Mary Ann Kliethermes, BS, PharmD, the director of medication safety and quality at ASHP, applauded ISMP for focusing on these three critical areas of medication safety. She said the recommendations to standardize the concentrations of oxytocin are particularly timely because ASHP is making similar efforts through its Standardize 4 Safety program.“We’vehad a lot of requests to address oxycontin,” Dr. Kliethermes said.
Source: Institute for Safe Medication Practices.
Taming ‘the Wild, Wild West’
Improve safety with high-alert medications
1. Outline robust processes for managing risk, affecting as many steps as possible.
2. Standardize to a single concentration/bag size for both antepartum and postpartum oxytocin infusions.
Extend barcoding beyond inpatient areas
6. Establish outcome and process measures to monitor safety.
Patient education is an important but often forgotten aspect of medication safety, Dr. Jew added. Every time a high-alert medication is being administered, think of how to educate the patient so they can be their own advocate if something doesn’t seem right or if they experience troubling side effects. They, too, can help avoid medication errors.
The speakers reported no relevant financial disclosures.
3. Standardize how oxytocin doses, concentration and rates are expressed; communicate in dose rate and align with infusion pumps.
Table. Three New Medication Safety Best Practices FromSafeguardISMPagainst
inpatient care areas is another timely effort—and one that could have prevented the tragic error that led to the death of a Ohio patient who was mistakenly given vecuronium instead of midazolam by RaDonda Vaught, as reported in Pharmacy Practice News (bit. ly/3QNSRka-PPN). “If a barcoding system was being used in the radiology unit, the vecuronium error would not have happened,” Dr. Kliethermes said.
BEST PRACTICES continued from page 9 For classified advertising, contact Craig Wilson 212-957-5300 Financialcwilson@mcmahonmed.comx235&LegalServicesEducationMedicalEquipmentCareerOpportunitiesFor classified advertising, contact Craig Wilson 212-957-5300 Financialcwilson@mcmahonmed.comx235&LegalServicesEducationMedicalEquipmentCareerOpportunities For classified advertising contact Craig Wilson 212-957-5300 Financialcwilson@mcmahonmed.comx235&LegalServicesEducationMedicalEquipmentCareerOpportunitiesFor classified advertising, contact Craig Wilson 212-957-5300 Financialcwilson@mcmahonmed.comx235&LegalServicesEducationMedicalEquipmentCareerOpportunities Pharmacy Practice News • September 2022 Medication Safety 10 Clinical
ASHP Applauds Initiative
“There are about six premixed concentrations of the medication on the market, which is a recipe for confusion; it’s way too easy for someone to pick an unintended concentration and cause a potential medication error. Our expert panel is scheduled to review this at the end of August, with the goal of standardizing down to just a few choices.”
1. Standardize the approach to labor induction/augmentation and control of postpartum bleeding.
2. Address system vulnerabilities in each stage of the medication-use process and apply to all practitioners, including prescribers, pharmacists, nurses and others involved in medication use, such as respiratory therapists.
4. Limit the use of independent double checks to select high-alert medications. This avoids practitioners being immune to the process.
4. Provide oxytocin in a ready-to-use form; label both sides of the infusion bag.
Dr. Kliethermes acknowledged there is a case to be made for having some flexibility in oxycontin dosing, primarily driven by the variable fluid restriction needs of obstetrics patients. “We do have that obstetrics expertise on the Standardize 4 Safety expert panel, so anything we recommend will reflect practice realities and evidence-based medicine,” she stressed. “But bottom line, as soon as you have that many concentrations of any drug, you’re just asking for trouble. That definitely has to be addressed.”TheISMP’s best practices recommendation to expand the use of barcode medication verification beyond
2. Regularly review compliance and other metric data to assess utilization and effectiveness.
Some Flexibility Needed
5. Avoid bringing oxytocin infusion bags to the patient’s bedside until it’s needed.
5. Regularly assess for risk by using information from internal and external sources, including error reporting data or audits.
are underutilized,” Dr. Harte said. Pharmacists can play an important role in closing that gap, she noted, by helping patients access financial assistance programs, navigate prior authorizations and other inaurance hassles “and preventing clinical inertia—starting these medications and helping patients reach their [hemoglobin] A1c goal.”
continued from page 1 Free CME now available! This continuing medical education activity is provided by MedEdicus LLC in collaboration with Amedco. This continuing medical education activity is supported through an educational grant from Arena Pharmaceuticals, Inc. Distributed by Gastroenterology & Endoscopy News and CMEZone.com 1.5 AMA PRA Category 1 Credits ™ 1.5 ANCC contact hours RELEASE DATE: AUGUST 1, 2022 EXPIRATION DATE: AUGUST 31, 2023
University of Chicago Medicine Chicago, Illinois
see DIABETES, page 18
Dr. Harte and her colleagues studied patient records from Jan. 1, 2020, through June 30, 2021. Patients were excluded if they were not candidates for SGLT2 inhibitor and GLP-1 RA therapy.
Chair, International Organization for the Study of Inflammatory Bowel Disease
Northwestern University Chicago, Illinois
A1c of less than 9%, which just emphasizes that pharmacists are not only starting these medications in patients who are way above their A1c goal, but also in those patients who might be near their goal, just to make sure they’re on the most optimal medications,” Dr. Harte said. “This shows the importance of making sure that a pharmacist is on the team in the outpatient setting, because they promote utilization of guidelinedirected medications and make sure that they are initiated in patients.”
—Katherine Harte, PharmD
Professor of Medicine
Mutliple Benefits
Professor of Microbiology and Immunology
Vice Chair for Research, Department of Medicine
Access today at www.cmezone.com/CU221 Pharmacy Practice News • September 2022 Medication Safety Clinical 11
Miami, Florida
Maria T. Abreu, MD
‘This [study] shows the importance of making sure that a pharmacist is on the team in the outpatient setting, because they promote utilization of guidelinedirected medications and make sure that they are initiated in patients.’
by other providers, lead study author Katherine Harte, PharmD, a clinical pharmacist specialist at Rhode Island Hospital Center for Primary Care, in Providence.Thestudy (abstract 12M) was based on a review of records from 1,246 patients with type 2 diabetes who had clinic appointments at the center, and who were being managed by pharmacists under a collaborative practice agreement, Dr. Harte noted.
Patients managed in the pharmacistled diabetes clinic were 3.01 times as likely to be prescribed an SGLT2 inhibitor or a GLP-1 RA as those not seen by a pharmacist (adjusted risk ratio, 3.01; 95% CI, 2.31-3.91; P<0.001).
Joseph B. Kirsner Professor of Medicine
Stephen B. Hanauer, MD
Director, Crohn’s & Colitis Center
University of Miami Miller School of Medicine
Researchers compared use of these medication classes in patients seen by pharmacists within the primary care clinic versus those seen only by nonpharmacist primary care providers.
DavidFacultyT.Rubin, MD (Chair)
DIABETES
Medical Director, Digestive Disease Center
Feinberg School of Medicine
“Pharmacist involvement was most effective in increasing utilization in patients who had a baseline hemoglobin
SGLT2 inhibitors and GLP-1 RAs are recommended for most patients, according to the American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes. The medications are particularly well-suited for helping to minimize hypoglycemia and weight gain, but also for patients with relevant comorbidities such as heart failure, atherosclerotic cardiovascular disease and chronic kidney disease, said Dr. Harte, who was a PGY-2 ambulatory care pharmacy resident at the time of the“Despitestudy. the strong recommendations from the ADA, a lot of data show that [these two medication classes]
Chief, Section of Gastroenterology, Hepatology, and Nutrition
Clifford Joseph Barborka Professor of Medicine
• medication delivery device acquisition, use and monitoring;
• patient education; and
risk management.
• environmental factors, workflow and staffing patterns;
The final recommendations were informed by best-practice statements that clinical experts, representatives from professional organizations and industry leaders developed during ISMP’s two-day national invitational perioperative medication safety summit, held in November 2021.
—Susan Paparella, MSN, RN
“We would love to see ways in which barcode technology or other advancing technologies—whether it’s RFID [radiofrequency identification] or other machine-readable coding—can be used to support the anesthesia providers and the inter-op providers as they select and administer medications,” she added.
By Kate Baggaley
“With these [guidelines] coming out, there’s finally beginning to be some substance and a foundation regarding medication management and safety in the perioperative area.”
• staff competency and education;
‘The goal is to remove the potential for human error from the equation and make it safer for the patient.’
with the FDA, ISMP released a medication safety selfassessment survey for perioperative settings last year. That assessment “confirmed our suspicions that the perioperative areas may not be using technology for medication safety to the greatest extent as we do in other areas of the hospital,” Susan Paparella, MSN, RN, the vice president of services at ISMP, told Pharmacy Practice News.
Free CE/CME now available! Managing HIV Multidrug Resistance: A Persistent Challenge RELEASE DATE: DECEMBER 1, 2021 EXPIRATION DATE: DECEMBER 31, 2022 PaulFacultyE.Sax, MD Clinical Director, Division of Infectious Diseases Professor of Medicine, Harvard Medical School Brigham and Women’s Hospital Boston, Massachusetts Julia Garcia-Diaz, MD, MSc, FACP, FIDSA, CPI Director Clinical Infectious Diseases Research Director Medical Student Research Associate Professor, University of Queensland Brisbane, DepartmentAustraliaInfectious Diseases Ochsner Health System New Orleans, Louisiana This activity is jointly provided by Global Education Group and Applied Clinical Education. This activity is supported by an educational grant from ViiV Healthcare and Merck & Co., Inc. Distributed by Infectious Disease Special Edition and CMEZone.com 1.0 AMA PRA Category 1 Credit ™ Access today at www.cmezone.com/CU213 Pharmacy Practice News • September 2022 Medication Safety 12 Clinical
New ISMP Guidelines Address Perioperative Medication Safety
•••elements:patientinformation;druginformation;communicationofdrug orders and other drug information;
• quality processes and
• drug labeling, packaging and nomenclature;
Undersettings.acontract
Within the last five years, “there’s been a better focus and strategic planning toward perioperative services, but
more importantly what a vital role pharmacists can play in it,” said Gourang Patel, PharmD, MSc, a clinical pharmacist at the University of Chicago, who headed the American College of Clinical Pharmacy’s Perioperative Practice Research Network, which reviewed the ISMP guidelines before their publication.
Medication errors are common in all phases of perioperative care, ISMP noted in its new guidelines, estimating that at least 787,218 such errors occur annually in the United States. Medications frequently involved in errors include antibiotics in preoperative settings; analgesics, antibiotics, muscle relaxants and vasopressors in intraoperative settings; and antibiotics and anticoagulants in postoperative
The guidelines focus on 10 key
A new set of recommendations from the Institute for Safe Medication Practices (ISMP) tackles the issue of perioperative medication safety in both inpatient and ambulatory surgery centers (ASCs). The numerous handoffs and fast pace of patient care present unique
challenges for medication safety in these settings, the organization said, motivating it to develop its first best-practice guidelines to help facilities identify and address gaps (https://bit.ly/3AEHuFT).
• drug standardization, storage and distribution;
practitioners can work together to accomplish best practices.”
7 Environmental factors, workflow and staffing patterns: Medications are prescribed, transcribed, prepared, dispensed and administered in the perioperative setting within an efficient and safe workflow and in a physical environment that offers adequate space and lighting, and allows practitioners to remain focused on the medication-use process.
Pharmacy Practice News • September 2022 Medication Safety Clinical 13
ISMP Guidelines Focus
8 Staff competency and education: Perioperative practitioners receive sufficient orientation to the perioperative medication-use process and undergo baseline and annual competency evaluations of knowledge and skills related to safe medication practices.
multiple opioid and pain medications to ensure the drugs, doses and combination thereof are safe for patient care,” Dr. Patel said. “In other words, it’s not just approving in the computer the medication order simply based on the dose or frequency but reviewing it more comprehensively in today’s era of complex pain management.”
A New Road Map
Another concern discussed in the guidelines involves monitoring patients after opioid administration in the postanesthesia care unit. “It’s taking the role/responsibility beyond the OR pharmacy itself and reviewing the impact of
The sources reported no relevant financial disclosures.
There are more than 10,000 ASCs in the United States., Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), the president emeritus of ISMP, previously told Pharmacy Practice News. “There is a lot of work to be done in ambulatory surgery because most don’t have pharmacies; they don’t have a full-time pharmacy operation,” he said (https:// bit.ly/3wsEV7w).Thenewguidelines add up to a “pretty comprehensive list,” Ms. Paparella acknowledged. “It’s not something that, we recognize, will happen in a short time.”Many organizations are approaching this task in an interdisciplinary way. “There are guidances here that are going to cross pharmacy, nursing, anesthesia, surgery, etc., so we want to make sure that no decisions are made for practice without everyone at the table,” Ms. Paparella said. “We want to make sure that as they look to these guidelines for direction, it’s a road map for how to reduce risk and where interdisciplinary
9 Patient education: Patients are included as active partners in their perioperative care and are educated about their medications and ways to avert errors.
Some of the recommendations represent practices that are already widely applied; for example, many practitioners participate in organization-wide quality and safety committees focused on perioperative and procedural medication use. Other recommendations, such as using printed barcode labels on practitioner-prepared syringes to ensure the correct medication and dose are administered, will be new territory for many organizations.
ASCs represent a growing segment of healthcare delivery and “merit the same level of attention to medication safety practices and standards as acute care facilities,” ISMP wrote in its guidelines.
3 Communication of drug orders and other drug information: Methods of communicating drug orders and other drug information in the perioperative setting are streamlined, standardized and automated to minimize the risk for error.
4 Drug labeling, packaging and nomenclature: Strategies are undertaken to minimize the possibility of perioperative errors with manufacturerprepared, pharmacy-prepared or commercially prepared drug products that have similar or confusing labeling/packaging and/or drug names that look and/or sound alike.
Instead of being reactive after an event occurs in an organization, “we’re hoping that these guidelines will represent a way for organizations to more proactively go after some of the risks that we know exist throughout the country in perioperative settings,” Ms. Paparella said.
1 Patient information: Essential patient information is obtained, readily available in useful form and considered when prescribing, dispensing and administering perioperative medications, and when monitoring their effects.
5 Drug standardization, storage and distribution: IV and regional anesthesia solutions, drug concentrations, doses and administration times are standardized whenever possible.
Such risks frequently involve over- or under-delivery of fluids during infusions and mix-ups among syringes, vials and ampules that resemble each other. To avert these mistakes, the guidelines highlight the importance of implementing technologies such as smart infusion pumps and the use of barcode scanning to identify medications. “The goal is to remove the potential for human error from the equation and make it safer for the patient,” Ms. Paparella said.
0 Quality processes and risk management: A safety-supportive culture (e.g., just culture) and model of shared accountability for safe system design/redesign and safe behavioral choices are in place and supported by perioperative leaders, managers and the associated board of trustees/directors.
The guidelines are intended to be used by providers in a variety of perioperative facilities.“Whatwas nice to see is that many of these medication management principles did not necessarily apply to only one area or type of setting, [and] some of them can be extended to ambulatory care settings,” Dr. Patel said.
On 10 Key Elements
“It’s up to each organization to look at these guidelines in their entirety, evaluate themselves against these guidances to see what’s already in place and what they need to work on, and then prioritize them internally,” Ms. Paparella said. “We’re hoping the organizations that may implement some of these guidances will evaluate themselves over time, so a couple of years from now [they will] take the opportunity to again pull out the assessment tool and look at where they may still have some opportunities for improvement” (https://bit.ly/3Ct9SMB).
2 Drug information: Essential drug information is readily available in useful form and considered when prescribing, preparing, dispensing and administering perioperative medications, and when monitoring their effects.
6 Medication delivery device acquisition, use and monitoring: The potential for human error is mitigated through careful procurement, maintenance, use and standardization of devices used to prepare and administer medications in the perioperative setting.
Trastuzumab-dttb (Ontruzant, Samsung Bioepis)January 2019
Of note, some institutions have avoided the need to bring biosimilars through the full pharmacy and therapeutics committee approval process by creating policies establishing equivalence and interchangeability of biosimilars within the walls of the hospital. Such policies place emphasis on financial considerations and allow the pharmacy to drive much of the product selection process.
Bevacizumab-maly (Alymsys, 2022
DOUGLAS HACKENYOS, PHARMD, BCOP Oncology Pharmacy Clinical Coordinator Department of Pharmacy UConn Farmington,HealthConnecticut
One key factor is the approved indications for a biosimilar, which may not include all of the approved indications of the reference product. For example, the indications for rituximab (Rituxan, Genentech) include pemphigus vulgaris and certain pediatric indications, while its biosimilars (rituximab-abbs; Truxima, Celltrion; rituximabpvvr; Ruxience, Pfizer) are not approved for those 2 therapeutic uses.4-7 Providers should consider the patient populations seen at their institutions when deciding among products, given potential coverage issues resulting from different approved indications. Additional factors to weigh include the reliability of the manufacturer in terms of product quality and availability.
Pfizer)July
Trastuzumab-pkrb (Herzuma, Celltrion)December 2018
2. Pharmacoeconomic evaluation. In tandem with any clinical review is the necessary pharmacoeconomic evaluation of available biosimilars. Historically, the average wholesale price is approximately 20% to 30% lower for biosimilars compared with reference products.19 Additional savings may be realized through participation in group purchasing organizations (GPOs). A further benefit of many GPOs is their ability to provide ongoing evaluation of available biosimilars and coverage considerations, thus shifting some of this process away from the individual institution. A growing trend is a push toward “portfolio” contracts in which a manufacturer negotiates cost savings through GPOs utilize all the biosimilars they offer, such (Zirabev,
Based on references 4-17. Pharmacy Practice News • September 2022 Educational Review 14 Clinical
Amgen)June
that
as the Table 1. Approved Antineoplastic Biosimilars and Reference Products Reference productBiosimilarFDA approval date (Avastin,BevacizumabGenentech) Bevacizumab-awwb (Mvasi, Amgen)September 2017 Bevacizumab-bvzr
1. Clinical review and comparison. As with any agent being considered for formulary addition, a thorough review of the safety and efficacy data is a necessary first step. When reviewing and deciding among biosimilar products, consider the potential for varying levels of supporting data for each agent. Biosimilars receive FDA approval based on analytical studies of structure and function, animal studies, and clinical studies. The data from these studies are used to compare pharmacokinetic, pharmacodynamics, safety, and efficacy end points of the medications under review.18 Depending on the provided data, the FDA may allow extrapolation and approval of indications without additional clinical studies. Although the FDA approval process for biosimilars helps to reduce significant clinical differences among products, pharmacy and therapeutics committees must ultimately choose among products and establish any restrictions in use.
Although the introduction of biosimilars in oncology came with the hope of significant healthcare savings, individual institutions continue to struggle with formulary management and optimization of biosimilar use. This article serves as an update on the practical management, uptake, and optimization of biosimilars in oncology practice, covering factors related to product selection, information technology (IT) integration, and the role of the pharmacist in educating providers and patients about these agents.
Amgen)December
December
Pfizer)June 2019
Nearly 8 years have passed since the 2015 FDA approval of filgrastim-sndz (Zarxio, Sandoz) under the Biologics Price Competition and Innovation Act of 2009.1,2
Selecting a Preferred Product
(Rituxan,RituximabGenentech)
Rituximab-arrx (Riabni, 2020
Rituximab-pvvr (Ruxience, 2019
Trastuzumab-anns (Kanjinti, 2019
Trastuzumab-qyyp (Trazimera, Pfizer)March 2019
Rituximab-abbs (Truxima, Celltrion)November 2018
Although it is becoming increasingly difficult to select a single preferred biosimilar for a hospital formulary, selecting a preferred product out of the competing biosimilars and reference products remains an important first step (Table 1).4-17 Two key processes are involved in evaluating biosimilar product selection:
Genentech)(Herceptin,Trastuzumab
Amneal)April
During that time, 35 more biosimilars—biologics that are highly similar to and have no clinically meaningful differences from a previously approved reference product in terms of safety, purity, and potency—have reached the US market.2,3
Practical Considerations For Implementing Biosimilars In Oncology Practice
Trastuzumab-dkst (Ogivri, Mylan) 2017
THE UNBRANDED REFERENCE PRODUCT
Coverage and reimbursement may be the biggest factors in any biosimilar formulary decisions, given that the majority of their use occurs in the outpatient setting. Familiarity with an institution’s payor mix and the formulary preferences of major commercial payors is essential in biosimilar implementation. The Centers for Medicare & Medicaid Services (CMS) has incentivized utilization of newly approved biosimilars compared with older biosimilars or reference products via 340B pass-through status; however, in June 2022, the US Supreme Court ruled unanimously in favor the American Hospital Association and others to end varying CMS reimbursement cuts for 340B hospitals.20-21 While a final ruling is expected in November 2022, biosimilars that have lost pass-through status would be expected to revert from a payment rate of average sales price (ASP) minus 22.5% to ASP plus 6% in 2023. This would stand to significantly change strategy for reviewing reimbursement in biosimilar product selection.
Although yet to be seen in oncology, Janssen introduced another strategy to compete with biosimilars by introducing unbranded infliximab. Marketing materials heavily emphasize that unbranded infliximab is “the same product as Remicade with the same patient support.”26 As such, it carries the same indications as the reference product, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis, among others. Although the strategy seems to undermine the foothold of biosimilars, the release of unbranded biologics comes as a clear acknowledgment of the shifting market and overall price reductions brought forth by competition. Unbranded biologics will undoubtedly emerge in oncology in the near future.
The ever-changing landscape of biosimilar approvals and insurance formularies makes it nearly impossible for most institutions to select a single biosimilar to replace any given reference product. Making preferred product selection clear across systems may help minimize inappropriate orders and support PA requests; however, a successful biosimilar implementation process will allow conversion to a reference product or nonpreferred biosimilar in cases of insurmountable insurance restrictions or rare clinical exceptions. Additional patient-specific exceptions may be required for clinical trials and mail-order or specialty pharmacy-supplied medications.
Unfortunately, using 1 preferred biosimilar is becoming unrealistic as payors become increasingly divided in the products they will cover. An effective order set will allow flexibility in accommodating third-party payor preferences and products supplied by specialty pharmacies or manufacturer assistance programs. While there are many ways to approach this problem, 2 options are worth highlighting:
DISPENSING TECHNOLOGY
After selecting a formulary-preferred product, full implementation involves IT integration as well as significant provider and patient education; these areas will be the focus of subsequent articles in this series. The overall approach to implementation may involve use in only newly started patients or active conversion of those established on therapy with a reference product. In either approach, careful coordination with care team members and prior authorization (PA) staff is necessary.
Table 2. Reference Products and Innovative Subcutaneous Formulations Adding Competition to the Biosimilar Market referenceIntravenousproduct Novel formulationsubcutaneous FDA dateIndication(s)approval
see BIOSIMILARS, page 16 Pharmacy Practice News • September 2022 Educational Review Clinical 15
Genentech)(Herceptin,Trastuzumab
In addition to their many other benefits, electronic order sets and oncology treatment pathways can greatly aid biosimilar uptake. A formulary-preferred biosimilar may be set as the default agent in any given plan to bolster use and avoid provider confusion at order entry. Practice advisories or other wording may be added to treatment plans, and electronic consent forms may be used, to further highlight formulary preferences and promote patient education on biosimilars. Defaulted treatment plans also may assist in streamlining the PA referral process and make the preferred biosimilar selection clear to authorization staff.
Genentech)(Rituxan,Rituximab
Based on references 4, 12, and 23-25.
Biosimilar IT Integration ELECTRONIC MEDICATION RECORD BUILD
• Breast cancer, metastatic
• Diffuse large B-cell lymphoma
2. Automatic substitution based on authorized product. Sophisticated electronic health records may automatically drive product selection based on a patient’s insurance type with rules defining the payor’s covered biosimilar(s). In this case, the payor type or HCPCS code entered in an authorization note triggers a change in the ordered biosimilar to the covered product. This strategy also requires collaboration between pharmacy and PA staff and acceptance of biosimilar equivalency fromWithproviders.anystrategy, careful review of the authorized versus ordered biosimilar is essential to avoid denied insurance claims. Finally, efforts to minimize or avoid use of brand names in oncology treatment pathway titles, plan parameters, and other order set fields outside of the specific medication order may make future substitutions or product conversions more efficient.
February 2019• Breast cancer, early adjuvant
June 2017• Chronic lymphocytic leukemia
Trastuzumab hyaluronidase-oyskand (Herceptin Hylecta, Genentech)
Technology within the pharmacy can drastically improve an institution’s ability to incorporate biosimilars into practice. Inventory management systems with electronic barcode scanning can help pharmacy staff differentiate between biosimilars and reference products as soon as medications enter the pharmacy. Biosimilar products may be assigned segregated locations using inventory
Implementing Biosimilar Use
ADDRESSING PAYOR PREFERENCES
Successful incorporation of biosimilars into the electronic prescription record begins with well-constructed building blocks: electronic prescriptions or medication records. Unlike interchangeable generic and brand-name medications, it is important to recognize that biosimilars have distinct National Drug Codes and billing codes. Biosimilar electronic medication records should include the unique National Drug Code, Healthcare Common Procedure Coding System (HCPCS) code, generic name (with 4-letter suffix), and brand name associated with each unique product. Comprehensive biosimilar builds can help to minimize look-alike/sound-alike (LASA) errors that may arise with order entry, verification, preparation, and administration (Table 3). LASA warnings also may be added to each build to appear on the medication administration record and drug labels.
• Follicular lymphoma
Pertuzumab, trastuzumab, and (Phesgo,hyaluronidase-zzxfGenentech)
• Breast cancer, metastatic
Rituximab and hyaluronidase (Rituxan Hycela, Genentech)
BIOSIMILAR ORDER SETS
Competition breeds innovation, and this can be seen via additional non-biosimilar products that are poised to draw away from biosimilar use (Table 2).4,12,22-24 Monoclonal antibodies with hyaluronidase intended for faster, more convenient subcutaneous administration, for example, are attractive treatment options compared with existing IV reference products and biosimilars.26 However, insurance authorization hurdles, site-of-care issues, and narrower FDA-approved indications hamper widespread utilization of these subcutaneous agents. As more innovative formulations reach the market and lists of approved indications grow, competition with biosimilars will undoubtedly increase.
1. Placeholder orders in treatment plans. Use of a placeholder or “dummy” biosimilar order in a treatment simplifies the product selection process by allowing PA staff to determine which biosimilar(s) will be covered up front. A pharmacist may review the authorized product(s) for the plan, substitute an actual order, and route for a co-signer as needed. This strategy requires a close relationship between pharmacy and PA staff; reports to identify “dummy” orders needing replacement; and general acceptance of biosimilar equivalency from providers.
INNOVATION IN REFERENCE PRODUCT LINES
June 2020• Breast cancer, early adjuvant or neoadjuvant
following biosimilars marketed by Amgen: bevacizumab-awwb (Mvasi), trastuzumab-anns (Kanjinti), and rituximab-arrx (Riabni). This may be another strategy to consider in maximizing cost savings with biosimilar optimization.
MANAGING EXCEPTIONS AND CHANGES
Discrete medication records for each biosimilar with full generic name, 4-letter suffix, and brand name
Although retrospective reviews continue to be published comparing real-world clinical outcomes between biosimilar and reference products, providers may find internal data more comforting and convincing. Pharmacists may promote further biosimilar uptake by reviewing their institutions’ biosimilar and reference product data and comparing factors such as incidence of infusion-related reactions and clinical outcomes, where available.
Technology greatly facilitates safe administration of all medications, including biosimilars. The use of barcode scanning and smart infusion pumps can reduce errors that may come with multiple product options. Many institutions are opting to minimize build and maintenance work for their smart pump libraries by using a single entry under a generic name to address both reference and biosimilar products with identical administration instructions. Some medication administration records also may allow the addition of intranet links to drug information and patient education resources for biosimilar products for easy access at the point of care.
•
Segregated inventory locations for reference, biosimilar, and subcutaneous product formulations Verification • Discrete medication records for each biosimilar with full generic name, 4-letter suffix, and brand name • Minimize need for substitution upon verification
MEDICATION ADMINISTRATION TECHNOLOGY
continued from page 15 Pharmacy Practice News • September 2022 Educational Review 16 Clinical
The massive influx of information that patients must process at the start of a new regimen necessitates succinct, patient-friendly written information. Biosimilar manufacturers often provide helpful explanations and figures if branded patient education materials may be used at your institution. The FDA also has a host of unbranded materials with infographics that quickly explain key biosimilar concepts in patient-friendly terms.41
Default order sets/treatment pathways to formulary product preference Preparation • Barcode scanning
BIOSIMILARS
CURBING BIOSIMILAR MISINFORMATION
EDUCATING THE CLINICIAN
•
BECOMING INFORMED
In addition to clinician education, support staff should be informed of new considerations with the addition of biosimilars. Pharmacists may facilitate the education of patient access and PA staff by explaining care plan changes, emphasizing changes in preferred products, and providing clinical rationale for biosimilar PAs. Pharmacy technicians also should be educated to minimize risk for LASA errors in compounding and dispensing.
Segregated inventory locations in automated dispensing cabinets Order entry • Discrete medication records for each biosimilar with full generic name, 4-letter suffix, and brand name
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Patient education remains a vital component to cancer care utilizing antineoplastic biosimilars. The education of new-start patients on biosimilars is comparable to that of other patients initiating treatment with a biologic. Given the growing potential for changing payor formularies and institutional cost savings with change in formulary preferences, it may be appropriate to introduce patients to the term “biosimilar” and explain key concepts of biosimilar “switching,” safety, immunogenicity, and production (Table 4).
Barcode scanning
consulting in-house legal Table 3. Tips for Minimizing Look-alike/ Sound-alike Medication Errors With Biosimilar AdministrationImplementation
Several studies have identified areas for improvement in oncology clinician understanding of biosimilars, and pharmacists may play a key role closing these knowledge gaps.32-34 Survey findings shared at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) indicated 88% of responding oncologists had used biosimilars, but nearly half lacked knowledge on key concepts such as interchangeability. 35 Position statements and resources from ASCO, HOPA, the National Comprehensive Cancer Network, and the Oncology Nursing Society are extremely helpful in supporting pharmacist-led education of clinicians and ultimately increasing acceptance and understanding.36-39 Education efforts and the identification of a physician champion for biosimilar use are critical steps in successful biosimilar implementation.
EDUCATING THE PATIENT
The rapid introduction of multiple biosimilar agents has challenged all clinicians, including pharmacists, to stay informed. In a 2019 survey conducted by the International Society of Oncology
The Pharmacist’s Role
Theinfusion.need to re-consent patients upon conversion to an antineoplastic biosimilar is a frequently asked question. Reviewing institution-specific consenting policies and
Education at the time of conversion from an antineoplastic reference product to a biosimilar is an important, sensitive step to maintaining a respectful patient–provider relationship during implementation. Conversions may be driven by institutional cost-savings opportunities or insurance formulary preferences; in either case, it is important to be open about general motivation for increasing biosimilar use. In the outpatient setting, education should be coordinated in advance of order conversion, PA, and actual treatment with the biosimilar. An example conversion time line may include patient education on the biosimilar in person or via phone at the time of their treatment with a reference product, PA between treatments, order conversion, and follow-up at the first biosimilar
Given patients’ and providers’ relatively limited experience with biosimilars, some key concepts may be poorly understood. For example, the term “similar” may be misunderstood as implying a clinical difference rather than its true intention of emphasizing inherent variability among biologic products.40 The “abbreviated” approval pathway for biosimilars also can be misinterpreted as being more lenient or cutting corners compared with that of reference products. Pharmacists play an important role in educating and avoiding the negative impact that misinformation can have on biosimilar uptake.
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Pharmacy Practitioners, 3 key areas were identified by respondents as requiring more training: biosimilar comparative efficacy to innovator products (74%), practical guidance managing biosimilar conversions (74%), and biosimilar medication safety, including immunogenicity (74%).27 Pharmacists must have a fundamental understanding of biosimilars to be in a position to implement and educate providers and patients on their use. Numerous biosimilar review articles are available, including publications geared specifically toward oncology pharmacists.28,29 Pharmacists also may stay abreast of the most recent biosimilar approvals through resources such as FDA alerts and weekly FDA briefings from the Hematology/ Oncology Pharmacy Association (HOPA).30,31
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management technology to avoid confusion in stocking and picking physical inventory. Barcode scanning, image capturing, and dose compounding verification technology also can minimize preparation errors that may result from LASA biosimilar products. Dose preparation and verification technology also can aid in avoiding preparation errors that may result from differences in specific product preparation. For example, vial sizes, reconstitution instructions, and the need for sterile water for injection (SWFI) versus bacteriostatic SWFI vary between single- versus multidose trastuzumab products.12,17 Inventory management and dose preparation may be further complicated by the need to stock multiple biosimilars as well as subcutaneous formulations for any given reference product; barcoding technology is essential to avoid errors in such scenarios.
38. Hematology/Oncology Pharmacy Association. Biosimilars issue brief: an important new category of medications for cancer patients. Revised December 2015. Accessed August 10, 2022. bit.ly/3QwhhPi
10. Zirabev [package insert]. Pfizer, Inc; 2019.
39. Vizgirda V. Clin J Oncol Nurs. 2017;21(2):E54-E60.
What biosimilars?are
2. FDA. Biosimilar product information. Accessed August 10, 2022. drugs/biosimilars/biosimilar-product-www.fda.gov/information
• Biosimilars are tested and compared with reference products before FDA approval.
• These agents are not generic versions. As biologics, they are large, complicated molecules made by living cells that cannot be copied exactly.
14. Herzuma [package insert]. Celltrion, Inc; 2018.
• The function, purity, potency, and immunogenicity of biosimilars are similar to those of reference products.
12. Herceptin [package insert]. Genentech, Inc; 2018.
counsel, if available, may be helpful steps in determining the most appropriate course of action. In either case, it may be appropriate to update
19. Mulcahy AW. Rand Health Q. 2018;7(4):3.
4. Rituxan [package insert]. Genentech, Inc; 2018.
27. Chan A. J Oncol Pharm Pract. 2020;26 (3 suppl):11-21.
36. Zelenetz AD. J Natl Compr Canc Netw 2011;9(4 suppl):S1-S22.
Why biosimilars?use
• These agents provide more treatment options.
9. Mvasi [package insert]. Amgen, Inc; 2019.
consent forms or policies to contain broader wording (eg, “treatment with: x drug and similar products”) to allow for future conversions.
33. Williamson C. Am J Manag Care. 2019;25 (6 Spec No.):SP188-SP191.
17. Kanjinti [package insert]. Amgen, Inc; 2019.
6. Ruxience [package insert]. Pfizer, Inc; 2021.
• Safety tracking continues after the biosimilar has been approved and reaches the market.
• They enhance competition and increase cost savings in healthcare.
13. Ogivri [package insert]. Mylan; 2017.
24. Rituxan Hycela [package insert]. Genentech, Inc; 2017.
37. Lyman GH J Clin Oncol. 2018;36(12): 1260-1265.
34. Edgar BS. J Manag Care Spec Pharm 2021;27(8):1129-1135.
35. Peipert J. J Clin Oncol. 2021;39 (28 suppl):Abstract 35.
Table 4. Key Patient Counseling Points For Biosimilar Medications
20. Centers for Medicare & Medicaid Services. Fed Regist. November 21, 2018. Accessed August 10, 2022. bit.ly/3zXRcSl
5. Truxima [package insert]. Celltrion, Inc; 2022.
Get the latest news FREE from the most widely read hospital pharmacy publication in the United States, including multimedia and web-only content, delivered directly to your inbox! Sign up ArticlesPharmacyPracticeNews.com/@Registrationfromthecurrentmonth’sissue•Articlesaheadofprint•Web-exclusivecontent Brought to you by the same team who publish Educational Review Clinical 17
30. FDA. Get email updates. Accessed August 10, 2022. bit.ly/3QxrCuC
Is it safe to switch to biosimilar?a
16. Trazimera [package insert]. Pfizer, Inc; 2019.
1. FDA. Drugs@FDA: FDA-approved drugs. Filgrastim-sndz. Accessed August 10, www.accessdata.fda.gov/scripts/cder/daf/2022.index.cfm
28. Cuellar S. Am J Health Syst Pharm 2019;76(21):1725-1738.
21. American Hospital Association et al v. Becerra, Secretary of Health and Human Services, et al. No. 20-1114. (Supreme Court of the United States 2022). Accessed August 10, 2022. bit.ly/3K1LhjW
40. Cohen HP. BioDrugs. 2020;34:407-414.
8. Avastin [package insert]. Genentech, Inc; 2020.
29. Foreman E. J Oncol Pharm Pract 2020;26(3 suppl 2).
• Insurance coverage may require use of biosimilars.
• There are no meaningful differences in effectiveness or side effects compared with reference products.
3. FDA. Title VII—improving access to innovative medical therapies. Subtitle A— Biologics Price Competition and Innovation. Accessed August 10, 2022. www.fda.gov/ media/78946/download
25. Anderson KC. Future Oncol 2019;15(28):3267-3281.
18. FDA. Guidance document: scientific considerations in demonstrating biosimilarity to a reference product. Accessed August 10, 2022. bit.ly/3CaGY3y
41. FDA. Patient materials: biosimilar basics for patients. Updated October 7, 2020. Accessed August 10, 2022. bit.ly/3QsmSGl
Dr Hackenyos reported no relevant financial disclosures.
22. Herceptin Hylecta [package insert]. Genentech, Inc; 2019.
31. Hematology/Oncology Pharmacy Association. Drug updates. Accessed August 10, 2022. bit.ly/3w83E0S
• Biosimilars use the same dosage and administration as reference products and are produced in FDA-licensed facilities.
23. Phesgo [package insert]. Genentech, Inc; 2020.
References
11. Alymsys [package insert]. Amneal Pharmaceuticals, LLC; 2022.
32. Cook JW. Ther Adv Med Oncol 2019;11:1758835918818335.
26. Unbranded infliximab [package insert]. Janssen; 2021. Accessed August 10, 2022. www.infliximab.com
• Biosimilars improve access to care.
• These biologic agents are highly similar to a reference product and safe and effective.
15. Ontruzant [package insert]. Samsung Bioepis Co, Ltd; 2019.
7. Riabni [package insert]. Amgen, Inc; 2020.
SGLT2 Inhibitors
It makes sense that pharmacist involvement leads to more usage of these recommended medications, commented Patrick Gregory, PharmD, BCACP, CPP, the coordinator for primary care population health pharmacy services at the Duke Population Health Management Office, Duke Health, in Durham, N.C., and an assistant professor of clinical education at the UNC
demonstrated effectiveness in reducing MACE (Ther Adv Endocrinol Metab 2021;12:2042018821997320).
any barriers to access, he noted.
In August 2017, Dr. Gregory began working in a Duke Health primary care clinic one half-day per week to help manage patients with diabetes. There was a statistically significant increase in SGLT2 inhibitor and GLP-1 RA prescribing in his clinic versus two others that did not include a pharmacist (J Am Pharm Assoc 2022;62[1]:209-213. e1). The percentage of patients prescribed either medication rose to 15% in his clinic versus 11.6% in the other clinics.
Pharmacists have the knowledge and the time to be more involved with patients, not only prescribing the medications, but ensuring they don’t have
relevant financial
Although Dr. Gregory still works in the clinic a half-day weekly, data he helped collect supported a business plan to hire two full-time pharmacists working across four primary care clinics, he said. Now, with their combined work, the office is recruiting for three additional positions to have five fulltime pharmacists covering 10 clinics and two part-time pharmacists covering two more clinics.
What are the current options within these classes of drugs, and how can pharmacists help ensure optimal medication management using these agents?
DIABETES continued from page 11 GLP-1 RAs and SGLT2s cause a mean weight loss of about 4.5 to 6.5 pounds Source: Obes Rev 2019;20(6):816-828. Pharmacy Practice News • September 2022 Endocrinology 18 Clinical
“These agents originally came to the market to lower blood sugar; they allow the sugar to be eliminated through the urine,” Dr. Whitley said. “While they do achieve that goal, they have an even more profound impact on the heart and kidneys.” These benefits include:
The FDA approved the first long-acting GLP-1 RA, liraglutide (Victoza, Novo Nordisk) in 2010. It was followed by exenatide (Bydureon, AstraZeneca), dulaglutide (Trulicity, Lilly), semaglutide injection (Ozempic, Novo Nordisk) and oral semaglutide (Rybelsus, Novo Nordisk). Three of the agents—dulaglutide, liraglutide and injectable semaglutide—have
“It adds a lot more work to primary care providers’ plates to get these new medications on board for patients, because typically they need a prior authorization, and even if you get the prior authorization through, costs can still be a big factor with these particular medications,” Dr. Gregory said.
ecent evidence shows that not only do sodiumglucose cotransporter-2(SGLT2) inhibitors and long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) help control blood sugar in people with type 2 diabetes, but some of them also have additional health benefits, including weight loss and improved kidney and cardiac outcomes.
Eshelman School of Pharmacy, in Chapel Hill.
Drs. Gregory and Harte reported no disclosures.
“What is even more remarkable about these agents is that they work fast. The benefit in terms of heart failure begins within the first week,” Dr. Whitley noted. “They also lower the risk for major adverse cardiovascular events, as noted, but this is a benefit that takes a bit longer—about three months or so. The kidney function benefits, which are unique to this class, take about 18 months to achieve. Nonetheless, in the world of pharmacy, it’s an extremely important benefit. Below a certain level of kidney function, we can’t use certain classes of medications, such as antibiotics, to treat infections.”
Patient Perspective on Treatment Choice
• a 33% reduction in risk for cardiovascular death or hospitalization for people with heart failure, according to a January 2022 meta-analysis of 10 highquality randomized clinical trials (JAMA Netw Open 2022;5[1]:e2142078);
Each of these five agents is slightly different in terms of its magnitude of benefit and side-effect profile, but the most common side effect with the injectable agents is gastrointestinal disturbances, including nausea, vomiting and diarrhea. Studies suggest that patient satisfaction is highest for dulaglutide, a singleuse, disposable pen device. (Ther Adv Endocrinol Metab 2021;12:2042018821997320).BothSGLT2inhibitorsand GLP-1 RAs also have been found to result in weight loss, which can improve insulin sensitivity and glucose control as well as reduce cardiovascular risk factors and comorbidities. Clinical trial data indicate that both classes of drugs cause a mean weight loss of 2 to 3 kg, or about 4.5 to 6.5 pounds (Obes Rev 2019;20[6]:816-828). “Both have weight loss benefits, but our experience is that weight loss is more profound in the GLP-1 RA class,” Dr. Whitley said.
• a smaller, but still statistically significant, reduction in major adverse cardiovascular events (MACE) (SGLT2 group, 9.82%; placebo group, 10.22%; P=0.03); and
GLP-1 RAs
R
By Gina Shaw
Evidence Mounts for Benefits Of SGLT2 Inhibitors and GLP-1 RAs
The risks associated with these agents often are related to their mechanism of action—that is, allowing blood sugar to be eliminated via the urine. “That means that fluid also follows the sugar out through the urine, so you have a risk of dehydration and orthostatic hypotension, along with an increased risk of general yeast infections,” Dr. Whitley said.
“The novel thing about these two classes is that the FDA, in 2008, mandated that all new type 2 diabetes drugs coming to market must prove cardiovascular safety before their approval,” said Heather Whitley, PharmD, a clinical professor at Auburn University’s Harrison College of Pharmacy, in Alabama, and a certified diabetes educator (CDE). “In these large-scale cardiovascular outcome trials, we found that all of the SGLT2s and many of the GLP-1 RAs not only are safe, but also have unique cardiovascular benefits.”
For patients who have type 2 diabetes with cardiovascular disease and/or kidney disease, SGLT2 inhibitors have revolutionized treatment. Currently available agents include canagliflozin (Invokana, Janssen), dapagliflozin (Farxiga, AstraZeneca/Bristol Myers Squibb), empagliflozin (Jardiance, Boehringer Ingelheim) and ertugliflozin (Steglatro, Merck).
• a slowed progression of kidney disease in people with type 2 diabetes and those with chronic kidney disease (CKD) who do not have diabetes. Trials have found that these agents reduce the risk for worsening kidney function, end-stage renal disease and renal death by 30% to 46%, depending on the patient subgroup, with more significant benefits in patients with kidney disease and atherosclerotic cardiovascular disease (Front Med 2021;8:728089).
Patient preference—whether based on the aforementioned preference for pen injectors or other factors— “definitely plays a significant role in agent selection,” said Katherine Harte, PharmD, a PGY-2 ambulatory care pharmacy resident at the Rhode Island Hospital, in Providence. “For example, some patients really prefer an oral option, while others prefer an injectable with a longer dosing interval like dulaglutide. Financial considerations are also an important factor. Unfortunately, right now, every single long-acting GLP-1 RA and SLGT2 inhibitor is brand-name only and they are expensive medications. There’s no black-and-white answer as to which is most affordable, because it will differ depending on the patient’s insurance coverage and formulary, and if they qualify for other programs such as manufacturer assistance.”
Dr. Harte reported no relevant financial disclosures. Dr. Whitley reported financial relationships with Abbott Laboratories and Abbott Rapid Diagnostics.
Lessening the Load on PCPs
Dr. Whitley advised using a “STEPS” mnemonic while counseling patients on selecting between these classes and among agents in these classes: Safety, Tolerability, Efficacy, Price and Simplicity.
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