Guidance released at ISOPP meeting
UP FRONT
Multimedia, plus top-read articles you may have missed .............
3
CLINICAL
Oncology pharmacists teach, and learn, in Nigeria ............................
4
Fine-tuning immune checkpoint inhibitor therapy ..................................
8
ISMP’s Michael Cohen: a career dedicated to medication safety ....
RFID challenges, opportunities outlined in new ASHP report ....
19
Safety experts ask for more regulatory muscle behind IV-WMS ............. 21 REVIEW ARTICLE
Rapid Diagnostic Testing See insert after page 12.
Knowledge Gap On Extravasation May Be Closing
‘Test-to-treat’ initiative spurs debate
AMA: Pharmacist Skills Fall Short in COVID-19 Rx
By Dave Doolittle
By Gina Shaw
E
P
xtravasation caused by antineoplastic drugs has been well documented in guidelines, databases and reference papers, but there is little consensus on recommended treatments. There also is a lack of agreement on the risk for tissue damage posed by each antineoplastic drug. After reviewing these gaps, the Extravasation Working Group of the Spanish Oncology Pharmacy Group (GEDEFO) belonging to the Spanish Society of Hospital Pharmacists (SEFH) has proposed a classification of antineoplastic drug-induced tissue damage. The group also has recommended specific measures to be implemented in the event of extravasation.
12
TECHNOLOGY
Volume 49 • Number 4 • April 2022
The Best-Read Pharmacist’s News Source
pharmacypracticenews.com
hysicians usually understand the value pharmacists bring to the care team, given the latter profession’s proven expertise in managing medications. But the American Medical Association (AMA) apparently didn’t get the memo, judging by the contention that has broken out between the two groups over President Joe Biden’s “test-to-treat” initiative governing COVID-19 therapeutics. Pharmacists are praising the initiative, which allows people to get tested for COVID-19 at pharmacy-based clinics and receive oral treatments immediately if they test positive, as a critical component of the national effort to protect Americans from the coronavirus. But in a March 4 statement, the AMA blasted the plan. “Establishing pharmacy-based clinics as one-stop shopping for COVID-19 testing and treatments is extremely
Continued on page 6
Continued on page 14
PharmD Stewards Deemed ARTisans In HIV Rx Safety
Navigating the Complexities Of Biosimilar Use in Pediatrics
By David Wild
hen switching from an originator biologic to a biosimilar for pediatric patients, making the choice can be complicated by the fact that most biologics research is performed in adults receiving the reference product. Still, there are useful guideposts to follow, including some data on bioequivalence and also dilution and stability requirements that may point to the best formulary choice for a given institution. But for formulary managers who like to base such decisions on a strong and consistent body of evidence, this will not always be an easy process. “The literature for biosimilars in pediatric patients is often retrospective or observational,
E
xpanding inpatient medication stewardship efforts to encompass antiretroviral therapy (ART) can slash medication errors and 30-day hospital readmission rates by more than 50% in people living with HIV, recent studies suggests. “ARVSPs [antiretroviral stewardship programs] improve outcomes for patients because they ensure patients get the right medications, at the right time, in the right doses,” said Elizabeth Sherman, PharmD, an associate professor of pharmacy Continued on page 18
By David Wild
W
and data from adult participants in biologics research is frequently extrapolated by clinicians for use in younger patients,” said Elsen Jacob, PharmD, an assistant professor at St. John’s University College of Pharmacy and Health Sciences, in New York City. “So it can be challenging to decide whether and how to use biosimilars in our pediatric populations.” As for why children have been left out of drug trials historically, Dr. Jacob cited concerns about medication safety. But there have been attempts to address that data gap, he noted. In 2002, the Best Pharmaceuticals for Children Act incentivized companies to perform pediatric clinical trials by granting them a six-month patent exclusivity extension if Continued on page 16
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4 Clinical
Pharmacy Practice News • April 2022
Oncology
U.S. Hem/Onc Pharms Teach, and Learn, in Nigeria By Dave Doolittle
C
indy O’Bryant, PharmD, didn’t know quite what to expect in the days leading up to a trip to Nigeria late last year that was designed to help strengthen cancer treatment and care in the African nation. Although she has met several Nigerian healthcare professionals and students as a clinical pharmacy professor at the University of Colorado Anschutz Medical Campus in Aurora, she had no firsthand knowledge of how her colleagues there treated cancer patients. “They have a wide variety of facilities and resources for oncology pharmacists throughout Nigeria. Some work in modern hospitals that have clean rooms and hoods to make chemotherapy and personal protective equipment,” Dr. Bryant told Pharmacy Practice News. “But in some of these areas, I found that they don’t have any resources: We saw people mixing chemotherapy on a table with no protective equipment, no hood, no anything. It’s pretty amazing the things that they do without to be able to provide care.” Dr. O’Bryant spent two weeks in Nigeria along with R. Donald Harvey, PharmD, a professor of hematology and medical oncology at Emory University School of Medicine, in Atlanta, Ga., meeting healthcare workers and officials, hosting training sessions and sharing best practices in oncology pharmacy. The trip was sponsored by the U.S. Embassy’s Fulbright program and organized by Project Pink Blue, a Nigerian nonprofit dedicated to raising cancer awareness and providing resources and support to patients. “We were brought in to help educate the country’s pharmacists on disease states and to help them learn how to make chemotherapies and sterile
Cancer Care In Nigeriaa 206,139,590 Population
124,815 New cases
233,911 Prevalent cases (5-year)
78,899 Deaths a
As of 2018.
Source: International Agency for Research on Cancer; bit.ly/3tgO8P3
techniques—the best way to use protective equipment to do that—and to model what we do as oncology pharmacists here in the United States,” Dr. O’Bryant said. “We also met with the Nigerian health ministry to talk with them about the resources that were needed and the things that would help improve the ability to provide oncology pharmacy services in the country.”
Overcoming Challenges Brings New Ones Nigeria sits along the western coast of Africa approximately 700 miles north of the equator. It is about twice the size of California with a population of almost 200 million people, making it Africa’s most populated country and the sixth most populated nation in the world. Its healthcare system has faced numerous challenges over the years, exacerbated by climate problems, overpopulation, crumbling infrastructure and a shortage of healthcare professionals, including pharmacists. Although responding to infectious diseases continues to be a major healthcare struggle, the country has made notable strides in recent years to control outbreaks, facilitated in part by the establishment of the Nigerian Centre for Disease Control in 2011. As a result, “Nigeria has gotten a handle on infectious disease issues that people might have died from earlier,” Dr. O’Bryant said. However, as these patients live longer, “they are developing cancer. So right now, you’re seeing cancer rates going up in Nigeria.” Since 2013, Project Pink Blue has worked to change how cancer is treated and perceived in Nigeria. It is specifically focused on rural and hard-to-reach areas, which typically do not have the same facilities and resources found in major cities like the capital, Abuja, and Lagos, Nigeria’s largest city. In addition to screenings, Project Pink Blue offers patient support and education as well as fundraising for patient care, research and oncology training. (For more details, see sidebar, page 11.) “[Project Pink Blue is] very savvy about what they have and where they want to be, and they’re very tactical to get there,” Dr. Harvey told Pharmacy Practice News. “They’ve used Fulbright, they’ve
From left: Jenny Foltz with the U.S. Embassy in Nigeria; R. Donald Harvey, PharmD; Project Pink Blue Executive Director Runcie Chidebe; Cindy O’Bryant, PharmD; and Gloria Olkwu with Project Pink Blue.
used other mechanisms internationally—the [World Health Organization], the UICC [Union for International Cancer Control]—and other international cancer consortium resources to help get them what they need.”
Meeting of the Minds In Abuja, Drs. O’Bryant and Harvey met separately with members of the Federal Ministry of Health and the U.S. Embassy to discuss overall cancer care in Nigeria, how it is treated in the United States, and how oncology pharmacists from both countries can build relationships and partnerships with organizations like Project Pink Blue. “There were a lot of concerns about what could be done there,” Dr. Harvey said. “A lot of their questions were, ‘What’s our aspirational place to be, and how do we get there?’” The pair also toured the city’s medical university hospital, where they saw a variety of care procedures, including nurses making chemotherapies at patients’ bedsides and then administering the treatment via drip, Dr. O’Bryant said. “So, again, not a lot of the more modern things we have here with pumps, and relatively limited access to protective equipment,” such as closed system drugtransfer devices, she said. “But they’re doing some very cool things. They have a tumor board where they meet with a multidisciplinary group of physicians and they bring in pharmacists to talk about how to manage their cancer patients.” In Lagos, Drs. O’Bryant and Harvey toured several hospitals and spent a day with 34 oncology pharmacists from across the country, giving lectures and providing hands-on training on sterile procedures, drug therapies and disease states. “The pharmacists really had the desire to continue to grow
their knowledge, and to learn how to handle relationships in all aspects of cancer, not just chemotherapy but also supportive care such as nausea and pain management and other things that have to go along with the care of the patient,” Dr. Harvey said. “The passion was there. There was a deep desire for pharmacists in the country to continue to grow in their work and be the drug expert for cancer patients.”
Problems Persist Both Drs. O’Bryant and Harvey said their trip was an important step in improving cancer care in Nigeria and in building relationships among pharmacists and other healthcare professionals from both countries. But they also acknowledged that the country has many challenges it must overcome—structurally, politically, economically and socially. For example, cancer treatment is not covered by insurance in Nigeria, Dr. O’Bryant said, so patients tend to have to pay out of pocket for therapy, unless they work with foundations such as Project Pink Blue. “That can really limit the ability for patients to get care because they’re having to raise money to pay for their own medications,” she said. “There are some government programs that can help them get those at a discounted price, but the weight of that is still falling on the patient.” In addition, asking family and friends to help pay for medications and treatment can be difficult because of prevalent social stigmas regarding a cancer diagnosis, both pharmacists said. “There are still a lot of thoughts that if you get cancer, that means you’ve done something bad or you’ve been cursed, and the best way to treat your cancer is to go to your religious leader and have see NIGERIA, page 11
So ly/
Smart Labels
6 Clinical
Pharmacy Practice News • April 2022
Oncology
Extravasation Gap continued from page 1
María Asunción Albert-Marí, PhD, a clinical oncology pharmacist at the Hospital Universitario y Politécnico La Fe, in Valencia, Spain, presented the working group’s proposals at the International Society of Oncology Pharmacy Practitioners (ISOPP) Virtual Symposium in early March. “Extravasation is a medical emergency because, if not properly and timely managed, [it] can lead to severe consequences,” Dr. Albert-Marí said. “It can impact safety but also can adversely affect quality of life, and if there is a need for cycle delays, it can [degrade] the effectiveness of a therapeutic plan.” Antineoplastic extravasation is rare, occurring in up to 6% of peripheral infusions and up to 4.7% via the central route (Memo 2016;9[4]:226-230) and has been declining to between 0.05% and 0.5% of all infusions (Tumori 2016;102[3]:290-293), the working group said. But the risks posed still is cause for vigilance, they noted. The most common symptoms are edema and swelling, which occur in 60% of cases, but serious complications can occur, such as ulceration, necrosis and death. There are many patient- and administration-based risk factors that
can lead to antineoplastic extravasation, from patients with phlebitis or sclerosed veins to multiple venipuncture attempts, mechanical cell compression, inexperienced staff and high workloads, Dr. Albert-Marí said. Additionally, there are drug-related risk factors for direct cellular toxicity, including concentration and volume extravasated of the medication, she said. For example, cisplatin is classified as a vesicant in doses greater than 0.4 mg/mL and as a high-risk irritant in concentrations lower than 0.4 mg/mL. The working group recommends diluting cisplatin and administering it in minibags to avoid a concentration that can cause potentially fatal extravasations. Another known drug-related risk factor for extravasations is whether a therapy is a DNA-binding or non– DNA-binding vesicant, Dr. AlbertMarí said. DNA-binding vesicants, such as anthracyclines, amsacrine, dactinomycin and mitomycin, are absorbed locally and cause apoptosis of cells, she noted. “They are not metabolized, and they are liberated again in the extracellular space and also can destroy healthy cells. They produce continuous, chronic and progressive tissue damage.” Non–DNA-binding vesicants, such as vinca alkaloids, have less necrotizing
Table 1. Classification of Antineoplastics Based On Extent of Tissue Injury Vesicant amsacrine carmustine dactinomycin daunorubicin doxorubicin epirubicin idarubicin mitomycin mitoxantrone paclitaxel trabectedin vinblastine vincristine vincristine liposomalc vindesine vinflunine vinorelbine
High-Risk Irritants
Low-Risk Irritants
bendamustine busulfan cisplatina dacarbazine daunorubicin liposomalc dexrazoxane docetaxel doxorubicin liposomalc (pegylated/ nonpegylated) melphalan oxaliplatin paclitaxel albumin-bound streptozocin trastuzumab emtansine treosulfan
arsenic trioxide cabazitaxel carboplatinb etoposideb etoposide phosphate fluorouracilb fotemustine gemcitabine ifosfamide irinotecan irinotecan liposomalc ixabepilone topotecan
Non-Irritant aflibercept aldesleukin asparaginase azacitidine bleomycin bortezomib brentuximab vedotin carfilzomib cladribine clofarabine crisantaspase cyclophosphamide cytarabine eribulin fludarabine gemtuzumab ozogamicin inotuzumab ozogamicin methotrexate monoclonal antibodies (non-conjugated) nelarabine pegasparaginase pemetrexed pentostatin raltitrexed temsirolimus thiotepa
a
Cisplatin: concentrations of above 0.4 mg/mL are classified as vesicant.
b
High concentrations of carboplatin (≥5 mg/mL), etoposide (≥10 mg/mL) or fluorouracil are associated with a greater risk for tissue damage.
c
Liposomal formulations have a lower risk for causing tissue damage, but little information exists.
capability, she said. Based on data from eight reference documents (guidelines, databases and reference papers), the working group classified various antineoplastic drugs based on their risk for tissue damage, Dr. Albert-Marí said (Table 1). see EXTRAVASATION, page 10
Table 2. Recommended Extravasation Treatment Guidelines (Peripheral Routea) Nonpharmacologic Measures Apply local dry cold compresses (dry cold packs, refrigerated saline bags, or closed bags filled with water to 0°Celsius) as much as tolerated for erythema relief • For LRIs: apply topically for first hour • For vesicants and HRIs: apply for first hour as much as tolerated and then in cycles of 15-20 min 3-4 times daily for 2 to 3 d • Do not apply directly to skin; loss of sensitivity can facilitate cold burns; remove in case of burning sensation, pruritus, or increasing pain • Contraindications: epipodophyllotoxins, hyaluronidase, and vinca alkaloids Apply local dry heat compresses (dry heat packs, electric pads, steam-free iron-heated cloths) • Recommended for vinca alkaloids, etoposide and oxaliplatin; exception: liposomal vincristine • Apply topically for 15-20 min 3-4 times daily for 2 d • Do not apply directly to skin; loss of sensitivity in the area can facilitate burns; remove in case of burning sensation, pruritus, or increasing pain • Contraindications: anthracyclines, bleomycin, carmustine and cisplatin Photoprotection for photosynthesizing drugs, such as cisplatin, dacarbazine, fluorouracil, and mitomycin • Wear long sleeves and avoid sun exposure; do not use OTC creams Pharmacologic Measures Apply 99% DMSO to gauze and cover the affected area • Recommended for amsacrine, conventional anthracyclines, dactinomycin, mitomycin, mitoxantrone, carboplatin (C>5 mg/mL), cisplatin (C>0.4 mg/mL or V>20 mL), fluorouracil (high C caused by infusion error, or V>20 mL) • Apply two 4-cm2 drops of DMSO to 7.5-cm2 gauze and cover the affected area; allow to air-dry 15-20 min and remove; repeat 3-4 times daily for at least 7 d (preferably 14 d) • Avoid applying pressure or bandages • Reduce application times if itching or intolerance occurs • Apply on dry and intact skin because an exothermic reaction can happen with water • Contraindications: not recommended for extravasation of liposomal anthracyclines Administer subcutaneous hyaluronidase around the periphery of the affected area • Recommended for vinca alkaloids, docetaxel, paclitaxel, etoposide (C>10 mg/mL or volume >20 mL); exception: liposomal vincristine • Administer in subcutaneous punctures (25-gauge needle), around the periphery of the affected area, according to the concentration used: –1,500 IU/mL for punctures of 0.1-0.2 mL –150 IU/mL for punctures of 0.2-0.5 mL • Maximum dose: 1,500 IU, usually 5-6 punctures • Administer heat 30 min after hyaluronidase, if needed • Reconstitute formulation of 150 and 1,500 IU with 1 mL • Administration can cause pain; analgesic may be needed Intravenous dexrazoxane for 1 or 2 h within the first 6 h after extravasation for 3 consecutive days • Days 1 and 2: 1,000 mg/m2 (maximum dose, 2,000 mg) • Day 3: 500 mg/m2 (maximum dose, 1,000 mg) • Administer once daily through a large vein located in the contralateral affected arm; if creatinine clearance is >40 mL/min, administer 50% of the dose • Monitor renal, hepatic, and hematologic function; availability depends on institutional or corresponding PTC approval • Contraindicated with simultaneous DMSO and cold; not recommended for use with liposomal anthracyclines • If institutional or PTC approved, dexrazoxane can be used in central or severe extravasation by peripheral route (eg, large volume and concentrated solution) a For treating extravasations via the central route, as well as special situations, see an expanded version online at www.pharmacypracticenews.com.
C, concentration; DMSO, dimethyl sulfoxide; HRIs, high-risk irritants; LRIs, low-risk irritants; OTC, over-the-counter; PTC, percutaneous transhepatic cholangiography; V, volume
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8 Clinical
Pharmacy Practice News • April 2022
Oncology
Pharmacokinetics May Help Optimize Dosing of ICIs By Gina Shaw
F
lat and extended-interval dosing of some immune checkpoint inhibitor (ICI) drugs can be used in certain circumstances based on their efficacy and safety, but more studies are needed to determine whether lower doses are effective for achieving similar outcomes, an expert noted during a session at the International Society of Oncology Pharmacy Practitioners (ISOPP) 2022
Virtual Symposium. Currently approved ICIs fall into three categories based on the immune checkpoints they target: • Cytotoxic T lymphocyte-associated protein 4 (CTLA-4): ipilimumab (Yervoy, Bristol Myers Squibb) • Programmed cell death protein 1 (PD-1): nivolumab (Opdivo, Bristol Myers Squibb), pembrolizumab (Keytruda, Merck), cemiplimab
(Libtayo, Sanofi), dostarlimab (Jemperli, GlaxoSmithKline) • Programmed death-ligand 1 (PD-L1): atezolizumab (Tecentriq, Roche), avelumab (Bavencio, Merck/Pfizer), durvalumab (Imfinzi, MedImmune/ AstraZeneca) “As pharmacists, we really care about whether the dose of a drug correlates with efficacy and toxicity,” said Alison Palumbo, PharmD, a clinical oncology
pharmacist at Oregon Health & Science University, in Portland. “Ipilimumab is unique among these drugs in that its dosing does correlate with safety and efficacy. At a higher dose, you get more toxicities, but the drug is also more effective. That’s not necessarily the case with the PD-1 and PDL-1 inhibitors. A higher dose is typically not associated with more toxicities, but also, once you give enough of the drug to achieve a response, more
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of the drug isn’t necessarily going to be more effective. Cemiplimab and dostarlimab are the new kids on the block, so there is not a lot of data yet on their exposure-efficacy and exposure-safety relationships. But similar to the other PD-1s and PDL-1s, there doesn’t appear to be a correlation.”
Yet Another COVID-19 Effect The COVID-19 pandemic has brought on another key consideration when dosing ICIs. Because ICIs are the backbone of therapy for the majority of patients with advanced lung cancer in the absence of actionable driver mutations, and since cancer patients also are particularly vulnerable to COVID-19 complications (Cancer Treat Res Commun 2021;26:100285. Epub 2020 Dec 13), extended dosing intervals represented an opportunity to limit these patients’ exposure to potentially risky healthcare settings, Dr. Palumbo noted. Extended-interval flat dosing of nivolumab had already paved the way for this option. In 2018, the FDA approved a supplemental biologics license application (BLA) updating the nivolumab dosing schedule to include 480 mg infused every four weeks for a majority of approved indications. “Modeling studies compared data from 3,817 patients from clinical trials across tumor types and found that the exposure end points were very similar
Clinical
Pharmacy Practice News • April 2022
9
Oncology among patients receiving 3 mg/kg every two weeks, 240 mg every two weeks or 480 mg every four weeks,” Dr. Palumbo said. (Ann Oncol 2018;29[11]:2208-2213; Front Oncol 2020;10:1193). A pharmacokinetics modeling study yielded similar data for pembrolizumab, with established exposure-response relationships showing that clinical efficacy and safety of 400 mg every six weeks would be similar to the previously approved 200 mg and 2 mg/kg everythree-week dosing across tumor types (Eur J Cancer 2020;131:68-75).
‘As pharmacists, we really care about whether the dose of a drug correlates with efficacy and toxicity.’ —Alison Palumbo, PharmD
qualified for intermittent dosing. With a median follow-up of 48 weeks, only one patient restarted therapy. The four remaining patients had a sustained response for a median of 34 weeks
off therapy, and no patient developed progressive disease while off therapy (J Immunother Cancer 2019;7[1]:127). “This is the first bit of evidence to suggest that intermittent dosing may be
an option with nivolumab, that maybe we can give these patients a break,” Dr. Palumbo said. “Of course, this needs to be a conversation between the patient and the oncologist, because we can’t say they aren’t going to progress, and larger trials are obviously needed. Studies are underway to see if we can eventually do intermittent dosing with PDL-1 and PD-1 inhibitors, so stay tuned.” Dr. Palumbo reported a consultantship for The Dedham Group and Oncology Reimbursement Management.
Alison Palumbo, PharmD
FDA Approves Modified Dosing In 2020, yet another variable in ICI medication management was introduced when the FDA approved two modified dosing regimens for ICIs: • Pembrolizumab: 400 mg every six weeks, as an alternative to its originally approved dosing schedule of 200 mg every three weeks. • Durvalumab: a fixed dose of 1,500 mg every four weeks in unresectable stage III non-small cell lung cancer, as an alternative to its originally approved dosing schedule of 10 mg/kg every two weeks. Dr. Palumbo offered some perspective on the FDA’s actions. “Durvalumab was initially approved [in February 2018] at 10 mg/kg every two weeks in non-small cell lung cancer and bladder cancer,” she said. “Then, it was studied and approved [in March 2020] at a 1,500 mg flat dose every four weeks in extensive-stage small cell lung cancer, so the FDA elected to approve that dosing in all indications.” Some small studies also have suggested intermittent ICI dosing regimens are safe and effective, Dr. Palumbo noted. A 2019 study of 14 patients with metastatic renal cell cancer included an initial 12-week nivolumab treatment arm, after which patients who achieved 10% or greater tumor burden reduction entered a treatment-free observation phase, with reimaging every 12 weeks. Five (36%) of the patients
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10 Clinical
Pharmacy Practice News • April 2022
Oncology
EXTRAVASATION continued from page 6
She cited the following categories: • Non-irritant: antineoplastics with no tissue aggression potential. They do not normally cause irritation when extravasated. • Low-risk irritant: antineoplastics that can cause local irritation that may be associated with pain, a burning sensation or pressure, with or without signs of local inflammation and phlebitis,
both at the injection site and along the vein. Necrosis or ulceration do not develop in most cases. • High-risk irritant: antineoplastics that can cause damage associated with LRI drugs, with confirmed cases of lesions compatible with vesicant damage. • Vesicant: antineoplastics that may cause local or extensive tissue necrosis, with or without ulceration, and complete loss of skin thickness and underlying structures.
Route Is Key to Treatment The best strategy to manage extravasation is prevention; however, if extravasation occurs, the group created treatment guidelines based on its review of the literature. For extravasation via the peripheral route, the group recommended both nonpharmacologic and pharmacologic measures. The group’s recommendations for extravasation through the central route are based in part on how deep the extravasation occurs. Extravasation at the surface level or in the subcutaneous tissue
can be managed as peripheral extravasation, according to the recommendations. In contrast, if the extravasation is in deep tissues, a thoracic surgeon must assess drainage and management. For more details on treating extravasations via the peripheral route, see Table 2, page 16. For extravasations involving the central route, as well as special situations, such as extravasation of a binary/tertiary mixture or during Y-site administration, see expanded treatment Tables at www.pharmacypracticenews.com.
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The group stressed that some steps need to be taken immediately following all extravasations, regardless of the cause or route: • immediately stop the infusion; • disconnect and remove the administration/infusion system, but do not remove the cannula; • immobilize the affected limb; • aspirate the residual liquid gently (10-mL syringe) through the cannula. If blisters are present, remove contents (using 1-mL syringe and a 25-G needle); • notify the rest of the interdisciplinary team for evaluation/assessment; • remove the peripheral IV line and apply hygiene measures; • for central line extravasation, consult the corresponding surgeon; • avoid applying pressure in the extravasated area; • locate the extravasation kit; • apply as soon as possible the specific non-pharmacological and/or pharmacological treatment recommended for each antineoplastic; • keep affected limb elevated above the heart; • if needed, administer the remaining dose by another line and by the other extremity; • if necessary, administer analgesics prescribed; • inform or provide written instructions of treatment to patients; • assess and document the incident in healthcare records and document variables related with extravasation in the registration form/information system; • schedule follow-up appointments with the patient to follow evolution of symptoms. In case of worsening/ persistence of symptoms/signs, contact the oncologist to consider treatment and referral to corresponding surgeon; • if extravasation progresses or presents necrosis, there are no uniform guidelines for the surgical management. Dr. Albert-Marí reported no relevant financial disclosures.
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Clinical
Pharmacy Practice News • April 2022
11
Oncology
NIGERIA continued from page 4
them help you,” Dr. O’Bryant said. “As a result, people are not getting proactive care and are coming into the healthcare facility with quite advanced disease.” Even if patients are able to get funding and treatment, the pipeline of generic medication from wholesalers in India and China is not always reliable, Dr. Harvey said. The country also needs to invest heavily in equipment, including basics such as hoods, to ensure chemotherapy is made safely and correctly, and a reliable communication system among healthcare professionals, Dr. Harvey said. “If a patient is treated in the north and then comes to Lagos for treatment, there’s no way to transfer records,” he said. “There’s no way to tell what happened.”
Staffing Shortages Perhaps the biggest challenge Dr. Harvey identified is a severe shortage of healthcare professionals, caused in large part by a “brain drain” over the past few years. “Nigeria has a very good education system, but I think what happens is sometimes particularly good people look up and say, ‘I can’t really practice in the way I want to unless I leave this country,’” he said. “I think
Project Pink Blue
P
roject Pink Blue is a nongovernmental organization in Nigeria focused on cancer awareness; providing support to cancer patients; and fundraising for cancer patients, cancer research, oncology training and psychological support. Its goals, according to the website, are: • to change the way Africans think about cancer by demystifying cancer through community outreach and audio-visual strategies that are culturally relevant and socially acceptable; • to phase out late/advanced diagnosis of cancer through the provision of cancer screenings; • to provide cancer support programs for poor, rural and hard-toreach communities; • to advocate for people battling cancer and provide psychological support through cancer care navigation; and • to stimulate cancer research and advocacy as a central measure for cancer control in Nigeria and Africa. Source: projectpinkblue.org/who-we-are
that is something very challenging for them, and they’re going to have to have a significant investment from the government to prevent that.”
‘I’ve Done My Job’ Those who do stay are passionate, capable and eager to learn and to improve, both pharmacists said. “Those pharmacists were coming from all parts of the country; many of them paid out of their own pocket in various ways. So, I was amazed by the general enthusiasm and work ethic of the people to help
change, and the leadership of Project Pink Blue to help that happen was certainly there,” Dr. Harvey said. Dr. O’Bryant encouraged American pharmacists to offer their time and expertise to help other developing nations improve healthcare. That can be as simple as working with organizations or missions to distribute leftover medications in the United States to countries where they’re needed, she said. She noted that working in Nigeria with Project Pink Blue reminded her to be thankful for what is available for
patients and caregivers in the United States—and for the opportunituy to share her expertise. “If this trip helps one patient who has cancer somewhere in the world, if we’ve improved their side effects because we trained a pharmacist to better manage their medications, or we’ve improved their care because the pharmacist we trained was able to get a more appropriate medication for this patient, then I’ve done my job.” The sources reported no relevant financial disclosures.
12 Clinical
Pharmacy Practice News • April 2022
Medication Safety
One Error, One Journal Article, One Movement Toward Medication Safety By Marie Rosenthal
I
f you think it’s not possible to make a difference as one pharmacist, consider the story of Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, who was “just” a hospital pharmacist when he wrote about one medication error and turned that article into a movement dedicated to improving medication safety for all patients. Mr. Cohen is stepping back as the president of the Institute for Safe Medication Practices (ISMP), an organization that he founded almost 30 years ago. ISMP is now a leader in helping to prevent medication errors, not just in the United States but globally. Mr. Cohen and ISMP are called upon by hospitals, agencies like the FDA and even pharmaceutical and device companies to investigate medication errors or, more importantly, to provide solutions to prevent them.
ISMP’s Origin Story It all began in 1974, when he and his first collaborator, Neil M. Davis, PharmD, heard about a patient who had died from an overdose of insulin at a local hospital. Both men were pharmacists at Temple University Hospital, in Philadelphia, and were discussing the incident, when Dr. Davis suggested Mr. Cohen write it up as a cautionary tale for the journal Hospital Pharmacy, which Dr. Davis edited at the time (1975;10[3]).
The positive response led to a column about errors, which was based on real cases. “When we published information those first few months, we heard from pharmacists from all over the country, and out of complete altruism, they were willing to share information,” Mr. Cohen said, as long as he did not identify the individuals or the organization involved. “In fact, we’ve never done that in all the years we’ve been doing this work.” Withholding identities in the reports was important, because talking about medication errors in the 1970s was just not done, according to Mr. Cohen. Although the pharmacists and nurses appreciated the alerts, the C-suite would have preferred they remained silent. “People were kind of upset with us at first, so we didn’t know what was going to happen as we moved along,” Mr. Cohen admitted. “Pharmacists certainly got it. They saw these things happening in their own practice, and I think a lot of nurses did, too, but those in some leadership circles were upset that we were talking about very serious harms that could come to patients from medical errors,” and they thought that could scare patients away from care, he said. Dr. Cohen and his colleagues continued their efforts with a book, “Medication Errors: Causes and Preventions,” published in 1981 by G.F. Stickley Co. “It got a lot of publicity, and that brought us even more reports [of medication errors],
A Just Culture
O
ne of the important tenets of the Institute for Safe Medication Practices (ISMP) is encouraging people to come forward and report errors. To do that, the focus needs to be on fixing and preventing the error from occurring again, rather than focusing on blame and punishment. The idea is to form a just culture, explained Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, the president emeritus of ISMP. “We subscribe to a just culture, and that isn’t necessary blame-free. There are some situations that cross over into reckless behavior.” Reckless behavior “truly should never happen, because we know better,” like taking shortcuts even though you are well aware that behavior can sometimes lead to patient harm, Mr. Cohen explained. But once a behavior is noticed, the organization can work to correct and change that behavior, he said. ISMP, however, analyzes the systems that healthcare workers use to see whether there is a better way to encourage safety. “Our work from the very start has been identifying the system-based causes of medication errors. We’ve never really focused blame on individuals when errors happen,” Mr. Cohen explained. “We are looking at the systems that literally set people up for making a medication error and identifying what they are.” In many cases, it is product related, he said (products with similar names and dosing, labeling issues, etc.). “So, those are the things that we focused on over the years and working with individuals, as well as organizations, hospitals, community, pharmacies, etc., and trying to work with drug companies and the Food and Drug Administration and regulators to make corrections that hopefully will not set people up for making errors. “That’s what it’s been about for us, and from the very beginning, we were not focusing on blame,” he said. —M.R.
Michael R. Cohen, RPh, MS, FASHP (second from right), was invited to the White House to discuss medication safety issues with former President Bill Clinton around the time the famous IOM report, “To Err is Human,” was released.
and then Dr. Davis and I started getting requests to go to state pharmacy meetings and give talks. We were thrilled to be able to do that, to share our information.”
The FDA Takes Notice People outside of pharmacy began to take notice, and by the late 1980s, the FDA asked to meet to discuss productrelated medication errors, and the agency formed the labeling and nomenclature committee. Mr. Cohen and Dr. Davis realized that this “could be a full-time operation,” said Mr. Cohen, who was then an assistant director of pharmacy at Temple. They sought help and received it initially from USP, and established a national reporting program. By the time ISMP was founded, Dr. Davis was retiring, and medication safety was becoming Mr. Cohen’s entire focus, but to call it a full-time job would be a gross understatement. For Mr. Cohen, it was a calling, a mission, a passion—one he is stepping away from, but not leaving completely, he told Pharmacy Practice News. “Why did I decide to retire? Well, I am not retired completely,” he admitted. “I couldn’t do it. This work is just amazing. It’s enjoyable to be in a position to help colleagues around the country, and to work with the kind of staff that we have at ISMP. “How can you just stop?” he asked, but admitted there were many activities he enjoyed outside of pharmacy that he wanted to start doing, including spending more time with his grandchildren. “I’m in my upper 70s, I hate to say that, and it’s time that I tried to enjoy life a little, too, so I’m trying to get a nice mix,” he said. “But so far, it hasn’t quite
worked out that way,” he joked, adding that he’s still working but finding time to grow orchids, play golf and travel as COVID-19 abates. Dr. Davis retired as ISMP was kicking off, and Mr. Cohen put together a board of trustees with the help of Allen Vaida, PharmD, FASHP, who retired in 2021 as the executive vice president of ISMP. At first, Mr. Cohen had no idea that those first couple of articles would be his life’s work, but by the time they were registered as a nonprofit in 1994, “I think we did have a premonition that this could turn into something big, and of course over time, with the help of organizations like ASHP that helped us get the word out, the Food and Drug Administration, USP and quite a few others, it really grew into something that has had a major impact on productand practice-related issues.”
Another Landmark: Medication Safety Self Assessments One program, the ISMP Medication Safety Self Assessments, is a shining example of how ISMP helps medical professionals. The self-assessments allow professionals in various healthcare settings to assess their practices and processes related to medication use. They are meant to be completed by an interdisciplinary team that includes front-line staff and management. The first assessment evaluated acute care and was done with support from the American Hospital Association. It had almost 200 characteristics of a safe drug distribution system in hospitals, and was released about the same time that the former Institute of Medicine (IOM; now the National Academy of Medicine) issued its famous report “To
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Pharmacy Practice News • April 2022
13
Medication Safety I believe there has been a vast improvement in patient safety over the years, thanks to medication safety.”
ECRI Helps ISMP Become A Global Presence
Michael R. Cohen, RPh, MS, FASHP, still takes every medication error report seriously. Here he discusses labeling with an ISMP staff member.
‘Mike Cohen is like the grandfather of medication safety. He created this field basically, and no one will ever be able to fill his shoes.’ —Rita Jew, PharmD, MBA, BCCPPS, FASHP Err is Human,” about medical errors. In addition to being on a national call about the IOM report, Mr. Cohen and his colleagues were invited to the White House to meet former President Bill Clinton. “President Clinton greeted us, and we had a roundtable in the cabinet room, and then went out to the Rose Garden and met with the press,” he said. “That was pretty thrilling for me, a hospital pharmacist.” The self-assessments gave hospitals an opportunity to really look at their operations, and a guide to work on not only medication safety but also other patient safety issues and to compare themselves with other hospitals around the country. The assessments are sponsored by agencies such as the FDA and the Agency for Healthcare Research and Quality or private foundations such as the Commonwealth Fund. Currently, ISMP is working on a perioperative medication safety assessment, which was sponsored by the FDA. Many of the assessments become guidance statements.
Technology Helps, But Not Foolproof Many technological changes have greatly improved patient safety, Mr. Cohen said. For instance, electronic prescribing was really helpful because the old joke about a doctor’s poor handwriting was no joke. Some prescriptions were nearly impossible to read. However, just having electronic prescribing doesn’t preclude the occurrence of
errors, he reminded. There are computer selection errors, similar drug names or dosing issues. “Without a doubt, electronic prescribing has been really helpful, but I do want to mention a caveat, and that is when we had handwriting problems, if you had trouble reading an order, you could call the doctor or the prescriber [and find out what should be dispensed],” he said. “I think we’ve made great improvements, and it is largely due to getting the information out there and having individuals and organizations who take this seriously. We’ve set up safety committees. We’ve developed technologies. We have barcoding and electronic prescribing now that we didn’t have 20, 30 years ago.” There have been improvements with labeling, such as tall man lettering, changes and standards set by USP and other accrediting bodies, and work in the FDA and other federal agencies that has improved patient safety. ISMP has been working alongside many of them, gathering information and disseminating it to others. “We also take the opportunity to publicize [the issues] in our various columns and journals and newsletters. Pharmacy Practice News has been a tremendous [source of support] in helping us get the word out on so many of the major issues,” Mr. Cohen said. “The culture of safety has changed dramatically. There are still problems out there, and there are still improvements to be made for sure,” he said. “But
In 2019, ISMP became an affiliate of ECRI (formerly the ECRI Institute of Emergency Care Research Institute), which bolstered the ability for both organizations to make medication, medical devices and healthcare practice settings safer for patients. The affiliation made ISMP the largest nonprofit organization dedicated to patient safety in the world, a crowning achievement for a man who graduated with a Bachelor of Science degree in Pharmacy in 1968 from Temple University School of Pharmacy. Mr. Cohen would go on to receive a Master of Science in Pharmacy, also from Temple, as well as honorary doctorates from Thomas Jefferson University, the University of the Sciences in Philadelphia, Long Island University and the University of Maryland. He also received the John M. Eisenberg Patient Safety and Quality Award from the National Quality Forum and the Joint Commission, the Harvey A.K. Whitney Award from ASHP, and was recognized as a MacArthur Fellow by the John D. and Catherine T. MacArthur Foundation. But anyone who spends any time with Mr. Cohen quickly realizes that these honors have not gone to his head, that he is quick to list all the people who have helped him and his organization improve the safety of medical care, and that he is truly honored by the opportunity to help others and to share what he has learned with them. “Mike Cohen is like the grandfather of medication safety. He created this field basically, and no one will ever be able
to fill his shoes,” said Rita Jew, PharmD, MBA, BCCPPS, FASHP, who recently assumed the role as the president at ISMP. And just like a grandfather, unsolicited, Mr. Cohen made a point of bragging about her qualifications: “I have great confidence in the person who’s following me, and that’s Dr. Rita Jew. She is sharp about technology. She is great management-wise, having graduated from the Wharton School with an MBA as well as a PharmD. She has a great background in patient safety. “I’ve known Rita for years, and I think she’s going to do a fantastic job as president of ISMP.” Dr. Jew said she is grateful for his confidence as well as humbled by the task ahead. “It will take me a long time to even get to the point where I can feel like I can represent some of what Mike has represented in the past. “It will be a lot of on-the-job training,” she joked, adding that she was grateful he is still there to offer advice. But the best advice she has received is watching him work and working alongside him. “He never directly sat down and said, ‘Hey, Rita, this is my advice for you.’ But over the year I’ve worked at ISMP ... it is really his example [that has inspired me], the way he handles things, that is really the advice I’ve taken in,” she said. “Watching how he takes every single medication error that is reported seriously, and deliberates [the issues]—it’s just his passion,” Dr. Jew said. “I’ve learned a lot over the years from Mike, and I just continue to do so. Every single conversation I have had with him is sound advice that I can take on and keep doing this job.” The sources reported no relevant financial disclosures.
Michael R. Cohen, RPh, MS, FASHP (far right) talks with hospital staff about preventing medication errors.
14 Clinical
Pharmacy Practice News • April 2022
Practice Models
Test-to-Treat continued from page 1
risky,” the group noted. The clinics “typically treat simple illnesses such as strep throat. Yet, COVID-19 is a complex disease and there are many issues to consider when prescribing COVID-19 antiviral medications. Leaving prescribing decisions this complex in the hands of people without knowledge of a patient’s medical history is dangerous in practice and precedent.”
with these antivirals, and that predates the test-to-treat program.” The test-to-treat initiative, which launched in hundreds of pharmacy-based clinics across the United States during the week of March 7, 2022, offers immediate access to the COVID-19 antiviral pills nirmatrelvir plus ritonavir (Paxlovid, Pfizer) and molnupiravir (Merck/ Ridgeback) for people who test positive for the virus. The initial rollout focused on large retail chains that offer on-site healthcare services, such as CVS Minute Clinics. “I’m 100% confident that the
Michael Ganio, PharmD, the senior director for pharmacy practice and quality at ASHP, disagreed with that characterization. “Pharmacists are the most qualified healthcare professionals to review DDIs [drug-drug interactions], make dose adjustments and navigate a patient’s medical history,” Dr. Ganio said. “That is literally what we do all day, collaborating regularly with an interdisciplinary team. In fact, our members are frequently being consulted by physicians who are not comfortable with managing all the DDIs associated
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skills and the training of the pharmacists in these clinics are well suited to manage these medications, identify drug-drug interactions and contraindications, and consult with a patient’s physician when appropriate,” Dr. Ganio said. He noted that additional sites, including ambulatory care and retail pharmacies affiliated with hospitals and health systems, will be added to the program in the coming weeks and months as supplies of the antivirals are made available from both federal and state resources. “There’s a reason why brick-and-mortar pharmacies are the places that have done so much of the COVID-19 testing and vaccinations,” said Jeff Little, PharmD, the chair of ASHP’s Section of Pharmacy Practice Leaders. “It’s because pharmacists are the most accessible healthcare professionals, and we’re also the medication experts and the profession that is best suited to deal with complicated [DDIs].” The AMA’s statement sparked controversy on social media, including comments from several doctors who disagreed with the organization’s stance. “It’s offensive that the AMA chose Biden’s Test-to-Treat COVID-19 plan as an opportunity to double down on their ‘scope creep’ messaging and to take a swipe at pharmacists, when in fact, it’s pharmacists that are *the* experts on drug-drug interactions,” tweeted emergency physician Uché Blackstock, MD, a former associate professor of emergency medicine at NYU Grossman School of Medicine, in New York City, and the founder and CEO of Advancing Health Equity. “I can’t even share the number of times that pharmacists have called the ER to tell us that one of our physicians had prescribed a medication that could have had a potentially dangerous interaction with another medication a patient was taking and helped us to find a substitute.” “I trust PharmDs to manage routine Paxlovid drug interactions, & to get MDs involved for tough calls (?stop a med while taking Pax?),” tweeted Bob Wachter, MD, the chair of the Department of Medicine at the University of California, San Francisco School of Medicine. “Your plan (Rx by MDs only) will markedly limit/delay access to key Covid med.”
EUAs Getting in the Way? Regulatory barriers already exist that prohibit pharmacists from taking a leading role in making test-to-treat a success, according to ASHP. Both nirmatrelvir plus ritonavir and molnupiravir currently are available under an emergency use authorization (EUA) that specifically limits prescribing authority to physicians, nurse practitioners (NPs) and physician assistants (PAs)—and excludes pharmacists, despite the fact that many states license pharmacists to order medications, either independently or in collaboration with a physician. Therefore,
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Pharmacy Practice News • April 2022
15
Practice Models only pharmacies that have prescribing authorities on site can participate in the program. Leading pharmacy organizations are responding by calling for changes to the EUA to permit pharmacists to provide increased access to treatment in locations where access to physicians is limited. In a March 9 letter to President Biden, ASHP and 13 other pharmacy groups called for the removal of these restrictions, noting that in September 2021, the Department of Health and Human Services authorized pharmacists in all 50 states to order oral treatments for COVID-19. “Unfortunately, the FDA’s limitation undermines the intent of your announcement and patient access to pharmacies as a one-stop shop for COVID-19 testing and treatment with antivirals. This limitation is also inconsistent with FDA’s normally providerneutral prescriber directives in approval and EUA decisions,” the letter stated.
do not have a physician or NP/PA on site. Many pharmacies have been offering testing at their locations throughout the pandemic, and this is just a natural extension. If the test is positive, the next logical step is for the pharmacist to look up the patient profile, make sure there aren’t any DDIs or contraindications, and give the patient immediate access to the medication they need.” Dr. Mahoney acknowledged that there are justified concerns from community pharmacists about understaffing issues, given the increased demand
on pharmacies. “There were staffing issues even prior to the pandemic, and testing and dispensing takes time,” she said. “We need to make sure that there is adequate staffing to support these pharmacies and that whatever dispensing fee is available covers those costs, so that more of our community pharmacy colleagues can provide these therapies without unduly burdening them.” Dr. Little echoed the workforce concerns. “The healthcare system has probably never been more strained than it is right now, and we need to do whatever
we can do to get patients more access to these treatments—not less,” he said. “Pharmacists are very well positioned to provide these therapies to patients. In fact, in hospitals and health systems, we are usually the go-to people to manage medication order sets and therapy plans. Anything we can do as a healthcare system to increase access to care is something we need to do.” Drs. Ganio and Little reported no relevant financial disclosures. Dr. Mahoney reported a financial relationship with Merck.
F U N G I T E LL STAT
Cut Out of the Equation When the Public Readiness and Emergency Preparedness Act was passed in September 2021, it specifically expanded the scope of authority for licensed pharmacists to order and administer oral, intramuscular and subcutaneous COVID-19 therapeutics. “But then, when the FDA issued the EUAs for these agents in December 2021 for molnupiravir, they disallowed pharmacists from being able to order them,” Dr. Little said. Restricting oral antiviral prescribing to physicians, NPs and PAs will significantly limit the number of locations where patients can receive these drugs on the spot, the organizations noted, pointing out that many pharmacies do not have in-house non-pharmacist prescribers. This burden is likely to fall disproportionately on rural and underserved communities, the letter added. “Approximately 90% of Americans live within five miles of a pharmacy, and that can’t be said with regard to primary care physicians or other healthcare providers,” said Monica Mahoney, PharmD, a clinical pharmacy specialist in infectious diseases at Beth Israel Deaconess Medical Center, in Boston, who noted that she spoke on her own behalf as a pharmacist and not as a representative of her institution. “If pharmacists were given the authorization to prescribe these antivirals, either as part of a collaborative practice agreement or in states where we are recognized as independent prescribers, that would vastly improve access to test-to-treat.” Most independent pharmacies in small towns and rural areas are trusted members of their communities and have excellent relationships with their patients, which facilitates communication and encourages testing and treatment, Dr. Mahoney said. “But they often
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16 Clinical
Pharmacy Practice News • April 2022
Pediatrics
Navigating Biosimilars continued from page 1
they did. In 2003, the Pediatric Research Equity Act required manufacturers to assess pediatric-specific dosage forms, dosing regimens, routes of administration and active ingredients when submitting a New Drug or Biologics Product Application, Dr. Jacob noted in a session at the 2021 annual meeting of the American College of Clinical Pharmacy (ACCP). Nevertheless, “the data for biosimilars in pediatrics is still limited,” said Dr.
Jacob, who is also a clinical pharmacy faculty member at the Mount Sinai Hospital, in New York City. These limitations behoove pediatric pharmacists to “become experts on each of the medications and the biosimilars for use in their pediatric populations, and to serve as a source of knowledge for physician specialists, nurses and anybody else on the care team that is going to be involved in use of these medications,”
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Biosimilar
Adalimumab
• Reference product (Humira, AbbVie) approved for JIA (age ≥2 years), pediatric Crohn’s disease (age ≥6 years), uveitis (age ≥2 years), hidradenitis suppurativa (age ≥12 years) and UC (age ≥5 years) • Six biosimilars available • Biosimilar pediatric approvals only for JIA (age ≥4 years); other indications under orphan drug exclusivity • Limited biosimilar pediatric literature, with one study revealing safety and efficacy in JIA
Epoetin alfa
• Pediatric approval for anemia due to CKD in patients on dialysis and not on dialysis (age 1 month to 16 years), anemia due to zidovudine in patients with HIV infection (age 8 months to 17 years), and anemia due to concomitant myelosuppressive chemotherapy • One biosimilar available, approved for these indications based on extrapolation of reference biologic (Epogen, Amgen) data • No pediatric studies of biosimilar
Etanercept
• Reference product (Enbrel, Amgen) and biosimilar approval for polyarticular JIA (age ≥2 years) and plaque psoriasis (age ≥4 years) • Two biosimilars approved • One study showed no difference in safety and efficacy in JIA
Filgrastim
• Reference product (Neupogen, Amgen) approved for PN, mobilization of autologous hematopoietic progenitor cell and HARS • Three biosimilars available, all approved for all indications, except HARS, which is under reference drug exclusivity • Minimal pediatric literature on biosimilars, but data showed safety and efficacy in mobilizing peripheral blood stem cells and for prophylaxis of CIN
Infliximab
• Four available biosimilars • All approved for pediatric IBD (age ≥6 years) • Pediatric infliximab biosimilar studies primarily in CT-P13a for IBD • No outcomes differences between reference product (Remicade, Janssen) and CT-P13 in IBD • No data on multiple switches among biosimilars and reference drug or various biosimilars in pediatric IBD patients
Pegfilgrastim
• Reference product (Neulasta, Amgen) approved for pediatric CIN and HARS • Three available biosimilars • HARS indication under orphan drug exclusivity until November 2022 • No biosimilar studies in pediatric patients
Rituximab
• Reference product (Rituxan, Genentech) approved for PGP and MP (age ≥2 years) • Three available biosimilars • Reference biologic has market exclusivity for pediatric indications until 2026
CT-P13 is an investigational biosimilar; see bit.ly/35qSv0Q for more information.
CIN, chemotherapy-induced neutropenia; CKD, chronic kidney disease; HARS, hematopoietic acute radiation syndrome; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; MP, microscopic polyangiitis; PGP, pediatric granulomatosis with polyangiitis; PN, pediatric neutropenia; UC, ulcerative colitis Source: Elsen Jacob, PharmD. Adapted from presentation at the 2021 annual meeting of the American College of Clinical Pharmacy.
Clinical
Pharmacy Practice News • April 2022
17
Pediatrics and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently with biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient-years was comparable before (26.4) and after (32.1) the switch. Sara Hovey, PharmD, a pediatric clinical pharmacy specialist at Rush University Medical Center, in Chicago, said during the ACCP meeting session.
When to Switch When it comes to deciding whether to switch from a reference biologic to a biosimilar, it is critical to consider not only clinical data but logistical and operational angles as well, Dr. Hovey said. “For example, if there are differences between a biosimilar and its reference biologics in the approved indications, pulling data on your institution’s usage and seeing what indications you use the medication for most often can help determine which drug to add to your formulary.” Adalimumab is one drug for which indications between the reference biologic and biosimilars differ, she noted. While adalimumab biosimilars have pediatric approvals only for juvenile idiopathic arthritis (ages ≥4 years), the reference biologic (Humira, AbbVie) has exclusive approval for a number of additional pediatric indications, including Crohn’s disease (Table). In this case, if the agent is used in a hospital primarily for pediatric patients with Crohn’s disease, staying with the reference product may make more sense, Dr. Hovey noted. Other considerations may make a switch from a reference biologic to a biosimilar less straightforward, she said. For example, variations in dilution and stability between biosimilars and reference biologics can affect how they are prepared in the pharmacy. “Particularly in our pediatric population, a lot of the dilution and stability information comes from post-marketing studies of reference biologics,” Dr. Hovey said. “Because minor differences in the formulations and in the molecules between biologics and biosimilars could affect stability, those post-marketing biologics data may not always be applicable to biosimilars.” In terms of the cost savings associated with a biosimilar implementation switch, institutions should consider a number of factors before concluding that direct savings on a drug makes a switch worthwhile. For example, pharmacists should consider how much work is needed to revise electronic order sets. “Think about how many different order sets include the drug and how many IT [information technology] and clinical pharmacist
hours would be needed to make changes to these builds,” Dr. Hovey said. “Some changes might be simple, but some might be a lot more complex, and the cost of making these changes may outweigh any direct drug cost savings.”
A Case in Point: Infliximab Dr. Hovey used a hypothetical example of infliximab use to illustrate how the above considerations can factor into the decision to switch to a biosimilar. In the pediatric population, both the originator biologic (Remicade, Janssen) and its biosimilars are approved for use in pediatric patients ages 6 years and older with inflammatory bowel disease (IBD). Although the agent is commonly used off-label for juvenile idiopathic arthritis, Kawasaki disease and Behcet’s disease, as well as several other conditions, because there are no differences in approved indications between the reference product and its biosimilars, an institution’s on- and off-label use of infliximab should not affect the decision to implement a biosimilar. Originator infliximab and all three biosimilars are dispensed operationally as IV piggybacks in the inpatient setting, and all are available in the same format and formulation, with the same dilution, storage and stability requirements. If there is only one order set for infliximab, as Dr. Hovey said is the case at some institutions, it would be logistically straightforward to implement a biosimilar switch. “In this case, because there aren’t many operational changes to make within the pharmacy, it might make sense to simply switch to the cheapest biosimilar available,” she said. Another strategy is to look at the data. The literature, albeit limited, suggests that pediatric patients can fare well on both originator and biosimilar versions of biologic medications. One study included 384 patients with juvenile idiopathic arthritis who were started on the originator version of etanercept and 55 on a biosimilar version of the medication. Another 57 patients switched to the biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups, according to the researchers (ACR Open Rheumatol 2021;3[11]:779-787). The safety profiles were comparable, and the frequencies
Patient Outreach Once a decision on a biologic or biosimilar is made, pharmacists and providers should put aside time to speak with patients set to undergo a switch, according to Shubha Bhat, PharmD, an IBD clinical pharmacy specialist in the Digestive Disease and Surgery Institute at Cleveland Clinic, and Jacob Kurowski, MD, the medical director of pediatric IBD at Cleveland Clinic Children’s. “Suggesting a switch to another medication, albeit with the same mechanism of action, can be anxiety-provoking for patients and their families, so it’s very important to educate them about biosimilars and reassure them of equivalent efficacy,” Drs. Bhat and Kurowski, who were not involved in the ACCP presentation, said in a joint email interview. “This can prevent a nocebo effect,
which is when the perception that a medication is inferior potentially leads to worse outcomes.”
Ensuring Insurance Coverage Managing insurer issues for pediatric patients can be an ongoing logistical hurdle, they said, noting that although many payors now include biosimilars on their formulary, it can take time to identify the specific biosimilar included, leading to potential delays in treatment. “In addition, if a parent moves between employers and the biosimilar needs to change based on the new payor’s formulary, the patient might need to undergo multiple switches, which we do not have supporting data for in the pediatric population,” they said. Drs. Bhat and Kurowski said they regularly appeal to insurers to keep patients on the same biosimilar, but those appeals are frequently denied and they reluctantly proceed with a switch. “In these cases, we closely monitor the patient to ensure medication efficacy and safety is not compromised despite multiple switching.” The sources reported no relevant financial disclosures.
18 Clinical
Pharmacy Practice News • April 2022
Infectious Disease
HIV Rx Safety ARTists continued from page 1
practice at Nova Southeastern University, in Fort Lauderdale, Fla., who helped launch her own institution’s program. Inpatient medication errors related to ART or opportunistic infection (OI) treatments occur in up to 72% of hospitalized patients with HIV (Open Forum Infect Dis 2020;7[8]:ofaa073), making medication monitoring imperative in this population, Amber Ladak, PharmD, an HIV pharmacist in the Division of Infectious Disease at the Medical College of Georgia at Augusta University, said during a session on ARVSPs at the 2021 annual meeting of the American College of Clinical Pharmacy (ACCP). “Hospitalized patients with HIV require careful medication review and management, both because of their complex antiretroviral regimens and because they are receiving increasingly more medications for non-HIV comorbidities,” Dr. Ladak said. Part of the reason the error rate is so high is that many hospital physicians do not have expertise in HIV treatment and can make mistakes when initiating or modifying complex HIV regimens, Dr. Ladak said. “There are just so many different combinations of antiretrovirals that it’s quite easy for physicians to start a regimen without a booster, for example, or to prescribe a regimen that doesn’t match the patient’s outpatient treatment,” she explained. The good news is that pharmacists can help reduce these errors by implementing simple ARVSP interventions. For example, adding clear instructions in computerized physician order
entry (CPOE) systems can guide accurate dosing and prompt physicians to double-check the regimen they are prescribing, Dr. Ladak said. Another low-cost measure that Dr. Ladak and her colleagues have found helpful in mitigating errors for ART orders has been to add brand names alongside single-tablet multidrug treatments in their CPOE system. “If someone is ordering quickly and looking only at the first couple of drugs of a regimen, they can easily confuse it for another regimen,” she said.
Reducing Mix-Ups Although Dr. Ladak did not share details on the effectiveness of adding brand names to the CPOE system at her institution, she said it has reduced the number of mix-ups between ART treatments that share some of the same components. She also cited data showing CPOE-based tools such as this have reduced inpatient ART-related errors by more than 40% (Clin Infect Dis 2020;70[11]:2241-2246).
Table. ARVSP Initiatives Clinical checklist—ART-specific medication review • Conducted by HIV/ID specialist • What is patient’s most recent outpatient regimen?
Order entry • Guided ordering instructions • Removal/alert of outdated ARV/inappropriate doses • Including brand names for combination products. Example: emtricitabine/ tenofovir disoproxil fumarate versus emtricitabine/tenofovir alafenamide
Leveraging EHR capabilities • Generating patient lists of admitted people with HIV • Notification of ARV orders
Formulary management • Ensure most commonly used products available • Restriction of ARV prescribing to ID team
Education • Common ART pearls (incomplete regimens, drug interactions) • Who to reach for questions/consults ARV, antiretroviral; ARVSP, antiretroviral stewardship program; EHR, electronic health record; ID, infectious disease Source: Amber Ladak, PharmD, based on material presented at the 2021 annual meeting of the American College of Clinical Pharmacy.
Other stewardship tools pharmacists can use include HIV-specific clinical checklists, Dr. Ladak said. Checklists can augment medication reviews at the time of admission and discharge and can be tailored to the specific institution. Common components in use by Dr. Ladak and her colleagues, and described in a 2020 study she co-authored, include patients’ outpatient and inpatient ART and non-ART medications, drug allergies, interactions with non-ART drugs, OI prophylaxis and a review of their most recent HIV viral loads, to verify treatment efficacy (J Int Assoc Provid AIDS Care 2020;19:2325958219898457). In a separate study examining the impact of an ARVSP with a strong emphasis on medication reviews, investigators found that 17% of patients admitted with HIV had medication errors
their ARVSP in January 2020 and found that the program significantly reduced the number of uncorrected ART errors. Six months before rollout, the error rate was 64% versus 31% six months after implementation (P<0.05) (J Am Pharm Assoc 2022;62[1]:264-269). Moreover, the proportion of patients with at least one medication error fell from 55.5% to 32.6%, reported Dr. Sherman, who was not part of the ACCP session.
Taking It Slow Institutions interested in launching their own ARVSP can set themselves up for success by implementing the program gradually, Dr. Ladak advised. “Perform a baseline evaluation and identify areas with the greatest need, whether that’s improving medication reviews at the time of admission or
‘Hospitalized patients with HIV require careful medication review and management, both because of their complex antiretroviral regimens and because they are receiving increasingly more medications for non-HIV comorbidities.’ —Elizabeth Sherman, PharmD prior to an ARVSP (Open Forum Infect Dis 2020;7[8]:ofaa073). These included D omissions of OI treatment or ART, drug–drug interactions and incorrect therapy. After the program’s implementation, the error rate dropped to 6%, all errors were resolved prior to discharge and the 30-day all-cause readmission rate fell from 27% to 12% (P=0.03). To ensure they don’t miss any opportunity to conduct a thorough medication review and use their checklist, Dr. Ladak said she and her colleagues have set their electronic health record (EHR) to generate a daily list of patients admitted with HIV. They use the checklist at the time of admission and discharge, when they also educate patients on any new medications, document changes to their treatment regimens and contact patients’ outpatient providers to notify them of these changes.
Errors Slashed at Nova Southeastern University Reviewing thrice-weekly EHRgenerated reports of inpatients receiving an ARV has had a profound effect on medication error rates at Nova Southeastern University, noted Dr. Sherman, who served as one of four pharmacists in the nation selected to author the ASHP Guidelines on Pharmacist Involvement in HIV Care (bit. ly/3vEb2kR). Her team implemented
educating physicians,” she said. “Focus on one or two stewardship activities first, do them well and then add more activities as needed.” It is also important to designate a program lead with expertise in HIV or other infectious diseases who can provide oversight, assume responsibility for the ARVSP, spearhead the development of policies and review the program’s results after implementation, Dr. Ladak said. In addition, one of the most important steps the ARVSP program lead can take is to provide prescriber education, she said. “Sharing ART pearls, educating prescribers about the most common prescribing errors and drug interactions, and providing regular updates on available treatments can go a long way,” Dr. Ladak said. Dr. Sherman echoed this sentiment, urging institutions that may not have the resources to implement a full ARVSP to focus on education as one way of improving ART use in hospitals. “Educating healthcare staff about clinical pearls and using medication errors as learning lessons, or even just having a dedicated person the staff can call with questions about ARV regimens, can be very helpful in preventing ARV medication errors.” Dr. Ladak reported serving on an advisory board for Theratechnologies. Dr. Sherman reported no relevant financial disclosures.
Technology
Pharmacy Practice News • April 2022
19
Automation
RFID Gaining Traction: New ASHP Report By Gina Shaw
R
adiofrequency identification (RFID) technology is gaining momentum as an increasingly important component of medication management in hospitals and health systems, with about 40% of participants in a recent survey reporting that their institution has adopted some form of RFID. The survey, part of a new ASHP Foundation report on the challenges and opportunities for pharmacy to leverage RFID technology in medication-use systems, also found that 31% of respondents are interested in exploring RFID, and 16% are evaluating the technology but have not yet committed or made a vendor selection (Figure, page 20).
There are many potential applications of RFID in pharmacy. “The tracking of medications with an RFID tag can improve many steps in the medication review and distribution process,” noted the ASHP report. In the survey, about 75% of respondents who had already implemented RFID were using it within their pharmacies. Other common areas of use were pharmacy-supported functions in the emergency department,
anesthesia areas, ICUs and ORs. Code trays and boxes are the most common area where RFID technology is being used, with 84% of current users reporting such use. “However, use in kits [65%] and anesthesia trays [57%] continues to grow,” said David Aguero, PharmD, the director of medication systems and informatics at St. Jude Children’s Research Hospital, in Memphis, Tenn., and a member of the
report’s advisory committee, speaking during an ASHP webinar. (Both the report and the webinar are available for free at bit.ly/3wjoevN.) But other areas, including temperature-sensitive medications, hazardous drugs, patientspecific medications and ambulatory medication adherence, represent “novel uses to get important information for patient care,” Dr. Aguero said. see RFID GAINING, page 20
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20 Technology
Pharmacy Practice News • April 2022
Automation
RFID GAINING continued from page 19
Health systems evaluating a possible RFID pharmacy deployment should consider the following: Staffing and training needs. “RFID is not going to completely displace the staff that are supporting this part of medication use, but it is going to change when you need to staff different components of the process,” Dr. Aguero said. As for training, this is an important consideration inside the pharmacy and among end users. “They need to know how their workflows will change, and how they need to consume and return medications,” he said. Vendor support. This is critical during implementation and long-term use. “It may be that you don’t have the project support in-house to get this technology implemented, and the vendor can support you there,” he said. “When it comes to repackaging and tagging individual medication units of use, rely on the vendor where you can.” Analytics capabilities. “These are extremely important in terms of optimizing the system after deployment,” Dr. Aguero said. Tag-specific considerations. “The adhesive quality, the cost structure and active versus passive tags—these factors can have huge implications for implementation,” he said. “If you’re implementing active tags for a real-time location strategy, then you’re going to need an adhesive that will stay on a pneumatic tube or infusion pump for years at a time. In passive RFID in medication repackaging, you still cannot have the tag come away from the medication, but you do not expect it to stay on for years at a time.” Ensuring that tags stay where they are placed “is especially true with products that require specific temperature-sensitive storage like refrigeration or freezers.” Pretagged 503B medications. “This is a game changer for pharmacy,” he said. “The ability to get specific medications repackaged [from manufacturers and/ or distributors] has safety and efficiency implications. The cost of performing this activity has been prohibitive but is quickly coming down, and manufacturers are starting to provide some of these medications pretagged.” Set firm goals. The goals of your RFID project will determine its scope and drive decisions. Inventory management, for example, was cited by the majority (73%) of respondents to the ASHP survey as one of their top two reasons for considering RFID, with reinforced safety, process standardization and recall management also being important factors.
UIC Pilots RFID in the OR The University of Illinois at Chicago (UIC) began implementing RFID tagging
in its pharmacy about four years ago, beginning with a pilot in the OR. “We have several different trays and kits and boxes in our OR setting, so we started with the main anesthesia tray, which has the highest use and highest turnover,” Matthew Gimbar, PharmD, UIC’s associate director of hospital pharmacy operations, told Pharmacy Practice News. “That tray has 75 individual items, and each time it was turned over, we’d have the technician sifting through each item, looking for use, looking for expiration dates, and then we’d have the pharmacist doing the same thing. Now, the pharmacists on the front end verify and tag the product, and then the turnover is completely tech-driven, freeing up an enormous amount of pharmacist time.” Having that extra time “has allowed us to expand our controlled substance reconciliation and drug diversion surveillance program,” Dr. Gimbar said. He added that UIC has since expanded RFID use to other kits and specialty trays in the OR setting. The RFID system is popular with technicians as well. “They like having more consistency in their day-to-day routine, and using the data from RFID helps us structure the technicians’ work each
Adopted RFID in some forma
40%
Emory Starts From Scratch Tony Scott, PharmD, the director of pharmacy services at Emory University Hospital, in Atlanta, is starting from scratch with RFID, leveraging his experience with the technology from his previous position as an assistant director of pharmacy operations at University of Chicago Medicine, where RFID had been implemented in adult procedural areas since 2017-2018. “We found that it improved our efficiency significantly, as well as reducing filling errors,” he said. “In addition, when there was a recall, we were easily able to pull all of the affected medications because we knew immediately exactly where they were.”
31%
11% Contracted with a vendor but implementation not yet completed
technicians into using that,” Dr. Gimbar said. When a new ambulatory surgery center opens across from the main hospital in September 2022, RFID will also be incorporated into a standardized procedural tray. “Instead of a drawer with 20 to 30 different drugs, we’ll have a drawer with one RFID-checked tray,” Dr. Gimbar said. “With rapid turnover of 15 to 20 minutes between cases in ambulatory surgery, we don’t want pharmacy throwing that pace off.”
16%
Interested in exploring RFID
Evaluating the technology but no firm commitment or vendor selection
2%b Chose not to evaluate RFID, or underwent an evaluation and chose not to pursue RFID
Figure. RFID uptake. a
About 75% of respondents who implemented RFID were using it within their pharmacies. b Approximate
RFID, radiofrequency identification
day,” Dr. Gimbar said. “For example, on Wednesday, which is our late start day in the OR, we can do more of our product tagging. We typically tag a week’s worth of supplies on any given day. We now have the tagging down to a science, and it’s ingrained into the workflow. Then on Mondays, a pharmacy student reviews the data on how much drug we’re using in the trays per week, and we analyze that data for usage and turnover.” Next on the list for adding RFID are code trays and crash carts, a step that’s planned for summer or fall 2022. “Once we do that, we will be able to add another scanning station in the central pharmacy and incorporate all the pharmacists and
Source: ASHP Foundation (bit.ly/3wjoevN).
At Emory, Dr. Scott plans to start with anesthesia trays. “Our general OR volume includes up to 100 cases per day, so that’s a pretty big footprint on our main campus and represents a good launching point for us,” he said. “The OR uses a lot of high-dollar medications, so being able to streamline their utilization and potentially eliminate waste is always a good thing.” However, other institutions may not select the OR as the site to pilot RFID technology. “It’s important to take time to look at your resources and do a risk-costbenefit analysis,” Dr. Scott said. “For sites with smaller OR volumes, you may want to instead target code carts or other things within the main pharmacy, depending on
UIC pharmacy technician Veronica Flores removes an RFID-tagged anesthesia tray from the scanning station in the OR satellite pharmacy for distribution.
utilization. Other institutions may want to do all trays and kits within the pharmacy space, whether procedural or nonprocedural. You need to break down not just the financial impact but also how to operationalize the technology. Preimplementation planning is key, because if you don’t set up successfully, you negate some of the benefits.” Vendors can help with these analyses, Dr. Gimbar said. “They’re the content expert, and they’re not trying to pull the wool over your eyes. With our vendor, all we paid for was the tags and they did a great job preparing us for go live. For example, they recommended that we identify a good mix of key pharmacists and technicians who work in the appropriate areas and pull them out of the regular schedule so that they could help with the initial tagging oversight and rollout.”
Staff Preparation Is Key For Emory’s implementation planning, Dr. Scott has particularly focused on preparing pharmacy staff. “Initially, there is going to be more work for them involved with tagging these drugs and separating inventory by tagged and nontagged,” he said. “In the long run, we will have more pretagged drugs coming in, but for now there will be that shift in their work, and they need to understand its importance to patient safety. We can also point to the fact that in Illinois, we were able to free up pharmacists for other clinical activities, and that was a nice win for them.” “It’s essential to educate and engage your staff before the RFID gets to your front door,” Dr. Gimbar agreed. “Get them excited about how it will affect their day-to-day and the promise of a better workflow. There will be temporary growing pains, but you’ll get it down to a science.” The sources reported no relevant financial disclosures.
Technology
Pharmacy Practice News • April 2022
21
Medication Safety
Should IV-WMS Be Mandatory? By David Wild
M
edication safety experts are urging various regulatory bodies to make IV workflow management systems (IV-WMS) mandatory, based on the technology’s track record for preventing catastrophic medication errors. “Most hospitals today are using the same manual compounding verification processes used back in the previous millennium,” said Mark Neuenschwander, the founding director of THRIV Coalition, a group of healthcare stakeholders based in Bellevue, Wash., that advocates for wider use of IV workflow technologies (THRIVcoalition.org.) That manual verification process can result in up to 9% of IV preparations being compounded with errors, and in 2% of cases, the errors can be potentially clinically significant, because they involve antineoplastics or other drugs requiring pharmacokinetic monitoring (Am J Health Syst Pharm 1997;54[8]:904-912). In fact, “too many
of these errors can cause patient harm and death,” Mr. Neuenschwander said. But the errors don’t have to happen. In a study published in 2019, researchers investigated the impact of IV-WMS technology that employed barcoding, digital image capture and, in some cases, gravimetric verification. They compared error detection rates at four hospitals that used these technologies with four hospitals that used manual workflows. The investigators found that facilities with IV-WMS technologies had an error detection rate of 3.13%, compared with 0.22% among those using a manual compounding process (P<0.05) (Am J Health Syst Pharm 2019;12[15]:895-901). The most common errors caught when an IV-WMS was used were incorrect medication (63%), incorrect base fluid volume (11%) and incorrect medication volume (6%), while the most common errors detected when these technologies were not used included incorrect medication volume (18%),
‘[IV-WMS] should definitely be a requirement for compounded product preparation, at least for oncology and pediatric medications, because of the high risk to patients if they don’t get an accurate dose.’ —Lindsey Amerine, PharmD incorrect base fluid volume (17%) and incorrect medication (17%). The authors speculated that there is likely “underreporting of errors in [compounded sterile products] when using non–[technology-assisted workflow], potentially leading to an increased number of medication errors that go undetected and reach the patient.” “Barcode medication preparation [BCMP]-based technologies are to medication-use processes what orderfulfillment technologies are to Amazon—a
URMC’s Experience
W
hen David Webster, RPh, MSBA, the director of pharmacy - acute care operations at the University of Rochester Medical Center (URMC), in New York, and his colleagues purchased an IV workflow management system (IV-WMS), they had a good sense of what they were looking for in a vendor. “We wanted something with a robust safety system that includes barcode verification of ingredients, digital image capture and integrated gravimetric checking, because it allows confirmation of the correct amount of each ingredient being added to the compound,” Mr. Webster said. Today, all three of the cleanrooms at URMC where patient-specific IV formulations are compounded incorporate IV workflow technologies. In the two oncology compounding rooms, nearly all doses are processed through IV Dispense Prep, a system built into their Epic electronic medical record system (EMR) that includes barcoding and digital imaging. Meanwhile, at the main non-oncology cleanroom, staff compound 30% of their doses using the Omnicell IVX system, which includes the additional step of gravimetric verification in a single integrated device located in the hood. “More than 90% of all patient-specific doses compounded across all three cleanrooms are processed through our IV workflow systems, and we intend to continue to increase and maximize the use of the IVX system, with gravimetrics,” he said. Mr. Webster’s team has not formally analyzed its error detection rate before and after implementation of the systems, but he said he believes “there has been a significant decrease in errors, and we have confirmed the accuracy of all doses produced on the IVX system prior to dispensing.” He added several other criteria that his team looked for while evaluating IV-WMS vendors. “It was important for us to have a system with hard stops, so that any failure point at a critical step stops the process altogether, rather than allowing the user to acknowledge the error but then complete the product,” he said. Flexibility in handling both hazardous and nonhazardous products and in compounding complex mixtures that require multiple compounding steps was also important to Mr. Webster. “For example, gravimetric analysis may not be possible for some very low-volume additions, but the
A URMC pharmacy technician compounds a sterile product using an IV-WMS employing barcoding, digital image capture and gravimetric verification. system we chose was configurable to allow us to use the other safety checks built into the device.” Other priorities they had when looking for a vendor included the ability to integrate the device with their EMR so that they could fully use tools such as dose tracking and rate-based infusion replacement, and to be able to expand the number of devices in the system as the workload grows. For those considering an IV-WMS, Mr. Webster suggested first developing a clear understanding of the resources needed to implement and maintain the system. “Some costs that might not come to mind include developing the interface with your EMR and maintaining protocols and medication libraries within the system,” he said. Although every system has its limitations—for example, some might not have hard stops or may not be as flexible in allowing for custom workflow designs—“no system is perfect,” he said. “You have to understand your priorities and find the vendor that best fits your needs.” —D.W.
company that realizes error rates below 0.1%,” Mr. Neuenschwander said.
Switching to Gravimetrics Lindsey Amerine, PharmD, the executive director of pharmacy at UNC Health, in Chapel Hill, N.C., said her organization switched to a gravimetricbased IV-WMS after finding deep faults in its manual syringe pull-back verification technique—the method most often employed in the absence of IV-WMS. Specifically, 28.3% of UNC’s sterile products were outside of the ±5% range in volume, and almost 13% were over ±10% off the prescribed dose, a range outside of which there is considered to be a risk for suboptimal clinical responses and toxicity (J Oncol Pharm Pract 2016;22[1]:3-9). “Every patient deserves an accurate dose, and we wanted to make sure we were sending out accurate preparations,” Dr. Amerine told Pharmacy Practice News. After settling on an IV-WMS (BD Pyxis IV Prep) that included barcoding, digital imaging and gravimetric verification, they found the percentage of finished doses outside the ±5% range dropped to 0.4%, with a negligible number of doses outside the ±10% range (Am J Health Syst Pharm 2018;75[17]:1286-1292). Seeing the benefit of IV-WMS to patient safety has left Dr. Amerine with a clear opinion on the necessity for some type of regulatory forcing function to promote more widespread IV-WMS adoption. “This technology should definitely be a requirement for compounded product preparation, at least for oncology and pediatric medications, because of the high risk to patients if they don’t get an accurate dose,” she said.
Implementation Gap Despite the incidence of compounding errors and the ability of IV-WMS technologies to mitigate those risks, most institutions do not use these systems, as a 2020 survey by the Institute for Safe Medication Practices (ISMP) showed. ISMP surveyed 634 pharmacists and pharmacy technicians, mostly from hospital settings, and found that only 47% used IV-WMS technologies with see IV-WMS, page 22
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barcode and image verification (ISMP; October 22, 2020; bit.ly/3MTOCCC). Moreover, 74% said they knew of at least one pharmacy sterile compounding error occurring within the previous 12 months. The top three compounding errors reported by respondents were incorrect dose or concentration (58%), incorrect base solution (51%) and incorrect base solution volume (43%). Although the majority of the errors cited in the ISMP survey did not reach the patient, that is not a reason for complacency, noted medication safety expert Dan Degnan, PharmD, MS, an associate director of professional skills laboratories at Purdue University College of Pharmacy, in West Lafayette, Ind. Even a small number of errors reaching the patient should be concerning, given that “compounding errors have a high potential to harm a patient,” he told Pharmacy Practice News. Such errors “can be difficult to detect, and we probably would not know the true incidence of IV medication errors that may have reached a patient," Dr. Degnan noted, explaining that voluntary error reporting rates are “notoriously unreliable for determining the true incidence of error.” He cited, as an example, an early, seminal study on voluntary error reporting that found as few as 1.5% of all adverse events in the hospital are reported voluntarily (Ann Intern Med 1993;119[5]:370-376). Dr. Degnan added that any errors detected by an institution should be used to drive improvements to medication-use systems, and that institutions should use technologies that can prevent these types of errors—including IV workflow management technologies. But according to Mr. Neuenschwander, many health systems aren’t getting the message. “Too many pharmacy departments, convinced that BCMP technologies are as critical, if not more critical than barcode medication administration [BCMA] technologies, find their repeated budget requests for IV workflow technologies rejected,” he lamented. Although he acknowledged that price can be a concern, he stressed that compounding workflow systems cost a fraction of medication-use technologies, such as automated dispensing cabinets, computerized physician order entry (CPOE) systems and BCMA systems.
The Regulatory Gap The most common reason that Mr. Neuenschwander has heard for IV-WMS funding being denied is the lack of any regulatory body requiring the technology. Pharmacy Practice News contacted USP and the Joint Commission to ask whether they have
considered requiring use of IV-WMS. In a response from USP, Anne Bell, the group’s senior communications manager, said the “topic is very much on the radar of the Compounding Expert Committee, and is one of the considerations being discussed for the proposed revisions to the compounding chapters.” Robert Campbell, PharmD, the clinical director of standards interpretation and director of medication management at the Joint Commission, Oakbrook Terrace, Ill., wrote in an email that “with exception to the National Patient Safety Goal requiring
the use of smart pumps for the IV infusion of heparin, The Joint Commission standards focus on processes of care and do not identify a technology that must be used to achieve desired outcomes.”
Not Necessarily Regulatory Mr. Neuwenschwander noted that nonregulatory bodies have managed to boost implementation rates for several patient safety technologies, and he hopes his group can convince them to do the same with IV-WMS. For example, although neither CPOE
nor BCMA systems are mandated, both technologies are part of the Leapfrog Group’s grading structure, “which is no small reason why using these two technologies has become de facto standards of practice,” he said. ISMP is yet another nonregulatory body that is a staunch advocate of IVWMS, arguing in an online article (bit. ly/3tdDrg3) that the technology should be “both a leadership and regulatory mandate.” Furthermore, the organization’s 2022-2023 Targeted Medication Safety Best Practices for Hospitals
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Medication Safety includes a recommendation to employ IV-WMS (bit.ly/3pJa1kX). As for which specific vendor or IVWMS technology to choose, one useful approach is to consider the experiences of other health systems that already have implemented an IV-WMS system (sidebar, page 21).
‘People Respect What’s Regulated’ Although ISMP holds sway within the pharmacy community and among patient safety experts, Christina
Michalek, RPh, a medication safety specialist at ISMP and the administrative coordinator for the Medication Safety Officers Society at the organization, said “the bottom line is that people respect what’s regulated.” “People in the pharmacy community look to ISMP and other professional organizations, and they follow the literature in pharmacy, so they have a sense of the value of this technology,” she added. “But it’s people outside of pharmacy that need to see the value, and that is most effectively done if it’s required.”
Administrators “might question the value of these systems because they might not see a clear association between IV compounding errors and patient safety.” If compounding errors occur and go undetected, they may not be linked directly with a patient’s change in condition, Ms. Michalek said. “Errors are happening; administrators just might not know about them.” The sources in the main article and sidebars reported no relevant financial disclosures.
More on the Web UNC Health recently adopted an IVWMS and achieved significant operational and cost benefits. To read about its experience, see expanded version of article at www.pharmacypracticenews.com.
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atient safety was the main rea tor of pharmacy at UNC Healt tioned to an IV workflow manage have also realized some operation Ninety days after implementing fell from an average of 7.42 to 5.9 spent verifying a finished product Pharm Pract 2016;22[1]:3-9). “Newer technicians also saved s to triple-check themselves,” Dr. A what to do, and they had hard sto IV-WMS also can allow remote ciencies, as Dr. Amerine found ou and her colleagues at four sites w cists remotely verifying products based IV-WMS detected a similar vs. 0.38%, respectively) (Am J He cases, errors documented by the local pharmacist. Remote verifica $23,770 in annual cost savings, th work. Dr. Amerine said the capacity fo early days of the COVID-19 pande with the North Carolina Board of technology,” she said. “It’s hard to technology allowed us to keep ev
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