Pharmacy Practice News - April 2021 by McMahon Group

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CLINICAL

Pharmacy’s Steps For Addressing Vaccine Inequities

Volume 48 • Number 4 • April 2021

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New Models for Practicing At the Top of Your License

Tips for managing adverse reactions to COVID-19 therapy ...... Choosing Wisely campaign focuses on antibiotics .................

POLICY

Cold chain strategies for ensuring vaccine safety ................. 13 Navigating the PPE waste stream ..................

What’s your white bagging payment plan? ....................................

SPECIALTY PHARMACY

Anti-kickback statutes and other hidden dangers of SP outsourcing ....................

he first wave of COVID-19 vaccine distribution exposed racial and ethnic disparities in access to health care in America—disparities that were already exposed by the pandemic itself. By late February, reports from all over the country and national data showed that the distribution rates of COVID-19 vaccination were much lower among Black and Latinx Americans than whites. Whether the opening of mass vaccination sites announced in March will ease this vaccination gap for minorities remains to be seen. But several health systems have taken a proactive approach. Whether it’s providing transportation to vaccination sites or conducting registration drives for people with limited access to the internet, these pharmacistcoordinated efforts show the profession is willing to do its part.

linical pharmacists practicing at the top of their license have the opportunity to close provider shortage gaps and improve the quality of patient care, based on the experiences of several innovative states that have implemented advanced practice models. Pharmacists from New Mexico, North Carolina and Illinois are serving as examples of how this practice approach has evolved in recent years, along with the services covered, the unique roles advanced practice pharmacists perform, and current and future challenges to the model.

Continued on page 18

Continued on page 20

USP Compliance Remains a Focus Of TJC Surveyors

ISMP Highlights 2020’s Top 10 Medication Errors and Hazards

ike most things in 2021, this year’s Joint Commission compounding pharmacy surveys will take a different tack, based in part on the practice pressures of COVID-19. The main development is a continued delay in enforcing recent updates to USP’s Chapters on compounding and hazardous drug handling, along with a pandemic-related interim guidance issued for compounding pharmacies. For pharmacies that scrambled to obtain funding to build cleanrooms and update existing segregated Continued on page 14

he Institute for Safe Medication Practices (ISMP) has published its list of top 10 medication errors and hazards for 2020, covering everything from flawed use of programmable IV pumps and inappropriate opioid prescribing to new hazards introduced during the COVID-19 pandemic. One expert emphasized the value of having a list to use as a starting point for ensuring medication safety in her hospital during the coming year and beyond. “[2020] was such a hectic year for health care, and many organizations have been struggling just to keep up with the demands of the pandemic, let alone evaluate the safety

Special Focus:

COVID-19 Pandemic More coverage on pages 8, 13, 15

of their medication practices,” said Elizabeth Wade, PharmD, the medication safety officer at Concord Hospital, in Concord, N.H. “Given that institutions need to prioritize where they put their efforts during this time, one of the best ways to improve medication safety is to use the ISMP’s list and conduct a gap analysis to see if these externally reported errors could also happen internally, and proactively implement mitigation strategies to prevent these from happening.” Following are some key points from the ISMP’s list, along with selected recommendations. Additional details and Continued on page 4

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Pharmacy Practice News • April 2021

Digital

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The top 5 articles last month on Pharmacy PracticeNews.com

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Volume 48 • Number 4 • April 2021 • pharmacypracticenews.com

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INFECTIOUS DISEASES Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH David P. Nicolau, PharmD, Hartford, CT Jason Pogue, PharmD, Detroit, MI LEADERSHIP Ernest R. Anderson Jr., MS, RPh, Boston, MA

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4 Clinical

Pharmacy Practice News • April 2021

Medication Safety

ISMP Top 10 Hazards continued from page 1

recommendations can be found in the full document (bit.ly/3k2IKsD).

Extended-Release (ER) Opioids ISMP received three reports in 2020 of inappropriate prescribing of fentaNYL patches to elderly opioid-naive patients, sometimes to treat acute pain rather than chronic pain (ISMP Medication Safety Alert! July 2, 2020; bit.ly/2ZFY0Cs). The patients were documented as having “allergic reactions” to other analgesics, but further investigation by pharmacists or other providers revealed they were only mild intolerances that did not

justify prescribing of these medications. The errors were detected before patients suffered any serious harm, according to ISMP. “Inappropriate prescribing of these drugs often happens because [clinicians] are not aware of the dangers of this practice, or they don’t understand what constitutes the difference between ‘opioidnaive’ and ‘opioid-tolerant,’” said Mike Cohen, RPh, the president of ISMP. ISMP Recommendation: Prohibit prescribing of fentaNYL patches to opioid-naive patients and those with acute pain. This requires establishing definitions for opioid naivete and opioid tolerance, and creating a standard process for gathering and documenting opioid status and type of pain. Setting computerized order entry system defaults for extendedrelease opioids to the lowest starting dose and frequency, and creating electronic alerts to confirm opioid use history when prescribing and dispensing these agents also can help prevent inappropriate prescribing.

Not Using Smart Infusion Pumps With Dose Error Software Despite the increasing use of smart pumps with dose error reduction systems (DERS), the safety feature has been adopted less widely by anesthesia providers in perioperative settings, ISMP noted (bit.ly/3aKffc9). In one case reported to the organization in 2020, a provider selected dexmedetomidine from the smart pump drug library, erroneously entering “Min” for minutes, delivering an infusion of the drug at a rate of

0.15 mcg/kg per minute, instead of 0.15 mcg/kg per hour. Since the DERS feature was not engaged, the pump did not issue a dose error warning and the infusion continued for several hours before it was detected, and patient harm was averted. ISMP noted that anesthesia providers may not know these capabilities can be applied to loading and bolus doses, which are commonly administered in these settings. That knowledge gap may explain why DERS sometimes are not used in the perioperative setting. “Also, many organizations use smart pumps in the operating room in anesthesia mode, in which case hard stops are often reduced to soft stops and providers can easily override limits that should never be bypassed,” Cohen said. ISMP Recommendation: Include anesthesia providers when building a smart pump library. When possible, they should use upper and lower hard limits and employ the bolus feature with hard limits to avoid catastrophic doses being administered. Bolus doses should not be delivered by simply increasing infusion rate.

Preparation and Storage Challenges Product preparation and/or labeling problems

Lack of appropriate safe storage measures

IV AdministrationAssociated Errors Errors in infusion pump connections or IV line setup Infusion rate confusion

Communication and Documentation Gaps Absence of, or deviation from, protocol

At low flow rates, occlusion alarms might sound due to delays in the time it takes for a medication to reach the patient, or an occlusion alarm might sound at high flow rates, ISMP noted. Other risks associated with this practice include personnel tripping over extension tubing and electrical cords, and difficulty performing double checks and barcode scanning when the pump is outside the room. “Because nurses cannot scan the barcode on a patient’s identification band, some hospitals affix the patient’s name, birthdate and a barcode to the pump or IV pole outside the room,” Cohen said, cautioning there is a risk for transferring these IV poles to other patients without removing the labels. ISMP Recommendation: Follow guidelines issued by ECRI (bit.ly/ 37CZPnY). ECRI suggests conducting periodic infusion pump rounds in the hallway to verify pump settings, and developing temporary processes that include

Incomplete handoffs at transitions of care

Figure. Main themes identified from oxytocin-associated medication incidents. Source: ISMP Canada; bit.ly/3dF03ia.

“We also encourage organizations to analyze their smart pump data to better understand why DERS are not being used in the perioperative setting,” Cohen added.

Errors With Oxytocin Providing a bolus of oxytocin too rapidly can overstimulate the uterus, potentially causing fetal distress or uterine rupture, and leading to emergency cesarean delivery (ISMP Canada Safety Bulletin 2019;19[8]:1-5; bit.ly/3dF03ia). “This can happen, for example, when flushing IV lines with retained drug,” Cohen said. A separate joint report by ISMP and ISMP Canada found that oxytocin-related errors have been caused by look-alike mix-ups, with generic oxytocin and brand PITOCIN vials both using the same green caps as a number of ondansetron vials (bit.ly/2NvEnu7). Several prescribing errors also have occurred due to the selection of similarly named drugs on electronic order entry screens. For example, a search for “OXY10” can bring up oxycodone, while searches for “PIT” can yield a result for PITRESSIN. Other

errors reported to ISMP were caused by verbal orders being misheard. In other cases, oxytocin infusions prepared outside the pharmacy and inadequately labeled led to administration errors, with doses up to 10 times higher than intended being administered, or infusion bags being swapped. ISMP Recommendation: Require prescribers to use at least five letters from a drug’s name when searching an electronic order entry system. Additionally, oxytocin should be mixed only in the pharmacy and dispensed in readyto-administer, clearly labeled bags in standardized concentrations. Once an oxytocin infusion is completed, the IV line should be changed or tubing should be flushed after it is disconnected.

Infusion Pump Hazards Many hospitals have reported positioning infusion pumps outside of COVID-19 patients’ rooms to conserve personal protective equipment (PPE), limit staff exposure to patients with COVID-19, and ensure pump alarms are heard and responded to promptly (bit.ly/3brCw1z). ISMP noted that this practice requires long extension sets, which often have a smaller diameter than typical tubing. “This means more fluid is needed to prime the tube, and flow rates might be affected,” Cohen said.

some elements of barcode scanning or independent double checks prior to medication administration, as Pharmacy Practice News previously reported (bit.ly/ 3os0K1s-PPN). ISMP recommended not continuing to situate infusion pumps in hallways once the pandemic has abated.

Errors With COVID-19 Vaccines A number of errors involving COVID-19 vaccines reported to ISMP are included in the 2020 medication errors list (bit.ly/ 3umgwhd). The errors included several reported allergic reactions, dilution errors with the Pfizer/BioNTech vaccine, and vaccines being given to patients outside the current eligibility groups. ISMP also cautioned against administration errors, citing one incident involving the Moderna COVID-19 vaccine. Instead of receiving the first dose of the vaccine, 44 adults at a West Virginia clinic received IM injections of

Clinical

Pharmacy Practice News • April 2021

Medication Safety casirivimab, one of two new Regeneron monoclonal antibodies recently granted emergency use authorization in the United States to treat adults and children with mild to moderate COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. No serious adverse reactions were reported, and patients were offered the vaccine as soon as possible. Although ISMP said it did not have a detailed description of why the error happened, “product packaging and labeling issues were likely involved,” the safety group stated in an earlier, more detailed report on the error (bit.ly/ 3umgwhd). ISMP noted that the Moderna vaccine vial has a red cap, similar to the red cap on vials of Regeneron’s monoclonal antibodies, possibly leading to the administration mixup. Further adding to the confusion, both monoclonal antibodies were shipped in cartons that did not include the name of the specific antibody contained within and instead listed a product code number for casirivimab (REGN10933) and imdevimab (REGN10987). Although the vial label contains a barcode, at the time of the errors, the bar code was not functional or associated with a National Drug Code (NDC) number, according to ISMP. ISMP Recommendation: To limit administration errors, ISMP suggested drawing on cautions it already has issued in response to flu vaccine errors, such as keeping an eye out for lookalike vaccine names and labels and avoiding the unsegregated storage of vaccines and other vials. As for more general errors involving COVID-19 vaccines, ISMP suggested ensuring there is enough space at the site to evaluate patients after an injection for possible allergies and to treat them in case of a reaction, while still following social distancing guidelines and other pandemic measures. ISMP also recommended verifying that vaccinators have competencies in storing, preparing and administering vaccines; assessing patients; identifying the proper vaccine injection site; and providing emergency treatment in case of anaphylaxis.

‘Syringe Pull-back’ Method Still In Use—and Still Deadly As ISMP previously reported, syringe pull-back verification is associated with an error rate as high as 9% (Am J Hosp Pharm 1997;54:904-912). Failure to detect wrong concentrations, wrong strengths and wrong products or diluents can cause fatal errors, ISMP noted. Using the pull-back method, an ingredient is injected from the syringe into the final container, and then the plunger is pulled back to the amount on

Safety Best Practices for Hospitals” (bit.ly/3pJa1kX). ISMP also recommended that organizations implement barcode scanning, gravimetric verification, robotics and IV workflow software in the compounding process. But it added a caveat: “When technology is in use, it is important that processes are in place to ensure it is maintained, the software is updated, and that the technology is always used in a manner that maximizes the medication safety features of these systems.”

the syringe that was injected. It is this “pulled-back” syringe that is checked to determine the accuracy of the amount injected. Errors may not be detected if the syringe does not reflect the actual amount added or if the syringe is not partnered with the correct container, ISMP noted. ISMP Recommendation: Eliminate use of this method. Instead, have other staff verify the proper ingredients and volumes before they are added to the final container, as ISMP reported in its 2020 “Targeted Medication

see TOP 10 HAZARDS, page 6

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6 Clinical

Pharmacy Practice News • April 2021

Medication Safety

TOP 10 HAZARDS continued from page 5

Dangerous Admixtures Outside of the Pharmacy A 2020 ISMP survey of 444 nonpharmacist hospital practitioners found that 28% of respondents said they often or always admixed a variety of IV infusion types outside the pharmacy (bit.ly/ 3qL5RdQ). “This is an error-prone practice that happens often during emergency situations, but is some-

times done routinely,” Cohen said. Most survey respondents were nurses (77%, including advanced practice nurses) and anesthesia providers (8% certified registered nurse anesthetists and anesthesiologists). The remaining respondents (15%) included decentralized pharmacists or technicians who prepare admix medications and/or infusions in clinical areas, as well as physicians, supervisors and others. Nearly half the survey respondents said they had no formal training in admixture, and many said they had to

rush preparations, could not label the product appropriately, did the mixing by memory, were interrupted or distracted, and were concerned about the sterility and accuracy of the final product. Roughly one-third said they were

aware of errors associated with their outside-of-pharmacy compounding. ISMP Recommendation: Institutions should conduct their own survey and use the results to hold discussions about this unsafe practice and find ways to increase the use of ready-to-use products prepared by the pharmacy or manufacturers. ISMP included survey questions in the August 2020 ISMP Nurse AdviseERR newsletter (bit.ly/3dCMtMc).

Medication Loss When Administering Small-Volume Infusions Patients can be significantly underdosed when small-volume (50-100 mL) intermittent infusions are given through longer primary administration sets that are connected to a vascular access device, ISMP noted.

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“Residual medication may be left in the tubing and this could, of course, have a clinical impact on a patient’s outcomes,” Cohen said. An ISMP analysis of data from one health system found roughly 360,000 small-volume infusions that were likely administered to patients at significantly lower doses than prescribed due to using a primary administration set (bit.ly/ 3aJcU0R). Based on ISMP’s observations in other organizations and the literature, “the scope of this problem is much larger than only within this health system,” the report noted. Although flushing the tubing of the intermittent infusion can help ensure the full dose is given, the flush volume needs to be as large as the residual volume left in the primary administration set, and that amount may not always be administered, ISMP added. ISMP Recommendation: Administer intermittent infusions using a shorter secondary set and embed an appropriate carrier fluid in order sets for smallvolume infusions. The tubing should be flushed with the carrier fluid after the medication has been administered to ensure the full dose has been delivered. In the case of the health-system cited in the report, several additional steps were taken to reduce the opportunity for small-volume infusion errors: • Health system–engaged nurse educators created an educational docu-

Clinical

Pharmacy Practice News • April 2021

Medication Safety ment on the topic and came up with a catchy slogan: If the bag is the small kind, put it on a secondary line. • They also created a pop-up warning on automated dispensing cabinet screens to administer small-volume intermittent infusions with a secondary set. • The pharmacy also affixed labels to minibags stating, “Infuse via secondary set” for the first few months of the educational program.

Wrong-Route Errors With Tranexamic Acid ISMP received a number of reports of intraspinal tranexamic acid injections administered instead of intraspinal injections of local anesthetic for epidural or spinal anesthesia, and the mistake has led to seizures (bit.ly/ 3dCRG6I). These errors often are due to mix-ups between bupivacaine, ropivacaine and tranexamic acid, which are packaged in vials with the same blue cap, ISMP noted. “Particularly when the vials are stored upright, practitioners can pick up a vial based on cap color and not notice it is the wrong vial,” Cohen said. ISMP Recommendation: Purchase bupivacaine, ropivacaine and tranexamic acid with different colored caps from separate manufacturers, or premix bags and prepare syringes or infusions in the

“Error-prone abbreviations, symbols, and dose designations that are included on the Joint Commission’s ‘Do Not Use’ list (Information Management standard IM.02.02.01) are highlighted in the ISMP list, as are the error-prone abbreviations, symbols and dose designations that are relevant mostly in handwritten communications.” abbreviations, symbols and dose expressions, and avoid their use. The list was recently updated for 2021 and can be accessed at bit.ly/3cKVot0. “We

encourage organizations to review our updated list and to use it to create or update your organization’s ‘Do Not Use’ abbreviation list,” ISMP stated.

—David Wild, David Bronstein The sources reported no relevant financial disclosures.

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pharmacy only. It is also recommended to avoid upright storage of the vials to ensure labels are visible, and to store tranexamic acid vials away from other look-alike vials.

Use of Error-Prone Abbreviations, Symbols or Dose Designations Given the potential risks related to misunderstanding of abbreviations, symbols and dose designations (Jt Comm J Qual Patient Saf 2007;33[9]:576-583), ISMP continues to emphasize safe use of these practices. “These may be convenient and save time, and using them is one way of fitting a word, phrase or dose into a restricted space, but they can be misunderstood, misread or misinterpreted, and cause patient harm,” Cohen said, adding that they should NEVER be used when communicating medical information verbally, electronically, and/or in handwritten applications. ISMP Recommendation: Review ISMP’s most recent list of error-prone

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8 Clinical

Pharmacy Practice News • April 2021

Critical Care

COVID-19 Rx, Alternative Pain Meds Carry Toxicities N

ew treatments for COVID-19 and the ongoing opioid epidemic have expanded options for clinicians, but these therapies bring some unique toxicities that warrant vigilance, pharmacists said during the 2021 Critical Care Congress Virtual Event.

Multiple EUAs for COVID-19 Treatments The rapid emergence of the COVID-19 pandemic led to several emergency use authorizations (EUAs) in 2020 for treatments, including hydroxychloroquine (revoked in June), remdesivir (Veklury, Gilead), convalescent plasma, baricitinib (Olumiant, Lilly), and the monoclonal antibodies bamlanivimab (Lilly) and casirivimab plus imdevimab (Regeneron). Although the EUA for hydroxychloroquine was revoked in June, the other agents have led to some concerning toxicities, such as gastrointestinal and hepatic effects, thrombosis and secondary infections, according to Megan Rech, PharmD, an emergency medicine clinical pharmacist with Loyola University Medical Center, in Chicago. Adverse effects for remdesivir, an antiviral IV infusion, most commonly include gastrointestinal issues such as nausea, vomiting, diarrhea, constipation and gastroparesis; hepatic injury also has been reported (Hepatol Int 2020;14[5]:881883). Three case reports discussed liver injury induced by remdesivir (Pharmacotherapy 2020;40[11]:1166-1171). Kidney damage is another issue seen in patients treated with remdesivir, due to the cyclodextrin diluent solubility agent included, Rech said. Avoid using the drug when creatinine clearance is less than 30 mL per minute, because the body may not be able to clear cyclodextrin. Hypersensitivity reactions, including anaphylaxis, also have been reported. In the ACTT1 study of 1,000-plus patients receiving either remdesivir or placebo, 273 of 532 (51%) patients taking remdesivir had serious grade 3 or 4 adverse effects, such as respiratory failure, versus 295 (57.2%) in the placebo group (N Engl J Med 2020;383[19]:1813-1826). However, many of these adverse reactions in the active treatment group could have been caused by the underlying disease state, Rech said. Baricitinib, a Janus kinase inhibitor used for rheumatoid arthritis, also has been used in the treatment of hospitalized patients with COVID-19 to lessen cytokine release syndrome. The most common adverse effects are secondary infections, such as upper respiratory infections and nasopharyngitis, so it should be avoided in patients with active tuberculosis. Some cases of thromboses also have been reported, as well as laboratory abnormalities including increases in platelets,

triglycerides, liver transaminase levels and creatinine phosphokinase. The ACTT-2 study (N Engl J Med 2021;384[9]:795-807) of 1,000-plus patients receiving remdesivir plus baricitinib or placebo found the incidence of grade 3 and 4 adverse effects in baricitinib to be about 40%, but the incidence in the placebo group also was similar, again likely due to the underlying disease, Rech said. Some toxicities have been observed with bamlanivimab and the casirivimab plus imdevimab combination, Rech said. The data are limited,

The search for alternative agents has led to greater use of gabapentin, tramadol and other oral analgesics. Prescriptions of tramadol, perceived as safer than traditional opioids, doubled from 23 million in 2008 to 44 million in 2013, according to a 2015 report from the Substance Abuse and Mental Health Services Administration. However, tramadol-related emergency department visits also have increased—by 250%, from 6,255 visits in 2005 to 21,649 in 2011, the report noted. The drug’s dual mechanism of action as both an opioid agonist and a serotonin– norepinephrine reuptake inhibitor leads to many of its toxicities (Clin Pharmacokinet 2004;43[13]:879-923), Brown said. “I refer to it as a ‘dirty drug’ because its metabolism is not very clean,” Brown said. Tramadol is metabolized by Gabapentin Risks the CYP2D6 gene, so Causes sedation, dizziness and ataxia patients could be fast or 50% of patients slow metabexperiencing overdoses olizers of the need to be admitted drug depending to the ICU on their pharmacogenomics. Coprescription of And, both tragabapentin and opioids can madol and its nearly double the risk for active metaboopioid-related death lite are elimiSource: Clin Toxicol 2020;58(7);763-772; nated renally, Am J Psych 2015;172(5):487-488. so someone with kidbut clinicians should watch for infusion ney injury or disease could have excess reactions including anaphylaxis. Gastro- accumulation, leading to more activity intestinal issues such as nausea and vom- on opioid receptors (Clin Pharmacokinet iting have been commonly reported, but 2004;43[13]:879-923). the incidences of serious adverse effects Severe toxicities seen with tramadol in clinical trials were very low, from 0% ingestion include respiratory depresto 2% (N Engl J Med 2021;384[3]:229-237 sion, seizures and serotonin syndrome and others). Of note, Rech said, because (Clin Pharmacokinet 2004;43[13]:879the treatments are directed at the spike 923), Brown noted. Studies have protein on cell surfaces and messenger reported the incidence of seizures to RNA vaccines produce a spike protein, range from 14% to 55% (Clin Toxicol COVID-19 vaccines should not be given 2019;57[8]:692-696). Seizures occur at until at least 90 days after these agents. a variety of doses down to 200 mg, most often within the first two hours Opioids Muddy the Water after ingestion. Respiratory depression With all the focus on COVID-19, it’s has been reported in 0.5% to 20%, in been easy to overlook the ongoing opioid doses ranging from 800 to 2,100 mg or epidemic, said Caitlin Brown, PharmD, higher (Am J Emerg Med 2013;31[1]:26an emergency medicine and neurocriti- 31). Nausea and vomiting have been cal care pharmacist at Mayo Clinic in reported in 22% to 76% in studies (Hum Rochester, Minn. However, overdoses and Exp Toxicol 2008;27[3]:201-205); antioverdose-related deaths continue. More emetics can be used. Another potenthan 19,000 people died of a drug over- tial toxicity is hypo- or hyperglycemia, dose in the United States in the first three Brown said, so it’s important to monitor months of 2020—a 10% increase in opi- glucose in these patients. Treatments for respiratory depresoid-related overdose deaths from March 2019 to March 2020, Brown said, citing sion can include naloxone and intubation. For seizures or serotonin syndrome, data from the CDC (bit.ly/3sd1JDY).

use benzodiazepines (Int J Prev Med 2014;5[3]:302-307), Brown noted. Activated charcoal may be a benefit if tramadol ingestion has occurred within the past hour; otherwise it carries risks for vomiting or aspiration (Daru 2013;21[1]:46). There also has been increased prescribing for gabapentin, largely used for neuropathic pain. In 2016, the drug was the 10th most commonly prescribed medication in the United States, and prescriptions more than doubled from 13.3 per 1,000 beneficiaries in 2009 to 27.1 per 1,000 beneficiaries in 2016 (J Manag Care Spec Pharm 2020;26[3]: 246-252). Meanwhile, gabapentin exposures reported to poison centers had a 72.3% increase from 2013 to 2017 (Clin Toxicol 2020;58[7]:763-772). Common toxicities seen with gabapentin use include sedation, dizziness and ataxia. About 16% of patients experiencing overdoses need to be admitted to the hospital, 50% of them to the ICU (Clin Toxicol 2020;58[7]:763-772), Brown said, “so these toxicities can be severe.” About 60% of patients also ingest benzodiazepines or opioids, which worsens respiratory and central nervous system depression and sedation. In one study (Am J Psych 2015;172[5]:487488), coprescription of gabapentin and opioids resulted in increased risk for opioid-related death (odds ratio, 1.99; 95% CI, 1.61-2.47; P<0.001). Treatment for gabapentin overdose depends on what patients coingested, she said. Because the likely result is sedation and drowsiness, supportive care and airway management are helpful.

More Pain Points Toxic reactions in pain management aren’t always limited to medications with the highest potency, Brown stressed. They also can occur with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), so risk versus benefit should be considered when prescribing these agents. Problems most often occur when used beyond the recommended dosing, she noted. In 2018, analgesics such as acetaminophen and NSAIDS ranked No. 1 in toxic exposures, according to the 2018 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (Clin Toxicol 2019;57[12]:1220-1413). Brown added: “We should continue to use these agents when they are appropriate for pain management, but be considerate and conscious of the toxicities associated with them.” —Karen Blum The sources reported no relevant financial disclosures.

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10 Clinical

Pharmacy Practice News • April 2021

Critical Care

ABx Make the Top 5 in Choosing Wisely Campaign T

he Critical Care Societies Collaborative has put added scrutiny on unnecessary use of antibiotics, making it one of the next five areas of focus in its Choosing Wisely campaign of best practices to avoid waste and promote value in critical care. “Don’t continue antibiotic therapy without evidence of need” is the third new recommendation released this year (Crit Care Med 2021;49[3]:472-481) by the group—which includes the Society of Critical Care Medicine, the American College of Chest Physicians, the American Thoracic Society and the American Association of Critical-Care Nurses—said Pamela Smithburger, PharmD, an associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy, and an ICU clinical pharmacy specialist at UPMC Presbyterian. “Limiting duration of antibiotics to the shortest effective course and eliminating exposure to unnecessary antibiotics are primary principles of antibiotic stewardship,” Smithburger said during a presentation at the 2021 Critical Care Congress Virtual Event. “These measures maintain antibiotic efficacy, and reduce adverse events and cost.” Other items on the list include the following: • Don’t retain catheters and drains in place without a clear indication. • Don’t delay liberation from mechanical ventilation. • Don’t delay mobilization of ICU patients. • Don’t provide care that is discordant with the patient’s goals and values. Reducing unnecessary use of antibiotics—and other medications—in the ICU is one area where pharmacists can take charge, said Mitchell Buckley, PharmD, a clinical pharmacy specialist for Banner – University Medical Center Phoenix. It’s important to look at how medications are used in the whole strategy of patient care, he said, and consider the value of the medication in light of its effectiveness. “This changes our perspective,” Buckley said. “Rather than just get rid of stuff, promote the use of high-value medications. If it brings value, then cost is just part of the conversation.”

‘Rather than just get rid of stuff, promote the use of high-value medications. If it brings value, then cost is just part of the conversation.’

—Mitchell Buckley, PharmD

Antimicrobials are just one aspect of care, he said. “There are several other drug classes that are not as formalized as far as their evaluation and focus on promoting optimal medication use, getting rid of waste and unnecessary medications.” There may be opportunities to improve the use of sedation, opioids, fluid management, antipsychotics and neuromuscular blockers, for example. Medication optimization opportunities and available resources vary among institutions, he said. Look at your institution’s data and medication use for areas to add value to patient care, and then ensure support and buy-in for a potential pilot project from your pharmacy and other members of an interprofessional team.

Targeting Acid Suppression Solving even lower cost medication overuse can yield big savings, Buckley noted. Several years ago, he noticed rampant use of acid suppression therapy in the ICU and general wards. About a third of patients were started on the medications inappropriately in the hospital and discharged still on therapy. A pharmacistled stress ulcer prophylaxis management program helped reduce inappropriate use of these medications by 58% in the ICU and by 83% on the general wards (Am J Med 2015;128[8]:905-913). The program resulted in an estimated cost savings of over $200,000 annually. Pharmacists also can be part of teams working to improve patients’ experience in the ICU, with the goal of not providing care that does not align with the documented health care goals, values and preferences of patients and their families, said Julie Rogan, MSN, CNS, ACCNSAG, a clinical nurse specialist at Temple University Hospital, in Philadelphia. Many hospitals use satisfaction surveys sent after patients are discharged, but Rogan said she likes to follow up

directly with patients either in person or by telephone. “Patients, once they get home and think of things, want to talk,” she said. “If they don’t have a good experience, they may be reluctant to discuss it with their family, but if I call, they will share.” If there is an opportunity to make an improvement, Rogan said she takes that back to the floor.

follow through to determine whether it’s being used correctly. If not, find out whether you need to change the design. Be flexible and adapt as needed, and keep your leadership up-to-date on how the intervention is going. Finally, evaluate the program either through electronic medical record audits, walking around and observing the process, or through surveys or direct interviews with patients and families. “Following up in person is so much better because it opens up more possibilities and ways to connect and build trust,” Rogan said. Other presenters discussed tips to reduce the use of imaging and lab tests in the ICU environment, and to promote

A pharmacist-led SUP management program reduced inappropriate use by

58% in the ICU, 83% on the general wards and saved

$200,000 annually. Source: Am J Med 2015;128[8]:905-913; SUP, stress ulcer prophylaxis

Figure out what you can provide to help, Rogan advised. High-tech or highcost items aren’t necessary. Her hospital created an ICU diary, for example, to track care when families couldn’t be present. This proved helpful for one patient who became disoriented and thought he was in a sinking boat; the diary entry noted that five to six staff members rushed to his room to check on the patient and ensure we would not fall out of bed. The diary thus proved a useful tool for easing the patient’s concerns and documenting his clinical status for the care team. As with other interventions, it’s helpful to get ICU leadership on board and build interprofessional teams to implement them, Rogan said. Leaders could have available funds or ideas on where to apply for funding. If possible, include patient and family input during your design phase. Construct a process map for a solid plan of what you’re doing and why, and who qualifies for these interventions. Then, be an active participant in your proposed plan to ensure success, and

early mobilization of patients. With the release of the new recommendations, “we must continue to deploy strategies to encourage compliance,” Smithburger said. “These strategies should expand beyond simple education of the Choosing Wisely list to potential ties to performance metrics, as well as reimbursement structure such as disincentives for ordering unnecessary tests.” The collaborative’s first set of Choosing Wisely recommendations was released in 2014 (Crit Care Med 2014;42[11]:24372438). It included recommendations not to order diagnostic tests at regular intervals but in response to specific clinical questions, not to deeply sedate mechanically ventilated patients without a specific indication, and not to continue life support for patients at high risk for death or severely impaired functional recovery. —Karen Blum The sources reported no relevant financial disclosures.

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INDICATIONS AND USAGE Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia. IMPORTANT SAFETY INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. • Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. • Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. • Known or suspected gastrointestinal obstruction, including paralytic ileus. • Hypersensitivity to morphine.

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NDC 76045-004-11

Makes narcotic inventory management easier with 5-pack bundling and 10-pack cartons

Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. Common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch. Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms. Pregnancy: May cause fetal harm. Overdosage: Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. This important safety information does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information, including Boxed Warning, for MORPHINE SULFATE INJECTION at www.fresenius-kabi.com/us.

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Morphine Sulfate Injection, USP CII Simplist for intravenous or intramuscular use. BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use MORPHINE SULFATE INJECTION, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for MORPHINE SULFATE INJECTION, USP at www.fresenius-kabi.com/us. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Warnings and Precautions]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions and Drug Interactions]. • Reserve concomitant prescribing of Morphine Sulfate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. INDICATIONS AND USAGE Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions], reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia CONTRAINDICATIONS Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions]. • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment [see Warnings and Precautions]. • Concurrent use of mon oamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions]. • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions]. • Hypersensitivity to morphine (e.g. anaphylaxis) [see Adverse Reactions]. WARNINGS AND PRECAUTIONS (also see BOXED WARNING) • Addiction, Abuse, and Misuse: Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death [see Drug Abuse and Dependence]. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions.

• Life-Threatening Respiratory Depression: Serious, lifethreatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection, or following a dose increase. Because of delay in maximum CNS effect with intravenously administered morphine (30 min), rapid IV administration may result in overdosing [see Overdosage]. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper. • Neonatal Opioid Withdrawal Syndrome: Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be lifethreatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations]. • Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Morphine Sulfate Injection with benzodiazepines or other CNS depressants (e.g. non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. Follow patients closely for signs and symptoms of respiratory depression and sedation. • Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available. • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during dose initiation and titration. • Interactions with Monoamine Oxidase Inhibitors (MAOIs): Morphine Sulfate Injection should not be used in patients taking MAOIs or within 14 days of stopping such treatment. • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. • Risks of Use in Patients with Gastrointestinal Conditions: Morphine Sulfate Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. • Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients with a history of seizure disorders for worsened seizure control. • Withdrawal: Use of mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms. • Central Nervous System Toxicity: Dysphoric reactions may occur after any size dose and toxic psychoses have been reported. • Exposure, Hypothermia, Immersion and Shock: Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock, since impaired perfusion may prevent complete absorption; if repeated injections are administered, an excessive amount may be suddenly absorbed if normal circulation is re-established. • Risks of Driving and Operating Machinery: Morphine Sulfate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Morphine Sulfate Injection and know how they will react to the medication.

The most frequently observed adverse reactions included: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. Other possible adverse reactions include: euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation, constipation, biliary tract spasm, tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, oliguria and urinary retention, pruritus, urticaria, skin rashes, opioid-induced histamine release (flushing of the face, diaphoresis, pruritus, and wheals and urticaria at the site of injection), androgen deficiency, anaphylaxis, serotonin syndrome, and adrenal insufficiency.

ADVERSE REACTIONS [see Boxed Warning and Warnings and Precautions] Serious adverse reactions associated with Morphine Sulfate Injection included: addiction, abuse, and misuse, lifethreatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with benzodiazepines or other CNS depressants, cardiac instability, adrenal insufficiency, severe hypotension, gastrointestinal adverse reactions, seizures, withdrawal, respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously.

For full Prescribing Information please go to www.simplist-us.com

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, option 5, or FDA at 1-800FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Clinically significant drug interactions with Morphine Sulfate Injection: benzodiazepines and other central nervous system (CNS) depressants; serotonergic drugs; monoamine oxidase inhibitors (MAOIs); mixed agonist/antagonist and partial agonist opioid analgesics; muscle relaxants; cimetidine; diuretics; anticholinergic drugs; and oral P2Y12 inhibitors. USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm [see BOXED WARNING for Neonatal Opioid Withdrawal Syndrome]. • Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Naloxone must be available for reversal for reversal of opioidinduced respiratory depression. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. • Lactation: Present in breast milk. Lactation studies have not been conducted and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Monitor infants for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of opioid analgesic is stopped, or when breast-feeding is stopped. • Females and Males of Reproductive Potential: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. • Pediatric Use: The safety and effectiveness in pediatric patients below the age of 18 have not been established. • Geriatric Use: Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. Monitor for signs of central nervous system and respiratory depression. Start at the low end of the dosing range, titrate the dosage slowly and monitor for signs of CNS and respiratory depression. • Hepatic and Renal Impairment: Morphine sulfate pharmacokinetics are altered in patients with cirrhosis and renal failure. Start these patients with a lower than normal dosage and monitor for signs of respiratory depression, sedation, and hypotension. OVERDOSAGE Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose. In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced lifesupport techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Injection, carefully monitor the patient until spontaneous respiration is reliably reestablished.

Policy

Pharmacy Practice News • April 2021

Purchasing

Cold Chain Collaborations a Key to Success W

hen adding technology to pharmacy operations, strong vendor partnerships often are cited as a key to success. Whether it’s tweaking features to ensure interoperability or making last-minute install changes to match workflow, having an engaged vendor can ensure a seamless launch. That certainly has been the case as hospitals race to expand and improve their storage and temperature monitoring capabilities to protect the current crop of COVID-19 vaccines. Mark Lyons, RPh, the interim vice president of pharmacy at the University of North Carolina (UNC) Health Care System, in Durham, N.C., noted that such vendor guidance has been critical to UNC’s cold chain strategy. At the pandemic’s start, Lyons noted, UNC Health ordered three ultracold freezers to raise its safe storage capacity across all 11 hospitals to 1.2 million doses. “We collaborated intensively with vendors in two areas—which freezers we should buy for the vaccine volumes we’d need to receive and store, and the procurement, handling, storage and replenishment of dry ice because we didn’t have a lot of experience with it,” he said. UNC Health administers COVID-19 vaccinations at its hospitals and megasites statewide, including two sites that aim to vaccinate at least 1,000 people per day. UNC also employs community outreach programs, including small neighborhood clinics and mobile sites that help to increase vaccine access to all eligible people. Lyons said UNC Health is ready for the

8 Tips for Evaluating Vendors expected higher flow of vaccinations that should come as a result of these outreach efforts, not to mention the emergency use authorization (EUA) granted to the Janssen COVID-19 vaccine. Storage, transport, thawing, mixing and inoculation processes and vital equipment are in place, he noted, such as ultracold and regular medical freezers, refrigerators, data loggers, and automated temperature monitoring and alarm systems. All of these tech installations were done with vendor support, which is ongoing, he noted. Indeed, “at UNC, we strive to be a customer of choice by building longterm relationships with our vendors,” Lyons said. “This helps us create solutions that benefit us in the long run. Often times, we’re able to gain insight from vendors that we might not be able to obtain on our own.” (For tips on how to make these partnerships a success, and suggestions from vendors, see sidebars.)

Reason for Optimism Lyons said that beyond strong pharmacy–vendor partnerships, there are several added reasons to be optimistic about the future direction of COVID-19 vaccinations, including the Biden administration’s commitment to have 600 million vaccine doses available by July,

The Vendors’ Take

s hospitals raced to expand their storage capacities and temperature monitoring capabilities to protect the integrity of the COVID-19 vaccines, they gleaned insights from cold chain vendors. When Primex consults with hospitals about managing COVID-19 vaccines with its OneVue automated temperature monitoring system, it asks strategic questions, such as what changes they’re putting in place, noted Katie McMillan, PhD, the company’s director of health care solutions. “We like when hospitals scale processes already familiar to them. If they’re flexing to a different approach, such as drive-up locations or pop-up vaccination centers in their parking lots, we support with our analytics team and introduce them to other hospitals doing something similar for additional advice. We’ve seen many workflows from smaller rural hospitals to major health systems.” Primex predicts that the messenger RNA (mRNA) technology created by Pfizer/BioNTech and Moderna “will be used in other vaccines. This isn’t a one-shot deal. The need to monitor extreme temperatures will continue into 2021 and beyond,” added Rob Klinck, Primex’s senior vice president of sales. The company’s automated OneVue system single- and dual-probe sensors continually monitor between –200° C and 150° C; eliminate manual monitoring and data logging; comply with CDC, FDA and

as well as the use of the Defense Production Act to escalate manufacturing of specialized “low dead space” syringes to extract a sixth dose from the Pfizer/ BioNTech vials. Moderna also is getting in on the effort to stretch its own vaccine supplies, he noted: In mid-February, the FDA announced that it will allow Moderna to increase the amount of vaccine in its vials by 40%, which will enable the company to boost the number of doses from 10 to 14 per vial. But potential potholes remain, Lyons said. Although he confirmed that Pfizer low dead space syringes arrived with his February vaccine shipments, he expressed “deep concern” if this doesn’t continue. “The problem with this and limited vaccine supplies and a two-dose series is if you have low dead space syringes for the first injections and get six doses out of each vial, you’re committed to the same for the second injections 21 days later,” he said. “If you don’t have them, you either have to borrow from a new batch of first doses, which you can do if you receive the same brand, or else cancel some appointments.” —Al Heller The sources reported no relevant financial disclosures beyond stated employment.

Joint Commission regulations; export data for compliance reports or regulatory audits; preconfigure to the hospital’s network; run on batteries, electric or PoE (Power over Ethernet); detect whether vaccine storage units are securely closed; and trigger audiovisual local alarms and customized email, text and phone temperature-excursion alerts. Primex has more than 38,000 sensors in about 700 hospitals. “We’re working nearly 24/7 to meet the large increase in demand. The same day we have supply, we ship out sensors to customers,” McMillan said. Grace Qiu, the vice president of operations at Across International, agreed that the persistence of mRNA technology for COVID-19 vaccinations will support the continued need for ultracold freezers. Indeed, the demand for such freezers is so high that there’s an industrywide eight- to 10-week backlog from suppliers on orders today, she noted, adding, “just because a supplier says it’s in stock doesn’t mean it’s the right purchasing decision.” Across International provides ultralow and medical freezers, as well as reusable, insulated, ultracold shipping cubes packed with dry ice “to help others bridge the gap until they get freezers for vaccine storage, transport and redistribution,” Qiu added. Maxwell Dubin, sales development, R&D and trainer at Across International, offered these tips for hospital buyers of cold chain technology: • Seek reputable brands that also offer data loggers,

Seek data that support what vendors claim, ask about their study methodology or hire a technical advisor to help if you don’t have the expertise in-house. Ask about staff training, equipment calibration, and setup, maintenance, custom service and performance at certain temperatures. Expect same-day replies to any query. Try to write into the agreement (nothing verbal) that you’ll be able to collect damages in case of mechanical failure, water leaks or a door not closing tightly; this will usually be in accord with the hospital’s local laws. Many vendors educate customers how to use their products only; seek one that’s neutral so you can make your own decisions. Be sure what you buy enables you to handle all vaccines according to label instructions. Regarding the vaccines: Work within proper channels to avoid falling victim to vaccine counterfeiting, tampering or diversion. Check that what arrives has a bill of shipment bearing the manufacturer’s logo, and that the vials match the images. Source: Rafik Bishara, PhD, technical advisor and chair, Pharmaceutical Cold Chain Interest Group of the Parenteral Drug Association, and member, URAC’s Pharmacy Advisory Council.

alarms and security features, biosafety cabinets, battery backups and compressor surge protection. • Insist on CDC, Vaccines for Children (VFC), and Underwriters Laboratories’ UL61010-1 (for U.S.A.) or CSA (Canada) compliances. • Acquire backup carbon dioxide systems connected to tanks to keep vaccines cold enough while technicians fix any problem. • Use 4-20mA wireless temperature transmitters to export data to automated temperature monitoring systems that use the common RS-232 and RS-485 interfaces to communicate with vaccine storage devices. • Require prompt service, including flying technicians to your practice sites, to help avoid downtime and product waste. Jed Dutton, the vice president of marketing at TemperPack, cited temperature tracking as an essential cold chain capability that health systems need to master. The company’s TransTracker monitors are being used to transport temperature-sensitive COVID-19 vaccines as a way to identify any temperature impact on the way from national distribution centers to health systems nationwide, said Mike Montana, the senior business development manager at Zebra/Temptime. More than 100 U.S. hospitals already use the company’s Edge smart sensors for storage and transport, and TransTracker for transport and redistribution of COVID-19 vaccines. —A.H.

14 Policy

Pharmacy Practice News • April 2021

Sterile Compounding

TJC Eyes USP Compliance continued from page 1

compounding areas (SCAs) to meet requirements for the 2019 revision of USP <797> guidance on sterile compounding, USP’s decision to uphold stakeholder appeals for more expert deliberation on the new revision was reassuring. “The organizations that were not able to get the funding for such significant projects can breathe a sigh of relief that their current setup is adequate to keep them in compliance with USP <797>,” said Susan Reed, RPh, a pharmacy consultant at Steve Hirsch and Associates, in Fountain Valley, Calif. In contrast, organizations that had upgraded their facilities to comply with the 2019 revision will likely meet or exceed the 2008 version from a structural perspective, Reed noted during the virtual ASHP 2020 Midyear Clinical Meeting and Exposition, while in her former role as a consultant at Joint Commission Resources, Inc. One of the more stringent rules in the 2019 USP <797> revision is a requirement for anterooms and buffer rooms to be supplied with HEPA-filtered air through outlets located at the ceiling level, with returns placed low on the walls, Reed noted. In addition, unlike the 2008 revision of USP <797>, which only permits low-risk nonhazardous compounding in SCAs, the latest revision allows hazardous drug compounding in SCAs, assuming facilities are upgraded, she said. “The two revisions address sterile product compounding differently,” Reed explained. Whereas the 2008 revision categorized sterile products by the number and type of ingredients used in the preparation, the 2019 revision still under expert review categorizes compounded sterile products by the location in which products are prepared.

USP Chapter <800> According to Reed, organizations that have geared up to comply with USP <800> can continue with early adoption and ask surveyors to assess their adherence to this chapter. However, they should expect scrutiny of everything from staff training and competencies to receipt of product, through to compounding preparation and appropriate use of personal protective equipment (PPE). One detail that surveyors will want to see in place for organizations requesting assessment for USP <800> compliance is that an individual has been designated to oversee hazardous medication compounding, Reed noted. “This individual needs to ensure that staff that handle and prepare hazardous medications receive appropriate training, including the appropriate use of PPE for their role,” she said.

“The individual needs to work with a multidisciplinary team to perform an assessment of risk for hazardous medications and to determine proper handling, including PPE for receipt and storage, product preparation, disposal, and decontamination and cleaning requirements,” Reed added.

USP Interim Guidance During Pandemic The USP has made exceptions to some rules during the COVID-19 pandemic. For example, to help with management of drug shortages, pharmacies may perform medium-risk compounding in SCAs until the public health emergency is declared over, Reed noted. “However, if you’re following this interim guidance, make sure that when the pandemic has cleared, you return to the 2008 revision of USP <797>,” she cautioned. Interim guidance issued by the USP during the pandemic includes these other allowances: • For as long as the public health emergency continues, institutions may extend beyond use dating (BUD) for low- and medium-risk, nonhazardous compounded sterile preparations that have been prepared in an SCA to 12 hours at a controlled room temperature, or to 24 hours when refrigerated (bit.ly/3958yjq). • If there are PPE shortages, organizations may conserve PPE by storing garb in a way that minimizes contamination or maintain garb within the perimeter of the SCA, or use other measures that USP has outlined (bit.ly/3165IX3). • Pandemic-era interim guidance also allows organizations to delay recertification of primary and secondary engineering controls as long as these controls are being continuously monitored, and assuming the time between certifications does not exceed 12 months. • If there is a supply shortage of sterile 70% isopropyl alcohol, institutions may compound the product in-house. “USP understood that organizations have really been challenged in maintaining compounded sterile areas and coping with limited product,” Reed said, urging facilities to increase the frequency of personnel monitoring to every six months while adhering to interim guidance to ensure they are maintaining standards of performance. With the exceptions listed, organizations need to comply with all the usual USP rules, Reed reminded meeting attendees. This year, surveyors will be looking to make sure: • there is standardized training in place

Technicians at Massachusetts General Hospital prepare daily compounded sterile preparations.

for staff who prepare and verify compounded sterile preparations; • annual assessments for donning and doffing garb are done; • gloved fingertip sampling is performed, and • media fill challenges and didactic assessments are conducted. Surveyors will want to see that staff members who perform surface cleaning are adequately trained and have documented competency in this task, and that they clean surfaces in the correct sequence using only products approved by the organization, Reed added. Another aspect of compounding compliance that surveyors will be placing emphasis on this year is ensuring prior certification reports have been reviewed for completeness, and that positive culture results from air and surface sampling have been addressed. “Perhaps the most common area of noncompliance with regard to engineering controls is staff or pharmacy leadership not knowing how to read certification reports and not acting on the results,” Reed said. Remediation strategies need to be documented, and contaminated surfaces and air samples should be retested, she stressed. Although the Joint Commission has found that organizations do a “really good job training staff and assessing their competencies, some have been challenged in documenting this training and competency,” Reed noted. For example, “organizations that still use paper documents in particular tend to have a problem if they group their papers by date rather than individual, because it makes it difficult to retrieve the information in a timely manner. By filing paper-based competencies by individual, all tasks completed can be found in a single record and location.”

USP Compliance at MGH Paul Baker, PharmD, the compounding compliance coordinator at Massachusetts General Hospital, in Boston, said he and his colleagues are making sure they have

all the proper documentation for compliance in place this year. This is particularly important given that some surveys are being conducted virtually, he noted, and this shifts surveyor attention away from direct observation and toward checking documents. “We’ve gotten everything in order by conducting internal audits of our documentation pertaining to certifications, environmental monitoring, scheduled tasks, cleaning logs and other items,” said Baker, who was not part of the ASHP session.

Monthly Meetings To be certain his facility is complying with USP requirements, Baker and his team hold monthly meetings to review documentation and results of reports, and update standard operating procedures (SOPs). “Each of our five compounding pharmacies’ managers of record, their lead technicians, the quality compliance team and the chief pharmacy officer have a seat at the table.” Another strategy that the team uses to increase the likelihood of full compliance with USP standards ahead of a survey is auditing reports that have been issued by vendors’ engineering control certifiers. The team is making sure this equipment is being tested to current standards and is properly calibrated, Baker said. “For our environmental monitoring, too, we work with a third-party vendor to ensure that sampling frequency, selection of sites and media use, for example, meet or exceed the USP standard and follow SOPs,” Baker added. Mock quarterly audits, in which a member of the compliance team observes personnel to see if SOPs are being followed as written, also have been useful in identifying potential issues with compliance, Baker said. “These [drills] have helped us to ensure that what is written in procedures is practiced by staff.” —David Wild The sources reported no relevant financial disclosures.

Policy

Pharmacy Practice News • April 2021

Hazardous Waste Handling

Navigating PPE Waste Disposal During a Pandemic

he increase in the need for personal protective equipment (PPE) and its use during the COVID-19 pandemic has produced a rise in medical waste as institutions dispose of gowns, gloves, masks, face shields and shoe covers that have been exposed to the virus. “There definitely is more regulated medical waste being generated, and a lot of it is derived from PPE,” said Rudy Vingris, the health care business development manager at Waste Management Sustainability Services. The challenge, he noted, “is that there isn’t a national standard that applies across the board to determining what types of COVID-19– related PPE should be regulated as medical waste. It’s up to individual states.’ The Occupational Safety and Health Administration and the CDC released guidance specific to COVID-19 waste, which determined that the virus is a Category B infectious substance. This means PPE and other medical waste generated in the treatment of patients with COVID-19 can be managed in the same way as other waste related to Category B infectious substances, in contrast to the more hazardous Category A infectious waste generated in the management of diseases such as Ebola. “This classification means that, unless the PPE is grossly contaminated with blood or bodily fluids to the extent it could lead to an infection, it is technically just trash and can go to the solid waste stream,” Vingris said. However, given that COVID-19 is a highly communicable disease, treating exposed PPE as ordinary waste rather than hazardous medical waste gives some people pause. “The University of Nebraska Medical Center has done studies on surface and air contamination associated with the virus, and has found measurable concentrations in the air and on surfaces where patients have been,” said Fred Massoomi, PharmD, the senior director at Visante (Sci Rep 2020;10[1]:12732). “We know this is a virus that likes to linger. So, while some systems are managing COVID-related PPE as routine waste, others are treating it as biohazard waste that gets autoclaved or incinerated, depending on how they classify it.”

California allows for some discretion in its regulations on PPE: “If the facility determines that any PPE should be disposed of [as solid waste], used gloves, face masks, coveralls, etc., should be placed in a lined container, preferably with a lid/ cover. Tightly close off the bag before disposing the solid waste items into the ... waste bin for pickup by the waste management company.” Disposal of regulated medical waste is,

of course, much more costly than solid waste. “It’s more expensive by probably an order of magnitude of 10 times or more, although not as expensive as something like RCRA [Resource Conservation and Recovery Act] waste that we would see in an oncology pharmacy,” Vingris said. “So is it breaking the budget? No, but it is definitely something that folks have had to adapt their planning and budget for as part of overall waste management.”

Furthermore, “as hospitals and pharmacies set up vaccination centers, they will also be generating even more waste that is definitely considered regulated medical waste, such as sharps containers. That is definitely going to drive up costs at these institutions.” —Gina Shaw The sources reported no relevant financial disclosures.

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16 Policy

Pharmacy Practice News • April 2021

Reimbursement Matters

Getting in sync with payors on this issue is key

What’s Your White-Bagging Strategy? I

established practices intended to t would be an understatement to line of sight into the origin and handling ensure patient safety.” say that hospital pharmacists are of a drug prior to receipt by the hospital, disgruntled with the concepts of white raising significant concerns and creat- • “White bagging negatively impacts pharmacists’ ability to validate medibagging and mandated restricted drug ing substantial challenges. These actions cation integrity and maintain overdistribution models that commercial pay- pose significant risks to quality of care sight of storage and handling.” ors include in their armamentarium of as providers have inadequate control in drug spending control tools. Some phar- ensuring patient access to high quality • “By sidestepping well-established supply chain procedures, white bagmacists have prohibited white bagging drugs, as well as the appropriate storage ging disrupts efforts to maintain at their facilities and diligently try to and handling of those [medications].” adherence with protocols designed The AMA statement (bit.ly/3rSU91h) avoid restricted drug distribution, perto ensure patient safety, quality, and haps even closing formularies to those added that “these policies simply serve continuity of care.” affected products. Is this developing into to drive more revenue to health insurers a standoff between hospital pharmacists through their pharmacy benefit management and specialty pharmacy lines of It’s All in the Contract and commercial payors? In my December 2020 column, “Ring- business.” Let’s turn our focus to another aspect of ASHP has taken extensive action to white bagging and other restrictive payor ing in the New Payment Year” (bit.ly/ 3vyaOt6), I suggested that payor require- address payer-mandated white bagging strategies that rarely, if ever, are addressed ments will continue to increase. So it will with an advocacy agenda announced in the pharmacy literature: the business be worthwhile to negotiate payments for March 18. The organization stated that: contracting relationships that your facilthe work done by pharmacy. The negotia- • “[It] stands opposed to payer-manity has established with the commercial dated white bagging models that tions could touch on anything from hanpayors, including MA. These annual conjeopardize optimal, safe, and effective tracts have been put into place to provide dling fees for zero-priced (white-bagged) medication use.” drugs (sidebar) to any number of outpathe covered beneficiary (the patient) with tient and ambulatory clinical services. • “Payer-mandated distribution models services that the hospital system offers— that require clinician-administered The assumption is that there is a desire for example: ER visits, inpatient care, drugs to be dispensed exclusively via at the facility for a workable solution that outpatient care including infusion clinthird-party specialty pharmacies are provides some remuneration for its work ics, perhaps ambulatory services, laboraplacing patients at risk and threaten in handling and administrating, as well as tory services, radiology services, and perto compromise organizations’ welladministering, the affected zero-priced haps physical and occupational services, drug products, albeit not the billed etc., depending on contract terms. revenue from the markup on the The covered beneficiary (patient) drug that was lost. has signed up with this carrier for Such involvement also is based their health insurance at what can on the assumption that hospital be a substantial sum. Imagine their pharmacists are willing to continue shock at arranging for services at to be advocates for patient assisyour infusion clinic only to find that tance programs, working with their your pharmacy has denied the use of in-house financial navigators and expensive drugs that their insurance supporting agencies. Another piece carrier is willing to provide as zeroof this puzzle involves negotiating priced (white-bagged) drugs to you. with pharmaceutical companies. They may very well have chosen this Remember that you can negotiate plan because of coverage of those the handling fees for these patientdrugs that you are now blocking. specific zero-priced drugs, because My point is this: Refusing to work there is no billed revenue from with white bagging isn’t a viable hite bagging is the practice of having their use. The functions of receivoption. Whether it is the foremenpatient-specific medications or suping, storing, handling, prepartioned contracting for handling fees plies delivered directly to the practice seting and returning or disposing of for these medications or some othting (outpatient infusion center, physician zero-priced patient-specific drugs er strategy, work with your payors office, hospital) for use by a specific patient. is very similar to those for zeroto come up with a mutually benThe specialty pharmacy shipping the prodpriced white-bagged medications. eficial solution. Also, remember that uct directly to the practice site has already billed the insurance company for the product Many of the frustrations and conthis isn’t a decision that pharmacy and collected the copay from the patient or cerns that hospital pharmacists have should be making unilaterally withsecondary insurer. There is no opportunity for about zero-priced drugs relate to out the endorsement of the C-suite the practice site to bill for the product; it is prethe areas of supply chain, storage, and their disclosure of this decision paid or complimentary. The practice evolved security and vetting of the products. to the health insurance carrier and due to some insurance carriers mandating that These are valid concerns that need all key stakeholders. patients and providers use specialty pharmato be addressed. They’re time-concies to obtain their medications. ManufacturerCollaborative Practice suming and often can go against the supported patient assistance programs and Agreements grain of established departmental some FDA-assigned Risk Evaluation and Mitstandard operating procedures. Payor relationships aren’t the only igation Strategies programs also are cited as In a March 8 white paper, the ones that hinge on effective negotireasons why specialty pharmacies become the AMA addressed the issue by urging ating; collaborative practice agreemandated source for prescription dispensing. regulators to prohibit health insurments also require all stakeholders (Clear bagging, a related process, is the term ance pharmacy policies that “limit to be equally involved and advocatused when the health care system supplies the medications from its own specialty pharmacy.) the ability of hospital staff to have ing for their interests. But for that

What W hat IIs sW White hite Bagging?

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered.

Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon AMA, American Medical Association; CPT, Common Procedural Terminology; E/M, evaluation and management; MA, Medicare Advantage; MLN, Medicare Learning Network; PFS, Physician Fee Schedule

to happen, a basic grasp of how payments are made in this setting is required. Let’s start with the basics: Because collaborative practice agreements establish a formal relationship between the pharmacist and the physician, your first step is to understand the reimbursement structure that governs physician payment. From a Medicare perspective and any commercial plans that follow Medicare’s lead, this is found in the PFS regulations. Some of those commercial plans may be the ones that cover your MA patients. Payment for office and outpatient E/M visits should be a focus. MLN Bulletins are an easy way to stay on top of this, because they provide the key rule-set changes as well as background material and references just as they do for drugs and biologicals. For instance, a recent publication addresses PFS payment of office and outpatient E/M visits (CPT 99201-99215) to illustrate how Medicare generally adopts the new AMA coding, language and interpretive guidance framework (go.cms.gov/3rVj18u; go.cms.gov/2QbfsgB).

Promoting Wellness COVID-19 cases are down, but the pandemic is still with us. Amid those pressures, it’s all too easy for patients and caregivers to forget about wellness. Are you part of the “Annual Wellness Visit” or “Yearly Wellness Visit” that focuses on preventive health? Pharmacists are uniquely qualified to perform a health risk assessment and develop or update a personalized prevention plan for the patients they routinely see while providing or managing their medications. And it’s a reimbursable service! For more information, visit go.cms.gov/3eNTLxs. For details on how to properly provide and bill for Medicare preventive services, visit go.cms.gov/3cyZ9Sg.

Drug Exclusions Finally, a note on yet another oft-overlooked area of reimbursement: keeping up with the latest version of the selfadministered Drug Exclusion list, which took effect April 1, 2021. This is a vital step in ensuring the accuracy of billing and reimbursement. For more guidance, see go.cms.gov/2QfP6u1. ■

Q&A

Pharmacy Practice News • April 2021

Advertorial

The following advertorial is provided by Across International. It is designed to support the advertisement below.

Across International How do you see the role of an equipment supplier or manufacturer in fighting the COVID-19 pandemic, or any health emergency? Every community and human being relies at some point on the health care infrastructure around them, and that infrastructure relies on professionals and the instruments they work with. The responsibility of a manufacturer and supplier is not only to offer something that meets equipment specifications, it is also about foreseeing equipment features that will make the daily tasks of health care workers easier and quicker to perform, so they can get more done every day. It also involves providing a support structure to make sure providers have all the tools they (and their patients) need. Temperature precision, uniformity so every sample (and thus patient) receives the same care conditions, medical-grade compliance to meet CDC and VFC guidelines as well as electrical and safety certification standards, and a robust quality assurance and control process are three pillars in the foundation of this effort, as well as a variety of features unique to us.

this global initiative other than Energy Star–rated equipment? Certainly, and any customer should question what the companies they buy from are doing for the environment and community around them. Not only does Across International construct our hardware for maximum temperature retention, accomplishing the goals of good, consistent chilling or heating performance as well as minimizing energy usage maintaining temperatures of the equipment or laboratory they are working in, but Ai uses only environmentally friendly CFC- and HCFC-free refrigerants,

and the latest RapidChill lines use HC refrigerants that chill faster, use less energy and are readily available for recharge. Finally, Across International is a member of the NJ SEEDS Scholars Program board of trustees, helping to give the next generation of innovators the resources they need to get the education and opportunities to be successful in their career goals.

Earlier you mentioned a support structure to back your equipment. Can you tell us more about that? All Across International equipment is supported by trained engineers available out of three locations in Livingston, N.J., Sparks, N.V., and Baywater, VIC Australia, and undergoes a strict inspection

process both after manufacturing and before shipment. Every unit comes with a warranty including parts and labor from trained technicians, while many competitors simply send customers components and expect them to hire local repair technicians that may not be available as urgently as samples such as vaccines need them, and are unfamiliar with the equipment once they get there. Even surpassing industry-leading warranty guarantees, Ai is always there to support the timely answer of questions or quoting after-warranty repairs for no more than a reasonable fee that reflects what it costs. Scientists sense that Ai has the same values of customer satisfaction that they look for in a supplier and a partner in innovation.

COVID-19 VACCINE COLD STORAGE SOLUTIONS

What are some of these unique features you refer to? One example is the wide variety of data-logging and communication capabilities Across International offers to make audits and ensuring vaccines or other critical samples were properly stored and easily accessible for lab teams. The flagship RapidChill and Glacier –86° C freezers have onboard data-logging that can be exported via USB to track temperature over time, and offer the option of an additional 4-20 mA transmitter for communicating with existing systems in hospitals, freezer farms, pharmacies or drug discovery departments, as well as a la carte wireless data loggers that can provide text and email alerts if any alarms are triggered on any of Ai’s cold storage or heat treatment options. These ULT freezers suitable for Pfizer/BioNTech vaccines also have backup batteries to continue reading temperature during a power failure, as well as the DeepFreeze -40 C series suitable for the Moderna vaccine, and the Medical Pharmacy 2-8C refrigerators suitable for the Johnson & Johnson, AstraZeneca, Novavex, and others seeking FDA emergency use authorization.

- 86 0C ULTRA-LOW FREEZER LINE

This all makes sense for vaccines fresh from production or already delivered to where they will be administered to recipients at distribution centers, but how do these vaccines get from point A to Z? That is a very good question, as many vaccines are unfortunately wasted (or even worse, administered to people anticipating their protective effects, and disappointed or even endangered when their quality has been compromised) due to mishandling in transportation. Across International applied another of our unique technologies, the VIP vacuum insulated panel made of Micro-Cellular Polyurethane insulation, to the Ai –70˚ C-rated 20-L shipping cube that retains the cooling power of dry ice for up to 72 hours until vaccines are safely delivered to long-term storage freezers or refrigerators. This same insulation technology, together with some other design features such as double seals, also earned several of the RapidChill –86˚ C freezers an Energy Star rating.

That brings up a great point that is important not to lose sight of in the pandemic panic: sustainability and the environment. Does Ai do anything else to contribute to

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18 Operations & Management

April 2021

COVID-19 Pandemic

Get the latest news from the most widely read specialty pharmacy publication in the United States, including multimedia and web-only content, delivered directly to your inbox! UCSF Health is deploying multiple strategies to reach underserved populations that may have limited access to vaccines, including partnering with Sutter Health to bolster drive-through vaccinations.

Vaccine Inequities continued from page 1

The challenge is a steep one, according to the initial data on vaccination access. In Maryland, for example, Black people make up 30% of the population and account for 33% of COVID-19 cases and 35% of deaths—yet as of Feb. 16, they represented only 17% of vaccinations, according to state-reported data on COVID-19 vaccinations gathered and analyzed by the Kaiser Family Foundation (bit.ly/3dSs9qz). In Ohio, Blacks make up 12% of the population, 13% of the COVID-19 cases and 12% of the deaths, but just 6% of those vaccinated. In Arizona, where Latinx people comprise 32% of the population, 36% of COVID-19 cases and 31% of the deaths, they accounted for just 13% of vaccinations. As for Texas, Latinx people make up 40% of the population, 42% of COVID-19 cases and 47% of deaths, yet they account for only 20% of those vaccinated. The reasons for these inequities in vaccination rates are complex, experts told Pharmacy Practice News. But availability is looking like a significant factor. In many parts of the country, minorities have to travel farther to receive a vaccine than white people do, according to a new pharmacist-led study by investigators at the University of Pittsburgh Medical Center (UPMC).

Vaccine ‘Deserts’

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Released in early February, the study, a white paper posted on the University of Pittsburgh’s website (bit.ly/37IDhCf ), found that in 69 counties, Black Americans would need to travel farther to get to sites such as hospital outpatient departments, federally qualified health centers and rural health clinics, and community pharmacies that formed the early backbone of large-scale vaccination efforts. The study, which used a sample population and geographic data supplied by the National Council for Prescription Drug Programs, the Centers for Medicare and Medicaid Services, and the Health

Resources and Services Administration, among others, found that some of the worst so-called “vaccine deserts” for Black people were in Georgia, Louisiana, Mississippi and South Carolina. In Lee County, Ga., for example, Black Americans are 825% more likely to live more than 10 miles from a vaccination location than whites. In Madison County, Miss., the figure is 976%. And in Chilton County, Ala., it’s 1,193%, the study found. But disparities are not limited to the rural South, according to lead investigator Lucas Berenbrok, PharmD, an assistant professor of pharmacy and therapeutics at UPMC School of Pharmacy. “Of those 69 counties, 23 are in urban areas, some are in the West and Southwest, and a few are in the Northeast,” Berenbrok said. “The point this analysis makes is that our existing health care infrastructure probably isn’t going to cut it in terms of achieving a good, equitable distribution of vaccines.” Barenbrok stressed, however, that his team’s analysis was based on sites representing existing, traditional vaccination infrastructure; it did not include the kinds of mass vaccination sites that, as previously noted, are now being established at stadiums, community pharmacies and convention centers. But even once those sites start ramping up vaccine distribution, they cannot guarantee widespread access to traditionally underserved populations, he noted. “Our research suggests that the sites that are popping up need to pop up in underserved areas. Where population density is lower, mobile vaccine clinics would be a good use of resources to meet people where they are, and that’s something hospital and health system pharmacies could play an important role in.” (For an account of one pharmacy that has been sending out COVID-19 support vans to underserved neighborhoods, see “Heeding the Call of COVID” in the December issue of Pharmacy Practice News; bit.ly/3slpVDP.)

Operations Operat & Management

Pharmacy Practice News • April 2021

COVID-19 Pandemic Pharmacies At the Ready The UPMC study underscores that, even in communities where there is less access to care generally, pharmacies stand ready to fill the COVID-19 vaccination gap, said Tom Kraus, JD, the vice president of government relations for ASHP. “While it is absolutely a problem that there are fewer pharmacies in those communities, let’s take advantage of those that are there and leverage them as vaccination sites, while we also establish mass vaccination sites, partner with community organizations and have the government step in to supplement resources already on the ground.” Kraus praised steps being taken by the Biden administration to bring the resources of the Federal Emergency Management Agency (FEMA) and Department of Defense to establish more vaccination sites in communities in need and to support logistics at those facilities. (In March, Biden promised enough COVID-19 vaccines to inoculate all adult Americans by the end of May.) “They are specifically allocating vaccine supplies to pharmacies in underserved communities, which is essential,” he said.

Signs of Progress The move to open mass COVID-19 vaccination sites has been done with at least an eye toward underserved populations. In March, four of the megasites opened in Florida—two in Orlando, one in Miami and one in Tampa. Each site has two smaller, mobile satellite sites that each can conduct 500 vaccinations per day in underserved areas. In addition, on Feb. 16, the first of several mass vaccination sites in California opened at California State University, Los Angeles (Cal State LA) and Oakland-Alameda Coliseum—in two of the areas’ most diverse and economically challenged communities. “[Cal State LA] serves communities that have been ravaged by the pandemic, including Boyle Heights, East Los Angeles, much of South Los Angeles and communities in Southeast Los Angeles County,” the university said in a statement. The Oakland site is complemented by another megasite at a campus of the City College of San Francisco, operated by the city in partnership with the University of California, San Francisco (UCSF) Health, which opened on Jan. 22. “City College is in an area with a large Black and Latinx population, and is very accessible by public transportation,” Desi Kotis, PharmD, an associate dean of the UCSF School of Pharmacy and chief pharmacy executive for UCSF Health, told Pharmacy Practice News. “Our partner, Sutter Health, has also worked with the city to open pop-up clinics at our produce markets so that people working in the fields, in agriculture, have easy access to vaccines.” UCSF Health is deploying multiple strategies to reach underserved

Significant disparities at P<0.05 Nonsignificant disparities at P<0.05

Figure. Counties where Black residents were more likely than white residents to have a driving distance more than 10 miles. populations who may have limited access to vaccines. “For example, for a group of our patients from Japantown, we sent a bus to bring them to the City College vaccination site,” Kotis said. “Lyft and Uber have also partnered with us in the city to get people to our drive-through vaccination sites.” Kraus pointed out that hospitals that provide services to underserved communities are often safety net/340B institutions, which have been negatively affected by recent cuts to the federal 340B Drug Pricing Program. “The administration should be thinking about ways to leverage those 340B programs to support existing infrastructure and improve access to vaccination services,” he said.

IU Health Meets Inequities Head-On Addressing racial and ethnic inequalities in vaccine access requires a variety of solutions for meeting specific community needs, noted Tate Trujillo, PharmD, the director of pharmacy for Indiana University Health. “Our hospital is in downtown Indianapolis, and the county hospital is also in a location that is accessible for much of our Black and Latinx population,” Trujillo said. “The bigger challenge is getting people registered for the vaccine. We have a statewide online vaccine scheduling system, but we recognize that some people in communities of color have limited access to these resources. So, we are planning to partner with community organizations and houses of worship to spend afternoons helping people sign up for appointments to get vaccinated, and answer their questions and address vaccine hesitancy at the same time.” Blue Cross Blue Shield of Massachusetts is partnering with the state’s League of Community Health Centers to contribute $1 million to fund free rides to and from COVID-19 vaccination sites across the state to support community health centers, underserved communities and vulnerable populations. “First, we are doing quick interventions like our community health center and Lyft partnership and $1 million grant

announced last week,” said Cedric Terrell, PharmD, MHA, the insurer’s chief pharmacy officer and vice president of health and medical management. “Lack of access to transportation is a significant barrier in communities hardest hit by COVID-19. Partnering with the community health centers will help more people get vaccinated.” Kraus noted that the current, concerted efforts to respond to inequities in vaccine access must continue past the pandemic. “Those disparities won’t go away when the vaccine effort ends. We should be

th thinking about how we address them long tterm,” he said. “If we identify resources in communities that are good avenues in ccaring for patients, that doesn’t have to eend with vaccines.” If pharmacies are the sites of care available in otherwise underserved a ccommunities, “let’s figure out how we provide primary care solutions through p tthese avenues,” Kraus said. “Let’s leveraage the attention this issue is getting to aaddress these disparities long term.” The government also recognizes the need to identify and eliminate health n and social disparities that has resulted in disproportionately higher rates of exposure, illness, hospitalizations and death related to COVID-19 among minorities. The COVID-19 Health Equity Task Force was established in January to make recommendations to mitigate all of the inequities caused or exacerbated by the pandemic, including vaccination, according to Marcella Nunez-Smith, MD, who heads the taskforce. At a White House briefing in February, Nunez-Smith said the task force is focused on three key areas: testing, treatment and vaccination. —Gina Shaw The sources reported no relevant financial disclosures.

20 Operations & Management

Pharmacy P Pha Ph harm h Practice News • April 2021

Practice Models

Top of Your License continued from page 1

New Mexico: 2 Advanced Practice Pharmacist Designations New Mexico has two different advanced practice pharmacist licensures: The Pharmacist Clinician (PhC) license. In place since 1993, the PhC allows pharmacists prescriptive authority under a collaborative drug management protocol, which includes laboratory and diagnostic ordering. They

participate in comprehensive disease management and can receive authorization from the Drug Enforcement Administration to prescribe controlled substances. Independent pharmacist prescriptive authority. This approach was established in 2001 in response to low immunization rates in the state. This designation is most commonly used in community pharmacy settings and narrower in scope, with a limited set of authorized drugs that includes adult and pediatric immunizations, hormonal contraception, tobacco cessation, tuberculosis testing and naloxone. The protocols are individualized, but each practitioner must complete the state Board of Pharmacy–approved 60-hour assessment course and a 150hour direct care preceptorship with 300 patient contacts, supervised by a practitioner with prescriptive authority, according to Gretchen M. Ray, PharmD, an associate professor in the College of Pharmacy at the University of New Mexico Health Sciences Center, in Albuquerque. “The individual PhCs’ protocol will include their purpose, scope of practice and procedures they can perform and conditions they can treat, and a list of policies, such as when the pharmacist clinician should contact the supervising physician,” Ray said during a session on advanced practice models at the American College of Clinical Pharmacy 2020 virtual annual meeting.

“The supervisors do not need to o be physically present when the pharmacist clinician is practicing, orr even in the same city; they only must be available for contact by phone or electronic ectronic messaging. Under my own protocol, ocol for example, each time I see a patient, I forward my notes to their primary care provider to facilitate continuity of care.” Protocols for PhCs often extend beyond the primary disease states, bey aallowing for flexibility if the pharmacist needs to make an adjustment m tto another medication. For example, Ray shared the protocols for a PhC R iintegrated into a family medicine cclinic providing diabetes and cardiovascular risk reduction services. d In addition to the expected disease states, this PhC also is authorized to st refill medications, provide drug dose re adjustments and otherwise offer disad ease ea management for a range of other conditions, including osteoporosis, co gastrointestinal disorders, chronic and ga acute acu pain and neuropathy, and respiratory disorders such as asthma and rat chronic obstructive pulmonary disease. chr “So “ if a patient comes in for a diabetes medication and the pharmacist clinician notes that his creatinine clearance is at 45, and the gabapentin he is on has not been adjusted, that pharmacist can titrate that dose at the same time she is providing glycemic management,” Ray explained. PhCs in New Mexico practice in a wide variety of clinical settings, ranging from heart failure and general cardiology clinics to neurology, rheumatology, endocrinology, hepatitis C, HIV, transgender health and geriatric clinics, among others, Ray said. Many clinicians in the state remain unaware of the two types of advanced practice pharmacist designations. In a survey published in the Journal of the American Pharmacists Association, conducted in 2019 and completed by 634 physicians, osteopaths, nurse practitioners and physician assistants in New Mexico, Ray found that 78% of respondents were aware of the PhC designation and 75% would refer to a PhC if available, but only 32% knew about both types of licensure (J Am Pharm Assoc 2021;61[1]:101-108). “There was high awareness for adult immunizations, but fewer people knew about pediatric immunizations and the other independent prescriptive authority pharmacists can obtain,” she said. “Only 41% of respondents knew about hormonal contraception, and 40% about tobacco cessation medication. But once they knew about this authority, their willingness to refer was

much higher, with 71% willing to refer for hormonal contraception, 89% for tobacco cessation medication and 92% for naloxone.”

Following the Money Reimbursement and cost has been a key barrier to broader adoption of topof-license clinical pharmacy practice in New Mexico, Ray said. That barrier was partly dismantled in March 2020, when the state legislature passed H.B. 42, the Pharmacist Prescriptive Authority Services Reimbursement Parity Act, which requires commercial insurance and state Medicaid to reimburse pharmacists with prescriptive authority at the standard contracted rate at which the plan reimburses other providers. “Lack of reimbursement from Medicare Part B will continue to remain a significant barrier to expansion of services, however,” she said. (Because they are still not recognized as providers under Medicare Part B, pharmacists cannot directly bill Medicare for most of their clinical services.)

North Carolina: CPPs Improve Outcomes, Patient Satisfaction North Carolina is one of six states ( joining California, Maine, Maryland, Montana and New York) and the District of Columbia that include certification by the Board of Pharmacy Specialties (BPS) as one of several qualifying credentials for an expanded scope of practice, according to the ACCP. These states use various titles for their advanced practice pharmacist designations; North Carolina’s is the Clinical Pharmacist Practitioner (CPP) license, established in 2001 as a collaboration between the state Board of Pharmacy and Board of Medicine. Researchers have documented the value of North Carolina’s CPP license, which requires either board certification from the BPS, residency training plus two years of clinical experience, a PharmD plus three ee years of experience, or a Bachelor of Science in Pharmacy plus five years of experience and two certificatee programs, as well as 35 hours of practice-relevant continuing ng education

annually. annua A 2018 study involving patients in a family-centered patien medical home model, seen medic in a ttransitions of care clinic, found that CPP involvement reduced h hospital readmissions to compared with 18.8% with7.7% com out CPP involvement (J Pharm 2018;31[2]:175-182). Earlier Pract 20 research found similarly significant improvements in hospital readmission rates (J Manag Care Spec Pharm 2015;21[3]:256-260), as well as high rates of patient satisfaction (J Manag Care Spec Pharm 2017;23[11]:1125-1129).

A Solid-Organ Transplant Program Clinics within the UNC Health system that incorporate CPPs operate under a variety of models, said Christina Teeter Doligalski, PharmD, BCPS, CPP, a solidorgan transplant specialist. “In our transplant service, I am responsible for all primary care issues, triaging all lab follow-up in between visits—we may have patients coming in only once a month, but getting labs as much as twice a week—and the overall plan of care. But 90% of visits are multidisciplinary, with a collaborative discussion about immunosuppression. By contrast, endocrine clinic visits are 100% conducted by the CPP, who is responsible for initiation and adjustment of endocrine therapy only, with minimal between-visit triage,” Doligalski said at the ACCP virtual annual meeting. There are multiple challenges to the CPP model, Doligalski acknowledged. “For the CPP, deep disease state–specific specialty knowledge is required to provide thorough and well-considered recommendations for patients. For the health system, the unique and disparate services mean that it’s almost impossible to have consistent metrics to apply to all clinics, and it’s also difficult to have an ‘elevator speech’ to sum up the importance of the program when talking to those outside of the pharmacy realm.” Providers also may not understand the value of the CPP. “I’ve encountered situations with physicians who are incredibly pharmacy friendly, but who still don’t know what I as a CPP can do. I’m not just a drug information resource; I can actively

Operations & Management

Pharmacy Practice News • April 2021

Practice Models manage pharmacotherapy for our patients,” Doligalski said. To overcome challenges, she urged early, robust assessment and training for the new CPPs, along with mentor partnering with more seasoned CPPs; clearly defined metrics that can apply to all CPP clinics (e.g., the patient satisfaction and readmission measures described in the studies above), accompanied by clinicspecific metrics meaningful to both the health system and clinic leadership; and early and frequent communication with key providers about the CPP’s role and scope of practice. “What has made our program so successful is that we go into each clinic and assess its specific needs, rather than rotating pharmacists between clinics and having them cross cover each other,” Doligalski said. “We’ve customized our CPP service to the needs of each clinic, which hopefully leads to enhanced patient and provider satisfaction as well as improved outcomes.” With the help of residents in the health-system pharmacy administration and leadership residency program, Doligalski and her colleagues are developing clinic-specific metrics to assess those outcomes. “We’ve done a couple of small looks at individual clinics. In mine, for example, we did find decreased hospitalization rates and improvement in certain outcomes like blood pressure control and guidelinedirected medication therapy utilization, but since we are putting together a manuscript on that, we can’t release any more specific data right now.”

Getting Paid for These Efforts Reimbursement for CPP services in the UNC Health system takes one of two approaches. The physician-owned practices are able to employ “incident to” billing, in which nonphysician practitioners can bill for certain services under the provider’s National Provider Identifier number. “Our family medicine clinic, for example, is a physician-owned practice, and the physician sees the patient annually but then may want them to see the pharmacist in three months for medication management follow-up for conditions such as diabetes, hypertension and osteoporosis,” Doligalski said. “The pharmacist sees them independently and manages those disease states, and the billing is done as ‘incident to’ at varying levels of reimbursement depending on complexity.” Where the hospital owns the clinic practice—as in the case of Doligalski’s transplant clinic and many others—CPP care is billed under facility fees. “The addition of a pharmacist to those visits allows for a higher level of facility fee billing,” she said. “That is typically not enough to cover the entire salary for the pharmacist, so the remainder has to be

made up elsewhere.” e.”

Illinois: A ProtocolocolBased Agreement ent Unlike New Mexico xico and North Carolina, ina, Illinois is one of several veral states that has not ot established specific advanced practice pharmacist designations. At the he University of Illinois at Chicago (UIC), pharmacists operate te under protocols that are approved by the medical staff. ff. “A protocol includes predetermined mined criteria defining appropriate ate care and treatment so that a nonphysician can initiate orders to provide timely care and services to o a patient,” explained Vicki Groo, PharmD, mD, BCCP, a clinical associate professor off pharmacy at UIC. h UIC “All protocol orders must be signed by a physician/credentialed practitioner within 72 hours of the order.” Such protocols are the foundation for the pharmacist-directed medication titration assistance clinic (MTAC) at UIC, developed as a resource to assist general cardiologists in implementing goal-directed medication therapy (GDMT) in heart failure patients with reduced ejection fraction, which has grown dramatically since it was first established in 2011. “We began with four slots every other week, but we did not anticipate how many patients would be sent our way,” Groo said. “We rapidly increased to four slots weekly, then six, then seven, and in 2018 we added a second half-day as a new attending physician began to refer patients to us who had heart failure with preserved ejection fraction or primary hypertension.” Pharmacists in the clinic are privileged under a protocol agreement established by the health system, which outlines the delegation of patient care functions, including initiating, modifying or discontinuing drug therapy, and ordering and/or interpreting lab tests. Content experts for the protocol include the prescribers who will be referring patients to the pharmacists. In a 2018 study, patients in the MTAC had a higher rate of achieving their target or maximum tolerated dose of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers compared with those in the general cardiology clinic (64% vs. 40%; P=0.01) (Ann Pharmacother 2018;52[8]:724-732). The pharmacist role at UIC has evolved over time, Groo said. “In 2019, the protocol was due for update and reapproval, and hospital administration

wanted much more detail as to how the de pharmacist [would] p practice.” The protop ccol states that drug ttherapy adjustment or titration will be based t on current clinical o sstatus (i.e., physical assessment and laboa ratory data), current r medication regimen m as a well as physician preference, if docup mented in the progress note. It specifies interventions tthat may include adding, m removing or adjusting rem doses, but that doses may dose be iincreased by no more than 100% at each visit. “We’re very pleased with “We’r our ability bil to achieve GDMT for heart failure patients, but there is more progress we could make,” Groo said, noting variability among cardiologists in referring to the clinic. “Among the general cardiologists, four refer to us regularly, seven occasionally, and five have never referred to us despite lots of advertising and outreach, and

I’m sure they have heart failure patients in their clinics. Keep in mind, therapy for heart failure is only getting more complex.” The clinic continues to expand, with a second PharmD recently added. “If you do a good job, your clinic will grow,” Groo said.

Lack of Nationwide Prover Status Still a Hindrance As they practice under a hospitalbased agreement, the UIC pharmacists’ services also are billed under the facility fee. “It would be wonderful to have state-based provider authority designations like the CPP, or PhC they have in New Mexico,” Groo said. “We have definitely found ways to work at the top of our license and provide top-quality care under the existing system. But if pharmacists were given provider status nationwide under the Social Security Act, as ASHP and many other groups have been working toward, we would be able to participate in Medicare Part B and be fully and appropriately reimbursed for our services.” —Gina Shaw The sources reported no relevant financial disclosures.

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Outsourcing SP Expertise? Warnings to Heed

s more health systems enter the specialty pharmacy space, many are using an outside third-party entity to manage their on-site specialty pharmacies. Although the arrangements offer many benefits, stakeholders need to be ready for state and federal scrutiny surrounding anti-kickback statutes, reimbursement and other compliance issues that could derail these arrangements if they are not managed proactively. In these partnerships, the pharmacies are still owned by the hospitals, but they’re managed by outside vendors with specific expertise in specialty pharmacy operations—such as Recept, Shields Health Solutions and Trellis Rx— in exchange for fees and, sometimes, a share of the profits. “There are core competencies that come with running specialty pharmacies, and depending on what expertise a health system already has, the management companies can really help with those, including access to payor networks, access to limited distribution drugs and assistance with accreditation,” said Todd Nova, JD, an attorney with Hall, Render, Killian, Heath & Lyman, an Indianapolisbased firm specializing in health law.

Legal, Regulatory Trouble Ahead? Contracting with a third-party specialty pharmacy management company poses a set of legal and regulatory issues that hospital and health-system compliance departments will have to navigate, said John W. Jones Jr., JD, a partner in the Philadelphia-based firm Troutman Pepper Hamilton Sanders LLP, in a session on compliance issues facing hospital-based specialty pharmacies at the ASHP 2020 Midyear Clinical Meeting and Exposition. Jones explained that the Department of Health and Human Services Office of Inspector General (OIG) will focus on a number of factors to ensure that the arrangement between the health system and management company is compliant with key statutes. Anti-kickback regulations are a major focus for HHS OIG, he noted. The regulators have highlighted several areas of concern that would raise red flags suggesting a questionable contracting arrangement, he said: • The owner (the hospital or health system) expands into a related line of business, which depends on referrals from, or other business generated by, its existing business. • The hospital or health system neither operates the new business itself nor commits substantial financial, capital or human resources to the venture— in this case, a specialty pharmacy.

Instead, it substantially contracts out virtually all of the new business. • The third-party contractor is an established provider of the same services as the new line of business and, absent the contract, would be a competitor, providing items and services in its own right, billing insurers and patients in its own name, and collecting reimbursement. • The owner and third-party contractor

share in the economic benefit (the profits) of the business. • Payments to the third-party management company vary by the value or volume of business generated for the specialty pharmacy by the hospital. “Summed up, the arrangement needs to be commercially reasonable, at arm’s length and at fair market value. And the hospital has to be at risk,” Jones said. “You can’t just have a management

company coming in and taking over everything and giving the hospital a fee for this contractual arrangement.”

Pay Attention to Physician Relationships Another key issue, Jones noted, is the relationship between the hospital’s prescribing physicians and the pharmacists in the specialty pharmacy managed by the third-party company. “What, if anything, is your management company doing for those doctors?” he asked. “You have to evaluate that. Equipment and free

Indication and Usage HYPERRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. Important Safety Information For infiltration and intramuscular use only. Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur. HYPERRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain. Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine. Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration. Please see brief summary of Prescribing Information on adjacent page or visit HyperRAB.com for full Prescribing Information.

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services, for example, are a real hot-button item for the OIG with regard to the AntiKickback Statute. I recommend that you make sure everything is at arm’s length and at fair market value, with no free services unless directly blessed by the OIG.” Nova also stressed the need for caution, citing this specific caveat: “The compensation methodology for the third-party management company must not create perverse incentives to overutilize the health care system, such as dispensing higher-cost drugs for no additional therapeutic benefit.”

‘Watch This Space’ To date, Nova said, OIG hasn’t scrutinized these partnerships—but watch this space. “Although there has not been a lot of affirmative movement at this point, I anticipate that will change in the near to midterm. This is care that is funded both directly and indirectly by federal payment programs, and you absolutely have to be aware of that. It’s time for hospitals that are involved in these ventures to be thinking about these issues and making sure that the reimbursement models

you implement with these third-party companies are cognizant both of federal laws and state laws, particularly as related to percentage-based fee arrangements and joint ventures.” When scrutinizing contractual arrangements with a third-party specialty pharmacy management company, focus on utilization, costs and outcomes, and what the relationship does with respect to those issues, Jones said. “If you can reduce costs, keep utilization low, improve patient outcomes and not be anticompetitive, then it should be a

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Rabies Immune Globulin (Human) These highlights do not include all the information needed to use HYPERRAB® safely and effectively. See full prescribing information for HYPERRAB. HYPERRAB [rabies immune globulin (human)] solution for infiltration and intramuscular injection Initial U.S. Approval: 1974 ----------------INDICATIONS AND USAGE------------------HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons previously immunized with rabies vaccine that have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. --------------DOSAGE AND ADMINISTRATION------------For infiltration and intramuscular use only. Administer HYPERRAB within 7 days after the first dose of rabies vaccine. Postexposure HYPERRAB • Administer as soon prophylaxis, 20 IU/kg as possible after along with body weight exposure, preferably rabies OR at the time of the first vaccine, after 0.0665 mL/kg rabies vaccine dose. suspected body weight • Infiltrate the full exposure to dose of HYPERRAB Single dose rabies thoroughly in the area around and into the wound(s), if anatomically feasible. • Inject the remainder, if any, intramuscularly.

-------------WARNINGS AND PRECAUTIONS-------------• Severe hypersensitivity reactions, including anaphylaxis, may occur with HYPERRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • HYPERRAB is made from human blood; it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. --------------------ADVERSE REACTIONS--------------------The most common adverse reactions in >5% of subjects in clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, ﬂatulence, nasal congestion, and oropharyngeal pain. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. --------------------DRUG INTERACTIONS------------------• Repeated dosing after administration of rabies vaccine may suppress the immune response to the vaccine. • Defer live vaccine (measles, mumps, rubella) administration for 4 months.

Grifols Therapeutics LLC Research Triangle Park, NC 27709 USA U.S. License No. 1871

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very good arrangement under the AntiKickback Statute.” —Gina Shaw The sources reported no relevant financial disclosures other than their stated employment.

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References: 1. Cabasso VJ, Loofbourow JC, Roby RE, Anuskiewicz W. Rabies immune globulin of human origin: preparation and dosage determination in non-exposed volunteer subjects. Bull World Health Organ. 1971;45(3):303-315. 2. Aoki FY, Rubin ME, Fast MV. Rabies neutralizing antibody in serum of children compared to adults following post-exposure prophylaxis. Biologicals. 1992;20(4):283-287. 3. Kuwert EK, Werner J, Marcus I, Cabasso VJ. Immunization against rabies with rabies immune globulin, human (RIGH) and a human diploid cell strain (HDCS) rabies vaccine. J Biol Stand. 1978;6(3):211-219. 4. Aoki FY, Rubin ME, Friesen AD, Bowman JM, Saunders JR. Intravenous human rabies immunoglobulin for post-exposure prophylaxis: serum rabies neutralizing antibody concentrations and side-effects. J Biol Stand. 1989;17(1):91-104. 5. Data on ﬁle, Grifols.

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