51 minute read
drug shortages
Drug Shortages Continue … And Proliferate
By Bob Kronemyer
Many medications commonly used in anesthesiology and pain medicine are in serious shortage, according to an American Society of Health-System Pharmacists (ASHP) member survey (bit.ly/3M6CxsR).
“Although I am not surprised by [these] drug shortages, I am quite alarmed by the impact they are having,” said principal investigator Michael Ganio, PharmD, a senior director of pharmacy practice and quality for ASHP, in Bethesda, Md. “Drug shortages have been problematic for 20 years now, but we had been doing fairly well until recent years.”
Dr. Ganio noted that Hurricane Maria had caused shortages of some saline products and sterile water in Puerto Rico in 2017. “We then did better until the COVID-19 pandemic hit,” he said. “We had problems securing anesthesiology medications and drugs for ventilators. Then things seemed to improve some. But now, with supply chain issues and workforce challenges, drug shortages are becoming very prevalent again.”
The survey, conducted in March 2022, was inspired by anecdotal reports of drug shortages by ASHP members and an increase in the number of reports of shortages in the ASHP service database. “There was also an overall concern for the availability of some of these products,” Dr. Ganio said.
Almost Everyone Affected
Of the 345 respondents, most worked primarily in a hospital setting. More than 99% of participants reported being negatively affected by shortages of critical drugs.
“A lot of other surveys show a high percentage, but rarely are they nearly 100%,” Dr. Ganio said. “I think our finding underscores how severe the shortages are at the moment.”
Moreover, 50% of respondents were severely affected by basic sterile injectables like sterile water and flush syringes, local anesthetics, injectable narcotics, saline bags, pre-filled emergency syringes, concentrated electrolyte injections, and some heparin products.
In addition, 7% of respondents reported more than one drug shortage–related medication safety event that caused at least temporary patient harm. These medication safety events most often involved drugs in short supply: pre-filled 50% dextrose syringes or other dextrose solutions, heparin, injectable opioids, and antibiotics. (A July check of the ASHP Drug Shortages list showed that many of these agents, including 10% dextrose injection, still were in short supply.)
How to Combat Shortages
To combat shortages, individual centers should consolidate inventory and determine how many days supplies will last. Perhaps the center will need to ration supplies or seek alternate suppliers. “Centers might also be able to purchase from a 503B outsourcing facility, which can sometimes meet some of the demand that the commercial manufacturers cannot meet,” Mr. Ganio said.
Therapeutic alternatives also can alleviate drug shortages, although these alternatives may not be as effective, have different side effects or may be more expensive, he noted. “During the beginning of the pandemic, it was very common for anesthesiologists not to have their anesthesia agent of choice and have to use a second-line treatment.”
Implementing alternative drugs also entails considerable effort in educating staff and updating electronic health records and dispensing cabinets.
“There are also usually anesthesia trays in the OR that are stocked uniformly, so if you have to change out a product in one tray, you have to change it out in all trays,” Dr. Ganio said. “Communication and education are vitally important to prevent errors when you are used to a specific product or concentration of a product being in a specific location. You cannot overcommunicate a change, particularly for concentration changes.”
The survey found that roughly 75% of respondents increased internal/ insourced sterile preparation production and that about one-third of respondents repackaged 0.9% saline and/or 5% dextrose from large bags, while more than 20% purchased drugs from a gray market wholesaler.
Incentives Needed
As noted in a joint statement from ASHP and the American Medical Association, the American Society of Anesthesiologists, the Association for Clinical Oncology and USP (bit.ly/3a09Orx), incentivizing the development of advanced manufacturing technology for critical drugs and active pharmaceutical ingredients is one of five recommendations to bolster the quality and resilience of the U.S. healthcare supply chain.
The other recommendations are: • improving the function and composition of the Strategic National
Stockpile (SNS); • engaging pharmacists, physicians, other clinicians and supply chain experts to develop processes for maintaining and refreshing products in the SNS; • incentivizing quality and resilience; and • replicating requests for critical drug manufacturing transparency and oversight for medical devices and ancillary supplies, such as personal protective equipment.
Erin Fox, PharmD, the senior director of Drug Information and Support Services at University of Utah Health, in Salt Lake City, agreed that a lack of transparency is a concern. Without complete disclosure from the pharmaceutical manufacturing sector, it will continue to be difficult for pharmacies to get ahead of a potential shortage, she told Pharmacy Practice News.
Incentives Needed
There also is a lack of clarity about the larger supply chain, Dr. Ganio noted. “What do [those disruptions] mean?” he asked. “Product that has been shipped and waiting to arrive at port? Trucks moving across country? Raw materials? There is certainly some workforce concern. I know there are drug manufacturers that have had omicron outbreaks within their staff, which reduces attendance and productivity.”
One long-term solution advocated by ASHP is improving transparency to identify and begin addressing some of the root causes of drug shortages. “Some of our proposals reimagine the SNS to keep a buffer inventory, so there would be prespecified amounts of product—maybe a two- to threemonth supply—available immediately to help mitigate that type of shortage,” Dr. Ganio said.
New forms of manufacturing technologies that are more reliable would help, too.
However, medications that are made exclusively in the United States are just as vulnerable to supply interruptions as those produced internationally. “We have found that anytime you concentrate drug manufacturing to any one region, especially to one facility, you are predisposed to a supply disruption,” said Dr. Ganio, who cited the example of shortages of injectable morphine, hydromorphone and fentanyl from a plant in Kansas in 2018 and 2019, due to quality concerns and difficulty acquiring raw materials.
The war in Ukraine has likely caused shortages in plastic because of oil disruptions. “There could also be raw material issues with plastic over time here in the U.S.,” he said.
Over time, Dr. Ganio said he expects some of these drug shortages to return to baseline. “Unfortunately, though, baseline still represents more than 100 drugs in shortage at any given time for the past 10 to 15 years,” he said. Some projections anticipate a return to baseline by fall of 2022, while others predict a full year.
—Michael Ganio, PharmD
Gender-Affirming Care
continued from page 1
seeking healthcare, noted Maya Leiva, PharmD, a hematology/oncology clinical pharmacy specialist at Inova Schar Cancer Institute, in Fairfax, Va. “The 2015 U.S. Transgender Survey [the largest such survey in the country, with more than 27,000 respondents] found that 33% of those who saw a healthcare provider reported having at least one negative experience related to being transgender, with higher rates for Black, Indigenous and other people of color, as well as persons with disabilities,” Dr. Leiva noted. “And 23% said that they did not see a doctor when they needed to because of fear of being mistreated as a transgender or nonbinary person.”
Robbie Goldstein, MD, the founder and medical director of the Transgender Health Program at Massachusetts General Hospital, in Boston, agreed that transgender patients have been conditioned to fear inadequate care—and, unfortunately, sometimes to avoid that care. “Transgender and nonbinary people are nervous about how they may be treated because of their gender identity when they walk into any healthcare practice, be it oncology or another specialty, which means that they’re much less likely to come in for the routine care and screening tests that they may need, such as mammography and colonoscopy,” Dr. Goldstein said in a separate interview.
There are four key principles to practicing gender-affirming care in oncology and other clinical settings, Dr. Goldstein said:
Do not assume anything about a patient’s identity, but ask
respectfully. “Every patient who walks in is asked their name, pronouns, gender and sexual orientation,” he said. “We ask these questions to validate them as an individual and show them that we care and want to know who they are.”
Validate patients’ gender identity and/or sexual orientation in
all elements of your practice. “When we ask someone their name and pronouns, we use those in all recordkeeping and communications with patients, consultants, family members and partners,” Dr. Goldstein said.
Recognize that everyone is human and can make mistakes.
“In practice, when you make a mistake, such as referring to someone by the wrong pronouns, that means you need to apologize for the mistake when you recognize it and correct it,” he said.
Remember that anatomy doesn’t
define the patient. “We keep an anatomic inventory for our patients, so we know what anatomy is present,” he said. “Don’t make assumptions that a person may or may not have a cervix, prostate or breast tissue that needs screening, or anything else about what anatomy may or may not be present.”
Language Counts
Dr. Leiva recommended applying gender-neutral language, or terms the patient uses, to describe body parts. “For example, if you are meeting with a transmasculine patient, when doing pelvic or chest examinations, refer to a chest exam rather than a breast exam, bleeding instead of menstruation or cancer screening rather than Pap smear,” she said.
In larger institutions, this may require further effort beyond your individual department or division. “In our clinic, we ask a patient’s name and pronouns at every visit, because we know that these are sometimes fluid,” Dr. Goldstein said. “At the higher level within our institution, we have worked very hard to ensure that there is visibility for both patients and providers into those highimpact questions, to make sure there are places to document pronouns, gender identity and other data in the record. As patients register or re-register with the hospital, we work to update the records to ensure that those questions are answered and we can lower barriers across the institution to using a person’s right name and pronouns.”
Moreover, cancer screening among transgender and nonbinary individuals should be organ-based, noted Karen Gunning, PharmD, a clinical professor of pharmacotherapy at the University of Utah College of Pharmacy, in Salt Lake City. “If an individual has a particular body part or organ, and otherwise meets the criteria for screening based on risk factors or symptoms, then screening should proceed regardless of gender identity or hormone use. But these conversations need to be very nuanced and patient-centered. For example, Pap smears are uncomfortable and can be traumatic for a transgender man if the medical provider isn’t sensitive to their patient’s needs, but on the other hand, these patients are potentially at increased risk for HPV and deserve to have that screening.”
“Everyone with a cervix is at risk for cervical cancer, whether you are a transgender man, a cisgender woman or nonbinary,” Dr. Goldstein agreed. “And it doesn’t matter what your sexual orientation is or who you’re having sex with. Studies show that trans men, nonbinary individuals and lesbian women have much lower rates of cervical cancer screening because of preconceived notions among healthcare providers that these individuals may not be at risk. A lot more education is needed [Can Fam Physician 2019;65(1):e30-e37].”
Breast cancer screening also is a major area where transgender patients may not be appropriately served, Dr. Goldstein said. “All breast tissue has the potential to mutate and go on to develop a cancer, whether that breast tissue has been present since a cisgender woman’s original puberty in her teens or developed later in life for a transgender woman. On the flip side, for trans men who have gone through top surgery like a mastectomy, the assumption is often that it was a complete mastectomy similar to what is done with a cancer diagnosis. But, in reality, it is often a cosmetic and not an oncologic surgery. Some breast tissue usually remains and is used to contour and shape, and that certainly has the risk of developing into a cancer and should be screened—often through physical examination and ultrasound, because mammography is not as effective in transgender men.”
Few pharmacy schools provide specific education for their students in gender-affirming care, Dr. Gunning said. But she cited the work of Cheyenne Frazier, PharmD, an assistant professor of pharmacotherapy at Washington State University in Spokane, as a leading model for incorporating transgender care into the pharmacy curriculum. “There also have been more continuing education programs presented recently at meetings like HOPA and the American Society of Health-System Pharmacists,” said Dr. Gunning, who with Dr. Frazier co-presented the session “Caring for Transgender People: Insights and Points of Controversy in Medication Therapy” at the ASHP 2021 Midyear Clinical Meeting and Exhibition. “But this is still an area that most oncology pharmacists, or pharmacists in general, have probably not experienced in their training. There is still not a lot of evidence in this area, and there is significant need for more information, discussion and research to inform best practices. But providing an inclusive environment in your practice is always an essential first step.”
A Lack of Official Guidelines
There are no established cancer screening guidelines or protocols for transgender and nonbinary patients at any point in their transition.
Moreover, large databases in the United States, such as the National Cancer Database, do not capture nonbinary gender identity, making it difficult to estimate whether cancer risk for transgender people differs from that of the general population (Transl Androl Urol 2020;9[6]:2771-2785). But there are other information sources clinicians can turn to for help
“Probably the best reference for the clinician is the University of California, San Francisco’s guidelines for primary care of the transgender patient,” said Karen Gunning, PharmD, a clinical professor of pharmacotherapy at the University of Utah College of Pharmacy, in Salt Lake City. “They have several sections on cancer screening that review best practices, including the general approach to cancer screening, breast cancer screening in transgender women, prostate and testicular cancer concerns in transgender women, breast cancer screening in transgender men, screening for cervical cancer in transgender men, and ovarian and endometrial cancer considerations in transgender men. Cancer screening is also mentioned in the Endocrine Society’s transgender health clinical practice guideline [J Clin Endocrinol Metab 2017;102(11):3869-3903] and the standards of care from the World Professional Association for Transgender Health [bit.ly/3PBzydB], but those are less detailed, so the UCSF guidelines are most useful at the moment.” —Gina Shaw
—Robbie Goldstein, MD
AT A GLANCE
12195 Dearborn Place Poway, CA 92064 (888) 909-7700 www.pharma-choice.com For decades, Acute Care Pharmaceuticals has been the pharmacy cleanroom supplier of choice, delivering exceptional products and service to healthcare providers nationwide. We were pioneers in the industry long before the guidelines became requirements. This history has placed us at the forefront of the pharmacy compounding market and as true experts in the day-to-day, real-world requirements of USP and regulations.
Acute Care Pharmaceuticals offers an unparalleled range of USPcompliant disposable products that are manufactured under the highest standards. This unique dedication to compliance, coupled with our decades-long commitment to partnering with hospital pharmacies and critical environments, has helped make Acute Care a market leader. As part of the Hospeco Brands Group, Acute Care Pharmaceuticals has access to the entire Hospeco family of cleaning and safety products, making us even better equipped to satisfy your facilities’ critical environment needs. This new broader range of products has given us the capability to be the supplier of choice to a wide range of healthcare-related entities, including independent (non-hospital) pharmacies, labs, veterinary pharmacies, nursing homes, aerospace manufacturing, food processing, medical device manufacturing and more.
Product Overview
Our broad range of products and services affords us the opportunity to supply your facility with all your most important safety and cleaning needs for USP Chapters <797> and <800>. With 20 group purchasing organization (GPO) and integrated delivery network contracts in place, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ brand of products is stocked at a variety of national distribution partners including AmerisourceBergen, Cardinal, McKesson and Medline, where you can receive your special discounted contract pricing.
We supply: • sterile alcohol • non-linting wipes (dry and pre-saturated) • disinfectants • media test kits • gloves • disposable apparel • personal protective equipment • cleaning equipment • spill kits
Key Business Partners
• AmerisourceBergen • Cardinal • McKesson • Medline • AvMEDICAL
Markets Served
• Hospital/Acute • Clinic • HMO • Home Health Care • Home Infusion • Surgery Centers • Retail • Long-Term Care
GPO Affiliations
• Vizient • Premier • HealthTrust GPO Affiliations • American Pharmacy Cooperative, Inc. • Ascension (The Resource Group) • Asembia • Fairview Pharmacy Services • GeriMed • Managed Health Care Associates Inc. • Northside Hospital System
To order our full line of USP-compliant products, visit us at www.Pharma-Choice.com or speak directly to a product and contract order expert at (888) 909-7700.
Offering a Broad Portfolio of Barcoded Unit-Dose Products
With a responsive line of barcoded unit-dose oral solutions, a growing liquid unit-dose offering and individually wrapped inhalants, American Health Packaging continues to deliver on its commitment to supporting pharmacy efficiency.
Company Background
Located in Columbus, Ohio, American Health Packaging (AHP) is an industry leader in manufacturing serialized, barcoded unit-dose (UD) medications provided for the health care marketplace. As a UD manufacturer, AHP’s commercially available UD products are available to hospital, institutional and long-term care pharmacies nationwide through partner GPOs and wholesalers.
AHP’s reputation for quality is supported by a 30-plus–year history of broad manufacturing expertise—operating a facility that is registered with the FDA, fully adherent to current good manufacturing practices guidelines, and licensed by the Drug Enforcement Administration to package Schedule II to V controlled substances. Synonymous with unit dose, following years of success and leadership in the production of oral solids, AHP expanded its offering in 2017 to include liquid UD cups and inhalants in 2019.
Product Overview
AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing nearly 600 UD oral solid stock-keeper units (SKUs) for the health care marketplace, AHP’s broad selection of products is made with quality components and printed with legible barcodes that facilitate effective execution of barcoded point-of-care (BPOC) initiatives. The wide selection of products reduces the gap between what pharmacies are forced to repackage themselves and what is commercially available on the market, thus supporting health systems nationwide in their efforts to create efficiencies throughout the chain of care.
AHP’s tailored offering of UD oral liquids provides similar efficiency, safety and cost-savings benefits as its oral-solids products. Product features include right-sized packaging, thoughtful tray design, differentiated labeling and accurate barcodes. AHP’s UD inhalants provide efficiency and feature individually wrapped vials and pouches barcoded to the dose level. AHP oral solids, liquids and inhalants include major therapeutic classes and product groups to meet unique pharmacy needs. They are continuously evolving to meet the changing demands of caregivers and staff to support more effective medication procurement strategies.
As facilities nationwide compete to demonstrate they provide the highest quality of care, AHP UD products support caregivers as they strive to promote positive outcomes for patients. Pharmacies simultaneously strive to be cost-effective as they provide necessary resources for caregivers. AHP UD supports these objectives while providing cost-savings opportunities. Sourcing prepackaged UD allows pharmacies to obtain adequate supply while mitigating capital expenses, such as those related to repackaging equipment, bulk supply and labor.
AT A GLANCE
Benefits for Health Systems
Patient Safety
Ensuring the right medication is given to the right patient at the right time, and in the right strength, is imperative. Pharmacies can facilitate effective execution of these “rights” by providing caregivers with as many products in a prepackaged UD format as possible. Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the UD process as medications arrive to pharmacies ready to dispense. Pharmacy Efficiency
Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentially complex repackaging steps to the procurement process not only harms the ability of pharmacy to supply caregivers effectively, but also removes clinicians from their core patient care competencies. In addition, prepackaged UD often allows for products to be sourced more quickly than third-party repackaging can support. Cost-Savings Opportunity
Health systems that choose to package on-site must consider all direct costs, such as purchasing capital equipment for packaging areas and paying highly trained clinical professionals to perform, manage and support non-core work. AHP UD products allow for pharmacies to avoid these costs while also shifting the potential costs associated with packaging errors. The prepackaged format also prevents additional fees that may result from using third-party repackaging services. Hitting the Mark for BCMA, USP <800> Support
Effective execution of barcoded medication administration (or BCMA) initiatives requires medications that scan correctly at the bedside. With a robust oral-solids portfolio, and a growing offering of UD liquids, AHP UD provides reliable access to UD treatments. AHP products promote safety toward BPOC and efficiency in pharmacy while freeing up internal resources. AHP UD supports pharmacies as they strive for compliance with USP General Chapter <800> guidelines. As pharmacies craft effective procurement strategies to meet the needs of their facilities, protecting patients and caregivers alike from potential harm while handling hazardous drugs is a priority. AHP’s UD portfolio has many National institute for Occupational Safety & Health and USP <800> products already packaged for bedside dispensing, which supports compliance with USP <800> handling procedures.
2550 John Glenn Avenue, Suite A Columbus, OH 43217 (800) 700-4621 customersupport@ americanhealthpackaging.com www.americanhealthpackaging.com
AT A GLANCE
2 Harbor Park Drive Port Washington, NY 11050 Phone: (516) 684-8200 Fax: (516) 684-8202 Toll-free: (855) 378-2744 Email: info@equashield.com Equashield Compounding Technologies is a leading developer, manufacturer and wholesaler of compounding technologies. The company was established in 2009, with a mission to provide healthcare workers— primarily pharmacists and nurses—with a simple and efficient plug-and-play closedsystem transfer device (CSTD), which later developed into robotics for the automated compounding of hazardous drugs.
Equashield’s CSTD is unparalleled in safety due to its unique patented, closed pressure-equalizing mechanism and dry disconnection system, which features its flagship closed-back syringe. The EQUASHIELD® Pro is the only CSTD that uses automated compounding to ensure the utmost protection to all hospital healthcare workers and patients throughout the healthcare facility from the health risks associated with exposure to residues and vapors resulting from the preparation and administration of hazardous drugs.
The Equashield CSTD portfolio includes a wide array of patented closed-back syringes and adaptors to accommodate any vial size and shape and all IV bags in the pharmacy. Equashield also has developed a patented selection of connectors and tubing sets for the safe and easy compounding and administration of hazardous drugs by pharmacists and nurses.
The EQUASHIELD Pro takes CSTD compounding beyond the industry standard with the first-ever CSTD compounding robot. The EQUASHIELD Pro’s image processing–based artificial intelligence (AI), multitasking, versatility and automated capability allow for a compounding rate of up to 70 doses per hour with the highest level of assured dosage accuracy and air bubble detection. Equashield Compounding Technologies is compliant and cleared for the following:
• FDA approved for preventing microbial ingress for up to seven days • FDA ONB code product clearance for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs • Passed National Institute for
Occupational Safety and Health for alcohol vapor containment performance test
Working in tandem with the Equashield CSTD, the EQUASHIELD Pro is the first CSTD-enabled automated compounding system that uses a CSTD throughout the entire compounding process. Unlike other automated compounding systems, the EQUASHIELD Pro is designed to prevent the escape of hazardous drug vapors and drug residues during the compounding process through the use of the CSTD.
The EQUASHIELD Pro automated compounding system provides additional layers of protection to pharmacy workers and, in addition, provides the following benefits: • high throughput, meeting compounding demands during peak hours • medication error prevention through image processing–based AI • small footprint (similar size to a standard biological safety cabinet) • low capital acquisition cost The EQUASHIELD Pro was designed to reimagine the automation process safely and efficiently and to operate like a factory line, with eight simultaneous compounding workstations that deliver high throughput, shortening the duration of the entire process. In addition, the image processing cameras detect air bubbles, and verify and validate the dose accuracy.
EQUASHIELD Pro’s automated compounding system outperforms other robotic technologies with: • proprietary CSTD • ability to accommodate a wide variety of vial sizes • high syringe unit and vial storage capacity • versatility to compound patient-specific prescriptions • image recognition–based AI technology The EQUASHIELD Pro can be used for high-throughput, patient-specific dose preparation, storing 67 syringes and up to 60 large drug vials, allowing it to produce up to 70 individual doses per hour. It also offers medication error control by using image processing–based AI algorithms and software for each dose and detection of air bubbles, which could result in inaccurate dosing. The factory-style lineup is housed in a machine comparable in size to a standard biological safety cabinet.
Equashield invites you to find out how it can help keep your healthcare teams safe and efficient when compounding and administering hazardous drugs.
For more information about Equashield Compounding Technologies’ award-winning CSTDs and the EQUASHIELD Pro automated compounding system for cytotoxic drugs, contact us at info@ equashield.com.
Equashield Compounding Technologies CSTD: A Proven Closed System
Equashield Compounding Technologies’ innovative design makes its CSTD the preferred system to prevent syringe plunger contamination by hazardous drugs, covering most routes of exposure during your daily hazardous drug preparations and IV pushes. The unique and exclusive closed-back syringe proved its performance across multiple independent and peer-reviewed studies focused on vapor contamination, optimization of sterile use, plunger contamination, surface contamination and efficiency of use.
Unlike standard luer-lock syringes, an Equashield Compounding Technologies syringe unit can be used safely even at its full volume, as the encapsulated plunger rod is secured by its closed back. This feature prevents the potential for spillage. Due to its leak-safe membranes, the Equashield syringe unit has FDA approval to be used for up to 10 manipulations. The Equashield closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposures to drug vapor, aerosols and spills, and also prevents microbial ingress for up to seven days.
This biannual supplement to Pharmacy Practice News and Specialty Pharmacy Continuum covers best practices in automation, informatics and patient safety.
Featured Content
Pharmacy Technology Report (PTR) includes articles on real-world methods for adding technology to pharmacy operations. For example, in the September 2022 issue, several le hospitals will detail how they are using teleph macy to ensure cancer patients receive top-notc follow-up care. Developed during the height of the COVID-19 pandemic, these telepharmacy models are continuing to be useful for health systems that want to remain nimble and flexible amid an unpredictable pandemic caseload.
Other technologies on tap in the September issue include “smart” programmable infusion pumps, radiofrequency identification, robotics, and how to encourage more widespread adoption of IV workflow management systems (IV-WMS).
We will continue to keep an eye on technology th the potential to improve pharmacy practice. rations. For eading harch e d Vat has
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AT A GLANCE
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David Bronstein davidb@mcmahonmed.com Ext. 212
Publication Director
Readers looking to access PTR content can easily find it by choosing “Pharmacy Technology Report” under the “Sections” tab of the pharmacypracticenews.com homepage. Once there, a dedicated PTR landing page serves as an easily navigable portal to all of our technology content.
To ensure PTR readers don’t miss a single article from the print issue—as well as late-breaking technology news posted to the web— we send out a dedicated PTR e-Newsletter twice monthly. To sign up, visit www.pharmacypracticenews.com/ Registration.
Advisory Board
The editorial advisory board for PTR includes some of the top experts in the field, including Mark Sullivan, PharmD, MBA, BCPS, the executive director of pharmacy operations at Vanderbilt University Hospital, in Nashville, Tenn.; Beth Prier, PharmD, MS, CPHIMS, the associate director of pharmacy informatics at The Ohio State University, in Columbus; and Mark euenschwander, the presint of The Neuenschwander pany, in Bellevue, Wash., and of THRIVE, a coalition to promote more widespread use of IV-WMS technology.
Each of these board members helps ensure PTR is a must-read in this challenging area of pharmacy practice.
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Plus, starting in 2023, PTR will be published twice yearly!
Dave Kaplan dkaplan@mcmahonmed.com (973) 885-2315
Senior Editor
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Lillie Onday londay@mcmahonmed.com (732) 979-7009
AT A GLANCE
Innovation in Secure Drug Delivery
2981 Gateway Drive Devoted to the Needs of the Pompano Beach, FL 33069 Compounding Pharmacist (800) 344-2884 sales@imiweb.com www.imiweb.com Founded in 1967 and exclusively devoted to the needs of the compounding pharmacist, creating products for the compounding pharmacist is the sole focus at IMI. As a result, our customers experience the quality, service and value that only a specialized partner can offer. Through our partnerships with compounding professionals, we continue to advance our devices to serve the health care community. From new product developments to customized packaging configurations, IMI’s customer-focused ethos and superior engineering capabilities allow us to be responsive to the needs of our partners and customers. Our capabilities and highly trained teams are the reasons we have remained the industry standard for tamper-evident cap technology and continue to deliver customer-focused products to enhance pharmacy productivity, safety and security. All IMI products are manufactured in the United States at our FDA-registered, ISO 13485–certified facility under the strictest quality standards.
Innovation in Secure Drug Delivery
Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The benefits of tamper-evident products to address this risk have been recognized within the standards and guidelines of multiple influential organizations, including the American Society of Health-System Pharmacists and the FDA. Tamper-evident products increase overall accountability in the chain of custody of mediations, maintain sterility, prevent leakage, ensure patients receive the full intended dose and reduce the risk for contamination. Experts agree that the use of tamper-evident products increases the confidence of pharmacists, health care workers and patients. IMI’s Prep-Lock™ Line of products provides high-value, high-quality, tamper-evident closure devices for a variety of drug delivery containers, including IV, enteral and oral syringes, medication cassettes, and IV bags.
Prep-Lock Tamper-Evident Caps for IV Syringes
Hospitals that partner with an outsource compounder may already be familiar with Prep-Lock Tamper-Evident Caps for IV syringes. Over 85% of the top 503B compounding facilities trust IMI Tamper-Evident Caps to secure their preparations. Incorporating these caps for in-house preparations can provide standardization of all syringes throughout the hospital. As a result, clinicians will not need training for administering syringes with multiple tamperevident methods. Tamper-Evident Caps help to ensure the integrity of your compounds by providing a visual indication of tampering, misuse or access. Installation and administration are highly efficient. Each sterile tray of 10 includes a unique keyed feature that allows the pharmacist to install a cap with a simple twist of the syringe, helping to reduce the risk for touch contamination and enhance aseptic technique. To administer, simply pull off the outer sleeve of the tamper-evident cap and unscrew the remaining luer lock cap. Clinicians and pharmacists appreciate not having to deal with sticky tapes or frustrating shrink wrap. Tamper-Evident Caps represent a convenient and comparatively low-cost risk mitigation mechanism for pharmacies and health systems.
Prep-Lock Tamper-Evident Additive Port Caps
The Tamper-Evident Additive Port Cap provides remarkable protection and protocol assurance to the medication ports of IV bags. The simple one-handed installation and considerable contributions to the integrity of IV compounds have gained acclaim from pharmacists and health care professionals. “I find their products to be the best on the market in terms of the device itself, the functionality and the securement, ” said Neil Colby, RPh, the director of Infusion Pharmacy Services at CDRx Infusion. These products extend the intention of USP General Chapter <797> from pharmacy to patient by providing last-mile security that strengthens pharmacist and health care provider confidence and reduces risk for contamination and diversion.
Prep-Lock Tamper-Evident Caps Featuring RFID
Radio-frequency identification (RFID) technology continues to garner adherents in hospital pharmacy systems. The technology enables real-time scanning that optimizes inventory management, efficiency and medication safety while creating quantifiable pharmaceutical supply chain benefits by providing item-level inventory visibility down to the National Drug Code and lot. Recognizing the advantages that RFID technology presents, IMI joined industry consortium DoseID to help increase interoperability, quality and performance of RFIDtagged products. Tamper-Evident Caps with RFID provide a laborreducing solution to incorporating RFID into your drug doses. With a simple twist of a syringe, your CSPs are equipped with renowned tamper-evident protection and powerful analytical automation capabilities. These two powerful technologies in combination enhance workflow efficiencies, eliminate time-consuming manual inventory control processes, provide assistance with growing regulatory demand, and supply a comprehensive strategy to prevent, detect and resolve drug diversion events. In addition, by incorporating RFID technology into IMI’s industry-leading TamperEvident Caps, facilities can significantly reduce their cost of RFID implementation with little time-to-live, minimal staff investment, procedural changes, or capital investment.
La Jolla Pharmaceutical Company is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. Giapreza® (angiotensin II) is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. Xerava® (eravacycline) is approved by the FDA for the treatment of complicated intraabdominal infections. For more information, please visit www.ljpc.com.
AT A GLANCE
201 Jones Road, Suite 400 Waltham, MA 02451 ljpc.com
Product Portfolio
Product Indication Pivotal Studies Regulatory Status
GIAPREZA® (angiotensin II)
XERAVA® (eravacycline) Septic or other distributive shocka 321-patient, multinational, double-blind, randomized, placebo-controlled study
Complicated intraabdominal infectionsb 538-patient, multinational, double-blind, randomized, active-controlled study
499-patient, multinational, double-blind, randomized, active-controlled study FDA-approved (December 2017)
FDA-approved (August 2018)
a GIAPREZA® is a vasoconstrictor used to increase blood pressure in adults with septic or other distributive shock. b XERAVA® is a tetracycline-class antibacterial indicated for the treatment of complicated intraabdominal infections in patients 18 years of age and older. Limitations of Use: XERAVA® is not indicated for the treatment of complicated urinary tract infections.
• Hypersensitivity Reactions: Life-threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA® . Avoid use in patients with known hypersensitivity to tetracyclines. • Tooth Discoloration and Enamel Hypoplasia: The use of XERAVA® during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. • Inhibition of Bone Growth: The use of XERAVA® during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. • Clostridium difficile–associated diarrhea: Evaluate if diarrhea occurs
For more information on XERAVA®, including important safety
information and full prescribing information, please visit www.XERAVA.com. GIAPREZA® (angiotensin II) injection Warnings and Precautions
• There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA® . Use concurrent venous thromboembolism prophylaxis.
For more information on GIAPREZA® , including important safety
information and full prescribing information, please visit www.GIAPREZA.com.
This is the place where quality means something
AT A GLANCE
13796 Compark Boulevard Englewood, CO 80112 Phone: (800) 292-6772 Fax: (408) 288-8252 info@leiters.com www.leiters.com
Hospital and Surgery Center Products and Services
• Prefilled syringes, vials and bags • Avanos ON-Q® Pain Relief System
Fill Service
• Opioid-free surgical pain services • Compatible with the Kit Check automated medication tray management system • Cardioplegic solutions • Partnered with Prodigy Health to provide access to their innovative pharmacy supply chain services Leiters, founded in 1926, is an FDAregistered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services. Our team of industry experts provides a sophisticated understanding of what it takes to elevate quality and consistency of supply in outsourcing.
Place
• FDA-registered and inspected Current Good Manufacturing
Practices (cGMP)-compliant 503B outsourcing provider • Licensed to ship to all 50 states (and the District of Columbia) • State-of-the-art equipment and automation is used throughout our sterile manufacturing process
Product
Ophthalmology Products and Services
• Prefilled syringes, vials and dropper bottles • Comprehensive portfolio including: – Injections, antibiotics, dilating agents and topical anesthetics • FDA-Compliant Repackaged
Avastin® Service
– Multiple presentations available based on physician preference • Compatible with Besse Medical’s inventory management systems
We combine our team, our robust processes and our state-of-the-art outsourcing facility to ensure the highest-quality outsourced medications for you and your patients. Through three key pillars, People, Place and Product, Leiters is elevating the standards in pharmaceutical outsourcing.
People
• Our highly trained multifunctional teams of pharmaceutical experts ensure quality and regulatory compliance for all released products. • Our team has relevant industry experience with sterile injectable pharmaceutical companies, hospital pharmacies and academia. • Our customer experience team of regionally based account representatives, account managers and customer service specialists work together to provide you with consistent and reliable service. • All sterile preparations are produced under 503B of the Food, Drug, & Cosmetic Act (503B Guidance), cGMP and USP Chapter <797>. • Release, stability, potency and sterility testing is performed on every batch made. • We provide a Certificate of Analysis (CoA) with every shipment.
Your Journey to Better Medicine Begins Here
Leiters provides medicines and pharmacy services across the continuum of care, including hospitals, surgery centers, clinics and physicians’ offices. We are also strategically partnered with many market–leading, innovative healthcare companies that complement what we do here at Leiters. The products and services offered by these partners—and available through Leiters—may provide additional value to your organization.
We Don’t Want to Simply Tell You About What We Do, We Want to Show You
We invite you to visit our facilities to better understand the cGMP regulations, sterile manufacturing processes and automation we use to elevate the quality of our products and services. Come join the growing list of organizations that have visited our facilities.
To schedule a site visit or learn more about how Leiters is Compounding Health™, please visit www.leiters.com.
For over 50 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory.
Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, president, remembers: “My dad was acutely aware of the requirements of hospital pharmacy. He saw the need for inexpensive, manual unit-dose packaging allowing hospitals to convert from traditional dispensing. He developed systems to package, handle and dispense predetermined amounts of medication so they would be accessible for one regular dose.”
Although familiar today, launching the unit-dose packaging was a huge problem the new company faced. “We were one of the pioneers, the innovators promoting unit dose in hospitals,” Mr. Braverman recalled. “Due in part to Medi-Dose’s educational efforts, pharmacists and nurses accepted the validity of unit dose.”
Inexpensive, Easy and Flexible
Because of its unique Cold-Seal technology, the Medi-Dose System is simple to use and requires no special in-service training or additional space. Medi-Cup blisters are available in 15 styles and eight sizes to accommodate the largest medications or the smallest storage spaces, and are particularly ideal for USP <800> medications. Ultraviolet-inhibitant blisters provide additional protection from light. Plus, a combination of special blister plastics with aggressive tamper-evident label adhesives provides either six-month or one-year beyond-use dating for all your unit-dose packaging needs.
The Medi-Dose System offers these additional benefits: • Sealed units can be left in sheets or easily torn down to individual doses. • Lid-Label Covers are available in 8” × 11” laser sheets of 25 doses or 4” × 6” direct thermal sheets of five doses. • Laser Lid-Label Cover Sheets are available in a wide variety of colors to facilitate color coding of medications. • Circular and Oval Blisters have been designed to fit your dispensing machines and storage cabinets. • New MPB® - Multi-Purpose Blisters allow you to easily package, label and secure even more sizes and types of medications, including large medications, compounded drugs, double and triple “0” capsules, unit-of-use packaging, repackaged medications and suppositories. • All Medi-Cup Blisters and Lid-Label Covers work with our MILT 4
Software, which can be used for all your barcoding and labeling needs.
Adapts to Your Needs
With our MILT 4 Software, you can design your labels any way you want (for solids, liquids, syringes, ampules, IVs—even equipment and supplies). In addition to the ability to use graphics, special fonts and shapes—even logos and symbols—to better identify your medications, MILT 4 has been designed to easily create barcodes with the information your barcode-enabled point-of-care and barcode medication administration systems require. Popular 1D and 2D barcode formats can be created with National Drug Code numbers, beyond-use dates, lot numbers and special codes. Plus, MILT 4 suggests tall man lettering options (e.g., DOPamine instead of DOPAMINE) for medications as recommended by the FDA and the Institute for Safe Medication Practices. In addition, newly entered and previously saved medication names are compared with the CDC’s “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.” If a match is found, the user is notified that this medication may potentially be hazardous to handle.
Using our MILT 4 Software, you can label and identify all your medication, complete with graphics and a barcode. Brightly colored Lid-Label Covers call attention to medication requiring special handling. AT A GLANCE 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-8966 Fax: (800) 323-8966 info@medidose.com www.medidose.com
To get started, all you will need is:
• Medi-Cup Blisters: 15 styles to suit your packaging needs. • Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters. • MILT 4 Software: Design and manage Lid-Label Cover printing. • Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to Medi-Cup
Blisters, ensuring a positive seal between labels and blisters. • Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or barcoding needs, then the Medi-Dose System is the perfect fit for you!
Products
• Medi-Dose® (Solid) and TampAlerT® (Liquid) Oral Unit-Dose
Packaging • Medi-Cup® PLUS packaging for extended beyond-use dating • MILT® by Medi-Dose unit-dose and barcoding software • LiquiDose® labeling, IV additive and filtration products • Nultraviolet® ultraviolet light inhibitant bags • Steri-Dropper sterile ophthalmic dropper bottles • High Alert and IV Line Tracing Labels • Resealable bags, bottles, and other pharmacy supplies and disposables
AT A GLANCE
545 W. 45th Street, 8th Floor New York, NY 10036 Phone: (212) 957-5300 Fax: (212) 957-7230 pharmacypracticenews.com
Editorial Director
David Bronstein davidb@mcmahonmed.com Ext. 212
Publication Director
Dave Kaplan dkaplan@mcmahonmed.com (973) 885-2315
Senior Editor
Marie Rosenthal mrosenthal@mcmahonmed.com Ext. 265 Launched 40 years ago, Pharmacy Practice News remains loyal to an editorial mission focused on giving health-system pharmacists the information they need to deliver highquality, cost-effective patient care.
Meeting Coverage
To achieve that goal, our editors follow the latest developments in hospital practice. Much of our content comes from attending meetings convened by the major pharmacy groups, such as ASHP and the American College of Clinical Pharmacy. But we also attend smaller, more focused conferences to keep our readers abreast of the latest trends in patient care, including the annual meetings of the Hematology/Oncology Pharmacy Association and MAD-ID: Making a Difference in Infectious Diseases.
We also rely on content partnerships to keep our readers informed, such as one with the American Society for Parenteral and Enteral Nutrition, which contributes annual review articles and access to webinars on several hot topics in the field.
Supplements
Pharmacy Practice News publishes educational supplements such as Special Reports and Literature Reviews bound inside the newsmagazines. These supplements are produced by our Special Projects division and can be accessed via the “Medical Education” tab on our website.
Website Enhancements
Associate Editor Peer-to-Peer Content
Pharmacy Practice News welcomes contribuKate Baggaley kbaggaley@mcmahonmed.com (973) 768-2185 tions from readers to facilitate a peer-to-peer exchange of best practices. Recent examples include an article on emergency preparedness by Sales Account Manager the University of Illinois at Chicago, which details how the hospital kept serving the medication Lillie Onday therapy needs of its patients during the heightlonday@mcmahonmed.co (732) 979-7009 m of civil unrest triggered by the George Floyd protests (bit.ly/3OC5ddB). We continue to feature regular contributions from thought leaders in pharmacy, including Bonnie Kirschenbaum, MS, FASHP, who pens the monthly “Reimbursement Matters” column. Our newest addition, “TechTrends,” is coordinated by series editor and new advisory board member David Aguero, PharmD, the director of medication use systems and informatics, Division of Pharmaceutical Services, at St. Jude Children’s Research Hospital, in Memphis, Tenn.
Special Sections
Our special sections focus on important clinical and operational areas of pharmacy practice. Topics that receive this in-depth coverage include medication safety, biosimilars, sterile compounding, oncology, drug diversion, cold chain shipping, accreditation, antibiotic stewardship and more.
Given the increasing importance of providing Pharmacy Practice News in multiple engaging digital formats, we have introduced several online enhancements. For example, we’ve added a Conference News landing page, where readers can find our pharmacy meeting coverage arranged chronologically. We also added a Digital Issue page, which features all articles from our monthly print issues for easy access.
All of these print and digital innovations are the reason why Pharmacy Practice News continues to be a leading source of information in a challenging practice environment. Our goal is to help our readers meet those challenges on a daily, weekly and monthly basis, for year-round relevance.
Home Delivery Now Available!
Given the variable nature of working onsite during the COVID-19 pandemic, many of our readers are opting for home delivery. It’s a great way to ensure you won’t miss a single FREE issue. Rest assured, we value your privacy and will not share your address with third parties. To get home delivery for new subscriptions, visit www. pharmacypracticenews.com/NewSubscription; for renewals, visit www.pharmacypracticenews.com/RenewSubscription
Review Articles
One of the core editorial features of Pharmacy Practice News is our review articles. Written by pharmacists with specialized clinical training and experience, the reviews offer comprehensive summaries of state-of-the-art clinical care. Topics this year included parenteral nutrition and ISMP’s exclusive annual review of top medication errors. Many of these reviews are featured in Pharmacy Practice News Special Edition, our annual print compendium that mails in October.
Multimedia Initiatives
Each month, print articles are posted to pharmacypracticenews.com and promoted on the leading social media platforms, including Facebook, Twitter and Instagram. Web-only, breaking news stories are posted daily. We deliver this content right to you through our thrice weekly e-newsletters. To subscribe to our e-newsletter, visit www.pharmacypracticenews.com/Registration.
Video interviews with the nation’s top health-system pharmacy experts continue to post to the website. One recent example is a discussion with Lisa Holle, PharmD, BCOP, a hem/onc pharmacist at the University of Connecticut School of Pharmacy, in Storrs. In a wideranging interview, Dr. Holle offers more of her insights on the breakthrough study of rectal cancer detailed in this issue (page 1), including how to manage the expectations of patients who have heard of the 100% remissions reported, and who expect similar results.
Your Containment and Protection Ally
Put your mind and hands at ease with true containment.
True drug containment that offers comfort and peace of mind, HALO® CSTD is your complete solution for hazardous drug preparation and administration. • Airtight and leak-proof1 • Ergonomically designed for hand
comfort2
• Strong and secure attachment3 • No internal filter to maximize vial
extraction4
Make the HALO system your standard of care for enhanced protection of patients and caregivers. To request a demonstration or to order the HALO System, call 1-888-386-1300 or visit us at www.HALO-CSTD.com.
HALO® is a registered trademark of Corvida Medical, Inc.
AT A GLANCE
503B: Resiliency, Reliability & Transparency
3 Sugar Creek Center Boulevard QuVa Pharma is a leading national 503B Suite 250 outsourcing services company, covering all Sugar Land, TX 77478 50 states, providing ready-to-administer (888) 339-0874 sterile injectable medicines critical for highQuVaPharma.com quality patient care. QuVa was purpose-built to change the 503B industry for the better, and with unmatched expertise in Current Good Manufacturing Practices and deep experience in sterile pharmaceutical manufacturing, achieves the highest quality and safety standards. Through our products and services, hospitals gain resiliency, reliability and transparency. Our reliable and accountable service has delivered the answers needed by thousands of hospitals, and more than 90% of the customers who started with us three years ago are still customers today. With QuVa, always have an answer.
Capacity & Scale to Deliver Today and Tomorrow
Our redundancy and scale, including 300,000 square feet of capacity across four facilities, and diverse supplier relationships enable us to operate as one of the largest 503B outsourcing companies in the industry. QuVa services 90% of America’s Best Hospitals* and provides high-quality resources, processes and technologies so they can focus more time on improving healthcare delivery, patient safety and clinical outcomes. We continue to invest significantly in our Production Innovation Program, incorporating automation and integrated technologies that support increased resiliency and reliability.
Deep & Broad Product Portfolio
As a full-service 503B service provider, our portfolio of ready-toadminister sterile products supports hospital OR, post-op, ICU, labor and delivery, ER and general medicine areas. We also service hospitals through our robust and proven product development capabilities that have resulted in many new products that are requested by hospitals to meet their evolving treatment needs and that are essential for clinical care.
Our product presentations span syringes (including Kit Check® RFID tagging), IV bags, CADD cassettes, PCA vials, Monoject Barrel syringes and pharmacy bulk bag packages.
Pharmacy Solutions Consulting
QuVa offers a complimentary, confidential medication management assessment to support your process improvement projects, data analysis, regulatory compliance and clinical implementations to help your pharmacy and hospital excel. We partner confidentially with hospital pharmacy leadership, as well as anesthesia, OR and ICU/CCU clinical leaders to help design and implement strategies that increase operational efficiency between your pharmacy and other clinical departments. Find out more about this service offering by visiting QuvaPharma.com/PSC.
* U.S. News & World Report 2021-22 Annual Best Hospitals Rankingst
Paxlovid Face-Off
continued from page 1
nirmatrelvir+ritonavir to eligible patients, but with certain limitations to ensure appropriate patient assessment and prescribing of the drug.
“While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving—requirements far beyond a pharmacist’s scope and training,” said Jack Resneck Jr., MD, the president of the AMA, in a statement.
The FDA’s new initiative is part of a revised emergency use authorization (EUA) for nirmatrelvir+ritonavir aimed at improve access to the medication for some patients at high risk for COVID-19. The agency said it made the change because nirmatrelvir+ritonavir can reduce severe consequences of the disease, such as hospitalization and death, but it must be taken early in the course of the disease.
“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” explained Patrizia Cavazzoni, MD, the director of the FDA’s Center for Drug Evaluation and Research, in a statement.
However, as noted, the agency placed some limitations on the authority given to pharmacists. Specifically, state-licensed pharmacists should refer patients for clinical evaluation with a physician, an advanced practice registered nurse, or a physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: • Sufficient information is not available to assess renal and hepatic function. • Sufficient information is not available to assess for a potential drug interactin. • Modification of other medications is needed due to a potential drug interaction.
Although the AMA agreed that nirmatrelvir+ritonavir was a “critical tool in the fight against COVID-19,” the limitations set by FDA were not enough to ensure patient safety.
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams—teams that include pharmacists,” Dr. Resneck said. “But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one.”
AMA Stance ‘Extremely Disappointing’
Pharmacists said Dr. Resneck’s comments demonstrate a lack of understanding about the profession’s high level of education and the important role it plays in patient therapy. In fact, the ASHP told Pharmacy Practice News that it has been working with the administration, including the FDA and the White House, to expand pharmacist prescribing authority for oral antivirals.
“As a clinical pharmacist and academician for 30 years, I have educated at least 1,000 physicians during my clinical career,” said Michael J. Cawley, PharmD, RRT, CPFT, the chair of the Department of Pharmacy Practice at Temple University School of Pharmacy, in Philadelphia, who was not part of the ASHP lobbying effort. “Pharmacists educate medical students, medical interns and residents, and routinely provided grand rounds presentations to physicians on the appropriate use of drug therapy. I find it extremely disappointing that the AMA makes statements that ‘this is far beyond the scope and training of a
pharmacist’ when their knowledge of pharmacy education is very limited or absent. Pharmacists receive far more education on pharmacology, pharmacotherapeutics, pharmaceutics, pharmacodynamics than physicians.”
Dr. Cawley added that he routinely works with physicians, as well as ensuring patient safety and preventing medication errors. “When interacting with physicians, many times I have heard, ‘I had no idea you had this much knowledge and education in drug therapy use’; how many times as a part of the medical team the pharmacist prevented medication overdoses, wrong doses, drug-drug, drug-disease and drug-laboratory [test] interactions; or how many times have the pharmacist prevented the patient from being harmed by medications.”
The FDA did state that after testing positive for COVID-19, “patients should first consider seeking care from their regular healthcare provider or locating a Test-to-Treat site in their area.” The community pharmacies not already participating as a Test-to-Treat site can
decide if or how they will offer this service to patients, the agency said.
In addition, the FDA recommended that COVID-19–positive patients who want to know if they are eligible for nirmatrelvir+ritonavir at locations where prescribing by state-licensed pharmacists is available, bring enough information to ensure the state-licensed pharmacist has sufficient information to determine their eligibility to receive nirmatrelvir+ritonavir. Such information includes a list of all the medications they are taking, as well as “electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work, for the state-licensed pharmacist to review for kidney or liver problems.”
If pharmacists need more information, they could also receive this information through a consult with the patient’s healthcare provider. “The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Dr. Cavazzoni said.
The ASHP agreed with Dr. Cavazzoni. “ASHP is pleased to see the FDA remove this barrier to patients’ access to this critical treatment,” said Tom Kraus, the group’s vice president of government relations. “Pharmacists have played a vital role in our pandemic response efforts and are well positioned to help patients, particularly those in rural and underserved communities, benefit from this medication.”
Dr. Cawley echoed the important role pharmacists can play in this care setting. “Pharmacists have the knowledge in drug therapy utilization and laboratory interpretation to assess and prescribe Paxlovid,” and their accessibility and past work during the pandemic are an advantage in this situation, he told Pharmacy Practice News.
More Resources Needed To Meet COVID-19 Mission
However, pharmacists might need more resources to carry out this pandemic mission, Dr. Cawley admitted. “Although [they] would be the perfect healthcare provider to prescribe Paxlovid, the major problem is pharmacists are understaffed, overwhelmed and simply ‘burned out’ in the community setting,” he said.
That burnout is due to pharmacists having had “more responsibilities, including COVID-19 testing and vaccinations on top of all their other responsibilities, including providing a variety of other immunizations, hundreds of prescriptions needing to be filled, calling physician offices, answering hundreds of phone calls and many other responsibilities,” Dr. Cawley added. “Unless pharmacists are given the quality time to assess, prescribe, monitor and follow up with patients on Paxlovid, I am concerned patients’ safety may be at risk.”
—Michael J. Cawley, PharmD
Stuart Monk - stock.adobe.com
—Tom Kraus