40 minute read
UP FRONT
Have We Conflated Low- and High-Risk Compounding?
To the Editor: Re: “Lessons Learned From a Once Not-So-Sterile CR” (bit.ly/3cqg7jD):
[It seems] to me that there is far too much energy and resources devoted to surrogate end points in sterile compounding. Have we entered an era where we “can’t see the forest for the trees”?
The legitimate end point is product contamination. Where are the studies showing that the USP’s [U.S. Pharmacopeial Convention’s] surrogate end points make a difference in the end product? This is especially true for low-risk compounding (which is mostly what hospitals do) involving the simple transfer of a sterile drug solution to a sterile diluent (IV piggybacks). Risk for contamination is minimal because the sterile
Before recent USP updates, compounding practices showed a lack of understanding of proper aseptic technique.
ingredients are sequestered within sterile syringes, needles and closed system drug-transfer devices. Indeed, the only study I could find comparing traditional and sterile room influences concluded: “The most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded” (Am J Health Syst Pharm 2005;62[22]:2386-2392).
Have we conflated low-risk compounding with the problems of high-risk compounding? Should we be asking who profits from perpetuating a culture of regulatory extremism? How much has it cost us? Does anybody care? —Ray Vella, PharmD Central Coast, Calif.
Jerry Siegel, PharmD, one of the sources interviewed in the story, responds:
I can’t speak for USP on the issue of surrogate end points, but I can speak to the main question underlying Dr. Vella’s letter: whether fully outfitted and USPcompliant cleanrooms are necessary or overkill. As both a microbiologist and pharmacist, I, too, often have questioned the need for the increasing requirements of USP <797> for compounding sterile products. Certainly, these requirements are a far stretch from the practices of the 1970s, when I first started working as a hospital pharmacist. We didn’t use key personal protective equipment, such as gloves, and we just started employing laminar airflow in cleanrooms, but typically not in any type of buffer room— so basically, compounding in street clothes, with no guidelines on hand hygiene. I participated in studies to wear scrubs and move our “hoods” to separate rooms but not with measured air pressures. Morever, validation testing to document changes in nosocomial infections were not done.
The wake-up call was the New England Compounding Center disaster in 2012, when nearly 800 people were sickened and more than 100 died from fungal contamination in compounded sterile products. The lawsuits that followed, along with CDC and FDA investigations, prompted a stern look at the in-hospital and outsourced pharmacy compounding state of affairs.
In my own work with cleanrooms, I saw many deplorable conditions in hospital compounding facilities. Practices and facilities were inconsistent across every state as well as any level of enforcement. Although USP was and is still trying to set standards that are enforceable, not all states have or will accept this standard. As a result, I have seen not only poor facilities but very poor practices as well. I have so many examples of sinks in compounding areas leaking water contaminated with Pseudomonas spp, with compounded IVs stacked up right next to them, that the chance of not infecting the patient is relatively small in that situation.
As for the financial burden that cleanroom renovations can pose—and the pushback that often results—I understand those concerns. Still, I am in favor of risk reduction for patient care; it’s hard to put a price on that! Jerry Siegel, PharmD Vice President of Safe Medication Management Associates Inc. East Greenwich, R.I.
Promised Safety Solutions Fall Short
To the Editor: Re: “Preventing Medication Errors At Small and Rural Hospitals” (bit.ly/3cqmcwt)
Humans make mistakes, but computers should catch them. Despite the fact that insulin dosages change and new orders are generated, the “chain of custody” referring to the original order should always be maintained back to the first patient-specific order for that medication. This might have been problematic in 1985, but not today.
The workaround that was cited in the article—creating a “dummy order with the patient’s ID but no dose information, which generated a patient-specific barcode that stayed with that patient, even if dosing information changed”— is a solution that embarrasses the software vendor, the hospital and the pharmacist, and is dangerous for the patient. Pharmacy Practice News does everyone a disfavor by not identifying the electronic health record (EHR) vendor and following up with them as to why such an important safety net is unavailable in their system. I'll even give the EHR vendor the benefit of the doubt because this may be a configuration issue that the people who bought this system are unaware of, but critically need to know how to fix. If not, it behooves the vendor to fix the problem as soon as possible and provide the promised safety solution that the customer thought they were purchasing in the first place.
—Bruce Kiacz, BSPharm Toledo, Ohio
ISMP Responds:
Thank you for your interest in our work. Health care practitioners working in smaller hospitals with fewer resources are often compelled to be creative with the tools that are available to ensure the safest care for our patients. The function identified as a contributing factor in the case described is not unique to one EHR vendor. This issue and potential solutions were in fact discussed with the EHR vendor. ISMP's advocacy efforts include regular discussions with EHR (and other medication-related technology) vendors when medication safety risks for which they should be aware are identified. ISMP offers vendors safe practice recommendations based on our experience investigating and analyzing medication errors, that can be used in a plan of action to prevent further events. We disagree, however, that any disfavor was done by not providing the name of the EHR vendor in the article. In fact, one might argue that if the vendor name were included, those who do not use that vendor may have dismissed the importance of the message being conveyed.
It is important to learn and use information about medication safety risks and errors that have occurred outside one’s organization. Establishing a process for learning from external risks helps to assess an organization’s vulnerability to similar events and can trigger them to take preventative action. It is our hope that through sharing this event and the challenges that are specific to those practicing in small and/or rural hospitals, not only practitioners, but also vendors will be motivated to investigate their insulin use in the hospital setting and take action to implement processes that will make it harder for us to err.
Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices Horsham, Pa. Deborah Sadowski, RPh, MHA Director of Pharmacy Services Deborah Heart and Lung Center Browns Mills, N.J.
Vendor Offers More Information On Telepharmacy
To the Editor: Re: “Trying Telepharmacy? Here’s What You Need to Know” (bit.ly/3gI9oop)
As a representative of TelePharm, the proprietary HIPAA-compliant software used by the Medicap telepharmacy provider described in this article, I thought it might be worth mentioning that the main barrier listed in the article—that all communications have to be conducted via HIPAA-compliant software—can be addressed by using available software. Additionally, as noted correctly in the article, regulations governing telepharmacy vary state to state. So it may be worth mentioning that we at TelePharm have comprehensive resources fully briefing pharmacists from every state as to the regulatory landscape for telepharmacy. We also have a full-time regulatory affairs staff available to help efforts in both states where the practice is and is not allowed.
As noted in the article, reimbursement is a critical component of a successful telepharmacy operation. As far as the standard practice of remote dispensing using telepharmacy goes, the scope of practice is exactly the same as in a traditional pharmacy, and thus reimbursement works the same way. Pharmacists are not reimbursed for their consultations in a traditional setting, and that remains the same in telepharmacy. Indeed, the issue of reimbursement is not unique in the telepharmacy versus traditional fields of pharmacy operation.
ICU Delirium
continued from page 1
A major factor in the resurgence was the growing shortage of first-line medications for managing the pain, agitation and confusion that patients on ventilators typically experience, and the increasing use of benzodiazepines for sedation.
By mid-June, those shortages were still widespread. Indeed, many of the first-line agents used for COVID-19 patients on mechanical ventilation— cisatracurium, fentanyl, ketamine, vecuronium and midazolam—were still in shortage, according to the FDA (bit.ly/ 2YoXBEH). Shortages of ketamine, propofol, lorazepam, morphine and fentanyl also were reported.
In the absence of such agents, many clinicians are turning to benzodiazepines—and that’s a problem, Dr. Ely noted. Given the risks these agents pose, “when possible, we really need to get away from them,” he said.
That’s easier said than done. A recent New England Journal of Medicine study (doi: 10.1056/NEJMc2008597) found that 50 of 58 patients (86%) with COVID-19 received a benzodiazepine (midazolam). “We stopped using benzodiazepines years ago because of how deliriogenic they are,” Dr. Ely said. “To see 86% of people on a ventilator getting a benzodiazepine is like going back to how we practiced in 1995.”
Dr. Ely is an advocate for the ICU Liberation Bundle (A-F) protocol (formerly known as the A-F bundle), which focuses specifically on the prevention and treatment of delirium. “This is a six-step approach to taking care of patients in the ICU, where we modify sedation, try to avoid benzodiazepines, and try to wake people up and get them out of the bed,” he said.
The increasing number of COVID-19 patients with acute respiratory distress syndrome has stretched the ability of some hospitals to keep up with the shortages of drugs, personal protective equipment (PPE), and critical care physicians and nurses needed to treat them. Some hospitals find it easier to keep patients deeply sedated instead of implementing the A2F Bundle. Another factor is fear of viral transmission occurring at the bedside of COVID-19 patients.
“People are just scared,” said Joanna L. Stollings, PharmD, a critical care pharmacy specialist at Vanderbilt University Medical Center. “It’s a new virus and we don’t completely understand how it’s transmitted. Providers are sometimes afraid to go in and see the patients, not necessarily because they are afraid of contracting the virus but because they are afraid of transmitting it to someone else, and are trying to conserve PPE. Because of that, we’re having trouble implementing some of the letters in the bundle.”
ARDS Causing Hardships
—E. Wesley Ely, MD, MPH
These include the spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) described in the letter B of the ABCDEF bundle, Dr. Stollings said, and the early mobility and exercise called for in letter E. Both steps have been shown to facilitate a reduced need for sedation and earlier removal from the ventilator.
The importance of family involvement and empowerment in ICU patient recovery (letter F) has been another casualty in the delirium reduction protocol, as hospitals with COVID-19 in their ICUs bar family visits out of fear of transmission. “When people become delirious [letter D], we know medications typically don’t work to prevent or treat this,” Dr. Stollings said. “So one intervention that we might use is to have the family reassure and calm the patient.” But that option has been virtually eliminated by the need to curb transmission of the virus. “We have had to get creative and use
50 of 58 patients (86%) with COVID-19 received a benzodiazepine despite the drug’s deliriogenic effects.
Source: NEJM doi: 10.1056/NEJMc2008597.
things like phones and tablets to allow patients to communicate with their families,” she added.
Forced Substitutions
Dr. Stollings cited other factors in the resurgence of ICU delirium, including the growing shortage of medications used to induce sedation in ventilated patients. She noted that guidelines for managing pain, agitation and delirium recommend the use of dexmedetomidine or propofol for sedation—two drugs that, as of mid-June, were still listed in the current shortages section of the ASHP’s tracking site (bit.ly/2MohoNK), dovetailing with what the FDA reported. Because of this, she added, critical care physicians are forced to use benzodiazepines, such as midazolam or lorazepam, to induce sedation. “We’ve done a fair amount of research to show that these agents can cause delirium,” Dr. Stollings said.
“Then there’s the shortage of PPE,” she added, including the N95 respirators and powered air-purifying respirators that reduce the risk for viral exposure among physicians and nurses when they enter patients’ rooms.
In early June, the FDA reported that PPE shortages continued to affect hospitals nationwide. Part of the challenge for some facilities is how PPE is distributed. “We have received information from health care organizations that some distributors may have placed certain types of [PPE] on allocation, basing the quantity available to the health care organization on previous usage, not projected use,” the agency stated (bit.ly/2XXw3EI). “Increased use may exceed the available supply of PPE, resulting in shortages at some health care organizations.”
Dr. Stollings works in the ICU every day, rounding with physicians and helping them to decide what medications to prescribe and what not to prescribe. “I look for drug interactions and make sure everything is cost-effective,” she said. “I’m wearing scrubs for the first time and wearing a mask. We’ve had a shortage of fentanyl, for example, so I help them figure out different pain medications we can use so patients have adequate [relief ].”
An Algorithm for Delirium Rx
So far, Vanderbilt Medical Center has avoided the surge in critically ill COVID-19 patients that has struck other health systems. Dr. Stollings has developed a tiered algorithm for the use of ventilation medications “as we get more of these patients and experience more shortages.”
The algorithm, she said, has been submitted for publication and hopefully will be available soon for others to use to guide alternative treatment of pain and agitation. It suggests different options to consider, for example, when first-line sedation drugs and even less optimal second-line agents, such as the benzodiazepines, become unavailable. “When you get deeper into the algorithm,” Dr. Stollings said, “you’re thinking about things like antipsychotics,” such as haloperidol or drugs like ketamine, “which have limited data in critically ill patients.”
Speaking of alternative therapies for delirium, Dr. Ely said: “What doctors in hotbeds of COVID-19 are telling me they are doing is transitioning to shorter-acting drugs for less time, even antipsychotics, though not for delirium—they don’t treat delirium—but at least they can calm the patient and they won’t cause respiratory suppression. They won’t keep patients on the ventilator longer. So, antipsychotics, the alpha-2 agonists—clonidine and dexmedetomidine—these choices will at least not suppress the respiratory drive and won’t build up as much.” —Bruce Buckley
Benefits do not outweigh risks
FDA Pulls COVID-19 EUAs for Antimalarial Drugs
Saying that the benefits no longer with COVID-19 when a clinical trial was authorized uses in the EUA,” the agency of benefit outweighs the risk of treatoutweigh the potential risks, the unavailable, or participation in a clinical said in a statement. ing patients with hydroxychloroquine or FDA revoked the emergency use authotrial was not feasible. The agency deter“It was not surprising to see the chloroquine.” rization (EUA) for hydroxychloroquine mined that the legal criteria for issuing announcement,” said Michael Ganio, In April, just four weeks after grantsulfate (HCQ) and chloroquine phosan EUA were no longer met. PharmD, the director of Pharmacy ing the EUA, the FDA issued a warnphate (CQ) to treat COVID-19. “Based on its ongoing analysis of the Practice and Quality at ASHP. “There’s ing about reports of serious arrhythmias
The EUA allowed hydroxychloroquine EUA and emerging scientific data, the been mounting evidence that the drug in patients with COVID-19 treated with and chloroquine to be donated to the FDA determined that chloroquine and is not effective in treating hospitalized either drug, especially when prescribed Strategic National Stockpile to be used hydroxychloroquine are unlikely to be COVID-19 patients. And at some point with azithromycin and other QT-prolongto treat certain hospitalized patients effective in treating COVID-19 for the the amount of evidence about the lack ing medicines. The warning noted that the EUA was not a new drug approval, but allowed the drug to be used in clinical trials. “We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine,” the agency said in a statement at the time, adding that it would continue to investigate the reports, which included arrythmias, such as QT interval prolongation and ventricular tachycardia. As of May 6, 347 HCQ and 38 CQ cases with possible adverse events (AEs) were identified, according to the FDA. Most of the cases were among men in their early 60s. Five cases reported HCQ use through the EUA. QT prolongation was the most commonly reported AEs for both HCQ and CQ. There were 109 cases with serious cardiac AEs, some reporting one or more of the following: • 80 reported QT prolongation; • four reported torsades de pointes; • 14 reported ventricular arrhythmia, ventricular tachycardia or ventricular fibrillation; and • 25 had a fatal outcome. Among the 109 cases, 92 (84%) reported concomitant use of at least one other medication that prolongs the QT interval, and 75 (69%) reported concomitant use of azithromycin. There were 113 cases with serious noncardiac AEs, and among those, hepatitis, increased liver enzymes and hyperbilirubinemia were the most common AEs.
RECOVERY Data
In addition to the AEs reported, the FDA said it considered many factors before rescinding the EUA, including an announcement by the chief investigators of the RECOVERY trial, which closed the hydroxychloroquine arm of its study on June 5, due to a lack of benefit.
Sponsored by Oxford University in England, the RECOVERY trial (www. recoverytrial.net; Clinical Trials.gov: NCT04381936) is assessing the effectiveness of different potential COVID-19 treatments on their ability to reduce all-cause mortality within 28 days. More than 11,000 patients have been enrolled. The study randomized
1,542 patients to HCQ and 3,231 to the usual care comparator, and an interim analysis found that mortality trends favored the usual care comparator. In the HCQ arm, mortality was 25.7%, versus 23.5% in the usual care arm (hazard ratio, 1.11; 95% CI, 0.98-1.26).
The agency said several studies are still looking at the use of HCQ or CQ in COVID-19. Dr. Ganio said rescinding the EUA would not stop any of the trials. However, institutional review boards overseeing those trials might request preliminary data to decide whether they should be continued.
This is what happened at the National Institutes of Health and the World Health Organization (WHO). The NIH halted its hydroxychloroquine trial after an interim analysis found that while there was no harm, it was “very unlikely to be beneficial in hospitalized patients with COVID-19.”
In addition, the WHO suspended the hydroxychloroquine treatment arm from the SOLIDARITY trial.
Relief from Shortages
The FDA’s decision to pull the EUAs for hydroxychloroquine and chloroquine promises to ease shortages of the medications that developed when they were being touted as potential cures for COVID-19. At the height of that promotion, first-time prescriptions for the agents poured into community pharmacies at more than 46 times the average weekly rate, industry figures showed (bit.ly/3dc46yt). As a result, patients who take the drugs for chronic diseases, such as rheumatoid arthritis (RA) and lupus, had difficulty obtaining the medications. Access for malaria prophylaxis also was adversely affected.
Dr. Ganio said he hoped that as a result of the EUA cancellation, fewer outpatient prescriptions would be written for people trying to use the drugs as a COVID-19 prophylaxis, increasing the number of patients with RA and lupus who can regain access to the medications.
Dr. Ganio said pharmacists are going to be asked about hydroxychloroquine and chloroquine, and they need to have a discussion about the drugs’ risks and benefits, especially for people who still want to take them prophylactically.
Mortality in patients treated with HCQ was 25.7% versus 23.5% in the usual care arm.
CQ, chloroquine phosphate; HCQ, hydroxychloroquine sulfate.
Source: FDA (bit.ly/2UWZdmW). They should consider the patient’s medical history, what medications they might be taking, and their risk for infection for COVID-19, he suggested.
Thomas M. File Jr, MD, president of the Infectious Diseases Society of America, which has issued COVID-19 treatment guidelines, agreed that a cautious approach is needed. “As our body of knowledge expands in response to the COVID-19 pandemic, our nation must remain committed to following the science and ensuring policies that protect the health of residents as we investigate effective treatments to counter this insidious virus,” he said in a statement.
In related news: • The FDA said that HCQ or CQ could reduce the antiviral activity of remdesivir, another drug being tested for
COVID-19 (bit.ly/3fMwKIj). • Two widely publicized COVID-19 papers have been retracted following questions about the accuracy of the Surgisphere database used by the investigators (see pages 10-11).
—Marie Rosenthal
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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Retractions Question Claims Database
The recent retraction of two papers that used the Surgical Outcomes Collaborative registry, a database developed and maintained by Surgisphere Corp., to evaluate the impact of drugs in COVID-19 patients is a cautionary tale, according to C. Michael White, PharmD, who was not involved in both studies but was asked his thoughts about them. The authors of the two papers, which appeared in The New England Journal of Medicine and the Lancet, retracted the papers after concerns were raised about the data set used in the studies.
“By their nature, studies based on claims data or other databases do not provide a high quality of evidence to answer clinical questions, such as the risks versus benefits of a therapy for a condition,” said Dr. White, the department head and a professor of pharmacy in the Department of Pharmacy Practice at University of Connecticut School of Pharmacy, in Storrs. Dr. White recently co-authored a review about the use of hydroxychloroquine for COVID-19 (Ann Intern Med 2020 May 27. [Epub ahead of print]).
The retraction of the Lancet paper likely will reverberate most, given the ongoing controversy surrounding the antimalarial drugs at the center of the research. Published online on May 22, the study found
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that mortality was higher in gher in people receiving hydroxychloroquine, hloroquine, chloroquine, or either of these drugs with ith a macrolide antibiotic versus those treated without them. In addition, the investigators reported that patients treated with hydroxychloroquine or chloroquine were far more likely to experience ventricular arrhythmias than their counterparts who had not received the drugs.
The NEJM paper reported that the use of angiotensin-converting enzyme inhibitors and statins were not associated with worse outcomes in patients with COVID-19.
Surgisphere Data Come Under Fire
In early June, a group of researchers outlined their concerns about the integrity of the Surgisphere data set in a letter to the editor of NEJM (2020 May 1. doi: 10.1056/NEJMoa2007621). They noted, for example, that in some countries that contributed to the data set, “a relatively small number of hospitals are reported to have provided electronic patient record data to Surgisphere, yet these reports describe a remarkably high proportion of all confirmed cases in the respective countries.”
Based on such concerns, an independent auditor was to review the raw data and the studies, but apparently could not obtain the necessary information from Surgisphere, so the authors withdrew the papers.
“Because all the authors were not granted access to the raw data and the raw data could not be made available to a thirdparty auditor, we are unable to validate the primary data sources underlying our [NEJM] article, ‘Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.’ We therefore request that the article be retracted,” wrote Mandeep R. Mehra, MD, of Brigham and Women’s Hospital Heart and Vascular Center, in Boston, and lead author of the studies.
The retraction for the NEJM study was signed by all four authors, including Sapan S. Desai, MD, PhD, the president and CEO of Surgisphere.
The Lancet retraction, which came about an hour before the NEJM retraction, was not signed by all of the authors. Although longer, it essentially noted the same difficulty in analyzing the raw data. “We launched an independent third-party
—C. Michael White, PharmD—C. M
peer review of Surgisphere with the pe consent of Sapan Desai to evaluate the c origination of the database elements, to or confirm the completeness of the database, con and to replicate the analyses presented in an the paper. Our independent peer reviewers informed us that Surgisphere would not transfer the full data set, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements,” Dr. Mehra; Frank Ruschitzka, MD; and Amit N. Patel, MD, wrote. “As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peerreview process.
“We always aspire to perform our research in accordance with the highest ethical and professional guidelines,” the researchers added, noting that they “no longer vouch for the veracity of the primary data sources.”
The researchers said they collaborated in good faith and apologized for the papers.
Claims Data Sets Problematic
However, even if the trial data sets were
A Conversation With Dr. C. Michael White
legitimate, there are inherent weaknesses in this type of study that should be noted, said Dr. White, who is a member of the Pharmacy Practice News editorial advisory board. “The big issue is that while you might be able to statistically correct for the impact of some demographic factors [in claims data or other databases], you cannot correct for those factors you do not know at the time are important, and you cannot factor in the thought processes of the treating clinicians as they are making treatment choices.”
More rigorous data began pointing people away from hydroxychloroquine for COVID-19. The U.K.’s Randomized Evaluation of COVid-19 thERapY (RECOVERY) trial reported that there was no beneficial effect of hydroxychloroquine in hospitalized COVID-19 patients. The researchers compared 1,542 patients taking hydroxychloroquine with 3,132 patients receiving usual care alone. “There was no significant difference in the primary endpoint of 28-day mortality (25.7% hydroxychloroquine vs. 23.5% usual care; hazard ratio 1.11 [95% confidence interval 0.98-1.26]; P=0.10). There was also no evidence of beneficial effects on hospital stay duration or other outcomes,” the researchers said in a statement.
As a result, the FDA withdrew its emergency use authorization for hydroxychloroquine and chloroquine, and the National Institutes of Health and the World Health Organization stopped their hydroxychloroquine treatment studies. —Marie Rosenthal
The sources reported no relevant fi nancial relationships.
DRIVEN TO FULFILL THE PROMISE OF BIOSIMILARS— THE PFIZER WAY
The Pfizer Promise is simple:
To help you provide patients with more treatment options while delivering the largest portfolio of potentially cost-saving biosimilars. 1-3
Breadth of offerings
Pfizer has the largest portfolio of oncology biosimilars on the market, including both cancer therapies and supportive care products, to give patients more treatment options. 2,3
Quality focused
Pfizer oncology biosimilars are all produced to meet the same high-quality standards as its biologics—using the same robust protocols for monitoring quality throughout every stage of the manufacturing process. 4
Manufacturing and supply experience
Pfizer leverages more than 30 years of state-of-the-art manufacturing and supply-chain experience in biologics to reliably deliver biosimilars to patients. 4
Although the evidence points away from hydroxychloroquine as a treatment for COVID-19, it is still being considered as a prophylaxis. In a ZOOM interview, C. Michael White, PharmD, talked with us about what that could mean for patients. Watch at bit.ly/2Nphwgc-PPN.
To learn more about Pfizer’s oncology biosimilars, visit us online at PfizerBiosimilars.com
References: 1. IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. Parsippany, NJ: IMS; March 2016. 2. Drugs.com. How many biosimilars have been approved in the United States? https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/. Updated December 8, 2019. Accessed April 6, 2020. 3. McGowan S, Jesse M. Biosimilars Pipeline Report. AmerisourceBergen. https:/www.amerisourcebergen.com/-/ media/assets/amerisourcebergen/biosimilars-pipeline-report_0420_v3.pdf?la=en&hash=1071304C7B66ED62628201B8268C0B633 627CB6B. Updated May 1, 2020. Accessed June 4, 2020. 4. Data on file. Pfizer Inc., New York, NY.
Q & A: Steve Rough, Senior Vice President, Visante
Q: Hospitals and health systems consultants (many with minimal pharmacy experunderstand pharmacy, and our values are highly are faced with serious financial tise and understanding) to help lead finanaligned with advancing health-system pharmacy challenges post COVID-19. How will this impact pharmacy leaders and their departments? cial recovery efforts. Pharmacy occupies a large expense in most organizations, therefore pharmacy leaders will likely be asked to critically evaluate how services are provided, and pharmacy practice. We bring deep expertise in pharmacy financial recovery strategy, with most of our team members having previously served as contemporary chief pharmacy officers in major health systems A: As we start to see some glimmer of hope as departments will likely be targets for labor and and integrated delivery networks. We’ve successa society post COVID-19, health systems will non-labor savings mandates. fully run large-scale pharmacy organizations, and face significant financial distress, with a quick turnaround unlikely. Pharmacy leaders will be Q: How can Visante help? understand what it takes to maintain high-value pharmacy services and programs and to deliver on challenged to preserve core services, and it is A: Visante strives to serve as a business partner to financial improvement initiatives. likely that senior leaders will engage outside health-system pharmacy, not as a consultant. We We are uniquely positioned and stand ready to
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Learn more at visanteinc.com, or contact us at solutions@visanteinc.com or (866) 388-7583. help health-system pharmacy leaders quickly identify and successfully implement revenue growth and non-labor cost savings initiatives in their organizations. We do this with the goal of preventing otherwise imminent pharmacy workforce reduction mandates which could negatively impact patient care and safety.
A: Visante can help clients quickly identify successful revenue enhancement strategies that can be swiftly achieved with little to no new resources or through resource reallocation. Examples of quick-win opportunities can include medical and pharmacy benefit revenue cycle optimization to enhance collections and minimize write-offs, retail and specialty pharmacy optimization that leads to profitable business growth and important/convenient solutions that meet patient needs, site of care strategies pertaining to infusion and home infusion therapy, and direct-to-employer and health plan pharmacy services contracting.
A: There are many examples of non-labor savings pharmacy initiatives that can be quickly and effectively implemented to save health systems millions of dollars annually. Examples include innovative 340B and pharmacy supply chain optimization strategies, drug (including innovative therapies and biosimilars) utilization initiatives, insourcing of compounded sterile products, employee drug benefit redesign, and centralization/consolidated services implementation.
Q: What workforce (labor savings) strategies do you suggest?
A: In general, broad-scale reductions in pharmacy workforce are shortsighted and can negatively impact the quality of patient care as well as health-system financial performance. However, post COVID-19, it is advisable that every pharmacy leader proactively identifies opportunities for improved labor efficiency without compromising quality, and that every pharmacy leader has a plan to gain efficiency of between 5% and 20% in a worst-case scenario. Visante is able to help pharmacy leaders with centralization and remote services strategy as well as with leveraging technology and skill mix enhancements to improve productivity and lower labor costs if needed. Some examples include work-from-home and remote dispensing to help match resources with workload, for example. It is vital that any pharmacy workforce savings strategy does not negatively impact patient care, and we offer innovative approaches in this regard.
Mr. Rough has more than 20 years of hospital pharmacy and health care leadership experience, in which he successfully built and led all aspects of strategic, operational, clinical, programmatic and fi nancial performance for a large health-system pharmacy enterprise. He has delivered more than 145 presentations to national pharmacy audiences and has served in countless volunteer leadership positions within professional pharmacy organizations.
COVID-19 Takes a Global Toll on Oncology Practice
Oncology pharmacy practices around the world are struggling to cope with the numerous supply and safety challenges brought on by the COVID-19 pandemic, according to a global survey by the International Society of Oncology Pharmacy Practitioners (ISOPP).
Among these practitioners’ top concerns, the survey found, is the impact of shortages in medications and personal protective equipment (PPE) on the delivery of therapy to cancer patients, who are already at higher risk for coronavirus infection and worse outcomes than the general population.
“Oncology pharmacists are looking for guidance,” said Alexandre Chan, PharmD, MPH, a professor and the founding chair of the Department of Clinical Pharmacy Practice at the University of California, Irvine. “We wanted to come up with data that could help them make decisions.”
Dr. Chan told Pharmacy Practice News that the snapshot survey, covering the period from April 10 to April 20 when the worldwide infection rate was rapidly increasing, was just the “first step” in ISOPP’s long-term objective to develop evidence-based pandemic response guidelines for oncology pharmacy practitioners.
The survey, with responses from 42 oncology pharmacy leaders worldwide, found that more than eight out of 10 respondents (82%) had changed their treatment practices to adjust to the new realities brought by the pandemic (doi.org/10.1177/1078155220927450; bit.ly/3hzgoEN).
The practice changes were hardly uniform across the 28 countries and five regions surveyed. The most common changes were fewer clinical trial referrals, reported by respondents in 10 of 28 countries; increased use of supportive care medications (nine of 28); and timing changes or delays in treatments or transplants (nine of 28). In the palliative care setting, the most frequent changes involved the use of more oral cancer therapies (12 of 28); switches to less myelosuppressive cancer therapy regimens (eight of 28); and a reduction in clinical trial referrals (eight of 28).
In 12 of the 28 countries, the survey found that shortages of PPE—particularly N95 masks—had put a strain on the compounding and administration of hazardous antineoplastic agents. To cope with the shortfall, some practices extended pharmacists’ and technicians’ work hours. Others altered their hours to facilitate split shifts or team separation. A handful of practices were forced to reduce hours because of illness or quarantine. Longer shifts helped to extend PPE supplies, but the trade-off was the potentially negative effect on workers’ mental health and quality of life, Dr Chan noted.
Medication shortages also took a toll on oncology practice, with the impact felt most acutely in Africa, where importation has been an ongoing challenge. Of responding African countries, 86% reported experiencing shortages of both anticancer and supportive care medications, and 71% have had problems importing anti-infectives.
Dr. Chan said this survey report was published because “a lot of oncology pharmacists around the world are looking for guidance on how to ensure occupational safety during the pandemic. ISOPP’s mission is to support not just members, but the entire oncology pharmacy profession. We want to come up with data that can help decision making.”
Moving forward as a society, he added, “we’re going to use some of the best practices being developed around the world to inform practitioners. But ultimately, we need research to develop evidencebased guidelines. That is what is in shortage right now, which is why everyone is scrambling and doing different things.” —Bruce Buckley
Dr. Chan reported no relevant fi nancial relationships.
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NMBA Caps Pose Risk
continued from page 1
agency said the short-term measure was necessary to ease severe supply disruptions caused by the high demand for agents needed to immobilize critically ill COVID-19 patients on mechanical ventilation. Specially marked warning caps also have been in short supply, the FDA reported.
Figure 1.
Images of currently approved cap (left) and temporary cap (right) for vecuronium bromide injection 10-mg vial and 20-mg vial.
The easement was scheduled to continue through July 2020 for rocuronium and through September 2020 for vecuronium.
To ensure safe use of these high-alert medications in the meantime, ISMP published images of the approved and temporary blank caps (Figures 1, 2) and urged pharmacists and nurses to exercise extreme vigilance in storing the unmarked vials (Figure 3) and selecting and preparing them for administration.
“There may be other vials of the same size that also have a gray cap or nearly gray cap,” said Michael R. Cohen, MS, RPh, the president of ISMP. If they’re stored next to each other and below eye level with only the caps visible, he said, the odds of choosing and injecting the wrong medication greatly increase.
Figure 2.
Images of currently approved cap (left) and temporary cap (right) for rocuronium bromide injection, 50 mg per 5 mL and 100 mg per 10 mL.
Figure 3.
When vials are standing upright in storage, staff may select a vial based on cap color and may not notice if they have the wrong vial in hand (tranexamic acid, left, ropivacaine, right).
Photo credit: ISMP.
Deadly Versed Error
As an example of the risks, Mr. Cohen cited a December 2017 case at a Tennessee hospital where a nurse, who was supposed to administer the sedative Versed (midazolam) to a patient with anxiety, typed “VE” into the computer instead of “MID” for midazolam, and vecuronium popped up. The result was she prepared and injected the paralyzing agent, and the patient died (bit.ly/2zVn8M2-PPN). “We’ve had these accidents from time to time with these agents given in error,” Mr. Cohen said.
One way to reduce the risk, he suggested, is to attach auxiliary “warning: paralyzing agent” labels to the tops of the unmarked vials. “They’re readily available from different medical supply houses,” he said.
Other suggestions highlighted in the safety alert included reminding staff of the importance of barcode scanning before drug preparation and administration. Another strategy is to make sure vials “are lying down so that labels are visible in automated dispensing cabinet drawers, anesthesia trays, or in other storage containers or shelving, particularly on low shelves in a refrigerator.”
The FDA has temporarily allowed manufacturers of rocuronium and vecuronium to distribute vials of the paralyzing agents without the required cautionary cap labels. The agency said the measure was necessary to ease severe supply disruptions caused by the high demand for agents needed to immobilize critically ill COVID-19 patients on mechanical ventilation.
Deb Saine, MS, RPh, the director of the quality program at Valley Partners in Winchester, Va., emphasized the critical importance “for pharmacists to ensure safe processes are in place, and followed, for storing and dispensing these high-alert medications.
“It’s also a good time,” she said, “to physically visit each area where neuromuscular blockers are stored or used so you can resolve any inconsistencies and take the opportunity to provide education to keep patients safe from harm.”
Rush University’s Approach
Many health systems and hospitals have already taken special safety precautions with paralyzing agents in response to the growing number of ventilated COVID-19 patients with severe acute respiratory syndrome.
Drayton A. Hammond, PharmD, a critical pharmacy specialist at Rush University Medical Center in Chicago, said the center’s adult medical ICU “has been vigilant with barcode scanning at the bedside to help reduce the likelihood of an error involving any medications, but especially high-risk medications, at the time of administration.”
Dr. Hammond said the ICU also changed its “process to use intravenous push neuromuscular blockade in critically ill adults in response to COVID-19, which involved pharmacists reeducating all registered nurses on the agents and their risks, as well as monitoring parameters.” Additionally, an alert now goes off whenever a neuromuscular blocking agent is removed from an automatic dispensing cabinet “to remind the nurse of the care needed when administering these agents.
“These are not foolproof measures,” Dr. Hammond said, “but we do believe they’ve allowed us to feel comfortable with short-term use of the vials that do not have the labeling on the cap. We do remain vigilant with these agents and, thankfully, have not had any issues so far with this change.” —Bruce Buckley
The sources reported no relevant fi nancial relationships.
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