American Journal of Health-System Pharmacy

Dentzer,, Susan

doi: 10.1093/ajhp/zxz268pmid: 31789357

artificial intelligence, machine learning, medication optimization, workforce Is artificial intelligence (AI) about to reinvent healthcare, or are its applications to the field not yet ready for prime time? The answer is yes on both counts. In the realm of pharmacy, for example, AI is already being used to predict adverse drug events, including drug–drug interactions, as well as to power mobile platforms that aid patients in boosting medication adherence. But as ASHP’s Commission on Goals1 points out in its report on AI in this issue of AJHP, the most dramatic potential applications lie ahead—and the prospects are both exhilarating and unsettling. When developed and used appropriately, AI will enable far superior diagnosis and treatment, as well as greater efficiency in operational aspects of pharmacy care. Used inappropriately, however, AI could lead to great harm—for example, if algorithms based on genomic studies of a relatively narrow patient cohort were used to make flawed diagnostic or treatment decisions for an altogether different population of patients.2 Given both the possibilities and the potential pitfalls, leaders in health-system pharmacy should create a robust research agenda for determining how best to reap AI’s potential to achieve beneficial outcomes and drive toward the Triple Aim. In so doing, they would follow a wise old dictum: The best way to predict the future is to create it. Use-case identification As the Commission on Goals proposed, compiling this research agenda would start by identifying various use cases in which AI-enabled applications, particularly those based in machine learning, could make significant contributions to improving patient care. Such use cases could include actual clinical decision-making and operational changes in pharmacy management, such as the broad array of activities inherent in optimizing medication delivery and use. This complex area is overripe for vast improvement, given estimates that the annual cost of drug-related morbidity and mortality resulting from nonoptimized medication therapy totaled more than $528 billion—a staggering 16% of U.S. healthcare expenditures—in 2016.3 The broad capacities of machine learning in particular—to detect patterns, categorize like people and processes, predict outcomes based on patterns, identify unknown patterns and relationships, and detect anomalies—can help to address the myriad ways that medication use goes awry, as well as to pinpoint multiple opportunities for better clinical care and pharmacy process improvement. By specifying these and other key research areas that AI and machine learning could shed light on, health-system pharmacy could signal for both academia and the commercial sector where to place their efforts to make inroads in an area of healthcare that produces tremendous waste and human harm. Data standards framework Because much of AI—and indeed, all of machine learning—is at root about processing, analyzing, and learning from data, how these data are gathered, used, labeled or tagged, and otherwise stewarded will determine AI systems’ ultimate utility and effectiveness. As a result, a second item on the research agenda for health-system pharmacy should be devising a set of “best data practices” to govern the development and use of AI applications related to pharmacy. Creating what amounts to a “data checklist” for health systems and others to use is essential. In particular, detailing how systems should follow appropriate consent procedures for gathering data on individuals that will be used to train machine learning systems, as well as observing any applicable privacy or security laws and regulations, is essential. Algorithm transparency and accountability AI is built on algorithms, which as Topol4 has described, now exist along a “continuum from those that are entirely human guided to those that are entirely machine guided.” An example of the former is “rules-based” software that analyzes an array of symptoms to arrive at a particular cancer diagnosis; an example of the latter, machine-guided algorithms, is software that trains itself to perform tasks, such as categorizing cancers into new subtypes based on ever-increasing volumes of data.5 Yet, it isn’t always clear why or how these machine-guided algorithms actually work—a “black box” problem that could grow worse with time. Health-system pharmacy should team with other leading healthcare groups to define minimum acceptable standards for transparency and “explainability” of algorithms, especially those that could affect clinical pharmacy practice. Workforce and systems preparedness Almost every sector within healthcare lacks the people, skills, and knowledge to both gain the most from AI and avoid the pitfalls. What’s more, shockingly enough, no existing set of healthcare workforce projections takes account of AI or any other information technology. Today, it may only be possible to guess at what the future may look like, but sound decisions about investments in education and training can’t be based on such a flimsy foundation. A research agenda that carefully considers these investment decisions as they pertain to the future pharmacy workforce is essential—and arguably well within the bounds of even human intelligence to achieve. Disclosures: The author has declared no potential conflicts of interest. References 1. American Society of Health-System Pharmacists. Executive summary of the 2019 ASHP Commission on Goals: impact of artificial intelligence on healthcare and pharmacy practice . Am J Health-Syst Pharm. 2019 ; 76 : 2087 - 2092 . WorldCat 2. Topol E. Deep medicine: how artificial intelligence can make healthcare human again. New York : Basic Books ; 2019 : 99 . COPAC 3. Watanabe JH , McInnis T , Hirsch JD . Cost of prescription drug-related morbidity and mortality . Ann Pharmacother. 2018 ; 52 : 829 – 37 . Google Scholar Crossref Search ADS PubMed WorldCat 4. Topol E . Op Cit. : 69 . 5. Ching T , Himmelstein DS , Beaulieu-Jones BK et al. Opportunities and obstacles for deep learning in biology and medicine . J R Soc Interface. 2018 ; 15 : 20170387 . DOI 10.1098/rsif.2017.0387 Google Scholar Crossref Search ADS PubMed WorldCat © American Society of Health-System Pharmacists 2019. All rights reserved. For permissions, please e-mail: [email protected]. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Coralic,, Zlatan

doi: 10.1093/ajhp/zxz238pmid: 31789356

medical literature, medication reconciliation, research methods Maintaining and communicating accurate medication information across the continuum of patient care is a National Patient Safety Goal. The primary reason for this goal is that “there is evidence that medication discrepancies can affect patient outcomes.” 1 Over the past decade, tremendous financial and personnel resources were invested in pursuing this goal. Correlatively, published literature has increased, including medication reconciliation systematic reviews and meta-analyses. Still, little is known about the overall effects of medication reconciliation on direct patient outcomes. In this issue of AJHP, Anderson et al. provide a systematic overview of medication reconciliation systematic reviews. This type of study design is usually intended to provide a summary of the highest level of evidence available.2 The study’s primary outcome focuses on the most important patient-centered question: What is the effect of medication reconciliation programs on morbidity, mortality, and healthcare use? Using standardized and validated systematic review tools, the authors narrowed the medication reconciliation studies performed over the past decade to 9 peer-reviewed manuscripts meeting stringent inclusion criteria. The included reviews varied in patient population, including the elderly, adults, and children. While the majority of systematic reviews analyzed transitions in and out of the hospital setting (i.e., medication reconciliation at admission and discharge), 1 review focused on primary care. The overall quality of evidence of included systematic reviews was poor, with only 3 meeting moderate evidence criteria. The reviews suffered from poor study quality, nonrandomized design, and conflicting and varied outcome effects. Overall, medication reconciliation was found to be effective in reducing medication discrepancies; nevertheless, studies with such conclusions were based on low-quality evidence. Of the studies that examined clinically significant discrepancies, mortality, and adverse events, most yielded mixed results, with positive results usually suffering from poor-quality evidence. Study designs such as this are not easy, and the authors should be commended on taking on a challenging question with this methodology. As the authors mention, only 1 similar study reporting similar results is currently available.3 Some limitations of the overview are the inclusion of heterogeneous settings, patient populations, and broad definitions of medication reconciliation activities. While medication reconciliation discrepancies occur commonly, errors and patient harm from such discrepancies are uncommon. Finding adequately powered studies for the detection of rare events is a limitation of the included systematic reviews, which inherently limited the researchers’ ability to make patient-specific conclusions. What to make of the results of this study? Should hospitals decrease investments in improving medication reconciliation processes, as they have no effect on ultimate patient-specific outcomes? The study suggests that stakeholders should not expect to improve patient-specific outcomes solely with medication reconciliation. While this study raises important questions about effect, it also shows that the latest quality evidence about effect is still lacking. Additionally, the heterogeneity of settings and patient populations analyzed represent distinct cohorts with unique medication history requirements. As such, drawing overarching conclusions about medication reconciliation effect should be done with caution. Further, stakeholders should not conflate low-quality evidence with no evidence of benefit. The authors recognize the dilemma between medication reconciliation “face validity” (i.e., clinical importance) and their results. Anyone who has performed a detailed medication history at a transition of care can likely attest to catching discrepancies that may have led to catastrophic consequences. No provider would deny the importance of a meticulous list of current medications and allergies at hospital admission or discharge as being part of good clinical care. However, medication reconciliation does not equally influence patient outcomes across all patient settings and populations. For example, a medication history of an otherwise healthy patient presenting to the emergency department for appendicitis is much less likely to identify a life-threatening problem than one conducted for a 65-year-old man with new-onset kidney failure 2 months after a bilateral lung transplant. Is it reasonable to lump these 2 patients into the same group when comparing outcomes? Medication reconciliation remains a laborious and resource-intensive process but nevertheless an indispensable part of good patient care. Perhaps improving clinical outcomes through medication reconciliation involves freeing providers from tedious clerical tasks of data collection. Such time may be better spent face to face with patients, where important subtleties not apparent in dispensing histories are identified. One way to achieve this is with the creation of an easy-access national database for all prescriptions (similar to controlled substance prescription drug monitoring databases). Other authors have suggested developing clinical decision rules guiding providers to those patients at highest risk of discrepancies and medication errors.4 While there may be other ways to improve medication reconciliation, priority should be placed on maximizing interaction with the source of the latest information—the patient. The study by Anderson et al. is an important addition to the medication reconciliation literature. It reveals that there is a large body of evidence of low-to-moderate quality and that further rigorous high-quality studies are needed. As the study is meant to inform decision makers, close attention should be paid to the authors’ discussion and limitations in light of the “underwhelming” primary outcome results. Disclosures: The author has declared no potential conflicts of interest. References 1. National Patient Safety Goals Effective January 2019 . https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2019.pdf ( accessed 2019 Apr 20 ). 2. Aromataris E , Fernandez R , Godfrey CM , Holly C , Khalil H , Tungpunkom P . Summarizing systematic reviews: methodological development, conduct and reporting of an umbrella review approach . Int J Evid Based Healthc 2015 ; 13 : 132 - 40 . Google Scholar Crossref Search ADS PubMed WorldCat 3. Holte HH , Hafstad E , Vist GE. Overview of reviews on effect of medical reconciliation . Oslo, Norway : Norwegian Knowledge Centre for the Health Services (NOKC); 2015 . COPAC 4. De Winter S , Vanbrabant P , Laeremans P et al. Developing a decision rule to optimise clinical pharmacist resources for medication reconciliation in the emergency department . Emerg Med J 2017 ; 34 : 502 - 8 . Google Scholar Crossref Search ADS PubMed WorldCat © American Society of Health-System Pharmacists 2019. All rights reserved. For permissions, please e-mail: [email protected]. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Gregory,, Nancy

doi: 10.1093/ajhp/zxz282pmid: 31789361

ASHP’s Opioid Task Force kicked off its work to address the critical role that pharmacists play in combating the nation’s opioid crisis during a meeting held October 2–3 at ASHP headquarters in Bethesda, Maryland. The 23-member ASHP task force, chaired by Past President Lisa Gersema, included policy and public health leaders; clinicians from pharmacy, nursing, and medicine who specialize in pain management, emergency medicine, and behavioral and mental health; community pharmacy; as well as the patient voice. The 2-day meeting culminated in the development of a series of draft recommendations that will undergo review and be published in AJHP in early 2020. A vital component of ASHP’s ongoing efforts to combat the opioid epidemic, the interdisciplinary ASHP Opioid Task Force is charged with identifying actionable solutions, tools, and resources through the engagement of pharmacists as medication therapy experts, clinicians, and healthcare providers on the interprofessional care team. “The opioid crisis, which has impacted families and communities nationwide, is an issue that requires our urgent attention and collaboration,” said ASHP Chief Executive Officer Paul W. Abramowitz. “ASHP has been working on several fronts for the past several years to address this problem. Through collective efforts such as our Opioid Task Force, we are committed to working together with other stakeholders on solutions that will help solve our nation’s opioid epidemic.” The meeting focused on: Identifying the roles that pharmacists play in initiating, building, and growing opioid stewardship; Identifying best medication-related pain management prescribing practices that optimize the use of nonopioid therapies; Identifying the public health roles that pharmacists play in their communities as related to the prevention and treatment of opioid use disorders; Developing recommendations on a solutions-focused public policy agenda; and Identifying education, tools, and other resources to help hospitals and health systems address the opioid crisis, including in areas related to drug diversion, prevention, and mitigation. During the meeting’s first day, task force members with expertise in opioid stewardship programs outlined efforts to address opioid use disorder in their respective communities, including one program that resulted in a 74% reduction in high-dose opioid use. Following the case study presentations, 2 workgroups focused on drafting policy and practice recommendations. The draft recommendations ranged widely in scope, from those that address prevention efforts, such as advocating that pharmacists be trained in mental health first aid and empowered to screen and identify patients at risk of substance use disorder, to recommendations for pharmacy practice, such as contributing to pain management and opioid stewardship teams. Task force members also worked on recommendations for care planning, diversion prevention, addressing research gaps, and more. Task force members also discussed challenges on a number of fronts, including a need for greater awareness of multimodal interventions, using functional evaluation of pain rather than pain scales alone, and the need to more holistically address the root of the opioid problem. As healthcare professionals go through the process of reeducating patients, “we need to reeducate ourselves on what successful pain management represents,” one task force member said. Participants agreed that there is a continued opportunity for pharmacists to take the lead on patient education, which was a strong focus throughout the discussions, as well as on other emerging areas, such as prescribing, virtual care, and health equity for patients in need of pain management, treatment for opioid use disorder, and other recovery services. Paul W. AbramowitzRepresenting the voice of the patient, Joan Maxwell, patient advisor for John Muir Health in Walnut Creek, California, thanked ASHP and the members of the task force for including “a patient at the table.” She described a relative’s opioid use disorder that developed after 2 failed back surgeries and said she sees an opportunity for more hands-on patient counseling to clearly communicate treatment plans involving opioids and other medications. Open in new tabDownload slide Joan Maxwell Open in new tabDownload slide Joan Maxwell Open in new tabDownload slide Paul W. Abramowitz Open in new tabDownload slide Paul W. Abramowitz “I was wowed, I have to say,” Maxwell said after the meeting. “I wish all patients could have the opportunity to be in the room with this kind of interdisciplinary team to see how committed everyone is to making things better. It’s very inspiring.” Maxwell said she views the pharmacist’s role in educating a patient who is prescribed an opioid as crucial to the patient’s journey. She said pharmacists could help prevent people from becoming dependent on opioids. “Everyone I know really trusts pharmacists. . . . They’re the ones watching out for us,” she said. Outcomes from the ASHP Opioid Task Force will be shared with the National Academy of Medicine Action Collaborative on Countering the U.S. Opioid Epidemic, of which ASHP is a sponsor. ASHP serves on the Action Collaborative’s Pain Management Guidelines and Evidence Standards Working Group and Prevention, Treatment, and Recovery Services Working Group. ASHP will also share the final recommendations and any resources that are developed as a result of the task force’s work with all members. Current resources include toolkits on pain management, controlled substances management, and opioid management. The Mainstreaming Addiction Treatment Act, which would eliminate a barrier preventing pharmacists from prescribing and dispensing buprenorphine for medication-assisted treatment of opioid use disorder, was introduced in Congress this year. ASHP urges members to help pass this legislation by contacting their members of Congress and asking them to support it. Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Traynor,, Kate

doi: 10.1093/ajhp/zxz269pmid: 31789359

The emerging science of precision medication dosing can help patients who might otherwise forgo drug therapy, says Michael Neely, professor of pediatrics and clinical scholar at the University of Southern California (USC) Keck School of Medicine in Los Angeles. During an August 12 public workshop on precision dosing at FDA’s Silver Spring, Maryland, headquarters, Neely described a patient at his multidisciplinary clinic: a 45-year-old woman with HIV infection and a history of medication intolerance who was newly prescribed fosamprenavir and blamed the drug for causing fatigue. He said the patient wanted to either discontinue the medication or take all 4 of her 700-mg tablets at bedtime—instead of taking 2 tablets twice daily—to avoid daytime fatigue. So the healthcare team measured the amount of medication in the patient’s bloodstream under the prescribed regimen and used modeling software to calculate trough levels. The model determined that the patient would need to take 70 tablets at bedtime to maintain an adequate bloodstream concentration of the antiretroviral drug throughout the day. Neely said the result made it clear to the patient that a once-daily fosamprenavir regimen was a bad idea. “But I didn’t give up on her,” he added. Instead, he used the model to develop a personalized dosing schedule, with fosamprenavir taken at 10- and 14-hour intervals, that maintains sufficient trough drug concentrations to suppress viral replication. He said the patient is happy with the tailored regimen. And, he said, “her viral load is undetectable.” Neely referred to the process of crafting the patient-specific dosage as clinical pharmacometrics. Daniel Gonzalez, assistant professor of pharmacotherapy and experimental therapeutics at the University of North Carolina (UNC) Eshelman School of Pharmacy in Chapel Hill, said clinical pharmacometrics has the potential to provide better outcomes at the population level. He noted that dosage regimens are based on data from clinical trials that typically exclude “a large fraction of the real-world patient population,” such as pregnant and lactating women, patients at the extremes of age or body size, and people with organ dysfunction. Gonzalez and colleagues have conducted pharmacometric modeling studies to simulate optimized dosage regimens that could fill some of these patient care gaps. One example is a creatinine clearance (CLcr)–based regimen for rivaroxaban in patients with atrial fibrillation. The drug’s labeling recommends 2 dosages to reduce the risk of stroke in this population—15 mg once daily for patients whose CLcr rate is ≤50 mL per minute and 20 mg once daily for patients whose CLcr rate exceeds 50 mL per minute. The UNC team’s model evaluated 5 CLcr ranges, from <15 mL per minute to ≥160 mL per minute, and used pharmacokinetic (PK) data to recommend dosages of 10 or 15 mg taken once or twice daily that were calculated to produce acceptable drug exposure levels. Under this model, rivaroxaban is not recommended in patients whose CLcr rate is <15 mL per minute. Gonzalez cautioned that there are “numerous scientific challenges that need to be overcome” with respect to developing and selecting pharmacometric models. But he predicted that technologies such as artificial intelligence and machine learning will play important roles in overcoming those challenges. USC’s Neely said existing technology already has the potential to the produce custom medication formulations that are needed to create precise dosage regimens. “We have 3D printing now. We can 3D-print any formulation that we want,” at least in theory, he said. He suggested that wearable devices could be configured to rapidly measure and record bloodstream drug concentrations and guide dosage recommendations. Neely said the lack of reimbursement from payers hinders the adoption of clinical pharmacometrics. He said that although physicians and pharmacists can bill for therapeutic drug monitoring services, the monitoring generally needs to occur during a face-to-face patient encounter. A better solution, he said, would be for payers to reimburse clinicians for remote therapeutic monitoring services. He also proposed that FDA create an advisory committee to help the agency address regulatory issues related to precision dosing. Issam Zineh, director of FDA’s Office of Clinical Pharmacology, said the agency recognizes the need and demand for precision dosing. He acknowledged that medication therapy in the clinic setting is often a matter of trial and error. “A patient presenting with a given condition could be given any of a number of treatment options,” he said. “We like to think that that would be patient centric, but it often isn’t. It’s driven by clinician comfort, what’s on the formulary, what’s reimbursed—things that aren’t necessarily patient specific.” Zineh said “science, policy, implementation, and opportunities may be converging” to advance the discussion of precision dosing. He said key questions for FDA include “what drugs are amenable to precision dosing and how big of a problem is imprecise dosing.” FDA evaluated 181 drugs approved during 2013–17 and determined that about half may be suitable for precision dosing. Zineh said FDA also found that the labeling for 61% of the candidate drugs lacked titration information that clinicians could use to develop precise dosages. Robert Temple, deputy center director for clinical science at FDA’s Center for Drug Evaluation and Research, said it’s now routine for new drug applications to include analyses of drug metabolism and drug–drug interactions and for applicants to perform PK studies on the basis of age, gender, and liver and kidney function. Temple said some PK and pharmacodynamic (PD) data haven’t been verified in clinical studies and therefore don’t appear in product labeling. He said the idea of releasing unverified data makes regulators “nervous.” Nevertheless, he said, “We have to think about possibly using these PK/PD data for labeling.” Neely said he understands the basis for FDA’s nervousness but agreed that it’s time for the agency to consider releasing the data so that clinicians can make better dosage decisions. “As a physician, I’m allowed to prescribe doses that have not been studied,” he noted. Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Traynor,, Kate

doi: 10.1093/ajhp/zxz272pmid: 31789362

Christopher J. Decker, inaugural executive director and chief executive officer (CEO) of the Pharmacy Society of Wisconsin (PSW), died July 30 from glioblastoma. He was 54 years old. Open in new tabDownload slide Chris Decker Open in new tabDownload slide Chris Decker “We are all deeply saddened by the loss of our longtime friend and colleague, Chris Decker,” said ASHP CEO Paul W. Abramowitz. “Chris leaves behind so many friends and family who admired and loved him and a legacy of meaningful contributions to the advancement of pharmacy practice in Wisconsin and beyond. We will all miss Chris very much.” Steven Rough, senior director of pharmacy at UW Health, called Decker “one of my closest colleagues and best friends.” “He served as an inspiration for so many people on the right way to live life and what it takes to lead. And he did this effortlessly and with a special grace that may never be matched,” Rough said. Rough said his friend was widely known throughout Wisconsin pharmacy for his upbeat motto: “Let’s keep making a difference together, while enjoying every bit of sunshine along the way.” Those who knew Decker said that in addition to his love of pharmacy, he was passionate about great food and wine, friends, golf, and, above all, his family. Decker was born on September 6, 1964, in Cedar Rapids, Iowa, and he received a bachelor’s degree in pharmacy from the University of Iowa in 1988. After graduating, he completed an executive internship at the Iowa Pharmacy Association (IPA) and then worked for 2 years as the organization’s director of professional affairs. He left IPA in 1990, at the age of 26 years, to serve as executive vice president of the Wisconsin Pharmacists Association (WPhA). His early work at the association focused on promoting leadership roles for young pharmacists and underrepresented practitioner populations in the state. Decker was instrumental in shepherding the 1998 joining of WPhA and the Wisconsin Society of Health-System Pharmacists to form PSW, the first merged pharmacy association in the United States. He led the association through the remainder of his professional career. Rough said Decker transformed PSW into an organization that members aspired to serve. “He was part of PSW, and PSW was part of him,” Rough said. “He inspired and built a culture of excellence, innovation, collaboration, mutual respect, and giving boldly that will transcend for decades into the future. His smile and laughter provided a comfort for people to come together, to work together, and to celebrate together. He always let others shine, it wasn’t in his nature to take the credit, ever.” In a typically lighthearted 2014 autobiographical post for PSW’s website, Decker stated that his decision to become a pharmacist was influenced by summers spent working in the heat in a tire shop. A family friend owned a pharmacy, and it was air conditioned, Decker explained. He also stated that he learned years after starting at PSW that his colleagues had expected their youthful new leader to either fail at the job within 2 years or use it as a steppingstone to bigger things. Decker stayed, he stated, because “we haven’t been doing the same thing . . . year after year.” “We have had a consistent goal—to advance pharmacy practice in the state—but PSW’s programs, services, and activities have evolved each year. PSW is an organization with a culture of collaboration and progressive action. We strive to do big things while making sure we pay attention to the little details critical to the success of any organization. That’s inspirational work,” Decker added. Decker’s accomplishments at PSW include securing a $3 million grant from the Centers for Medicare and Medicare Services (CMS) in 2008—a first for a pharmacy association—to support the newly established Wisconsin Pharmacy Quality Collaborative. PSW obtained an additional $4.1 million CMS award for the project in 2012, and the collaborative continues to serve as a statewide resource to help pharmacists provide comprehensive medication therapy management services. Decker also served terms as chairman of the Wisconsin Patient Safety Institute and president of the Wisconsin Pharmacy Foundation and the National Council of State Pharmacy Association Executives. His excellence was recognized with numerous awards, including the 2018 Certificate of Merit Award from the University of Wisconsin–Madison School of Pharmacy and the 2016 University of Iowa College of Pharmacy Distinguished Alumni Award. Sarah Sorum, Acting CEO for PSW, called Decker “a mentor and friend to many.” “Chris built a strong culture of leadership and strong leaders. It will be these leaders that will carry us forward, and Chris will always be with us in that way,” she said. Mike Gillard, PSW president-elect and inpatient pharmacy manager at Ascension Southeast Wisconsin Hospital in Franklin, first met Decker about 26 years ago while on a pharmacy school rotation at PSW, and the 2 worked together over the years as Gillard remained involved with PSW. Gillard said his life “is better personally and professionally because of Chris.” “I have seen the growth of PSW and how a person like Chris had direct impact on its success,” Gillard said. “Chris always demonstrated his positive, passionate, and affirming outlook on the profession and life. He will always be remembered as a shaker and a mover, a game changer, an influencer, and so many more positive things.” Decker had been living with glioblastoma since 2016, and he used the Caring Bridge platform to chronicle his treatment experiences and his optimism. “A dire prognosis does not constitute reason for waving of the white flag of surrender. There are lots of reasons to be undaunted and resilient. One is love. Another is commitment to something bigger than oneself,” he wrote on January 23, 2018. Six months later, Decker described himself as the luckiest man in Wisconsin pharmacy. “I have been able to do what I love with people who I care about for nearly 30 years. We have made memories and we have made a difference. The good will and the good people within PSW is remarkable. I’m grateful to be a part of it,” he wrote. The Wisconsin Pharmacy Foundation has collected more than $80,000, including a contribution from ASHP, in Decker’s honor to create a new patio space at PSW headquarters that will be christened “The Deck.” The foundation describes The Deck as a social space and a place to foster a culture of collaboration for the future of pharmacy practice. Decker is survived by his children Joe, Mary Catherine, and John; parents Richard and Patricia; brother Todd and sister Laura; and numerous aunts, uncles, and cousins. Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Wild,, David

doi: 10.1093/ajhp/zxz270pmid: 31789360

Glen Gard, vice chair and inaugural/ returning member Open in new tabDownload slide Glen Gard Open in new tabDownload slide Glen Gard After Glen Gard completed his journalism studies, he took what some might consider a sharp turn and dedicated his energies to the field of pharmacy. From Gard’s perspective, working as a pharmacy technician has allowed him to balance a knack for creative thinking with what he discovered is a love of science. “Although there is lots about pharmacy that’s black and white, there are gray areas and difficult problems, which is where I get to flex my muscles and come up with solutions,” said Gard, who is vice chair and inaugural/returning member of the Pharmacy Technician Forum (PTF) Executive Committee and manager of pharmacy compliance for Option Care Health in Bannockburn, Illinois. Since starting his career as a pharmacy technician in 2007 at a 200-bed hospital in the Chicago area, Gard said he’s filled “every imaginable role” in the health-system setting. “At one of the health systems I worked at early on, the director of pharmacy really pushed the envelope in terms of what a pharmacy technician can do,” he recalled. He said that organization was an early adopter of pharmacy technician– conducted medication reconciliation, which meant Gard was at patients’ bedsides obtaining thorough medication histories. He also worked in the facility’s emergency department, responding to codes and compounding i.v. preparations, and then moved on to a chemotherapy infusion center within the health system where he worked directly with patients and their families. “I really felt like I was part of the care team there,” Gard said. Today, Gard has a managerial role in the corporate clinical department at Option Care Health. He supervises cleanroom operations west of the Mississippi, oversees pharmacy policies and manufacturer recall notifications, assists with accreditation applications and renewals, and has many other duties. Gard frequently travels across the country to the company’s many locations to train pharmacists and pharmacy technicians in sterile compounding and improving processes and workflows. He once thought travel was a rarity for pharmacy technicians, but he said he increasingly meets pharmacy technicians who also travel as part of their job. “As pharmacists are becoming more clinically focused, leaders within health systems and other organizations are seeing the value of having pharmacy technicians take on more operational and business functions, which brings . . . opportunities for travel and growth,” he said. This expansion of opportunities means that more technicians are seeing the field as not just a job but a career, Gard said. And he believes pharmacy technicians are increasingly committed to the field and eager to increase the value they bring to the table. “Having people feel they can grow in their work encourages investment in more education and certification,” he noted. Like other pharmacy technician leaders, Gard believes advancement of the pharmacy technician field is inevitable. “We’ve reached a tipping point,” he said. “Everyone I encounter acknowledges the value of pharmacy technicians, and I only see that recognition growing more and more.” He noted that states are advancing legislation to support advanced pharmacy technician duties. “I hope that one day soon all states will have licensure and certification requirements,” he said. As vice chair of the PTF Executive Committee, Gard brings expertise in state and national pharmacy law as well as volunteer experience at the Pharmacy Technician Certification Board and the National Home Infusion Association. Contributing to the PTF Executive Committee is an opportunity for Gard to give back to what he feels is a tight-knit community. “Pharmacy really is like a family where everyone watches out for each other,” he said. For budding pharmacy technicians, Gard believes that closeness can be an important asset. “One of the biggest benefits I had early on was being surrounded by a great group of people that pushed me to challenge myself and supported me at the same time,” he said. “As I always tell people new to the field, if you keep an open mind and open ears, you can learn a lot from those around you.” Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

doi: 10.1093/ajhp/zxz288pmid: 31789363

• ASHP Chief Executive Officer Paul W. Abramowitz, Pharm.D., Sc.D. (Hon), FASHP, attended the New Mexico Society of Health-System Pharmacists (NMSHP) Annual Symposium in Albuquerque, New Mexico, on October 13–14, 2019. He gave the keynote presentation, “Pharmacists Must be Leaders: Perspectives on Leveraging Leadership to Improve Patient Care.” Dr. Abramowitz met with NMSHP leadership, University of New Mexico (UNM) College of Pharmacy leadership, and student leaders from the UNM Student Society of Health-System Pharmacists while there. He also installed the NMSHP officers and presented the ASHP State Affiliate Presidents’ Award to outgoing President Dr. Jason Koury at the Awards and Installation Luncheon. Published by Oxford University Press on behalf of the American Society of Health-System Pharmacists 2019. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Matson, Hannah, H;Jones, Bruce, M;Wagner, Jamie, L;Motes, Madalyn, A;Bland, Christopher, M

doi: 10.1093/ajhp/zxz247pmid: 31789358

antibiotic resistance, multidrug-resistant organism, Stenotrophomonas maltophilia While there is no universal definition of a multidrug-resistant organism (MDRO), the Centers for Disease Control and Prevention (CDC) defines MDROs as microorganisms, usually bacteria, that exhibit resistance to one or more classes of antimicrobial agents.1 MDROs, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and certain gram-negative bacilli, are emerging worldwide health concerns and are associated with increased mortality and cost to health systems. CDC estimates that at least 2 million people in the United States acquire an infection from bacteria that are resistant to at least 1 guideline-recommended antibiotic. These infections in turn extend hospital stays, require more costly care, and increase morbidity and mortality.2 One MDRO that is not highlighted as frequently as others is Stenotrophomonas maltophilia. S. maltophilia is an aerobic, nonfermenting, gram-negative bacillus generally isolated from environmental sources such as soil and water.3S. maltophilia infections are most commonly opportunistic and associated with the respiratory tract, but S. maltophilia can be responsible for infections of soft tissue, bone, joints, and the urinary tract and in endocarditis and meningitis.4 Risk factors for infection due to S. maltophilia include underlying malignancy, the presence of indwelling devices, chronic respiratory disease, an immunocompromised state prior to the use of antibiotics, and long-term hospitalization or a stay in an intensive care unit. Many organisms acquire resistance to antimicrobials over time, but S. maltophilia is intrinsically resistant to most antibiotics. This resistance is hypothesized to be due to low membrane permeability and the presence of efflux pumps that are characteristic for this organism.4 Due to historically high susceptibility rates, trimethoprim–sulfamethoxazole and levofloxacin are considered first-line agents for S. maltophilia infections. Other antimicrobials used for S. maltophilia include tigecycline, ceftazidime, and polymyxins.5 The average reported susceptibility rates for trimethoprim–sulfamethoxazole and levofloxacin are >90% and >80%, respectively. However, recent data from our institution bring into question the appropriateness of trimethoprim–sulfamethoxazole and levofloxacin for empirical treatment of infections caused by S. maltophilia. Initially, we constructed a “stenobiogram,” or S. maltophilia–specific antibiogram, at our facility for 2015 to 2017. For all inpatient isolates, the susceptibility rates for trimethoprim–sulfamethoxazole and levofloxacin were 78% and 80%, respectively. After noticing more resistant isolates, we reviewed susceptibility trends over a 3-year period from October 2015 to September 2018. Among 152 unique respiratory S. maltophilia isolates, 50 (33%) were resistant or had intermediate susceptibility to 1 or more first-line agents. Since the vast majority of S. maltophilia infections involve the respiratory tract, we chose to focus on respiratory cultures. We found susceptibility rates of 76% for trimethoprim–sulfamethoxazole (n = 152), 76% for levofloxacin (n = 151), 33% for ceftazidime (n = 18), 32% for tigecycline (n = 25), and 86% for polymyxin B (n = 7); for first- and second-line agents, such as ceftazidime and tigecycline, our rates were substantially lower than the published national averages.5 Our data reveal susceptibility rates for current treatment options for S. maltophilia lower than most in the published literature and raise concerns for treating multidrug-resistant S. maltophilia infections. With limited agents and lower susceptibility rates for current treatment options, new options for S. maltophilia treatment are needed. Several new antimicrobial agents have been approved, with in vitro data demonstrating susceptibility for S. maltophilia. These agents include eravacycline,6 omadacycline,7 and delafloxacin.8 Eravacycline, a fluorocycline, is currently approved for the treatment of complicated intraabdominal infections, while omadacycline, an aminomethylcycline, is indicated for complicated acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Delafloxacin is a newer fluoroquinolone indicated for acute bacterial skin and skin structure infections. While there are in vitro data supporting S. maltophilia coverage with these agents, there are currently no clinical data on the use of these agents for S. maltophilia infections. Cefiderocol, a siderophore cephalosporin that penetrates gram-negative bacteria through iron-mediated uptake, is currently undergoing Phase III trials for carbapenem-resistant Enterobacteriaceae infections and nosocomial pneumonia and displays promising in vitro activity against S. maltophilia.9,10 Multidrug-resistant S. maltophilia is an organism of concern with decreased rates of susceptibility to first-line antimicrobial agents at our facility. Further study is needed to evaluate the prevalence of multidrug-resistant S. maltophilia in other regions as well as potential risk factors associated with associated infections. In vitro data on newer agents look promising, but only time will tell if they translate to positive clinical outcomes. Disclosures: Dr. Jones is on the speakers’ bureaus for Allergan, Tetraphase, and Paratek. Dr. Bland is on the speakers’ bureaus for Merck and Tetraphase and on the advisory board for Merck and Paratek. The other authors have declared no potential conflicts of interest. Previous affiliations At the time of writing, Dr. Matson was a PGY1 resident at the St. Joseph’s/Candler Health System, Savannah, GA; Dr. Motes was a pharmacy student at the University of Georgia, Savannah, GA. The Letters column is a forum for rapid exchange of ideas among readers of AJHP. Liberal criteria are applied in the review of submissions to encourage contributions to this column. The Letters column includes the following types of contributions: (1) comments, addenda, and minor updates on previously published work, (2) alerts on potential problems in practice, (3) observations or comments on trends in drug use, (4) opinions on apparent trends or controversies in drug therapy or clinical research, (5) opinions on public health issues of interest to pharmacists in health systems, (6) comments on ASHP activities, and (7) human interest items about life as a pharmacist. Reports of adverse drug reactions must present a reasonably clear description of causality. Short papers on practice innovations and other original work are included in the Notes section rather than in Letters. Letters commenting on an AJHP article must be received within 3 months of the article’s publication. Letters should be submitted electronically through http://ajhp.msubmit.net. The following conditions must be adhered to: (1) the body of the letter must be no longer than 2 typewritten pages, (2) the use of references and tables should be minimized, and (3) the entire letter (including references, tables, and authors’ names) must be typed double-spaced. After acceptance of a letter, the authors are required to sign an exclusive publication statement and a copyright transferal form. All letters are subject to revision by the editors. References 1. Siegel JD , Rhinehart E , Jackson M , Chiarello L; the Healthcare Infection Control Practices Advisory Committee . . Management of multidrug-resistant organisms in healthcare settings ; 2006 . Atlanta, GA : Centers for Disease Control and Prevention . https://www.cdc.gov/infectioncontrol/pdf/guidelines/mdro-guidelines.pdf. Accessed 2018 July 15. COPAC 2. U.S. Centers for Disease Control and Prevention . Antibiotic resistance threats in the United States , 2013 . https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed 2018 July 15. WorldCat COPAC 3. Looney WJ , Narita M , Mühlemann K , Shidyak A . Stenotrophomonas maltophilia . Antimicrobe. http://www.antimicrobe.org/b236.asp. Accessed 2018 July 15. 4. Brooke JS . Stenotrophomonas maltophilia: an emerging global opportunistic pathogen . Clin Microbiol Rev. 2012 ; 25 : 2 - 41 . Google Scholar Crossref Search ADS PubMed WorldCat 5. Farrell DJ , Sader HS , Jones RN . Antimicrobial susceptibilities of a worldwide collection of Stenotrophomonas maltophilia isolates tested against tigecycline and agents commonly used for S. maltophilia infections . Antimicrob Agents Chemother. 2010 ; 54 : 2735 - 7 . Google Scholar Crossref Search ADS PubMed WorldCat 6. Lawrence K , Efimova E , Morrissey I et al. Global in vitro activity of eravacycline and comparators against Enterobacteriacae, Acinetobacter baumannii, Stenotrophomonas maltophilia, Staphylococcus aureus and Enterococcus spp. including multidrug-resistant (MDR) isolates from 2016. Tetraphase Pharmaceuticals . ASM Microbe. 2018 ; poster no. 630. WorldCat 7. Pfaller MA , Huband MD , Rhomberg PR , Flamm RK . Surveillance of omadacycline activity against clinical isolates from a global collection (North America, Europe, Latin America, Asia-Western Pacific), 2010–2011 . Antimicrob Agents Chemother. 2017 ; 61 : e00018-17 . Google Scholar Crossref Search ADS PubMed WorldCat 8. Almer LS , Hoffrage JB , Keller EL , Flamm RK , Shortridge VD In vitro and bactericidal activities of ABT-492, a novel fluoroquinolone, against gram-positive and gram-negative organisms . Antimicrob Agents Chemother. 2004 ; 48 : 2771 - 7 . Google Scholar Crossref Search ADS PubMed WorldCat 9. Hackel MA , Tsuji M , Yamano Y et al. In vitro activity of the siderophore cephalosporin, cefiderocol, against carbapenem-non-susceptible and multidrug-resistant isolates of gram-negative bacilli collected worldwide in 2014–2016 . Antimicrob Agents Chemother. 2018 ; 62 : e01968-17 . Google Scholar Crossref Search ADS PubMed WorldCat 10. Kish T . New antibiotics in development target highly resistant gram-negative organisms . P T. 2018 ; 43 : 116 - 20 . Google Scholar PubMed WorldCat © American Society of Health-System Pharmacists 2019. All rights reserved. For permissions, please e-mail: [email protected]. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Sierra, Caroline, M;Calabrese, Samuel, V

doi: 10.1093/ajhp/zxz248pmid: 31679014

career mobility, change management, emotional intelligence, mentors, organization and administration Succession planning is a key part of any organization’s strategic plan. Developing human capital by providing employees opportunities for growth is essential to retaining talent and achieving strategic goals. Managers are constantly assessing their teams for individuals who demonstrate interest in obtaining additional responsibilities to make lateral or vertical moves within the organization. This is the definition of succession planning—identifying and developing people within your organization to replace personnel or to fill new positions as pharmacy services change and expand.1 It is important for managers to identify these employees early and provide them with professional development experiences that prepare them to move into these key roles. Often, succession planning is approached from the manager’s perspective, such as how to find and develop key people and how to optimize employees’ progression so they are promoted to where they will excel.2 Additionally, employees can identify positions for which they would like to be considered and take steps to achieve this. Aligning development with a desired position allows employees to stand out to management and provides a competitive advantage if this or a similar position becomes available. In pharmacy practice, many new practitioners enter their first position with ambitious career goals but may not understand how to prepare themselves for advancement. This leads to the question, how can new practitioners take early initiative to be successfully positioned for their dream career? Develop a niche, be proactive, seek out mentors, collaborate, and grow emotional intelligence. Develop a niche One of the biggest challenges new practitioners can face is determining where they want to focus their energy and expertise. Many determine an area of practice interest, whether it be clinical or administrative; however, even within these areas of interest, there is opportunity for more specialization. To advance one’s career beyond a midlevel point, one must be seen as an expert in an area. New practitioners can further their career by finding a particular skill or interest and developing it fully. A starting point is to become involved in key projects. Consider an example of a critical care pharmacist who has become increasingly involved with medication safety. The project provides an opportunity to work with nursing personnel programming infusion pumps to operate in mL/hr rather than ng/hr. Taking initiative to attend medication safety meetings, speaking to nursing and pharmacy management about how to improve workflow, and collaborating to create a proposal for the appropriate committee(s) showcase the new practitioner’s clinical knowledge and emphasizes the need for collaboration leadership to advance patient care. This critical care pharmacist has become established not only as a specialist in a clinical area but also as a go-to clinician for medication safety projects. It is important to keep in mind one’s end goal prior to project involvement. Many projects will surface throughout one’s career, and being intentional about which projects will be beneficial will not only hone skills but will also create focus. Becoming involved in several projects simultaneously can be overwhelming, especially for a new practitioner. Working with a mentor or a supervisor can help with narrowing down potential projects to ones that are most important for patient care and are career advancing. Be proactive If the aforementioned critical care pharmacist had not been proactive, she would not have had the opportunity to demonstrate her ability to think beyond the immediate problem and be part of a solution. New practitioners start jobs and take on new roles with fresh eyes and are not influenced by long-held biases or thinking “This is how things are always done.” Therefore, when presented with a situation where there may be opportunity for improvement, it is essential that new practitioners step up and contribute their ideas. It is important to look for additional opportunities to contribute to the organization. These include serving as a preceptor to pharmacy students, residents, and/or pharmacy technicians, volunteering to take the lead on a new pharmacy-led medication monitoring protocol, or conducting a drug use evaluation to ensure appropriate medication use. These opportunities can even evolve into initiation of new protocols and procedures or possibly into scholarly activity. Taking the initiative in something new not only develops personal skills, but it also signals to organizational leadership that the new practitioner is willing and able to successfully take on new challenges. Seek out mentors Mentorship is an invaluable resource to improve clinical abilities and develop leadership skills. In addition, mentors provide sage advice and help (re)direct time and effort on topics beneficial to the mentee and the institution. Succession planning is a focused aspect of mentorship. Mentors in these areas are typically 1 of 2 types: those formed by a personal relationship and those in a position one might desire to take on.3 Mentors with whom one has a personal relationship can help develop hard and soft skills to improve one’s ability to lead and succeed. These mentors are likely to be forthright and constructive and know how to provide feedback in a personally beneficial manner. They have likely followed the mentee’s professional development over time and can help direct him or her on a pathway to suit both personal and career trajectories. Successful mentors realize they are in a unique position to assist in developing the mentee’s career, and they are generally not threatened by competition. Seeking out mentorship from those in a desired position can result in greater understanding about the position and the skills it requires to be successful. Proactively seeking out mentors can provide unique opportunities for the mentee to identify, develop, and practice skills needed for that position and, ultimately, emphasize candidacy to management. This mentorship relationship can also have a considerable influence on supervisors’ short list when seeking candidates to advance internally. Mentors can be identified from many sources, such as school, training, time spent at other institutions, professional meetings, or conferences. Maintaining connections is essential for career development and should not be forgotten as new practitioners engage in early career transitions. Mentors from different professions can also be extremely valuable in helping set career goals and defining plans and trajectories. It is ideal to identify ways to stay in contact with mentors and update them on progress and goals.4 Mentors can be critical in relaying career opportunities, providing guidance in new or expanded roles, and providing encouragement at pivotal times in career advancement. Collaborate Seeking out new practitioner peers with similar goals and areas of interest can be mutually beneficial. Colleagues who have similar interests but likely different strengths can be great collaborators and provide counterpoints to each other. Similarly, working with more established colleagues who desire to grow in areas of personal interest can help all parties achieve collective goals. Viewing others as collaborators and not competition is essential to success. Networking at professional meetings or through mentors can create new connections and help develop one’s niche area of specialty. For example, an oncology pharmacist is interested in demonstrating the effectiveness of a protocol for assessing and treating febrile neutropenia. The oncology pharmacist contacts others via message boards and at conferences to determine what other institutions are doing and if they have a similar protocol, providing feedback on the protocol and generating new discussion. This leads the oncology pharmacist to develop professional relationships with people at other institutions. Colleagues at other institutions can then serve as resources for clinical advice, provide guidance when encountering new professional situations, and even become coinvestigators on research projects. Develop emotional intelligence Daniel Goleman is often credited with popularizing the term “emotional intelligence.” He defines emotional intelligence as having the following 4 domains: self-awareness, self-management, social awareness, and relationship management.5 These areas come together to provide a set of soft skills that require ongoing development as a practitioner and a leader. People who recognize their strengths and areas for improvement in emotional intelligence are better prepared for leadership roles, and they know how to work as a team, manage conflict, adapt to challenging situations, and maintain an awareness of organizational and institutional needs while simultaneously developing themselves. Self-awareness looks at confidence in oneself, one’s emotional self-awareness, and an ability to accurately self-assess. In contrast, social awareness focuses on being aware of the organization overall and being aware of, and striving to work toward, the goals of the institution. It also includes an essential component of leadership, empathy. Relating to one’s colleagues and employees is necessary to help guide and mentor them while also finding one’s place within the larger organization.5 Relationship management encompasses many things, such as teamwork, conflict management, influencing change, and coaching and mentoring others. As an example, someone with a strength in this area would not only excel at providing unpleasant feedback to coworkers, but he or she would be able to do it in a way that is personally constructive to them. Someone else might be able to lead with a vision and drive change. This is different from self-management, as self-management skills include developing a positive attitude, being adaptive to new situations, and having control over one’s emotions. Many leaders recognize the value in assessing and developing emotional intelligence. As a new practitioner, recognition of personal and professional strengths and weaknesses shows an interest in personal development. Honing these skills as a new practitioner can be crucial in preparation for leadership roles, project management tasks, and even promotion. Managers interested in advancing their personnel will look for people with these skills and appreciate their expertise in leading others. Reviewing and assessing these 4 emotional intelligence domains can be beneficial in determining what areas might need further development. While formal assessment tools exist, personal reflection is extremely valuable in driving improvement. Working with mentors also aids with developing emotional intelligence. Mentors should be able to provide individual examples of strengths and areas of opportunity in several complex situations, directing efforts to develop balance. Next steps Goal setting is an essential first step on the path to success. Start by thinking of the big picture and then break it down into steps and consider what can be done on a smaller scale. Regardless of trajectory, it is essential to set concrete goals to focus one’s time and effort and prepare for upward movement. Concrete goals are often more easily achieved and can be created as part of a scaffolding to achieving a larger, more comprehensive goal. One way of ensuring that goals are concrete and achievable is to create SMART goals (see below), which is an excellent way to ensure a prime position for career success. SMART goals are specific, measurable, assignable, realistic, and time-related.6 For example, setting a goal such as “I would like to do more research” is not a SMART goal. While it may be realistic and assignable, there is no clear timeline for meeting it, and it is too vague a goal to know if it has been achieved. A better goal would be “I would like to submit 2 original research articles for publication in peer-reviewed journals within the next 12 months.” The individual can determine if this is a realistic goal, but it is specific, measurable, assignable, and time-related. Determining personal strengths, areas for improvement, and long-term goals is key to developing effective SMART goals. While it may feel like there are many areas for improvement, having too many simultaneous goals can be overwhelming and ultimately self-defeating. One should focus on a few goals, ideally with different timelines, to optimize efficiency. Setting these goals can help keep one on track for the position of interest. It is easy to let day-to-day activities take over, which is why revisiting goals will help with steady advancement toward the big-picture goal. It is important to realize this process will not be achieved quickly. Most leaders establish their succession plans thinking several years down the line.7 It is critical to be realistic with goal setting and understand that goals might take months or years to achieve. Consistently assessing progress, identifying areas for improvement, and implementing change will help make strategic moves and result in being in an optimal position when a career growth opportunity becomes available. Taking steps to showcase oneself as the high performer a supervisor is looking for will encourage him or her to provide more opportunities for growth and development, accelerate career progression, and enhance success. Disclosures: The authors have declared no potential conflicts of interest. This article is part of a new series focusing on leadership developed by members of the New Practitioners Forum Executive Committee. References 1. The Wall Street Journal . Why the best leaders want their superstar employees to leave. https://www.wsj.com/articles/why-the-best-leaders-want-their-superstar-employees-to-leave-1475460841 ( accessed 2018 Oct 5 ). 2. The Robert Half Blog . What is succession planning? Your steps to success. https://www.roberthalf.com/blog/management-tips/7-steps-to-building-a-succession-plan-for-success ( accessed 2018 Sep 5 ). 3. Modern Workforce . Leveraging internal and external mentors for optimal growth. https://www.geteverwise.com/mentoring/leveraging-internal-and-external-mentors-for-optimal-growth/ ( accessed 2018 Nov 5 ). 4. Straus SE , Johnson MO , Marquez C , Feldman MD . Characteristics of successful and failed mentoring relationships: a qualitative study across two academic health centers . Acad Med. 2013 ; 811 : 82 - 9 . Google Scholar Crossref Search ADS WorldCat 5. Harvard Business Review . Emotional intelligence has 12 elements. Which do you need to work on? https://hbr.org/2017/02/emotional-intelligence-has-12-elements-which-do-you-need-to-work-on ( accessed 2017 Feb 2 ). 6. Doran GT . There’s a S.M.A.R.T. way to write management’s goals and objectives . Manag Rev. 1981 ; 70 : 35- 6 . WorldCat 7. Harvard Business Review . Succession planning: what the research says. https://hbr.org/2016/12/succession-planning-what-the-research-says ( accessed 2018 May 11 ). © American Society of Health-System Pharmacists 2019. All rights reserved. For permissions, please e-mail: [email protected]. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Siden,, Rivka;Modlin,, Jessie;Lee-Gabel,, Linda;Redic, Kimberly, A

doi: 10.1093/ajhp/zxz239pmid: 31696208

investigational drugs, oral chemotherapy, patient education, patient instruction, safe administration The use of oral medications for the treatment of cancer has increased significantly in recent years.1,2 A 2008 National Comprehensive Cancer Network task force report on oral chemotherapy included an estimate that more than 25% of chemotherapy drugs in the pipeline were for oral administration.2 This percentage is expected to grow, causing an increase in the number of oral chemotherapy medications (OCMs) used in clinical trials.3 The growth is also reflected in the number of new drug applications for OCMs approved for marketing by the U.S. Food and Drug Administration (FDA). From 2015 through 2017, 19 of the 29 (66%) new molecular entities approved by the FDA Center for Drug Evaluation and Research for the treatment of cancer were oral medications.4–6 As researchers continue to develop more OCMs, medication administration responsibilities can be expected to shift from healthcare provider–supported infusion facilities to research subject self-administration at home. These responsibilities include the administration of the correct dose at the right time in relation to food and other medications; proper medication preparation, storage, and disposal; and the identification and management of interactions and adverse effects. Because the majority of these medications are considered hazardous,7 their use introduces new challenges that include the safe handling of these oral medications in the home by nonhealthcare workers. Research subjects and caregivers are now faced with complex oversight and management of OCMs, which increases the potential risks of medication errors, poor adherence, inappropriate adverse effect management, and contamination. Participation in a clinical trial that includes an oral investigational medication introduces additional challenges. Unlike marketed medications, investigational medications do not come with a manufacturer’s label or an information handout targeted to study subjects. Additionally, information on these medications is more difficult to locate on commercially available sources or the Internet. Therefore, information on investigational medication use and storage is not readily available. Subjects participating in clinical trials are presented and provided with an informed consent form. Although potential adverse effects and drug interactions are included in the consent process, the Code of Federal Regulations and FDA guidance on informed consent do not require or suggest that instructions on medication storage, handling, and disposition or information that is specific to adherence while participating in a trial be included in the consent process.8,9 Labels that are placed by the pharmacy on the medication containers may include administration and storage information, but this information may be abbreviated and lack detail. As the development of OCMs continues to increase, the need for study subject counseling and education in the investigational setting becomes imperative to ensure that trial data are accurate and safety is appropriately addressed. During a clinical trial, monitoring for adverse effects and adherence are crucial for the validity and reliability of study results. Therefore, it is important that study subjects are provided with clear instructions on when to report untoward effects. Correct and completed medication administration is of special importance because administration or dosing errors and issues with adherence may result in drawing erroneous conclusions and making inappropriate dose changes. In a risk assessment study of 5 OCMs, the identified key vulnerabilities included patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities.10 One of the recommended risk-reduction strategies was making improvement in patient education and including a written document for all OCM treatment. The American Society of Clinical Oncology (ASCO), the Oncology Nursing Society (ONS), and the American Society of Health-System Pharmacists have published guidelines and recommendations on safe administration of FDA-approved OCMs.11,12 These include a list of items that should be included in the education material. The ASCO/ONS standards include a statement that patient education material must be written in or presented at a level that is appropriate for the patient’s reading level and literacy and patient–caregiver understanding. In 2014, the Hematology/Oncology Pharmacy Association released a paper calling for best practice standards within an investigational drug service.13 The paper specifically highlights the need for medication counseling for study subjects receiving investigational medications, including medication handling and safe storage. In addition, the authors state, “This is especially crucial for patients receiving oral investigational medications.” Currently, pharmaceutical companies, medical institutions (i.e., hospitals and clinics), and professional organizations prepare medication information handouts for commercial OCMs that can be included in patient counseling sessions. For example, the Association of Community Cancer Centers, Hematology/Oncology Pharmacy Association, National Community Oncology Dispensing Association, and ONS have created oral chemotherapy education sheets to provide information to patients with cancer and caregivers.14 Templates for creating brochures for the preparation, administration, and handling of OCMs were published in 2014.15 These brochures focused on the manipulation of solid dosage forms for administration to patients with swallowing difficulties, but they do not address the specific issues for investigational medications. Other than informed consent documents, study-subject education handouts are not readily available for investigational medications. Creating medication-specific handouts for investigational drugs may be restricted by the proprietary nature of and confidentiality agreements established for drugs in development. However, the increased needs, challenges, and risks associated with the use of oral investigational medications call for the provision of detailed counseling, including, written instructions in plain language to study subjects and/or caregivers who administer OCMs at home. To fulfill the need, a general handout detailing specific requirements associated with the use of investigational OCM was developed ( appendix). This handout can be used while counseling study subjects who receive investigational OCMs. Specific information related to the importance of adherence in the context of clinical trials, as well as information about placebo controls, the use of a medication diary, hazardous drug handling precautions, and storage in the original container are included. Reference to the informed consent document is included, as is a space to include study-team contact information. This document may be provided to a subject by the study team at the time of enrollment, included by the pharmacy dispensing the investigational medication, or provided as a general handout in a patient-education resource center. As with other documents provided to subjects who participate in clinical trials, clinicians and study teams must consult with their institutional review boards on the best way to make this handout available to study participants before distributing it by any of these or other means. The material has been edited for plain language following the guidelines in the Centers for Medicare and Medicaid Services Toolkit for Making Written Materials Clear and Effective and scored 85% on the Patient Education Materials Assessment Tool for printable materials for understandability and 80% for actionability.16,17 Consequently, it may be valuable to reinforce content verbally with some study subjects or limit use to provision at the time of obtaining consent, when the content can be reviewed in person with the subject. Providing a quick, easy-to-read handout can enable healthcare providers such as pharmacists and research associates to comply with their important good clinical practice responsibilities.18 Acknowledgments: The authors thank Ruti M. Volk, M.S.I., AHIP, Patient Education and Health Literacy Program Lead at Michigan Medicine, for plain-language recommendations and review. Disclosures: The authors have declared no potential conflicts of interest. The Frontline Pharmacist column gives staff pharmacists an opportunity to share their experiences and pertinent lessons related to day-to-day practice. Topics include workplace innovations, cooperating with peers, communicating with other professionals, dealing with management, handling technical issues related to pharmacy practice, and supervising technicians. Readers are invited to submit manuscripts, ideas, and comments to AJHP, at [email protected]. References 1. McCue DA , Lohr LK , Pick AM . Improving adherence to oral cancer therapy in clinical practice . Pharmacotherapy. 2014 ; 34 : 481 - 94 . Google Scholar Crossref Search ADS PubMed WorldCat 2. Weingart SN , Brown E , Bach PB et al. NCCN task force report: oral chemotherapy . J Natl Compr Canc Netw. 2008 ; 6 ( suppl 3 ): S1 - 14 . Google Scholar Crossref Search ADS PubMed WorldCat 3. Buffery , D . Innovation tops current trends in the 2016 oncology drug pipeline . Am Health Drug Benefits . 2016 ; 9 : 233 - 238 . Google Preview WorldCat COPAC 4. Food and Drug Administration . Novel drug approvals for 2015. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm ( accessed 2018 Sep 22 ). 5. Food and Drug Administration . Novel drug approvals for 2016. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm ( accessed 2018 Sep 22 ). 6. Food and Drug Administration . Novel drug approvals for 2017. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm ( accessed 2018 Jun 16 ). 7. National Institute for Occupational Safety and Health . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016 https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf ( accessed 2019 Oct 5 ). 8. U.S. Food and Drug Administration . Code of Federal Regulations Title 21, Part 50, Subpart B, Section 50.25 (April 1, 2018) . https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25 ( accessed 2019 Jan 26 ). 9. Food and Drug Administration . Informed consent information sheet: guidance for IRBs, clinical investigators, and sponsors (July 2014) . https://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm ( accessed 2019 Jan 26 ). 10. Weingart SN , Spencer J , Buia S et al. Medication safety of five oral chemotherapies . J Onco Pract. 2011 ; 7 : 2 - 6 . Google Scholar Crossref Search ADS WorldCat 11. Neuss MN , Polovich M , McNiff K et al. 2013 Updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy . J Oncol Pract. 2013 ; 9 : 5s - 13s . Google Scholar Crossref Search ADS PubMed WorldCat 12. Goldspiel B , Hoffman JM , Griffith NL et al. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy . Am J Health-Syst Pharm. 2015 ; 72 : e6 - 35 . Google Scholar Crossref Search ADS PubMed WorldCat 13. Amin SR , Lee JS , Avila JG et al. HOPA investigational drug service best practice standards. http://www.hoparx.org/images/hopa/resource-library/professional-tools/HOPA16_IDS_Guidelines.pdf. ( accessed 2018 Aug 19 ). 14. OralChemoEdSheets.com, the Patient and Healthcare Providers Resource. https://www.oralchemoedsheets.com/index.php/sheet-library ( accessed 2019 Oct 5 ). 15. Siden R , Kem R , Ostrenga A et al. Templates of patient brochures for the preparation, administration and safe-handling of oral chemotherapy . J Oncol Pharm Practice. 2014 ; 20 : 217 - 24 . Google Scholar Crossref Search ADS WorldCat 16. Centers for Medicare and Medicaid Services . Toolkit for making written material clear and effective ( 2012) . https://www.cms.gov/Outreach-and-Education/Outreach/WrittenMaterialsToolkit/index.html ( accessed 2018 Sep 21 ). 17. PEMAT for Printable Materials (PEMAT-P) (October 2013). Rockville, MD : Agency for Healthcare Research and Quality . http://www.ahrq.gov/professionals/prevention-chronic-care/improve/self-mgmt/pemat/pemat-p.html ( accessed 2018 Sep 21 ). COPAC 18. U.S. Food and Drug Administration , Department of Health and Human Services. International Conference on Harmonisation: good clinical practice consolidated guideline . Fed Regist. 1997 ; 62 : 25692 - 709 . www.gpo.gov/fdsys/pkg/FR-1997-05-09/pdf/97-12138.pdf ( accessed 2019 Jan 26 ). WorldCat Appendix—Handout for patients receiving investigational oral chemotherapy Oral Medications Used in Clinical Studies Medications used in clinical studies include: Medications that have not yet been approved by the U.S. Food and Drug Administration (FDA). Medications that have been approved by the FDA for certain health conditions and now being tested for safety and effectiveness to treat new or different health conditions. You are participating in a clinical study and are taking a study medication by mouth. The name of the medication that you are taking is: _________________________ and the study number is: ____________________. Here is some important information on participating in a study and how to safely take, handle, and store the study medication: What do I need to know about being in a clinical study? Your study medication may be available to patients with other diseases and information on its use may be available in ads and on websites. However, because you are taking this medication as part of your participation in a clinical study, you must follow the instructions that the study team gave you. Some clinical studies use a “control group” to determine if the investigational treatment is effective. This means that you may receive the standard treatment or a placebo instead of the investigational medication. ◦ A placebo is an inactive tablet, capsule, or other treatment. In clinical studies with control groups or placebos, you and your doctor may not know which medication you are taking. Even if you may be taking a placebo, it is important to take your study medication exactly as directed. The “Informed Consent” document you signed at the beginning of the clinical study has more information about your study medication and how to contact the study team. How should I take the study medication? Take your study medication exactly as instructed. This will ensure your safety and allows the study team to receive accurate information from your participation. If you are taking medications by mouth, it is important that you swallow each tablet or capsule whole. Do not chew, crush, or open the medication unless the study team tells you that you can do that. If you cannot swallow the study medication, contact your study team about other ways to take your medication. If you miss a dose or vomit up a dose, check the instructions that the study team gave you or contact the study team as soon as you can to find out what you should do. If you receive a medication diary or a study log, fill it out completely and accurately. In the medication diary, be sure to list any doses that you missed or vomited and any side effects that you felt. Bring the medication diary or your log with you to the next hospital or clinic visit. How do I store the medication? Keep the study medication in its original container. Do not transfer the medication to another container or medication box. Store your medication in a safe place, away from other family medications or food, and out of the reach of children and pets. Check the medication label to see if it requires special storage, such as refrigeration or protection from light. If your medication needs to be stored at room temperature, store it away from excessive heat and moisture and out of direct sunlight. Do not store your medication in the bathroom. If your medication needs to be stored in the refrigerator, use a zip-top bag to keep it away from food. If the medication needs to be protected from light, place it in a brown paper bag or a dark cabinet or closet. When you travel, do not store the medication in the car to avoid exposure to extreme temperatures. When you fly, take the medication in your carry-on luggage to ensure that the temperature is controlled and to avoid losing the medication. What are some important tips to study participants? Be sure to bring all bottle(s) or container(s) (including empty containers) to each clinic visit or if you are admitted to the hospital. Do not dispose of any study medication yourself. Study medications may interact with other medications, supplements, or herbal products. Include your study medication in the list of medications you take at home. Tell your pharmacist and primary care doctor about your study medication so that they will have an accurate list of all your medications. How should I protect myself if the medication is considered hazardous? Wash your hands before and after handling study medications. Check with the study team to determine if it is necessary to wear gloves while handling the medication. If you spilled the medication on your skin, remove contaminated clothing, wash the area with soap and a large amount of water, and contact the study team. Do not wash soiled clothes with your other laundry. If the medication got into the eyes, flush with water for at least 15 minutes and contact the study team. If you are instructed to dissolve the study medication in liquid or mix it with food, check with the study team to see if you need to cover the work area to protect from contamination and to use disposable dishes and utensils. If you have a low-flush or high-efficiency toilet, close the lid and flush twice to ensure all body waste is removed. When do I need to contact the study team? If you accidently spilled the study medication on your skin or the medication got into your eye. If you dropped a pill or misplaced the medication bottle. Before starting a new medication (including over-the-counter medications and herbal supplements). If you feel that you are having side effects from taking the study medication. If you have any questions or concerns about the study or study medication. If you are not sure how to take the study medication. Whom can I contact? During office hours contact: _________________________ _________________________ Name  Phone After hours contact: __________________________________________________ Where can I find more information on clinical studies or study medications? https://www.cancer.gov/about-cancer/treatment/clinical-trials http://www.fda.gov/forpatients/clinicaltrials/default.htm Notes: ____________________________________________________ __________________________________________________________ __________________________________________________________ __________________________________________________________ Disclaimer: This document is for informational purposes only and is not intended to take the place of the care and attention of your personal physician or other professional medical services. Talk with your doctor if you have questions about individual health concerns or specific treatment options. 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