MEDICALLY INTEGRATED DISPENSING OF REGORAFENIB FOR METASTATIC COLORECTAL CANCER PATIENTS NCODA.
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The National Community Oncology Dispensing Association, Inc., (NCODA) created the Positive Quality Intervention (PQI) as a peer-reviewed clinical guidance document to empower healthcare providers with the knowledge required to provide excellent patient care. This PQI in Action article incorporates opinions and experiences from oncology experts within the medically integrated teams at Tennessee Oncology and Texas Oncology that have implemented PQIs into their standard workflow.
Established in 1976, Tennessee Oncology is one of the nation’s largest community-based cancer care organizations today. Based in Nashville, Tennessee, it provides on-site chemotherapy treatments at more than 30 locations across the state, where patients can receive cancer care close to home. Park Pharmacy serves as the one central pharmacy that dispenses oral medications to all of its patients throughout the state. As one of the leading clinical trial networks in the country, Tennessee Oncology strives for incessant innovation.
Similarly, Texas Oncology was founded to ensure cancer ca could be delivered in local communities where patients can be fully supported by their family and friends. This independent, physician-led organization accomplishes its mission to help Texans fight cancer through its 210 sites of service across the state with more than 460 physicians. The dispensing pharmacy at the Sammons Cancer Center in Dallas, Texas, services all patients who are not seen at one of the 44 locations that have dispensing services on site. Leading-edge medical treatments are discovered through innovative technologies and clinical trials within Texas Oncology.
Funding for this PQI in Action educational article was provided by Bayer
INCESSANT INNOVATION: NCODA ENDEAVORS FOR EXCELLENCE
Despite building a successful medically integrated dispensing (MID) pharmacy process at Tennessee Oncology dating back to 2009, the work was far from done, according to Senior Vice President of Pharmacy, Stacey McCullough, PharmD.
“Our pharmacists were having regular interaction with providers, which was useful, but the value behind those conversations was lacking,” she said. Instead of merely looking at fundamental, yet simple, factors such as correct day supply or quantity, McCullough desired more from her clinical pharmacy team. “I wanted to raise the level of value and quality within those conversations between professional disciplines,” she said.
But how could one align the entire medically integrated team on one consistent set of standards? In an age of information overload, one must sift through a lot of excess material to unveil the key criteria. Undeniably, she noted, “NCODA’s Positive Quality Intervention (PQI) is what good looks like. These concise clinical guidance documents are vetted and instill confidence in our team to elevate the conversation with providers on behalf of the patient.”
Texas Oncology Pharmacy Manager Raquel Rhone, PharmD, similarly held the resolve to do more and empower her MID team. “Educating the technicians with PQI principles is so critical for success,” Rhone said. “With that knowledge, they become empowered to intervene on behalf of the patient.”
Implementing a new pharmacy service amidst an already shifting treatment paradigm can be quite daunting for any individual or organization. Creating a solid foundation and maintaining a culture of excellence is an achievement that cannot be reached alone. It takes a team. Equip passionate, engaged healthcare professionals with efficient tools like the PQI and they can use those foundational building blocks to create bridges to optimum health outcomes. This is more than an idea: it’s a solution.
By adopting NCODA’s PQI resource tools (www.ncoda.org/pqi), all organizations will be similarly empowered with peer-reviewed guidance information for effective practices that improve knowledge exchange within a medically integrated dispensing (MID) pharmacy team and result in positive patient outcomes. This article will examine examples of common barriers within these treatment settings and provide suggestions to improve outcomes for metastatic colorectal cancer (mCRC) patients receiving Stivarga® (regorafenib) therapy. For example, the Regorafenib PQI was instrumental in building a dose escalation regimen directly
into the Electronic Medical Record (EMR) at US Oncology sites of service. According to the World Health Organization and the National Cancer Institute, colon cancer is the third most common form of cancer and the second most common cause of cancer death.1,2 Compelling facts like these illustrate the current need for improved patient outcomes in the mCRC setting. Knowledge is paramount to success, and PQIs empower all clinicians to elevate the quality of care.
Through work with expert leaders at Tennessee Oncology and Texas Oncology, NCODA provides meaningful insight and solutions to common problems within all cancer treatment centers. While some procedural intricacies vary between organizations, the underlying goal is the same across the spectrum of care worldwide: become personally driven to think critically and hold firmly the resolve to do more.
By adopting consistent clinical guidance documents like the PQI as described here, NCODA creates a foundation for all members of the MID team to achieve operational efficiency and optimize patient outcomes. As one of the recommended resources within the American Society of Clinical Oncology (ASCO) and NCODA Patient Centered Standards for Medically Integrated Dispensing, the PQI will continue to be a recognized and essential cornerstone in cancer care today.3
Caring for cancer patients has become increasingly complicated over recent years with a transformation
that includes both inpatient infusions and outpatient oral agents as a standard of care.4 Navigating the convoluted continuity of care today requires experts not only in diagnosis and treatment, but also in
communication with insurance companies, financial assistance groups, manufacturer hubs, mail-order pharmacies, clinical follow-up and management. The legacy of traditional intravenous (IV) chemotherapy treatment and its antiquated workflow beckons the necessity for upgrading processes at many institutions today.
Consequently, many organizations have adopted medically integrated dispensing services in-house to best accommodate the growing list of needs that inherently accompany prescriptions for oral oncolytics. This emerging MID delivery model has made significant improvement in providing patient care. Despite these efforts, further refinement is required; hence the ongoing need for innovative resources like the PQI.
When a prescription must be filled by a mail-order pharmacy rather than being dispensed directly in the oncologist’s office, the care may become disjointed, resulting in treatment delays, increased costs, and diminished effectiveness.5 Staff within the medically integrated dispensing team are best-positioned to attend to the rapid and frequent changes in patient insurance, finances, adherence, toxicity, tolerability, dosing and adverse event management that are all instrumental components in today’s care continuum.6 Regular, ongoing monitoring and intervention can contain rising healthcare costs and improve patient outcomes.7 Tasks that were once managed by only the provider are now handled by a multitude of professional disciplines within the clinic.
“If I were to follow-up on adverse event (AE) management alone, my schedule would be filled for weeks,” said Scott Paulson, MD, a medical oncologist at Texas Oncology. “The MID team is
an essential component to care and serves as a priceless resource for me and my patients. In addition, the MID team supports providers such as myself with key reminders like those referenced in the PQI to keep track of the many intricacies for each of the countless new drugs available today.”
The Positive Quality Intervention (PQI), along with other NCODA initiatives such as Oral Chemotherapy Education (OCE) Sheets for patient education, Treatment Support Kits (TSK) for initiation of therapy, Cost Avoidance and Waste Tracker for data documentation, as well as the Financial Assistance Tool for expedited resolutions are all types of resources created as
solutions for the growing number of challenges facing providers and patients alike. Implementing these tools into the workflow provides immediate value to the practice and is recommended by the expert panel in the ASCO/NCODA Standards.3
CREATING CLINICAL CONFIDENCE THROUGH POSITIVE QUALITY INTERVENTIONS
Empowered with innovative tools, the MID teams at both Tennessee Oncology and Texas Oncology have improved the quality of care delivered at their institutions through adoption of NCODA resources. These leading oncology organizations value the PQI which provides concise, clinical guidance information to raise the standard of care across all the professional disciplines.
In general, PQIs afford attention to any critical aspect of drug therapy that may be easily overlooked (“if you see ‘x’, remember to do ‘y’”). In a world where new and novel treatments arise almost daily, healthcare professionals need an easy-to-use reference to enact the key clinical principles for each therapy. The PQI serves that need.
Tennessee Oncology medical oncologist Edward Arrowsmith, MD, described the current dilemma when he declared, “It is nearly impossible for clinicians to stay on top of the many developments in care today. Especially important are those details that are subtle but can be paramount to success.” Herein lies the value of the PQI.
BUILDING BRIDGES FOR METASTATIC COLORECTAL CANCER (mCRC) PATIENTS
Augmenting the inherent complexity of oncolytic drug therapy is the ever-expanding options of potential treatments. Once upon a time, chemotherapy could only be followed by additional chemotherapy.
Now, mCRC patients benefit from a multitude of treatment alternatives; for providers of care, however, the expanded options create increased need for knowledge of effective practices like those described in PQIs.
As the number of patients receiving third-line or greater therapy continues to climb, data around appropriate sequencing of agents is lacking. In the absence of predictive biomarkers, providers must tailor drug therapies to individual patient characteristics and performance status (PS).
Although not comprehensive, an expert panel recommended initiation of regorafenib for patients with certain characteristics, for example: good PS, baseline cytopenias, liver function, longer progression free survival (PFS) and no prior exposure to bevacizumab.8
Previous exposure to bevacizumab or episodes of hand-foot skin reactions should not preclude a patient from receiving regorafenib; by adopting the principles in the PQI, clinicians can feasibly overcome that potential adverse event through reinforced education and ongoing monitoring.
NCODA has provided the foundational elements for MID teams to build bridges to success for their mCRC patients.
SAME TEAM, MORE TRUST, BETTER CARE
The old adage of “it takes a village to raise a child” still rings true even when viewed from the perspective of providing healthcare in the modern age. Unquestionably, it takes a well-aligned, multidisciplinary team to appropriately care for a cancer patient today. With the entire suite of clinical services built under one roof, the MID model offers patients personalized, comprehensive support through one trusted source.
“Our patients are very open about what is going on with them,” said Vonda McClendon, CPhT. “When they call in, there is no phone tree here, so they talk to a person whom they know is within Texas Oncology; the quality of the ensuing conversation is naturally elevated.” Pharmacy Manager Raquel Rhone, PharmD, agreed. “As technician confidence rises, patients, too, become more open about their true situation which enables superior clinical management,” Rhone said. PQIs enable the MID team to build bridges to truthful, meaningful conversations with their patients.
At Tennessee Oncology, once the decision is made to start a patient on therapy, providers load the regorafenib treatment plan for the patient within the EMR. Pharmacists then review the treatment plan, tailoring the next steps to individual patient characteristics (age, disease, comorbidities, concomitant therapies, education level, etc.). Next, the pharmacist generates the order for the prescription themselves to ensure appropriateness and improve efficiency. Maximizing the potential of their license, these clinical pharmacists prevent future delays by addressing therapeutic appropriateness, dose, quantity, days supply and administration instructions upfront.
At Texas Oncology, the physicians, nursing staff or Advanced Practice Providers (APPs) generate the prescription order within the EMR. Similar to pharmacists at Tennessee Oncology, the nurses and APPs at Texas Oncology maximize their clinical acuity at this crucial intersection in the drug therapy process through review of PQI principles. At this stage in the prescription process, personnel from pharmacy, nursing and provider teams all align on the consistent clinical standards outlined within NCODA’s PQI on Regorafenib for mCRC. Access the PQI here: www.ncoda.org/mcrc-regorafenib-updated/.
A vital component of those PQI principles is the implementation of a dose-escalation strategy during regorafenib therapy initiation. Data from the ReDOS trial exemplifies the type of practical clinical information within the PQI resource. In this case, patients started on 80mg for the first week with weekly dose escalations in the absence of significant drug-related toxicities. Weekly dose escalation of regorafenib from 80 mg to 160 mg/day (Arm A) was found to be superior to a starting dose of 160 mg/day (Arm B).
A trend for improved overall survival (OS) was seen in the dose escalation arm which did not appear to compromise quality of life (QOL). Median Overall Survival (OS) was improved in Arm A vs. Arm B (9.8 months vs. 6.0 months) with Median Progression Free Survival (PFS) at 2.8 months vs. 2.0 months, respectively.9
Translating these results into real-world patient benefit, NCODA members across disciplines ensure optimal dosing before the prescription is sent on for further processing. This dose escalation protocol is built directly into the EMR regimens at both organizations. When drug-utilization review (DUR) is complete, the prescription for 80mg of daily regorafenib for three weeks on, one week off, is sent to the organizations’ own MID pharmacy.
At Tennessee Oncology, Park Pharmacy exists to handle all prescription needs for their patients within the organization.
At Texas Oncology, the dispensing site in Dallas, Texas, handles all prescriptions for the 166 locations that do not have a dispensing pharmacy on site. Prescriptions are received and processed by the oncology pharmacy technicians on staff who have intimate connectivity to the EMR and the patient’s entire care team. Here, highly-skilled individuals conduct data entry to submit the claims to insurance and begin prior authorizations and financial assistance.
Outside mail-order prescription deliveries are still tracked and patients are counseled and managed the same as those dispensed in-house. “Although some patients are not receiving their medication from our pharmacy, they know they can rely on us for any of their needs,” said Jared Crumb, PharmD, a clinical pharmacist at Tennessee Oncology. Indeed, patients here are assured dependable care from their MID team.
Certified pharmacy technician Brian Rucker echoed that sentiment.“The MID pharmacy team takes care of all patient needs,” Rucker said. “This personalized level of service we offer provides job satisfaction and is humbling at the end of the day.”
The same-team approach keeps the patient at the center of the equation and emanates trust. The PQI aligns the care continuum for optimal treatment of metastatic colorectal cancer with regorafenib therapy.
PRACTICE TO THE TOP OF THE LICENSE: COLLABORATING WITH TEAMMATES
At Tennessee Oncology, clinical pharmacists build the oral treatment plans for all oral agents. By building the regorafenib PQI principles into oral treatment plans in the EMR, the entire team operates upon a consistent standard from the start. Employing PQI principles within the EMR upstream in the prescription process is a major implementation strategy for PQIs. This efficient methodology empowers the entire team to “work smarter, not harder.” Once built into a care plan, these parameters are reviewed by an overseeing physician to ensure appropriateness. Thus, the PQI enables valuable collaboration across disciplines on behalf of the patient. Consequently, the conversation with the provider becomes sophisticated and efficient.
Crumb, the pharmacy manager at Tennessee Oncology, said his pharmacy team has a unique best practice to ensure consistent delivery of high-quality care. “The staff engages in twice-monthly meetings that serve as an internal quality control measure to ensure all patients are being offered consistent, exceptional care,” he explained. “By counseling each other and conducting mock scenarios for patient management, we confirm alignment in the delivery of care.”
PQIs are an instrumental resource for these clinical conversations. Texas Oncology advanced practice providers engage in similar educational discussions around PQI principles. With references cited at the end of all PQIs, these providers are confident in the recommendations made.
Indeed, pharmacists are not the only discipline that benefits from expertise on specific drug therapies derived from using PQIs. “We’re often the first line of contact by patients for their issues,” said Brian Rucker, CPhT at Tennessee Oncology. “The key principles contained within PQIs provide critical understanding which enables us as technicians to handle issues and care for patients in an elevated fashion. At many other pharmacies the patients will be greeted by a robot in a phone tree but here they speak to an informed human, 24 hours a day.”
Similarly, at Texas Oncology, certified pharmacy technicians play an instrumental role in the care of their patients and benefit from ongoing meetings and training amongst the MID team. “We engage in team huddles to review new drugs, including new developments in dosing and management such as the case with Stivarga®,” McClendon said. Rhone, the practice’s pharmacy manager, noted that “technicians are always included at in-services with drug manufacturers and the representatives speak specifically to the needs of technicians.”
With awareness of innovative management techniques for “high-touch” therapies, technicians follow these patients more closely using a calendar reminder system with PQI principles built within those reminders (i.e. weekly follow-up, dose escalation, and use of urea cream). These effective practices can be readily replicated at cancer treatment centers across the globe.
Also, pharmacy technicians are empowered to conduct higher quality follow-up up through a guided workflow in the treatment plan, partially resulting from built-in PQI principles. These efforts free up pharmacist time for clinical interventions and management. “I appreciate these resources that bring value to our patients,” McClendon said. “Some providers are still initiating regorafenib at the higher dose. Trained on this Positive Quality Intervention, we as technicians can confidently refer to the pharmacist and provider to evaluate the lower dose option.” McClendon encourages all oncology pharmacy technicians to refer to NCODA PQIs during initial data entry to familiarize themselves with intricacies of individual therapies. After seeing an unusual dose, the principles in the PQI instill conviction in her to reach out for intervention on behalf of the patients. Furthermore, with the awareness that weekly follow-up calls and utilization of urea cream can improve the patient experience, technicians are further prepared to provide keen insight and superior care to regorafenib patients.
Advanced Practice Providers (APPs) today are an instrumental member of the MID team at most organizations and have brought significant value to the process by diminishing physician burden and reducing burnout. APPs work in concert with the physician to diagnose, treat, and manage patients. The pharmacy team, subsequently, promotes further delegation of duties within the clinic.
“Pharmacy has served us well by overseeing some of the numerous responsibilities once done only by APPs,” said Holly Bushart, MSN, ACNP-BC, AOCNP, Director of Advanced Practice Providers at Tennessee Oncology. “We’re lucky to have that multidisciplinary approach. PQIs enable the entire team to manage the significant side effects from therapy and keep patients on drug longer, which takes a large load off the shoulders of our APPs.”
Moreover, Bushart recognizes the unique value that PQIs bring to the team, “Complementing the Prescribing Information (PI) that most clinicians consult, the information within PQIs provides the missing pieces including how to manage the adverse events,” she said.
Over at Texas Oncology, Dr. Paulson promotes the optimization of each professional discipline (commonly described as “practicing to the top of the license”) as paramount to success. “In a community setting, physicians have less time for these types of regular intervention and management,” Paulson said. “Compliance and ongoing management of complex drug regimens like regorafenib makes the logistical aspects quite difficult. APPs, nurses, pharmacists, and pharmacy technicians make it all possible. When onboarding new APPs and training them on the multitude of available therapy options, a standard framework does not exist. PQIs are excellent best practices for physicians to have available for their staff.”
Erica Carone, R.PA-C, who works side-by-side with Paulson, noted that “We often learn the intricacies of drug therapies directly from physicians at the time an agent is prescribed.
The PQI is a concise resource to consult before therapy initiation, during follow-up calls and throughout office visits.”
Dr. Arrowsmith shared a similar sentiment. “Having the pharmacy team and the in-clinic team being well-aligned through the adoption of standard best practices like PQIs has been the best thing for quality and for reassurance for the patient and family,” he said.
FURTHER VALUE OF THE REGORAFENIB PQI FOR METASTATIC COLORECTAL PATIENTS
When the full array of professional disciplines operate under these consistent standards of care, patients benefit. As PQIs are implemented into action, the entire team works in concert to genuinely promote successful outcomes.
”The PQI is an easy, reliable resource to have during patient follow-up and management. Aligning with physicians on the same standards is advantageous. The PQI is an algorithm I can follow for dose escalation and follow-up,” said Carone.
At Tennessee Oncology, McCullough elaborated on the process, “Since starting this PQI, more patients with mCRC on Stivarga® are starting on a dose-escalation regimen,” she said. “Adding a weekly follow-up has provided us the opportunity to intervene before problems arise or become worse. Including supportive care medicine like urea cream is another essential consideration. By providing additional education and adverse event interventions, we can keep patients on their medication up until their follow-up appointment. Without these interventions, the patients may have self-discontinued due to side effects. We are still gathering duration of use data to compare to our baseline data in order to prove the need for these valuable interventions.”
Yet again, pharmacy leaders are adopting effective tools and resources to do more for their patients. Taken a step further, some are gathering the data to prove the value, further promoting the idea that collaboration and innovation breeds excellence. Physician leaders, too, are recognizing the value of operating upon consistent clinical standards. “I haven’t initiated at the 160mg dose for some time,” Paulson said. “Now the whole team has a PQI document that outlines the dose escalation strategy which has been built directly into our EMR regimens.”
Texas Oncology Nurse Manager Christina Craig, RN, BSN, OCN, CBNC, follows-up with patients as part of the standard processes at their organization. She and her team engage in weekly outreach calls to patients during the first month of any new drug therapy. Prompts for clinical intervention in the PQI are a big help, she noted. “Anything that makes it easier for us to manage side effects is very useful,” Craig said. “It’s helpful to also have a skilled MID pharmacy team that is able to provide guidance and education to the nursing staff.”
POSITIVE QUALITY INTERVENTIONS ENABLE TEAMS TO DO MORE FOR THEIR PATIENTS
Although momentous strides have been made to tailor care to individuals receiving regorafenib for mCRC, the work isn’t done. Intolerable doses are being dispensed, patients are being left alone to manage their side effects, and care teams are operating without quality standards. Nothing is more satisfying than staring at an obvious problem directly in the face and challenging oneself to do more. This article has provided several ideas for implementation of PQIs and the principles they contain into the workflow at a modern cancer treatment center. Ultimately, the onus is on individuals to think strategically, efficiently, and optimally.
When asked how other organizations could approach and implement PQIs, McCullough suggested “It starts with standardizing the initial education and adherence/tolerability follow-up process. This ensures that all patients are given the same quality of information. It is also important to train staff on best practices when providing patient education,” she said. “Regular refresher meetings are a good way to socialize this information and verify all are on the same page. Communication is key in interdisciplinary teams and documenting interactions and vital information is crucial for successful patient interventions.”
Additionally, new oral treatment plans will be created while refining the existing plans with current best practices as defined by NCODA’s PQIs. Furthermore, these plans will include the use of supportive care medicines put directly into the flow sheets so those critical elements cannot be overlooked. Several professionals suggested adding the PQI links directly into the organization’s intranet to provide awareness to all staff of its availability and beneficial utility.
Within the EMR regimen itself, the references currently listed link out to the prescribing information (PI) or a drug reference database, yet these sources are missing the critical criteria that is contained in PQIs. As a result of this, efforts will be made to incorporate a link to PQIs directly from the regimen within the EMR.
At Texas Oncology and other US Oncology sites, the regorafenib dose escalation is built directly into the available regimens displayed while entering the patient case through the clinical decision-making tool within the EMR. Further opportunity exists in refining the communication script between the technicians and the patients to find true adherence, tolerance, and in that way improve patient care. Standardizing the patient education material with OCE sheets is another positive step for patients.
At Texas Oncology, the team will continue to bring awareness of these tools throughout their many sites of service. Here the professionals have recognized that the value of a PQI is only limited by the number of people who frequently review and utilize this clinical guidance information. “PQIs should be used during follow-up as a reminder of the key treatment principles, including proper dosing and supportive cream,” McClendon said.
Indeed, consistent referral to the same high-quality clinical standards in PQIs is an effective practice that all disciplines can readily adopt into their workflow. Another important takeaway is to keep a close eye on the dose as the patient progresses from cycle one to cycle two when the dose and instructions often change.
McCullough, of Tennessee Oncology, summarized the opportunities to do more: “The value NCODA’s PQI brings is to transform best practices into standardized practices. We are able to standardize documentation and workflows to deliver the highest quality patient care.”
Paulson concurred: “Establish a workflow that delegates the needs of the prescriber to other capable individuals on the MID team. Equip those professionals with consistent,
excellent resources like the PQI to conduct care at the highest standards.”
Rhone noted: “We are so grateful NCODA has generated useful resources like the PQI and OCE to empower the MID team. It is useful in the orientation of individuals new to oncology, as well as experienced professionals who may not see every therapy at a high frequency and occasionally need simple reinforcement of clinical principles.“
PQIs provide the foundational building blocks for MID teams to build bridges to success. McCullough stated, “The PQI has greatly improved communication and brought about collaborative discussion between the prescribers and pharmacy team. Overall, our patients’ experience is being affected in a positive manner with these PQIs and we look to expand this further into our pharmacy practice.”
CONCLUSION: PQI PRINCIPLES BUILD THE BRIDGE TO FUTURE SUCCESS
Regorafenib therapy is safe, effective and provides extended time for patients to enjoy more life experiences – to embark upon other adventures and other bridges to cross. However, those journeys can only be possible with the close support of caregivers who are empowered with the skills and knowledge to properly enable their patients to achieve their goals.
PQI principles promote quality care and create an environment in which the patient feels safe with regular check-ins on their health status. Surrounded by one team of expert professionals with each individual cohesively contributing to the overall journey, these metastatic colorectal cancer patients are in a position to maintain health and quality of life throughout the treatment process. That’s a comforting feeling for everyone involved.
Individuals within cancer treatment organizations are the builders who provide the bridge to success with regorafenib therapy. Employers, payers, providers, pharmacists, and patients are continuing to recognize the value of this delivery model for every stakeholder.
NCODA exists to advance the value of dispensing practices for oncology physicians through the provision of innovative and effective resources like the Positive Quality Intervention (PQI). These tools reduce physician burden and instill confidence in health care professionals to achieve optimal outcomes for their patients. But the work is far from over.
All organizations, and more importantly, individuals, should challenge themselves to simply do more. The updated adage is true: it takes a team to care for a cancer patient.
NCODA has provided a foundation, but only the individuals within an empowered MID team can take the necessary steps to successfully build the bridge to optimal patient care. Once these tools are properly operationalized, professionals can enable patients to climb up and over the waters and find success on the other side. We are all in this together; let us move forward confidently.
Author: Matthew Schulz, PharmD
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View original article in pdf form HERE.