HOPA Publications Committee
Bonnie Labdi, PharmD RPh, Chair
Ashley Glode, PharmD BCOP, Vice Chair
George Carro, RPh MS BCOP, Board Liaison
Jayde Bendarik, PharmD BCOP
Megan Bodge, PharmD
Megan Brafford, PharmD BCOP
Morgan E. Culver, PharmD BCOP
Christine Gegeckas, Rph BCOP
Lindsay Hladnik, PharmD BCOP
Lisa Lohr, PharmD BSPharm BCOP BCPS
Katie Long, PharmD
David Reeves, PharmD BCOP
Lisa Savage, PharmD BCOP BCPS
Alexandra Shillingburg, PharmD
Candice Wenzell, PharmD BCOP
Board Update
Scott Soefje, PharmD MBA BCOP FCCP
HOPA President
Annual Meeting Recap
The HOPA annual meeting exceeds expectations every year, and this year was no exception. We topped 1,000 attendees for the first time ever. Holy buckets! As a native Texan and an Austinite, I’m proud that attendees enjoyed a successful annual meeting in our city.
The Programming Committee did another outstanding job. The John G. Kuhn Keynote Lecture was thought-provoking and entertaining. Toby Clark made us consider the footprint we will leave on the profession and the footprint HOPA will leave on health care. The boot camps, concurrent sessions, BCOP sessions, and other educational offerings provided something for everyone.
Every year it gets harder and harder to top the year before. Still, we are already off to a fantastic start for the 2016 Annual Meeting in Atlanta, GA. We have a very special keynote speaker lined up for next year whom I think everyone will be excited about. As teasing as it sounds, you’ll just have to wait until we make the formal announcement.
Strategic Plan
HOPA Past President Mike Vozniak unveiled our new strategic plan at the annual meeting. This plan was developed in early 2015 and will take us through 2020. Like our previous plan, this one comprises four core areas:
• Professional development
• Advocacy
• Research
• Professional resources and tools.
The purpose of the first three areas is to improve our previous work. We are finding ways to expand our professional development offerings, connect with a wider audience through advocacy, and re-focus our research on demonstrating the value of the pharmacist in the hematology/oncology setting.
We added the fourth area, professional resources and tools, because we want HOPA to expand beyond standards. Although standards will remain a large part of this section, we want to explore HOPA’s potential to aid hematology/oncology pharmacists in their daily practice. Our goal is to become the go-to place for all things related to hematology/oncology pharmacy.
In May, the board approved the final plan including the prioritization of the objectives under each of the four core areas. You will see the new strategic plan posted on the website shortly.
BCOP Proposal
HOPA is pleased to announce that the Board of Pharmacy Specialties (BPS) has approved HOPA as a provider of Board Certified Oncology Pharmacist (BCOP) recertification professional development for a 7-year cycle that will begin January 1, 2016.
HOPA’s program will provide 38 hours per year of opportunities for BCOPs to address and refresh their knowledge on topics essential to practice and earn the required 100 continuing education hours over a 7-year period. The comprehensive approach will address the four domains of oncology pharmacy specialty practice as defined by BPS, and assess participants’ knowledge and problem-solving skills pertinent to the application of the scope of material in each of the four domains.
HOPA’s proposal is built around four core professional development components:
• Oncology Pharmacy Updates Course
• Live BCOP recertification programming (expansion of our current 6-hour annual conference offerings)
• Self-study modules
• Emerging Issues in Oncology webinar series.
Much more information will be forthcoming in the weeks ahead, including opportunities for members to serve as volunteers on the BCOP Recertification Committee or provide expertise as speakers. Please look for those announcements in the next few days as we will be ramping up quickly to begin programming in January 2016.
The American College of Clinical Pharmacy and American Society of Health-System Pharmacists (a combined program) also were approved to provide BCOP recertification offerings.
Hill Day
As part of our advocacy agenda in our strategic plan, the board and the Health Policy Committee had our first HOPA Hill Day on April 29. We went to Capitol Hill to meet Representatives and Senators from Connecticut, Florida, Indiana, Kentucky, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Texas, and Washington. In attendance were Mike Vozniak, Jill Rhodes, Heidi Finnes, Ryan Bookout, Lisa Holle, Helen Marshall, Niesha Griffith, David DeRemer, Kellie Weddle, and Jolynn Session, and I, along with staff from HOPA and the District Policy Group.
We went to promote the role of the hematology/oncology pharmacist and to discuss the value we bring to patients. We also asked for sup- port for H.R. 592/S. 314: Pharmacy and Medically Underserved Areas Enhancement Act. This act would allow pharmacists to bill for clinical services. We also promoted oral chemotherapy access, supporting parity between oral and IV chemo while describing how specialty tier co-pays hurt patients. Our message seemed well-received, and our advocacy is starting to be noticed in Washington, DC. As a small group, we still have a long road ahead, but we’re off to a great start.
Each member of HOPA can make a significant impact in advocacy. Take the time now to contact your senators and local representatives and ask them to support H.R. 592 or S. 314. Every time you reach out to Congress, our voice gets louder and our message gets closer to being heard and accepted.
Fellow Program
The call for nominations/applications for the Fellow of the Hematology Oncology Pharmacy Association (FHOPA) has gone out. We are looking for those individuals who have made a lasting impact on HOPA. This inaugural class will be introduced in Atlanta in March 2016. If you know someone who you think deserves this qualification, please submit a nomination.
The List
So far I have talked about what we’ve been doing, and I want to end today with what we have planned. In my opening remarks in Austin, I stated I have a list of items that I have been collecting. Many of the things on my list are areas we are already working on; some are ideas that we should start on but will take more than a year to accomplish; and some are just ideas that we should keep in mind. Like many to-do lists, this one is constantly changing. As I check off “submit BCOP proposal to BPS,” I add many additional items that will be required should the proposal be accepted. As we meet with one external organization, we identify two more that may be potential partners with HOPA. And as we promote our healthcare agenda, we ask ourselves how to help our members meet the challenges of being a provider should that bill pass. We will be doing an internal review of the organization, but more on that next time. We are working to expand our influence by partnering with an increasing number of cancer or pharmacy organizations—this will be the topic of the winter update. We will be looking for big ideas, developing new programming, taking a leadership role in oral chemotherapy, and continuing to deliver the quality products you have come to expect from HOPA.
We will continue to provide quality professional development programming, so don’t forget about the quarterly webinars, journal club, and the practice management symposium in September. We are becoming a strong voice for cancer care in Washington, and external organizations now seek out our opinions. We are talking with LiveSTRONG, Oncology Nursing Society, American Society of Clinical Oncology, and other like-minded organizations. Our call for research proposals has gone out. We are exploring new areas, have a new strategic plan, and are expanding our influence in care for cancer patients. The board, committees, task forces, and work groups are energized to push HOPA to new heights. The coming year will be a busy one for HOPA, but I know we are moving in the right direction.
Bridging the Gap Between Clinical and Specialty Pharmacy Services
Kane Hosmer, PharmD
PGY2 Hematology/Oncology Pharmacy Resident
The University of Chicago Medicine
Chicago, IL
Regulatory agencies and insurance companies favor restricted drug distribution systems to dispense specialty drugs that make up much of the armamentarium of antineoplastic agents used today. From the U.S. Food and Drug Administration’s perspective, specialty pharmacies limit the distribution of high-risk specialty medications to pharmacies that have the most experience complying with complicated risk evaluation and mitigation strategy programs.1 From a payer perspective, specialty pharmacies create economies of scale while simplifying the distribution of expensive medications, thus reducing costs to insurance companies.2
As specialty drug prices balloon, cost containment has become increasingly important to insurance companies. It is estimated that in 2008, $54 billion was spent on specialty medications, accounting for 25%–30% of overall medical costs to health plans.1 National drug expenditure forecasts for 2014 predicted growth in specialty drugs of 13%–24%.3 Perhaps unsurprisingly, oncology practice is heavily impacted by specialty pharmacy because many antineoplastic agents fall into this high-cost, high-risk category.
In response, hospital systems have increasingly developed their own specialty pharmacies to capitalize on the financial opportunities that specialty pharmacy offers. According to an article published in Pharmacy and Therapeutics, hospital systems are hoping to purchase specialty medications at 340B prices, then bill insurance companies for the higher, nondiscounted cost.4
At least one hospital-based specialty pharmacy pro- gram has reported revenue of $7.5 million during the first year.5 Although the incentive to start a specialty pharmacy exists, health-system administrators will need to integrate specialty pharmacy into preexisting practice models to prevent fragmentation of care.
When a specialty pharmacy is being developed, one challenge is the lack of an official definition of specialty pharmacy, and services vary significantly between institutions.3 There are no mandatory certificates for accreditation, which also is problematic. There are, however, accrediting bodies that hospital systems may voluntarily seek out. Both the Accreditation Commission for Health Care and URAC (formerly the Utilization Review Accreditation Commission provide standards for performance. URAC’s measures are available online6 and focus mainly on medication adherence for nonspecialty medications; overall patient satisfaction; and distributive functions such as accurate dispensing, on-time delivery, and call center performance. URAC has not yet established a measure for specialty medication adherence.
In 2010 the National Comprehensive Cancer Network (NCCN) published a task force report on the potential advantages and risks of using specialty pharmacies to distribute oncology therapeutic agents.3 Potential advantages include appropriate selection of medication, increases in adherence, avoidance of unnecessary drug costs, and increasing patient and provider satisfaction.3,7
However, if the specialty pharmacy is not operated by the hospital system, patient care may be compromised by lack of access to a patient’s electronic medical record, poor communication between providers and the specialty pharmacy, and a breakdown in the drug’s chain of custody because medications often are delivered to a patient’s home.3
The University of Illinois at Chicago (UIC) recently published its approach to integrating existing clinical pharmacy with specialty pharmacy services.8 In the UIC model, the clinical pharmacist provides services for one-half day per week. The specialty pharmacy has pharmacists, prior authorization specialists, students, and residents to staff its 24-hour call center.
The clinical pharmacist serves on the care team and interfaces with the specialty pharmacy, bridging a gap in care that NCCN warns may occur with the introduction of specialty pharmacy services. When the provider writes a prescription, the clinical pharmacist evaluates the order for appropriateness, then sends the fill to the specialty pharmacy if the patient does not have contraindications to therapy. The clinical pharmacist also coordinates any other education the patient may need, such as injection technique training. Meanwhile, some of the responsibilities of the specialty pharmacy include verifying prescription benefits, assisting with referrals to prescription assistance programs, and sending prior authorizations appeal forms to the clinical pharmacist for justification.
If permitted, the specialty pharmacy processes the fill for the patient’s first visit with the clinical pharmacist. The clinical pharmacist continues therapeutic drug monitoring. The specialty pharmacy continues to monitor the patient for adherence and adverse effects through the use of clinical surveys, which are reported to the clinical pharmacist. The clinical pharmacist can then discuss alternate treatment options with the attending physician, if needed.
Utilizing an integrated clinical and hospital-based specialty pharmacy model offers the advantage of sharing electronic medical records, fostering closer collaboration between providers and specialty pharmacy because of closer geographic proximity, and ensuring proper storage of medications by direct delivery to clinics. Development of such models will be increasingly important as healthcare systems seek to develop their own specialty pharmacies.
References
1. Kirschenbaum BE. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists. Am J Health Syst Pharm. 2009;66(24 Suppl 7):S13-S20.
2. Schwartz RN, Eng KJ, Frieze DA, et al. NCCN task force report: specialty pharmacy. J Natl Compr Canc Netw. 2010(8 suppl 4):S1-S12.
3. Schumock GT, Li EC, Suda KJ, et al. National trends in prescription drug expenditures and projections for 2014. Am J Health Syst Pharm. 2014;71(6):482-499.
4. Barlas S. Specialty pharmacy networks for hospitals in the offing: absence of onsite access to specialty pharmaceuticals has care and financial implications. P T. 2014;39(2):123-143.
5. Hlubocky JM, Stuckey LJ, Schuman AD, Stevenson JG. Evaluation of a transplantation specialty pharmacy program. Am J Health Syst Pharm. 2012;69(4):340-347.
6. URAC. Specialty pharmacy [version 2.0 and 2.1, measures version 1.0]. Washington, DC: URAC Inc.; 2011.
7. URAC. Specialty pharmacy white paper. Washington, DC: URAC Inc.; 2011. www.urac.org/ Whitepaper/ PQM-Specialty_Pharmacy.pdf
8. Hanson RL, Habibi M, Khamo N, Abdou S, Stubbings J. Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis. Am J Health Syst Pharm. 2014;71(6):463-469.
Mentoring/ Precepting Students and Residents During a PGY2 Residency
Jason Jared, PharmD
PGY2 Oncology Resident
University of Wisconsin Hospital and Clinics
Madison, WI
Jason J. Bergsbaken, PharmD
Pharmacy Coordinator, Regional Oncology Services University of Wisconsin Hospital and Clinics
Madison, WI
The number of pharmacy learners, including students and residents, continues to increase within our profession. As of 2014, there are more than 130 pharmacy colleges and schools in the United States with an accredited or candidate professional degree program and an estimated graduating class of more than 14,000 students. In addition, more new practitioners are pursuing specialty residency training, including PGY2 oncology programs. According to the American Society of Health-System Pharmacists' Resident Matching Program statistics, there were 121 available PGY2 oncology positions among 75 total programs in 2014, up from 74 positions at 50 total programs in 2010.1 As the number of pharmacy students and residents increases, it is vital that we prepare and utilize these learners appropriately to maximize educational experiences and organizational value.
Layered Learning Practice Model
The Layered Learning Practice Model (LLPM) was developed at the University of North Carolina (UNC) Eshelman School of Pharmacy and UNC Hospitals to enhance patient care and provide new educational opportunities for student and resident learners. This innovative model of pharmacy practice mimics the medical model of active learning and features an attending pharmacist who is responsible for all aspects of a patient’s care and residents (PGY1 or PGY2) and students who function as extenders to provide expanded clinical patient care services. In addition to clinical services, the attending pharmacist oversees student/resident education. In this model, learning is handled in a layered fashion from attending pharmacist to resident to student, providing opportunities for resident and student learners to be responsible for patient care on rotation. In addition, it affords the PGY2 resident opportunities to lead topic discussions and serve as preceptors for PGY1 residents and student pharmacists. Attending pharmacists benefit by gaining dedicated time for leadership, scholarship, and program expansion activities.
PGY2 Resident Precepting Roles
In the LLPM, PGY2 residents can have a large impact on the education and development of PGY1 and student learners while freeing up attending pharmacists’ time for high-level clinical activities. PGY2 residents have the necessary experience to fill all formal precepting roles such as direct instruction, modeling, coaching, and facilitating. For example, PGY2 residents may provide direct instruction by leading topic discussions. Rounding experiences and the subsequent opportunities to provide specific feedback and education allow the PGY2 resident to model and coach desired behaviors. In addition, PGY2 residents can serve as a coach and mentor for residents and students working on case presentations, rotation projects, or journal clubs. Ultimately, the PGY2 resident can facilitate independent experiences for other learners, such as patient monitoring and documentation. Under the LLPM, PGY2 residents develop the valuable skills necessary to serve as strong future preceptors.
PGY2 Resident Benefits and Challenges
The development of nonclinical skills is essential for PGY2 residents to complement their direct patient care experiences. Expanding the skills necessary to function as an excellent preceptor is arguably one of the most important outcomes of residency training and can serve as the foundation of a resident’s clinical practice. Benefits of mentoring and precepting learners as a PGY2 resident include sharpening these skills, freeing time for the attending pharmacist, and providing a high-quality learning experience for PGY1 residents and students. From an organizational perspective, PGY2 precepting can add efficiency to the training of learners. For example, utilizing a PGY2 resident to lead supportive care topic discussions allows an attending pharmacist to focus on patient care while allowing the preceptor to have more time and energy to focus on other projects.
Serving as a preceptor while completing a PGY2 residency can be challenging. Because PGY2 residents lack the same clinical experience as an experienced pharmacist they may be perceived as a less formal educator, which may negatively impact learner structure. Learner proximity of experience and coresident comradery could potentially adversely affect the PGY2 resident’s influence and ability to successfully precept in the LLPM. Setting clear expectations regarding preparation and communication can help ensure a successful professional relationship between the PGY2 and the learner. Another key to successful PGY2 mentoring and precepting of learners is appropriate oversight and mentorship of the PGY2 resident. As a PGY2 resident, receiving feedback on your precepting skills from attending pharmacists ensures continued professional growth and development.
PGY2 Resident Experience
As a PGY2 oncology resident at the University of Wisconsin Hospital and Clinics, an academic medical center that utilizes the LLPM, I have regular opportunities to work with various learner groups. From direct topic instruction to rounding facilitation, I use all four formal precepting models on a daily basis. Pre- and postrounding patient review has been one of the more fulfilling PGY2 residency experiences and allows me to work one on one with learners to sharpen their clinical skills while enhancing my precepting skills. In addition, PGY2 residents serve as formal facilitators for PGY1 residents and pharmacy students for our triweekly “Resident Report” sessions. Resident Report is an opportunity for a learner to present clinical or administrative topics to the learner group via lecture and discussion. As a PGY2 resident, I help the learner with topic selection and delivery while providing formalized feedback for self-improvement. In addition, the learner provides feedback to improve my facilitation and evaluation skills. These are just a few examples of methods the University of Wisconsin Hospital and Clinics uses to allow their PGY2 residents to improve learner training, facilitate attending pharmacist clinical practice, and achieve a comprehensive PGY2 training experience.
Reference
1. National Matching Services, Inc. ASHP National Matching Program Statistics. www.natmatch.com/ashprmp/aboutstats.html. Accessed March 25, 2015.
Recalls and Safety Alerts from the FDA
Ashley Glode, PharmD BCOP
Clinical Oncology Pharmacy Specialist; Assistant Professor
University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences
University of Colorado Anschutz Medical Campus
Aurora, CO
Recalls
Mitoxantrone
In December 2014 Hospira, Inc., announced a voluntary recall of 10 lots of mitoxantrone (human and veterinary) for confirmed subpotency and elevated impurity levels. Hospira has not yet received any reports of adverse effects associated with this issue. The impacted lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. A root-cause analysis initiated improvements for batches manufactured March 2014 and later. For a full list of recalled products, visit www.fda.gov/ Safety/ Recalls/ ucm427952.htm.
Sodium Chloride Injection
In January 2015 Hospira, Inc., issued a voluntary nationwide recall of one lot of 0.9% sodium chloride injection, USP, 250 ml (NDC 0409-7983-02) because of particulate matter found in a single unit. Hospira has identified the particulate as a human hair sealed inside the bag at the additive port area. There have been no reports of adverse effects associated with this issue for this lot. This lot was distributed nationwide from September to November 2014. Hospira is conducting a root-cause analysis to determine corrective and preventive actions. For more information, refer to www.fda.gov/ Safety/ Recalls/ucm430929.htm.
Safety Alerts
Lanreotide (Somatuline Depot Injection)
The list of contraindications for lanreotide has been updated to include patient history of hypersensitivity to lanreotide. Postmarketing reports indicate some patients have experienced allergic reactions, including angioedema and anaphylaxis, after receiving lanreotide.
The package insert has been updated to include additional warnings and precautions. In a postmarketing study of 81 patients treated with lanreotide who had baseline heart rates of at least 60 beats per minute (bpm), 23% (19/81) had a heart rate < 60 bpm after lanreotide ad- ministration versus 16% (15/94) of patients treated with placebo. Ten patients (12%) had more than one episode of a heart rate < 60 bpm. In both intervention and control groups, 1% in each experienced a heart rate < 50 bpm and had bradycardia reported as an adverse event. www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm429783.htm
Paclitaxel Protein-Bound Particles (Abraxane)
The use of paclitaxel protein-bound particles in patients with hepatic impairment may put them at increased risk of toxicity, particularly myelosuppression requiring close monitoring. Use is not recommended for patients with total bilirubin values > 5 × upper limit of normal (ULN) or aspartate transaminase (AST) > 10 × ULN. Paclitaxel protein-bound also is not recommended for patients with metastatic adenocarcinoma of the pancreas with moderate to severe hepatic impairment (total bilirubin > 1.5 × ULN and AST = 10 × ULN). www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm359951.htm
Ramucirumab (Cyramza)
Several labeling updates were made for ramucirumab. Additional information was added to warnings and precautions for hemorrhage and hypertension. In one study assessing patients with non-small-cell lung cancer (NSCLC), the incidence of severe bleeding was 2.4% with ramucirumab and docetaxel compared with 2.3% with placebo. This trial excluded patients who were receiving therapeutic anticoagulation or chronic nonsteroidal anti-inflammatory drug (NSAID) therapy or other antiplatelet therapy besides once daily aspirin. Patients with major airway or blood vessel invasion or intratumor cavitation were also excluded. The risk of pulmonary hemorrhage for these patients is unknown because of their exclusion from the study. The incidence of hypertension also was updated to indicate occurrence in 6% of patients who received ramucirumab plus docetaxel compared with 2% of patients who received docetaxel alone.
Information regarding immunogenicity was edited in the context of the study on ramucirumab with docetaxel for NSCLC. No pharmacokinetic interactions were found between ramucirumab and docetaxel. The study included several geriatric patients, allowing outcomes in this group to be assessed in an exploratory subgroup analysis. The hazard ratio for overall survival (OS) for patients < 65 years was 0.74 (95% CI:0.62, 0.87) and for patients ≥ 65 years 1.10 (95% CI: 0.89, 1.36).
Information regarding ramucirumab use in hepatic impairment was added to clarify the definition of mild hepatic impairment (AST > ULN or total bilirubin > 1.0–1.5 × ULN), for which ramucirumab does not require a dose adjustment.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm429773.htm
Obinutuzumab (Grazyva)
The warnings and precautions section was updated to include fatal infections reported with use of obinutuzumab. The percent incidence was updated to 33% for grades 3 or 4 neutropenia and 10% for grades 3 or 4 thrombocytopenia when used in combination with chlorambucil. www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm404996.htm
Ruxolitinib (Jakafi)
The ruxolitinib package insert was updated to include information regarding symptom exacerbation to pretreatment levels after discontinuation of ruxolitinib. This may occur over a period of 1 week, and patients may experience one or more of the following: fever, respiratory distress, hypotension, disseminated intravascular coagulation, or multiorgan failure. Periodic skin evaluations should also be conducted for patients taking ruxolitinib because nonmelanoma skin cancers (basal cell, squamous cell, Merkell cell carcinoma) have occurred.
Myelosuppression, thrombocytopenia, anemia, and neutropenia were added to the list of adverse reactions.
Additional information was included in the organ dysfunction section. In patients with polycythemia vera and moderate (creatinine clearance [CrCl] 30–59 ml/min) or severe (CrCl 15–29 ml/min) renal impairment, a dose reduction of ruxolitinib is recommended. Hepatic impairment is another factor that can necessitate dose reductions.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm377314.htm
Sunitinib (Sutent)
Additional information regarding risk for hypoglycemia was included in the warnings and precautions and patient counseling sections of the sunitinib package insert. Hypoglycemia was seen in 2% of patients with renal cell carcinoma and gastrointestinal stromal tumor who received sunitinib and 10% of patients with primitive neuroectodermal tumor. Not all patients had preexisting abnormalities in glucose control. Glucose values should be regularly assessed during and after discontinuing treatment with sunitinib.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm224050.htm
Everolimus (Afinitor)
An increased incidence of angioedema has been recorded with concomitant use of everolimus and angiotensin-converting enzyme inhibitors (ACEIs). The incidence of angioedema for patients taking everolimus and an ACEI was 6.8% versus 1.3% for patients taking an ACEI only in a pooled analysis of randomized double-blind oncology clinical trials.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm433415.htm
Imatinib (Gleevec)
Warnings and precautions about the use of imatinib have been updated. Patients with chronic phase, newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+CML) were given imatinib or nilotinib. In this trial the incidence of severe, grade 3 or 4 fluid retention was seen in 2.5% of patients taking imatinib and in 3.9% of patients taking nilotinib 300 mg twice daily (BID). Similar rates of effusions (pleural or pericardial effusions or ascites) and pulmonary edema occurred: 2.1% (0% grade 3 or 4) in the imatinib arm and 2.2% (0.7% grade 3 or 4) in the nilotinib arm.
The incidence of congestive heart failure and left ventricular dysfunction was assessed in another randomized trial in the same population. Cardiac failure occurred in 1.1% of patients (0.7% grade 3 or 4) in the imatinib arm and 2.2% of patients (0.7% grade 3 or 4) in the nilotinib 300 mg BID arm.
Gastrointestinal (GI) hemorrhage was also evaluated in a randomized trial comparing imatinib and nilotinib as initial treatment for patients with chronic phase Ph+CML; 1.4% of patients receiving imatinib and 2.9% of patients receiving nilotinib 300 mg BID experienced GI hemorrhage (0% grade 3 or 4 and 0.7% grade 3 or 4, respectively). Gastric antral vascular ectasia has been reported through postmarketing experience.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm255333.htm
Nilotinib (Tasigna)
Changes have been made to the warnings and precautions associated with nilotinib. Additional clinical trial results are available to describe the incidence of cardiac and arterial vascular occlusive events and hemorrhage seen with nilotinib use. The incidence of cardiovascular events seen among patients receiving a median of 60 months of treatment was dose-related, occurring in 9.3% of patients on nilotinib 300 mg BID and 15.2% of patients on nilotinib 400 mg BID. The rates of GI hemorrhage were 2.9% in patients on 300 mg BID (0.7 % grade 3 or 4) and 5.1% in patients on 400 mg BID (1.4% grade 3 or 4). Fluid retention has also been a reported adverse event in clinical trials. Severe, grade 3 or 4 retention occurred in 3.9% of patients receiving nilotinib 300 mg BID and 2.9% of patients receiving 400 mg BID. It is recommended to monitor for signs of severe fluid retention and symptoms of respiratory or cardiac compromise and evaluate and treat patients according to etiology. Additional information on regular monitoring of lipid profiles and glucose (periodically during the first year, at least yearly during chronic therapy) and the use of HMG-CoA reductase inhibitors has been included. Drug-drug interactions should be assessed before initiating lipid lowering therapy.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm218929.htm
Abiraterone (Zytiga)
The drug interactions section for abiraterone has been updated to include information on CYP2C8 drug-drug interactions in healthy subjects. The area under the curve of pioglitazone, which is a CYP2C8 substrate, was increased by 46% when patients were given pioglitzone and a single dose of 1,000 mg abiraterone. Patients should be monitored closely when given CYP2C8 substrates with narrow therapeutic indexes and abiraterone.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm314608.htm
Goserelin Acetate Implant (Zoladex)
Reports of injection-site injury and vascular injury comprising pain, hematoma, hemorrhage, and hemorrhagic shock requiring blood transfusions and surgical intervention have been documented with the use of goserelin acetate implant. Extra care and caution should be utilized in patients with a low body-mass index and patients receiving full-dose anticoagulants.
Conference Recap
It turns out everything is bigger in Texas, including the HOPA Annual Conference which took place in Austin, TX, in March and brought in record attendance with more than 1,000 registrants! Hematology/ oncology pharmacists from across the nation gathered to discuss current research in the screening and treatment of patients with solid tumors and hematologic malignancies, learned about new and emerging therapies for patients, and reviewed recent developments in medical literature regarding medications and dosing. Nearly half of the HOPA membership joined together to share knowledge and expertise over 3.5 days. Meeting attendees took advantage of Austin to discover the great food and arts and entertainment scene the host city offered.
Several preconference events allowed attendees to maximize their time in Austin with extended networking and education events. New this year was a postconference offering from the American Society for Blood and Marrow Transplantation, Fundamentals of Hematopoietic Cell Transplantation.
Toby Clark, MSc FASHP FFOP, delivered the John G. Kuhn Keynote Lecture. His address offered thoughts and reflections from his unique vantage point as a pharmacy observer and traveler to more than 500 facilities throughout the world. With nearly 50 years of experience in observing and consulting for hospitals and health systems throughout the world, his keynote address, What Is Your Footprint?, was extremely impactful and thought-provoking.
In addition to six specialty sessions and 10 breakout sessions, HOPA was pleased to offer a breadth of general session topics delivered by industry experts throughout conference, including the following:
Emerging Therapies in CLL
Jeffrey Bryan, PharmD
Investigational Agents
Rowena Schwartz, PharmD BCOP
New Drug Update: Marketed Agents
Monique Giordana, PharmD BCOP
Practice Panel: Survivorship
Jeff Sivik, PharmD BCOP; Lew Iacovelli, PharmD BCOP CPP; Sarah Peters, PharmD MPH BCOP; Kerry Parsons, PharmD BCOP
Resistance, New Antibiotics, and Continued Fun with Fungus: What the Oncology Pharmacist Needs to Know
James Lewis II, PharmD FIDSA
Targeting the Immune System in Cancer
David Frame, PharmD
HOPA extends a huge thanks to the many other industry professionals who shared their insights throughout conference events!
New this year was an attendee lounge that provided opportunities to “Relax, Network, and Get Charged.” The conference also held oncology interest group discussions with conversations on administrative, ambulatory, bone marrow transplantation, new practitioner, and pediatrics topics.
President Michael Vozniak, PharmD BCOP, delivered exciting high- lights from the year during his member address: the launch of the HOPA Central online discussion group, the possibility of becoming the primary professional development provider for BCOP Recertification, and the success of the 2nd Annual Oncology Pharmacy Practice Management Program. Dr. Vozniak announced the launch of HOPA’s Fellow Program, which will further advance oncology pharmacy as a profession. HOPA also made great progress as an organization through our health policy work. These developments are just a portion of the efforts HOPA has undertaken to continue to serve our mission: to support pharmacy practitioners and promote and advance hematology/oncology pharmacy to optimize the care of individuals affected by cancer. HOPA was pleased to acknowledge the contributions of board members who worked diligently throughout their time in office and whose terms came to a close:
• Niesha Griffith, Past President
• Daisy Yang, Secretary
• George Carro, At-Large Member
• Michelle Rockey, At-Large Member.
Once again, thank you all for your leadership, service, and commitment to HOPA.
Dr. Vozniak’s term as president also came to a close, and he welcomed our new president, Scott Soefje, PharmD MBA BCOP FCCP. Dr. Soefje’s career is filled with numerous milestones and contributions to the field of hematology/oncology pharmacy, and we are thrilled to welcome him as the leader of HOPA. As the board members mentioned above completed their leadership service to the organization, HOPA is delighted to welcome several new board members.
2015–2016 HOPA Board of Directors
• President, Scott Soefje
• Past President, Michael Vozniak
• President-Elect, Sarah Peters
• Secretary, Helen Marshall
• Treasurer, Jolynn Sessions
• At-Large Member, David DeRemer
• At-Large Member, Jill Rhodes
• At-Large Member, Ryan Bookout
• At-Large Member, Heidi Finnes
We thank you in advance for your willingness to continue driving HOPA’s success and future direction!
With a strategic plan that will carry HOPA through 2020 and a variety of new developments in the works, we are confident that HOPA will continue to advance the field of hematology/oncology pharmacy and will serve our members to ensure that their investment is a worthy one.
Thank you to all who attended HOPA’s 11th Annual Conference. We look forward to HOPA’s 12th Annual Conference March 16–19, 2016, in Atlanta, GA, and hope to see you there!