SUPPLEMENT JNCCN - Oncology · 2010-07-29 · Volume 8 Supplement 4 Journal of the National...

JNCCN Volume 8 Supplement 4 Journal of the National Comprehensive Cancer Network

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NCCN Task Force Report: Specialty PharmacyRowena N. Schwartz, PharmD, BCOP; Kirby J. Eng, RPh; Deborah A. Frieze, PharmD, BCOP; Tracy K. Gosselin, RN, MSN, AOCN; Niesha Griffith, MS, RPh, FASHP; Amy Hatfield Seung, PharmD, BCOP; Jennifer M. Hinkel, MSc; Philip E. Johnson, MS, RPh, FASHP; Shirley A. Johnson, RN, MS, MBA; Edward C. Li, PharmD, BCOP; Audrea Hotsko Szabatura, PharmD, BCOP; and Michael K. Wong, MD, PhD

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ACPE credit provided by Postgraduate Institute for Medicine

Volume 8 Supplement 4 Journal of the National Comprehensive Cancer Network

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DisclaimerThe treatment algorithms presented in JNCCN and its supplements are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual circumstances to determine any patient’s care or treatment. The research articles, reviews, and other individually authored papers presented herein are the work of the authors listed. Furthermore, the reader is advised that, except where specifically stated, all of the ideas and opinions expressed in JNCCN are the authors’ own and do not necessarily reflect those of NCCN, the member organizations, the editor, or the publisher. Publication of an advertisement or other product mention in JNCCN should not be construed as an endorsement of the product or the manufacturer’s claims.

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JNCCNNCCN Member InstitutionsCity of Hope Comprehensive

Cancer Center Los Angeles, California

Dana-Farber/Brigham and Women’s Cancer Center| Massachusetts General Hospital Cancer Center Boston, Massachusetts

Duke Comprehensive Cancer Center Durham, North Carolina

Fox Chase Cancer Center Philadelphia, Pennsylvania

Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah

Fred Hutchinson Cancer Research Center/ Seattle Cancer Care Alliance Seattle, Washington

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland

Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago, Illinois

Memorial Sloan-Kettering Cancer Center New York, New York

H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida

The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute Columbus, Ohio

Roswell Park Cancer Institute Buffalo, New York

Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine St. Louis, Missouri

St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute Memphis, Tennessee

Stanford Comprehensive Cancer Center Stanford, California

University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama

UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan

UNMC Eppley Cancer Center at The Nebraska Medical Center Omaha, Nebraska

The University of Texas MD Anderson Cancer Center Houston, Texas

Vanderbilt-Ingram Cancer Center Nashville, Tennessee

For more information, visit www.NCCN.org

JNCCN is dedicated to improving the quality of cancer care locally, nationally, and internationally while enhancing the collaboration between academic medicine and the community physician. JNCCN is further committed to disseminating information across the cancer care continuum by publishing clinical practice guidelines and reporting rigorous outcomes data collected and analyzed by experts from the world’s leading care centers. JNCCN also provides a forum for original research and review papers focusing on clinical and translational research and applications of the NCCN Guidelines in everyday practice, as well as correspondence and commentary.

Mission Statement

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit www.NCCN.org.

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JNCCN*C,PRowena N. Schwartz, PharmD, BCOP∑

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

*PKirby J. Eng, RPh∑CVS Caremark Specialty

*PDeborah A. Frieze, PharmD, BCOP∑Seattle Cancer Care Alliance

*PTracy K. Gosselin, RN, MSN, AOCNλ#Duke Comprehensive Cancer Center

*PNiesha Griffith, MS, RPh, FASHP∑The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

*PAmy Hatfield Seung, PharmD, BCOP∑The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

*Jennifer M. Hinkel, MScNational Comprehensive Cancer Network

*PPhilip E. Johnson, MS, RPh, FASHPλH. Lee Moffitt Cancer Center & Research Institute

PShirley A. Johnson, RN, MS, MBAλ#City of Hope Comprehensive Cancer Center

*Edward C. Li, PharmD, BCOPNational Comprehensive Cancer Network

PAudrea Hotsko Szabatura, PharmD, BCOP∑

Dana-Farber Cancer InstitutePMichael K. Wong, MD, PhD†

Roswell Park Cancer Institute

KEY:

*Writing Committee Member; CChair; PPresenter

Specialties: ΣPharmacology, Specialty Pharmacy Oncology, and Clinical Pharmacy: Hematology/Oncology; λProgram Administration; #Nursing; †Medical Oncology

NCCN Task Force Report: Specialty Pharmacy Panel Members

Disclosure of Affiliations and Significant RelationshipsDr. Schwartz has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Mr. Eng has disclosed that he has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Dr. Frieze has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Ms. Gosselin has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Ms. Griffith has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Dr. Hatfield Seung has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Mr. Johnson has disclosed that he has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Ms. Johnson has disclosed that she has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Dr. Li has disclosed that he has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity. He is an employee of the National Comprehensive Cancer Network.

Dr. Szabatura has disclosed that he has no financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity.

Dr. Wong has disclosed that he has financial interests, arrangements, or affiliations with the manufacturer of products and devices discussed in this report or who may financially support the educational activity. He is on the advisory board, speakers’ bureau, or consultant for Argos Therapeutics, Inc.; Bristol-Myers Squibb Company; Bayer HealthCare; Onyx Pharmaceuticals, Inc.; BioVex Inc.; Genentech, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; and Pfizer Inc.

Activity planning staff have no financial interests to disclose.

NCCN: Kimberly Callan, MS, ELS; Genevieve Emberger Hartzman, MA; Kerrin Robinson, MA; Lynn Rubin, MS

The following PIM planners and managers, Jan Hixon, RN, BSN, MA; Trace Hutchison, PharmD; Julia Kimball, RN, BSN; Samantha Mattiucci, PharmD; Jan Schultz, RN, MSN, CCMEP; and Patricia Staples, MSN, NP-C, CCRN hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.


JNCCNCME AccreditationThe National Comprehensive Cancer Network (NCCN) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The NCCN designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation on the activity.

This educational activity was planned and produced in accordance with ACCME Essential Areas and Policies.

The NCCN adheres to the ACCME Standards for Commercial Support of Continuing Medical Education.

This activity is approved for 1.0 contact hours. NCCN is an approved provider of continuing nursing education by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

Approval as a provider refers to recognition of educational activities only and does not imply ANCC Commission Accreditation of PA Nurses approval or endorsement of any product. Kristina M. Gregory, RN, MSN, OCN, is our nurse planner for this educational activity.

Pharmacist Continuing Education

Accreditation StatementPostgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Credit Designation

Postgraduate Institute for Medicine designates this continuing education activity for 1.0 contact hour(s) (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number- 0809-9999-10-123-H04-P)Type of ActivityKnowledgePIM supports Green CME by offering your Request for Credit online. If you wish to receive acknowledgement for completing this activity, please complete the post-test and evaluation on www.cmeuniversity.com. On the navigation menu, click on “Find Post-test/Evaluation by Course” and search by course ID 7405. Upon registering and successfully completing the post-test with a score of 70% or better and the activity evaluation, your certificate will be made available immediately. Processing credit requests online will reduce the amount of paper used by nearly 100,000 sheets per year.

Continuing Education Information

Target AudienceThis educational program is designed to meet the needs of oncologists, oncology pharmacists, pharmacy directors, advanced practice nurses, and other clinical professionals who treat and manage patients with cancer.

Educational Objectives After completion of this CME activity, participants should be able to:• Discuss the current mechanisms of specialty pharmacies as a distribution channel

for oncology therapeutic agents and other medications used in the drug therapy of the individual with cancer.

• Examine the potential benefits and risks associated with the use of specialty pharmacy distribution of oncology therapeutic agents.

• Describe financial implications of specialty pharmacy distribution of oncology therapeutic agents for oncology practices, cancer centers, oncologists and individuals with cancer.

• Identify potential patient safety issues associated with the distribution of oral and parenteral oncology therapeutic agents through specialty pharmacy channels.

• Identify potential risks and liability concerns for oncology practices and oncologists that may result from the use of specialty pharmacies as distributions channels for oncology therapeutic agents.The opinions expressed in this publication are those of the participating faculty

and not those of the National Comprehensive Cancer Network, PIM, Amgen Inc., Pfizer Inc., or the manufacturers of any products mentioned herein.

This publication may include the discussion of products for indications not approved by the FDA.

Participants are encouraged to consult the package inserts for updated information and changes regarding indications, dosages, and contraindications. This recommendation is particularly important with new or infrequently used products.

Activity InstructionsParticipants will read all portions of this monograph, including all tables, figures, and references. A post-test and an evaluation form follow this activity, both of which require completion. To receive your continuing education certificate, you will need a score of at least 70% on the post-test. The post-test and evaluation form must be completed and returned by July 12, 2011. It should take approximately 1.0 hours to complete this activity as designed. There are no registration fees for this activity. Certificates will be e-mailed within 4 to 6 weeks of receipt of the post-test.

Copyright 2010, National Comprehensive Cancer Network (NCCN). All rights reserved. No part of this publication may be reproduced or transmitted in any other form or by any means, electronic or mechanical, without first obtaining written permission from the NCCN.

Supplement

© Journal of the National Comprehensive Cancer Network | Volume 8 Supplement 4 | July 2010

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Key Words

NCCN, specialty pharmacy, oncology, drug distribution, coordina-

tion of care, mail order pharmacy

Abstract

The use of specialty pharmacies is expanding in oncology phar-

macy practice. Specialty pharmacies provide a channel for distrib-

uting drugs that, from the payor perspective, creates economies

of scale and streamlines the delivery of expensive drugs. Proposed

goals of specialty pharmacy include optimization of pharmaceuti-

cal care outcomes through ensuring appropriate medication use

and maximizing adherence, and optimization of economic out-

comes through avoiding unwarranted drug expenditure. In on-

cology practice, specialty pharmacies have become a distribution

channel for various agents. The use of a specialty pharmacy, and

the addition of the pharmacist from the specialty pharmacy to

the health care team, may not only provide benefits for care but

also present challenges in oncology practice. The NCCN Specialty

Pharmacy Task Force met to identify and examine the impact of

specialty pharmacy practice on the care of people with cancer, and

to provide recommendations regarding issues discussed. This re-

port provides recommendations within the following categories:

education and training of specialty pharmacy practitioners who

care for individuals with cancer, coordination of care, and patient

safety. Areas for further evaluation are also identified. (JNCCN

2010;8[Suppl 4]:S1–S11)

NCCN Task Force Report: Specialty Pharmacy

Rowena N. Schwartz, PharmD, BCOP; Kirby J. Eng, RPh; Deborah A. Frieze, PharmD, BCOP; Tracy K. Gosselin, RN, MSN, AOCN; Niesha Griffith, MS, RPh, FASHP; Amy Hatfield Seung, PharmD, BCOP; Jennifer M. Hinkel, MSc; Philip E. Johnson, MS, RPh, FASHP; Shirley A. Johnson, RN, MS, MBA; Edward C. Li, PharmD, BCOP; Audrea Hotsko Szabatura, PharmD, BCOP; and Michael K. Wong, MD, PhD

The use of specialty pharmacy is expanding in oncol-ogy pharmacy practice.1 Specialty pharmacies provide one channel for distribution of drugs and biologics that, from the payor perspective, creates economies of scale and streamlines delivery of therapeutics that are ex-pensive or may require special expertise. Historically, payors or pharmaceutical manufacturers have required

the use of specialty pharmacy distribution chan-nels for medications that are costly to purchase, used in specific populations, and associated with complex management issues, including regimen adherence. In oncology, specialty pharmacies have become a distribution channel for various agents, including self-injectable supportive care agents (e.g., erythropoiesis stimulating agents, myeloid growth factors), oral anticancer agents, and, in some instances, parenteral chemotherapy or biologic agents. The proposed goals of specialty pharmacy include the optimization of pharmaceu-tical care outcomes through ensuring appropriate medication use, maximizing medication adher-ence, and optimizing economic outcomes through avoiding unwarranted drug expenditure. Patient satisfaction may be an additional goal, as the spe-cialty pharmacy practice provides the opportunity for direct interaction and delivery of information from various health care professionals. However, although the specialty pharmacy mechanisms have found favor with payors because of the po-tential economic and operational benefits, and have helped optimize patient care, specialty phar-macies also present some challenges to the deliv-ery of optimal patient care. These challenges may include issues related to coordination of care, pa-tient safety, cost/reimbursement, and operational efficiency.

Task Force Objectives and ApproachThe objectives of the NCCN Specialty Pharmacy Task Force included:

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• Describe the current mechanisms of specialty pharmacies as a distribution channel for oncol-ogy therapeutic agents and other medications used in drug therapy for individuals with cancer.

• Examine the potential benefits and risks associ-ated with the use of specialty pharmacy distribu-tion of oncology therapeutic agents.

• Describe financial implications of specialty phar-macy distribution of oncology therapeutic agents for oncology practices, cancer centers, oncolo-gists, and individuals with cancer.

• Identify potential patient safety issues associ-ated with the distribution of oral and parenteral oncology therapeutic agents through specialty pharmacy channels.

• Identify potential risks and liability issues for on-cology practices and oncologists associated with the use of specialty pharmacies as distribution channels for oncology therapeutic agents.To address these objectives, the task force initi-

ated discussions on how specialty pharmacy affects the care of the individual with cancer, formulated recommendations regarding the issues discussed, and identified issues that may require further evaluation within the changing environment of oncology care.

Defining Specialty PharmacySpecialty pharmacy is not easy to define, especially in relation to oncology practice, because it encom-passes a range of business models that can include disease management or case management features. Medication distribution methods from specialty pharmacies are not standard and may include mod-els such as mail-order distribution (the traditional model for specialty pharmacy) or distribution from a community pharmacy.

One historic feature of specialty pharmacy is the focus on diseases that are chronic and low-incidence medical conditions. The role of specialty pharma-cy has been to coordinate the clinical, fulfillment, medication, and disease management functions as-sociated with medication delivery under one organi-zation. Ideally, specialty pharmacy has the potential to reduce expenditures by facilitating appropriate use, and also to optimize patient adherence. Phar-macy service models within the “Specialty Pharma-cy” scope have been designed to fill the perceived gaps associated with pharmaceutical care provided

by the traditional health care system. However, no universally accepted definition of specialty pharma-cy exists and the terms specialty pharmacy and spe-cialty drug vary among health plans and pharmacy benefit programs. Defining specialty pharmacy is also challenging because no mandatory certifica-tion standards exist for a specialty pharmacy, and specialty pharmacy practice beyond that of standard pharmacy practice is not regulated at a federal level, although state regulations may be in place in some instances. This is an area where change is occurring. The task force did not discuss specialty pharmacy accreditation organizations such as URAC (www.urac.org) or the Accreditation Commission for Health Care (www.achc.org).

Specialty Pharmacy Business ModelsSpecialty pharmacy has a wide range of pharmacy de-livery models; it can be an independent standalone organization, integrated with a pharmacy benefit management (PBM) company. It can include func-tions of retail pharmacies or home infusion, or be combined with health insurance plans. Some major corporate players in the specialty pharmacy arena in-clude CVS Caremark, Medco, Express Scripts, Unit-edHealth (United Health Prescription Solutions), Aetna (Aetna Specialty), Walgreens (Walgreens Spe-cialty), Diplomat Pharmacy, and US Oncology (US Oncology Care Advantage). In addition to oncology therapeutics, other disease areas of focus include but are not limited to asthma, HIV/AIDS, hemophilia, hepatitis, multiple sclerosis, and rheumatoid arthritis.

Operationally, specialty pharmacies may use several different mechanisms to distribute special-ty medications. Some medications are distributed through a limited or closed distribution model, in which a manufacturer or payor works with a single specialty pharmacy or selected number of specialty pharmacy providers to control all distribution of a drug or biologic. Infusible medications may be de-livered through home infusion services or shipped directly to a provider or provider’s pharmacy for administration to a patient. Oral drugs and inject-ables for self-administration may be mail-ordered or distributed through community retail pharmacy net-works. Some institutions are successful in obtaining specialty pharmacy status from payors for their spe-cific patient population.

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Recommendations for Specialty Pharmacy Business ModelsSpecialty pharmacy distribution models should facil-itate methods of increased communication between patients and pharmacists that enhance adherence to medications, identify potential safety issues, and al-low for the timely administration in accordance with prescriber directives. Alternatives that allow face-to-face interaction between the pharmacist and patient should be explored.

Traditional Pharmacy Model Versus Specialty Pharmacy ModelIn a traditional community pharmacy model (see Figure 1), pharmacies purchase medications from a wholesaler. After a prescription is received from a licensed prescriber, the pharmacist dispenses and provides patient information about the medication. Traditionally, pharmacies receive payment directly from the patient or third-party payors through the pa-tient’s insurer. Pharmacists may monitor medication and treatment plan adherence, but this often falls to the original prescriber or health care team. Some pharmacies routinely notify prescribers when patients fail to pick up their prescriptions, and may provide longitudinal follow up of patients during the course of therapy. Importantly, neither the traditional com-munity pharmacy model nor the specialty pharmacy model routinely provides the entire therapy (i.e., all of the patients’ medications) when treating individu-

als with cancer, therefore their patient-specific treat-ment information may not be comprehensive.

In the specialty pharmacy model (see Figure 2), the pharmacy acts as one “hub” of care by interacting directly with the providers, patients, and payors on a routine basis. The specialty pharmacy may also as-sume a role in monitoring medication adherence and tracking prescription information. One challenge for practitioners working within a specialty pharmacy practice is coordinating information and education with the primary oncology care team; these issues are discussed in more detail later.

Specialty pharmacy services may include patient and caregiver education, such as instruction on self-administration of medications, information regarding adverse drug events, medication handling and admin-istration guidelines, and disease-specific information resources. The specialty pharmacy also may take a role in medication therapy management, assessing medi-cation therapy side effects and management, evaluat-ing medication efficacy, and encouraging medication adherence through prescription refill reminders. Ad-ditionally, the specialty pharmacy may coordinate in-formation with providers regarding changes in treat-ment and medication dose modifications.

Apart from these services, specialty pharmacies may monitor use through prior authorization mecha-nisms, develop customized guidelines for use of drugs in a specialty class, and undertake measurement of clinical and financial outcomes. Institutional phar-macies also provide this full scope of service.

Drug Manufacturer

Oncology Care Team

Wholesaler or Specialty

Distributor

Community Pharmacy• Clinical services (drug utilization, review, patient education, etc.)• Submit Rx claims• Dispensing functions

Drug Procurement

Monitoring for adherence, outcomes, etc.

Patient

Drug Dispensing

Prescription

Figure 1 Traditional community pharmacy medication distribution model. Abbreviations: Rx, prescription.

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Scope of Specialty Pharmacy for Patients with CancerWhen an individual with cancer obtains medica-tion through a specialty pharmacy, that pharmacy may assume a role in communicating with that pa-tient regarding the anticancer or supportive care therapies. The specialty pharmacy may also com-municate with patients regarding treatment-related toxicities or adverse events, and in some cases as-sumes a larger disease management role, also dis-cussing cancer-related complications, comorbidi-ties, and health maintenance issues. However, this communication may contribute to fragmented care. Although the specialty pharmacy practitioner may communicate with a designated member of the health care team, the team is comprised of an im-portant integral group of health care professionals. As with all communications regarding patient care issues, the information should be available to the entire team. The task force emphasized potential patient care issues that could occur if information regarding adherence to therapy, adverse events, toxicities, or side effects is not efficiently communi-cated across all relevant providers.

For patients with cancer, the model for drug dis-tribution and management of drug therapy often dif-fers depending on treatment settings and the oncol-ogy care team. Coordination of care is essential, with multidisciplinary care teams being optimal. The care

model should encompass not only management of the disease but also treatment-related toxicities, can-cer-related complications, comorbidities, and overall health maintenance. In some cases, it is important to also include the clinical research team in the overall coordination. When specialty pharmacies are used, these professionals must coordinate information with this complex health care team.

Better informatics systems are needed to facili-tate this information flow among the complex health care team, including, when applicable, specialty pharmacy. In addition, this strategy is important for increasing the real-time reconciliation of the often-evolving patient medication lists. Ideally, electronic health records would be centralized so that the same information can be retrieved by the specialty phar-macy and all members of the oncology care team. Face-to-face interactions between the patient and the pharmacist can also assist in this exchange of in-formation, and should be an available option when specialty medications are dispensed.

Specialty pharmacy has growing significance for the patient with cancer for several reasons. First, oral anticancer agents are becoming more numer-ous, with an estimated 25% of antineoplastic agents in the research pipeline planned as oral drugs. Ad-ditionally, spending on oral agents has more than doubled between 2002 and 2006.2 As a result, oral agents are becoming more common, consuming a larger fraction of cancer care spending and attracting

Dispensing functions

• Mail-order• Community pick-up

Dispensed to patient

Prescription for oral anticancer agents, self-injectible

medications, etc.

Monitoring for adherence, outcomes, etc.

Drug Procurement Drug Dispensing/Administration

Specialty Pharmacy

DrugManufacturer

Wholesaler or Specialty

Distributor

Oncology Care Team

Patient

Clinical services

• Assessment• Monitoring• Patient education• Etc.

Figure 2 Specialty pharmacy distribution model.

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the scrutiny of public policy makers, employers, and contracted health plan administrators.3 For example, in a 2005 survey to 38 Blue Cross and Blue Shield plans, 78% responded that oncology specialty drugs were a concern.4 Because many of these therapies may be distributed through specialty pharmacies, systems must be in place for communication be-tween specialty pharmacies and all members of the health care team.

Administrative requirements put in place by payors (e.g., commercial, government, employers) also have implications for the role specialty phar-macies may play in the care of patients with cancer. With increasing needs to coordinate patient infor-mation and complete prior authorization processes before a drug can be dispensed, specialty pharma-cies may share some of these responsibilities with the oncology care team. The challenge that exists when a specialty pharmacy assumes the primary re-sponsibility for administering the anticancer medi-cation is the potential for fragmentation of care between the specialty pharmacy and the oncology care team, including questions regarding the initial quantity of medication dispensed, communication of dose changes or modifications, and timeframe within which medication is delivered and the avoidance of unnecessary delays.

Education and TrainingPharmacists and other health care professionals involved in the specialty pharmacy setting are of-ten very knowledgeable about specific medications and their place in therapy, but may have a limited patient-specific knowledge base related to underlying disease, comorbidities, and general clinical manage-ment of other patient-specific issues. Furthermore, these pharmacies may not provide all drug therapy for the patient, and therefore may not be aware of interactions or impact of care on other medications. Ideally, pharmacists who are handling oncology agents in the specialty pharmacy setting should re-ceive comprehensive oncology pharmacy training or be specialty certified so that they can recognize and make recommendations regarding patient-specific clinical management issues, and effectively commu-nicate this information with the patient’s primary care team. This practice model is currently the stan-dard in some specialty pharmacies.

Recommendations for Education and TrainingSpecialty pharmacies who employ technicians or other support staff (especially staff who have direct patient contact or who may be conducting telephone follow-up) should institute standardized pathways to triage problems to ensure that patient concerns are escalated to the appropriate health care provider. These staff should also receive additional training tailored to the specialty, specialty products, or pa-tient populations with which they most frequently work. The focus for all pharmacy care should be on the patient care issues, and extend beyond product-specific issues.

Challenges in Specialty Pharmacy

Coordination of CareThe NCCN Task Force felt that coordination of care was a major area of concern in its discussions. Specialty pharmacy presents unique challenges in the coordination of care for patients with cancer. Ef-ficient and effective collaboration with a specialty pharmacy may necessitate changes in practice for the oncology care team, because patient informa-tion must be coordinated with an additional party. Requirements for prior authorization or other feed-back of clinical information from the care team to the specialty pharmacy can also add to the oncology practitioner’s workflow. The practitioner within the specialty pharmacy also has a challenge in commu-nicating information back to the patient and clini-cian in a manner that “closes the loop,” to ensure that patients are receiving the correct medications in a timely fashion and to relay critical information regarding adverse events or other patient concerns to the care team.

Recommendations for Coordination of CareIn a system in which information is often fragment-ed and care can be difficult to coordinate among diverse practice settings, specialty pharmacy can in-corporate an additional layer of complexity to the challenge of coordinating care. Solutions to these challenges include better informatics systems to fa-cilitate communication of information and medica-tion reconciliation.

Drug Distribution and DispensingWith the advent of numerous oral anticancer agents, drug distribution to patients is a growing challenge

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in the oncology-specific context for specialty phar-macy. The issues associated with dispensing anti-cancer drugs often relate to different dosing models than those associated with drugs for other “specialty” diseases, including asthma or rheumatoid arthritis. Although dispensing a large quantity (e.g., 90-day supply) of drugs for chronic illnesses such as asthma may be both efficient and appropriate, doing so with an anticancer agent may actually lead to waste, ex-pense, and safety issues. Many oral anticancer agents are both expensive and require dose adjustments or discontinuation based on patient response in a rela-tively short time. Additionally, drug therapy is of-ten modified within a relatively short time (e.g., a medication is discontinued) secondary to changes in patient status or toxicities.

Dispensing a smaller medication supply without cost penalties (e.g., 14–30 days) may lower over-all expense and decrease drug waste if a patient’s therapy is adjusted or discontinued. However, be-cause of the current reimbursement restrictions, reducing the quantity of dispensed oral medication has implications for patient copayments or coin-surance, perhaps leading to higher patient out-of-pocket costs. For example, if each refill requires a copayment, regardless of the quantity dispensed, it is often more expensive to patients to have small amounts dispensed. The task force recommended that if smaller quantities are to be dispensed, copay-ments and benefit design should be adjusted to not penalize patients for accepting a smaller quantity, especially because a smaller quantity may lead to improved safety and efficiency in the system (see Case Report).

Communication of dose changes from the care team to the specialty pharmacy can also present a lo-gistic challenge. For example, dispensing large quan-tities of a drug combined with frequent dose adjust-ments could lead to scenarios in which patients are combining or splitting tablets to reach the correct dose, which in turn creates a higher risk for error or adverse events and could lead to patient confusion. Furthermore, drug manipulation by the patient pres-ents a safety concern as other family members could be exposed to cytotoxic chemotherapy.

A challenge with the use of mail order distribu-tion models for specialty pharmacy is the impact of the timeframe necessary for medication delivery. De-lays in the initiation of therapy may occur if key in-

formation (prior authorization, patient information) is not fully communicated to the specialty pharmacy. Often the clinician’s office, and occasionally the patient, is responsible for communicating informa-tion to the specialty pharmacy before initiation of therapy. Additionally, delays may occur secondary to the availability of mail/shipping services. Although patients may expect to begin therapy immediately, this may be unrealistic when the medication must be ordered and shipped from a specialty pharmacy and when extra controls are in place to monitor appro-priate use of an agent.

One challenge in dispensing select medications through specialty pharmacy is identifying those that are appropriate for this distribution mechanism. Oral medications seem to present fewer challenges to dispensing than parenteral products that require manipulation before administration, but issues do exist, as discussed previously. Additionally, when in-jectable medications that do not require manipula-tion for preparation are provided through a specialty pharmacy, appropriate patient education regarding

Case Scenario: Hypothetical Cases of Waste and Safety Concerns by Dispensing Higher Initial Quantities

Example 1: Drug WasteA patient recently diagnosed with metastatic non-small cell lung cancer is to start treatment with erlotinib, 150 mg, by mouth daily. Ten days after initiation of treatment, the patient develops complications thought to be secondary to cancer progression and the decision is made to discon-tinue therapy. If the initial amount dispensed was a 30-day supply, 20 tablets will be wasted.

Example 2: SafetyA patient is prescribed capecitabine, 500 mg, tab-lets, 3 tablets by mouth twice daily on days 1 to 14 (of a 21-day cycle) for the treatment of colon can-cer. The initial quantity dispensed was 168 tab-lets, representing 28 days of medication consump-tion. Because the quantity dispensed represents 2 active treatment cycles (separated by 1 week off of the medication), the patient could potentially continuously take the capecitabine during the off week. This represents a safety concern because se-rious toxicities are likely to occur in this scenario.

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administration and handling of medication is impor-tant. If a self-injectable medication is sent directly to a patient, the specialty pharmacy or benefit pro-vider should have the responsibility for appropriately educating the patient regarding self-administration techniques.

The task force recommends that medications requiring sterile compounding before infusion, or those that a patient cannot self-administer, not be distributed through specialty pharmacy, whether the product is sent directly to the patient or directly to a hospital, clinic, or physician’s office. Sending phar-maceuticals that require infusion directly to a pa-tient (“brown bagging”) creates obvious risk to the medication in terms of storage and handling. Phar-macists cannot evaluate the integrity of the product or the chain of custody, nor can they verify storage and handling conditions from manufacturers. Pa-tients may not be equipped or educated to store or handle the drug properly after receiving it from the specialty pharmacy. Brown bagging could therefore lead to administration of a potentially adulterated or misbranded drug product.

Additionally, distribution in this manner may skirt state-specific pedigree laws that mandate veri-fication of the supply chain of pharmaceutical prod-ucts from manufacturer to administration. Lastly, this scenario creates an uncomfortable situation for providers who are asked to administer a medication, the integrity of which they are unable to verify, and therefore may raise liability concerns for the phar-macist or institution.

Dispensing medications that require infusion al-ready prepared for a specific patient directly to a hos-pital, clinic, or physician’s office (“white bagging”) does not necessarily eliminate the concerns of brown bagging and creates additional logistic and efficiency issues. Sending prepared drugs in this manner does not allow for flexibility of dose or schedule changes, including dose modifications or discontinuation of therapy based on patient-specific data (e.g., chang-ing laboratory values). As a result, white bagging may contribute to waste of the prepared drug and financial loss for the provider.

Moreover, the structure of oncology reimburse-ment does not compensate for preparation of prod-ucts directly before administration, storage of infu-sion products, cognitive services involved in the dispensing and checking of high-risk medications, or

similar pharmacy services, whether the medication comes from the pharmacy’s inventory or is shipped from a specialty pharmacy. Therefore, white bag-ging can have a detrimental financial consequence for oncology practices that must still manage, han-dle, dispense, and administer these agents without the ability to claim reimbursement. Again, white bagging may skirt pedigree laws because the supply chain cannot be verified, and may be considered re-dispensing of already dispensed product and there-fore illegal in some circumstances.

Finally, drugs received for a specific patient can-not be re-dispensed to another patient. For example, if patient A has a drug discontinued, it cannot be provided to patient B and must be wasted. However, if the medication were procured through the stan-dard supply chain, this scenario would not exist and the medication would not have to be wasted.

Distribution models for specialty pharmacy should be developed to minimize delay in initiating therapy, and an appropriate estimate of drug delivery should be given to both the provider and patient. Although patients might expect immediate treat-ment, starting a drug immediately may not be nec-essary, but these expectations should be consistent among the entire health care team. Both providers and specialty pharmacies should educate patients to have reasonable expectations about when medica-tions will be delivered from a specialty pharmacy.

Only agents that can be safely and appropriately self-administered should be dispensed through the spe-cialty pharmacy model. Therefore, select oral agents and self-injectables (after the patient is sufficiently educated and competent in the self-administration technique) may be appropriate for this channel. Infu-sion agents and injectables that cannot be self-admin-istered are not appropriate for this channel of distribu-tion, and should not be sent directly to the patient or directly to an infusion center for administration.Recommendations for Drug Distribution and Dispensing: Specialty pharmacies should dispense a small quantity of drug on the first fill without penal-ties to the patient. Copayment/benefit design should be adjusted so that patients are not penalized for more frequent refills because of smaller quantities dispensed. Implementation of this recommendation requires engagement with payors and other provid-ers (e.g., physicians and other prescribers, traditional community pharmacy).

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Cost of CareAlthough a specialty pharmacy model may low-er drug costs for the third-party payor (insurer), it may not necessarily lower overall health care costs for patients. Additionally, the extra administrative responsibility of communicating with the specialty pharmacy may add cost to the oncology practice. For patients, because specialty pharmacy most often focuses on oral agents, an increase in cost from co-insurance and copayments may occur. Although in-dividual clinicians or hospital-based pharmacies may have means of mitigating patients’ out-of-pocket costs or waiving copayments in some circumstanc-es, specialty pharmacies are unlikely to have these mechanisms. However, specialty pharmacies may be better equipped to direct patients and clinicians to patient assistance programs because of their relation-ships with manufacturers and external providers of these services.

Overall, although many aspects of specialty pharmacy have the potential to reduce system costs by adding efficiency and creating economies of scale, some aspects have the potential to increase costs or lead to waste, depending on how the model is ex-ecuted. Moreover, specialty pharmacies may have little to no influence over a patient’s out-of-pocket costs if these are determined by policies instituted by third-party payors as part of the patient’s medical or pharmacy benefit.

Although the task force discussed cost of care in the context of specialty pharmacy, it also recognized that the overall cost of oncology care is a sufficiently large issue that fell outside the scope of this targeted initial discussion. The task force provided no specific recommendation other than that this topic should be addressed at a future date.

Medication Safety and Specialty Pharmacy

Potential Safety AdvantagesThe appropriate and effective use of specialty phar-macy has the potential advantage of improving care for people with cancer. A pharmacist or nurse work-ing for a specialty pharmacy or institutional practice may have greater familiarity with oncology products than a generalist community pharmacist. Also, by the nature of their size and number of patients with-in their catchments, specialty pharmacies have ac-cess to data and information that could more quickly

identify safety issues. If specialty pharmacies were to leverage these data for tracking events and for out-comes research, patient safety could be significantly improved. Specialty pharmacies have established strategies to monitor medication adherence, includ-ing routine follow-up telephone calls.

However, the distance to a specialty pharmacy can be a disadvantage compared with local hospi-tals or community pharmacies. Adverse events or side effects that could be quickly recognized by an in-person evaluation of the patient may be missed or downplayed in a telephone conversation with the patient, and the opportunity to report the adverse event to a national incident reporting database may be lost. Under the current paradigm, specialty phar-macy can improve patient safety when the staff has a deep knowledge and understanding of specialty products and the conditions they treat.

Recommendations for Medication SafetyAll pharmacies, including specialty pharmacies, should participate in a national incident reporting database to include medication errors and adverse events, and “near miss” errors/events. Because spe-cialty pharmacies participate in a niche market that aggregates several patients with similar diagnoses across large geographic areas, data collected by spe-cialty pharmacies could be a leading indicator of po-tential safety issues. In other words, specialty phar-macies may be able to identify trends or problems with more robustness compared with the community or institutional practices.

Potential Safety ChallengesThe largest challenges to patient safety–related to specialty pharmacy are in communication/coordina-tion of care, access to medical information, product integrity, product manipulation, and disposal of haz-ardous waste.

Safety Implications: Communication and Coordination of CareIf a specialty pharmacy acts as a silo outside of the care team and information does not flow in both directions, errors may occur if a dose modification is not communicated to the pharmacy or an event that is communicated in a telephone conversation with the pharmacy is not shared with the clinician. Adding another layer to the mix of care coordina-

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tion can be challenging for practices and hospitals already burdened with administrative overhead and communication with third parties. Likewise, spe-cialty pharmacies may not have full access to other medical information (e.g., complete medication list, concurrent disease states, comorbidities) needed to perform comprehensive medication reconciliation to assess for interactions and adverse events.

Product IntegrityProduct integrity becomes a safety issue for products that require special handling, especially for products that are not for self-administration and need to be delivered di-rectly to a patient. Lack of temperature control during shipping is one example of how a product’s integrity may be compromised by a mail-order model.

A larger safety concern, however, occurs in the practice of “brown bagging,” which involves a prod-uct being shipped to a patient, who then brings the product to a health care provider for administration. The provider may not be able to verify that the prod-uct has been handled properly, or even mixed cor-rectly if, for example, it is an infusion drug. There-fore, inability to track a product’s pedigree from the manufacturer to the point of administration is a potential safety concern with specialty pharmacy, especially for non–self-administered agents. It is also important to note that pedigree laws are primarily designed to ensure that counterfeit drugs, which are a particular problem with oncology-related products, do not enter the national drug distribution system.

Hazardous Waste DisposalPrescription drug disposal is rapidly becoming an industry-wide problem, for which recommendations on appropriate disposal methods clearly must be de-veloped. Furthermore, patients require education on proper disposal of pharmaceutical waste, especially when it is labeled hazardous. Recently, the Environ-mental Protection Agency (EPA) proposed adding “hazardous pharmaceutical waste” to the Universal Waste Rule to allow for a more streamlined system to manage this waste.5 The proposal would facilitate pharmaceutical take-back programs from households (by breaking down regulatory barriers) so that health care and other facilities can collect the waste from households and dispose of it properly.

Disposal of hazardous pharmaceutical waste is of major concern to hospitals, physician offices, and any practice that generates this waste when prepar-ing or administering chemotherapy. In its guidelines for handling hazardous drugs, the American Society of Health System Pharmacists provides background information on what constitutes hazardous waste and guidance for proper disposal.6 Although these guidelines focus on disposal of hazardous waste within an institution, patient disposal of these mate-rials is also a concern.

Although the concerns about patient disposal of hazardous waste (e.g., oral agents) are not neces-sarily different with specialty pharmacy than they would be with a traditional community pharmacy model, the payor mandate for specialty pharmacy to dispense larger amounts of drug covering 60 to 90 days of treatment creates the potential for more waste (see previous discussion regarding dispensing quantities) and therefore more concerns regarding its proper disposal.

Specialty Pharmacy Implications for Clinical ResearchOpportunities are available for specialty pharmacy to collaborate with clinical research efforts, but con-cerns also exist about patients enrolled in clinical studies using a specialty pharmacy. Timely access to drugs, coordination of dose modifications, report-ing of adverse events, and coordination of patient information are challenges for patients on research protocols, and these challenges might be potentiated if a specialty pharmacy is involved (especially if the drug must be procured through a restricted distribu-tion channel). Another concern is that drugs man-dated to have a restricted distribution system (e.g., through a specialty pharmacy) may not be studied in a clinical trial in which multiple oncology drugs are used in combination, because it would be impossible for a single provider to provide and coordinate the entire therapy.

However, specialty pharmacy can contribute to the clinical research process by facilitating the ag-gregation of data, especially for patients with rare or low-incidence tumor types, and may be able to as-sist in better delivery and distribution of drugs when patients are disseminated across a wide geographic area. Through telephone follow-up and disease man-

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agement capabilities, specialty pharmacies may also have the opportunity to collect additional data from patients and better facilitate exchange of informa-tion as part of clinical research.

Summary of Task Force RecommendationsThe NCCN Task Force identified recommendations within the following broad categories:• Modification of specialty pharmacy processes to

better support care of oncology patients• Training and education of specialty pharmacy

practitioners who care for patients with cancer• Coordination of care• Coordination of information• Regulations for specialty pharmacy practice

Recommendations for Modification of Specialty Pharmacy Processes to Better Support Care of Oncology Patients• Specialty pharmacy should allow patients the

option of obtaining their medications at a com-munity pharmacy outlet or receiving them through mail order.

Recommendations for Training and Education of Specialty Pharmacy Practitioners Who Care for Patients With Cancer• Specialty pharmacy personnel should possess

specific expertise in oncology.• Pharmacists should be knowledgeable about

cancer-related disease processes, with oncology board certification encouraged and supported for the long term.

• Pharmacy technicians and other support staff should be trained in appropriate safety and dis-pensing requirements.

• Pharmacy technicians and other support staff should be trained in appropriate triage and el-evation of issues.

Recommendations for Specialty Pharmacy to Ensure Optimal Coordination of Care for Patients and Their Families• Standardize methods to communicate with the

oncology health care team.• Implement rapid communication strategies to

assure ability to dose modify.• Adopt common language to expedite

communication.• Incorporate a comprehensive approach; include

members of the health care team involved in drug therapy decision-making.

• Develop strategies to assure that the coordina-tion of care for individuals receiving care in multiple treatment settings (e.g., hospital, out-patient clinics, home) is executed seamlessly.

Recommendations for Coordination of Information Between the Health Care Team and Specialty Pharmacies• Develop and use health information technol-

ogy systems to foster collaboration of care (i.e., EHRs).

• Integrate case management and insurance coverage.• Include clinical information and outcomes with-

in EHR databases.• Develop national standards based on identified

shared data needs.

Recommendations for Regulation of Specialty Pharmacy Practice• Develop and implement regulations for the dis-

pensing and handling of oral chemotherapy. ! Individualize education for patients and

caregivers. ! Develop guidelines for proper disposal of

hazardous drugs that are dispensed directly to the community.• Develop standards and requirements for care

coordination and medication safety (and enact into legislation).

! Develop strategies to report adverse events. ! Develop an incident reporting system for ad-

verse events or safety issues similar to those used in health care systems.

• Eliminate the use of “brown bagging” for inject-able chemotherapy, anticancer agents, and sup-portive care or other medications that are not able to be self-administered.

ConclusionsA vibrant specialty pharmacy industry exists that provider valuable services to patients with can-cer, and its impact in oncology practice will ex-pand. An opportunity currently exists for health care providers to engage and collaborate with the specialty pharmacy industry to address the current barriers to care in oncology practice. Training/education of specialty pharmacy practitioners and

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improving the communication of clinical informa-tion to foster collaboration should be priority top-ics. The patient must be the collaborative focus of all providers, and patients must fully understand how to navigate and work within a complex multi-provider system. Breaking down these barriers will benefit both specialty pharmacy and individuals with cancer through the improvement of patient care. Next steps include developing and evaluat-ing best practices within specialty pharmacy, and its interaction with the oncology care team. Al-though the economics of drug costs and specialty pharmacy were too broad for this initial NCCN Task Force to address, this issue should also be ad-dressed in the future.

References 1. Holcombe DG. Is oncology compatible with specialty pharmacy?

Commun Oncol 2005;2:173–181. 2. Weingart SN, Brown E, Bach, PB. NCCN Task Force Report: oral

chemotherapy. J Natl Compr Canc Netw 2008;6(Suppl ):S1–14 3. Lipsy RJ, Fuller MG, Roski J, et al. Anticipating the future: how

the emergence of innovative biologic agents impacts benefit design, utilization, and provider relations. J Manag Care Pharm 2004;10(Suppl S-a):S4–9

4. Mullins CD, Lavallee DC, Pradel FG, et al. Health plans’ strategies for managing outpatient specialty pharmaceuticals. Health Affairs 2006;25:1332–1339

5. Environmental Protection Agency. Amendment to the Universal Waste Rule: Addition of Pharmaceuticals. Washington, DC: Environmental Protection Agency. Fed Regist 2008;73:73520–73544.

6. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm 2006;63:1172–1193.

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Table 1 Individual Disclosures for the NCCN Task Force Report: Specialty Pharmacy

Panel MemberClinical Research Support

Advisory Boards, Speakers Bureau, Expert Witness, or Consultant

Patent, Equity, or Royalty Other

Date Completed

Rowena N. Schwarz, PharmD, BCOP

None None None None 6/15/10

Kirby J. Eng, RPh None None None None 11/23/09

Deborah A. Frieze, PharmD, BCOP


Tracy K. Gosselin, RN, MSN, AOCN


Niesha Griffith, MS, RPh, FASHP


Amy Hatfield Seung, PharmD, BCOP


Philip E. Johnson, MS, RPh, FASHP


Shirley A. Johnson, RN, MS, MBA


Edward C. Li, PharmD, BCOP


Audrea Hotsko Szabatura, PharmD, BCOP


Michael K. Wong, MD, PhD

None Argos Therapeutics, Inc.; Bristol-Myers Squibb Company; Bayer HealthCare; Onyx Pharmaceuticals, Inc.; BioVex Inc.; Genentech, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; and Pfizer Inc.

None None 6/17/10


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1. In the oncology setting, specialty pharmacies have become a distribution channel focusing on self-injectables and oral agents, and to a lesser extent parenteral chemotherapy.a. Trueb. False

2. Which of the following statements best describes the Task Force’s recommendation for specialty pharmacy business models?a. They should not include functions of a

traditional community retail pharmacy.b. They should integrate the functions of a

pharmacy benefits management (PBM) company.

c. They should facilitate communication, especially face-to-face interaction, between the patient and pharmacist.

d. They should use closed distribution models more often to control all distribution of a drug or biologic agent.

3. Which of the following is/are services that specialty pharmacies might provide?a. Education regarding the self-administration of

medicationsb. Medication therapy managementc. Encouragement of medication adherenced. Specialty pharmacies might provide all of the

above services.

4. According to the Task Force, what can facilitate the information flow between multiple providers, including specialty pharmacy?a. Administrative requirements mandated by

payersb. Centralized electronic health recordsc. Increased federal regulations for specialty

pharmacyd. Having specialty pharmacy assume the primary

responsibility for the anticancer medications

5. By adding efficiency and creating economies of scale, the use of specialty pharmacy may lower drug costs for which of the below?a. Patients’ out-of-pocket costsb. Physician practices c. Institutionsd. Third-party payers

6. The practice of “white bagging” can contribute to some financial loss for a provider.a. Trueb. False

7. According to the Task Force, which of the following is NOT a challenge to patient safety as related to specialty pharmacy practice?a. Communication and coordination of careb. Product integrity c. Hazardous waste disposald. All of the above are challenges.

8. In the oncology setting, which is a contributing factor that causes problems with dispensing large quantities of anticancer medications?a. Anti-cancer drugs often do not follow different

models of dosing than for other “specialty” diseases including asthma or rheumatoid arthritis.

b. A patient’s status often changes quickly, leading to dose adjustments or discontinuation based on the patient’s response in a relatively short period of time.

c. The drugs are often expensive, and patient co-payments are expected to increase with higher quantities.

d. It is optimal to begin treatment immediately, but large quantities cause a delay in treatment because they use mail order distribution.

9. According to the Task Force recommendations, specialty pharmacy can help to improve medication safety by:a. Developing strategies to educate patients in-

person instead of over the telephone.b. Allowing for patients to bring a drug dispensed

to them by a specialty pharmacy to the physician’s office for administration.

c. Identifying trends or problems through adverse events data collected.

d. Establishing strategies to monitor medication adherence.

10. Which type of distribution mechanism(s) may be illegal in some states, citing state-specific pedigree laws?a. “Brown bagging”b. “White bagging”c. Both “brown bagging” and “white bagging”d. Neither “brown bagging” nor “white bagging”

Post-test Please circle the correct answer on the enclosed answer sheet.


S-14

The activity content helped me to achieve the following objectives:

(1 = Strongly disagree; 3 = Not sure; 5 = Strongly agree)

Discuss the current mechanisms of specialty pharmacies as a distribution channel for oncology therapeutic agents

and other medications used in the drug therapy of the individual with cancer.

1 2 3 4 5

Examine the potential benefits and risks associated with the use of specialty pharmacy distribution of oncology thera-

peutic agents.

1 2 3 4 5

Describe financial implications of specialty pharmacy distribution of oncology therapeutic agents for oncology prac-

tices, cancer centers, oncologists and individuals with cancer.

1 2 3 4 5Identify potential patient safety issues associated with the distribution of oral and parenteral oncology therapeutic agents

through specialty pharmacy channels.

1 2 3 4 5

Identify potential risks and liability concerns for oncology practices and oncologists that may result from the use of

specialty pharmacies as distributions channels for oncology therapeutic agents.

1 2 3 4 5

Please indicate the extent to which you agree or disagree with the following statements:

You were satisfied with the overall quality of this activity.

Strongly agree Agree Undecided Disagree Strongly disagree

This activity addressed issues that will help you improve your professional competence and/or performance.


You will make a change in your practice as a result of participation in this activity.


The activity presented scientifically rigorous, unbiased, and balanced information.


This supplement was free of commercial bias.


Post-Test Answer SheetPlease circle one answer per question. A score of at least 70% on the post-test is required.

1. a b 6. a b

2. a b c d 7. a b c d

3. a b c d 8. a b c d

4. a b c d 9. a b c d

5. a b c d 10. a b c d

Please circle the correct answer below.


S-15

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I certify that I have participated in this activity as designed.

Signature Date

NCCN Task Force Report: Specialty Pharmacy

Release Date: July 27, 2010Expiration Date: July 27, 2011

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