Z O T H
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`E D I T I O N
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`n n
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`n
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`n
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`ALFON50 R GENNARO
`C hairman of the Editorial Board
`and Editor
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`Page 1
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`SHIRE EX. 2063
`KVK v. SHIRE
`IPR2018-00290
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`

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`Editor: Daniel Limmer
`Managing Editor: Matthew J. Hauber
`Marketing Manager: Anne Smith
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`Page 2
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`30
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`CHAPTER 4
`
`the magnitude of the drug-related morbidity and mortality
`problem and affirming the need for improvement in medication
`management. Disease prevention and patient education as
`ways to reduce overall medical and prescription costs.
`Community pharmacists are in a position to fulfill this so-
`cietal need and provide pharmaceuticals and pharmaceutical
`services with the intention of improving patient health out-
`comes. They have the education and ability to manage drug
`therapy and provide prevention and education services to pa-
`tients. Moreover, pharmacists are the most accessible and
`trusted health-care professional. The 1995 Report of the Pew
`Health Professions Commission supports pharmacists fulfilling
`these alternate roles and recommends that pharmacists, in
`particulaz, engage in activities related to comprehensive drug
`therapy management, such as selecting appropriate drug ther-
`apies, educating and monitoring patients, and continually as-
`sessing therapy outcomes.lz
`
`PHARMACEUTICAL CARE
`In response to our societal need for medication management,
`community pharmacists are ben nning to assume the addi-
`tional responsibility of increasing the effectiveness of drug
`therapy through the provision of pharmaceutical care. They aze
`shifting from a dispensing focus, which emphasizes the drug
`product, to apatient-oriented focus, which emphasizes proper
`use of drug therapy for the patient. Although pharmacists have
`always provided patient care, the caze was not systematic and
`consistent, it was not documented, and it was reactive.13 Alter-
`natively, pharmaceutical care necessitates a proactive health-
`care provider who assumes interactive and participatory re-
`sponsibilitieswith the intention of improving outcomes. This is
`reflected in the definition of pharmaceutical care by Hepler and
`Strand.'
`"Pharmaceutical care is the responsible provision of drug ther-
`apy and other patient care services for the purpose of achieving
`outcomes related to the prevention or cure of a disease, the
`elimination or reduction of a patient's symptoms or the preven-
`tion, arrest or slowing of a disease process. It involves the
`process through which pharmacists in cooperation with the
`patient and other health-care professionals design, implement,
`and monitor a therapeutic plan that will produce specific ther-
`apeutic outcomes for the patient and improve the patient's
`quality of life."
`Embracing this new practice philosophy is one issue; actually
`implementing it in community pharmacy is another. Fortu-
`nately, innovative leaders in the profession have been develop-
`ingnew practice styles, modifying their work environment, and
`providing patient-centered care in an effort to change the prac-
`tice paradigm.
`Aa role models and practice models emerge, community
`pharmacists are slowly providing pharmaceutical care services.
`Many of these services can be categorized as therapeutic inter-
`ventions, health screenings, prevention and wellness services,
`and disease management activities. The findings of the 1998
`National Community Pharmacists Association (NCPA) Searle
`Survey of independent pharmacists, as shown below, provide
`some evidence that community pharmacists are engaging in
`pharmaceutical care activities.14
`74% offered nutrition services.
`56% offered blood pressure monitoring.
`48% offered diabetes training.
`42% offered health screenings.
`36% offered asthma training.
`30% conducted patient education programs.
`143'0 offered immunizations.
`6%a offered AIDS specialty services.
`5% offered anticoagulation services.
`
`Furthermore, contemporary community pharmacy practi-
`tioners are discovering that providing comprehensive patient
`care is more satisfying than only dispensing medications. Thus,
`while the prescription and nonprescription drug products are
`still the preeminent domain of community pharmacy, the
`patient-centered approach is diffusing throughout community
`practice settings and advancing the profession.
`
`Changes to Support Pharmaceutical Care
`
`Implementing pharmaceutical care has been a challenge for
`community pharmacists. There have been regulatory, techno-
`logical, educational, and reimbursement issues that have
`hindered the rapid adoption and diffusion of this new
`paradigm.4.15.1s Moreover, the public generally recognized com-
`munity pharmacists as business people and less as health-care
`professionals. Despite these difficulties, pharmacists in com-
`munity settings are overcoming these limitations and are
`implementing pharmaceutical-care activities. Pharmacy or-
`ganizations, educators, regulators, and practitioners have con-
`centrated their efforts and advocated changes to help advance
`community pharmacy.
`
`REGULATORY CHANGES
`Most state boards are in the process of or have completed full
`revisions of their pharmacy practice acts to expand the role of
`pharmacists.17 These changes have given pharmacists the op-
`portunity to engage in innovative practices and to promote
`patient health. Of specific importance are the regulatory
`changes that allow for Collaborative Practice Agreements be-
`tween pharmacists and physicians. Many pharmacists who
`provide pharmaceutical-care services view such an agreement
`as the nest logical step to the expansion of their professional
`role. Collaborative practice agreements between pharmacists
`and physicians enable pharmacists to initiate, monitor, and
`manage a patient's drug therapy, usually within the parame-
`ters of an. agreed upon treatment protocol. The agreements
`permit them to authorize prescription renewals, change dos-
`ages, administer immunizations and initiate certain types of
`drug therapy without waiting for physician approval. Accord-
`ing to the National Association of Boards of Pharmacy (March
`1999), at least 24 states have approved collaborative practice
`arrangements that grant varying degrees of authority to phar-
`macists.18 Furthermore, pharmacists are collaborating with
`physicians informally in states where no such legislation
`exists.
`As a result of these formal and informal arrangements,
`pharmacists are increasingly working with physicians to en-
`hance their roles as providers of health care. Collaborative
`practice agreements allow pharmacists to extend the provision
`of pharmaceutical care to the actual management of various
`therapies for patients.
`
`TECHNOLOGICAL CHANGES
`Software and technology to support the provision of pharma-
`ceutical care are now in the marketplace.l°,ls First, profes-
`sional pharmacy organizations and pharmacy leaders have
`worked with computer vendors to give pharmacists the soft-
`ware they need to provide pharmaceutical care. One example is
`a pharmaceutical-care package called Guardian Plus marketed
`by CareP.oint (Chazleston, SC). It is a Windows-based system
`that supports pharmacist intervention documentation and dis-
`ease management initiatives. It is now integrated into the
`dispensing software to allow expanded focus on patient care
`using a single set of patient data. Pharmacists are using these
`type software packages to support their pharmaceutical-care
`activities.
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`Page 3
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