AACP REPORTS

Report of the 2008-2009 Standing Committee on Advocacy

James P. Kehrer,a,* Gayle A. Brazeau,b Nancy DeGuire,c Anna Legreid Dopp,d Kathy B. Orrico,e

Heidi C. Marchand,f,** and William G. Langg

aCollege of Pharmacy, Washington State UniversitybSchool of Pharmacy and Pharmaceutical Sciences, University of BuffalocThomas J. Long School of Pharmacy and Health SciencesdSchool of Pharmacy, University of Wisconsin-MadisoneSchool of Pharmacy, University of California, San FranciscofOffice of Special Health Projects, U.S. Food and Drug AdministrationgAmerican Association of Colleges of Pharmacy*Chair**Liaison member

INTRODUCTIONAccording to the Bylaws of the AACP, the Advocacy

Committee:‘‘will advise the Board of Directors on the formation ofpositions on matters of public policy and on strategiesto advance those positions to the public and privatesectors on behalf of academic pharmacy.’’report on how communities and individual patients cancapitalize on the collaboration between the FDA andacademic pharmacy to improve medication use safetythroughout the drug life cycle.

COMMITTEE CHARGEPresident-elect Vic Yanchick charged the 2009-2010

Advocacy Committee to:The committee conducted its business entirely

through conference calls and e-mail. Each member ofthe group was asked to select one of the four strategic goalsof the U.S. Food and Drug Administration (FDA) as theirprimary report submission effort. The committee agreedto a format for reviewing the academy’s ability to supportand enhance the FDA strategic goals that included:

1. an assessment of evidence that the academy isactively engaged in areas relevant to the goal;

2. determining that, if the academy is not directlyengaged in areas relevant to the goal, should itbe?; and

3. a review of the literature, including AmericanAssociation of Colleges of Pharmacy (AACP)educational policy and recommendations, andsuggestions of AACP standing committees, toassist in the determination that if the academyshould be involved in areas relevant to thegoal, what should that engagement be or howshould it be presented to the academy to createengagement?

BACKGROUNDThe role of the pharmacist in public health continues

to evolve. This evolution is establishing the pharmacist,especially the community-based pharmacist, as essentialto the identification of potential public health threatsthrough his or her competency to determine patient trendsand effectively communicate those trends to public healthagencies. Pharmacists in ambulatory and inpatient set-tings are effective public health advocates as they workwith general and disease-specific patient populations.The ability to effectively communicate population healthinformation is supported by both professional and educa-tional documents outlining the role of the pharmacist inpublic health.1-4

The pharmacist is distinguished from other healthprofessionals by this educational and professional com-mitment towards medication effectiveness and safety, in-cluding all aspects of medication literacy associated withappropriate use. This focus on the public health impact ofmedication use creates substantial opportunity for part-nering the pharmacist’s public health competencies withthe missions of federal public health agencies.

During the development of legislation that created theFDA Amendments Act (FDAAA) of 2007, AACP ac-tively engaged in the education of members of Congress,their staff and the FDA. This education focused on theopportunity for the public health mission of the FDA to bestrengthened in partnership with academic pharmacy.The AACP issue paper developed to address the FDAlegislation included the following:

‘‘Academic pharmacy faculty are exceptionally po-sitioned to help the FDA ‘‘keep pace with the rapidevolution of science, technology and the health caresystem. . .’’Part of the medication safety equation is theappropriate oversight of manufacturers, prescribers, and

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patients by the Food and Drug Administration (FDA).There is ample empirical and anecdotal evidence thatthe FDA is currently at a disadvantage in its ability toprovide sufficient oversight. Clinical trials are fraughtwith problems, scientific integrity of clinical trials is oftenchallenged, and little or no post-marketing evaluation ofdrugs occurs – all of which increase the risks for drugmisadventures.’’

As a result the FDAAA includes several provisionsthat direct the FDA to seek the input of ‘‘academic in-stitutions.’’ This report is an opportunity to determinecurrent and future roles of the academy and our graduatesin ensuring the FDA is competent and efficient in meetingits public health mission.

The FDA’s current strategic action plan focuses onfour strategic goals:

1. strengthening the FDA,2. improving patient and consumer safety,3. increasing access to new medical and food

products,4. improving the safety and quality of manufac-

tured products and the supply chain.FDA leadership has undertaken specific measures to

address each of these strategic goals. AACP is uniquelypositioned to impact and directly influence pharmacycolleges’ view and integration of these key topics withintheir organization’s work plans. For each FDA goal, thecurrent report summarizes the evidence that that academyis or is not actively engaged in areas relevant to the goal.In areas where engagement is not currently evident, rec-ommendations are made as to whether the academyshould be involved. Where it is concluded that the acad-emy should be engaged in areas relevant to the goal, rec-ommendations are made regarding future steps of theacademy.

Overall, the committee believes that the academyis engaged to varying degrees in many activities relevantto each of the FDA’s strategic goals. However, the com-mittee also believes that the academy must becomeincreasingly and more visibly engaged in theseactivities. We agree that the academy should promotewhat we have to offer and what opportunities are availablefor our members to contribute to improving access andsafety.

RECOMMENDATION 1AACP should provide resources that direct

faculty members and students to opportunities with theFDA and elsewhere that advance the goals discussedin the report of the 2008-2009 Standing Committee onAdvocacy.

RECOMMENDATION 2It is recommended that AACP provide information to

outside entities regarding the education and service activ-ities the academy can provide in patient and consumersafety.

Goal 1: Strengthen FDA for Today and Tomorrowd Developing world-leading scientific experts ca-

pable of discovering and applying innovativetechnologies and therapeutic products

Evidence that the academy is actively engaged inareas relevant to this goal. Schools and colleges ofpharmacy have, and continue to play an important rolein educating future world-leading scientific experts whowill be involved with the discovery and application ofinnovative technologies and therapeutic products throughinteractions and involvement with the FDA. The questionfacing the academy is: what is the optimal post-PharmDeducation and training needed to be successful clinicaland pharmaceutical scientists to address these future chal-lenges? There has been controversy over what advancedtraining these individuals should attain to assume posi-tions in the FDA and other research venues. The contro-versy remains whether post-doctoral fellowships versusgraduate degrees (e.g., masters and doctoral) can providethe necessary foundations and research experiencesneeded to develop world-leading scientific experts.5,6

The AACP Educating Clinical Scientists Task Forcerecommended a need for a new pharmacist clinical scien-tist program that could be developed and available atselected pharmacy colleges/schools associated with aca-demic health centers.7 It would be essential for theseprograms to be interdisciplinary, to incorporate clinicalexperience elements, and to involve pharmaceutical andclinical scientist mentors.

Perhaps the issue to be addressed is not necessarilythe nature of the post-PharmD educational experiences,but rather what types of scientific expertise are needed forworld-leading scientific experts to shape the future ofdrug development, regulatory science, the drug approvalprocess, and drug or medical product safety. There willalways be the need for individuals with expertise in spe-cific clinical areas such as product formulation, drugdelivery, medicinal chemistry and pharmacokinetics/pharmacodynamics to evaluate key elements in the drugapproval process. However, the academy must developthe next generation of scientists that can address the dif-ficult issues associated with the complexities faced in thedrug approval process. These include expediting transla-tional research opportunities, utilizing pharmacogenom-ics/pharmacogenetics to optimize drug therapy forspecific patient groups, the use of pharmacometrics to

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optimize the clinical trial process, the development ofnovel delivery systems for small molecules, peptidesand genes, while at the same time seeking to improvethe cost-effectiveness and safety of drug therapy in ourhealth care system.

Colleges/schools of pharmacy, and other entities,have developed innovative programs to educate the nextgeneration of experts for the pharmaceutical and clinicalpharmaceutical sciences.5-19 These include fellowshipprograms, certificate programs, specific masters pro-grams and PhD level clinical pharmaceutical scientistprograms. The importance of enhancing programs in thearea of clinical pharmacology and quantitative clinicalpharmacology, specifically pharmacometrics, has beenproposed by Cohen20 and Holford and Karlsson.21 Yet,these programs, like other graduate programs in our col-leges/schools, remain challenged to attract our PharmDstudents. The reasons underlying these challenges inattracting our professional students to post-doctoral studiesand fellowship opportunities have been discussed in pre-vious reports and publications and will not be the focus ofthe current discussion.

If the academy is not directly engaged in areasrelevant to this goal, should it be? Our colleges/schoolsmust be engaged in educating the next generation of sci-entific experts to the extent that resources and programsare available at each institution. Not all colleges/schoolsof pharmacy will have the ability to develop programsfocusing on a part or all or the above areas. An opportunitythat has not been significantly exploited in our programsis the collaboration of our colleges/schools of pharmacywith engineering, computer science and other technologyprograms to address the many issues we may face withincreasing technological advances for the delivery andadministration of therapeutic agents, and informationmanagement. Given the expertise existing in our col-leges/schools, we are in an optimal position to strengthenour involvement through the Critical Pathway Initia-tive22-23 and the Sentinel Initiative24 by refocusing andincorporating additional specific elements into our post-PharmD educational programs.

If the academy should be engaged in areas rele-vant to this goal, what should that engagement be orhow should it be presented to the academy to createengagement? The missing link needed to enhance theeducation of the next generation of experts involves ad-ditional or novel collaborations between our colleges/schools with the FDA. This could involve exchange pro-grams for our professional students, graduate students,post-doctoral fellows and faculty to have short term re-search experiences, summer internships, advanced phar-macy practice experiences, research collaborations and

faculty sabbaticals located at the FDA. Alternatively,the opportunity for individuals from the FDA to interactwith our professional students, graduate students, post-doctoral fellows and faculty members could be achievedthrough visiting scientist programs and short-term sabbat-icals that would enhance knowledge and skill sets of FDAscientists. The development of collaborative short sum-mer workshops, similar to that initiated by the NationalInstitutes of Health to advance whole animal system phar-macology studies, to enhance knowledge and researchcapacities in specific areas (e.g., product safety, informa-tion systems) provides another means to developing futurescientists and to enhance the skills of existing scientists.

Distance learning platforms could be used to providethe means for our students and fellows to learn about thechallenges and opportunities available at the FDA. Theseeducational programs could involve podcasts, webinarsand short courses ranging from several hours, to weeks, toa full semester and could be offered to more than oneinstitution at the same time in the academy. These tech-nologies could also be extended by programs offered byour institutions to enhance the educational opportunitiesat the FDA.

Another key collaboration is to engage in the similartype of innovative programs being offered outside theUnited States. Specifically, programs could be offeredthrough collaborations between our schools with the phar-maceutical industry or with non-profit organizations. Onesuch innovative program is the Graduate Research Train-ing Program Pharmacometrics & Computational DiseaseModelling. This novel joint initiative in Germany is a col-laboration between the Martin-Luther-Universitat Halle-Wittenberg, the Freie Universitat Berlin and research-driven pharmaceutical companies such as BoehringerIngelheim Pharma GmbH & Co. KG, Abbott GmbH &Co. KG, Merck KGaA, Bayer Schering Pharma AG,Bayer Technology Services GmbH, and Sanofi-AventisDeutschland GmbH (https://pharmacometrics.mi.fu-berlin.de/).25

One example involving a non-profit organization isthe Metrum Institute founded in 2005. The Metrum In-stitute is dedicated to the advancement of quantitativemodeling and simulation in biomedical research, withparticular emphasis on problems in clinical pharmacol-ogy and therapeutics. Their efforts include trainingcourses in modeling and simulation techniques/methods,development of quantitative tools and software, publica-tions (including a newsletter), methods and applied re-search, symposia, and collaboration with the academiccommunity in research and training of fellows and grad-uate students (http://www.metruminstitute.org/about.html) (26). Given the expertise and available technologies

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in our colleges/schools of pharmacy, the academy shouldconsider more extensive use of these alternative educa-tional strategies for the development of world-leadingscientists in our programs, the industry and the FDA.

d Modernize Information Technology PlatformsEvidence that the academy is actively engaged in

areas relevant to this goal. While our colleges/schoolsof pharmacy are strongly grounded in the foundations foreducating students for the pharmaceutical and clinicalsciences, our involvement in educating future generationsof scientists needed for the development and moderniza-tion of the information technology platforms critical forfuture drug development, database management and reg-ulatory affairs, has not been an area of expertise.

If the academy is not directly engaged in areasrelevant to this goal, should it be? Pharmacy practiceand education at the professional and graduate levelsshould promote the roles of pharmacists, pharmaceuticalscientists, and clinical scientists as they relate to the sci-ence of the safety of drug products as indicated in theFDA response to the Institute of Medicine Report on drugsafety.27 At the professional level, it is critical for ourpharmacy programs to provide the knowledge, skillsand tools for future pharmacists to be engaged in riskidentification, assessment and minimization. The devel-opment of these tools could represent scholarly opportu-nities for faculty members, fellows and graduate students.In addition, our research programs should be encouragedto develop the state-of-the-art information technologiesand infrastructure needed for practitioners and scientiststo have access to key information, to have the interfacesneeded to allow integration of this information and thestandards needed for this information during the receiv-ing, managing and communication process as indicated inthe Sentinel Initiative.24

Pharmacy Educational Roles for Pharmacists andfor Pharmaceutical Scientists. Pharmacy education,practice and research must be engaged in the NationwideHealth Information Network (NHIN) through public andprivate partnerships. It is also important for key individualsin the academy to be actively involved in the organizationalstructure for the Sentinel Initiative System as this processcould be significantly enhanced by the analytical and re-search capabilities of our clinicians and scientists. This canonly occur if we take a critical look and promote the im-portance of these areas of study and research in our grad-uate programs and fellowship opportunities.

If the academy should be engaged in areas rele-vant to this goal, what should that engagement be orhow should it be presented to the academy to createengagement? It is critical that the academy identify thosecurrent faculty members who have the requisite expertise

in these areas and promote their involvement in the keydecision processes as these safety and other new initia-tives are planned and initiated in the years to come. Fur-thermore, our educational programs at the professional,post-PharmD fellowship and graduate level should pro-vide the opportunities for attaining specific knowledge,skills and research opportunities in patient safety as itrelates to drugs and the monitoring of medical products.Finally, our continuing professional development pro-grams must provide practitioners with the knowledgeand tool sets to become involved in the process neededfor better monitoring of patient safety issues in the varioussettings where they care for their patients.

RECOMMENDATION 3AACP should offer programming in the areas of

FDA and NIH initiatives and provide assistance to collegesand schools to become involved with these initiatives.

Goal 2: To Improve Patient and Consumer Safetyd Network of Safety Databases and Public Com-

munication about Product Safetyd Application of Risk Evaluation and Mitigation

Strategy (REMS)Evidence that the academy is actively engaged in

areas relevant to this goal. The FDA has identified av-enues to improve information systems and databases thatwill support and promote public safety. These include theenhancement and modernization of FDA product safetysystems, building an easier safety reporting system throughMedWatch Plus, building a National Sentinel Network forPatient Safety, expanding agency officials’ real-time ac-cess to information related crises and emergencies, andreducing patient injury from medical devices. As an activeMedWatch Partner, the Academy works with the FDA tokeep the public informed about medical product safety in-formation and reporting.

Many AACP leaders and members have served onpast and present FDA Advisory Committees (AdComms)and workgroups such as the Drug Safety Risk Manage-ment Advisory Committee, and the NonprescriptionDrugs Advisory Committee. These committees provideAACP members an opportunity to serve the public asa scientific or health professional medication or pharma-cotherapy expert. One of the more recently formedAdComms is the Risk Communication Advisory Com-mittee which was developed specifically to counsel theagency on how to strengthen the communication of risksand benefits of FDA-regulated products to the public.More specifically, this AdComm will help FDA bettermeet the communication needs and priorities of the gen-eral public, advise FDA on the development of strategic

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plans to communicate product risks and benefits, andmake recommendations to FDA on what current researchsuggests about crafting risk and benefit messages, as wellas how to most effectively communicate specific productinformation to vulnerable audiences. The Academy wasactively engaged in nominating and supporting an AACPmember to join this committee.

Pharmacy faculty, through AACP and other phar-macy professional organizations, regularly comment onthe FDA’s Risk Evaluation and Mitigation Strategy(REMS) programs. This strategy will manage known orpotential serious risks associated with a drug or biologicalproduct. Several REMS have already been approved todevelop medication guides, communication plans, ele-ments to assure safe use, and implementation systems.

If the academy is not directly engaged in areasrelevant to this goal, should it be? The Committee feelsthat it is important for the academy to continue to beactively engaged in areas such as safety database enhance-ment and functionality, FDA AdComms and REMS. Notonly is this a benefit for AACP members in their profes-sional roles but it provides members an opportunity tolend their expertise to the FDA as it works to meet itsstrategic goals for improving patient and consumer safety.

This Committee considers it essential, within conflictof interest guidelines, for the academy to better communi-cate to its members the opportunity to serve on AdCommswith a particular emphasis on medication safety. The pur-pose of the AdComms is to provide evidence-basedrecommendations to the FDA, making evidence fromclinical faculty, practicing at the forefront of patient careof particular benefit.

Whether through AACP or pharmacy professional or-ganizations, the Academy must become more involved inREMS opportunities and programs. Scientists and phar-macists are capable of developing and promoting all ofthe following elements that assure safe use of drugs deter-mined to be of high risk: 1) Health care providers whoprescribe the drug have particular training or experience,or are specially certified; 2) pharmacies, practitioners, orhealth care settings that dispense the drug are speciallycertified; 3) the drug is dispensed to patients only in certainhealth care settings, such as hospitals; 4) the drug is dis-pensed to patients with evidence or other documentation ofsafe use conditions, such as laboratory test results; 5) eachpatient using the drug is subject to certain monitoring; or6) each patient using the drug is enrolled in a registry.

If the academy should be engaged in areas rele-vant to this goal, what should that engagement be orhow should it be presented to the academy to createengagement? The Committee recommends that theAcademy search for opportunities to help the FDA con-

tinue to improve their safety information systems anddatabases. This includes the MedWatch Plus Investmentproject that will create a fully automated system provid-ing up-to-date data facilitating more efficient data sharingand reporting. In addition, the Academy should continueto evaluate potential opportunities to provide support andact as a resource for the FDA’s Sentinel Initiative.

The Committee suggests that the Academy identifyopportunities to become more engaged with the FDA’sREMS initiatives. An example is to support academicpharmacy programs focused on drug safety that can part-ner with the FDA such as the University of Maryland’srecently launched Center for Drug Safety. This Centerwill serve to guide and inspire research and scholarshipin pharmacoepidemiology and drug safety. The Centerplans to collaborate with governmental agencies to pro-vide formal and informal opportunities for professionaldevelopment and access to a pool of skilled faculty, grad-uate students, and graduates. This is a creative approach tocollaborate with the FDA as well as to identify potentialemployment opportunities for our graduates at federalagencies such as the FDA.

The Academy is committed to aligning its 3-prongedmission of teaching, research, and service with the FDA’sStrategic Goal 2 to support and advance improvements inpatient and consumer safety. Public perception of the im-portant role the pharmacist plays in assuring patient safetycan be heightened through more closely linking the pro-fessional curriculum with the FDA. Academic strategiesmight include increasing the awareness of students toFDA careers by increasing their exposure to FDA safetytools, databases, and resources. Active participation indrug safety surveillance and MedWatch reporting shouldbe required during pharmacy practice experiences. Aca-demic pharmacy can support the FDA safety effortsby encouraging and committing to research designedto determine the best ways to communicate drug safetyinformation to the public. By developing and refiningbetter methods of database research, more clinically rel-evant conclusions can be drawn about true drug safetyrisk. Research focused on the survey and study of prac-tice models may translate the REMS recommendationsinto clinical practice (i.e. effective distribution of Medi-cation Guides). In keeping with the service aspect of itsmission, the Academy should continue to establish re-source and reference centers for assisting the public totranslate FDA safety warnings into consumer understand-able terms.

POLICY STATEMENT 1The Academy is committed to aligning its 3-pronged

mission with the FDA’s Science of Safety in order to

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support and advance improvements in patient and con-sumer safety.

FDA Strategic Goal 3: Increase Access to NewMedical and Food Products

Tools. FDA’s Critical Path Initiative is a compilationof key actions supporting the efficient translation of sci-entific discoveries into medical therapeutic applications.Scientific discoveries, such as genetic mutations, can helpclinicians determine a patient’s unique metabolic profile.For example, this type of scientific discovery was intro-duced into a product label update for warfarin. Health careproviders now have information on using genetic tests toimprove warfarin dosing for an individual patient to avoidunnecessary side effects. Further work in this area is con-tinuing and FDA is collaborating with external organiza-tions with a goal towards developing tools to personalizetreatment therapies based on each person’s geneticmakeup and other individual factors.

Applying modern evaluation tools may also improveour understanding about a product’s effectiveness in cer-tain patients or populations prior to commercialization.These evaluations will give practitioners and patients thebest available information about using a product to opti-mize its benefit and minimize side effects. In fact, many ofthe tools being considered would help personalize medi-cine by identifying who is likely to respond to a treatmentand who should avoid it.

Evidence that the academy is actively engaged inareas relevant to this goal. Several faculty membersat schools of pharmacy are engaged in areas relevant tothis goal in teaching, service, and collaborative clinicaland translational research in the study of human and vet-erinary biomarkers, genomics, proteomics, and the studyof metabolomes. Most notable are investigators at theUniversity of California at San Francisco, Universityof Wisconsin at Madison, University of North Carolina,State University at Buffalo, Rutgers University, andothers in a variety of disciplines including, but not limitedto, clinical pharmacy, molecular biology, biochemistry,medicinal chemistry, pharmacometrics, biopharmaceu-tics, biostatistics, and molecular diagnostics.27-36

The AACP Research and Graduate Affairs Commit-tee Task Force for Educating Clinical Scientists andthe Argus Commission have published numerous reportson the current and future work of the AACP in promotingthe profession’s commitment and advancements in thisarea. Additionally, these reports have comprehensivelyoutlined the opportunities and challenges associatedwith engaging the academy in these areas of scientificdiscovery and development of academic programsfocused on T1 and T2 research. Current policy has

been adopted as a result of the work of these commit-tees.37-39

If the academy is not directly engaged in areasrelevant to this goal, should it be? Yes, academic andclinical pharmacists are involved in using these tools aswell as educating patients, physicians, and other healthcare providers regarding the tools.40 Further support forthe training of pharmaceutical scientists and the collabo-ration between private and public funders of research andacademic pharmacy should be investigated.

If the academy should be engaged in areas rele-vant to this goal, what should that engagement be orhow should it be presented to the academy to createengagement? Many of these areas of study are relativelynew, and the challenge of increasing the amount of basicscience information in the pharmacy school curricula hasexisted for decades, even as the amount of clinical infor-mation required for the immediate use of the graduates oftoday increases. Further study and review of current pre-requisite and required coursework for pharmacy schoolshould be undertaken to ensure that future practitionersand scientists are well-positioned to promote and utilizetranslational biomedical research. Advancements in theseareas of basic science should be used to promote the prep-aration of pharmaceutical scientists and clinical pharma-cists to improve the utilization of these tools and toimprove patient outcomes.

RECOMMENDATION 4AACP should develop a coalition of professionals

from different disciplines and organizations includingAmerican Association of Pharmaceutical Scientists(AAPS), American College of Clinical Pharmacists(ACCP), American Pharmacists Association (APhA),American Society of Health-systems Pharmacists (ASHP),American Chemical Society (ACS), American Society forPharmacology and Experimental Therapeutics (ASPET)and American Society for Biochemistry and MolecularBiology (ASBMB). Meetings and seminars at annualor interim meetings should be arranged to improve collab-orative opportunities for its member schools and to in-crease access to information and networks of scientistsinvolved in biomedical and translational (T1 and T2) re-search.41

Generic Initiative for Value and Efficiency (GIVE)FDA’s generic information for value and efficieny

(GIVE) program aims to increase the number and varietyof generic drug products available. Having more generic-drug options means more cost-savings to consumers, asgeneric drugs cost about 30 to 80 percent less than brandname drugs.

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Knowledge by pharmacists and communication topatients and their physicians of generic drug productavailability is often the first source of information to rec-ommend a substitutable product to an often less expensivealternative as compared with the innovator’s drug product.

Evidence that the academy is actively engaged inareas relevant to this goal?

The academy is actively engaged in areas relevant tothis goal, particularly in the areas of teaching in drug andbiologic product development, managed care, pharmacybenefit design; research at schools of pharmacy regard-ing pharmacoeconomics and generic drug substitution(Creighton University, University of California at SanFrancisco, University of Rhode Island, University ofMississippi); and service in multiple schools (Universityof the Pacific, University of California San Francisco, Uni-versity of Arkansas), collaborating with AARP, Centersfor Medicare and Medicaid Services (CMS), and otherorganizations providing outreach in the area of genericdrug cost-savings to consumers.42-46 Knowledge ofgeneric drug availability is a becoming more widespreadas pharmacists seek better reimbursement from thirdparty payers, but physicians and patients need com-prehensive and scientific data that will give them theconfidence to prescribe and utilize these lower costalternatives. Considering the influence that pharmacistsretain in the drug product selection area, and the avail-ability of pharmacists in the community as drug experts,enhanced communication and partnerships betweenpatients, prescribers, and pharmacists should be stud-ied.47-49

If the academy is not directly engaged in areasrelevant to this goal, should it be?

Availability of generic drugs appears to be widelytaught in curricula throughout AACP member institutionsin the areas of drug development, pharmacoeconomics,pharmacy management, and therapeutic outcomes; how-ever, a focus on drug safety, comparative drug productanalysis and selection decision-making, enhanced ge-neric drug utilization, and mechanisms to enhance thecommunication regarding the safety and efficacy of theseproducts requires further review.

If the academy should be engaged in areas relevantto this goal, what should that engagement be or howshould it be presented to the academy to createengagement?

A commission of academic pharmacists in the areasof drug development, managed care, pharmacoeconom-ics, pharmacy management, and clinical outcomes should

consider reviewing the available information from scien-tific research, available white papers, foundation reports,and other nonbiased literature to develop a statement onthe availability and utilization of safe and effective ge-neric drugs.

RECOMMENDATION 5Collaboration with AACP, APhA, National Commu-

nity Pharmacists Association (NCPA), Association ofManaged Care Pharmacy (AMCP), Generic Pharmaceu-tical Association (GPhA), AARP, Pharmacy BenefitManagement Institute (PBMI), CMS, American Associ-ation of Family Physicians (AAFP), America’s HealthInsurance Plans (AHIP), and other parties influencingthe availability and utilization of generic drugs shouldbe considered and the development of a policy statementforwarded to the House of Delegates for consideration.

Direct-to-Consumer Advertising (DTC)As provided by the FDAA section 901, FDA is

requesting scientific research, data and information toassist the agency in its plans to conduct an assessmentof DTC advertising and its ability to communicate to sub-sets of the general population, including the elderly, chil-dren, and racial and ethnic minority communities.

The agency’s findings will be reported to Congressand must include recommendations on how to effectivelypresent and disseminate information to these groups.DTC advertisements are a source of product informationand pharmacists are first-line healthcare providers res-ponding to inquiries derived from information providedin DTC advertisements. At times, this interaction can bechallenging as a pharmacist may be unaware of a prod-uct’s consumer-directed promotional campaign.

Evidence that the academy is actively engaged inareas relevant to this goal?

Schools of pharmacy are actively engaged in researchand teaching relevant to studying how DTC advertising isinfluencing the attitudes of student pharmacists, patients,physicians, and payers, and have collaborated with otheracademic disciplines to develop this area of study (Uni-versity of Mississippi, University of New Mexico,Duquesne Mylan School of Pharmacy, University ofNorth Carolina, University of Wisconsin, Harvard Uni-versity).50-58 In the last decade, DTC advertising hasbeen an area of great debate in the profession of phar-macy, as considerations including drug product selection,patient engagement, physician prescribing habits, andFirst Amendment rights of manufacturers have madethe issue increasingly complex. Pharmacists and phar-macy schools are well positioned to actively engage in

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research to further elucidate the positive and negative in-fluences and outcomes of this information dissemination.

If the academy is not directly engaged in areasrelevant to this goal, should it be?

The academy’s engagement has been multidisciplin-ary, and should continue to evolve as providers and pa-tients require more detailed information relevant to DTCon clinical decision-making. More information should begenerated through these research and teaching agendas toinclude how consumers are receiving information and thehealth literacy challenges associated with consumer de-mand for pharmaceuticals.

If the academy should be engaged in areas relevant tothis goal, what should that engagement be or howshould it be presented to the academy to createengagement?

The academy should consider broadening its baseof research in this area, as it is clear that patients, phar-macists, and prescribers are in need of better decision-making tools relative to drug product selection.

RECOMMENDATION 6The academy should consider a collaborative effort

between schools of pharmacy, schools of public healthand public policy, schools of business, pharmaceuticalmanufacturers, and government entities to provide researchthat will allow prescribers and pharmacists to better informconsumers about evidence-based drug product selection.

Goal 4: Improve the Quality and Safety ofManufactured Products and the Supply Chain

Security of Drug Distribution System. The FDAhas taken steps to protect consumers from counterfeit drugsand to secure the U.S. drug distribution system. These mea-sures include implementation of new technologies (trackand trace) to better protect legitimate drugs against tamper-ing or replacement with counterfeits. FDA’s framework forpublic and private sector actions calls for a multi-layerapproach to address the problem and includes measuresto secure product/packaging, movement through the supplychain and, business transactions.59

Pharmacists are on the front-lines of observing andeffectively reporting counterfeit drugs to the FDA. Thisreporting helps strengthen FDA’s ability to communicateto participants in the drug distribution system so they canrespond rapidly to such reports.

Evidence that the academy is actively engaged inareas relevant to this goal. Faculty members at severalcolleges/schools of pharmacy are actively engaged in re-search on the drug supply chain. Perhaps most notable is

Dr. Marvin Shepherd of the University of Texas at Austin.He currently serves as President of the Partnership forSafe Medicines, an organization that actively combatscounterfeit medications.60 Another notable investigatoris Dr. Ronald J. Ziance from the University of SouthernNevada.61 There are also individual faculty membersresearching technology associated with areas relevant tothis goal. These activities were highlighted at a sympo-sium on ‘‘Counterfeit Medications: Current Approachesand Research Opportunities’’ held at Purdue University inOctober, 2008.

Another area where the academy is engaged is theNational Institute for Pharmaceutical Education andTechnology (NIPTE).62 This is a consortium of AACPmember schools and engineering schools to improve thepharmaceutical manufacturing process. NIPTE’s goal isto increase science and engineering-based understandingof pharmaceutical production such that novel state-of-the-art technologies can be developed and science-basedregulations can be implemented.62 These technologieswill also enable new drug discoveries to be brought tomarket faster with less variability, higher predictabilityof performance and at a significantly lower cost.

Overall, it is apparent that individuals within theacademy are activity engaged in areas relevant to the goalof improving the quality and safety of manufactured prod-ucts and the supply chain. As an overall entity, the acad-emy has been actively engaged through NIPTE, but couldbecome more directly and visibly involved in this goal.

If the academy is not directly engaged in areasrelevant to this goal, should it be? Some professionalpharmacy societies (notably APhA and ASHP) have gen-erated policy statements related to the safety of the supplychain, particularly focusing on the problem of counterfeitdrugs. These statements directly address the role of phar-macists in dealing with this significant problem. Theacademy has not, as a body, been as actively engaged inareas relevant to this goal as it should be. While there areindividuals in the academy researching this problem, ithas not been adequately addressed through curricular ac-tivities nor through formal policy statements from theacademy. Overall, the academy should become more di-rectly and actively engage in areas relevant to this goal.

If the academy should be engaged in areas rele-vant to this goal, what should that engagement be orhow should it be presented to the academy to createengagement? There are three ways the academy shouldbecome engaged in areas relevant to this goal.

1. The academy should issue a policy statement onits role in supply chain safety.

2. The academy should become a member of thePartnership for Safe Medicines

American Journal of Pharmaceutical Education 2009; 73 (8) Article S8.

8

3. The academy should help lead the developmentof curricular material that addresses this goal.

The following policy statement is recommendedfor consideration by AACP. This statement was derived,in part, from existing statements from ASHP63 andAPhA.64

POLICY STATEMENT 2AACP supports enhanced efforts to combat drug

counterfeiting which:d foster awareness in our faculty and students of

the problem of drug product counterfeiting;d educate our students in all aspects of the problem

and potential solutions; ensuring that studentpharmacist education supports the pharmacist’srole in drug procurement, distribution, surveil-lance and control;

d support graduate education and research to de-velop mechanisms by which legitimate drugsources can be identified;

d create appropriate educational scenarios so thatpatients become partners in identifying changesin the appearance, smell, taste, etc. of dispensedproducts or their effectiveness; and

d facilitate academic partnerships with the FDA tohelp develop an effective reporting system ofpossible supply chain problems (e.g., the Foodand Drug Administration’s MedWatch sys-tem).65

Counterfeit drugs are a reality in today’s drug distri-bution system. Academic pharmacy has an obligation toproactively work toward enhanced quality and safety ofmanufactured products and the supply chain, includingeliminating the presence of counterfeit products. Becausecounterfeit products can be visually identical to the realproduct, it is important for the academy to partner with theefforts of the FDA, the National Association of Boards ofPharmacy (NABP), drug wholesalers, and drug manufac-turers to stem these illegal activities, particularly throughenhanced educational activities.

Pharmacists are the penultimate defense in protectingpatients from counterfeit medications. Recognition of thisrole, however, is not consistent across the academy.AACP supports enhanced efforts to combat counterfeit-ing, including educating our student pharmacists in thisarea, and supporting graduate education and research ondetection and prevention methodologies. As stated by theAPhA, pharmacists fight counterfeit drugs in their threeroles as:

1. Prudent purchasers,2. Patient educators, and3. Reporters of possible counterfeit activities.

RECOMMENDATION 7It is recommended to the Board that AACP become

a member of the ldquo;Partnership for Safe Medicines’’.

RECOMMENDATION 8It is recommended that educational resources be co-

ordinated and/or developed to assist colleges and schoolsof pharmacy in providing education in the areas of drugquality and safety, and the supply chain.

CONCLUSIONRecent legislation, including the Food and Drug Ad-

ministration Amendments Act (FDAAA) of 2007, en-courages and supports partnership and collaborationbetween the FDA and academic institutions. This reporthighlights opportunities where academic pharmacy is al-ready contributing to improved medication use safetythroughout the drug life cycle as well as opportunities toimprove and enhance these attempts with the FDA.

Specifically, the Standing Committee on Advocacyperformed a gap analysis on the academy’s current activ-ities that contribute towards supporting each of the FDA’sfour strategic goals: 1) Strengthen the FDA for Today andTomorrow; 2) Improve Patient and Consumer Safety; 3)Increase Access to New Medical and Food Products; and4) Improve the Quality and Safety of Manufactured Prod-ucts and the Supply Chain. The committee agrees that theacademy should be engaged in activities relevant to eachgoal. The committee believes that while there is evidencethat the academy is currently engaged to varying degreesin many activities, there are many opportunities to im-prove and bolster those attempts.

In conclusion, this report outlines areas and opportu-nities for the academy to become more engaged in order tosupport the FDA’s strategic goals. Recommendationsrange from supporting educational strategies that promotethe development of world leading scientists in academia,industry, and the FDA to encouraging AACP members toplay a more active role on the numerous FDA advisorycommittees.

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