PharmGen

EXPERIENCE

J o u r n a l o f t h e A m e r i c a n P h a r m a c i s t s A s s o c i a t i o n www.japha.org S e p /O c t 2012 • 52:5 • JAPhA • e259

Received May 3, 2012, and in revised form July 23, 2012. Accepted for publication July 30, 2012.

Shanna K. O’Connor, PharmD, BCPS, at the time of this study was a visiting professor at Eshelman School of Pharmacy, University of North Carolina, Chapel Hill; currently she is Assistant Professor, University of Washing-ton School of Pharmacy. Stefanie P. Ferreri, PharmD, CPP, BCACP, CDE, FAPhA, is Clini-cal Associate Professor and Director of the PGY1 Community Pharmacy Residency Pro-gram at the Eshelman School of Pharmacy, University of North Carolina, Chapel Hill. Na-tasha M. Michaels, PharmD, CPP, is Clinical Coordinator at Kerr Drug in Chapel Hill, NC. Rebecca W. Chater, BSPharm, MPH, FAPhA, is Executive Vice President of Kerr Health, LLC of Kerr Drug, Inc. Anthony J. Viera, MD, MPH, is an Associate Professor in the Depart-ment of Family Medicine at the School of Medicine of the University of North Carolina, Chapel Hill. Hawazin Faruki is Vice President of Clinical Development with Laboratory Corporation of America Holdings. Howard L. McLeod, PharmD, FCCP, is Eshelman Distinguished Professor of Pharmacy and Medicine at the University of North Carolina, Chapel Hill. Mary Roederer is Research As-sistant Professor with the Eshelman School of Pharmacy and a Clinical Assistant Profes-sor with the Department of Family Medicine, University of North Carolina, Chapel Hill.

Correspondence: Stefanie P. Ferreri, Phar-mD, UNC Eshelman School of Pharmacy CB 7574 Beard Hall 115B Chapel Hill, NC 27599-7574. Fax: 919-843-3861. E-mail: [email protected]

Disclosure: Hawazin Faruki is an employee of Laboratory Corporation of America Hold-ings. Natasha Michaels and Rebecca Chater are employees of Kerr Drug, Inc. The other authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or hono-raria.

Funding Support: Community Pharmacy Foundation; Kerr Drug, Inc.; Eshelman School of Pharmacy, University of North Carolina, Chapel Hill; Laboratory Corpora-tion of America Holdings also provided “in kind” support of CYP2C19 pharmacogenetic testing for this study.

Acknowledgments: To Lisa Adams Padgett, PharmD, for securing funding and helping with the initial design of the study.

Previous presentations: American Pharma-cists Association Annual Meeting, Seattle, WA, March 26, 2011

Abstract

Objective: To provide information for community pharmacies considering imple-mentation of a pharmacogenetic testing service.

Setting: A single community pharmacy from a regional chain.Practice description: Community pharmacists at the study site routinely pro-

vide pharmacy services including medication therapy management, immunizations, point-of-care testing, blood pressure monitoring, and diabetes education. The phar-macy is a training site for post-graduate year 1 and 2 community-pharmacy residents and for introductory and advanced pharmacy practice experience students.

Practice innovation: Implementation of a pharmacogenetics testing service in a community pharmacy.

Main outcome measures: Feasibility of offering a pharmacogenetics testing service in a community pharmacy.

Results: Study investigators identified several internal and external barriers to the community pharmacy when initiating a pharmacogenetics service. This article shares experiences of the study team and solutions to the identified barriers.

Conclusion: Community pharmacies interested in providing pharmacogenetic testing can overcome barriers by identifying practice partners and planning appro-priately.

Keywords: Community pharmacy services, community pharmacy, pharmacoge-netics, pharmacogenomics, medication therapy management, clinical pharmacy ser-vice.

J Am Pharm Assoc. 2012;52;e259–e265.doi: 10.1331/JAPhA.2012.12108

Making pharmacogenetic testing a reality in a community pharmacyShanna K. O’Connor, Stefanie P. Ferreri, Natasha M. Michaels, Rebecca W. Chater, Anthony J. Viera, Hawazin Faruki, Howard L. McLeod, and Mary Roederer

EXPERIENCE PHARMACOGENETIC TESTING IN COMMUNITY PHARMACY

J o u r n a l o f t h e A m e r i c a n P h a r m a c i s t s A s s o c i a t i o nwww.japha.orge260 • JAPhA • 52:5 • S e p /O c t 2012

In 2011, the American Pharmacists Association released a white paper describing the importance and practicality of integrating pharmacogenetics or genomics in the medica-

tion therapy management (MTM) process to optimize pharma-cotherapy for patients.1 Although controversial, the discussion is fueled by the availability of genetic tests through prescriber-ordered clinical laboratory tests or direct-to-consumer (DTC) tests. At one time, patients had the potential for access to DTC genetic tests through two routes: purchasing from online companies or through a community pharmacy. As part of the online access, the company sends the patient a kit for sample collection, the patient returns the sample, and the lab returns the results with a limited, and often inaccurate, interpreta-tion of the results.2 The inaccuracies of the information pro-vided by these companies was highlighted in a 2010 statement from the U.S. Government Accountability Office.2 In 2010, the U.S. Food and Drug Administration (FDA) deemed it illegal to sell health-oriented DTC genetic tests in community pharma-cies.3 Despite the decision by the FDA, consumer demand for pharmacogenetic testing is growing, and the interpretation of results by pharmacists or prescribers regarding pharmacoge-netic tests may soon become a part of routine clinical practice.

The more reliable tests are offered by lab companies that ana-lyze samples pursuant to a prescriber's order.4 This require-ment is intended to ensure proper follow-up and the availability of counseling as necessary. As patient interest heightens and the available information trickles into clinical decision making, pharmacogenetics will become increasingly relevant to com-munity pharmacists.5

BackgroundPharmacogenetics is currently mentioned in the drug pack-age insert of more than one hundred drugs.6 Few primary care practitioners use the pharmacogenetic information contained in package inserts to order those pharmacogenetic tests that influence prescribing, even though we know that one in four prescription drugs dispensed is metabolized by polymorphic pathways.7 Given this information, not many studies have in-vestigated whether prospective pharmacogenetic testing influ-ences a therapeutic regimen.8,9 Furthermore, no studies in the United States evaluating prospective pharmacogenetic testing by pharmacists in a community pharmacy currently exist.

Community pharmacists are integral to patient care through MTM. Because of the relationships they have with pa-tients, pharmacists are poised to assume the role of obtaining samples and providing clinical pharmacy services in response to pharmacogenetic test results.10 In fact, it is a natural exten-sion of the MTM rubric for pharmacists to include the results of pharmacogenetic tests or the recommendation to test.1,11 Similar to other clinical pharmacy services, such as point-of-care tests for lipid management, the process for establishing a service to offer pharmacogenetic testing in a community phar-macy requires thoughtful consideration of the viability of a new service (Figure 1a). The objective of this experience paper is to provide information for community pharmacies to use when considering offering a pharmacogenetic testing service.

Setting and practice descriptionThe practice setting is a single pharmacy that is part of a re-gional chain known for providing clinical services. All commu-nity pharmacists at the study site routinely provide pharmacy services including MTM, immunizations, point-of-care testing, blood pressure monitoring, and diabetes education. The phar-macy fills approximately 1800 prescriptions weekly and has three full time pharmacists at the store. The pharmacy is also a training site for postgraduate year 1 and 2 community phar-macy residents and for introductory and advanced pharmacy practice experience students. Two of the pharmacists at this location provided the pharmacogenetic service to patients.

Practice innovationRecognizing the future of pharmacogenetics and the role it may play in health care, Kerr Drug, a regional pharmacy chain, Laboratory Corporation of America, a national lab testing com-pany, and the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill are collaborating to test the practicality of a pharmacogenetics testing service in a commu-nity pharmacy. Developing this collaboration was important to

At a GlanceSynopsis: The increasing need to apply pharma-

cogenetic information to patient prescriptions was ad-dressed in a new service described in this experience article. The authors helped to establish a pharmaco-genetic testing service in a community pharmacy, in a collaboration between physician, pharmacist, and genetic testing service. The complications described here involved legal, financial, and medical practice questions, all of which would need to be considered by anyone interested in implementing a similar service. The article discusses the barriers that were encoun-tered to such implementation with suggested ways to address those barriers.

Analysis: In an attempt to avoid the adverse ef-fects of drugs, or to ensure their efficacy, there is a growing capacity to connect individual differences in biochemistry causing these differences directly with personal genetic variations. More than 100 drugs now carry FDA pharmacogenetic information on the label, and this labeling trend will certainly grow. The application of such knowledge can be critical to a patient’s health, an application that requires test-ing and interpretation relative to medication. Phar-macists are the logical information nexus to bring together information on patient health, medications being taken or considered, and potential genetic in-teraction with those medications. The experience de-scribed here is a leading edge for what may reason-ably become common in pharmacy practice.

PHARMACOGENETIC TESTING IN COMMUNITY PHARMACY EXPERIENCE


establish this new service and to test feasibility for pharma-cogenetics. We decided to conduct pharmacogenetic testing for CYP2C19 using clopidogrel as the example. A complete de-scription of the research methods has been published.12

Main outcome measuresThe core questions and outcomes for the study address issues that any pharmacy or chain of pharmacies would likely address in considering initiation of a new service: questions of feasibil-ity, the ability to obtain reimbursement for the clinical service, and the level of satisfaction of patients and prescribers. While we were planning the study to investigate these issues, several unexpected barriers arose. The objectives of this manuscript are to discuss the barriers and solutions we identified to make a pharmacogenetic testing service practical in the real world of community practice and to discuss barriers and solutions for practitioners considering research in this area.

ResultsBarriers and solutions

� How will the pharmacist order the lab test?Barrier: Because most insurance companies do not recognize pharmacists as health care providers, lab companies, in turn, do not allow pharmacists to order or receive the lab results for patients. Furthermore, individual state regulations are incon-sistent regarding the legality of pharmacist-ordered lab tests.

Solution: The Pharmacy Practice Act in North Carolina defines the opportunity for pharmacists to serve as a provider extender, or Clinical Pharmacist Practitioner (CPP). Similar to a nurse practitioner or a physician assistant, a CPP can order lab tests under collaborative practice agreement. In order to achieve CPP designation, pharmacists in this study were re-quired, according to NC requirements, to submit an applica-tion, including a protocol mutually developed with their super-vising physician, to the North Carolina Board of Pharmacy and Board of Medicine. Once approval was granted by both Boards, study pharmacists were able to order the pharmacogenetic tests under their expanded scope of practice as CPPs.

In order for this service to be replicated in other states or sites, a similar provider status arrangement would need to be made to order the test. Alternatively, an agreement with indi-vidual prescribers could be obtained where the prescriber or-ders a lab test and he or she would share the result with the pharmacist for interpretation. Although this solution still pres-ents a communication barrier, it may be feasible in the absence of pharmacist-ordered lab tests. As the regulatory landscape differs from state to state, pharmacists interested in order-ing and interpreting pharmacogenetic data as an extension of their current practice need to be fully abreast of the state phar-macy rules and statutes under which they practice.

� How will the pharmacist receive the lab results?Barrier: The next barrier was pharmacist receipt of test-

ing results. The turnaround time to receive lab results was sev-en business days. Although the pharmacists involved were able to resolve the issue of ordering the test through a collaborative practice agreement with the supervising physician, also a coin-

Figure 1 Clinical pharmacy service implementation: Lipids and pharmacogenetics.

Patient presents with request for a new pharmacy service

Does the proposed pharmacy service match patient care trends?

Does the service match the mission and vision of the pharmacy organization?

Assessment of feasibility: Does this service expand the market share of the pharmacy? Is there a conflict with this service and other pharmacy services?

Assessment of expense to implement and market

Positive value to pharmacy (increased traffic, reimbursement)

Decision to offer cholesterol testing in community pharmacy

Patient on pravastatin 20 mg presents with appointment for

cholesterol testing

Cholesterol panel obtained via point-of-care device; TC: 176, LDL: 110

HDL: 27, TG: 145

Pharmacist interpretation of results:

LDL not at goal <100, need to increase dose of

pravastatin

Pharmacist coordination of care via fax with

prescriber to obtain new Rx, counsel patient

Decision to offer pharmacogenetics

testing in community pharmacy

Patient on clopidogrel presents with

appointment for pharmacogenetics

testing

Buccal swab obtained and sent to lab

Results returned: CYP 2C19 *2/*2

Pharmacist interpretation of results:

clopidogrel likely not being converted to active metabolite, alternate therapy

indicated

Pharmacist coordination of care via fax with

prescriber to obtain new Rx, counsel patient



vestigator, a precedent did not exist for a pharmacist to receive a copy of the test results from the lab company.

Solution: An online account for the pharmacogenetics re-search team was created with the lab company to ensure that all CPP-ordered lab results were delivered and accessible only to study personnel. This account was created using the super-vising physician's Drug Enforcement Administration number as part of the CPP protocol. Pharmacists in other states may be able to order lab tests without prescriber approval or may need to set up agreements with a physician and the lab company.

� How will the results be documented with the prescriber?Barrier: Medical record and prescription documentation

proved to be a concern. These systems, while both electronic, do not have the capacity to merge data, so the need to establish clear lines of communication and documentation was impera-tive. The documentation for the medical record was sent to the prescriber in a similar way to other pharmacist–provider com-munication.

Solution: Pharmacists communicated with prescribers via a 1- to 2-page fax that outlined the recommendation, the patient's genetic test result, and the lab company result sheet. Confirmation of receipt was requested, and lack of confirma-tion triggered a refax within 3 working days. The faxed infor-mation was intended to be integrated into the patient medical record at the prescriber's office.

� How will the results be documented within the pharmacy?Barrier: Integration into the pharmacy dispensing record

presented multiple challenges, as the operating software did not have an input for pharmacogenetic data to be automati-cally reviewed or manually reviewed by the pharmacist. This deficiency meant that, although the lab information could be reviewed for the study drug, the information could not inform clinical decision making during the process of dispensing other medications affected by the same polymorphic pathway.

Solution: An ideal resolution, outside of redesign of the pharmacy software, was not found. However, a temporary solu-tion was proposed for a pharmacogenetic testing service when launched outside of the study. Pharmacogenetic data can be entered as a message that would make this information avail-able to the pharmacist during the drug utilization review pro-cess at each dispensing. Pharmacists can also enter a message in this field stating the patient had been offered the test so they will not inadvertently receive the test again. Though the addi-tion of multiple messages is far from ideal, this solution would provide the dispensing pharmacist with the requisite informa-tion. The documentation component related to pharmacoge-netic test results will likely improve as the field becomes more integrated into patient care.13–15

� How will the results be interpreted?Barrier: Interpretation of the results from pharmacoge-

netic testing involved pairing pharmacists’ knowledge of drug metabolism with the relevance of test results. Assessment of the literature was vital in generating an algorithm for evaluat-ing results and generating appropriate responses.

Solution: Access to and expertise in reviewing the lit-erature was available through the partnership with a large

research institution. Pharmacists routinely draw on their knowledge, drug information databases, and the package in-sert when reviewing drug–drug interactions. Similarly, much of the information related to pharmacogenetic testing is available in the package insert, drug information databases for many drugs, and evolving evidence-based guidelines.16

� How will the pharmacy obtain reimbursement for the lab test?Barrier: Reimbursement for the lab test was a concern, as

the testing is expensive, and coverage across health insurance plans varies greatly. Furthermore, no mechanism currently ex-ists for a community pharmacist in North Carolina to bill for a lab test.

Solution: The solution reached for this study was that the lab company would provide the lab test at no cost to the com-munity pharmacy. Free testing from a clinical reference labo-ratory is not feasible outside of the study environment, so al-ternatives must be explored. Another option was requiring the patient to pay out-of-pocket and then request reimbursement from their insurance carrier. This option was eliminated by the study team, as they anticipated that it would seriously decrease patient interest in the service and would require the establish-ment of a billing subdepartment, which would not be cost effec-tive. In other scenarios, the lab company is also able to work with insurance companies to take charge of billing outside of study scenarios, which frees the pharmacist from needing to be involved with this process. Such freedom from billing does not preclude patient questions related to insurance billing, howev-er. Pharmacists involved in this solution would likely need to be familiar with the lab billing procedures and general insurance coverage policies pertinent to pharmacogenetic lab billing.

� How will the pharmacy obtain reimbursement for clini-cal services to interpret the genetic tests as they relate to MTM?Barrier: Several mechanisms existed for billing for cogni-

tive services at the outset of this project. First, patients can pay out-of-pocket on a per minute, per half hour, or per service basis.17 As the out-of-pocket expense was perceived to be a barrier to enrollment, alternative options were pursued. Bill-ing platforms such as MirixaPro and Outcomes Pharmaceuti-cal Health Care may be useful for billing claims of this nature and are beneficial in their ease of incorporation if the phar-macy is already using these platforms to deliver MTM services. However, the focused area of this service and the limited billing processes with current systems decreased the viability of the considered options.

Solution: The solution to this problem was found in work-ing through the existing billing service contracted by the phar-macy to process third party claims for administration of vac-cines. A mock national drug code number was created for ease of billing at the store, and the claim was sent to the intermedi-ary for adjudication. A formalized template was developed for the pharmacy team to use with each submission. The process was streamlined with other services offered and the template allowed the process to fit nicely into normal daily activities. This solution decreased the amount of time the pharmacist



spent on administrative duties related to reimbursement. In the future, contracts with insurers might be negotiated to fur-ther smooth pharmacist reimbursement for cognitive services.

� Will patients be interested in this type of service?Barrier: Patient interest in this type of service was a con-

cern, so extensive consideration was given to selecting the community pharmacy.

Solution: Kerr Drug in Chapel Hill, North Carolina, was selected because the patient population is accustomed to phar-macist-driven services. Generally, these patients are well in-formed regarding health care topics, are highly educated, and openly communicate with pharmacists and pharmacy support staff. Patients have come to expect innovative clinical services from this community pharmacy. Space for testing and counsel-ing was not an issue because the location was already equipped with multiple private rooms to speak with patients. Because of the sensitive nature of communicating pharmacogenetic infor-mation, a private space should be a top consideration for phar-macists interested in offering this new clinical service. With the space and processes for handling clinical matters already in place, it was a natural extension of current pharmacist-driven services to implement a pharmacogenetic testing study at Kerr Drug in Chapel Hill. Pharmacies considering this service must seriously consider conducting a needs assessment because pa-tient populations with different demographics than ours may have different needs for this type of service. Figure 1a offers basic considerations to think about prior to implementation.

� How will providers respond to this service?Barrier: Prescriber communication and response to this

service is crucial to its success. The pharmacists understood the importance of prescriber reception to the service—strong opposition from local prescribers would decrease its feasibil-ity; support from the medical community would improve the likelihood that the service would be sustainable.

Solution: The pharmacy prepared a press release related to the launch of the pharmacogenetics testing service to in-crease local visibility of the service. Pharmacogenetic test-ing is a natural extension of pharmacy services because it is tantamount to the rational use of drugs. This type of testing is not very different from other pharmacist-provided testing to select or monitor drug therapy (Figure 1b). In order to obtain prescriber feedback, the fax informing prescribers of patient results from the service requested a signature and referred any questions or comments to the research team. After the com-pletion of the study, increased face-to-face marketing may be needed to increase prescriber awareness of the service outside the study environment.

Practice partnersThis project would not have been successful without establish-ing relationships with collaborators. Each collaborator filled a vital role and brought important resources, expertise, and ex-perience that should be considered when establishing a phar-macogenetic service (Figure 2). The partners involved in the creation of the pharmacogenetic service are described below.

Lab partnerPartnering with a lab company with pharmacogenetic testing experience, fast turnaround for sample analysis, and a network of couriers meant that the sample collection at the pharmacy could be scheduled any day convenient to the patient. Addition-ally, results analysis and subsequent recommendations to pre-scribers could occur in a timely fashion. Pharmacies wishing to initiate pharmacogenetic testing would likely have access to a lab testing company either by courier or mail order.

Pharmacy partner

The pharmacy within which this clinical service was offered is known for providing innovative clinical services in the commu-nity setting. Patients of this pharmacy expect novel services in the pharmacy. Support for the start-up phase of this project from all levels of the company was vital in moving the project forward. Finally, the physical space in the pharmacy was gen-erous and flexible enough to allow for this service to be offered in a private office. Pharmacies that do not have private physical space allocated to clinical services would need to devise pri-vate screening areas, possibly by reallocation of space.

Billing partner

Compensation for cognitive services was possible through a partnership with a billing company. This company was already a contractual partner of the pharmacy for billing insurance for immunization services; a similar billing mechanism was creat-ed for billing for cognitive services delivered by the pharmacist related to pharmacogenetic medication counseling. The billing was done electronically out-of-house, which allowed the clini-cal service to run smoothly with patients. If a similar agreement is not feasible for other community pharmacies, compensation could be obtained through cash payment similar to billing for point-of-care testing or MTM services, or paper claims could be filed. These potential solutions present the obvious problems of patient willingness to pay and timeliness required for both filling out forms and long turnaround time for reimbursement to be processed by third party payers.

Institutional partner

The final partner in this project was a large research institu-tion. This institution was vital in the development of a proto-col for pharmacogenetic testing and providing resources such as recent references from the literature from which to draw information for clinical decision making. The research team was able to draw on the genetic expertise at the research institution, facilitate connections with the supervising phy-sician, and use previous experience of other researchers to generate the CPP agreement. As pharmacogenetics is a new and quickly evolving field, this partner was essential in en-suring that the patients received optimal care. Pharmacies without access to a research institution could implement pharmacogenetic testing services with a focus on information available in package inserts, drug information databases, and evidence-based guidelines (e.g., Clinical Pharmacogenetics Implementation Consortium). A research institution partner



is not crucial to have if research is not being conducted in this practice area.

ConclusionThe authors have presented their experience with barriers to offering pharmacogenetic testing in a community pharmacy, site-specific solutions to these barriers, and proposed reme-dies for a broader audience. As is evidenced in the increasingly common reports related to DTC genetic testing, this burgeon-ing area of science is likely one that will need to be integrated into routine practice. As community pharmacists have frequent interactions with a broad patient population, the application of pharmacogenetics can logically find a home in this arena. Working through barriers and solving problems will be com-monplace as this development occurs. We encourage further open communication related to experience in the field.

Broader applicationThe number of drugs whose package inserts reference phar-macogenetics is growing.6,7 Patient interest in genetic testing is also evident, but problems exist with DTC options for genetic

testing.2,3 The American Pharmacists Association suggests the need to integrate pharmacogenetics into MTM.1 Because community pharmacists routinely offer MTM and have a high level of contact with patients, it may be beneficial for pharma-cogenetics testing to be offered by a community pharmacist. No studies of community pharmacy–offered pharmacogenetic testing in the United States have been published to date; there-fore community pharmacists interested in offering such a ser-vice may need guidance regarding how to initiate their plan. This paper offers insight into barriers we encountered when initiating a pharmacogenetics testing service in a community pharmacy. Our discussion also explains solutions to these bar-riers and delineates partners to be considered in the establish-ment of the service. Future studies may explore the integra-tion of pharmacogenetics testing with other clinical pharmacy services in community practice or expand upon partnerships needed to make such a service successful.

References1. Reiss SM; American Pharmacists Association. Integrating

pharmacogenomics into pharmacy practice via medication therapy management. J Am Pharm Assoc. 2011;51:e64–74.

Figure 2 Considerations when establishing effective partnerships for a pharmacogenetic service.

Is there a courier service or are test kits mailed?

Is there a fee associated with test submission?

Are genetic counselors available to

answer questions of pharmacists

and patients?

How will the lab test be ordered?

Is there a need for a separate account with

the lab company?

Is there a cost for the buccal

swabs to collect the genetic

sample?

Is there sufficient space

to offer this service?

Can privacy of patient

interactions be assured?

Is there support for the service from all levels of organization

(site, region, corporate)?

Are the pharmacists amenable to using CPIC

guidelines and other resources

to interpret tests?

Are drug information references

reliably accessible?

Is there an additional fee or set-up cost associated with

pharmacogenomics testing?

Is there an efficient

method for handling

rejections?

If rejections occur, are

patients willing to pay for the

service? What is the turnaround time between billing

and reimbursement?

Will this affect other services

such as immunizations?

If planning a study, is IRB supervision available to help ensure

patient safety?

What outcomes will help to determine if

this service is feasible?

Is there genetic expertise that can be used

when creating this service?

Are there connections

with physicians who might be

willing to supervise this

project?

Collaborative partners

Billing partner

Institutional partner

Pharmacy partner

Lab partner



2. Government Accountability Office. Direct-to-consumer genet-ic tests: misleading test results are further complicated by de-ceptive marketing and other questionable practices. Accessed at www.gao.gov/new.items/d10847t.pdf, Feb 29, 2011.

3. Vorhaus D. Transparency first: a proposal for DTC genetic test-ing regulation. Accessed at www.genomicslawreport.com/index.php/2010/05/24/transparency-first-a-proposal-for-dtc-genetic-testing-regulation/, February 29, 2011.

4. Secretary's Advisory Committee on Genetics, Health and So-ciety. Realizing the potential of pharmacogenomics: opportu-nities and challenges. Accessed at http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_PGx_report.pdf, Feb 29, 2011.

5. Feero WG, Green ED. Genomics education for health care pro-fessionals in the 21st century. JAMA. 2011;306:989–90.

6. Food and Drug Administration. Table of pharmacogenom-ic biomarkers in drug labels. Accessed at www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm, Mar 1, 2012.

7. Frueh FW, Amur S, Mummaneni P, et al. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: prevalence of related drug use. Pharmacotherapy. 2008;28:992–8.

8. Epstein RS, Moyer TP, Aubert RE. Warfarin genotyping re-duces hospitalization rates : results from the MM-WES (Med-co-Mayo Warfarin Effectiveness Study). J Am Coll Cardiol. 2010;55:2804–12.

9. Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358:568–79.

10. Padgett L, O’Connor S, Roederer M, et al. Pharmacogenom-ics in a community pharmacy: ACT now. J Am Pharm Assoc. 2010;51:189–93.

11. Schommer JC, Doucette WR, Johnson KA, et al. Position-ing and integrating medication therapy management. J Am Pharm Assoc. 2012;52:e1–13.

12. O’Connor SK, Ferreri SP, Michaels NM, et al. Exploratory plan-ning and implementation of a pilot pharmacogenetic program in a community pharmacy. Pharmacogenomics. 2012;13:955–62.

13. Crews KR, Cross SJ, McCormick JN, et al. Development and implementation of a pharmacist-managed clinical pharmaco-genetics service. Am J Health Syst Pharm. 2011;68:143–50.

14. Snyder B. Scripps Research and Vanderbilt launch joint insti-tute to advance science at interface of chemistry and medi-cine. Accessed at http://news.vanderbilt.edu/2011/01/scripps-research-and-vanderbilt-launch-joint-institute-to-advance-sci-ence-at-interface-of-chemistry-and-medicine/, March 1 , 2012.

15. Overby CL, Tarczy-Hornoch P, Hoath JI, et al. Feasibility of incorporating genomic knowledge into electronic medical records for pharmacogenomic clinical decision support. BMC Bioinformatics. 2010;11(suppl 9):s10.

16. Scott SA, Sangkuhl K, Gardner EE, et al. Clinical pharmacoge-netics implementation consortium guidelines for cytochrome P450-2C19 genotype and clopidogrel therapy. Clin Pharmacol Ther. 2011;90:328–32.

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