RESEARCH

Implementation of personalized medicine services in community pharmacies: Perceptions of independent community pharmacists Katelyn M. Alexander, Holly S. Divine, Cathy R. Hanna, Yevgeniya Gokun, and Patricia R. Freeman

Abstract Objectives: To evaluate the perceptions of independent community pharmacists within a regional independent community pharmacy cooperative on implementing personalized medicine services at their pharmacies and to gauge the pharmacists’ self-reported knowledge of pharmacogenomic principles. Design: Descriptive, exploratory, nonexperimental study. Setting: American Pharmacy Services Corporation (APSC), 2011–12. Participants: Pharmacists (n = 101) affiliated with the independent pharmacies of APSC. Intervention: Single-mode survey. Main outcome measures: Independent community pharmacists’ interest in implementing personalized medicine services, perceived readiness to provide such services, and perceived barriers to implementation. Results: 101 completed surveys were returned for data analysis. The majority of pharmacists surveyed (75%) expressed interest in offering personalized medicine services. When asked to describe their knowledge of pharmacogenomics and readiness to implement such services, more than 50% said they were not knowledgeable on the subject and would not currently be comfortable making drug therapy recommendations to physicians or confident counseling patients based on results of genetic screenings without further training and education. Respondents identified cost of providing the service, reimbursement issues, current knowledge of pharmacogenomics, and time to devote to the program as the greatest barriers to implementing personalized medicine services. Conclusion: The majority of independent community pharmacists are interested in incorporating personalized medicine services into their practices, but they require further education before this is possible. Future initiatives should focus on the development of comprehensive education programs to further train pharmacists for provision of these services. Keywords: Community pharmacy, pharmacogenomics, personalized medicine. J Am Pharm Assoc. 2014; 54:510–517. doi: 10.1331/JAPhA.2014.13041

Received February 21, 2013, and in revised form October 10, 2013. Accepted for publication February 26, 2014. Published online in advance of print August 24, 2014. Katelyn M. Alexander, PharmD, is Assistant Professor, Bill Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN; at the time of research, she was Community Pharmacy Resident, College of Pharmacy, University of Kentucky, Lexington. Holly S. Divine, PharmD, BCACP, CGP, CDE, FAPhA, is Clinical Associate Professor, College of Pharmacy, University of Kentucky, Lexington. Cathy R. Hanna, PharmD, is Vice President of Professional Affairs, American Pharmacy Services Corporation, Frankfort, KY. Yevgeniya Gokun, MS, is Statistician, College of Nursing, University of Kentucky, Lexington; at the time of research, she was statistician, College of Pharmacy, University of Kentucky, Lexington. Patricia R. Freeman, PhD, is Clinical Associate Professor and Director of the Center for the Advancement of Pharmacy Practice, College of Pharmacy, University of Kentucky, Lexington. Correspondence: Katelyn M. Alexander, PharmD, Bill Gatton College of Pharmacy, East Tennessee State University, P.O. Box 70657, Johnson City, TN 37614. Fax: 423439-6784. E-mail: [email protected] Disclosure: The authors declare no conflicts of interest or financial interest in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: American Pharmacists Association Foundation Incentive Grant; additional support provided by the National Institute of Health’s (NIH) National Center for Research Resources and National Center for Advancing Translational Sciences (grant 8UL1TR000117-02). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH. Acknowledgment: The authors would like to acknowledge the American Pharmacists Association Foundation for providing an incentive grant to support this research. Additionally, the authors extend a special thank you to the American Pharmacy Services Corporation pharmacists who participated in this study. Previous presentation: American Pharmacists Association Annual Meeting, New Orleans, LA, March 10, 2012.

510 JAPhA | 5 4:5 | S E P /OCT 2 0 1 4

ja p h a.org

Journal of the American Pharmacists Association

PERSONALIZED MEDICINE SERVICES IN COMMUNITY PHARMACY RESEARCH

T

he field of pharmacogenomics and its use in personalized medicine has grown extensively throughout the past decade, and it is now transitioning from the lab bench to everyday medical practice. Pharmacogenomic testing identifies the influence of variations throughout an individual’s entire genome on drug response.1 Incorporating testing results with other patient-specific factors allows therapy and drug regimens to be tailored to meet the needs of each unique patient. The U.S. Food and Drug Administration (FDA) is working to add pertinent pharmacogenomic information to drug labeling and has efforts in place to proactively study the impact of genomics at the drug development level.2 With the necessary science available to successfully incorporate pharmacogenomic information into patient care plans, the question remains how this technology will be incorporated into the current medical model. Pharmacogenomic testing cannot expand without physicians and other prescribers committing to its use in their practice, as physicians are central to medication prescribing. A recent broad survey of U.S. physicians found that while a high percentage of respondents (98%) agreed that genetics may influence a patient’s response to medication, very few (10%) felt sufficiently informed about genetic testing and its relevance in making drug therapy choices in their practice.3 Additionally, the majority of physicians (71%) responded that they had no formal education in pharmacogenomics.3

At a Glance

Synopsis: Independent community pharmacists appear largely willing to include personalized medicine services such as pharmacogenomic screenings in their pharmacy practices, but many lack confidence in their existing knowledge of such services. This survey-based study of 101 pharmacists affiliated with a regional independent community pharmacy cooperative found that the majority of respondents are receptive to the comprehensive education programming on personalized medicine required for offering these services in the future. Analysis: Considering health care’s current focus on patient safety and outcomes, it is logical that personalized medicine will become an important component of pharmacy practice. Product information for numerous drugs already indicates genetic testing before dispensing. Community pharmacists are thus well-positioned to provide pharmacogenomic services and to maintain patients’ testing results for consideration in future drug therapy recommendations. The authors recommend that future initiatives focus on the development of comprehensive education programs targeted to this group of pharmacists to prepare them for provision of these services.

Journal of the American Pharmacists Association

Stanek et al. found that this disparity in knowledge in the physician community extends toward clinical issues as well, with physicians questioning how to incorporate testing into their practice, how to use the results, and how to apply them in real-world cases.3 These needs have led to calls for medical educators to better prepare new practitioners for personalized pharmacotherapy to increase the likeliness that they will incorporate pharmaco­genomic testing into their practice in the future.4 The level of patient interest in and acceptance of pharmacogenomic testing will also influence the extent to which such screenings are incorporated into practice. While a majority of patients have heard of genetic testing, many do not understand its benefits and place in health care.5 Surprisingly, this lack of understanding does not seem to adversely affect patients’ interest in having pharmacogenomic testing done for various purposes.6 One common concern among patient groups is how exactly such private health information will be stored and accessed. A nationwide survey found that the majority of patients are comfortable sharing the results of pharmacogenomic testing with their physician (90%) or pharmacist (74%).7 This finding points to the need for a collaborative partnership between the medical and pharmacy communities regarding the provision of pharmacogenomic testing services and the clinical use of testing results. Physicians’ hesitance to provide pharmacogenomic testing is at odds with the high level of patient interest in receiving these types of services, leading many patients to pursue testing elsewhere. Pharmacogenomic testing products are widely available on the Internet, for example, but patients are not capable of interpreting the results on their own. This presents an ideal opportunity for pharmacists, who are both accessible to patients and have extensive knowledge of medications, to play a critical role in the provision of pharmacogenomic services in collaboration with prescribers.8 Pharmacists could also provide counseling on testing results, as well as maintain patient-specific genetic information for use in future treatment decisions. However, the question remains as to whether or not pharmacists want to answer the call. Successful models involving pharmacist providers have already been demonstrated on the inpatient side,9 but implementation of such models is not widespread. In community-based practice, there may be opportunities to incorporate pharmacogenomic screenings with existing medication therapy management (MTM) services, which are already widely provided by many pharmacists.10–12 Previous research has identified some potential barriers to applying pharmacogenomic information in pharmacy practice, including lack of pharmacist knowledge on the subject,13–15 lack of reimbursement for services and other cost concerns,16 ethical concerns,16 j apha.org

SEP/OC T 2014 | 54:5 |

JAPhA 511

RESEARCH

PERSONALIZED MEDICINE SERVICES IN COMMUNITY PHARMACY

perceived limited clinical applicability,17 and inability to integrate data with current technology.18 However, these issues have primarily been explored separately and have never been considered specific to independent pharmacists. Independent community pharmacies are most likely to serve as initial sites for the provision of pharmaco­ genomic services. Historically, many patient care services have started in independent pharmacies because independent owners can more easily adapt their business plans to include unique programs. Independent community pharmacies are well-represented across the country, and many already offer other specialized services and point-of-care testing. According to the National Community Pharmacists Association, 23,106 independent community pharmacies employed more than 300,000 individuals in 2011.19 No recent literature has specifically addressed the interest of independent pharmacists in providing pharmaco­genomic services. In 2012, Roederer et al. assessed pharmacists’ knowledge of and attitudes toward pharmacogenomics testing by surveying practitioners from a wide array of settings, including inpatient, academic, and community practice sites;14 however, the study did not distinguish pharmacists in the independent sector from other community pharmacists. In 2003, Sansgiry and Kulkarni found that community pharmacists lacked confidence in their knowledge of genetic testing and pharmacogenomics, but fewer than 30% of those surveyed identified themselves as independent community pharmacists.15 Because independent community pharmacists generally have a much greater role in managing the business aspects of practice than pharmacists in other practice settings, it is critical to complete focused research to assess the unique challenges of these practitioners and their actual willingness to adopt pharmacogenomic and personalized medicine services.

Objectives The primary objectives of this study were to evaluate the perceptions of independent community pharmacists regarding the implementation of personalized medicine services at their pharmacies, and to gauge self-reported knowledge of pharmacogenomic principles. The secondary objective was to determine the perceived barriers that limit independent pharmacists’ willingness to provide such services.

Methods To identify the perceptions of independent community pharmacists about personalized medicine services, researchers at the University of Kentucky College of Pharmacy partnered with American Pharmacy Services Corporation (APSC), a local cooperative owned and operated by independent community pharmacies whose 512 JAPhA | 5 4:5 | S E P /OCT 2 0 1 4

ja p h a.org

mission is to represent the professional and economic interest of its shareholders and to keep them informed on legislative issues related to pharmacy.20 At the time of this study, APSC had shareholders throughout the United States, including in Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Ohio, Pennsylvania, and West Virginia. Research similar to this study as well as other clinical pharmacy education programs have been supported through the APSC Foundation for Education & Research, Inc., which provides access to continuing and post-graduate education for licensed pharmacists, student pharmacists, and ancillary pharmacy personnel. For the study, six pharmacists created and field­tested an anonymous 30-question survey to help refine development and enhance usability of the final survey instrument. The target survey audience included independent pharmacy owners, pharmacists-in-charge (PICs), and staff pharmacists affiliated with APSC shareholder pharmacies. The only inclusion criterion was affiliation with an APSC member pharmacy. There were no exclusion criteria. The study was reviewed and approved by the University of Kentucky Institutional Review Board. The final survey (Appendix 1, available under Supplemental Content on JAPhA.org) comprised three main sections. Section 1 collected demographic information (e.g., age, gender, practice location, years in practice, degrees/training, job status, and job satisfaction) and such pharmacy-specific information as number of prescriptions dispensed daily and currently offered patient care services. Section 2 evaluated self-reported knowledge of issues related to pharmacogenomics, confidence in providing personalized medicine services and pharmacogenomics counseling to patients and physicians, and willingness to participate in such services. Before introduction of questions in this section, the survey provided generalized definitions for several related topics, including personalized medicine; pharmacogenomics; genetic polymorphisms; and pharmacogenomics screening. Responses in this section were based on a 4-point Likert scale (1, strongly disagree, to 4, strongly agree). Section 3 of the survey assessed sources of educational exposure to personalized medicine concepts, interest in receiving further comprehensive training on pharmacogenomics, the means by which pharmacists would preferred to have such training delivered, overall interest in participating in personalized medicine services, and perceived barriers to the provision of such services. Every APSC member pharmacy (n = 416) was sent a survey via fax, and those with e-mail addresses registered with APSC were also sent an electronic copy. A cover letter provided explicit directions, including information on the study’s purpose and approximate time to complete the survey. Additionally, the cover letter Journal of the American Pharmacists Association

PERSONALIZED MEDICINE SERVICES IN COMMUNITY PHARMACY RESEARCH

assured potential respondents that participation in the survey, as well as completion of any individual survey question, was optional and anonymous, and made it clear that each pharmacist responder was to complete the survey only once. Participating pharmacists could return the finished survey to the APSC office by fax or complete the survey online. Data from online submissions were collected and managed using the secure Web-based application REDCap.21 After distributing the initial survey and cover letter by fax and e-mail, follow-up reminders were distributed at 2 and 4 weeks. A final reminder was sent at week 6. Surveys were collected over an 8-week period between December 2011 and February 2012. Microsoft Excel was used to tabulate all survey data­, and descriptive statistics were generated using SAS (version 9.3; SAS Institute, Cary, NC).

Results Of the 416 surveys sent out to shareholder pharmacies, 101 were returned for analysis. Because the survey was open to all pharmacists practicing at shareholder pharmacies and because each pharmacy employed an unknown number of pharmacists who were eligible for participation, it is impossible to calculate an exact response rate. If we assume that only one pharmacist from each pharmacy responded to the survey, the response rate would be 24.3%. Table 1 displays respondent demographics. All respondents were pharmacists; none identified themselves as pharmacy technicians. One-half of respondents (50%) were aged 50 years or older, and a majority (65%) had been practicing in

the community pharmacy setting for at least 15 years. Regarding education and training, a large majority of respondents graduated with a BSPharm degree, while only one-third held a PharmD, and few had completed postgraduate training. As for job status, 54% of respondents were pharmacy owners, 24% were PICs, and 22% were staff pharmacists. Most respondents reported that their pharmacies currently offered specialized services, including but not limited to immunizations (66%), sale of durable medical equipment (63%), disease state management programs (27%), MTM (69%), compounding (69%), and health screenings (37%). Additionally, 75% of respondents reported interest in offering personalized medicine services at their pharmacies (Figure 1). When asked to self-report their knowledge of pharmaco­genomics (Figure 2), 74% of the pharmacist respondents said they did not feel qualified to provide personalized medicine services at their pharmacy. Additionally, 63% of respondents expressed lack of confidence in their ability to counsel patients based on the results of a pharmacogenomic screening, while 56% said they would not be comfortable making recommendations to physicians based on those results. However, in terms of willingness to implement such services, an overwhelming number of respondents (69%) said they would be willing to conduct pharmacogenomic screenings at their pharmacy. Respondents were also asked to rank a series of nine commonly identified barriers to implementing pharmaco­genomic screenings and personalized medicine services in order of perceived burden (1, most burdensome, to 9, least burdensome; Table 2). Lack of reim-

60.00%

50.00%

40.00%

30.00%

20.00%

10.00%

0.00%

Very interested

Interested

Neutral

Not very interested

Definitely not interested

Figure 1. Pharmacists’ interest in offering personalized medicine services Journal of the American Pharmacists Association

j apha.org

SEP/OC T 2014 | 54:5 |

JAPhA 513

RESEARCH

PERSONALIZED MEDICINE SERVICES IN COMMUNITY PHARMACY

Table 2. Pharmacists’ perceived barriers to implementing personalized medicine servicesa

Table 1. Demographic profile of respondents (n = 101)a Characteristic Age (years) 20–29 30–49 ≥50 Years in community practice

Implementation of personalized medicine services in community pharmacies: perceptions of independent community pharmacists.

To evaluate the perceptions of independent community pharmacists within a regional independent community pharmacy cooperative on implementing personal...
2MB Sizes 2 Downloads 3 Views