Ready or not,here it comes: Direct-to-consumer pharmacogenomic testing and its implications for community pharmacists

ObjectiveTo explore the implications of direct-to-consumer pharmacogenomic testing for community pharmacy practice.SummaryIn October 2018, the U.S. Food and Drug Administration provided approval for direct-to-consumer genetic testing company, 23andMe (Mountain View, CA), to return select pharmacogenomic test results to their customers. Given the community pharmacist’s high accessibility to the public and in-depth knowledge of pharmacology, and the availability of direct-to-consumer genetic testing kits at pharmacies, it is likely that patients will present their pharmacogenomic test results to their pharmacists and expect them to incorporate those results into their care. It is important, therefore, that community pharmacists are aware of the clinical implications of these results, know where to turn for evidence-based clinical pharmacogenomics information, and be mindful of the need for confirmatory testing before changing therapy.ConclusionCommunity pharmacists are at the frontlines of health care, and as such will be at the frontlines of direct-to-consumer pharmacogenomic testing. In the near future, it is likely that community pharmacists will need to counsel patients on the interpretation and appropriate use of direct-to-consumer pharmacogenomic test results.     

Clinical impact of a community pharmacy-based health and wellness introductory pharmacy practice experience

ObjectiveTo assess the clinical impact of an intensive community pharmacy-based Health and Wellness Introductory Pharmacy Practice Experience (IPPE) completed by second-year (P2) student pharmacists.DesignThe Health and Wellness IPPE was a 1-week rotation developed to provide P2 student pharmacists with opportunities to provide clinical services to patients within the community pharmacy setting. Student pharmacists administered immunizations, performed blood pressure screenings and blood glucose measurements, and provided education to patients under the guidance of licensed pharmacist preceptors.Setting and participantsSecond-year student pharmacists completing a required Health and Wellness IPPE rotation in the community pharmacy setting.Outcomes measuredStudent pharmacist interventions were assessed to determine the course’s clinical impact, and preceptors were surveyed regarding the feasibility of student pharmacists performing clinical services at their training sites.ResultsA total of 147 student pharmacists completed the IPPE at 89 community pharmacy training sites and administered 9392 injections, 90% of which were influenza vaccinations. Student pharmacists performed 3458 patient health assessments, including measuring patients’ blood pressure and blood glucose and reviewing patient education materials. Most preceptors indicated that core activities were feasible during the experience.ConclusionThis study found that implementing a concentrated IPPE focused on immunizations and health screenings allowed student pharmacists to enhance their clinical skills and fulfill a large public health need, improving patient outcomes. Future studies should explore utilizing student pharmacists in community pharmacy settings to expand clinical services offered beyond these 2 services, such as diabetes risk tests, influenza point-of-care testing, and smoking cessation counseling.     

Retrospective financial analysis of medication therapy management services from the pharmacy's perspective

ObjectiveTo determine the net financial gain or loss for medication therapy management (MTM) services provided to patients by an independent community pharmacy during 16 months of operation.DesignRetrospective study.SettingIndependent community pharmacy in Iowa City, IA, from September 1, 2006, to December 31, 2007.PatientsPatients receiving MTM services during the specified period who had proper documentation of reimbursement for the services.InterventionMTM services were provided to the patient and documented by the pharmacist or student pharmacist.Main outcome measureNet financial gains or losses for providing MTM services. Sensitivity analyses included costs that might be incurred under various conditions of operation.Results103 initial and 88 follow-up MTM visits were conducted during a 16-month time period. The total cost for these services to the pharmacy was $11,191.72. Total revenue from these services was $11,195.00; therefore, the pharmacy experienced a net financial gain of $3.28. Sensitivity analyses were conducted, revealing the net gain/loss to the pharmacy if a student pharmacist was used and the net gain/loss if the pharmacist needed extra training to provide the services. Using a student pharmacist resulted in a net gain of $6,308.48, while extra training for the pharmacist resulted in a net loss of $1,602.72.ConclusionThe MTM service programs showed a positive financial gain after 16 months of operation, which should encourage pharmacists to incorporate these services into their practice.     

Integrating pharmacogenomics into pharmacy practice via medication therapy management: American Pharmacists Association

ObjectiveTo explore the application and integration of pharmacogenomics in pharmacy clinical practice via medication therapy management (MTM) to improve patient care.Data sourcesDepartment of Health & Human Services (HHS) Personalized Health Care Initiative, Food and Drug Administration (FDA) pharmacogenomics activity, and findings from the Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Stakeholder Workshop, convened by the American Pharmacists Association (APhA) on March 5, 2009. Participants at the Stakeholder Workshop included diverse representatives from pharmacy, medicine, pathology, health information technology (HIT), standards, science, academia, government, and others with a key interest in the clinical application of pharmacogenomics.SummaryIn 2006, HHS initiated the Personalized Health Care Initiative with the goal of building the foundation for the delivery of gene-based care, which may prove to be more effective for large patient subpopulations. In the years since the initiative was launched, drug manufacturers and FDA have begun to incorporate pharmacogenomic data and applications of this information into the drug development, labeling, and approval processes. New applications and processes for using this emerging pharmacogenomics data are needed to effectively integrate this information into clinical practice. Building from the findings of a stakeholder workshop convened by APhA and the advancement of the pharmacist's collaborative role in patient care through MTM, emerging roles for pharmacists using pharmacogenomic information to improve patient care are taking hold. Realizing the potential role of the pharmacist in pharmacogenomics through MTM will require connectivity of pharmacists into the electronic health record infrastructure to permit the exchange of pertinent health information among all members of a patient's health care team. Addressing current barriers, concerns, and system limitations and developing an effective infrastructure will be necessary for pharmacogenomics to achieve its true potential.ConclusionTo achieve integration of pharmacogenomics into clinical practice via MTM, the pharmacy profession must define a process for the application of pharmacogenomic data into pharmacy clinical practice that is aligned with MTM service delivery, develop a viable business model for these practices, and encourage and direct the development of HIT solutions that support the pharmacist’s role in this emerging field.     

Perceptions of patients on Medicare Part D medication therapy management services

ObjectivesTo determine patients’ perceptions and expectations about medication therapy management (MTM) services pertaining to the core elements of an MTM service in the community pharmacy setting, and to develop educational strategies and outreach programs aimed at increasing patients’ knowledge of MTM services and the expanded role of pharmacists in the community pharmacy setting.DesignMulticenter, cross-sectional, anonymous study.SettingFour regional community chain pharmacies in Maryland and Delaware in January and February 2006.Patients81 patients who were 18 years of age or older and able to complete the survey.InterventionSurvey containing 14 questions administered within pharmacies, two of which had patient care centers that were providing clinical services.Main outcome measurePatients’ perceptions and expectations regarding MTM services.Results49 of 81 patients (60%) had never heard of MTM services. A total of 65 patients (80%) had never had or received a medication therapy review, 63 (78%) never had or received a personal medication record, and 70 (86%) never had or received a medication action plan. Some 56% of participants (n = 45) thought that pharmacist provision of medication therapy reviews, personal medication records, medication action plans, recommendations about medications, and referral to other health care providers was very important. At least 70% of participants (n = 57) thought that having one-on-one consultation sessions with pharmacists to improve communication and relationships with their pharmacists and to improve their medication use and overall health was very important. More than 50% of participants indicated that they would like to receive brochures or talk to their pharmacist to learn more about MTM services.ConclusionPatients have very limited knowledge of the core elements of an MTM service in the community pharmacy setting. Patients reported that pharmacist provision of MTM services was important, but they were concerned about privacy and pharmacists’ time. Patients are also supportive of and believe that MTM services can improve communication and relationship with their pharmacist and improve medication use. Patients appear to prefer receiving brochures and talking to pharmacists to learn more about MTM services. This survey identified a key opportunity for pharmacists to inform patients about MTM services.     

Evaluation of pharmacist-provided medication therapy management services in an oncology ambulatory setting

ObjectivesTo determine the effect of formal medication therapy management (MTM) services on pharmacist workload, as well as to describe the population receiving MTM, describe the services provided, and determine the reimbursement rate for billed MTM services.Data sourcesMTM Current Procedural Terminology (CPT) code claims, electronic medical records, and pharmacist MTM logs.Data synthesisA retrospective review of all MTM charges from January 1, 2010, to March 31, 2010, was performed. Data collected included location of the MTM visit, age, gender, insurance, primary malignancy, comorbidities, home medications, time to complete and document the MTM visit, and rate of reimbursement.ResultsIn the 3-month period, 239 MTM visits were completed. It took pharmacists a median of 20 minutes (range 15–127) of face-to-face time and 18 minutes (5–90) for documentation per visit. To date, no claims for MTM have been rejected, and reimbursement rates range from 47% to 79% depending on the insurance provider.ConclusionsMTM in the ambulatory clinic is feasible despite the increase in pharmacist workload from documenting and billing. The increased visibility of clinical pharmacy services justifies the extra time required for formal MTM.     

Current trends in outpatient pharmacy services and billing

ObjectivesTo provide a summary of community and ambulatory pharmacy practices and billing patterns for medication therapy management (MTM) services and to identify reasons pharmacists report not billing for direct patient care services.DesignCross-sectional study.SettingUnited States, February 2011.ParticipantsMembers of the American College of Clinical Pharmacy Ambulatory Care Practice and Research Network, American Society of Health-System Pharmacists Ambulatory and Chronic Care Practitioners, and American Pharmacists Association MTM e-community.InterventionOnline survey.Main outcome measuresPractice setting, pharmacy services performed, billing technique, and payer, as well as reasons for not billing.ResultsMTM services were provided by 287 pharmacists. The most common practice settings included physician office (23.6%), health-system outpatient facility (21.7%), and community pharmacy (20.2%). A total of 149 of 276 pharmacists (54.0%) reported billing for MTM services; 16 of 276 (5.8%) did not know if they were currently billing. Community pharmacists were more likely to bill than all other sites combined (80.5% vs. 53.1%, P < 0.001), and pharmacists with >75% of visits face-to-face were more likely to bill (66.2% vs. 46.6%, P < 0.002).ConclusionA variety of MTM services are provided in outpatient settings with inconsistent billing techniques and reimbursement. Pharmacists should continue to work toward consistent, sustainable reimbursement to expand MTM services.     

Point-of-care testing for infectious diseases: Opportunities,barriers, and considerations in community pharmacy

ObjectivesTo identify opportunities to perform point-of-care (POC) testing and/or screening for infectious diseases in community pharmacies, provide an overview of such tests and how they are used in current practice, discuss how the Clinical Laboratory Improvement Amendments of 1988 (CLIA) affect pharmacists performing POC testing, and identify and discuss barriers and provide recommendations for those wanting to establish POC testing for infectious diseases services in community pharmacies.Data sourcesPubMed and Google Scholar were searched from November 2012 through May 2013 and encompassed the years 2000 and beyond for the narrative review section of this article using the search terms rapid diagnostic tests, POC testing and infectious diseases, pharmacy services, CLIA waiver, and collaborative drug therapy management. All state boards of pharmacy in the United States were contacted and their regulatory and legislative websites accessed in 2012 and January 2013 to review relevant pharmacy practice laws.Data synthesisPOC testing for infectious diseases represents a significant opportunity to expand services in community pharmacies. Pharmacist education and training are addressing knowledge deficits in good laboratory practices and test performance and interpretation. Federal regulations do not define the qualifications for those who perform CLIA-waived tests, yet few pharmacists perform such services. Fewer than 20% of states address POC testing in their statutes and regulations governing pharmacy.ConclusionPOC testing for infectious diseases could benefit patients and society and represents an opportunity to expand pharmacy services in community pharmacies. Existing barriers to the implementation of such services in community pharmacies, including deficits in pharmacist training and education along with state regulatory and legislative variance and vagueness in statutes governing pharmacy, are not insurmountable.