Jivan Moaddeb

Improving diabetes medication adherence: successful, scalable interventions.

Effective medications are a cornerstone of prevention and disease treatment, yet only about half of patients take their medications as prescribed, resulting in a common and costly public health challenge for the US health care system. Since poor medication adherence is a complex problem with many contributing causes, there is no one universal solution. This paper describes interventions that were not only effective in improving medication adherence among patients with diabetes, but were also potentially scalable (ie, easy to implement to a large population). We identify key characteristics that make these interventions effective and scalable. This information is intended to inform health care systems seeking proven, low resource, cost-effective solutions to improve medication adherence.

Comparison of delivery strategies for pharmacogenetic testing services.

The number and use of pharmacogenetic tests to assess a patient’s likelihood of response or risk of an adverse event is expanding across medical specialties and becoming more prevalent. During this period of development and translation, different approaches are being investigated to optimize delivery of pharmacogenetic services. In this paper, we review pre-emptive and point-of-care delivery approaches currently implemented or being investigated and discuss the advantages and disadvantages of each approach. The continued growth in knowledge about the genetic basis of drug response combined with development of new and less expensive testing technologies and electronic medical records will impact future delivery systems. Regardless of delivery approach, the currently limited knowledge of health professionals about genetics generally or PGx specifically will remain a major obstacle to utilization.

Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting

AIM To describe the rationale and design of a pilot program to implement and evaluate pharmacogenetic (PGx) testing in a primary care setting. STUDY RATIONALE Several factors have impeded the uptake of PGx testing, including lack of provider knowledge and challenges with operationalizing PGx testing in a clinical practice setting. STUDY DESIGN We plan to compare two strategies for the implementation of PGx testing: a pharmacist-initiated testing arm compared with a physician-initiated PGx testing arm. Providers in both groups will be required to attend an introduction to PGx seminar. Anticipated results: We anticipate that providers in the pharmacist-initiated group will be more likely to order PGx testing than providers in the physician-initiated group. CONCLUSION Overall, we aim to generate data that will inform an effective delivery model for PGx testing and to facilitate a seamless integration of PGx testing in primary care practices.

Incorporation of pharmacogenetic testing into medication therapy management

AIM To assess feasibility and patient satisfaction with a pharmacist-delivered medication therapy management (MTM) plus pharmacogenetic (PGx) testing service. METHODS Thirty patients from a cardiology outpatient clinic were enrolled to attend two MTM sessions, undergo PGx testing and complete pre- and post-intervention surveys. Outcome measures included duration of MTM sessions, clinical application of test results, self-reported medication adherence, patient recall of results and perceived value of testing and MTM. RESULTS Overall, patients were very satisfied with the MTM plus PGx testing service. About half of participants (47%) were able to accurately recall their PGx test results. Comparable to MTM without PGx testing, the first MTM session averaged 40 min and the follow-up MTM session averaged 15 min. CONCLUSION PGx testing incorporated into a clinical MTM service offered by pharmacists may be a feasible delivery model and is satisfactory to patients.

Pharmacogenetic testing: current evidence of clinical utility

Over the last decade, the number of clinical pharmacogenetic tests has steadily increased as understanding of the role of genes in drug response has grown. However, uptake of these tests has been slow, due in large part to the lack of robust evidence demonstrating clinical utility. We review the evidence behind four pharmacogenetic tests and discuss the barriers and facilitators to uptake: (1) warfarin (drug safety and efficacy); (2) clopidogrel (drug efficacy); (3) codeine (drug safety and efficacy); and (4) abacavir (drug safety). Future efforts should be directed toward addressing these issues and considering additional approaches to generating evidence basis to support clinical use of pharmacogenetic tests.

Community pharmacists’ experience with pharmacogenetic testing

OBJECTIVE Appendix 1 Statements of knowledge of correct medication use Appendix 2 Statements of self-efficacy of correct medication use Appendix 3 Statements of skills of correct medication use To characterize the experiences and feasibility of offering pharmacogenetic (PGx) testing in a community pharmacy setting. DESIGN Pharmacists were invited to complete a survey about PGx testing for each patient who was offered testing. If the patient consented, pharmacists were also asked to complete a follow-up survey about the process of returning PGx testing results to patients and follow-up with the prescribing provider. SETTING Community pharmacies in North Carolina from August through November 2014. PARTICIPANTS Pharmacists at five community pharmacies. MAIN OUTCOME MEASURES Patient consent for testing, time to introduce PGx testing initially and communicate results, interpretation of test results, and recommended medication changes. RESULTS Of the 69 patients offered testing, 56 (81%) consented. Pre-test counseling typically lasted 1-5 minutes (81%), and most patients (55%) did not have any questions about the testing. Most pharmacists reported test results to patients by phone (84%), with discussions taking less than 1 minute (48%) or 1-5 minutes (52%). Most pharmacists believed the patients understood their results either very well (54%) or somewhat well (41%). Pharmacists correctly interpreted 47 of the 53 test results (89%). All of the incorrect interpretations were for patients with test results indicating a dosing or drug change (6/19; 32%). Pharmacists reported contacting the ordering physician for four patients to discuss results indicating a dosage or drug change. CONCLUSION The provision of PGx services in a community pharmacy setting appears feasible, requiring little additional time from the pharmacist, and many patients seem interested in PGx testing. Additional training may be necessary to improve test result interpretation, as well as for communication with both patients and ordering physicians.

Pharmacogenetic information for patients on drug labels.

Advances in pharmacogenetic research have improved our understanding of adverse drug responses and have led to the development of pharmacogenetic tests and targeted drugs. However, the extent of the communication process and provision of information to patients about pharmacogenetics is unclear. Pharmacogenetic information may be included in sections of a drug’s package insert intended for patients, which is provided directly to patients or communicated via the health provider. To determine what pharmacogenetic information, if any, is included in patient-targeted sections of the drug label, we reviewed the labels listed in the US Food and Drug Administration’s Table of Pharmacogenomic Biomarkers in Drug Labels. To date, 140 drugs include pharmacogenetic-related information in the approved label. Our analysis revealed that pharmacogenetic information is included in patient-targeted sections for a minority (n=29; 21%) of drug labels, with no obvious pattern associated with the inclusion of pharmacogenetic information. Therefore, patients are unlikely to learn about pharmacogenetics through written materials dispensed with the drug. Given that there are also inconsistencies with regard to inclusion of pharmacogenetic information in the patient counseling information section, it is also unlikely that patients are receiving adequate pharmacogenetic information from their provider. The inconsistent presence of pharmacogenetic information in patient-targeted sections of drug labels suggests a need to review the criteria for inclusion of information in patient-targeted sections in order to increase consistency and patient knowledge of pharmacogenetic information.

Primary care providers’ use of pharmacist support for delivery of pharmacogenetic testing

AIM To investigate provider utilization of pharmacist support in the delivery of pharmacogenetic testing in a primary care setting. METHODS Two primary care clinics within Duke University Health System participated in the study between December 2012 and July 2013. One clinic was provided with an in-house pharmacist and the second clinic had an on-call pharmacist. RESULTS Providers in the in-house pharmacist arm consulted with the pharmacist for 13 of 15 cases, or about one of every four patients tested compared with one of every 7.5 patients in the on-call pharmacist arm. A total of 63 tests were ordered, 48 by providers in the pharmacist-in-house arm. CONCLUSION These findings suggest that the availability of an in-house pharmacist increases the likelihood of pharmacogenetic test utilization.

Evaluation of a pharmacogenetic educational toolkit for community pharmacists.

AIM Over the past several decades, the roles and services of community pharmacists have expanded beyond traditional medical dispensation and compounding, and include health services such as vaccinations, and clinical testing and screening. Incorporating pharmacogenetic (PGx) testing into the menu of pharmacy services is logical and feasible; however, few pharmacists have experience with PGx testing, and few educational resources about PGx are available to support the uptake of PGx testing in community pharmacies. METHODS We developed a toolkit of four resources to assist pharmacists to provide PGx testing. We conducted a survey of pharmacists in North Carolina to evaluate each component of the toolkit and the toolkit as a whole. RESULTS A total of 380 respondents completed the evaluation of one or more toolkit components (344 evaluated all four components and the overall toolkit). Most respondents (84%) have never ordered or used PGx test results. Though the usability of the toolkit overall was below average (65.1 on a range of 0-100), individual components were perceived as useful and more than 75% of pharmacists reported that they would use the toolkit components when offering testing, with the result summary sheet receiving the highest score (4.01 out of 5). Open-text comments highlighted the need for more patient-friendly language and formatting. CONCLUSION The majority of pharmacist respondents scored the components of the toolkit favorably. The next steps will be to revise and assess use of the toolkit in community pharmacy settings.

Proposal for a pharmacogenetics certificate program for pharmacists.

The delivery of pharmacogenetic (PGx) testing has expanded outside of the traditional clinical setting to include community pharmacies. While pharmacists have been involved as a liaison between the clinical testing laboratory and ordering clinician, assisting with interpretation or application of results [1–3], the delivery of clinical testing by a community pharmacist marks another step in the expansion of roles and pharmacy services. Many community pharmacies currently offer tuberculosis testing, blood pressure monitoring, and now some have begun to offer PGx testing. Despite their interest in PGx testing, pharmacists have recognized their limited training and lack of knowledge and skills regarding PGx [4–7]. For several years, professional pharmacy organizations have called for enhanced training and curricula in PGx to prepare pharmacists to use and apply PGx testing [8–13]. Some state pharmacy boards require certification or specialized training to perform certain services, but do not yet require it for PGx testing. In this article, we propose the development of a certification program that pharmacists would be required to complete before offering PGx testing. Pharmacist certification in PGx could ensure the appropriate and safe use of PGx testing and optimize the lifetime benefits to patients. In the USA, training requirements to provide specific pharmacy services are determined and approved by state pharmacy boards. For example, provision of immunization services requires completion of the pharmacy-based immunization delivery certificate training program, which provides pharmacists the knowledge to administer and implement immunization services [14]. For other services, additional training is recommended; completion of the Medication Therapy Management (MTM) Certificate Training Program is recommended for pharmacists wishing to provide MTM services. This training program provides skills-based training on how to interview a patient, identifying and prioritizing medicationrelated programs, developing interventions and documenting activities. States may opt to develop their own training programs or approve completion of training programs offered by national pharmacy groups or private vendors to meet the state requirements. For example, New Mexico pharmacists interested in offering tuberculosis testing must complete a training program offered by the state health department [15]. The American Pharmacist Association (APhA), one of the oldest pharmacy associations, has developed certificate or training programs to ensure pharmacists are qualified to perform certain services for immunization delivery, diabetes care, MTM and cardiovascular disease risk management [16]. A recent search (14 October 2015) of the three types of continuing education programs (knowledge, application, practice) approved by the US Accreditation Council for Pharmacy Education (ACPE [17]) Proposal for a pharmacogenetics certificate program for pharmacists