Christine M. Formea

Development and Evaluation of a Pharmacogenomics Educational Program for Pharmacists

Objectives. To evaluate hospital and outpatient pharmacists’ pharmacogenomics knowledge before and 2 months after participating in a targeted, case-based pharmacogenomics continuing education program. Design. As part of a continuing education program accredited by the Accreditation Council for Pharmacy Education (ACPE), pharmacists were provided with a fundamental pharmacogenomics education program. Evaluation. An 11-question, multiple-choice, electronic survey instrument was distributed to 272 eligible pharmacists at a single campus of a large, academic healthcare system. Pharmacists improved their pharmacogenomics test scores by 0.7 questions (pretest average 46%; posttest average 53%, p=0.0003). Conclusions. Although pharmacists demonstrated improvement, overall retention of educational goals and objectives was marginal. These results suggest that the complex topic of pharmacogenomics requires a large educational effort in order to increase pharmacists’ knowledge and comfort level with this emerging therapeutic opportunity.

Perspectives on Physical Activity Among Immigrants and Refugees to a Small Urban Community in Minnesota

Immigrants and refugees to the United States exhibit relatively low levels of physical activity, but reasons for this disparity are poorly understood. 16 gender and age-stratified focus groups were conducted among 127 participants from heterogenous immigrant and refugee groups (Cambodian, Mexican, Somali, Sudanese) in a small Minnesota urban community. We found many similarities in perceived barriers and facilitators to physical activity between heterogeneous immigrant and refugee groups. While the benefits of physical activity were widely acknowledged, lack of familiarity and comfort with taking the first steps towards being physically active were the most significant barriers to physical activity. Participants described being motivated by social support from family, friends, and communities to be physically active. Our findings suggest that shared experiences of immigration and associated social, economic, and linguistic factors influence how physical activity is understood, conceptualized and practiced.

A focus group study of healthy eating knowledge, practices, and barriers among adult and adolescent immigrants and refugees in the United States

BackgroundImmigrants and refugees to the United States exhibit lower dietary quality than the general population, but reasons for this disparity are poorly understood. In this study, we describe the meanings of food, health and wellbeing through the reported dietary preferences, beliefs, and practices of adults and adolescents from four immigrant and refugee communities in the Midwestern United States.MethodsUsing a community based participatory research approach, we conducted a qualitative research study with 16 audio-recorded focus groups with adults and adolescents who self-identified as Mexican, Somali, Cambodian, and Sudanese. Focus group topics were eating patterns, perceptions of healthy eating in the country of origin and in the U.S., how food decisions are made and who in the family is involved in food preparation and decisions, barriers and facilitators to healthy eating, and gender and generational differences in eating practices. A team of investigators and community research partners analyzed all transcripts in full before reducing data to codes through consensus. Broader themes were created to encompass multiple codes.ResultsResults show that participants have similar perspectives about the barriers (personal, environmental, structural) and benefits of healthy eating (e.g., ‘junk food is bad’). We identified four themes consistent across all four communities: Ways of Knowing about Healthy Eating (‘Meanings;’ ‘Motivations;’ ‘Knowledge Sources’), Eating Practices (‘Family Practices;’ ‘Americanized Eating Practices’ ‘Eating What’s Easy’), Barriers (‘Taste and Cravings;’ ‘Easy Access to Junk Food;’ ‘Role of Family;’ Cultural Foods and Traditions;’ ‘Time;’ ‘Finances’), and Preferences for Intervention (‘Family Counseling;’ Community Education;’ and ‘Healthier Traditional Meals.’). Some generational (adult vs. adolescents) and gender differences were observed.ConclusionsOur study demonstrates how personal, structural, and societal/cultural factors influence meanings of food and dietary practices across immigrant and refugee populations. We conclude that cultural factors are not fixed variables that occur independently from the contexts in which they are embedded.

Clinical Perspective on the Clinical Pharmacogenetics Implementation Consortium Updated 2014 Guidelines for CYP2D6 and Codeine

As pharmacogenomics makes further advances into clinical practice, the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines provide considerable assistance in clinical decision making. The new 2014 CPIC guidelines on CYP2D6 and codeine (1) have an update on considerations for clinicians and healthcare providers. The previous CPIC guidelines provided recommendations primarily on codeine and tramadol. The new guidelines maintain the dosing recommendations for codeine—specifically, to avoid codeine in both CYP2D6 poor and ultrarapid metabolizers; however, the guidelines take another step forward by noting that, not only may tramadol be problematic, but hydrocodone and oxycodone are also not considered good analgesic alternatives when metabolic concerns exist with CYP2D6. Additionally, this update recommends alternatives with the following statement: “To avoid treatment complications, opioids that are not metabolized by CYP2D6, including morphine, oxymorphone, buprenorphine, fentanyl, methadone, and hydromorphone, along with nonopioid analgesics, may be considered as alternatives for use in CYP2D6 poor metabolizers and in ultrarapid metabolizers….” Although appropriate from a CYP2D6 metabolic standpoint, these recommendations may present some challenges to healthcare providers when applied to some clinical settings. Pain is one of the leading reasons a patient presents to healthcare providers, which includes physicians, dentists, physician assistants, and nurse practitioners in both inpatient hospital and outpatient clinic community settings. Many healthcare providers follow a WHO ladder “type” approach for the treatment of pain (2). In this paradigm, depending on the severity of the pain, a nonopioid drug is considered as a first step in pain management (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs). The second step employs an opioid commonly used for moderate pain (e.g., tramadol, codeine, hydrocodone, and possibly oxycodone), often in combination with acetaminophen or nonsteroidal anti-inflammatory drugs. The third step includes the use of an opioid usually reserved for severe pain presentation (e.g., morphine, oxymorphone, fentanyl, methadone, and hydromorphone). Of concern, the new …

Implementing Genomic Clinical Decision Support for Drug‐Based Precision Medicine

The explosive growth of patient‐specific genomic information relevant to drug therapy will continue to be a defining characteristic of biomedical research. To implement drug‐based personalized medicine (PM) for patients, clinicians need actionable information incorporated into electronic health records (EHRs). New clinical decision support (CDS) methods and informatics infrastructure are required in order to comprehensively integrate, interpret, deliver, and apply the full range of genomic data for each patient.

Lessons Learned: Cultural and Linguistic Enhancement of Surveys Through Community-Based Participatory Research

Background: Surveys are frequently implemented in community-based participatory research (CBPR), but adaptation and translation of surveys can be logistically and methodologically challenging when working with immigrant and refugee populations. Objective: We sought to describe a process of participatory survey adaptation and translation. Methods: Within an established CBPR partnership, a survey about diabetes was adapted for health literacy and local relevance and then translated through a process of forward translation, group deliberation, and back translation. Lessons Learned: The group deliberation process was the most time-intensive and important component of the process. The process enhanced community ownership of the larger project while maximizing local applicability of the product. Conclusions: A participatory process of survey adaptation and translation resulted in significant revisions to approxi- mate semantic, cultural, and conceptual equivalence with the original surveys. This approach is likely to enhance com - munity acceptance of the survey instrument during the implementation phase.

An inter-professional approach to personalized medicine education: one institution's experience

Personalized medicine offers the promise of better diagnoses, targeted therapies and individualized treatment plans. Pharmacogenomics is an integral component of personalized medicine; it aids in the prediction of an individuals response to medications. Despite growing public acceptance and emerging clinical evidence, this rapidly expanding field of medicine is slow to be adopted and utilized by healthcare providers, although many believe that they should be knowledgeable and able to apply pharmacogenomics in clinical practice. Institutional infrastructure must be built to support pharmacogenomic implementation. Multidisciplinary education for healthcare providers is a critical component for pharmacogenomics to achieve its full potential to optimize patient care. We describe our recent experience at the Mayo Clinic implementing pharmacogenomics education in a large, academic healthcare system facilitated by the Mayo Clinic Center for Individualized Medicine.

Enhancing participant safety through electronically generated medication order sets in a clinical research environment: a medical informatics initiative.

While clinical medicine is often well supported by health system information technology infrastructure, clinical research may need to create strategies to use clinical‐medicine informational technology tools. The authors describe a medication‐safety initiative that was carried out in a National Institutes of Health Clinical and Translational Science Award (CTSA)‐sponsored clinical research environment. A web based, medical informatics application was designed and implemented that allowed research groups to build protocol specific, electronic medication templates that were subsequently used to create participant‐specific medication order sets for conductance of clinical research activities in the CTSA‐sponsored clinical research environment. The medical informatics initiative eliminated typewritten or handwritten medication orders, created research protocol‐specific templates meeting institutional order‐writing requirements, and formalized a rigorous review and approval process. Enhancing safety in medication ordering and prescribing practices in a clinical research environment provided the background for multidisciplinary cooperation in medical informatics. Clin Trans Sci 2010; Volume 3: 312–315

A patient-centered approach to the development and pilot of a warfarin pharmacogenomics patient education tool for health professionals

Objective To describe an exploratory project to develop and pilot a novel patient educational tool that explains the concept of pharmacogenomics and its impact on warfarin dosing that can be utilized by health professionals providing patient counseling. Methods A pharmacogenomics educational tool prototype was developed by an interdisciplinary team. During the pilot of the tool, focus group methodology was used to elicit input from patients based upon their perspectives and experiences with warfarin. Focus group sessions were audio-recorded and transcribed, and the data was analyzed through consensus coding in NVivo. Results The focus group participants were generally unfamiliar with the concept of pharmacogenomics but were receptive to the information. They thought the patient education tool was informative and would provide the most benefit to patients newly initiated on warfarin therapy. Conclusions Preliminary results from this exploratory project suggest that implementation and further feasibility testing of this pharmacogenomics patient education tool should be performed in a population of newly initiated patients taking warfarin.

A collaborative effort to comply with USP chapter 797 for compounding sterile preparations for investigational use.

PURPOSE A collaborative effort between two pharmacy specialty areas for ensuring compliance with United States Pharmacopeia (USP) chapter 797 for compounded sterile preparations (CSPs) is described. SUMMARY In September 2005, an investigational drug service (IDS) satellite was opened at a 1157-bed, level 1 trauma, academic hospital in Minnesota. After construction of the IDS satellite, a collaborative consulting service was established between the two pharmacy areas. Protocol-specific investigational medications requiring extemporaneous compounding were reviewed by both an IDS pharmacist and a hospital compounding pharmacist to provide recommendations to investigators. High-risk compounding was performed by the hospital compounding pharmacy, and patient-specific, medium- and low-risk compounding of CSP doses was performed by IDS pharmacy personnel for research participants. A small subset of investigational medications met high-risk criteria and was referred to the hospital compounding pharmacy. After final clearance from quarantine, the high-risk preparations were transferred to the inpatient IDS satellite for dispensing of patient-specific investigational medication doses. The compounding pharmacy followed standardized quality-assurance procedures to ensure sterility, purity, and endotoxin appropriateness for the investigational medications. Quality control of investigational CSPs was maintained by hand delivery of the investigational medication and documentation and disposition via hard-copy receipt on the nursing units. Based on chapter 797 requirements, the department of pharmacys education and training changed to reflect the new compounding requirements for CSPs, including 20 hours of didactic training for aseptic manipulation skills and practical assessments of aseptic technique using growth media. CONCLUSION A collaborative effort between two specialty areas of pharmacy services ensured compliance with USP chapter 797 requirements for compounded sterile preparations.