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OBJECTIVE: This paper describes the creation and refinement of a Workload Estimator to be used at Colleges/Schools of pharmacy to calculate faculty workload. METHODS: We describe the initial development of the Workload Estimator for pharmacy practice faculty, including the consensus-building methodology and the implementation process. Additionally, we describe the annual refinement and expansion of use to pharmaceutical and administrative sciences faculty. RESULTS: The final product is an Excel file with built-in multiplication factors used to estimate pharmacy faculty workload. CONCLUSION: This Workload Estimator was identified as the most comprehensive and readily adaptable tool to estimate pharmacy faculty workload in July 2023 by the American Association of Colleges of Pharmacy, Council of Faculties, and Council of Deans Task Force on Faculty Workload. The Workload Estimator is currently being studied in a multi-institutional implementation study across dozens of diverse programs across the country with norming data and qualitative perspectives on its use being collected and shared with the Academy in 2024.
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Diagnosis education is explicitly included in the Draft Accreditation Standards 2025 and should be wholeheartedly supported. To address the staggering number of diagnostic errors in the US, the National Academy of Medicine advocates for diagnosis education for all health professions. Misperceptions of pharmacists' involvement in diagnosis are exacerbated by use of implicit language and euphemisms, and it's long overdue that we provide clarity. Pharmacists are engaged in diagnosis and diagnostic reasoning in everyday practice whether realized or not. Diagnosis education is implicitly included in US pharmacy curricula in the Pharmacists' Patient Care Process, and it is time to give students the language to engage in it responsibly to be practice-ready in all states. The explicit inclusion of diagnosis in the Draft Standards 2025 has positive implications for education, practice, and graduates.
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Currículo , Educação em Farmácia , Humanos , Educação em Farmácia/métodos , Educação em Farmácia/normas , Educação em Farmácia/estatística & dados numéricos , Currículo/tendências , Currículo/normas , Acreditação/métodos , Acreditação/normas , Acreditação/tendências , Estados Unidos , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Farmacêuticos/estatística & dados numéricosRESUMO
The 50th Anniversary Commission to Reimagine the American Association of Colleges of Pharmacy (AACP) House of Delegates (HOD Commission) was charged to consider and recommend changes to the AACP Board of Directors and AACP HOD regarding a broad range of issues related to the HOD. The 2021-2022 HOD Commission met virtually many times throughout the year as 2 sub-groups and a full commission, using Basecamp for shared documents and timelines, and it provided interim reports to the Board of Directors in November and February. A survey of 2022 delegates was developed and administered; responses from 163 delegates informed final recommendations as described in the report. The HOD Commission affirms the need for and purpose of AACP's HOD and urges that all schools/colleges of pharmacy recommit to engaged governance for the common good.
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Educação de Pós-Graduação em Farmácia , Educação em Farmácia , Farmácia , Estados Unidos , Humanos , Aniversários e Eventos Especiais , Faculdades de Farmácia , Justiça SocialRESUMO
OBJECTIVES: To shed light on the growing prevalence of type 2 diabetes in sub-Saharan Africa and to highlight the important role that pharmacists can play in addressing this growing global concern. SUMMARY: The combination of scarce health care resources, a lack of general awareness and data to drive new policies, and the severe shortage of health workers has contributed to the escalation of chronic disease in sub-Saharan Africa. The profession of pharmacy offers extensive knowledge on disease and medication management that has proven to yield positive health outcomes. Deploying pharmacists from the United States who can train and support community health workers in sub-Saharan Africa and in other resource constrained settings may help address many of the challenges that currently exist. CONCLUSION: Despite the many challenges sub-Saharan Africa faces in overcoming the current and growing burden of chronic disease, pharmacists can make substantial contributions in addressing these challenges and creating sustainable solutions.
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Diabetes Mellitus Tipo 2/epidemiologia , Cooperação Internacional , Farmacêuticos , Papel Profissional , África Subsaariana/epidemiologia , Doença Crônica , Humanos , PrevalênciaRESUMO
Objective. To determine factors predictive of student failure or poor performance on advanced pharmacy practice experiences (APPEs) at a single pharmacy program. Methods. This retrospective cohort evaluated students entering the Doctor of Pharmacy (PharmD) program from 2012-2014 at St. Louis College of Pharmacy. Students who received a grade of F for one or more APPEs (failure group) were compared to all other students (non-failure group). A secondary evaluation compared students with a C or F on one or more APPEs (poor performers) to all other students (non-poor performers). Data were collected on didactic and experiential performance, identifiable professionalism issues from introductory pharmacy practice experiences (IPPEs), and academic honor code violations. Univariable and multivariable logistic regressions were performed to determine factors associated with APPE failure and poor performance. Results. A total of 669 students were analyzed. Twenty-eight students (4.2%) failed one or more APPEs and 81 students (12.1%) were identified as poor performers (grade of C or F). For the primary outcome, professional grade point average (GPA) of less than 2.7, practicum failure, IPPE professionalism issue(s), and pharmacotherapy course failure were identified for inclusion in the multivariable analysis. The IPPE professionalism issue(s) (HR 4.8 [95% CI 1.9-12.4]) and pharmacotherapy course failure (HR 4.2 [95% CI, 1.6-11.1]) were associated with APPE failure on multivariable regression. On the secondary analysis, the same variables were identified for multivariable regression, with professional GPA of less than 2.7 (HR 2.7 [95% CI 1.5-5]), IPPE professionalism issue(s) (HR 3.9 [95% CI 2.2-6.9]), and pharmacotherapy course failure (HR 2.0 [95% CI 1.1-3.7]) associated with poor performance. Conclusion. Poor academic performance and/or identified unprofessional behavior while completing IPPEs are associated with APPE failure and poor performance. Interventions should be aimed at identifying at-risk students and addressing risk factors prior to APPEs.
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Fracasso Acadêmico , Educação em Farmácia , Preceptoria , Estudantes de Farmácia , Desempenho Acadêmico , Competência Clínica , Currículo , Humanos , Papel Profissional , Estudos Retrospectivos , Medição de Risco , Fatores de RiscoRESUMO
The American Association of Colleges of Pharmacy, the Accreditation Council for Pharmacy Education, and the Center for the Advancement of Pharmacy Education frame patient safety from the perspective of medication management, which is also the current focus of pharmacy education and training. With the growing appreciation that diagnostic errors represent an urgent and actionable patient safety concern, the National Academy of Medicine has recommended diagnostic safety training for all health care professions. The Society to Improve Diagnosis in Medicine has worked with an interprofessional consensus group to identify a set of 12 key competencies necessary to achieve diagnostic quality and safety that focuses on individual, team-based, and system-related competencies. Much of this already exists in pharmacy education, but pharmacy training programs need to give graduates more guidance on how they contribute to the diagnostic process and the prevention and detection of diagnostic errors. We describe the current state of progress in this regard, and what steps are needed by training programs to provide content and assessment so that graduates achieve the requisite competencies. Governing and advisory bodies need to expand the expectations around patient safety to include diagnostic safety.
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Educação em Farmácia/normas , Faculdades de Farmácia/normas , Acreditação/normas , Currículo/normas , Humanos , Farmácia/normas , Estados UnidosRESUMO
PURPOSE: Present the research performed to identify and describe habits of effective pharmacy preceptors and provide a framework for targeted preceptor assessment and development. METHODS: A 5-round Delphi consensus-building process was used to refine the initial Habits of Preceptors Rubric (HOP-R) developed by the research team. Twenty experts in pharmacy experiential education participated. During the Delphi process, feedback and agreement on all parts of the HOP-R were sought, including the premise, introductory content, framework, preceptor domains, habits, habit level descriptions, and continuous professional development (CPD) plan. After each Delphi round, the research team grouped responses into themes and modified the draft rubric accordingly. These themes were used to frame the response document sent to the expert panel for the following Delphi round; this document explained modifications made to the HOP-R. Consensus was defined as a mean score of ≥3.25 on a 4-point scale (4 = strongly agree, 1 = strongly disagree) for posed statements or ≥70% agreement for ranked items. RESULTS: In the final Delphi round (response rate, 95%), consensus was achieved for all HOP-R individual structural and content elements except the habit level descriptors, for which a secondary rank order analysis was performed. The final HOP-R has 3 domains encompassing 11 preceptor habits that can be displayed across 4 habit levels progressing from developing to master. CONCLUSION: The HOP-R was developed to assess, quantify, and demonstrate growth across a wide variety of pharmacy preceptor habits. Potential utility includes use as a framework to articulate the knowledge, skills, and behaviors of effective preceptors, facilitate the creation of individualized CPD plans, and assess the impact of participation in teaching and learning curricula.
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Educação em Farmácia/métodos , Farmacêuticos/psicologia , Preceptoria , Desenvolvimento de Programas , Estudantes de Farmácia/psicologia , Currículo , Técnica Delphi , Feminino , Hábitos , Humanos , Masculino , Pessoa de Meia-Idade , Aprendizagem Baseada em ProblemasRESUMO
Background Given an unacceptably high incidence of diagnostic errors, we sought to identify the key competencies that should be considered for inclusion in health professions education programs to improve the quality and safety of diagnosis in clinical practice. Methods An interprofessional group reviewed existing competency expectations for multiple health professions, and conducted a search that explored quality, safety, and competency in diagnosis. An iterative series of group discussions and concept prioritization was used to derive a final set of competencies. Results Twelve competencies were identified: Six of these are individual competencies: The first four (#1-#4) focus on acquiring the key information needed for diagnosis and formulating an appropriate, prioritized differential diagnosis; individual competency #5 is taking advantage of second opinions, decision support, and checklists; and #6 is using reflection and critical thinking to improve diagnostic performance. Three competencies focus on teamwork: Involving the patient and family (#1) and all relevant health professionals (#2) in the diagnostic process; and (#3) ensuring safe transitions of care and handoffs, and "closing the loop" on test result communication. The final three competencies emphasize system-related aspects of care: (#1) Understanding how human-factor elements influence the diagnostic process; (#2) developing a supportive culture; and (#3) reporting and disclosing diagnostic errors that are recognized, and learning from both successful diagnosis and from diagnostic errors. Conclusions These newly defined competencies are relevant to all health professions education programs and should be incorporated into educational programs.
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Competência Clínica/legislação & jurisprudência , Atenção à Saúde/normas , Testes Diagnósticos de Rotina/normas , Pessoal de Saúde/educação , Competência Clínica/normas , Comunicação , Currículo , Erros de Diagnóstico/estatística & dados numéricos , Testes Diagnósticos de Rotina/estatística & dados numéricos , Humanos , Incidência , Relações Interprofissionais/ética , Equipe de Assistência ao Paciente/normas , Segurança do Paciente , Preceptoria/métodos , Qualidade da Assistência à SaúdeRESUMO
Gabapentin has been approved in the United States for the treatment of epilepsy and postherpetic neuralgia. Gabapentin has also demonstrated proven efficacy for the treatment of diabetic peripheral neuropathy and trigeminal neuralgia, although these represent off-label uses of the drug. However, to our knowledge, no data have been published regarding the efficacy of gabapentin for treating sciatica. We describe two patients with sciatica who were successfully treated with gabapentin. The first was a 32-year-old man with severe shooting pain in his left leg that was later diagnosed as sciatica secondary to a fifth lumbar-first sacral intervertebral disk herniation. The patient was treated with acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), narcotics, and muscle relaxants; he reported only limited pain relief with any of these agents or combination of agents. He was then prescribed gabapentin 300 mg once/day; his pain substantially improved, even after the first dose. The drug was titrated gradually up to 900 mg 3 times/day with good results. The patient subsequently underwent a laminectomy and diskectomy on the advice of his neurosurgeon, who assured him that the result would be immediate pain relief. After surgery, the patient continued to experience pain; however, his pain resolved completely after several weeks of receiving gabapentin 600 mg 3 times/day. The second patient was a 68-year-old Caucasian woman with renal insufficiency who experienced severe burning pain and numbness of abrupt onset in the posterior right leg; this was diagnosed as sciatica. The patient had contraindications for NSAID therapy and was intolerant of hydrocodone. Initial therapy with propoxyphene and acetaminophen, self-started by the patient, was ineffective. Gabapentin 100 mg at bedtime was started and then titrated up to 100 mg twice/day with 200 mg at bedtime. The patient's pain improved rapidly, and at follow-up approximately 5 weeks later, she was experiencing good pain control with gabapentin. Gabapentin is widely prescribed for management of peripheral neuropathic pain syndromes. To our knowledge, however, these two case reports are the first to describe sciatica successfully controlled with gabapentin. Because gabapentin has the potential to prevent central sensitization, consideration should be given to prescribing this therapy early in the course of sciatica. Further research using randomized, placebo-controlled trials are needed to validate the benefit of gabapentin in the treatment of sciatica.
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Aminas/uso terapêutico , Analgésicos/uso terapêutico , Ácidos Cicloexanocarboxílicos/uso terapêutico , Ciática/tratamento farmacológico , Ácido gama-Aminobutírico/uso terapêutico , Adulto , Idoso , Feminino , Gabapentina , Humanos , MasculinoRESUMO
The experiential component of a doctor of pharmacy curricula is an ideal, yet underutilized vehicle to advance interprofessional education (IPE) initiatives. To date, most experiential-based IPE initiatives occur in a naturally occurring, non-deliberate fashion. The American Association of Colleges of Pharmacy (AACP) Experiential Education Section formed the Task Force on Intentional Interprofessional Education in Experiential Education in academic year 2015-2016 to explore the issue. This commentary describes the work of the task force, including the following elements: defining intentional interprofessional experiential education as "the explicit effort by preceptors and practice sites to create/foster educational opportunities or activities designed specifically to achieve interprofessional educational competencies;" conducting a systematic literature review to identify examples of intentional interprofessional experiential education in the published literature; surveying faculty with oversight of experiential education programs and preceptors within those programs; and generating recommendations to stakeholders including AACP, pharmacy schools, and experiential education administrators.
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Currículo , Educação em Farmácia/organização & administração , Relações Interprofissionais , Docentes de Farmácia , Humanos , Preceptoria , Aprendizagem Baseada em Problemas , Faculdades de FarmáciaRESUMO
BACKGROUND: Warfarin sodium is commonly prescribed for the prophylaxis and treatment of venous thromboembolism. Dosing algorithms have not been widely adopted because they require a fixed initial warfarin dose (eg, 5 mg) and are not tailored to other factors that may affect the international normalized ratio (INR). OBJECTIVE: To develop an algorithm that could predict a therapeutic warfarin dose based on drug interactions, INR response after the initial warfarin doses, and other clinical factors. METHODS: We used stepwise regression to quantify the relationship between these factors in patients beginning prophylactic warfarin therapy immediately prior to joint replacement. In the derivation cohort (n = 271), we separately modeled the therapeutic dose after 2 and 3 initial doses. We prospectively validated these 2 models in an independent cohort (n = 105). RESULTS: About half of the therapeutic dose variability was predictable after 3 days of therapy: R2 was 53% in the derivation cohort and 42% in the validation cohort. INR response after 3 warfarin doses (INR3) inversely correlated with therapeutic dose (p < 0.001). Intraoperative blood loss transiently, but significantly, elevated the postoperative INR values. Other significant (p < 0.03) predictors were the first and second warfarin doses (+7% and +6%, respectively, per 1 mg), and statin use (-15.0%). The model derived after 2 warfarin doses explained 32% of the variability in therapeutic dose. CONCLUSIONS: We developed and validated algorithms that estimate therapeutic warfarin doses based on clinical factors and INR response available after 2-3 days of warfarin therapy. The algorithms are implemented online at www.WarfarinDosing.org.
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Anticoagulantes/administração & dosagem , Artroplastia de Quadril , Artroplastia do Joelho , Varfarina/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Embolia Pulmonar/prevenção & controle , Trombose Venosa/prevenção & controle , Varfarina/efeitos adversos , Varfarina/uso terapêuticoRESUMO
Objective. To develop a comprehensive instrument specific to student pharmacist-patient communication skills, and to determine face, content, construct, concurrent, and predictive validity and reliability of the instrument. Methods. A multi-step approach was used to create and validate an instrument, including the use of external experts for face and content validity, students for construct validity, comparisons to other rubrics for concurrent validity, comparisons to other coursework for predictive validity, and extensive reliability and inter-rater reliability testing with trained faculty assessors. Results. Patient-centered Communication Tools (PaCT) achieved face and content validity and performed well with multiple correlation tests with significant findings for reliability testing and when compared to an alternate rubric. Conclusion. PaCT is a useful instrument for assessing student pharmacist communication skills with patients.
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Comunicação , Educação em Farmácia/métodos , Relações Profissional-Paciente , Estudantes de Farmácia , Competência Clínica , Avaliação Educacional/métodos , Humanos , Reprodutibilidade dos TestesRESUMO
UNLABELLED: Pharmacogenetics (PG), the study of human genome function and its effects on drug response, represents an exciting approach for reducing adverse drug events and increasing therapeutic efficacy. However, there is no clear information of the potential impact of PG in the primary care setting. Therefore, a study was conducted to determine the frequency of use of medications under PG influence, including 16 PG adverse drug reaction (ADR)-associated medications, in the primary care setting. PATIENTS AND METHODS: A cohort of 607 consecutive patients was accrued over a 3-month period from three primary care practices. Patients were asked to answer a verbal survey of demographics and medication use during the past 12 months. The survey specifically evaluated 16 drugs known to commonly cause ADRs and undergo metabolism by polymorphic enzymes. Patients also disclosed information on all other medication use in the last year. Medication use was verified by chart review. The primary outcome was the frequency of medication use. RESULTS: Among the 16 ADR-associated medications, patients used analgesics (88.5%), antihypertensives (14.3%) and antidepressants (9.6%) most commonly. Overall, 28.6% of patients took more than one of the PG ADR-associated medications. Neither gender nor race appeared to influence the frequency of use of these medications (p=0.5 and p=0.08, respectively). Patients taking one or more of the drugs were older (p<0.001). More patients seen for a chronic visit took one or more of the ADR-associated drugs than patients seen for an acute visit (35.8 versus 18.5%, p<0.001). DISCUSSION: This is the first attempt to describe the potential role of pharmacogenetics in the primary care setting. The findings indicate that at least one in four primary care patients take at least one medication that commonly causes adverse drug reactions due to genetic variability in drug metabolism, indicating that there is a potential role of pharmacogenomics in primary care. Nearly every patient was on a medication with putative PG association. CONCLUSIONS: Studies of the ability of PG should not be limited to medical subspecialties, as there is a great potential impact of PG on the primary care setting.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacogenética/tendências , Atenção Primária à Saúde/tendências , Adulto , Estudos de Coortes , Coleta de Dados , Enzimas/genética , Enzimas/metabolismo , Feminino , Humanos , Masculino , Pacientes , Preparações Farmacêuticas/metabolismo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: Evaluate curricular changes related to health literacy and determine impact on independent-living senior residents as part of an introductory pharmacy practice experience for third-year student pharmacists. DESIGN: Students were randomly assigned a resident whom they visited multiple times to conduct assessments and provide various services using three methods: Ask Me 3™ Four Habits Model, and Teach-back. SETTING: The study was conducted at independent-living apartments within a 24-mile radius from the St. Louis College of Pharmacy, St. Louis, Missouri. PATIENTS, PARTICIPANTS: Participants (n = 147 to 173, across all three years) were volunteer, elderly residents, living at a facility that collaborated with the research. INTERVENTIONS: Within one academic year, students collected medical and medication histories, conducted household safety checks, performed screening assessments, assessed adherence, and provided general recommendations to a resident. MAIN OUTCOME MEASURE(S): Outcomes included resident satisfaction, student satisfaction, and correlations between student use of health literacy tools and resident satisfaction. RESULTS: Exit surveys indicated resident overall satisfaction with the program, increased understanding of health-related information, increased confidence in asking health care professionals questions about their health, and greater commitment to medication adherence as a result of the experience. Students were highly satisfied with the program. Analyses reveal some correlations between a previously determined performance level of student communication and resident satisfaction. CONCLUSIONS: Students' use of health literacy communication tools during encounters with independent-living senior residents can result in greater patient understanding and empowerment, which may in turn help improve medication adherence.
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Serviços Comunitários de Farmácia/organização & administração , Educação em Farmácia/métodos , Letramento em Saúde , Adesão à Medicação , Educação de Pacientes como Assunto/métodos , Estudantes de Farmácia , Idoso , Currículo , Humanos , Missouri , Papel Profissional , Relações Profissional-Paciente , Ensino/métodosRESUMO
OBJECTIVE: To determine whether there is a difference in student pharmacists' learning or satisfaction when standardized patients or manikins are used to teach physical assessment. DESIGN: Third-year student pharmacists were randomized to learn physical assessment (cardiac and pulmonary examinations) using either a standardized patient or a manikin. ASSESSMENT: Performance scores on the final examination and satisfaction with the learning method were compared between groups. Eighty and 74 student pharmacists completed the cardiac and pulmonary examinations, respectively. There was no difference in performance scores between student pharmacists who were trained using manikins vs standardized patients (93.8% vs. 93.5%, p=0.81). Student pharmacists who were trained using manikins indicated that they would have probably learned to perform cardiac and pulmonary examinations better had they been taught using standardized patients (p<0.001) and that they were less satisfied with their method of learning (p=0.04). CONCLUSIONS: Training using standardized patients and manikins are equally effective methods of learning physical assessment, but student pharmacists preferred using standardized patients.
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Educação em Farmácia/métodos , Manequins , Simulação de Paciente , Exame Físico , Estudantes de Farmácia , Ensino/métodos , Atitude do Pessoal de Saúde , Currículo , Avaliação Educacional , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Aprendizagem , Satisfação Pessoal , Estudantes de Farmácia/psicologia , Inquéritos e Questionários , Análise e Desempenho de TarefasRESUMO
OBJECTIVE: To determine the feasibility of using a validated set of assessment rubrics to assess students' critical-thinking and problem-solving abilities across a doctor of pharmacy (PharmD) curriculum. METHODS: Trained faculty assessors used validated rubrics to assess student work samples for critical-thinking and problem-solving abilities. Assessment scores were collected and analyzed to determine student achievement of these 2 ability outcomes across the curriculum. Feasibility of the process was evaluated in terms of time and resources used. RESULTS: One hundred sixty-one samples were assessed for critical thinking, and 159 samples were assessed for problem-solving. Rubric scoring allowed assessors to evaluate four 5- to 7-page work samples per hour. The analysis indicated that overall critical-thinking scores improved over the curriculum. Although low yield for problem-solving samples precluded meaningful data analysis, it was informative for identifying potentially needed curricular improvements. CONCLUSIONS: Use of assessment rubrics for program ability outcomes was deemed authentic and feasible. Problem-solving was identified as a curricular area that may need improving. This assessment method has great potential to inform continuous quality improvement of a PharmD program.
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Educação em Farmácia , Avaliação Educacional , Resolução de Problemas , Estudantes de Farmácia , Pensamento , HumanosRESUMO
OBJECTIVE: To assess whether student pharmacists' communication skills improved using the Four Habits Model (FHM) at the St. Louis College of Pharmacy. METHODS: During the Fall of 2009 and 2010, student pharmacists in the third professional year learned and practiced the FHM. They were given feedback by faculty on three of the four Habits, used the FHM for self and peer assessment, and were formally evaluated on all four Habits during a standardized patient encounter. RESULTS: Student pharmacist performance significantly improved from baseline during both Fall 2009 and Fall 2010 in the majority of the Habits assessed. CONCLUSION: Use of the FHM in pharmacy education can improve a student pharmacists' ability to display the four Habits of communicating and developing relationships with patients. Tailoring of the FHM to pharmacy encounters will further enhance the utility of this communication framework. PRACTICE IMPLICATIONS: Use of the FHM enhances the measurement and assessment of the relational aspects of student pharmacist-patient communication skills. Consistent use of the FHM over time is likely necessary to fully develop and retain communication skills. The overall goal is to improve patient's health literacy and appropriate medication use by improving communication and the pharmacist-patient relationship.
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Comunicação , Educação em Farmácia/métodos , Letramento em Saúde , Relações Profissional-Paciente , Estudantes de Farmácia/psicologia , Currículo , Avaliação Educacional , Feminino , Hábitos , Humanos , Masculino , Modelos Educacionais , Modelos Psicológicos , Projetos Piloto , Competência Profissional , Papel Profissional , Ensino/métodosRESUMO
By guiding initial warfarin dose, pharmacogenetic (PGx) algorithms may improve the safety of warfarin initiation. However, once international normalised ratio (INR) response is known, the contribution of PGx to dose refinements is uncertain. This study sought to develop and validate clinical and PGx dosing algorithms for warfarin dose refinement on days 6-11 after therapy initiation. An international sample of 2,022 patients at 13 medical centres on three continents provided clinical, INR, and genetic data at treatment days 6-11 to predict therapeutic warfarin dose. Independent derivation and retrospective validation samples were composed by randomly dividing the population (80%/20%). Prior warfarin doses were weighted by their expected effect on S-warfarin concentrations using an exponential-decay pharmacokinetic model. The INR divided by that "effective" dose constituted a treatment response index . Treatment response index, age, amiodarone, body surface area, warfarin indication, and target INR were associated with dose in the derivation sample. A clinical algorithm based on these factors was remarkably accurate: in the retrospective validation cohort its R(2) was 61.2% and median absolute error (MAE) was 5.0 mg/week. Accuracy and safety was confirmed in a prospective cohort (N=43). CYP2C9 variants and VKORC1-1639 GâA were significant dose predictors in both the derivation and validation samples. In the retrospective validation cohort, the PGx algorithm had: R(2)= 69.1% (p<0.05 vs. clinical algorithm), MAE= 4.7 mg/week. In conclusion, a pharmacogenetic warfarin dose-refinement algorithm based on clinical, INR, and genetic factors can explain at least 69.1% of therapeutic warfarin dose variability after about one week of therapy.
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Anticoagulantes/administração & dosagem , Anticoagulantes/farmacocinética , Hidrocarboneto de Aril Hidroxilases/genética , Cálculos da Dosagem de Medicamento , Oxigenases de Função Mista/genética , Varfarina/administração & dosagem , Varfarina/farmacocinética , Algoritmos , Citocromo P-450 CYP2C9 , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Polimorfismo Genético , Resultado do Tratamento , Vitamina K Epóxido RedutasesRESUMO
Via generation of vitamin K-dependent proteins, gamma-glutamyl carboxylase (GGCX) plays a critical role in the vitamin K cycle. Single nucleotide polymorphisms (SNPs) in GGCX, therefore, may affect dosing of the vitamin K antagonist, warfarin. In a multi-centered, cross-sectional study of 985 patients prescribed warfarin therapy, we genotyped for two GGCX SNPs (rs11676382 and rs12714145) and quantified their relationship to therapeutic dose. GGCX rs11676382 was a significant (p=0.03) predictor of residual dosing error and was associated with a 6.1% reduction in warfarin dose (95% CI: 0.6%-11.4%) per G allele. The prevalence was 14.1% in our predominantly (78%) Caucasian cohort, but the overall contribution to dosing accuracy was modest (partial R2 = 0.2%). GGCX rs12714145 was not a significant predictor of therapeutic dose (p = 0.26). GGCX rs11676382 is a statistically significant predictor of warfarin dose, but the clinical relevance is modest. Given the potentially low marginal cost of adding this SNP to existing genotyping platforms, we have modified our non-profit website (www.WarfarinDosing.org) to accommodate knowledge of this variant.