University Campus PGY1 Pharmacy Residency. The University of Arizona Medical Center University Campus

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1 The University of Arizona Medical Center University Campus Program ASHP Number William L. Fritz, M.S, FASHP Residency Program Director Subsection Page Number(s) Program Overview 2 Introduction 2 Purpose 2 Overview of Program 2 Certification 3 Resident Responsibilities 4 Clinical Pharmacy Conference 5 Resident Benefits 5 Resident Expectations 7 Program s Educational Outcomes with Associated Goals and Objectives 11 Program s Structure: Rotations 31 On-Call Responsibilities 32 Clinical Pharmacy Scholars Teaching Certificate Program 35 Residency Activity Overview 37 Presentations Overview 39 ACPE Continuing Education - Presentation Requirements 40 Journal Club Guidelines 42 Research Project Guidelines 45 Program s Three-Part Assessment Strategy 50 Summary of Requirements for Successful Completion of the Residency 55 1 of 55

2 Program Overview Post Graduate Year One (PGY1) Residency Program in Pharmacy with Emphasis on Pharmaceutical Care The University of Arizona Medical Center University Campus in cooperation with the University of Arizona, College of Pharmacy and the University of Arizona Health Sciences Center, offers a PGY1 residency program in pharmacy practice. University of Arizona Medical Center University Campus, is part of The University of Arizona Health Network and is located on the Arizona Health Sciences campus in Tucson Arizona, is a nonprofit, 550-bed, short-term general medical/surgical teaching hospital and level one trauma center providing all major inpatient and ambulatory care services. Intensive care units for medicine, surgery, cardiothoracic surgery, neurosurgery, pediatrics and neonatology are included. Specialized programs at University Medical Center include solid organ and bone and marrow transplantation surgeries, the Arizona Cancer Center is a national Comprehensive Cancer Center where oncology patients receive chemotherapy and radiation therapy on an outpatient basis, Diamond Children s Medical Center with special treatment and emergency medicine units, St. Luke s in the Desert Chest Clinic for the treatment of allergies and chronic lung ailments and the Department of Sports Medicine. University Medical Center serves as the primary teaching hospital for the adjacent Colleges of Medicine, Nursing, Pharmacy, and Public Health. Purpose The PGY1 pharmacy residency program is designed to train selected, highly-motivated and highly-qualified pharmacists so that they are prepared to provide pharmaceutical care as a clinical pharmacist in an acute, tertiary care facility and/or continue into an advanced residency or fellowship in an area of pharmacy practice or research. Residents also receive the fundamental experiences necessary for BCSP examination as well as training and experience in teaching so that they are prepared to precept pharmacy students and residents. Residents will learn to demonstrate professional leadership and to develop lifelong learning skills that will lead to career satisfaction. The residency program adheres to the standards described in the criteria: ASHP Statement on Accreditation of Pharmacy Residencies and ASHP Accrediting Standard for Residency Training in Pharmacy Practice. Program Overview The program consists of a 7 months of required training in specific aspects of acute care pharmacy practice. The program is customized to the needs of the individual resident with 5 2 of 55

3 months of elective opportunities. These core and elective rotations will provide the basic foundation for quality clinical practice into a career. The program is clinical in nature and is integrated with modern centralized unit dose, I.V. additive and computer-assisted distribution systems. The integration of the clinical programs with an excellent drug distribution system provides a solid background entering practice after completing the residency. The pharmacy resident s clinical training includes general medicine, critical care medicine and surgery, infectious diseases, surgery, drug information and clinical pharmacokinetics. The resident may elect additional training with services such as cardiology, pediatrics, emergency medicine, ambulatory care, neurology, oncology, toxicology and poison control services and other areas of hospital pharmacy practice. In addition, this program requires the resident to learn and use teaching and research techniques. Additional elective rotation may include an additional rotation of any on the schedule with preceptor approval or one of the following: Pharmacy Administration, Psychiatry, Southern Arizona VA Health Care System, Tucson Medical Center or UPH Kino Hospital. Other electives may be arranged at the request of the resident and the approval of the residency director. The off-site preceptor must also approve. In general, no more than one off-site rotation will be approved. Preceptor Interaction: When evaluating, working up and recommending monitoring or therapies for patients, the critical care resident will discuss cases with the preceptor. As the critical care resident becomes familiar with the environment and processes, the critical care resident will be expected to work independently. Topic discussions with preceptor will occur during slow times and at a frequency appropriate to patient cases encountered. Evaluation Strategy: ResiTrak will be used for documentation of formal evaluations. For evaluations, the resident and preceptor will complete the evaluations separately. Prior to signing the evaluation, the preceptor and resident will compare and discuss the evaluations. This discussion will provide feedback for both the resident and preceptor on their performance. Types of evaluation Summative: Preceptor, Resident at end of learning experience Summative Self-evaluation: Resident at end of learning experience Preceptor: Resident at end of learning experience Learning Experience Evaluation: Resident at end of learning experience Certification Upon successful completion of the program, an appropriate certificate shall be awarded to the resident by University Medical Center. 3 of 55

4 Requirements to receive a Residency Certificate: Meet all ASHP PGY1 Residency Requirements including making sufficient progress towards all the required goals and objectives as evidenced by either satisfactory progress or achieved being marked for all goals Satisfactory completion of all experiences as evidenced by all required work assigned being completed to the satisfaction of the preceptor Completion of a residency project with a manuscript that is ready for publication and approved by the Residency Program Director Completion of all assignments and projects, including an MUE or medication safety project and drug monograph, as defined by the preceptors and residency program director Compliance with all institutional and departmental policies General Resident Responsibilities Daily: Residents will report to assigned preceptors and be responsible for all assigned daily duties. Weekly: Residents will attend the weekly clinical pharmacy conferences (see below) and make formal presentations as scheduled. At least two of the presentations will be for pharmacy continuing education (accredited by ACPE). Monthly: Attend pharmacy journal club and case study programs and present as scheduled. Residents may attend Pharmacy and Therapeutics Committee meetings. Contact Jim Camamo, PharmD for schedule information. Residents will complete preceptor, rotation and self evaluation forms at the end of each rotation using ResiTrak. Quarterly: Residents will complete the ResiTrak self-evaluation based on learning objectives for the program. Residents will meet individually with the residency director to discuss progress and evaluation. If the residents feel it would be helpful, the residents will meet as a group with the residency director to discuss progress, concerns, etc Annually: Residents will complete a residency project approved by a residency preceptor and the residency director and will submit a written manuscript to the residency director and project preceptor at the end of the residency. The written manuscript is in the style for submission to a peer review journal. 4 of 55

5 Residents will prepare and present the results of their research project at the Western States Conference for Pharmacy Residents, Fellows and Preceptors. The conference is scheduled for May See Overview of Residency Activities Section Clinical Pharmacy Conference Every Wednesday from 3:00-5:00 pm. First hour consists of resident presentations (either two case presentation or one formal presentation) o Faculty, CSPs, Students invited Second hour consists of Faculty/CSP Lectures, Teaching Scholar Sessions, Meetings with residency director, Joint Commission Topic Series, etc o Primarily residents only (unless otherwise stated) Resident Benefits Time Off The resident will be entitled to all benefits provided to full-time, annually-appointed Clinical Assistant I at The University of Arizona. Each resident will be allowed to take up to 22 working days off. Residents will be allowed to use any part of the 22 days of leave for interviews for position of employment, advanced training or professional leave; however, no more than 10 days can be used for vacation. All time away from University Medical Center must be approved by the residency director and rotation preceptor in advance. Residents will not be allowed to take time off the last week of the residency year without special approval. Vacation days not taken before this time will be lost and not reimbursed. Travel Allowance Each resident will be provided $1600 travel allowance which may be used to attend Western States Conference, ASHP Midyear Clinical Meeting, or one other meeting of the resident s choice. Time off to attend professional meetings listed above will be considered part of the 22 days for vacation/professional leave. Sick Leave University policy allows up to one day of sick leave per month of employment. If additional days are needed, they will be deducted from vacation days. There will be no compensation for unused sick leave. It is the desire of the program to assist residents to successfully complete the residency program. If an extended illness or other issue arises, it is possible for the resident to petition the program director and residency advisory committee to consider special arrangements allowing completion. Office 5 of 55

6 Residents have priority over students in terms of computer/desk space. Each Resident will have cubby space for personal belongings. The key code for entry is Photocopying Residents can photocopy in room 5606 (across the hall from the residency office). The code to the room is 4431 and the username for the copier is 7401 and password is This machine can also be used for printing. Mail A Residents mailbox is located at the College of Pharmacy (Drachman Hall, 2 nd floor) and should be checked periodically. Paging System Each resident will be assigned a pager at the beginning of the residency program. Pagers must be returned prior to the end of the residency year. Residents are responsible for replacement of lost/damaged pagers. Pagers are to be carried and turned on at all times when at UMC and pages should be answered within 15 minutes unless it will interfere with patient care. Dialing 80 from in-house UMC phones connects to the paging system. To reach the paging system outside of UMC dial Lab Coats Each resident will be furnished one lab coat at the beginning of the residency year. Library Residents will have access to the Health Science Library and to online journal databases ( Off campus access to the online journal databases will require a UA netid. Parking Residents will have access to the parking. Residents will receive UMC parking permits at the beginning of the residency year and will have to reapply during annual registration in February. Professional Conduct Resident Expectations 6 of 55

7 It is the responsibility of all residents of the University of Arizona, and the profession of pharmacy to uphold the highest degree of professional conduct at all times. The resident will display an attitude of professionalism in all aspects of his/her daily practice. Professional Dress All residents are expected to dress in an appropriate professional manner whenever they are in the institution or attending any function as a representative of University of Arizona. Clean, pressed white lab coats of full length will be worn at all times in patient care areas (excluding Psychiatry and Pediatrics). Any specific problems with dress will be addressed by the resident's Advisor/Coordinator. A detailed policy may be found on UMC s Intranet Employee Badges UMC Security requires all personnel to wear his/her badge at all times when they are on campus. If the badge is misplaced a temporary badge is available at the Security station on the first floor of the hospital. If the employee badge is lost, the resident must report the loss immediately to Security, and render a fee for replacement. Patient Confidentiality Patient confidentiality will be strictly maintained by all residents. Any consultations concerning patients will be held in privacy with the utmost concern for the patients' and families' emotional as well as physical well-being. Residents will not leave confidential documents (profiles, charts, prescriptions, etc.) in public places. Residents will excuse themselves from the cases of College of Pharmacy faculty, staff or students who may be patients. Residents are required to complete HIPAA training and comply with all HIPAA policies. Communication The resident is responsible for promoting good communication between the pharmacists, patients, physicians, and the school. Constructive criticism is a means of learning and is not meant to embarrass. Any conflicts which may arise between the resident and preceptor should first be handled by discussing it with one another. If resolution is not achieved, then discussing the situation with the program director is the next appropriate step. 7 of 55

8 Licensure Residents are expected to become a licensed pharmacist as soon as possible, but no later than September 1, Not having a license by this date is one reason a resident can be terminated from the program. In the event of extenuating circumstances, the Residency Program Director may approve an extension, if deemed appropriate. Working Externally Resident s primary professional commitment must be to the residency program. Therefore, it is expected that any commitments made outside of the residency will not interfere in any way with residency obligations. Moonlighting is discouraged. However, the faculty also realizes a residency stipend can be limiting for a resident. Supplementing the residency stipend is acceptable unless the resident demonstrates an inability to function at the expected level. Limits must be placed on working outside of the residency training. No more than 20 hours/month of "moonlighting" will be accepted. All "moonlighting" needs to be brought to the Residency Program Director's attention. If a resident fails to meet deadlines, is unprepared for conferences, is using sick or annual leave excessively, or has scheduled "moonlighting" time as a priority over any residency activity the resident will be presented the options of resigning from the residency program or resigning from the secondary employment. Absences Residents are required to complete a College of Pharmacy Absence Record form (blue sheet) prior to any time off for vacation or professional meetings. Blue sheets are available from the Clinical Pharmacy Office. Forms should be completed as soon as possible after absences due to illness. Forms must be initialed by the rotation preceptor and submitted to the residency director for final approval. The original, signed form should be taken to Lee Becker at the UMC Inpatient Pharmacy Administration Room 0611 or Cas Sprout at the College of Pharmacy. The signed form will be filed with the College of Pharmacy (a copy will be kept in UMC Inpatient Pharmacy Administration). Residents failing to complete the blue sheet will be considered absent without leave (i.e., not paid for days absent). Failure to comply with the above procedures will result in disciplinary action possibly including suspension without pay or termination. All circumstances are different and will be considered individually by the RPD and possibly the Residency Advisory Committee. Evaluations The evaluation process of the residency involves evaluations at the completion of each rotation, quarterly evaluations and a final evaluation of the residency. At the end of each rotation, the responsible preceptor will complete a ResiTrak evaluation form and discuss it with the resident. On a quarterly basis, each resident will complete a ResiTrak selfevaluation of his/her progress to date based on customized and program objectives. The quarterly evaluation should also contain suggestions for improvement and reasons why some 8 of 55

9 objectives may have not been met. Each resident will meet with the program director to discuss the evaluations. Disciplinary Action and Dismissal Disciplinary action or dismissal from the program are actions that are considered with residents not meeting program or rotation expectations. Additionally, residents may receive disciplinary actions for violating professional standards. One area that is critical and can lead to immediate dismissal is violating patient privacy. Accessing records for patients who are not assigned to your service is one example of such a violation. Residents are informed of program requirements, expectations and deadlines. The preceptor at the beginning and during each rotation communicates rotation expectations. If problems arise, residents will be counseled by the preceptor(s). If the issues are not resolved, the ongoing concern will be documented and referred to the program director. The program director will discuss the issues with the resident and others as appropriate. When disciplinary action is indicated, the program director (or rotation preceptor in conjunction with the program director) will take the appropriate action based on the situation and circumstances. When dismissal from the program may be indicated, the program director and/or the director of pharmacy services will meet with the preceptors of required rotations to make the final decision. Under unusual circumstances, it may be necessary to terminate a resident from the program. The resident should understand that, in additional to general University of Arizona personnel guidelines, any of the following criteria are grounds for dismissal from the program: Failure to become licensed as a pharmacist in Arizona by September 1 of the residency year. Failure to have at least satisfactory progress with two or more objectives in two or more rotations. Involvement with or participation in the use of illicit drugs. Disciplinary actions It is not expected that any disciplinary actions will be needed during the residency. However, criteria have been established to avoid making an unpleasant situation more difficult. Each resident is expected to perform in an exemplary manner. If a resident fails to meet the requirements of the program, disciplinary action will be taken. Examples of inadequate or poor performance include dishonesty, repetitive failure to complete assignments, being late for clinical assignments, abuse of annual and/or sick leave, violating University or UMC policies and procedures, patient abuse, and violating ethics or laws of pharmacy practice. The following sequence of discipline are outlined: 9 of 55

10 1. Minor or initial failure to adhere to requirements will result in a verbal counseling by the primary preceptor or the Residency Program Director. A note stating a verbal counseling has occurred will be sent to the Residency Advisory Committee. 2. For repeated or more severe incidents, the Residency Program Director or Residency Advisory board will give residents a formal written warning of failure to meet the requirements of the residency program. A list of actions and/or additional assignments required to continue in the program will be determined by the Residency Advisory Board and must be signed by the resident. The board will follow the resident s compliance with the required actions. Failure with compliance may lead to the dismissal of the resident from the program. 3. Failure to comply with the required actions set forth by the Residency Advisory Board will be documented in writing by the preceptor, Residency Advisory Board, or Residency Director. The Residency Advisory Committee, Chief of Pharmacy, and Residency Program Director will decide whether dismissal is necessary after reviewing the situation with the resident and preceptor. If dismissal is necessary the proper process will be initiated. Attendance: The residency is a full-time temporary appointment of 1 year in duration. The resident is expected to be onsite to perform activities related to the residency as necessary to meet the goals and objectives of the program. Additional time is expected to complete assignments and projects in a timely manner. When the resident will not be onsite, the program director and preceptor must approve the time off or away and procedures for leave must be followed. Just as attendance is critical, so is adequate time away from the facility. To assure adequate time off, the residency program complies with the ASHP standards and the ACGME duty hours regulations. (See Resident Job Description). The Residency Program Director and the preceptors do not intend to violate these regulations. 10 of 55

11 Goal Statements The University Medical Center / University of Arizona PGY1 Pharmacy Practice Residency adheres to providing the resident with all of the required learning objective proscribed by ASHP and allowing for additional elective learning experiences based on the resident s needs and interests. The ASHP Objectives are listed below: Required By Accreditation Standard Outcome R1: Manage and improve the medication-use process. Goal R1.1: Identify opportunities for improvement of the organization s medication-use system. OBJ R1.1.1 (Comprehension) Explain the organization s medication-use system and its vulnerabilities to adverse drug events (ADEs). Explain the central concepts of systems theory. Explain the concept of system error. Explain the definitions of the various terms associated with adverse drug events (e.g., medication misadventure, medication error, adverse drug reaction, error, accident, systems error, individual error, latent error). State sources of information on the design, implementation, and maintenance of safe medication-use systems. From both the pharmacy department perspective and the organization perspective explain the potential for contribution to the occurrence of adverse drug events by the use of automation and information technology. From both the pharmacy department perspective and the organization perspective explain the role that automation and information technology play in preventing adverse drug events. Explain the meaning of the term culture of safety. OBJ R1.1.2 (Analysis) Analyze the structure and process and measure outcomes of the medication-use system. Explain methods for analyzing a medication-use system s structure. Explain how inputs to the medication-use system such as patients, staff, and environment make up its structure. Explain methods for analyzing processes within a medication-use system (e.g., root cause analysis, failure mode and effect analysis). Explain how the interactions between clinicians and patients constitute processes in the medication-use system. Exercise skill in process-mapping, a type of flowchart depicting the steps in a process, with identification of responsibility for each step and the key measures Exercise skill in cause-and-effect diagramming. Explain the organization s policies and procedures for handling a drug recall. 11 of 55

12 Explain the role of medication-use evaluation (MUE) in measuring medication-use processes. Explain methods for measuring outcomes of the medication-use system. Generate examples of the outcomes of a medication-use process which are changes in patients health status (e.g. length of stay; acuity). Explain the characteristics of a clinically significant ADE. Explain various methods, including decision trees, for determining the significance of adverse drug events. Explain how to categorize medication errors using the ASHP Guidelines on Preventing Medication Errors in Hospitals. Explain how to categorize medication errors using the National Coordinating Council for Medication Error Reporting and Prevention's medication error index for categorizing errors. Explain how to categorize medication errors using one s own institution s categorization methodology. When a clinically significant ADE is identified, report the event following the organization s policies and procedures. Explain the role of the MUE in measuring outcomes of the medicationuse process. OBJ R1.1.3 (Evaluation) Identify opportunities for improvement in the organization s medication-use system by comparing the medication-use system to relevant best practices. When a clinically significant ADE is identified, participate in determining the presence of any similar potential ADEs. Participate in the pharmacy department s ongoing process for tracking and trending ADEs. Explain how basic safety design principles such as standardization, simplification, and the employment of human factors training can minimize the incidence of error in the medication-use process. Explain safe practices for selecting and securing alternative medications when shortages occur and for adjusting the formulary and notifying prescribers. Explain safe practices for the storage, dispensing, administration, and security of pharmaceuticals. Use the results of an MUE to identify opportunities for improvement in the medication-use process. Explain how to use information on how to design, implement, and maintain safe medication-use systems from external sources to identify opportunities for improvement in the organization s medication-use system. Goal R1.2: Design and implement quality improvement changes to the organization s medication-use system. 12 of 55

13 OBJ R1.2.1 (Comprehension) Explain the process for developing, implementing, and maintaining a formulary system. Identify the components of a formulary system. Explain the approval process for establishing a formulary. Explain the role of committees in addressing formulary issues. Explain how formularies are revised and maintained. Explain procedures regarding exceptions to the formulary. Explain the process of making additions and deletions to the formulary including those resulting from drug shortages. Explain how to customize an existing drug monograph for use at your site (e.g, the FIX) Explain effective methods of communicating changes to the formulary including those resulting from drug shortages. OBJ R1.2.2 (Evaluation) Make a medication-use policy recommendation based on a comparative review (e.g., drug class review, drug monograph). State the elements of a comparative review. State sources to consult in the preparation of a comparative review. Explain the importance of including consideration of medication-use safety in the preparation of a comparative review. OBJ R1.2.3 (Synthesis) Participate in the identification of need for, development of, implementation of, and evaluation of an evidence-based treatment guideline/protocol related to individual and population-based patient care. Define treatment guidelines and protocols. Explain the indications/rationale for using guidelines and protocols. Explain guidelines/protocols as they relate to: patient care activities; provider networks; provider incentives; cost and reimbursement controls; utilization management; quality measurement; consumer incentives; accreditation; and benefit analysis (if applicable). Explain the use of evidence-based medicine in the development of treatment guidelines/protocols. Explain the process by which criteria for treatment guidelines/protocols are developed. Explain effective strategies for gaining necessary commitment and approval for use of a treatment guideline/protocol. Explain the importance of providing outcome information to the prescriber/provider as support for evaluative decisions on program continuance or revision. Explain methods for assessing the effectiveness/impact of guidelines and protocols. Explain the importance of assessing the clinical, economic and humanistic outcomes of treatment guidelines/protocols related to patient care. OBJ R1.2.4 (Synthesis) Design and implement pilot interventions to change problematic or potentially problematic aspects of the medication-use system with the objective of improving quality. 13 of 55

14 Explain the importance of continually reassessing medication-use policies. Exercise skill in the revision of a policy or procedure when necessitated by the implementation of a change in a medication-use process. Goal R1.3: Prepare and dispense medications following existing standards of practice and the organization s policies and procedures. OBJ R1.3.1 (Evaluation) Interpret the appropriateness of a medication order before preparing or permitting the distribution of the first dose. State the elements of a complete medication order and the essentials of legibility and accuracy. Use effective prescriber education techniques to secure agreement on modifications to medication orders. Document modifications to medication orders according to the organization's policies and procedures. OBJ R1.3.2 (Application) Follow the organization's policies and procedures to maintain the accuracy of the patient s medication profile. OBJ R1.3.3 (Application) Prepare medication using appropriate techniques and following the organization's policies and procedures. Explain standards of practice for the preparation of medications. Explain the organization's quality assurance standards for the preparation of medications. Prepare intravenous admixtures using aseptic technique. Prepare chemotherapeutic agents observing rules for safe handling of cytotoxic and hazardous medications. Appraise admixture solutions for appropriate concentrations, rate, compatibilities, stability, clarity, coring, and storage Formulate strategies for preparing extemporaneously compounded medications to produce the desired end products. Label medication products following the organization s policies and procedures. OBJ R1.3.4 (Application) Dispense medication products following the organization's policies and procedures. Compare and contrast the procedures used to dispense medications across the continuum of care settings. Follow a systematic procedure for checking the accuracy of medications dispensed, including correct patient identification, correct medication, correct dosage form, correct dose, correct number of doses, expiration dates, and properly repackaged and relabeled medications. Follow departmental procedures and standards of practice to insure the integrity of medication dispensed throughout the organization. Follow appropriate policies and procedures to document patients' medication refill histories. Goal R1.4: Demonstrate ownership of and responsibility for the welfare of the patient by performing all necessary aspects of the medication-use system. 14 of 55

15 OBJ R1.4.1 (Characterization) Display initiative in preventing, identifying, and resolving pharmacy-related patient-care problems. Explain the role of the pharmacist in preventing, identifying, and resolving pharmacy-related patient-care problems. Explain the importance of contacting the appropriate parties when a problem is identified. Explain the role of assertiveness in presenting pharmacy concerns, solutions, and interests. Explain the pharmacist s obligation for absolute attention to detail in the preparation/distribution process. Explain the interdependent relationship between operational tasks and clinical activities. Explain the importance of follow-through of medication-use system activities. Goal R1.5: Provide concise, applicable, comprehensive, and timely responses to requests for drug information from patients and health care providers. OBJ R1.5.1 (Analysis) Discriminate between the requesters statement of need and the actual drug information need by asking for appropriate additional information. Explain the characteristics of a clearly stated clinical question. OBJ R1.5.2 (Synthesis) Formulate a systematic, efficient, and thorough procedure for retrieving drug information. Explain the strengths and weaknesses of manual and electronic methods of retrieving biomedical literature. State sources of evidence-based metanalysis reviews. Compare the characteristics of each of the available resources for biomedical literature. OBJ R1.5.3 (Analysis) Determine from all retrieved biomedical literature the appropriate information to evaluate. OBJ R1.5.4 (Evaluation) Evaluate the usefulness of biomedical literature gathered. Assess the potential for bias of the author or preparer of all forms of drug information. Determine whether a study s methodology is adequate to support its conclusions. Determine whether the endpoint established for a study is appropriate. Explain methods used to test study end point (e.g., pulmonary function studies). Explain the effects on study outcomes of various methods of patient selection (e.g., volunteers, patients, or patients with different disease severity). Explain the effects of various methods of blinding (e.g., doubleblind, single-blind, open-research designs) on study outcomes. 15 of 55

16 University Campus Explain the effects on study outcomes of various methods of drug assay and quality assurance procedures (e.g., high performance liquid chromatography, assay coefficient of variations). Explain the types of pharmacotherapy studies (e.g., kinetic, economic, dynamic) and the kind(s) of data analysis appropriate for each. Explain how the choice of statistical methods used for data analysis (e.g., t test, analysis of variance) affects the interpretation of study results and conclusions. Determine if a study s findings are clinically significant. Explain the strengths and limitations of different study designs. Determine whether a study's conclusions are supported by the study results. Explain how data from a study can be applied to expanded patient populations. OBJ R1.5.5 (Synthesis) Formulate responses to drug information requests based on analysis of the literature. OBJ R1.5.6 (Synthesis) Provide appropriate responses to drug information questions that require the pharmacist to draw upon his or her knowledge base. OBJ R1.5.7 (Evaluation) Assess the effectiveness of drug information recommendations. Explain all factors that must be assessed to determine the effectiveness of a response. Outcome R2: Provide evidence-based, patient-centered medication therapy management with interdisciplinary teams. (When provided as part of the practice of direct patient care, this outcome always involves a series of integrated, interrelated steps.) Establish collaborative professional relationships with health care team members Place priority on delivery of patient-centered care to patient Establish collaborative professional pharmacist-patient relationship Collect and analyze patient information When necessary make and follow up on patient referrals Design evidence-based therapeutic regimen 16 of 55

17 Design evidence-based monitoring plan Recommend or communicate regimen and monitoring plan Implement regimen and monitoring plan Evaluate patient progress and redesign as necessary Communicate ongoing patient information Document direct patient care activity Goal R2.1: As appropriate, establish collaborative professional relationships with members of the health care team. OBJ R2.1.1 (Synthesis) Implement a strategy that effectively establishes cooperative, collaborative, and communicative working relationships with members of interdisciplinary health care teams. Demonstrate knowledge of other team members expertise, background, knowledge, and values in all interdisciplinary team interactions. Explain the training and expected areas of expertise of the members of the interdisciplinary with which one works. For each of the professions with which one interacts on an interdisciplinary team, explain the profession s view of its role and responsibilities in collaborations on patient-centered care. Exercise skill in the use of individual roles and processes required to work collaboratively on interdisciplinary teams. Define a collaborative professional working relationship. Explain the structures and content of collaborative working relationships that are possible between the pharmacist and the physician and between the pharmacist and other health care professionals. Explain the limits that are imposed on possible collaborative relationships by the presence or absence of guidelines, legal and regulatory requirements, and organizational policies and procedures. Exercise skill in the use of group techniques to include communication, negotiation, delegation, time management, assessment of group dynamics, and consensus building. Explain the principles and applications of negotiation as they apply to interdisciplinary team work. Explain the principles and applications of delegation as they apply to interdisciplinary team work. 17 of 55

18 Explain the principles and applications of time management as they apply to interdisciplinary team work. Explain the principles of group dynamics and how they apply to interdisciplinary team work. Explain the principles of conflict management and how they apply to interdisciplinary team work. Explain a systematic approach to building consensus. Explain how interdisciplinary team members develop unique communication patterns (shared language). Explain the importance of adhering to use of an interdisciplinary team s shared language. Exercise skill in the coordination and integration of pharmacist s care with the contributions of other members of the interdisciplinary team. Goal R2.2: Place practice priority on the delivery of patient-centered care to patients. OBJ R2.2.1 (Organization) Choose and manage daily activities so that they reflect a priority on the delivery of appropriate patient-centered care to each patient. Explain the meaning of patient-centered care and the rationale for its use. Explain methods for prioritizing the delivery of care to patients when time or resources prohibit the delivery of full direct patient care services to all patients. Goal R2.3: As appropriate, establish collaborative professional pharmacist-patient relationships. OBJ R (Synthesis) Formulate a strategy that effectively establishes a patientcentered pharmacist-patient relationship. Explain the meaning of the term patient-centered and the rationale for its use. Explain the appropriate sharing of power and responsibility between the pharmacist, patient and caregivers in a patient-centered, pharmacistpatient relationship. Explain why it is important that the pharmacist communicate with the patient in a shared and fully open manner in a patient-centered, pharmacist-patient relationship. Explain the role of demonstrating respect for the patient s individuality, emotional needs, values, and life issues in a patient-centered, pharmacist-patient relationship. Goal R2.4: Collect and analyze patient information. OBJ R2.4.1 (Analysis) Collect and organize all patient-specific information needed by the pharmacist to prevent, detect, and resolve medication-related problems and to make appropriate evidence-based, patient-centered medication therapy recommendations as part of the interdisciplinary team. Identify the types of patient-specific information the pharmacist requires to prevent, detect, and resolve medication-related problems and to make appropriate evidence-based, patient-centered medication therapy recommendations as part of the interdisciplinary team. 18 of 55

19 Explain the role of collecting information regarding the patient s culture, emotional needs, preferences, values, and life issues in formulating evidence-based, patient-centered care decisions. Explain patient or disease specifics that would require the pharmacist to collect pharmacogenomic and/or pharmacogenetic information. Explain issues surrounding confidentiality of patient information and the impact of HIPAA regulations on the collection and safeguarding of patient-specific information. Explain signs and symptoms, epidemiology, risk factors, pathogenesis, natural history of disease, pathophysiology, clinical course, etiology, and treatment of diseases commonly encountered. Explain the mechanism of action, pharmacokinetics, pharmacodynamics, pharmacoeconomics, usual regimen (dose, schedule, form, route, and method of administration), indications, contraindications, interactions, adverse reactions, and therapeutics of medications in the treatment of diseases commonly encountered. Explain current trends and issues in nontraditional therapy. Use standard patient medical charts, records and/or internal electronic information databases to collect information that may be pertinent to prevent, detect, and resolve medication-related problems and to make informed evidence-based, patient-centered medication therapy recommendations to an interdisciplinary team. Integrate effective communication techniques in interviews with patients, caregivers, health care professionals, or others so that the patientspecific information needed by the pharmacist for evidence-based, patient-centered care is collected. When presented with a limited time frame (e.g., ambulatory care office visit) use an interview strategy that elicits maximum pertinent information Explain effective phone techniques to be used to obtain information for the patient database. Explain the impact of having discontinuous or fragmented patient-care information when developing an interview strategy for patients (e.g., patient seeing multiple caregivers, last visit 6 months ago). Distinguish the meaning of non-verbal cues in patient encounters (e.g., broken sentences in an asthmatic patient, difficult ambulation in an arthritic patient). When appropriate, measure patient vital signs and use appropriate physical assessment skills. Determine the most reputable and credible source of required patientspecific information. Record required patient-specific information in a manner that facilitates detecting and resolving medication-related problems and making 19 of 55

20 appropriate evidence-based, patient-centered medication therapy recommendations to an interdisciplinary team. In a setting where none exists, create an effective organizational system for recording patient-specific data. OBJ R2.4.2 (Analysis) Determine the presence of any of the following medication therapy problems in a patient's current medication therapy: 1. Medication used with no medical indication 2. Patient has medical conditions for which there is no medication prescribed 3. Medication prescribed inappropriately for a particular medical condition 4. Immunization regimen is incomplete 5. Current medication therapy regimen contains something inappropriate (dose, dosage form, duration, schedule, route of administration, method of administration) 6. There is therapeutic duplication 7. Medication to which the patient is allergic has been prescribed 8. There are adverse drug or device-related events or potential for such events 9. There are clinically significant drug-drug, drug-disease, drug-nutrient, or drug-laboratory test interactions or potential for such interactions 10. Medical therapy has been interfered with by social, recreational, nonprescription, or nontraditional drug use by the patient or others 11. Patient not receiving full benefit of prescribed medication therapy 12. There are problems arising from the financial impact of medication therapy on the patient 13. Patient lacks understanding of medication therapy 14. Patient not adhering to medication regimen Explain psychological, cultural, and economic factors that influence patient compliance with prescribed medications. Explain factors to consider when comparing the benefits and risks of an alternative medication therapy. Explain factors to consider when trying to determine the likelihood that a reaction is occurring because of a medication. Assess criteria for assessing the severity of an adverse drug reaction. Explain acceptable approaches to the therapeutic management of an adverse drug reaction. ) Explain mechanisms of determining therapeutic consequence resulting from defective medications or drug products (e.g., exacerbation of asthma due to a defective inhaler). Use a functional format to list patients' pharmacotherapy problems. Prioritize patients' pharmacotherapy problems. OBJ R2.4.3 (Analysis) Using an organized collection of patient-specific information, summarize patients health care needs. Goal R2.5: When necessary, make and follow up on patient referrals. 20 of 55

21 OBJ R2.5.1 (Evaluation) When presented with a patient with health care needs that cannot be met by the pharmacist, make a referral to the appropriate health care provider based on the patient s acuity and the presenting problem. Explain the organization s process for making a patient referral. Explain the information needed to make an appropriate referral. Explain a systematic process for assessing the acuity of a patient s illness. OBJ R2.5.2 (Synthesis) Devise a plan for follow-up for a referred patient. Explain the importance of following up on patients who are referred to other health care providers. Explain the importance of integrating follow-up information into the longterm management plan. Goal R2.6: Design evidence-based therapeutic regimens. OBJ R2.6.1 (Synthesis) Specify therapeutic goals for a patient incorporating the principles of evidence-based medicine that integrate patient-specific data, disease and medication-specific information, ethics, and quality-of-life considerations. Explain the use of evidence-based consensus statements and guidelines in the setting of patient-specific therapeutic goals. Explain how culture influences patients perceptions of desirable outcomes. Explain the importance of the patient's perception of desirable outcomes when setting therapeutic goals for a patient with functional limitations. Explain the impact of quality-of-life issues on making decisions about therapeutic goals. Explain ethical issues that may need consideration when setting therapeutic goals. Compare and contrast the realistic limits of treatment outcomes among the various care settings. Explain how a patient's age or mental status might affect the setting of therapeutic goals. Explain how goals of others on the interdisciplinary team influence the specification and prioritization of therapeutic goals. Explain unique aspects of the patient s role in the ambulatory care setting in determining his/her therapeutic goals. OBJ R2.6.2 (Synthesis) Design a patient-centered regimen that meets the evidencebased therapeutic goals established for a patient; integrates patient-specific information, disease and drug information, ethical issues and quality-of-life issues; and considers pharmacoeconomic principles.. Explain the use of evidence-based consensus statements and guidelines in the design of patient-specific therapeutic regimens. Accurately interpret best evidence for use in the design of a patientcentered regimen for a specific patient. Explain where and how to find the best possible sources of evidence for a specific patient case. 21 of 55

22 Explain how to conduct a search for relevant answers to a specific clinical question, including searches of resources that evaluate or appraise the evidence for its validity and usefulness with respect to a particular patient or population. Explain how to integrate seemingly applicable findings of best evidence with clinical judgment to arrive at an optimal evidence-based regimen for a specific patient. Explain how culture influences patients perception of disease and how this affects responses to various symptoms, diseases, and treatments. Explain how patient-specific pharmacogenomics and pharmacogenetics may influence the design of patients medication regimens. Explain additional concerns with compliance, cost, and route of administration when making decisions on medication regimens. Goal R2.7: Design evidence-based monitoring plans. OBJ R2.7.1 (Synthesis) Design a patient-centered, evidenced-based monitoring plan for a therapeutic regimen that effectively evaluates achievement of the patientspecific goals. Explain the use of evidence-based consensus statements and guidelines in the design of patient-specific monitoring plans. Explain cultural and social issues that should be considered when designing a monitoring plan. Explain the importance of considering what is feasible and useful when designing a monitoring plan. Compare and contrast various methods for monitoring patient adherence (e.g., refill rates, questioning, return demonstration). Determine monitoring parameters that will measure achievement of goals for a therapeutic regimen. State customary drug-specific monitoring parameters for medical regimens commonly prescribed. Explain the relationship between what are normal value ranges for parameters and the influence on those ranges by a given disease state. Identify the most reliable sources of data for measuring the selected parameters. Define a desirable value range for each selected parameter, taking into account patient-specific information. Explain factors that should influence the frequency and timing of parameter measurements in monitoring plans. Explain effective approaches to assuring patient return for follow-up visits in the ambulatory setting. Identify the most appropriate person to collect monitoring data (e.g., family member, nurse, patient). Goal R2.8: Recommend or communicate regimens and monitoring plans. OBJ R2.8.1 (Application) Recommend or communicate a patient-centered, evidence-based therapeutic regimen and corresponding monitoring plan to 22 of 55

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