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Howard University College of Pharmacy Department of Clinical and Administrative Sciences Course Plan Integrated Therapeutics Lab II (87763-338) 4 credit hours Fall 2013 Course Coordinator: Salome B. Weaver, Pharm.D. Sequence: Fall Semester Year: 3rd Academic/Professional Year Format: 4-Credit course Faculty: Faculty and Guest Lecturers (Adjunct Faculty) Prerequisite(s): All Integrated Therapeutics I courses Office Hours/Location Fall 2012: Wednesday 2 p.m. – 4:00 p.m. and by appointment Annex 3, Room 121 (202) 806-7262 [email protected] Lab Meeting Times and Places Large Group: Monday 10:00 am – 1:00 pm in Room 3210 College of Medicine Small Groups: Tuesday, Thursday - 11:30 a.m. - 1:00 p.m. in assigned HSL/PBL rooms Friday – 10:00 a.m.-1:00 p.m.* *( Fridays are reserved for special activities including but not limited to remediation activities.) Required Textbooks: Pharmacotherapy: principles and practice, 8th edition Editors: Chisholm-Burns, Schwinghammer, Wells, Malone, Kolesar, DiPiro Publishers: McGraw-Hill ISBN: 978-0-07-162180-9 Applied Therapeutics: The Clinical Use of Drugs, 11th Edition Editors: Koda-Kimble, Young, Alldredge, Corelli, Guglielmo, Kradjan, Williams Publishers: Lippincott, Williams & Wilkins, Philadelphia, PA 19106 ISBN: 978-0-7817-6555-8 Drug Information Handbook, 19th Edition Authors: Lacy, Armstrong, Goldman, Lance Publishers: APhA Publications, Washington, DC LexiComp ISBN# 978-1-59195-278-7 Required Study Aid: Sigler’s Pharmacy Drug Cards Recommended references, books, study aids: 1 Remington The Science and Practice of Pharmacy 21st edition Editors: Beringer, DerMarderosian, Felton, Gelone, Gennaro, Gupta, Hoover, Popovich, Reilly and Hendrickson Publisher: Lippincott Williams & Wilkins ISBN#: 0-78717-4673-6 Supplemental readings (journals, newsletters, websites, etc.) as assigned by individual instructors and Course Coordinator. Course Description The Integrated Therapeutics (IT) Lab II is an infectious disease, hematology and oncology modular formatted course. During IT Lab II, the student is expected to acquire the knowledge and skills which are required to appropriately dispense and recommend prescription, OTC, complementary and alternative medicines (CAM), medical devices and other health care products. The appropriate selection, rational use, therapeutic efficacy and issues, warnings, precautions, contraindications, drug interactions, use in pregnancy and lactation of prescription medications, and use of non-prescription medications, complementary/alternative products and home and health aids in patients who have infectious or hematological and oncologic diseases will be studied. With consideration given to matters of health literacy the student is expected to demonstrate cultural competency in the development of patient-centered care and patient consultation skills. In addition, the module will provide the student with opportunities for increasing his or her problem-solving skills through the use of a modified problem-based learning approach. The student is expected to attend the large group session each week and one small group session each week. Remediation activities will be scheduled according to the needs of the student. The student is required to review Sigler’s Pharmacy Drug Cards as appropriate to each topic. Writing is an essential tool for thinking and communicating in virtually every profession. Therefore, in this course I will expect you to produce writing that is not only thoughtful and accurate, but also organized, clear, and consistent with the rules of Standard English. If your writing does not meet these standards, I may deduct points or ask you to revise. For assistance with your writing, go to the student section of the Writing across the Curriculum (WAC) website http://www.cetla.howard.edu/wac/students.aspx . Course Learning Goals The course is intended to enable the student to: 1. 2. 3. 4. Apply the knowledge of both basic and clinical sciences in the management of pharmaceutical care problems Gather and organize patient information in order to identify ongoing or potential drug-related problems and the root causes of the problems. Interpret and evaluate pharmaceutical data and related information needed to prevent or resolve medication-related problems. Formulate, implement, and modify pharmaceutical care plans, including the recommendation of pharmacotherapy specific to patient needs and desired outcomes. 2 5. 6. 7. 8. Display the attitudes, behavior and values required to render pharmaceutical [patient-centered] care. Demonstrate sensitivity to and facility with personal values and ethical principles in professional and social contexts. Demonstrate a basic understanding of the strengths and problems of cultural diversity and the historic responses of society, as they related to oneself and to others. Demonstrate effective interpersonal and intergroup behavior in a variety of situations and circumstances. Course Objectives: At the end of the course, the student shall have acquired competencies in the selection of prescription, OTC, CAM products and home and health care products used in the treatment of infectious and hematological /oncological diseases and in the advisement and counseling of patients on the proper use of the medications and products. The student shall demonstrate the following competencies; 1. Classify prescription medications used in the treatment of infectious, hematological and oncological diseases according to therapeutic uses. 2. Identify and discuss appropriate use of home care products and devices used in the treatment of infectious and hematological /oncological diseases. 4. Utilize an algorithm formatted process to determine the appropriateness of selftreatment versus triage for further medical evaluation in infected patients. 5. Properly advise health professionals on appropriate use, potential hazards or misuse of prescription, potential drug-drug, drug-food and drug- laboratory result interactions of antimicrobial and hematologic/oncologic agents. 6. Appropriately counsel patients on the proper use and handling of OTC medications and their contraindications with concurrent use of prescription drugs and dietary supplements in presence of infectious and hematologic/oncologic diseases. Emphasis will be placed on matters of health literacy while recognizing patients’ healing traditions and beliefs. 7. Identify an antimicrobial, hematological /oncological drug or product ingredient by its trade, generic or common name, identify the therapeutic use or pharmacological rationale for its use, and identify the known or postulated mechanism(s) of action. 8. Demonstrate the ability to verify the appropriateness of a medication regimen with respect to the presence of infectious disease(s), hematological /oncological and comorbidities. 9. Describe proper labeling (including auxiliary/cautionary) of prescription, OTC, CAM and home-care antimicrobial and hematological /oncological medications and products. 10. Identify, interpret or evaluate sources of drug information for use in answering questions regarding prescription products. Emphasis will be placed on matters of patient health literacy and critically appraising literature on health disparities. 11. Describe proper aseptic techniques and sterilization procedures for preparing sterile antimicrobial and hematological /oncological products. 3 12. Determine appropriate dosage, preparation, compatibilities and incompatibilities, storage, handling, transport and administration of antimicrobial and hematological /oncological products. 13. Recognize prescription products which may alter the therapeutic effect(s) of antimicrobial and hematological /oncological agents. 14. Explain contemporary infectious disease and hematological /oncological public health issues to other health professionals and patients in relationship to the treatment of diseases and medical or physiologic conditions with respect to health literacy status. 15. Advise/counsel patients and health care professionals on the appropriate use of antimicrobial and hematological/oncologic medications during pregnancy and lactation. 16. Display attitudes, behaviors and values required to render pharmaceutical care 17. Demonstrate sensitivity to personal values and ethical principles in professional and social contexts and value the historical impact of racism among various minority cultures. 18. Demonstrate a basic understanding of the strengths and problems of cultural diversity and the historic responses of society, as they relate to oneself and to others and be able to list ways to enhance patient adherence RELEVANT ACPE ACCREDITATION STANDARDS & GUIDELINES ON CULTURAL COMPETENCY ACPEa ACPE Guideline 9.1 Ensuring that the curriculum addresses patient safety, cultural appreciation, health literacy, health care disparities, and competencies needed to work as a member of an inter-professional team. a Accreditation Council for Pharmacy Education RELATED COURSE OBJECTIVES Course Objective 6, 10, 14, 16, 17 and 18 Course learning goal 5, 6, 7 and 8 RELATED TACCTb,c DOMAIN Objective 6 – K2(II) Objective 10 – S1(IV) Objective 14 - S1(III) Objective 16 – A1 (V) Objective 17 – A2 (IV) Objective 18 – K6 (V) bTool for Assessing Cultural Competence Training cK - Knowledge, A - Attitudes, S - Skill Activities in the Course related to the TACCT Domain Objective 6 – K2(II) – Recognize patient’s healing traditions and beliefs (Objective Structured Clinical Examination Practice Session) Objective 10 – S1(IV) – Critically Appraise literature on disparities (Journal Article Review) Objective 14 - S1(III) - Demonstrate strategies to address/reduce bias ( Problem Based Learning Cases for the Small Group) Objective 16 – A1(V) – Respect patient’s cultural beliefs (OSCE, Health Literacy Educational Toolkit) Objective 17 – A2 (IV) – Value the historical impact of racism (Health Literacy Lecture and Toolkits) 4 Objective 18 – K6 (V) – List ways to enhance patient adherence (Objective Structured Clinical Examination, Patient Counseling competition, Clinical Skills Competition and Case Studies) Relationship to NAPLEX Competencies (Revised) Upon completion of the course, the student should be able to fulfill the following NAPLEX competency areas: Area 1 Assure Safe and Effective Pharmacotherapy and Optimize Therapeutic Outcomes 1.1.0 Obtain, interpret and evaluate patient information to determine the presence of a disease or medical condition, assess the need for treatment and/or referral, and identify patient-specific factors that affect health, pharmacotherapy, and/or disease management. 1.1.1 Identify and assess patient information including medication, laboratory and disease state histories. 1.1.2 Identify and/or use instruments and techniques related to patient assessment and diagnosis. 1.1.3 Identify and define the terminology, signs, and symptoms associated with diseases and medical conditions. 1.1.4 Identify and evaluate patient factors, genetic factors, biosocial factors, and concurrent drug therapy that are relevant to the maintenance of wellness and the prevention or treatment of a disease or medical condition. 1.2.0. Identify, evaluate, and communicate to the patient or health-care provider, the appropriateness of the patient’s specific pharmacotherapeutic agents, dosing regimens, dosage forms, routes of administration, and delivery systems. 1.2.1. Identify specific uses and indications for drug products. 1.2.2. Identify the known or postulated sites and mechanisms of action of pharmacotherapeutic agents. 1.2.3. Evaluate drug therapy for the presence of pharmacotherapeutic duplications and interactions with other drugs, food, diagnostic tests, and monitoring procedures. 1.2.4. Identify contraindications, warnings and precautions associated with a drug product’s active and inactive ingredients. 1.2.6. Interpret and apply pharmacodynamic and pharmacokinetic principles to calculate and determine appropriate drug dosing regimens. 1.3.0 Manage the drug regimen by monitoring and assessing the patient and/or patient information, collaborating with other health care professionals, and providing patient education. 1.3.1. Identify pharmacotherapeutic outcomes and endpoints. 1.3.2. Evaluate patient signs and symptoms, and the results of monitoring tests and procedures to determine the safety and effectiveness of pharmacotherapy. 1.3.3. Identify, describe the mechanism of, and remedy adverse reactions, allergies, side effects and iatrogenic or drug-induced illness. 1.3.4. Prevent, recognize, and remedy medication non-adherence, misuse or abuse. 1.3.5. Recommend pharmacotherapeutic alternatives. 5 Area 2 Assure Safe and Accurate Preparation and Dispensing of Medications 2.1.0 Perform calculations required to compound, dispense, and administer medication. 2.1.3 Calculate the rate of drug administration 2.2.0 Select and dispense medications in a manner that promotes safe and effective use. 2.2.1 Identify drug products by their generic, brand and/or common names. 2.2.2. Determine whether a particular drug dosage strength or dosage form is commercially available, and whether it is available on a nonprescription basis. Area 3 Provide Health Care Information and Promote Public Health 3.1.0 Access, evaluate and apply information to promote optimal health care. 3.1.2 Evaluate the suitability, accuracy, and reliability of information from reference sources by explaining and evaluating the adequacy of experimental design and by applying and evaluating statistical tests and parameters. 3.2 Educate the public and health-care professionals regarding medical conditions, wellness, and dietary supplements, and medical devices. 3.2.1 Provide health care information regarding the prevention and treatment of diseases medical conditions, including emergency patient care. HUCOP Program Outcomes 11. Provide Patient-Centered Care: Through the ability to design, implement, monitor, evaluate, and adjust pharmacy care plans that are patient-specific; address health literacy, cultural diversity, and behavioral psychosocial issues; and are evidence-based; function effectively as a member of an interprofessional care team; manage a successful patientcentered practice (including establishing, marketing, and being compensated for medication therapy management and patient care services rendered). 11.1 Gather and organize patient information in order to identify ongoing or potential drugrelated problems and the root cause of the problems. 11.2 Interpret and evaluate pharmaceutical data and related information needed to prevent or resolve medication-related problem. 11.3 Plan and perform ongoing patient evaluation to identify additional drug-related problems. 11.4 Formulate, implement and modify pharmaceutical care plans, including the recommendation of pharmacotherapy specific to patient needs and desired outcome. 11.5 Retrieve, evaluate, and interpret health science literature efficiently and accurately for pharmaceutical care, research, and education. 11.6 Communicate effectively with health-care professionals and patients to ensure the provision of safe and effective pharmaceutical care. 11.7 Integrate cultural, sociological, behavioral, economic and environmental aspects of patient care into professional practice. 6 11.8 Prepare, dispense, and administer medications to promote safe and effective medication use 11.9 Document pharmaceutical care activities in the patient's medical record to facilitate communication and collaboration among providers. 11.10. Display the attitudes, behavior and values required to render pharmaceutical care. 11.11. Interpret and comply with pharmacy laws and drug regulations. 11.12. Demonstrate appropriate professional and ethical judgment in the provision of pharmaceutical care services. 11.13 Maintain professional competence by identifying and analyzing emerging issues, products, and services that may impact patient-specific therapeutic outcomes. Course Activities Course Instructors: This course is team-taught. Invited lecturers may represent a variety of area institutions and practices. The student is expected to present with a professional demeanor in all classroom and small group sessions. Reading Assignments: The student is expected to review assigned reading materials and supplemental articles provided by the instructor(s)/moderators(s) prior to the start of the scheduled lecture or series of lectures or small group sessions. Class Participation: The student is expected to participate in all activities and is held responsible for course material, even when absent. Objective Structured Clinical Examination (OSCE): There are 2 Evaluation OSCEs at the middle and end of the semester which are worth 50 points each. A student with an excused absence is only allowed to miss the first evaluation OSCE during the course of the module. If an excuse is not granted, the score for the missed OSCE will be zero. The Small Group Session provides opportunities for the student to review and/or apply information relevant to the lecture or lecture series. Case histories, study questions or other needed materials will be provided. Specific instructions will also be provided regarding the manner in which the session(s) will be conducted. Please follow these instructions carefully. The lecturer/moderator has ultimate responsibility for the content of the learning exercises. The student has the ultimate responsibility to understand and learn the material. The session will make use of the small group format to assure maximal student participation. The student is assigned to a small group and is expected to attend one small group session each week. Active participation is required. The student who is absent from the small group session is required to contact the instructor/moderator and course coordinator as soon as possible and make the absence known. The student will receive no credit (i.e. 0 points) for each unexcused absence from the small group session. Furthermore, the student who fails to report as assigned to the small group session on the scheduled date and time shall earn the grade of "zero" unless their absence is considered 7 “excused”. An absence from a small group session shall be considered "excused" when the student is allowed to complete a makeup assignment. In addition an absence is considered as “excused” if it occurs because of any one of the following circumstances: (a) Hospitalization of the student due to illness or accident. (b) Death in the student’s immediate family (e.g. spouse, parents, guardians, siblings and/or children). (c) Summons of the student to appear for jury duty or before a court of law. In these cases, the absentee student shall submit documents supporting the above claims (hospital admission form, death certificate or government/ court subpoena) to the course coordinator. Upon satisfactory verification, the student shall be allowed to complete a makeup assignment. The content of makeup assignment will be determined by the small group session moderator. If the student is absent from the large or small group session for a reason known prior to the session, but fails to contact the coordinator to discuss the potential excused absence, no excuse will be accepted and no credit will be awarded for that session’s activities and the grade will be recorded as zero (“0”). Assessment and Grading Policies Module II Evaluation/Final Grade Explanation The final course grade will be determined as follows: Small Group Participation (15 @ 10 pts) Special Projects/Small Groups Assignments (15 @10 points) Patient Counseling Assessment OSCE 1 Clinical Skills Assessment OSCE 2 Total = 150 points 150 points 50 points 50 points 50 points 50 points 500 points The numerical equivalent of letter grades is as follows: A = 90-100% B+ = 86-89% B = 80-85% C+ = 76-79% C = 70-75% F = <70% Please Note: The lowest passing grade is 70% (C). Should a student have a concern about a grade earned from an activity, he/she should make an appointment to speak with the appropriate conference moderator/lecturer. If adjustment is merited, the lecturer will communicate the change to the coordinator. The student has one week following the release of a grade to make an appeal. If, after good faith attempts have been made, the student is unable to contact the appropriate 8 moderator/lecturer during this one-week period, the student may address the matter(s) with the course coordinator. Exam Review Students are allowed to view their first OSCE video in the College of Pharmacy Computer Lab a week after the first OSCE is complete and uploaded for purposes of improving their second OSCE. Remediation The course coordinator will monitor student performance and identify the student who is experiencing academic difficulty. Remediation in this course means: students will have attended at least 13 out of 15 of all small group sessions before they can qualify for remediation with an excused absence for the other two missed sessions. The remediation option includes a corrective small group assignment given by the Course faculty. Course faculty will determine whether student deficiencies at the end of the course can be currently remediated or if the student would best benefit by repeating the course module. This assessment shall be undertaken in accordance with College of Pharmacy academic policy. No remediation will be given after the end of the final OSCE for the course. There will be no makeup if a student misses an assessment in the small/large group session (Patient Counseling Assessment, Clinical Skills Assessment and OSCE 2) Dress Code/Professionalism The student is expected to demonstrate professional attitudes in dress and demeanor at all times. The student is expected to attend all small group session dressed in a clean white lab coat. The student is referred to the HU College of Pharmacy for more specific information about the student dress code. * Policy Regarding Cheating For information regarding cheating the student is referred to the “Academic Code of Conduct” which is published in the “H-Book “and the “Howard University Student Reference Manual and Directory of Classes”. The pharmacy student is a professional student, demonstration of the highest levels of honor and integrity is expected. 2. Policy Regarding Audio or Video Recordings Neither audio nor video recording of a lecture is allowed without the expressed consent of the lecturer. 3. Class Attendance: i. The student is expected to attend all class sessions consistently and promptly. ii. The student is expected to attend all small group class sessions dressed in a clean white lab coat. iii. The student who refrains from attending class and lab sessions is held responsible for all course work. iv. The student will refrain from consuming food and drinks during class sessions. 9 The Non-Registered Student A non-registered student is not authorized nor permitted to continue in the Integrated Therapeutics Lab II course past the final day for registration as indicated by the University. No exceptions are permitted. A student whose name does not appear on the official University course roster will not be allowed to remain in the class or participate in any class activity. If the student has registered for the course and paid appropriate fees but is not on the class roll, the student may show the instructor/moderator/coordinator an official receipt and may be allowed to temporarily remain in class while registration procedure is in progress. A registration printout is not acceptable as proof of registration. HOWARD UNIVERSITY STATEMENT ON ADA PROCEDURES Howard University is committed to providing an educational environment that is accessible to all students. In accordance with this policy, students in need of accommodations due to disability should contact the Office of the Dean for special Student Services for verification and determination of reasonable accommodations as soon as possible after admission to the University or at the beginning of each semester. The Dean of the Office of Special Student Services, can be reached at (202) 238 2420. Withdrawal Date The deadline for course withdrawal is five business days prior to the scheduled final examination or according to the University calendar. Course Grade Posting/Course Information Information about grades and the course will be posted on Blackboard when access is made available to the course coordinator. Information about grades may be obtained by contacting the course coordinator if access to Blackboard is not available and general information about the course will be sent via email to at least one class officer. The class officer(s) is(are) expected to forward/share the information with each student who is enrolled in the course. If the student finds difficulty in receiving information about the course, they should contact the course coordinator immediately. Activity Content Inquiries Inquiries about specific activities must be addressed with the course coordinator no later than one week after posting of grades. The coordinator will determine when credit should be awarded. 10 Integrated Therapeutics Lab II 87763-338 Lecture/PBL Schedule Fall 2013 Salome Weaver, Pharm.D. Course Coordinator August 26, 2013 through December 5, 2013 Mon 10:00 am – 1:00 pm; large group MED-3210 and Tues or Thurs 11:30am-1:00 pm in small groups Louis B. Stokes HSL PBL Rooms **Wednesday 12:30- 2:00 pm Large Group Remediation Activities** **Friday 10:00 am -1:00 pm Small Group Remediation Activities** Tuesday: Small Groups 1, 2, 3, 4, 5, and 6 Thursday: Small Groups 7, 8, 9, 10, 11 and 12 Date Topic M 8/26 Course Introduction Pharmaceutical Care Plans/ Health Literacy Instructor(s)/ Moderator(s) Weaver Weaver T 8/27 Th 8/29 M 9/2 Health Literacy Weaver Labor Day Holiday No Class T 9/3 Th 9/5 General Principles of Antimicrobial Therapy Empiric vs Definitive Dosage Regimen MIC Interpretation Park M 9/9 CDC-12 step to prevent antimicrobial resistance Park T 9/10 Th 9/12 Laboratory Monitoring Exercise (Identify the different types of infection control methods – CDC.gov) Infection Control Antimicrobial Clinical Trial Review and Journal Critique and PK and PD Dosing Antimicrobial Clinical Trial Review/Journal Review PK/PD/AUC and Aminoglycosides and Quinolones bring 2cycle semilog paper and IDSA Vancomycin Guidelines Park M 9/16 T 9/17 Th 9/19 M 9/23 T 9/24 Th 9/26 M 9/30 T 10/1 Th 10/3 Multicultural Aspects of Self-Care Nonprescription Pharmacotherapy, Pt. Assessment & Consultation Legal & Regulatory Issues in Self-Care Pharmacy Practice Cases Studies in Treatment of Lower Respiratory Tract Infections OSCE Orientation and Demonstration College of Medicine Clinical Skills Center and COM 3210 Patient Counseling Assessment College of Medicine Clinical Skills Center 11 Park Park Mims Park Weaver Weaver M 10/7 Medications used to treat STDs and HIV Daftary T 10/8 Th 10/10 Medications used to treat STDs and HIV Daftary M 10/14 Columbus Day Holiday—No Class T 10/15 Th 10/17 *OSCE #1 Format (Evaluation OSCE) Groups #1 and #2 M 10/21 Antivirals, Antifungals and Tuberculosis: 10:00 – 11:30 AM Emergency Preparedness: 11:30 – 1:00 pm Antivirals Antifungals Tuberculosis T 10/22 Th 10/24 Weaver Residents **Faculty** Daftary Cephas Daftary M 10/28 Medications Used to Treat Skin and Soft Tissue Infections Medications used to Treat UTIs Medications used to Treat Central Nervous System Infections Parasites Daftary T 10/29 Th 10/31 Medications Used to Treat Skin and Soft Tissue Infections Medications used to Treat UTIs Medications used to Treat Central Nervous System Infections Parasites Daftary M 11/4 Clinical Skills Assessment College of Pharmacy PBL Rooms, 2 nd Floor and Multipurpose Dispensing Lab, 1st Floor Date Topic T 11/5 Th 11/7 Case Studies: Medications/Therapies Used in the Treatment of CML, CLL, AML, ALL, M 11/11 T 11/12 Th 11/14 No class – Veteran’s Holiday Cancer Chemotherapy Orders Weaver/ Residents **Faculty** Instructor(s)/ Moderator(s) Moore Lombardo Lombardo/ Weaver M 11/18 Supportive Care and Febrile Neutropenia Moore T 11/19 Th 11/21 Chemotherapy Pain Orders Parth M 11/25 Deficiency Anemia, Relative and Hemolytic lecture Curry T 11/26 Orals: The Treatment of Anemia Moore Lombardo 12 All small groups meet on Tues. 11/26/13 Weaver Curry Note: Thursday, November 28, 2013 Thanksgiving Day Holiday- No Class M 12/2 Supportive Care and Febrile Neutropenia Course Evaluation Moore T 12/3 Th 12/5 **OSCE #2 Format (Evaluation OSCE) Groups #1 and #2 Start time 9:00 am** Clinical Skills Center College of Medicine Second floor Weaver sbw 5/30/13 Note that revisions in this schedule may be necessary and will be announced as soon as possible. 13 **Faculty**