Drug Information and Statistics PHAR 455 Spring 2013 Course Description This 4 credit-hour course is designed to provide pharmacy students with an overview of drug information resources and statistics used in healthcare research. Students will learn the advantages and disadvantages of primary, secondary, and tertiary literature and will also gain experience extracting information from these types of literature. Students will learn how to evaluate the biomedical literature using a systematic approach and will assess the statistical analyses reported to determine whether the interpretation and conclusions are valid. Students will also be expected to select appropriate statistical procedures to analyze data and perform calculations. The focus of the statistics portion will be on the clinical application of the statistical tests to the primary literature. The recitation sections of this class are designed to provide the students with hands-on practice of the concepts taught during the lecture. Course Objectives Discuss the advantages and disadvantages of the tertiary, secondary, and primary literature. Conduct a systematic search of the tertiary, secondary, and primary literature in order to answer a drug information request. Differentiate when to apply various statistical tests and be able to perform the appropriate calculations. Critically evaluate all aspects of a clinical trial in verbal and written format. UIC-COP Outcome Competencies: I. Integrate critical and scientific thinking B. Use mathematics and logic to solve problems. 1. Make basic calculations applicable to contemporary pharmacy practice. 2. Create and interpret scientific graphs and plots that arise in the practice of pharmacy. 3. Apply basic statistical tools to the analysis of data sets. a. Recognize and apply the basic statistical concepts of normal and other distributions, sampling and sample size, and distribution moments. b. Recognize and apply statistical concepts particularly useful for pharmacists such as absolute and relative risk, number needed-to-treat, confidence intervals. IV. Manage Medication Use Systems C. Describe the processes involved in formulary management. 1. Explain the process of drug product inclusion in a formulary 2. Manage the formulary system at specific practice sites. D. Apply elements of continuous quality improvement in the delivery of pharmaceutical care. 1. Identify the elements of comprehensive quality assurance program(s). 2. Define and document quality assurance activities consistent with regulatory requirements and professional standards. 3. Define and evaluate measures of humanistic outcomes (e.g., health-related Quality of Life (QOL), patient satisfaction) in pharmaceutical care services. V. Promote Health, Wellness and Disease Prevention C. Provide appropriate emergency care when indicated. 2. Provide appropriate poison resources and referrals to consumers or health care professionals. VI. Provide Drug Information and Education A. Evaluate drug information literature and other pharmacy related literature. 1. Define and apply basic concepts of biostatistics including types of data, data distribution, descriptive and inferential statistics, and measures of variability. 2. Evaluate research designs within research studies. 3. Apply the evaluation skills and the result to decision-making. 1 4. Incorporate literature evaluation and results into an oral or written format in language appropriate for the target audience. B. Provide drug and health-related information to meet the specific needs of healthcare professionals and the general public. 1. Use effective communication skills to determine the nature and specific aspects of the drug information request. 2. Retrieve appropriate information to satisfy a drug information request. 3. Provide a timely, comprehensive response to requests using appropriate and content-specific vocabulary and format. C. Design, develop, present and evaluate informational and educational materials tailored to the needs and educational level of a given audience. 1. Assess the educational needs and background of the intended audience related to drugs, drug use, or health promotion. 2. Design and deliver educational programs about drugs, drug use, drug abuse and/or other health-related topics. 3. Use appropriate teaching methods to reach intended audience. 4. Evaluate the effectiveness of healthcare programs. D. Maintain professional proficiency that may affect the ongoing evaluation and analysis of drug literature. Location The lecture will meet from 8:30 to 9:20 am on Monday, Wednesday, and Friday. Lecture will be held in rooms 134-1 (Monday and Wednesday) and 134-3 (Friday) at the Chicago campus and in room E218 at the Rockford campus. The required recitation sections will meet Monday, Wednesday, and Friday from 1:30 to 4:20 pm (see recitation room calendar on page 5 for specific room assignments at the Chicago campus) and on Monday in room E218 at the Rockford campus. There are weeks when recitation will meet in other locations for both campuses; these exceptions will be announced during lecture and posted on Blackboard. Faculty Joan Stachnik, MEd, PharmD, BCPS (Coordinator) Office: B12 Phone: (312) 413-7699 E-mail: stachnik@uic.edu Heather Ipema, PharmD, BCPS Office: B12 Phone: (312) 355-0651 E-mail: hipema2@uic.edu Lara Ellinger, PharmD, BCPS (Coordinator) Office: B12 Phone: (312) 413-3804 E-mail: lellin2@uic.edu Maria Tanzi, PharmD Office: B12 Phone: (312) 413-1887 E-mail: mtanzi1@uic.edu Michael Gabay, PharmD, JD, BCPS Office: B12 Phone: (312) 413-3977 E-mail: mgabay@uic.edu Ryan Rodriguez, PharmD, BCPS Office: B12 Phone: 312-413-8363 E-mail: rwrodrig@uic.edu Rita Soni, PharmD, BCPS Office: B12 Phone: (312) 996-7045 Email: rsoni1@uic.edu Mary Lynn Moody, BSPharm Office: B12 Phone: (312) 996-2351 E-mail: mlmoody@uic.edu Courtney Krueger, PharmD, BCPS Office: B12 Phone: (312) 413-7341 E-mail: ceckhoff@uic.edu Carissa Mancuso, PharmD Office: B12 Phone: (312) 996-3769 Email: cmancuso@uic.edu 2 Shadi Ghaibi, PharmD Drug Information Resident Office: Room B-12 Phone: (312) 413-8432 E-mail: ghaibi@uic.edu Michelle Bryson, PharmD Drug Information Resident Office: B12 Phone: (312) 413-8364 E-mail: mbryson2@uic.edu Margaret Byun, PharmD Office: 345 CSB E-mail: mbyun1@uic.edu Simon Pickard, PhD Office: Room 287 (2nd floor, College of Pharmacy) Phone: (312) 413-3357 E-mail: pickard1@uic.edu Guest Lecturers Linda Kay, PharmD, MS Biomedical Communications Specialist Phone: (312) 425-5629 E-mail: Linda.Kay@draftfcb.com TBD Office: Illinois Poison Center Helga Brake, PharmD, CPHQ Patient Safety Leader Northwestern Memorial Hospital Email: hbrake@nmh.org Juhi Jain, PharmD Clinical Informatics Pharmacist Indiana University Health – South Campus jjain@iuhealth.org Rockford Class Coordinator Eric Junco Rockford Campus Phone: (815) 395-5809 E-mail: ejunco@uic.edu Teaching Assistants Kibum Kim Email: kkim204@uic.edu Shishir Chandra Sarangpur Email: ssaran3@uic.edu Deval Gor Email: dgor2@uic.edu Handouts will be available at lecture; they will also be available on the course Blackboard site and from the TAs after lectures. TA office hours will be available by appointment. Office Hours No specific office hours for the coordinators will be scheduled. Appointments can be made individually or as a group to discuss matters related to the class with the coordinators as needed. The preferred method of contact to set up an appointment is via email. Email addresses are provided above under the faculty listing. For information specific to a lecture, it is best to contact the specific faculty member who provided the lecture for which you need further clarification. Scheduled office hours will be available with faculty prior to the due date of the clinical question paper; these hours will be announced once available. Texts Recommended Dawson B, Trapp RG. Basic & Clinical Biostatistics. 4th ed. New York: McGraw-Hill; 2004. The primary focus is on statistics including mathematical calculations and clinical applications. This reference is available on-line, via the UIC Library of the Health Sciences’ AccessPharmacy database (http://www.accesspharmacy.com/resourceToc.aspx?resourceID=62). Malone PM, Kier KL, Stanovich JE. Drug information: A Guide for Pharmacists. 4th ed. New York: McGraw-Hill; 2012. The book provides an overview of drug information including clinical trial design and statistics. This reference is available on-line, via the UIC Library of the Health Sciences’ (http://www.accesspharmacy.com/resourceTOC.aspx?resourceID=695). 3 Iverson C, Christiansen S, Flanagin A, et al. AMA Manual of Style: A Guide for Authors and Editors. 10th ed. New York, NY: Oxford University Press; 2007. A guide to rules of style for medical writing. This reference is available on-line via the UIC Library of the Health Sciences (http://www.amamanualofstyle.com//oso/public/index.html). Examinations Exam #1 – Friday, February 22nd Exam #2 – Monday, April 8th Final Exam – Wednesday, May 8th (11:30 am-1:30 pm) Exams #1 and #2 are 50 minutes in length. The final exam is 2 hours in length. Seats may be assigned to all students in a random fashion for examination purposes. Students must complete and turn in scantron sheets within the 50 minute exam period. No additional time can be given after the exam has ended for a student to complete the scantron sheet. Faculty will not complete scantron sheets for students. Students cannot request to change the date of an exam. Assignments Recitation assignments are due at the end of the recitation session unless otherwise noted. There are 5 assignments that will be done outside of recitation—Summary of a drug/referencing, abstracting an article, Journal club lecture, Presenting your journal club, and the clinical question paper. The assigned dates and the due dates for these assignments are given in the Table below. One assignment, the Journal club lecture assignment, is due on Friday, April 5th at the beginning of lecture (8:30 am). Since this assignment will be discussed in class, no late assignments will be accepted; a grade of zero will be given for papers received after the start of the lecture. For all assignments, students are responsible for turning in their own assignments on the due date. See the section “Late assignments” for information on penalties for late assignments. Assignment Summary of a drug and disease state/referencing Summary and critique of an article Date assigned/distributed In recitation during week 1 Date due Journal club lecture assignment In class Wednesday March 20 Due week 3 on the day of recitation at the beginning (1:30 pm) Due week 9 on the day of recitation at the beginning (1:30 pm) Wednesday April 3 at the beginning of lecture Presenting your journal club assignment Distributed 2 weeks prior to the scheduled presentation date To be presented in recitation during weeks 15 or 16 as scheduled Clinical question paper In class Monday February 25 Thursday April 11 by 4:00 pm In recitation during week 8 4 Comments This assignment is due BEFORE the lecture begins. Once lecture begins, no assignments will be accepted (a grade of zero will be given) A schedule will be posted on Blackboard assigning the dates/groups for journal club presentation Any clinical question paper received after 4:00 pm will be considered late (see penalties below). The Drug Information Center is open on Saturdays from 10 am to 2 pm and this day will count toward the late penalty. Clinical question papers will be returned to students approximately 3 weeks after the due date and before the beginning of finals week. Recitation Rooms Calendar for Chicago Campus Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Monday 134-1 134-1 134-1 134-1 134-1 134-1 134-1 134-1 134-1 134-1 134-1 134-1 204/208/212/216 204/208/212/216 Wednesday 32 No recitation 32 32 32 32 32 204/208 204/208 204/208 Spring Break 204/208 204/208 204/208 204/208/212/216 204/208/212/216 Friday 134-1 134-1 134-1 134-1 134-3 134-1 204/208 204/208 204/208 204/208 204/208 204/208 204/208/212/216 204/208/212/216 Grading Policy Grades are determined based on scores obtained from the recitation (lab) assignments, other written assignments, the written clinical question paper, and the 3 examinations. Final grades are based on points achieved in the course. Grades will be posted on the course website via Blackboard. Students should frequently check Blackboard for their grades and other course announcements. A traditional 10% scale will be applied for grading purposes as follows: ≥90% = A (≥ 603 points) 80 – 89 = B (≥ 536 points) 70 – 79 = C (≥ 469 points) 60 – 69 = D (≥ 402 points) <60 = Not a passing grade (<402 points) There is no curve or rounding up of final grades in PHAR 455. Students who disagree with a grade assigned on any assignment may submit the assignment in question to the course coordinator for reevaluation within 5 days of the date of return of the graded assignment. The entire assignment will be re-graded, and the resulting score (higher or lower) will be final. Students will not be allowed to have assignments reevaluated at the end of the semester in order to improve a final grade. Plagiarism Plagiarized assignments (including the clinical question paper assignment) will be given a grade of zero. This includes any assignment where information is “cut and pasted” from electronic resources. Faculty are available to help you in understanding the concept of plagiarism and are more than happy to answer any questions you have related to this topic. A lecture on writing skills/plagiarism will be presented in PHAR 455 to further your understanding of the topic. Please consult the lecture schedule for the date of this lecture. Although some assignments are done in groups (such as the recitation assignments), each student is responsible for completing and turning in their own assignment, unless otherwise noted. Writing Skills The ability to convey information in a written format is an important and valuable skill. The Writing Center, located on the east side of the Chicago campus in 105 Grant Hall, offers free tutors to aid students in developing their writing skills. The phone number for the Writing Center is (312) 413-2206. More information can be obtained by visiting the Writing Center website (www.uic.edu/depts/engl/writing) 5 Points Available Lab (recitation) assignments 100 points* (11 labs/recitation; 10 points each) Summary of a drug 20 points Article summary and critique 20 points Journal club lecture assignment 10 points Presenting your journal club 20 points Clinical question paper 100 points Exams #1 and #2 200 points (100 points each) Final exam 200 points Total points available 670 points *There are 11 scheduled labs/recitations, each with an assignment; however, the lowest graded assignment will be dropped to make the total possible points for lab/recitation 100. Late Assignments All recitation assignments must be turned in by hand the day they are due, usually at the end of recitation. It will not be acceptable to email or fax your assignments to the faculty unless prearrangements have been made with the course coordinators. Failure to turn in any assignment by the end of recitation or by the date and time assigned (see Table) will result in loss of points: 10% of the total possible points will be deducted for each day (including Saturdays) an assignment is late, as listed below. Following day: 10% off 2 days late: 20% off 3 days late: 30% off 4 days late: 40% off 5 days late: 50% off 6 to 9 days late: 60% – 90% off We are aware that some factors are beyond our capability to control and that such factors could make the completion of an assignment by the due date impossible. If such a situation is applicable to you, please contact the course coordinator before the due date and your situation will be considered. Missed Examination/Recitation It is the student’s responsibility to contact the course coordinators via email only, no later than the day of, but prior to the start time, of the recitation or exam that the student intends to miss. It is in the best interest of the student to notify the course coordinators as soon as possible. Any absence for which a student has failed to comply with this stated policy will be considered an unexcused absence, and the student will receive a zero for that recitation or exam without the possibility of make-up. Students who comply with this policy may be granted an excused absence, with the possibility of a make-up assignment. The format and time of offering of any make-up exam or assignment will be at the discretion of the instructor and course coordinator. Attendance Attendance in lecture is highly encouraged and expected. Not all lectures have PowerPoint slides to be posted on blackboard; however, those that do have slides will be posted on blackboard. Attendance in recitation is required. Students arriving more than 15 minutes late to a recitation section, leaving before the recitation section ends, or attending a different recitation without prior approval will be treated as an unexcused absence. The student will receive a zero for that recitation, without the possibility of a make-up. It is not acceptable to obtain a copy of the recitation from students who have completed it earlier in the week and attempt to turn in a completed copy at the beginning of the recitation. This will be counted as an unexcused absence and given a grade of zero. Please do not 6 schedule appointments during the required recitation sections; assume all recitations go until 4:20 pm. Students must attend the recitation section to which they have been assigned. For excused absences only, arrangements will be made with one of the course coordinators, prior to recitation, for the student to make up the recitation session. Pledge of Professionalism The Pledge of Professionalism was designed to remind students what they should expect of each other in terms of attitudes, ethical behavior, and academic honesty. The coordinator expects that all students enrolled in PHAR 455 will use the Pledge as a guide to behavior within this course and all others. Furthermore, the course coordinator reserves the right to fail any student enrolled in PHAR 455 that demonstrates unprofessional behavior at any time. Professional behavior includes, but is not limited to, timely attendance, sustained presence, active participation, and the maintenance of an appropriate learning environment in the classroom, during recitation exercises, and all other course-related experiences. Cell Phones The use of cell phones (including texting) during class and recitation is not only distracting to the instructor, but also to your fellow students. Please silence all cell phones prior to the beginning of class. Off-campus Meetings Students who plan to attend off-campus meetings should contact the course coordinator through an organization representative at least 4 weeks prior to the meeting. A list of the students’ names attending the meeting should be given to the course coordinator. The course coordinator will work with the organization representative to resolve how missed assignments, recitations, or exams will be handled. If this procedure is not followed there is no guarantee that a satisfactory solution will be available. Religious Observance Statement The faculty of the University of Illinois at Chicago/Rockford shall make every effort to avoid scheduling examinations or requiring that student projects be turned in or completed on religious holidays. Students who wish to observe their religious holidays shall notify the faculty member by the 10th day of the semester of the date when they will be absent unless the religious holiday is observed on or before the 10th day of the semester. In such cases, the student shall notify the faculty member at least 5 days in advance of the date when he/she will be absent. The faculty member shall make every reasonable effort to honor the request, not penalize the student for missing the class, and if an examination or project is due during the absence, give the student an exam or assignment equivalent to the one completed by those students in attendance. If the student feels aggrieved, he/she may request remedy through the campus grievance procedures. Special Needs To obtain academic accommodations for this course, students with disabilities should contact the Office of Disability Services and the course coordinator as soon as possible after the beginning of the semester. The student will need to contact Disability Services at (312) 413-2183 (voice) or (312) 413-0123 (TTY). For more information, visit the Office of Disability Services website (http://www.uic.edu/depts/counselctr/disability/diswebpg.htm ). Privacy Statement The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a federal law that protects the privacy of student education records. This impacts you from the standpoint of receiving graded assignments. In order for us to return graded assignments via your student mailboxes, we are required to have your consent. If you do not wish to have your assignments returned in this manner, you will have the option to pick up assignments from the course coordinators. Class Schedule The lecture and recitation schedules are attached to this syllabus. The course coordinator reserves the right to make alterations in the lecture and recitation schedules. Furthermore, the course coordinator reserves the right to alter the syllabus as needed. 7 PHAR 455 Lecture & Lab Schedule Spring 2012 Date Lectures Faculty Recitation/Labs Mon, January 14 Introduction Ellinger/Stachnik Introduction/Summary of a drug and disease state/Referencing assignment distributed Wed, January 16 Survey of Tertiary References I Gabay Fri, January 18 Survey of Tertiary References II Krueger Mon, January 21 Dr. Martin Luther King Day Observance No Class Wed, January 23 Electronic Resources I Rodriguez Fri, January 25 Electronic Resources II Rodriguez Mon, January 28 Adverse Drug Reaction References Ghaibi Summary of a drug and disease state/Referencing due in lab Wed, January 30 Drug Interaction References Bryson Electronic database (recitation) Fri, February 1 Pregnancy & Lactation References Tanzi Mon, February 4 Application to Systematic Approach Gabay Wed, February 6 Introduction to Primary Literature Mancuso Fri, February 8 Secondary References Ellinger Mon, February 11 Clinical Trial Design I Ellinger Wed, February 13 Clinical Trial Design II Ellinger Fri, February 15 Medline/International Pharmaceutical Abstracts Tanzi Mon, February 18 Systematic Approach II Ellinger Wed, February 20 Introduction to Statistics Tanzi Fri, February 22 EXAM 1 (Material through 2/10) Faculty Writing Skills/Plagiarism/Clinical question paper Clinical question paper assignment distributed Ellinger Week 1 Week 2 No labs Week 3 Week 4 Tertiary references/Electronic databases Week 5 Tertiary references/Electronic databases Week 6 Medline/Answering a drug information question Week 7 Mon, February 25 Medline/Answering a drug information questions 8 Date Lectures Faculty Recitation/Labs Wed, February 27 Descriptive Statistics Krueger Fri, March 1 Randomization and Sampling Ipema Mon, March 4 Probability/Probability Distributions Ipema Wed, March 6 Confidence Intervals/Sample Size Determination Rodriguez Fri, March 8 Measures of comparative risk Rodriguez Mon, March 11 Hypothesis Testing Pickard Article summary and critique assignment due in lab Wed, March 13 Inferential Statistics (T-test I) Pickard Distributions/Confidence intervals/Comparative risk Fri, March 15 Inferential Statistics (T-test II) Pickard Mon, March 18 Inferential Statistics (ANOVA) Stachnik Wed, March 20 Inferential Statistics (Correlation/Regression) Journal Club lecture (Literature Evaluation) assignment distributed Stachnik Fri, March 22 Inferential Statistics (Correlation/Regression) Stachnik Spring Break No Class No Labs Mon, April 1 Inferential Statistics (Chi-Square/Nonparametric) Stachnik ANOVA/Correlation/Regression Wed, April 3 Literature Evaluation I Tanzi Fri, April 5 Literature Evaluation II Journal Club assignment due in class Ipema Week 8 Descriptive statistics of a study Article summary and critique assignment distributed Week 9 Week 10 T-tests Week 11 March 25-29 Week 12 9 Date Lectures Faculty Recitation/Labs Mon, April 8 Exam 2 (Material from 2/13 through 3/9) Faculty Chi-square/Nonparametric Presenting your journal club assignment distributed Wed, April 10 Literature Evaluation III Tanzi/Ipema Thurs, April 11 Clinical question paper Assignment due by 4pm Fri, April 12 Evidence Based Medicine I Ellinger Mon, April 15 Meta-analysis Stachnik Wed, April 17 Medication Safety Brake Fri, April 19 Drug Policy Development Paek Mon, April 22 Informatics Jain Wed, April 24 Poison Information TBD Fri, April 26 Pharmacoeconomics Byun Mon, April 29 Medical Communications Kay Wed, May 1 TBD Faculty/Panel Fri, May 3 TBD Faculty Wed, May 8 Final Exam 11:30-1:30 Faculty Week 13 Week 14 Literature Evaluation Presenting your journal club assignment distributed Week 15 Presenting Your Journal Club Week 16 Presenting Your Journal Club Chicago: room 134; Rockford: room E207b 10