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Homework answers / question archive / School of Health Policy and Management Faculty of Health York University       Course Description:   Examines the place of pharmaceuticals in the Canadian health care system

School of Health Policy and Management Faculty of Health York University       Course Description:   Examines the place of pharmaceuticals in the Canadian health care system

Health Science

School of Health Policy and Management

Faculty of Health York University

 

 

 

Course Description:  

Examines the place of pharmaceuticals in the Canadian health care system. Focuses on conflicts among stakeholders in policy formation, costs and physician prescribing behaviour.

Expanded Course Description:  

This course focuses on the place of pharmaceuticals primarily in the Canadian health care and regulatory systems, as well as in an international setting. This course will critically examine four major issues involved in the area of pharmaceuticals: criteria around development of drugs; how drugs are paid for; the regulatory system that controls how drugs reach the market and monitors drugs once they are available; and the relations of various groups to the pharmaceutical industry. 

During the course, students will examine the roles of the major stakeholders in Canada—the industry, government, health care professionals and patients/consumers. The primary focus will be on conflicts between the values of these stakeholders and how they have affected eventual outcomes: public versus private interests; patient autonomy versus professionalism. 

Prerequisite: AK/HH/HLST 2020 3.00 Health Policy: Power & Politics or permission of course instructor. 

Course credit exclusion: None

 

               

14

Course Learning Outcomes:  

 

  • Develop critical thinking skills (reflection, analysis, discernment, evaluation).
  • Develop clear and compelling writing skills.
  • Develop a critical understanding of Canadian drug approval processes, including strengths and weaknesses.
  • Develop knowledge of pharmaceutical industry practices, including knowledge creation, disease category creation and expansion, role in policy processes and direct-to-consumer advertising.  
  • Consider how gender and lifecycle conceptualizations are harnessed in the creation and maintenance of health risk and illness categories within pharmaceutical industry and health policy environments.
  • Develop skills in dissecting a pharmaceutical related policy “challenge” and, through the final research essay, propose recommendations to ameliorate the policy challenge.

 

Equity and Teaching:

As the COVID-19 pandemic unfolds and evolves, students and instructors are adapting to learning online. We recognize that the pandemic and the measures to control and treat it impact students in different ways. We are committed to and focused on providing our students a learning environment that is engaging, supportive, flexible and has academic integrity.  We encourage you to share your feedback as early as possible about your learning experience so that we can have a deeper understanding of the challenges you may be facing, and work towards finding solutions to the extent possible.  Talk to your Course Director (CD) or the Undergraduate Program Director (UPD) within SHPM, Lynda van Dreumel lyndavd@yorku.ca about access to technology and supports, academic accommodation, technology-enabled delivery of course material, assessments/evaluation instruments or any other academic challenges you are experiencing.  For more detail about how the pandemic is impacting students see the report “COVID-19 Impacts on Student Learning and Equity” from the Centre for Human Rights, Equity and Inclusion https://rights.info.yorku.ca/. For other updates on COVID-19 and York see  https://coronavirus.info.yorku.ca/

Text and Other Course Materials 

Required Textbook:  Lexchin, J. (2016). Private Profits vs. Public Policy: The Pharmaceutical Industry and the Canadian State. Toronto: University of Toronto Press.

Available electronically via York Libraries permalink: https://ocul-

yor.primo.exlibrisgroup.com/permalink/01OCUL_YOR/q36jf8/alma991015380899705164

Required readings: on schedule

 

The EClass course website will host:

 

  • course outline
  • slides from the lectures that are usually available at least one day before the lecture
  • any other material for the course (links to readings, multimedia)
  • any announcements about the course

 

Technical Requirements:

Online platforms and tools will be used in this course (e.g., EClass, Zoom, etc.) through which students will interact with the course materials, the course director, as well as with one another. 

  • Access to EClass:  Students will need to access course materials and online modules by logging in with their Passport York @ EClass.
  • Access to Zoom Web-Conferencing:  The course will use Zoom web-conferencing and students will need access to stable, high-speed internet connection, a computer, webcam and microphone, and/or a smart device with these features.  
  • If students encounter technical difficulties using EClass or Zoom, please contact UIT Client Services.  

Useful links and resources for students:

 

Students who do not have access to a computer should contact York University to register to borrow a laptop.  The process can be found here.

Assessments/Evaluation: (see below for full description)

Assessment (e.g. test, assignment, Exam)

% of total grade

Total Marks

(E.g. Graded out of 30 marks)

Due Date 

Tentative Date

Grade Returned to Student 

Critical Analysis & Reflection 1

20% 

20

Sept 27, 2021

Two weeks

Critical Analysis & Reflection 2

20%

20

October 18, 2021

Two weeks

Critical Analysis & Reflection 3

20%

20

November 8, 2021

Two weeks

Critical Analysis & Reflection 4

20%

20

November 29, 2021

Two weeks

Academic Poster

20%

20

December 6, 2021

Two weeks

 

100

 

 

 

 

Note 1 The final exam will take place any time during the official final examination period.  It is your responsibility as a student to ensure that you are available to sit for examinations during the entire exam period for the term corresponding to your course. We strongly recommend that you do not make any travel arrangements prior to the end of the term's examination schedule.

These course requirements and weights are final and will not to be modified throughout the term.

 

               

1) Critical Analysis & Reflection Assignments (20% each x 4 assignments)

 

Critical Analysis and Reflection Submissions (1000 - 1500 words each, excluding title page and reference list): 

Description:

Prepare a creative and critical analysis of assigned course material for the assigned weeks, along with your own reflections on the content. These submissions require concise, academic writing that effectively communicates your perception of, and response to, the week’s content. This will require the application of course content and theory to concepts and illustrative examples from the readings and multi-media. Your critical analysis of the course content should comprise 80-85% of your assignment (Note: critical analysis is not summary of the topic material). Your reflection component should comprise

10-15% of your assignment. If you choose to include personal experience, this should be no more than 5% of your assignment. Your reflections should include (a) your reactions after having read the readings, listening to the lectures, and watching the required multi-media content, (b) a brief summary of an experience or your previously-held knowledge of the content that may have influenced your reactions to, or reflection of, the content, (c) substantively marrying your critical analysis with your reflection of the content (i.e., specifically how has your experience shaped your understanding and application of the content?). 

No outside research is required. It is essential that students demonstrate that they have deeply engaged with the course content (i.e., lectures, readings, and multi-media assigned). 

The lectures/material to be analyzed and reflected upon in each submission is as per the Syllabus.

In our course, these submissions serve the following skills development purposes:

  • Clear and concise academic communication;
  • Demonstration of deep engagement with, and understanding of, the course content on a weekly basis;
  • Carving out time to think about the content;
  • Thoughtful reflection of academic content, communicated clearly and effectively; and,
  • Understanding the manner in which your perspectives/experiences shape your understanding and application of the course and content.

2)   Academic Poster Project (20%):   

 

Congratulations! You have been selected from a very impressive group of candidates to present a pharmaceutical policy issue from our course at our conference this year! In order to participate, please develop a creative, thoughtful academic poster on your policy issue. Students may decide to use paragraph form and/or bullet points as best suits their presentation style. In poster presentation, rather than essay, format, present the following content, supported with references from course material, using headings to organize your presented content.  

Students will submit a total of 2 documents for this assignment, both by the assignment deadline:  

1. The poster presentation in PDF form to a specified Assignment folder in eClass; and,  2. A Word version of the poster presentation with References, copied and pasted from your poster into a Word document, uploaded to TurnItIn on our eClass site.  

 

Lecture time will be dedicated to discussing poster presentations, their important components, and how to submit them. Be sure to review the following source for more information: https://undergradfair.library.yorku.ca/web/workshop-on-presenting-a-poster/  

 

You will be expected to attach an Assignment Attachment Form to each assignment and essay submitted (see attached form).  

 

Formatting:

All assignments are required to be formatted in APA style, including a title page, headers, page numbers, citations, and references. Please also include word count (excluding title page and reference list) on your title page. See Owl Purdue for formatting guide: https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_style_introduction.html

** You are required to attach an Assignment Attachment Form to each assignment submitted (form is appended to this document).

 

Lateness Penalty:  5% each day (up to a maximum of 5 days after which the assignment will not be accepted and a mark of “0” will be assigned.)

 

Plagiarism and similarity between students’ assignments will not be tolerated – It is very important that you understand exactly what constitutes plagiarism and academic integrity breaches. You are expected to review the Spark academic integrity module and understand the content (link provided below). 

On-line Academic Integrity Module

Students must review the on-line tutorial on academic integrity, at: https://spark.library.yorku.ca/academic-integrity-what-is-academic-integrity/ and then complete the Academic Integrity quiz.

 

The Academic Integrity Online test must be completed, and the results page submitted to the Course Director with the submission of Assignment 1. https://www.yorku.ca/health/yquiz/acadinte_nologin/quiz/acadinte_nologin.quiz1  Turnitin

The online academic honesty tutorial and paper submission to Turnitin is recommended for all courses with writing assignments. 

Turnitin is web-based software which scans submitted works for similarity to material in public websites, academic journals, papers purchased from an essay mill, etc., and to essays and assignments concurrently or previously submitted to Turnitin, which are stored in a database. An 'originality report' is then provided to the instructor, who remains responsible for determining any breach of academic honesty. 

 

If you do not wish to use TurnItIn, you must let the Course Director know in advance. You will be required to submit written reports on how you completed each of your assignments (required contents below), along with detailed annotated bibliographies. Each report and bibliography must be submitted with your assignment when it is due. You will also email an electronic copy of each report and bibliography (with hyperlinked URLs in it) to the Course Director. You may be asked to take an oral examination for any or all of your written assignments directed at issues of originality. 

 

The written report must contain the following information, as well as anything else you consider useful to the Course Director on the issue of academic integrity: 

  • A list of the documents and other sources you consulted to understand your topic, along with the dates you first used each of them; 
  • An explanation of how those documents and sources led you to the other documents and sources you used; 
  • An explanation of which of the sources you used had the most influence 

 

Requests for Regrading of Assignments: 

 

You are welcome to approach the teaching team to understand why you received the grade(s) that you did for your assignment(s) should you need additional clarifications. Keep in mind that while the teaching team is receptive in going over the strengths and weaknesses of your assignments with you, the teaching team normally does not remark assignments unless there are legitimate reasons (e.g., a technical error in the form of calculating your grade) given that the teaching team has assessed your work thoroughly before arriving at a mark that the teaching team feels is reflective of the quality of your submitted work. 

 

If you strongly feel that you deserve a higher grade in a given assignment, please request the Regrade Form from the Course Director. This form requires that you write a detailed letter or memo to the teaching team stating why and where you believe you should be awarded extra marks (e.g., identifying the strengths and weaknesses in your research essay based on careful review of the assignment and the teaching team's comments and then provide a clear argument, based on examples from your work, about why you feel your grade should be higher). The teaching team will then review your request and decide whether a remark is warranted. Note that if your request for a remark is accepted (which could be denied), you might be awarded a mark that is higher than, identical to, or lower than the original grade you received. 

 

Lateness Penalty:   

 

Assignments (excluding the Final exam) will be docked 5% per day, up to five days, after which the assignment will not be accepted and a mark of “0” will be assigned.

The online academic honesty tutorial is recommended for all courses with writing assignments. 

Students must review the interactive on-line Tutorial on academic integrity, at: http://www.yorku.ca/tutorial/academic_integrity/ and then take a self-test at: http://www.yorku.ca/tutorial/academic_integrity/testyourself.html  

The Academic Integrity Online test must be completed and the results page submitted to the Course Director with the submission of the assignments.

           

               

LECTURE SCHEDULE

Lecture

Required Readings

Due dates

1

September 13, 2021

Why does pharmaceutical policy and regulation matter?

  1. Syllabus and course requirements
  2. Textbook: Introduction (pp. 3-12)

 

2

September 20, 2021

Who is regulating and what are their interests?

1. Textbook: Chapter 1: (De)Regulation through cooperation (pp. 13-33)

 

3

Sept 27, 2021

Clinical Trials and Data Transparency

1. Textbook: Chapter 2: Biased testing, hidden results, and the regulation of clinical trials (pp. 3453)

Critical Analysis and Reflection (1/4) due by 11:59pm to

Turnitin on EClass

4

October 4, 2021

New Drug Approvals

1. Textbook: Chapter 3: Approving new drugs: Better or just more?  (pp. 54-80)

 

Reading Week

5

October 18, 2021

Marketing and Promotion of Pharmaceuticals

1. Textbook: Chapter 4: Regulating Promotion or licensing deception? (pp. 81-111)

Critical Analysis and Reflection (2/4) due by 11:59pm to

Turnitin on EClass

6

October 25, 2021

Health Canada and Drug Safety

1. Textbook: Chapter 5: Health Canada and drug safety: How safe are we? (pp. 112-134)

 

7

November 1, 2021

Intellectual Property and Pharmaceuticals

1. Textbook: Chapter 6: Is intellectual property a right? (pp. 135-156)

 

8

November 8, 2021

Pharmaceutical Profits and Pricing

1. Textbook: Chapter 7: How revenue is generated: Prices, volume, mix, and overall spending (pp. 157-

183)

Critical Analysis and Reflection (3/4) due by 11:59pm to

Turnitin on EClass

9

November 15, 2021

Pharmaceutical Research and Development

1. Textbook: Chapter 8: Who gets the value from research and development? (pp. 184-207)

 

10

November 22, 2021

Access to medicines internationally

1.  Textbook: Chapter 9: Canada, the pharmaceutical industry, and access to medicines in the Global South (pp. 208-224)

 

11

November 29, 2021

Closing Remarks and Future Directions

1.  Textbook: Chapter 10: Courage, my friends; 'tis not too late to build a better world (pp. 225-253)

Critical Analysis and Reflection (4/4) due by 11:59pm to

Turnitin on EClass

12

December 6, 2021

Course Review 

Academic Poster due by 11:59pm to eClass

 

Important Dates for Fall Term Courses

 

EVENT

FALL (TERM F)

YEAR

(TERM Y)

WINTER (TERM W)

Classes start

Sept. 8

Sept. 8

Jan. 10

Last date to announce components of final grades

Sept. 21

Sept. 21

Jan. 23

Fall Reading Week1

Oct. 9-15

Oct. 9-15

 

Last date to submit Fall term work

Dec. 7

Dec. 7

 

Fall classes end

Dec. 7

Dec. 7

 

Fall Study Day

Dec. 8

Dec. 8

 

Fall examinations

Dec. 9-23

Dec. 9-23

 

School of Health Policy & Management 

 

Policy on Requesting Late Assignments or Make-Up Exams  

 

The following table details the requirements for missing any course work.  Failure to do so will result in a grade of zero for the missed course work.  

 

Course Work

Forms and Documentation

To Whom/Where to Submit

Deadlines for Seeking

Approvals

 

Unable to submit term work (assignments or

papers) by the due date during the term

 

 

No forms required but instructor may require

documentation 

 

Negotiate with and seek approval from the Instructor directly by email 

 

 

No later than 1 calendar day after the unforeseen circumstance  

 

 

Unable to write the Midterm Exam at the

scheduled time 

 

 

Missed Test

Documentation

Form  and required documentation

 

The School of Health Policy

& Management 

Office (to be submitted electronically to

shpm@yorku.ca during

COVID-19 Remote course delivery

 

No later than 7 calendar days following the missed exam 

 

Unable to write the Final

Exam at the scheduled time  OR  Unable to submit outstanding course work by the last date of classes 

 

Final

Exam/Assignment

Deferred Standing

Agreement  and required documentation

 

The School of Health Policy

& Management 

Office (to be submitted electronically to

shpm@yorku.ca during

COVID-19 Remote course delivery) 

 

No later than 7 calendar days following the missed exam or due date of course work 

 

What documentation to submit? 

Prior to COVID-19 remote course delivery, all request forms and supporting documentation were to be submitted in hardcopy in their original form. Scanned/faxed/photographed copies were not accepted.   However, during COVID-19 remote course delivery, scanned copies will be accepted.  The instructor and the School of Health Policy & Management have the right to request valid supporting documents. All supporting documents are non-returnable. 

 

               

 

Examples of appropriate supporting documentation are: 

  1. Unforeseen Medical Circumstances  

NOTE 1: Other forms of medical notes are not accepted. 

NOTE 2: A student claim of a headache, stomach-ache, nausea or cold documented in the Attending Physician’s Statement as the indication for illness will not be accepted. 

  1. Non-Medical Circumstances 
    • Death of direct family members - death certificates, obituary notice, notice of funeral services, etc. 
    • Vehicle accidents - automobile accident reports, etc. 
    • Emergency travel – airline tickets with boarding passes, bus/train tickets, etc. The date that travel was booked on must be clearly shown. Airline/train/bus ticket/receipts for emergency travel must indicate destination, departure, and return dates. 
  2. Other Circumstances
    • Disability Accommodations  
    1. Foreseen accommodations - If you are seeking anticipated accommodations, submit your Letter of Academic Accommodation issued by Student Accessibility Services to your instructor at the beginning of the course and negotiate directly with your course director over term work assignments and papers no later than 14 calendar days prior to the due date.  During COVID19 remote course delivery, course directors will work with the student and Student Accessibility Services to determine how best to provide accommodation in the remote online environment.

 

    1. If your request is for unforeseen circumstances related to your documented disability, your Disability Counsellor can provide further supporting documentation to support your request.

 

    • Religious Accommodations - All requests must be arranged well in advanced.  For term work assignments, discuss due dates with your instructor no later than 14 calendar days prior to the due date.  For midterm examinations, submit a Missed Test Documentation form to the School of Health Policy & Management Office, by email (shpm@yorku.ca) no later than 14 calendar days prior to the examination date.  For all final exams, submit a Religious Accommodation Agreement to the School of Health Policy & Management no later than three weeks prior to the start of the examination period.

 

               

Who Makes the Decision? 

 

Instructors make the final decision based on above requirements.  Approvals are not guaranteed. 

 

 

If Your Request is Approved … 

 

If an extension is granted for an assignment, the new deadline is firm, and no further extensions will be considered. 

 

If a make-up exam request is approved, the student must be prepared to write the make-up exam at a date set and announced by the Course Director.  Only those with pre-approval will be allowed to take the deferred exam.  Deferred course work takes precedence over continuing school work.  If a student misses the original exam and the makeup exam, they will need to discuss their circumstances with their instructor.  Only one make-up exam date will be offered. Although the content to be examined will be the same, the format may or may not follow that of the original test/examination.

 

 

If Your Request is Not Approved …  

 

Instructor decisions on requests pertaining to make-up mid-term exams and requests to submit course work by the last day of classes are final - there are no options to appeal. Late assignments will be subject to mark deductions as detailed in the course outline. You will receive a grade of zero for the missed exams. 

 

Instructor decisions on requests pertaining to make-up final exams and requests to submit course work after the last day of classes may be petitioned through the Registrar’s Office. Follow the instructions posted on the Faculty of Health Office of Students and Academic Services website.

 

               

York University Important Course Information and Resources for Students & Instructors

 

 

Students should familiarize themselves with the following Student Rights & Responsibilities:

 

  1. Academic Honesty and Integrity (SPARK)  

 

Note:   The offering for sale of, buying of, and attempting to sell or buy test banks (banks of test questions and/or answers), or any course specific test questions/answers is not permitted in the Faculty of Health. Any student found to be doing this may be considered to have breached the Senate Policy on Academic Honesty. In particular, buying and attempting to sell banks of test questions and/or answers may be considered as

“Cheating in an attempt to gain an improper advantage in an academic evaluation” (article 2.1.1 from the Senate Policy) and/or “encouraging, enabling or causing others to cheat” (article 2.1.10 from the Senate Policy). 

 

In addition:  The course materials that form part of this course outline are designed for use as part of this course at York University and are the property of the instructor unless otherwise stated. Third party copyrighted materials (such as book chapters, journal articles, music, videos, etc.) have either been licensed for use in this course or fall under an exception or limitation in Canadian Copyright law.  Copying this material for distribution (e.g. uploading material to a commercial third-party website) may lead to a violation of Copyright law.

 

  1. Access/Disability  

 

  1. Ethics Review Process  

 

  1. Religious Observance Accommodation  

 

  1. Student Conduct and Responsibilities (Academic and non-Academic)

  

 

               

Other Important Course-Related Information

 

1. Important University Sessional Dates  

 

You will find classes and exams start/end dates, reading/co-curricular week, add/drop deadlines, course withdrawal period (withdraw from a course and receive a grade of “W” on transcript), holidays, University closings and more on the Registrar’s Office website. 

 

2. Tuition Refund Table 

 

You may be eligible for a full or partial refund depending on when you de-enroll from courses. Refer to the dates posted on the Office of Student Financial Services website. 

 

3. Referencing Style 

 

A referencing style approved by the course director must be used for all assignments and essays. As examples, this may include APA, AMA, MLA. York University Libraries provide manuals. 

 

4. Writing and Learning Skills  

 

You are strongly encouraged to seek assistance from the following university units.  a. Writing Centre  

  1. Learning Commons  
  2. Learning Skills Services  

 

  1. Undergraduate Grading Scale 

 

Refer to the Registrar’s Office website for details. 

 

  1. Grading Scheme and Feedback Policy  

 

Refer to the University Policy for details. 

 

7. 20% Rule

 

No examinations or tests collectively worth more than 20% of the final grade in a course will be given during the final 14 calendar days of classes in a term. The exceptions to the rule are classes which regularly meet Friday evenings or on Saturday and/or Sunday at any time, and courses offered in the compressed summer terms. (Note: Final course grades may be adjusted to conform to Program or Faculty grades distribution profiles.) 

 

8. Final Grade Reappraisals 

 

Refer to the Registrar’s Office website for details. 

 

9. Pass/Fail Legislation  

 

Refer to the University Policy for details.

 

               

School of Health Policy and Management

 

Assignment Attachment Form

 

 

Student Name:  

 

Student Number:  

 

Course Code:  

 

Assignment Title:  

 

Due Date:  

 

Tutorial Leader (if applicable): 

 

 

 

Please check each box after reading, to acknowledge agreement with each statement.

 

 

 

I have read and understand the Senate Policy on Academic Honesty found on website at the following York Secretariat website on Academic Honesty. 

 

I have read and understood the assignment submission described in the course outline

(syllabus) 

 

I have read and understood the criteria used for assessment in this assignment 

 

I have read and understood and followed the referencing guidelines required for assignments submitted at York University 

 

This assignment is entirely my own work, except where I have given documented references to work of others 

 

This assignment or substantial parts of it has not previously been submitted for assessment in any formal course of study, unless acknowledged in the assignment and previously agreed to by my Tutorial Leader and Course Director 

I understand that this assignment may undergo electronic detection for plagiarism and a copy of the assignment may be retained on the database and used to make comparisons with other assignments in the future

 

 

 

 

Signature: ___________________________                                            Date: ___________________

 

 

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