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Analyze and evaluate laws and regulations relative to product safety and liability.
Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
Due End of Week 9 and worth 300 points

You are a new associate at the law firm of Dewey, Chetum, and Howe. John, a former researcher at PharmaCARE, comes to your office. He has concerns about PharmaCARE’s use of AD23, one of the company’s top-selling diabetes drugs. Two (2) years ago, after PharmaCARE’s research indicated that AD23 might also slow the progression of Alzheimer’s disease, John and his team of pharmacists began reformulating the drug to maximize that effect. In order to avoid the Food and Drug Administration’s (FDA) scrutiny, PharmaCARE established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation to individuals on a prescription basis. CompCARE established itself in a suburban office park near its parent’s headquarters. To conserve money and time, CompCARE did a quick, low-cost renovation.
CompCARE benefited from PharmaCARE’s reputation, databases, networks, and sales and marketing expertise, and within six (6) months had the medical community buzzing about AD23. Demand soared, particularly among Medicare, Medicaid, and Veterans Affairs patients. Seeing the opportunity to realize even more profit, CompCARE began advertising AD23 directly to consumers and marketing the drug directly to hospitals, clinics, and physician offices, even though compounding pharmacies are not permitted to sell drugs in bulk for general use. To circumvent this technicality, CompCARE encouraged doctors to fax lists of fictitious patient names to CompCARE. PharmaCARE sold CompCARE to WellCo, a large drugstore chain, just weeks before AD23 was publicly linked to over 200 cardiac deaths.
As CompCARE and its new parent company enjoyed record profits and PharmaCARE’s stock price approached $300 per share, reports started surfacing that people who received AD23 seemed to be suffering heart attacks at an alarming rate. The company ignored this data and continued filling large orders and paying huge bonuses to all the executives and managers, including John, whose wife recently died from a heart attack after using AD23.
John has come to you with an internal company memo describing the potential problems with AD23, and information describing the company’s willingness “roll the dice” and continue to market the drug.
In preparation for this assignment, use the Internet or Strayer Library to research examples of intellectual property theft that occurred within the past three (3) years.

Write a six to eight (6-8) page paper in which you:
1. Research three to five (3-5) ethical issues in the scenario relating to marketing and advertising, intellectual property, and regulation of product safety and examine the extent to which PharmaCARE violated these issues. Be sure to identify the law and then the extent of the violations.
2 Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.
3. Analyze the manner in which PharmaCARE used U.S. law to protect its own intellectual property and if John has any claim to being the true “inventor” of AD23. Suggest at least three (3) ways the company could compensate John for the use of his intellectual property.
4. Summarize at least one (1) current example (within the past three (3) years) of intellectual property theft, and examine the effect on that company’s brand.
5. Analyze the potential product liability issues surrounding the death of John’s wife and other potential litigants against PharmaCARE as a result of AD23.
6. Specify the major arguments that John can make to claim that he is a whistleblower and the type of protections that he should be afforded. Justify your response.
7. Use at least three (3) quality resources in this assignment. Note: Wikipedia is not an acceptable reference and proprietary Websites do not qualify as academic resources.

Your assignment must follow these formatting requirements:

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Directions
Prepare a patient teaching plan for your participant based on the information you discovered in your previous assignments. Present your plan using Microsoft PowerPoint.
• Title slide (first slide): Include a title slide with your name and title of the presentation.
• Introduction/Identification (two to three slides): Introduce a modifiable risk factor (diet, smoking, activity, etc.) that will be the focus of your presentation.
o Identify at least one important finding you discovered in Milestone 1 that is associated with this risk factor.
o Explain how this places your adult participant at increased risk for developing a preventable disease (obesity, Type II Diabetes, etc.), which is described.
o List short and long-term goals.
• Intervention (four to five slides): Choose one evidence-based intervention related to the modifiable risk factor chosen that has been shown to be effective at reducing an individual’s risk for developing the preventable disease.
o Describe the intervention in detail.
o Provide rationale to support the use of this intervention. Support your rationale with information obtained from one scholarly source as well as Healthy People 2020 ( http://healthypeople.gov (Links to an external site.)Links to an external site.). Include any additional resources (websites, handouts, etc.) that you will share with your adult participant, if applicable.
• Evaluation (three to four slides): Describe at least one evaluation method that you would use to determine whether your intervention is effective. Outcome measurement is a crucial piece when implementing interventions.
o Describe at least one method (weight, lab values, activity logs, etc.) you would use to evaluate whether your intervention was effective.
o Describe the desired outcomes you would track that would show whether your intervention is working.
o Include additional steps to be considered if your plan proved to be unsuccessful.
• Summary (one to two slides): Reiterate the main points of the presentation and conclude with what you are hoping to accomplish as a result of implementing the chosen intervention.
• References (last slide): List the references for sources that were cited in the presentation.
• Speaker notes: Share in detail how you would verbalize the content on each of the slides to the patient.
Remember, you are creating a patient teaching plan so be sure to include terms easily understood by the general population and limit your use of medical jargon. Slides should include the most important elements for them to know in short bullet-pointed phrases. You may add additional comments in the notes section to clarify information for your instructor.

Class,
I hope your week has been off to a great start so far! By now, everyone should be back on track and submitting per established deadlines.
As I’m sure you are aware, we have our final project due at the end of this week. In an effort to assist you, I thought I would give you a brief overview of what I am looking for to get you started. To begin, you will need to first identify a health concern for your participant. Perhaps they are obese with a family history of coronary artery disease. In this instance, their modifiable risk factor to focus on would be their weight. So, your PowerPoint would be laid out like this:
Slide 1: title page
Slide 2: Identify the risk factor and how it relates to findings from your assessment (obesity)
Slide 3: Explain how obesity places your patient at increased risk for a disease (CAD)
Slide 4: List short and long-term goals for your patient (diet, exercise etc.)
Slide 5: Choose an evidenced-based intervention related to the risk factor proven to be effective and describe it in detail (diet modification)
Slide 6: Provide the rationale for the intervention (decreased caloric intake)
Slide 7: Support the rationale with information from 1 scholarly resource AND Healthy People
Slide 8: Identify resources that you would give the patient (websites, handout, etc.) that focus on the intervention
Slide 9: Identify one evaluation method for your intervention
Slide 10: Explain how you would evaluate the intervention (weight, measurements, BMI)
Slide 11: Describe desired outcomes you would track to see if your plan was working
Slide 12: Describe additional steps you would take if the plan proved to be unsuccessful.
Slide 13: Summary of key points: reiterate main points of presentation
Slide 14: Summary of key points: explain what you hope to accomplish with implementing the intervention identified in the presentation.
Slide 15: resources used in the PowerPoint
Remember that each of your slides should only have 4 or 5 bullet points with the main ideas highlighted. Down at the bottom of each slide, in the notes area, put all the information that you would include if you were discussing this with the patient.
THIS IS NOT A PRESENTATION ON A DISEASE PROCESS!

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Innovation and Strategic Environmental Assessment.1.Assess the external and internal environments using a systems-based perspective (SWOT, PEST, TOWS, or other analytic tool).2.

Synthesize environmental assessment information and propose where innovations are occurring or need to occur. Examples could include:Electronic medical records.mHealth/mobile apps.New services using nanotechnology.Electronic aspirin.Google glass.Robotics surgery.Microchips.3D printing.Microfabrication and biological materials.Optogenetics.3. Assess organizational vision, mission, culture/values and strategic plan for gaps or misalignment with the external environment. Examples could include:Affordable care reimbursement.Billing.Universal coverage.Integrate relevant environmental changes into an organizational strategic plan.Propose performance indicators and metrics for the organizational scorecard. Examples could include:Improve quality of care.Expand service lines.Leverage social media for marketing competitive advantage.Writing RequirementsWritten communication: Written communication is succinct, substantive, and concise as expected of doctoral-level writing. Writing is directly relevant to the assignment. Written communication is free of errors that detract from the overall message.APA formatting: Resources and citations are formatted according to current APA style and format.Length: The guiding principle is to cover your chosen topic in sufficient detail to address the assignment requirement. You may use a professional format such as an organized outline or a paper with a table of contents, headings, sub-headings, et cetera.Font and font size: Times New Roman, 12-point.Grading criteria1. Assesses external and internal environments using a systems-based perspective and uses professionally validated criteria to evaluate the evidence on which the assessment is based.—202. Proposes an environmental assessment that will facilitate innovation opportunities and cites credible literature for the framework utilized.3. Assesses organizational vision, mission, culture/values, and strategic plan for gaps or misalignment with the external environment, and provides a new insight for improvement or innovation.4. Integrates relevant environmental changes into an organizational strategic plan and cites peer-reviewed best practices literature to identify the assumptions or biases of the plan.5. Integrates environmental change into the organizational strategy by proposing performance indicators and metrics for the scorecard.PLEASE LOOK AT THE GRADING CRITERIA AND ANSWER ALL QUESTIONS BASED ON THE GRADING CRITERIA. Give each point in grading criteria a sub heading.

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Reflect on a PEDIATRIC Patient (CHILD or ADOLESCENSE) who presented with gastrointestinal disorders during your Practicum experience.

2). Describe your experience in assessing and managing the patient and his or her family.
3). Include details of your aha moment in identifying the patients disorder.
4). Then explain how the experience connected your classroom studies to the real-world clinical setting.
NOTE: If you did not have an opportunity to evaluate a patient with this background during the last 9 weeks you may select a related case study from a reputable source or reflect on previous clinical experiences.
NOTE: This paper is on a child; not an ADULT patient.
WRITE a 1 (one) PAGE PAPER.
–Due Saturday 4/28/17;before Midnight
–Must have Nursing background to take this job.
–Deliver scholarly written material not high school stuff I saw.
–APA format with at least 3-4 references on your topic of choice.
—All references cited on paper and must be within 5 years old.
— Must be original and FREE OF PLAGIARISM.
NOTE: Each paper is run through Turn-it- in
Answer
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