This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
73What is Special Education 1iStockphotoThinkstock.docxalinainglis
73
What is Special Education? 1
iStockphoto/Thinkstock
Pre-Test
1. You can use the terms disability and handicap interchangeably. T/F
2. The history of special education began in Europe. T/F
3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F
4. All students with disabilities should be educated in special education classrooms. T/F
5. Special education law is constantly reinterpreted. T/F
Answers can be found at the end of the chapter.
4Accreditation, Regulation, and
Agencies of Healthcare Quality
Alex Brandon/AP/Associated Press
Learning Objectives
After reading this chapter, you should be able to do the following:
• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.
• Analyze the role of accreditors, including The Joint Commission, along with major steps in the
accreditation of healthcare organizations.
• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute
the hospital safety score.
• Analyze the structure and process of the National Committee for Quality Assurance (NCQA)
accreditation for health plans.
• Assess the role of several government institutions on the quality of care.
fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM
Introduction
Introduction
At the turn of the 20th century, there were few federal regulations to protect the public from
dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe
Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag-
edy brought about the first real regulation to protect consumers health and safety. The Bio-
logics Control Act was passed in 1902 after two incidents involving the deaths of children
caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each
year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre-
vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in
1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks,
and drugs and mandated strict health safety and testing policies. The law was passed mainly
in response to shocking public disclosures of unsanitary conditions in meat packing plants, as
well as fears over poisonous preservatives and dyes in foods.
However, the 1906 law had its shortcomings and the government’s hands were tied when it
came to preventing the sale of medicinal products that carried wild claims of health cures.
In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination
Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod-
uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).
As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on
medicines that fals.
The Future of Off-Label Marketing Regulations in a Post Sorrell EraJared Iraggi
How Sorrel v. IMS Health impacted corporate scientific speech right and how this decision will likely be used in efforts to find FDA Labeling Regulations overly burdensome on truthful scientific speech.
OverviewThe US is currently undergoing an energy boom largel.docxjacksnathalie
Overview
The US is currently undergoing an energy boom largely because of the development of the greatly expanded use of a well technique developed over 40 years ago - hydraulic fracking. It can be used for both oil and natural gas wells.. The technique allows previously unrecoverable oil and gas in old, played out wells to be accessed and increases the efficiency of recovery in new wells significantly. The current level of both recovery and new well drilling is dramatically higher than it has been for decades. The dramatic increase in well activity, some of which has been near towns and places no one thought drilling would ever occur. It has brought a great deal of attention to the technique and associated effects on everything from ground water and air pollution, to biodiversity disruption and earthquakes.
One important fact to weave into your opinion about fracking pro or con is that all of the sub-surface mineral rights in the US are owned by someone (a private individual, a business, or the state or federal government) but surface and mineral rights can be separated, i.e. sold. Originally, mineral rights were sold along with the land and then companies or individuals could decide if they wanted to keep or sell the mineral rights. Before mineral rights were so valuable, many people opted to sell their mineral rights to oil & gas companies. It never occurred to many people that someone would actually be drilling on their property or their neighbors. Oil and gas companies have a legal right to exercise their ownership options and if you are going to say "no" to them, then you owe them for what you are not letting them have, i.e. the money that would be produced if they were allowed to drill. This is not a trivial issue.
Instructions
This week’s discussion focuses on the pros and cons of hydraulic fracking and asks for your SCIENCE informed opinion on whether the economics and political fossil fuel issues justify the negative tradeoffs.
Address each of the following in your discussion:
How is fracking done and why are companies doing this action versus traditional drilling?
Are the environmental issues with fracking worse than conventional drilling? Why or why not?
Why are people along the Front Range and in other states where fracking is widespread, so upset about it now even though fracking has been occurring for a long time?
*In your initial post, please provide 3-4 references in APA format with in-text citations.
.
OverviewThe United Nations (UN) has hired you as a consultan.docxjacksnathalie
Overview
The United Nations (UN) has hired you as a consultant, and your task is to assess the impact that global warming is expected to have on population growth and the ability of societies in the developing world to ensure the adequate security of their food supplies.
Case Assessment
As the world’s population nears 10 billion by 2050, the effects of global warming are stripping some natural resources from the environment. As they diminish in number, developing countries will face mounting obstacles to improving the livelihoods of their citizens and stabilizing their access to enough food. The reason these governments are struggling even now is that our climate influences their economic health and the consequent diminishing living standards of their peoples. Climate changes are responsible for the current loss of biodiversity as well as the physical access to some critical farming regions. As such, these changes in global weather patterns diminish agricultural output and the distribution of food to local and international markets. These difficulties will become even more significant for these countries as the Earth’s climate changes for the worse. Temperatures are already increasing incrementally, and polar ice caps are melting, so the salient question is: what does this suggest for developing societies?
The issue before the developing world is not its lack of food, but rather how to gain access to food. Simply put, changes in our climate are affecting the global food chain, and hence, the living standards of entire populations. Added to this is the fact that food is not getting to where it is needed in time to prevent hunger or starvation. In many developing countries, shortages are due to governments’ control over distribution networks rather than an insufficient supply of food itself. In effect, these governments are weaponizing food by favoring certain ethnic or religious groups over others. When added to dramatic climate changes that we are experiencing even now, the future for billions of poor people looks increasingly dim.
Instructions
You are to write a minimum of a 5 page persuasive paper for the UN that addresses the following questions about the relationship between atmospheric weather patterns and food security in the developing world:
Climate change and global warming are often used interchangeably, but they are not the same phenomenon. What are the differences between the two concepts and what leads to the confusion between them?
In 1900, the average global temperature was about 13.7° Celsius (56.7° Fahrenheit) (Osborn, 2021), but as of 2020, the temperature has risen another 1.2°C to 14.9°C (58.9°F). According to the Earth and climate science community, if the Earth’s surface temperature rises another 2°C (3.6°F), we will suffer catastrophic weather patterns that, among other things, will raise sea levels, cause widespread droughts and wildfires, result in plant, insect, and animal extinctions, and reduce agricultura.
More Related Content
Similar to Drug Use, Regulation, and the LawChapter 3Guid.docx
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
73What is Special Education 1iStockphotoThinkstock.docxalinainglis
73
What is Special Education? 1
iStockphoto/Thinkstock
Pre-Test
1. You can use the terms disability and handicap interchangeably. T/F
2. The history of special education began in Europe. T/F
3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F
4. All students with disabilities should be educated in special education classrooms. T/F
5. Special education law is constantly reinterpreted. T/F
Answers can be found at the end of the chapter.
4Accreditation, Regulation, and
Agencies of Healthcare Quality
Alex Brandon/AP/Associated Press
Learning Objectives
After reading this chapter, you should be able to do the following:
• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.
• Analyze the role of accreditors, including The Joint Commission, along with major steps in the
accreditation of healthcare organizations.
• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute
the hospital safety score.
• Analyze the structure and process of the National Committee for Quality Assurance (NCQA)
accreditation for health plans.
• Assess the role of several government institutions on the quality of care.
fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM
Introduction
Introduction
At the turn of the 20th century, there were few federal regulations to protect the public from
dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe
Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag-
edy brought about the first real regulation to protect consumers health and safety. The Bio-
logics Control Act was passed in 1902 after two incidents involving the deaths of children
caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each
year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre-
vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in
1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks,
and drugs and mandated strict health safety and testing policies. The law was passed mainly
in response to shocking public disclosures of unsanitary conditions in meat packing plants, as
well as fears over poisonous preservatives and dyes in foods.
However, the 1906 law had its shortcomings and the government’s hands were tied when it
came to preventing the sale of medicinal products that carried wild claims of health cures.
In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination
Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod-
uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).
As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on
medicines that fals.
The Future of Off-Label Marketing Regulations in a Post Sorrell EraJared Iraggi
How Sorrel v. IMS Health impacted corporate scientific speech right and how this decision will likely be used in efforts to find FDA Labeling Regulations overly burdensome on truthful scientific speech.
OverviewThe US is currently undergoing an energy boom largel.docxjacksnathalie
Overview
The US is currently undergoing an energy boom largely because of the development of the greatly expanded use of a well technique developed over 40 years ago - hydraulic fracking. It can be used for both oil and natural gas wells.. The technique allows previously unrecoverable oil and gas in old, played out wells to be accessed and increases the efficiency of recovery in new wells significantly. The current level of both recovery and new well drilling is dramatically higher than it has been for decades. The dramatic increase in well activity, some of which has been near towns and places no one thought drilling would ever occur. It has brought a great deal of attention to the technique and associated effects on everything from ground water and air pollution, to biodiversity disruption and earthquakes.
One important fact to weave into your opinion about fracking pro or con is that all of the sub-surface mineral rights in the US are owned by someone (a private individual, a business, or the state or federal government) but surface and mineral rights can be separated, i.e. sold. Originally, mineral rights were sold along with the land and then companies or individuals could decide if they wanted to keep or sell the mineral rights. Before mineral rights were so valuable, many people opted to sell their mineral rights to oil & gas companies. It never occurred to many people that someone would actually be drilling on their property or their neighbors. Oil and gas companies have a legal right to exercise their ownership options and if you are going to say "no" to them, then you owe them for what you are not letting them have, i.e. the money that would be produced if they were allowed to drill. This is not a trivial issue.
Instructions
This week’s discussion focuses on the pros and cons of hydraulic fracking and asks for your SCIENCE informed opinion on whether the economics and political fossil fuel issues justify the negative tradeoffs.
Address each of the following in your discussion:
How is fracking done and why are companies doing this action versus traditional drilling?
Are the environmental issues with fracking worse than conventional drilling? Why or why not?
Why are people along the Front Range and in other states where fracking is widespread, so upset about it now even though fracking has been occurring for a long time?
*In your initial post, please provide 3-4 references in APA format with in-text citations.
.
OverviewThe United Nations (UN) has hired you as a consultan.docxjacksnathalie
Overview
The United Nations (UN) has hired you as a consultant, and your task is to assess the impact that global warming is expected to have on population growth and the ability of societies in the developing world to ensure the adequate security of their food supplies.
Case Assessment
As the world’s population nears 10 billion by 2050, the effects of global warming are stripping some natural resources from the environment. As they diminish in number, developing countries will face mounting obstacles to improving the livelihoods of their citizens and stabilizing their access to enough food. The reason these governments are struggling even now is that our climate influences their economic health and the consequent diminishing living standards of their peoples. Climate changes are responsible for the current loss of biodiversity as well as the physical access to some critical farming regions. As such, these changes in global weather patterns diminish agricultural output and the distribution of food to local and international markets. These difficulties will become even more significant for these countries as the Earth’s climate changes for the worse. Temperatures are already increasing incrementally, and polar ice caps are melting, so the salient question is: what does this suggest for developing societies?
The issue before the developing world is not its lack of food, but rather how to gain access to food. Simply put, changes in our climate are affecting the global food chain, and hence, the living standards of entire populations. Added to this is the fact that food is not getting to where it is needed in time to prevent hunger or starvation. In many developing countries, shortages are due to governments’ control over distribution networks rather than an insufficient supply of food itself. In effect, these governments are weaponizing food by favoring certain ethnic or religious groups over others. When added to dramatic climate changes that we are experiencing even now, the future for billions of poor people looks increasingly dim.
Instructions
You are to write a minimum of a 5 page persuasive paper for the UN that addresses the following questions about the relationship between atmospheric weather patterns and food security in the developing world:
Climate change and global warming are often used interchangeably, but they are not the same phenomenon. What are the differences between the two concepts and what leads to the confusion between them?
In 1900, the average global temperature was about 13.7° Celsius (56.7° Fahrenheit) (Osborn, 2021), but as of 2020, the temperature has risen another 1.2°C to 14.9°C (58.9°F). According to the Earth and climate science community, if the Earth’s surface temperature rises another 2°C (3.6°F), we will suffer catastrophic weather patterns that, among other things, will raise sea levels, cause widespread droughts and wildfires, result in plant, insect, and animal extinctions, and reduce agricultura.
OverviewThis project will allow you to write a program to get mo.docxjacksnathalie
Overview
This project will allow you to write a program to get more practice with object-oriented ideas that we explored in the previous project, as well as some practice with more advanced ideas such as inheritance and the use of interfaces.
Ipods and other MP3 players organize a user's music selection into groups known as playlists. These are data structures that provide a collection of songs and an ordering for how those songs will be played. For this assignment you will be writing a set of PlayList classes that could be used for a program that organizes music for a user. These classes will be written to implement a particular PlayList interface so that they can be easily exchange in and out as the program requires. In addition, you will also be using the SimpleTrack class you wrote for the closed lab on Interfaces - if you did not finish this class before the end of lab, you will need to finish it before starting on this project.
Objectives
Practice with programming fundamentals
Review of various Java fundamentals (branching, loops, variables, methods, etc.)
Review of Java File I/O concepts
Practice with Java ArrayList concepts
Practice with object-oriented programming and design
Practice with Java interfaces
Project Description
The SimplePlaylist Class
Once you have coded and tested your SimpleTrack class, you will need to write a SimplePlaylist class that implements the Playist interface given in the project folder.
The SimplePlayList class stores music tracks in order - the first track added to the play list should be the first one removed from the play list. You should recognize this data structure as a
queue
(or a
first-in, first-out queue
). You do not need to implement the equals, hashCode and toString methods for this class but if you choose to do so make sure you document your implementations properly!
The PlayList Management Program
Once you have written and tested a SimpleTrack class and a SimplePlaylist class, it is time to use them to write a program to manage playlists. This program will simulate the playing of songs from a play list. For the SimplePlaylist, the songs are removed from the playlist as they are played, so you know that you're at the end of the list when your list is empty. This program should be implemented in the file MusicPlayerSimulator.java. Note that we are not defining ANY of the methods you are using for this program - the design is all up to you. You must, however, practice good programming style - make sure you are breaking the program up into smaller methods and aren't just trying to solve everything with one monolithic main method. If you have fewer than 5 methods for this program you are probably trying to fit too much into a single method.
Here is a sample transcript of the output of this program:
Enter database filename:
input.txt
Currently playing: 'Elvis Presley / Blue Suede Shoes / Elvis Presley: Legacy Edition' Next track to play: 'The Beatles / Wit.
OverviewThis week, we begin our examination of contemporary resp.docxjacksnathalie
Overview
This week, we begin our examination of contemporary responses to youths’ illegal behaviors. The goal for this week is to assess pre-adjudication responses to youths’ illegal behavior. Primarily, our focus will be on nonformal responses or diversion. As a prelude to this discussion, we will consider the “school to prison pipeline” as it provides a good way to understand the need for diversion in juvenile justice.
Objectives
Upon completion of this week’s lesson, you should be able to:
Define what is meant by the “school to prison pipeline.”
Explain how the political economy contributes to the school to prison pipeline.
Explain how trends in education, policing, and juvenile justice contribute to the school to prison pipeline
Describe juvenile arrest trends and trends in the willingness of police to refer youths to juvenile court.
Define radical nonintervention or true diversion and assess the role in can play in juvenile justice.
Explain the rationale for diversion and its value in juvenile justice.
Describe diversion programs that appear to be effective and programs that are not effective
Assess arguments that are made in support of diversion.
Assess the potential problems that should be addressed when developing or operating diversion programs
Tasks
View Video Lecture (Part 1 and Part 2 below) on the School to Prison Pipeline. While viewing the videos, use the pause feature to stop the slides when needed so that you can examine the content.
Part 1
Part 2
Watch the video:
Rethinking Challenging Kids-Where There's a Skill There's a Way | J. Stuart Ablon | TEDxBeaconStreet
Read the material below, Juvenile Diversion.
View Video Lecture 3
.
OverviewProgress monitoring is a type of formative assessment in.docxjacksnathalie
Overview
Progress monitoring is a type of formative assessment in which student learning is evaluated
on a regular basis to provide useful feedback about performance to both students and
teachers. Though there are a number of methods for monitoring a student’s progress, the most
widely used is general outcome measurement, sometimes referred to as curriculum-based
measurement (CBM). Progress monitoring consists of the frequent administration (e.g., once
per month, every two weeks) of brief probes or tests, which include sample items from every
skill taught across the academic year. After each probe is scored, the teacher or student plots
the score on an individual CBM graph. The teacher can then use this data to determine a
student’s:
• Rate of growth — Average growth of a student’s mathematics skills over a period of time
• Performance level — An indication of a student’s current mathematics skills, often
denoted by a score on a test or probe.
You will determine the rate of growth for the two students listed on page 3 using the data provided.
.
OverviewThe work you do throughout the modules culminates into a.docxjacksnathalie
Overview
The work you do throughout the modules culminates into a Customer Service Plan. This plan incorporates the following:
Module 2: Company Description & Evaluation
Module 3: Examine Customer Service & Quality
Module 4: Examine Customer Service Practices in the Twenty-First Century
Module 5: Company Analysis
Instructions
Part I:
Customer Perspective
In relation to what you have learned in Module 3 so far, observe and describe the following as you would view it from the customer’s perspective. Hint: What is each communicating to the customer?
Physical appearance of the business
How quickly is a customer greeted
Pace of the transaction
Parking lot
Hours of operation
Courtesy of customer service representative
Knowledge of customer service representative
Website - if there is a website, how user-friendly is it?
Part II: Quality Recognition
Discuss the following:
Identify criteria that your organization deems important in communications.
How do you know this criteria is important?
How are representatives evaluated on this?
What training is provided to employees in the five main methods of communication (Listening, writing, talking, reading, nonverbal expression)?
What are the expectations when using technology to communicate with customers?
Part III: Proactive Practices
Evaluate the practices in place to avoid challenging situations. What are the practices in place in your business to demonstrate:
Respecting the customer’s time
Keeping a positive attitude
Recognizing regular customers
Maintaining professional communication
Showing initiative
.
OverviewThis discussion is about organizational design and.docxjacksnathalie
Overview
This discussion is about
organizational design and leadership
, as well as
global leadership issues and practices
. Conduct research on current events relating to one of the unit concepts of interest to you. Then, share your findings in an initial post. Try to choose a concept that has not been, or is rarely, addressed by your classmates. Review peers' findings and then engage in an active discussion to learn more about the topic at hand.
Resources
Park LibraryLinks to an external site.
Click on the Library Sources tab.
Enter your topic in the search box.
Click on full text, and you will find one, or several, articles to analyze.
.
OverviewScholarly dissemination is essential for any doctora.docxjacksnathalie
Overview
Scholarly dissemination is essential for any doctoral level student. Posters are often a way to ease into scholarly communication. Building a poster is one of the ways scholars participate in the dissemination of knowledge.
Instructions
1. Your poster submission must have a central focus, as developed from the topic selected in Module 2, and that focus must be evident throughout the poster. Specifically, your introduction, analysis, and results must be focused on a set of research questions and/or hypotheses that are obvious in your theoretical diagram.
2. The focus must comprehensively place the problem/question in appropriate scholarly context (scholarly literature, theory, model, or genre).
.
OverviewRegardless of whether you own a business or are a s.docxjacksnathalie
Overview:
Regardless of whether you own a business or are a stakeholder in a business, understanding basic contract terms is important. Businesses enter into contracts with many areas, from shipping to suppliers to customers. As a business owner or manager knowledge of these basic terms will assist you in the day to day operations of the business, regardless of the field.
Instructions:
• Fill in the attached template.
• For each term, define the term with citation to authority, define the term in your own words and provide an example of each term.
Requirements:
• Use APA format for non-legal sources such as the textbook. Use Bluebook citation format for any legal citations.
• Submit a Word document using the template.
• Maximum two pages in length, excluding the Reference page.
.
OverviewImagine you have been hired as a consultant for th.docxjacksnathalie
Overview
Imagine you have been hired as a consultant for the United Nations. You have been asked to write an analysis on how global population growth has caused the following problem and how it affects
TURKEY
A growing global population that consumes natural resources is partially to blame for the release of greenhouse gases since human consumption patterns lead to deforestation, soil erosion, and farming (overturned dirt releases CO2). However, the critical issue is the burning of fossil fuels (hydrocarbons) such as coal oil and natural gas to produce energy that is used for things like electricity production, and vehicle, heating, and cooking fuels.
Instructions
Content
The U.N. has asked that your paper contain three sections. It has asked that each section be one page (or approximately 300 words) in length and answer specific questions, identified in the outline below. It also asks that you use examples from Turkey when answering the questions.
Introduction
Provide an introduction of half a page minimum that addresses points
points
1–5 below:
Explain the problem the U.N. has asked you to address in your own words.
Identify the three sections your paper will cover.
Identify the developing country (TURKEY) you will consider.
Telly
the U.N. which causes of greenhouse gases you will explore.
Provide a one-sentence statement of your solutions at the end of your introduction paragraph.
Section I. Background
What are greenhouse gases?
How do greenhouse gases contribute to global warming?
Section II. How Emissions Causes Problems for the Developing World
Which countries produce the most greenhouse gases?
What are the economic challenges of these emissions in Turkey?
What are the security challenges of these emissions in Turkey?
What are the political challenges of these emissions in Turkey?
Section III. Causes and
Solution
s of Greenhouse Gases
Name two causes of greenhouse gases.
What are potential solutions to address each of the causes you identified?
What is the relationship between population control and greenhouse gases?
Conclusion
Provide a conclusion of half a page minimum that includes a summary of your findings that the United Nations can use to inform future policy decisions.
Success Tips
In answering each question, use examples from Turkey to illustrate your points.
The U.N. needs facts and objective analysis on which to base future policy decisions. Avoid
personal opinion
and make sure your answers are based on information you find through research.
Formatting Requirements
Make sure your paper consists of 4–6 pages (1,200 words minimum, not including the cover page, reference page, and quoted material if any).
Create headings for each section of your paper as follows:
Section I. Background.
Section II. How Emissions Causes Problems for the Developing World.
Section III. Causes and
.
OverviewDevelop a 4–6-page position about a specific health care.docxjacksnathalie
Overview
Develop a 4–6-page position about a specific health care issue as it relates to a target vulnerable population. Include an analysis of existing evidence and position papers to help support your position. Your analysis should also present and respond to one or more opposing viewpoints.
Note
: Each assessment in this course builds on the work you completed in the previous assessment. Therefore, you must complete the assessments in this course in the order in which they are presented.
Position papers are a method to evaluate the most current evidence and policies related to health care issues. They offer a way for researchers to explore the views of any number of organizations around a topic. This can help you to develop your own position and approach to care around a topic or issue.
This assessment will focus on analyzing position papers about an issue related to addiction, chronicity, emotional and mental health, genetics and genomics, or immunity. Many of these topics are quickly evolving as technology advances, or as we attempt to push past stigmas. For example, technology advances and DNA sequencing provide comprehensive information to allow treatment to become more targeted and effective for the individual. However as a result, nurses must be able to understand and teach patients about the impact of this information. With this great power comes concerns that patient conditions are protected in an ethical and compassionate manner.
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:
Competency 1: Design evidence-based advanced nursing care for achieving high-quality population outcomes.
Evaluate the evidence and positions of others that could support a team's approach to improving the quality and outcomes of care for a specific issue in a target population.
Evaluate the evidence and positions of others that are contrary to a team's approach to improving the quality and outcomes of care for a specific issue in a target population.
Competency 2: Evaluate the efficiency and effectiveness of interprofessional interventions in achieving desired population health outcomes.
Explain the role of the interprofessional team in facilitating improvements for a specific issue in a target population.
Competency 3: Analyze population health outcomes in terms of their implications for health policy advocacy.
Explain a position with regard to health outcomes for a specific issue in a target population.
Competency 4: Communicate effectively with diverse audiences, in an appropriate form and style, consistent with organizational, professional, and scholarly standards.
Communicate an initial viewpoint regarding a specific issue in a target population and a synthesis of existing positions in a logically structured and concise manner, writing content clearly with correct use of grammar, punctuation, and spelling.
Integrate .
Overview This purpose of the week 6 discussion board is to exam.docxjacksnathalie
Overview:
This purpose of the week 6 discussion board is to examine social class and global stratification. Answer prompt 1. Then select and answer one prompt from prompts 2-4. Refer to Chapters 7 and 8 to answer the prompts.
Instructions:
Respond to prompts in paragraph form (200-400 words
Prompt 1:
Describe 3 topics from Chapters 7 and 8 that you found interesting. Three topics I found interesting from Chapter 7 and 8 were the Dependency Theory, World Systems Theory, and Modernization Theory.
Prompt 2:
Describe 3 different social classes and criteria for membership in each.
Prompt 3:
Describe the effect of social inequality upon dominant and minority groups.
Prompt 4
: Describe social mobility regarding how to rise up the social class ladder, if it is possible.
Prompt 5:
Apply a functionalist or conflict theory perspective to social inequality.
.
Overall Scenario Always Fresh Foods Inc. is a food distributor w.docxjacksnathalie
Overall Scenario
Always Fresh Foods Inc. is a food distributor with a central headquarters and main warehouse in Colorado, as well as two regional warehouses in Nevada and Virginia. The company runs Microsoft Windows 2019 on its servers and Microsoft Windows 10 on its workstations. There are 2 database servers, 4 application servers, 2 web servers, and 25 workstation computers in the headquarters offices and main warehouse. The network uses workgroups, and users are created locally on each computer. Employees from the regional warehouses connect to the Colorado network via a virtual private network (VPN) connection. Due to a recent security breach, Always Fresh wants to increase the overall security of its network and systems. They have chosen to use a solid multilayered defense to reduce the likelihood that an attacker will successfully compromise the company’s information security. Multiple layers of defense throughout the IT infrastructure makes the process of compromising any protected resource or data more difficult than any single security control. In this way, Always Fresh protects its business by protecting its information.
Scenario 1
Assume you are an entry-level security administrator working for Always Fresh. You have been asked to evaluate the option of adding Active Directory to the company’s network.
Tasks
Create a summary report to management that answers the following questions to satisfy the key points of interest regarding the addition of Active Directory to the network:
1. System administrators currently create users on each computer where users need access. In Active Directory, where will system administrators create users?
2. How will the procedures for making changes to the user accounts, such as password changes, be different in Active Directory?
3. What action should administrators take for the existing workgroup user accounts after converting to Active Directory?
4. How will the administrators resolve differences between user accounts defined on different computers? In other words, if user accounts have different settings on different computers, how will Active Directory address that issue? (Hint: Consider security identifiers [SIDs].)
.
OverviewCreate a 15-minute oral presentation (3–4 pages) that .docxjacksnathalie
Overview
Create a 15-minute oral presentation (3–4 pages) that examines the moral and ethical issues related to triaging patients in an emergency room.
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:
· Competency 1: Explain the effect of health care policies, legislation, and legal issues on health care delivery and patient outcomes.
. Explain the health care policies that can affect emergency care.
. Recommend evidence-based decision-making strategies nurses can use during triage.
· Competency 3: Apply professional nursing ethical standards and principles to the decision-making process.
. Describe the moral and ethical challenges nurses can face when following hospital policies and protocols.
. Explain how health care disparities impact treatment decisions.
· Competency 4: Communicate in a manner that is consistent with expectations of nursing professionals.
. Write content clearly and logically, with correct use of grammar, punctuation, and mechanics.
. Correctly format citations and references using APA style.
Context
Working in an emergency room gives rise to ethical dilemmas. Due to time restraints and the patient's cognitive impairment and lack of medical history, complications can and do occur. The nurse has very little time to get detailed patient information. He or she must make a quick assessment and take action based on hospital protocol. The organized chaos of the emergency room presents unique ethical challenge, which is why nurses are required to have knowledge of ethical concepts and principles.
Questions to consider
To deepen your understanding, you are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community.
· How does a triage nurse decide which patient gets seen first?
· How does health disparity affect the triage nurse's decision making?
· What ethical and moral issues does the triage nurse take into account when making a decision?
· What are triage-level designations?
Resources
Suggested Resources
The following optional resources are provided to support you in completing the assessment or to provide a helpful context. For additional resources, refer to the Research Resources and Supplemental Resources in the left navigation menu of your courseroom.
Capella Resources
· APA Paper Template.
· APA Paper Tutorial.
Library Resources
The following e-books or articles from the Capella University Library are linked directly in this course:
· Tingle, J., & Cribb, A. (Eds.). (2014). Nursing law and ethics (4th ed.). Somerset, NJ: John Wiley & Sons.
· Cranmer, P., & Nhemachena, J. (2013). Ethics for nurses: Theory and practice. Maidenhead, UK: Open University Press.
· Aacharya, R. P., Gastmans, C., & Denier, Y. (2011). Emergency department triage: An ethical analysis. B MC Emergency Medicine, 11(1), 16–29.
· Guidet, B., H.
Overall CommentsHi Khanh,Overall you made a nice start with y.docxjacksnathalie
Overall Comments:
Hi Khanh,
Overall you made a nice start with your U06a1 assignment; however, many of the required objectives have not been addressed in the first version of your assignment. Please carefully review the scoring guide, and review my feedback below, and be sure to contact me if you have any questions about my comments. You can reach me at: [email protected] or 813-417-0860.
Sincerely,
Dr. Marni Swain
COMPETENCY: Assess approaches for recruiting, selecting, and retaining talent.
CRITERION: Explain why and when candidate background checks will be authorized.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Basic
Explains why but not when candidate background checks will be authorized.
Faculty Comments:“
You made a nice start with this discussion; however, it is important to develop your content further to address the legalities involving when a background check can be conducted during the interview process, and the other steps employers have to follow to be in compliance with the law.
”
CRITERION: Identify the top three candidates to interview for the position.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not identify the top three candidates to interview for the position.
Faculty Comments:“
Please develop your content further to address this topic in your assignment.
”
CRITERION: Explain rationale for why the selected candidates should be interviewed.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not explain rationale for why the selected candidates should be interviewed.
Faculty Comments:“
Please develop your content further to address this topic in your assignment.
”
CRITERION: Identify pre-employment screening tests for the position being recruited.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Basic
Identifies a pre-employment screening test for the position being recruited.
Faculty Comments:“
I would like to see your content developed further to clearly identify your rationale for the pre-employment screening tests you selected, as this is not clear based on the limited information provided.
”
CRITERION: Select assessment methods to use based on the job being recruited and the budget available.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not select assessment methods to use based on the job being recruited and the budget available.
Faculty Comments:“
I would like to see your content developed further to clearly identify the assessment methods you will use for CapraTek's Regional Sales positions based on the available budget, as this is not identified in your work.
”
CRITERION: Develop the sequence in which methods will be used to screen applicants.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not develop the sequence in which methods will be used to screen applicants.
Faculty Comments:“
Please develop your content further to address this topic in your assignment.
”
CRITERION: Design a final candidate selection process for the CapraTek.
Overall CommentsHi Khanh,Overall you made a nice start with.docxjacksnathalie
Overall Comments:
Hi Khanh,
Overall you made a nice start with your U03a1 assignment; however, your content still does not address the required objectives. For this assignment you will need to focus the content on Capra Tek's regional sales position, and for objective #1 analyze the KSAs for this position, and for objective #2 you will need to analyze wage trends related to this position as well. Objectives 3 & 4 focus on job description and the job analysis so please carefully review what is required for these two objectives.
Please see my feedback below and be sure to let me know if you have any questions about my comments.
Sincerely,
Dr. Marni Swain
COMPETENCY: Describe how hiring practices support an organization's strategy.
CRITERION: Articulate the components of a job description for a position.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not articulate the components of a job description for this position.
Faculty Comments:“
Please see feedback above.
”
COMPETENCY: Assess approaches for recruiting, selecting, and retaining talent.
CRITERION: Identify the knowledge, skills, and abilities required for this position.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not identify the knowledge, skills, and abilities required for this position.
Faculty Comments:“
Please see feedback above.
”
COMPETENCY: Explore technology tools that support recruiting and staffing management.
CRITERION: Identify wage information and employment trends for this position in a selected state.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not identify wage information and employment trends for this position in a selected state.
Faculty Comments:“
Please see feedback above.
”
COMPETENCY: Analyze the impact of legal and regulatory issues on staffing management.
CRITERION: Explain why a job analysis is a requirement for any recruiting and selecting process.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not explain why a job analysis is a requirement for any recruiting and selecting process.
Faculty Comments:“
Please see feedback above.
”
COMPETENCY: Communicate in a manner that is scholarly and professional.
CRITERION: Communicate in a professional manner that is appropriate for the intended audience.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not communicate in a professional manner that is appropriate for the intended audience.
Faculty Comments:“
Please see feedback above.
”
Dysphagia .
Dysphagia is a serious problem and contributes to weight loss, malnutrition, dehydration, aspiration pneumonia, and death. Careful assessment of risk factors, observation for signs and symptoms, and collaboration with speech-language pathologists on interventions are essential.
Dysphagia, or difficulty swallowing, is a common problem in older adults. The prevalence of swallowing disorders is 16% to 22% in adults older than 50 years of age, and up to 60% of nursing ho.
Overall feedbackYou addressed most all of the assignment req.docxjacksnathalie
Overall feedback:
You addressed most all of the assignment requirements. The assignment had several requirements including, but not limited to: an introduction, 3 questions, conclusion, and at least 2 scholarly references to support your claims. You did include an introduction. However, the introduction should briefly identify the key areas/sections to be covered in the paper. This helps the reader navigate through the organization of both your paper and thought process. You did address the question requirements. The assignment required at least 2 scholarly peer reviewed journal articles. Although you included several references, I only saw one scholarly peer reviewed journal article. Moving forward. Be sure to carefully review the instructions before and after you complete your final draft to ensure all requirements have been met. Second, always include an introduction which briefly describes what areas will be covered. Finally, make sure that you include the required number of scholarly peer reviewed journal articles to support your claims. If you have questions, please contact me.
be sure to fully address the question with terminology and concepts from the book to apply to the case. This demonstrates proficiency at the required tasks. For example, question 2 asked:
Question #2: Discuss your plans for developing formal job descriptions for the employees at the second shop
For this question, I was looking for your approach in terms of methods discussed in the text (interviews, observations, questionnaires, etc.) and application to the case study to show application of the concepts/theories.
As far as the scholarly peer reviewed journal articles, this is an essential part of supporting your claims at the graduate level of writing. The assignment required 2 scholarly peer reviewed journal articles. I only saw one? The purpose of this requirement is to ensure that you are supporting your claims with contemporary research within the management/business discipline. Second, this also gives credit to the author's ideas. While I do not point out every error or missing item on your paper, I focus on those areas/content that are required and can be improved. Moving forward, be sure to fully address each question with terminology from the text/material, as well as provide examples to demonstrate the ability to apply the concepts to the case study. I look forward to receiving your next paper. Second, be sure to include the required number of current (within past 5 years) scholarly peer reviewed journal articles to support your paper.
.
Performance Management
Third Edition
Herman Aguinis
Kelley School of Business
Indiana University
Boston Columbus Indianapolis New York San Francisco Upper Saddle River
Amsterdam Cape Town Dubai London Madrid Milan Munich Paris Montreal Toronto
Delhi Mexico City Sao Paulo Sydney Hong Kong Seoul Singapore Taipei Tokyo
Credits and acknowledgments borrowed from other sources and reproduced, with per.
Overall Comments Overall you made a nice start with your U02a1 .docxjacksnathalie
Overall Comments:
Overall you made a nice start with your U02a1 assignment. Please see my specific feedback below for each objective, and I can be reached at: [email protected] or 813-417-0860 if you have any questions about my comments.
COMPETENCY: Analyze the impact of legal and regulatory issues on staffing management.
CRITERION: Describe the important issues in the case.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not identify the important issues in the case.
Faculty Comments:“
It is important to select a legal case of disparate impact as the focus of your assignment, and it is unclear if the case you selected is this type of case based on the information provided. Please develop your content further to clearly analyze the important issues of this case, and be sure to describe why this is a case of disparate impact.
”
CRITERION: Distinguish the theory of disparate (or adverse) impact from the theory of disparate treatment.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Basic
Partially distinguishes the theory of disparate (or adverse) impact from the theory of disparate treatment.
Faculty Comments:“
You made a nice start with this objective; however, I would like to see your content developed further to clearly distinguish the theory of disparate treatment from disparate or adverse impact, and this is only briefly addressed in your assignment.
”
CRITERION: Analyze the outcome of the case.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not state the outcome of the case.
Faculty Comments:“
It is important to select a legal case of disparate impact as the focus of your assignment, and it is unclear if the case you selected is this type of case based on the information provided. Please develop your content further to clearly analyze the outcome of this case, and be sure to apply disparate impact theory.
”
CRITERION: Analyze the evidence of discriminatory effects.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not describe the evidence of discriminatory effects.
Faculty Comments:“
It is important to select a legal case of disparate impact as the focus of your assignment, and it is unclear if the case you selected is this type of case based on the information provided. Please develop your content further to clearly analyze the evidence of discriminatory effects in this case, and provide specific examples of connections to the rule, policy or process.
”
CRITERION: Describe how the Uniform Guidelines on Employee Selection Procedures help employers avoid issues related to disparate or adverse impact.
DISTINGUISHED
PROFICIENT
BASIC
NON-PERFORMANCE
Non-Performance
Does not identify how the Uniform Guidelines on Employee Selection Procedures help employers avoid issues related to disparate or adverse impact.
Faculty Comments:“
Please develop your content further to address this in your work.
”
COMPETENCY: Communicate in a manner that is scholarly and professional.
CRITERION: Commun.
Overview This purpose of the week 12 discussion board is to e.docxjacksnathalie
Overview:
This purpose of the week 12 discussion board is to examine health, healthcare, and disability status. Answer prompt 1. Then select and answer one prompt from prompts 2-4. Refer to Chapter 13 to answer the prompts.
Instructions:
Respond to prompts in paragraph form (200-400 words)
Prompt 1:
Describe 3 topics from Chapter 13 that you found interesting.Three topics I found interesting in Chapter 14 was "A Functionalist Perspective: The Sick Role", "A Symbolic Interactionist Perspective:
Prompt 2:
Describe how stereotypes regarding disability status may lead to prejudice and discrimination.
Prompt 3:
Describe how access to healthcare is associated with social class location (e.g., socioeconomic status).
Prompt 4:
How is culture associated with attitudes towards health and healthcare.
Prompt 5:
Compare how the United States pays for health care with how other nations provide health services for their citizens.
.
Over the years, the style and practice of leadership within law .docxjacksnathalie
Over the years, the style and practice of leadership within law enforcement agencies has gradually changed. In the past, leadership was primarily relegated to one individual within the department. However, there has been a transformation in leadership theory resulting in a more dynamic, multifaceted nature of teamwork, inclusion, and dispersed leadership. More and more, police chiefs are being encouraged to move toward a more participatory leadership style of management, one that encourages collaboration and cooperation in the decision-making process.
Based on your readings in the text and credible Internet research, respond to the following:
What does the term
shared leadership
mean? What advantages or disadvantages do you see in this leadership approach?
What direction should law enforcement leaders take for the future, related to leadership styles?
What does the term
visionary leadership
mean?
2-3 pages
.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Drug Use, Regulation, and the LawChapter 3Guid.docx
1. Drug Use, Regulation,
and the Law
Chapter 3
Guidelines for Controlling Drug Development and Marketing
Society has the right to protect itself from the damaging impact
of drug use.
Society has the right to demand safe and effective drugs.
Strategies for Preventing Drug Abuse
Supply reduction
Using drug laws to control the manufacturing and distribution
of classified drugs
Inoculation
Aims to protect drug users by teaching them responsibility and
explaining the effects of drugs on bodily and mental functioning
Demand reduction strategy
Aims to reduce the actual demand for drugs
3
Patent Medicines
The term patent medicines signified that the ingredients were
2. secret, not patented.
The patent medicines of the late 1800s and early 1900s
demonstrated the problems of insufficient regulation of the drug
industry.
Issues Leading to Legislation
Fraud in patent medicines that were sold directly to the public
False therapeutic claims
Habit-forming drug content
5
Image source: Library of Congress Prints and Photographs
Division (Images Ch03_05PatMedKentucky,
Ch03_03PatMedJayne)
Issues Leading to Legislation
Cocaine
Present in many patent medicines
Viewed as a cause of increasing crime
6
Image source: National Library of Medicine, National Institutes
of Health (See image bank for Chapter 6; Image
Ch06_06CocaineDrops)
Reformism
3. Current laws trace back to two pieces of legislation from the
early 1900s
Racist fears about deviant behavior, including drug misuse,
played a role in the development of drug regulation
Laws were developed to regulate undesirable behaviors
7
Image source: Library of Congress Prints and Photographs
Division (Image Ch03_08OpiumPoster1)
Issues Leading to Legislation
Opium and the Chinese
U.S. was involved in international drug trade
Opium smoking brought to U.S. by Chinese workers (myth)
Laws passed against the importation, manufacture, and use of
opium
8
Image source: Library of Congress Prints and Photographs
Division (Image Ch03_07OpiumDen)
Issues Leading to Legislation
In the early 1900s, Collier’s magazine ran a series of articles
attacking patent medicines.
Drug manufacturers have a history of selling ineffective,
addictive and even harmful products to the public.
4. 9
Image source: Library of Congress Prints and Photographs
Division (Image Ch03_06ColliersMagazine)
1906 Pure Food and Drugs Act
Federal government law to protect the public (Dept. of
Agriculture)
Required accurate labeling and listing of ingredients
US Government intervenes in commerce of adulterated or
misbranded drugs and food
Misbranding only refers to the label, not advertising
10
The 1906 Pure Food and Drug Act
Required manufacturers to include on labels the amounts of
alcohol, morphine, opium, cocaine, heroin, or marijuana extract
in each product
Did not prohibit distribution of dangerous preparations
The Sherley Amendment in 1912
Accuracy of manufacturers’ therapeutic claims was not
controlled by the Pure Food and Drug Act.
The Sherley Amendment in 1912 was passed to strengthen
existing laws and required that labels should not contain “any
statement ... regarding the curative or therapeutic effect ...
which is false and fraudulent.”
5. Food, Drug, and Cosmetic Act
The sale and use of Elixir Sulfanilamide led to a tragic accident
that killed over 100 people.
Companies required to file applications with the government
showing that new drugs were safe.
Food, Drug, and Cosmetic Act
A drug is a product intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease
Before marketing, drugs must be shown to be
Safe when used as directed
Effective for their intended use
Food products and ingredients must be
Safe
Pure (unadulterated)
They are not required to show that they are effective or provide
any benefit
14
Food, Drug, and Cosmetic Act (continued)
Required safe tolerances be set for unavoidable poisonous
substances.
Authorized establishment of identity and quality for foods.
6. Durham-Humphrey Amendment
Made formal distinction between prescription and
nonprescription drugs
Established drug classification categories:
Drug is habit-forming
Drug is not safe for self-medication
Drug is a new drug and not shown to be completely safe
Kefauver-Harris Amendments
Passed, in part, as a consequence of the thalidomide tragedy
Drug manufacturers had to demonstrate the efficacy and safety
of drugs
The FDA was empowered to withdraw approval of a drug that
was already being marketed
The FDA was permitted to regulate and evaluate drug testing by
pharmaceutical companies
Thalidomide Tragedy
Regulating New Drug Development
The amended Food, Drug, and Cosmetic Act requires that all
new drugs be registered with and approved by the FDA.
7. Regulation of Pharmaceuticals
1. Purity
The contents of the product must be accurately listed on the
label
FDA encouraged voluntary cooperation and compliance
1912 Sherley Amendment outlawed false and fraudulent
therapeutic claims on labels
21
Regulation of Pharmaceuticals
2. Safety
Originally—no legal requirement that medications be safe
1938 Food, Drug, and Cosmetic Act required pre-market testing
for toxicity
Companies required to submit a New Drug Application (NDA)
to the FDA
Directions must be included
Adequate instructions for consumer OR
Drug can be used only with physician prescription
22
Regulation of Pharmaceuticals
3. Effectiveness
1962 Kefauver-Harris Amendments
Pre-approval required before human testing
8. Advertising for prescription drugs must include information
about adverse reactions
Every new drug must be demonstrated to be effective for the
illnesses mentioned on label
23
Regulating New Drug Development (continued)
The FDA is mandated by Congress to:
Ensure the rights and safety of human subjects during clinical
testing
Evaluate the safety and efficacy of new treatments
Compare benefits and risks of new drugs and determine if
approval for marketing is appropriate
Marketing a New Drug
1) Preclinical research and development
Testing on animals (ED, LD, toxicity)
2) Clinical research and development
Phase One—small doses, healthy volunteers
Phase Two—small number of patients
Phase Three—larger number of patients
3) Permission to market (NDA)
May require 10+ years and $800+ million
25
Regulatory Steps for New Prescription Drugs
9. Regulatory Steps for New Prescription Drugs (continued)
Step 1: Preclinical research and development
Step 2: Clinical research and development
Initial clinical stage
Clinical pharmacological evaluation stage
Extended clinical evaluation
Step 3: Permission to market
Postmarketing surveillance
New Drug Application (NDA)
If there is sufficient data to demonstrate that a drug is safe and
effective, the company submits an NDA as a formal request that
the FDA approve it for marketing.
Exceptions: Special Drug-Marketing Laws
“Fast-track” rule
Applied to testing of certain drugs, such as ones for rare cancers
and AIDS
Orphan Drug Law
Tax advantages for development of drugs to treat “rare
diseases” since this can be otherwise unprofitable
Prescription Drug User Fee Act of 1992
Increase reviewers and decrease review time
Secure and Responsible Drug Disposal Act
10. Addresses the problem that patients were not allowed to return
drugs to DEA registrants
Prescription Drugs were legally “controlled substances” and
people were not allowed to “give” it to other unauthorized
people
Secure and Resposible Drug Disposal Act Explained
The Regulation of
Nonprescription Drugs
In 1972, the FDA initiated a program to evaluate the
effectiveness and safety of nonprescription drugs.
The FDA evaluated each active ingredient in OTC medications
and placed ingredients into three categories:
I. Generally recognized as safe and effective
II. Not safe and effective or unacceptable indications
III. Insufficient data to permit final classification
Switching Policy
The drug must have been used by prescription for 3 years.
Use must have been relatively high during the time it was used
by prescription.
Adverse drug reactions must not be alarming, and the frequency
of side effects must not have increased during the time the drug
was available to the public.
Drug Advertising
Promotional efforts by pharmaceutical companies have a large
impact on the drug-purchasing habits of the general public and
11. health professionals.
As a general rule, the FDA oversees most issues related to
advertising of prescription products. The FTC regulates OTC
advertising.
Direct-to-Consumer (DTC) Advertising
Most physicians surveyed agreed that because their patient saw
a DTC advertisement, he/she asked thoughtful questions during
the visit. Approximately the same percentage of physicians
thought the advertisements made their patients more aware of
possible treatments.
The physicians surveyed indicated that the advertisements did
not convey information about risks and benefits equally well.
Direct-to-Consumer (DTC) Advertising (continued)
Approximately 75% of physicians surveyed indicated that DTC
ads cause patients to think that the drug works better than it
does, and many physicians felt some pressure to prescribe
something when patients mentioned DTC ads.
The physicians surveyed reported that patients understand that
they need to consult a health care provider concerning
appropriate treatments.
The Harrison Act of 1914
Marked the first legitimate effort by the federal government to
regulate and control the production and importation of addicting
substances
12. The Comprehensive Drug Abuse Prevention and Control Act
This 1970 act divided substances with abuse potential into
categories based on the degree of their abuse potential and
clinical usefulness.
Schedules I, II, III, IV, and V
“Scheduling”
Schedule I substances have high-abuse potential and no
currently approved medicinal uses.
Schedule II substances have high-abuse potential but are
approved for medical uses and can be prescribed.
Schedule II–V substances reflect the likelihood of abuse and
clinical usefulness.
Summary of Controlled Substance
SchedulesScheduleCriteriaExamplesIHigh potential for abuse
No accepted medical use
Lack of accepted safetyHeroin,
marijuana, MDMA (Ecstasy)IIHigh potential for abuse
Currently accepted medical use
Abuse may lead to severe dependenceMorphine,
cocaine, methamphetamineIIIPotential for abuse less than I and
II
Currently accepted medical use
Abuse may lead to moderate physical dependence or high
psychological dependenceAnabolic steroids, most
barbituratesIVLow potential for abuse relative to III
Currently accepted medical use
Abuse may lead to limited physical or psychological
dependence relative to IIIXanax, barbital, chloral hydrate,
fenfluramineVLow potential for abuse relative to IV
Currently accepted medical use
13. Abuse may lead to limited physical or psychological
dependence relative to IVMixture with small amounts of
codeine or opium
40
Factors Determining Scheduling
The actual or relative potential for abuse of the drug.
Scientific evidence of the pharmacological effects of the drug.
The state of current scientific knowledge regarding the
substance.
Its history and current pattern of abuse.
What, if any, risk there is to the public health.
Factors Determining Scheduling (continued)
The psychological or physiological dependence liability of the
drug.
The scope, duration, and significance of abuse.
Whether the substance is an immediate precursor of a substance
already controlled.
Principal Issues Influencing Laws Regarding Substance Abuse
If a person abuses a drug, should he or she be treated as a
criminal or as a sick person inflicted with a disease?
How is the user (supposedly the victim) distinguished from the
pusher (supposedly the criminal) of an illicit drug, and who
should be more harshly punished?
Are the laws and associated penalties effective deterrents
against drug use or abuse, and how is effectiveness determined?
14. Strategies for Preventing
Drug Abuse
Supply Reduction
– Attempts to curtail the supply of illegal drugs or their
precursors and exert greater control over other, more
therapeutic drugs
– Includes interdiction, the policy of cutting off or destroying
supplies of illicit drugs
– Limited success
Strategies for Preventing
Drug Abuse (continued)
Inoculation
– Aims to protect drug users by teaching them responsibility
and explaining the effects of drugs on bodily and mental
functioning
Demand Reduction
– Aims to reduce the actual demand for drugs
Suggestions for Reducing Demand
A top priority of prevention is to reduce demand by youth.
Education must be carefully designed for the target population.
Attitudes toward drug abuse must be changed.
Replacement therapy can be useful.
Drug Courts
Designed to deal with nonviolent, drug-abusing offenders
16. 50
Image source: Spike Mafford/Getty Images (Image
Ch03_13DrugTesting)
Pragmatic Drug Policies
The government must develop programs that are consistent with
the desires of the majority of the population.
Programs must consider de-emphasizing interdiction and stress
programs that reduce demand.
State and Local Regulations
Difference in penalties from state to state
Federal law overrides state law
Significant growth in number of Americans in prison
52
Figure from Drugs in Depth box in text
Impact of Drug Enforcement
Budget
International programs
Other federal agencies
In this raid, an international task force seized two tons of
cocaine in the Caribbean Basin.
53
Image source: U.S. Immigration and Customs Enforcement
17. (Image Ch03_14InternationalDrugControl)
Impact of Drug Enforcement
Other costs
Cost of prison population
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom
Drug use has not been eliminated
54
Effectiveness of Control
About 10-15% of illegal drug supply is seized each year
When supplies are restricted, prices go up
Higher prices and increased difficulty in obtaining drugs may
deter some would-be users
Seized Ecstasy
55
Image source: U.S. Immigration and Customs Enforcement
(Image Ch03_15SeizedEcstasy)
Pragmatic Drug Policies (continued)
Government and society must better understand how laws, used
properly and selectively, can reinforce and communicate
expected social behavior and values.
Programs, such as anti-smoking campaigns, should be
implemented that employ “public consensus” more effectively.
18. Homeostatic Systems
and Drugs
Chapter 4
Homeostasis
Internal and external changes in the environment
Body self-regulates via
nervous system and endocrine system
Equilibrium
Introduction to Nervous SystemsAll nervous systems consist of
specialized nerve cells called neurons and glia (supporting
19. cells).Neurons are responsible for conducting the homeostatic
functions of the brain and other parts of the nervous system by
receiving and sending information.Sending and receiving
information is an electrochemical process.
Transfer of Messages by NeuronsThe receiving region of the
neuron is affected by a chemical message that either excites or
inhibits it.Neuronal message:Impulse moves from the receiving
region of the neuron down the axon to the sending region
(terminal).Chemical messengers (neurotransmitters) are
released.
Transfer of Messages by Neurons (continued)Neurotransmitters
travel and attach to receiving proteins called receptors on target
cells.Activation of receptors causes a change in the activity of
the target cell; the target cells can be other neurons or cells that
make up organs, muscles, or glands.
Sending Messages by Neurons
Figure 4.1: The process of sending messages by neurons.
20. Neurons and NeurotransmittersNeurons can send discrete
excitatory or inhibitory messages to their target cells.Neurons
are distinguished by the type of neurotransmitter they
release.Neurotransmitters represent a wide variety of chemical
substances and functions.Example: Dopamine activates the
pleasure center.
Common NeurotransmittersNeurotransmitterType of EffectCNS
ChangesDrugs of AbuseDopamineInhibitory-excitatory
Euphoria
Agitation
Paranoia
AlteredAmphetamines,
cocaineGABAInhibitoryCognition
Sedation
Relaxation
Drowsiness
DepressionAlcohol, valium-type barbiturates
22. Neurons Dendrites are the receiving regions of a neuron’s cell
body.Each neuron in the central nervous system is in close
proximity with other neurons.Although they are close, neurons
never actually touch.Synapse is the point of communication
between one neuron and another.Synaptic cleft is the gap
between neurons at the synapse.
Neurons (continued)
Figure 4.2: Each neuron may have many synaptic connections.
SynapsesExcitatory synapse initiates an impulse in the receiving
neuron when stimulated, causing release of neurotransmitters or
increasing activity in target cell.Inhibitory synapse diminishes
likelihood of an impulse in the receiving neuron or reduces the
activity in other target cells.
Synapses (continued)A receiving neuron or target cell may have
many synapses.Final cellular activity is a summation of these
many excitatory and inhibitory synaptic signals.
Drug ReceptorsThe chemical messengers from glands and
neurons exert their effects by interacting with special protein
regions in membranes called receptors.Receptors only interact
23. with molecules that have specific configurations.
Drug Receptors (continued)
Figure 4.3: Cell membranes consist of a double layer of
phospholipids.
Drug Receptors (continued)Agonists: Substances or drugs that
activate receptorsAntagonists: Substances or drugs that attach to
receptors and prevent them from being activated
Drug Receptors (continued)
Figure 4.4: Interaction of agonist and antagonist with membrane
receptor.
NeurotransmittersMany drugs affect the activity of neuro-
transmitters by altering their synthesis, storage, release, or
deactivation. Neurotransmitters frequently altered by drugs of
abuse:Acetylcholine
CatecholaminesSerotoninGABAEndorphinsAnandamide
Figure 4.6: Synthetic pathway for catecholamine
neurotransmitters.
Major Divisions of the Nervous SystemTwo major components
24. of the nervous system Central nervous system (CNS) Peripheral
nervous system (PNS)
Central Nervous SystemCNS includes the brain and the spinal
cordCNS receives information from PNS, evaluates information,
then regulates muscle and organ activity via PNSReticular
activating systemReceives input from all the sensory systems
and cerebral cortexControls the brain’s state of arousal (sleep
vs. awake)
Central Nervous System (continued)Basal gangliaControls
motor activityLimbic systemRegulates emotional activities,
memory, reward, and endocrine activityIncludes the nucleus
accumbens, such as reward centerDopamine
Central Nervous System (continued)The cerebral cortexHelps
interpret, process, and respond to information; selects
appropriate behavior and suppresses inappropriate behaviorThe
hypothalamusControls endocrine and basic body functions
Central Nervous System Structure
Figure 4.7: Functional components of the central nervous
system.
Peripheral Nervous SystemConsists of input and output
25. nervesInput to brain and spinal cordConveys sensory info (pain,
pressure, temperature)Output: Two typesSomatic (control of
voluntary muscles)Autonomic (control of unconscious
functions)
Autonomic Nervous SystemSympathetic and parasympathetic
systemThese systems work in an antagonistic fashion to control
unconscious, visceral functions such as breathing and
cardiovascular activity Sympathetic
systemNorepinephrineParasympathetic systemAcetylcholine
Autonomic Nervous System Structure
Figure 4.8
Introduction to the Endocrine SystemThe endocrine system
consists of secreting glands (e.g., adrenal, thyroid,
pituitary)These glands produce substances called hormones
(e.g., adrenaline, steroids, insulin, sex hormones)These
substances are information transferring molecules
Introduction to the Endocrine System (continued)Hormones are
secreted into the bloodstream and carried by the blood to all the
organs and tissues of the body.Hormones affect selected tissues
that are designed to receive the information.Hormones may be
highly selective or very general with regard to the cells or
organs they influence.
27. 5. What are the main components of the 1952 Durham
Humphrey Act? How was this law attempting to protect the
public?
6. What are the main purpose and influence of the Kefauver-
Harris Amendment of 1962? How was this law attempting to
protect the public?
7. What is the main purpose of the Comprehensive Drug Abuse
Prevention and Control Act of 1970?
8. List and briefly describe the 5 levels of drug scheduling
under the controlled substances, schedule I-V”
9. What are the 3 main steps in regulating the development of
new pharmaceutical drugs?
10. Define and describe the 2 main drug prevention strategies:
Supply Reduction and Demand Reduction
28. Week Two
Physiology: Chapter 4
Explain the function of each of the following terms:
Neuron- basic structural unit of the nervous system- Draw and
label a neuron
Dendrite
Receptor
Pre-Synaptic
Synapse/synaptic cleft
Post-synaptic
Neuron, cell body
Axon
Terminal
Terminal vesicles
Neurotransmitters
Reuptake
Metabolizing enzymes
Understanding how receptors function:
Agonist
Antagonist
CNS
Brain Stem
Cerebellum
Cerebral Cortex
RAS
Basal Ganglia
Hypothalamus
Limbic System
29. Hypothalamus
PNS
Somatic nervous system
Sensory information neurons-(afferent)
Motor neurons-(efferent) voluntary actions
Autonomic Nervous system (ANS)
Sympathetic
Parasympathetic
Match the terms in the left column to the short definitions in the
right column:
Abstinence
Experimental use
Situational use
Misuse/ Abuse
Dependency
__________________ Obsessive or compulsive drug use
__________________ Drug use in stressful circumstances
_________________Drug use for curiosity or Peer pressure
__________________Drug use causes problems
30. __________________No drug use at all
Chapter 5 – How and why drugs work
Write a short definition in your own words for the following
terms:
1. Threshold Dose
2. Effect/side effect
3. Safety Margin
4. Lethal Dose
5. Potency
6. Toxicity
7. Metabolize/ biotransformation
8. Half Life
9. Tolerance
31. 10. Cross tolerance
11. Adaptive Process: Pharmacodynamic tolerance (Drug
dependence)
12. Withdrawal
13. Synergistic (potentiate) Drug Interaction
14. Antagonistic Drug Interaction
15. Name 2 main symptoms of Physical Dependence
16. Name 2 main symptoms of Psychological Dependence
Method of Description
Onset
Administration (what happens ) (how
32. fast)
oral
snorting
intraveneous
smoking
17. Elimination and Metabolism:
All drugs are metabolized (broken down) by the
_____________(organ of the body).
18. Most metabolites are excreted out of the body through
_______________.
Reflection Paper: Addiction and Theories
Ksir, C., Hart, C., Ray,O. Drugs, Society and Human Behavior,
Twelfth Edition. McGraw Hill Publisher
Read Chapter 2 of the text, note the definitions and the major
theories about how drug use leads to drug abuse/addiction.
33. What is your favorite theory(s) of Addiction?
Why do people become addicted to alcohol, tobacco and other
drugs (ATOD)?
Write a definition of addiction/dependency:
Nature of addiction/dependency – etiology: what happens to a
person who is addicted/dependent on ATOD (See also chapter 1
“Drug Dependence” and “Stages of Drug Dependence”; Chapter
2 “The vicious Cycle of Drug Addiction)
Bio-Psycho-Social Model: write your favorite explanations of
why someone might become addicted to AOD, based on specific
theories in each of the following categories
Biological causes/factors of addiction/dependency
Psychological causes/factors of addiction/dependency
Social causes/factors of addiction/dependency
The Biopsychosocial Approach
(
Biosphere
Society/ Nation
Culture/Subculture
Community
Family
Individual
Nervous System
Organs
34. Tissues
Cells
Molecules
)The biopsychosocial approach was developed at Rochester
decades ago by Drs. George Engel and John Romano. While
traditional biomedical models of clinical medicine focus on
pathophysiology and other biological approaches to disease, the
biopsychosocial approach in our training programs emphasize
the importance of understanding human health and illness in
their fullest contexts. The biopsychosocial approach
systematically considers biological, psychological, and social
factors and their complex interactions in understanding health,
illness, and health care delivery.
• Biological, psychological, and social factors exist along a
continuum of natural systems, as depicted in the list here.
• Systematic consideration of psychological and social factors
requires application of relevant social sciences, just as
consideration of biological factors requires application of
relevant natural sciences. Therefore, both the natural and social
sciences are ‘basic’ to medical practice. In other words,
psychological and social factors are not merely epiphenomena:
they can be understood in scientific ways at their own levels as
well as in regard to their biological correlates.
• Humanistic qualities are highly valued complements to the
biopsychosocial approach, which involves the application of the
scientific method to diverse biological, psychological, and
social phenomena as related to human health.
• While the biomedical approach takes the reductionistic view
that all phenomena are best understood at the lowest level of
natural systems (e.g., cellular or molecular), the
biopsychosocial approach recognizes that different clinical
scenarios may be most usefully understood scientifically at
several levels of the natural systems continuum.
To apply the biopsychosocial approach to clinical practice, the
clinician should:
• Recognize that relationships are central to providing health
35. care
• Use self-awareness as a diagnostic and therapeutic tool
• Elicit the patient’s history in the context of life circumstances
• Decide which aspects of biological, psychological, and social
domains are most important to understanding and promoting the
patient’s health
• Provide multidimensional treatment
The Biopsychosocial Approach
REFERENCES
Engel GL: The need for a new medical model: a challenge for
biomedicine. Science 1977;196:129-136.
Engel GL: The clinical application of the biopsychosocial
model. Am J Psychiatry 1980;137:535-544.
Frankel RM, Quill TE, McDaniel SH (Eds.): The
Biopsychosocial Approach: Past, Present, Future.University of
Rochester Press, Rochester, NY, 2003.
Borrell-Carrió F, Suchman AL, Epstein RM: The
biopsychosocial model 25 years later: principles, practice, and
scientific inquiry. Ann Fam Med 2004;2:576-582.
Cohen J, Brown Clark S: John Romano and George Engel: Their
Lives and Work.University of Rochester Press, Rochester, NY,
and Boydell and Brewer Limited, Suffolk UK, 2010.