MHAFP5032 Capella University Policy and Pharmaceutical Regulation Essay Assignment

MHAFP5032 Capella University Policy and Pharmaceutical Regulation Essay Assignment

MHAFP5032 Capella University Policy and Pharmaceutical Regulation Essay Assignment

Question Description
PREPARATION
Use the Capella University Library and the Internet to prepare for this assessment. Include the following activities as part of your preparation:

In addition to reading the suggested articles listed in the Resources, perform a Web search for “oral testimony tips” to compare and contrast suggestions from more than one type of advocacy group.
Visit the Archives and view three or four recorded oral testimonies.
POWERPOINT PRESENTATION
Condense your written testimony into a 5-minute-long recorded oral presentation. Create a 3–5-slide PowerPoint to present a structure to guide your recording. Follow this structure for your presentation:

Introductory remarks: Includes acknowledgement of committee chair and members, your credentials as the person preparing the testimony, and the organization you are representing.
Background: Brief statement regarding justification for the proposed policy.
Specific aspect of the issue: Summarize key points of the desired outcomes from the proposed policy with cited references. Provide a summary of current interventions for your specific issue and why additional action is needed.
Recommendations: Provide specific recommendations for the committee and those being implemented by the special interest group.
Concluding statement: One or two sentences summarizing why the committee should consider your proposed policy.
Closing: Thank the committee for the opportunity and note your availability for additional discussion or questions.

ADDITIONAL REQUIREMENTS
Number of slides: Approximately 3–5 (length should correspond with, and not exceed, content that would amount to five minutes of oral testimony).
Slide design: Use the notes section for your speaker notes. The slide design must meet the expectations of a professional presentation (bullet points, large font size, plenty of white space).
Oral communication: Use persuasive oral presentation techniques such as staying on topic, integrating your slides with your presentation, and staying within the time allotment.

This is what needs to be on the PowerPoint Presentation:

Introduction

A special acknowledgement the committee chairperson who happens to be the president and founder of Patients for Affordable Drugs, I also acknowledge the members of the committee who are boards members of the organization. This testimony has been prepared by the director of Patients for Affordable Drugs.

Background

Processes followed by pharmaceutical companies in the US are not made known to the public, and the patients have been at a disadvantage owing to the skyrocketed prices. The current pricing policy I place makes an allowance for the manufactures as there are no strict regulations that dictate the way pricing decisions are made. In addition, brand-named products are facing no significant competition in the market, owing to the stringent approval policies of generic drugs. As of now, the FDA has in place a rigorous metric array which gauges the standards and market-worthiness of any generic drugs.

Moreover, the approval process takes time that is if a generic drug will be accepted by the FDA. All these factors bars competition in the market hence the continuous increase of drug prices in the country. The desired health policy change is centered on loosening the strictness of the FDA in terms of the generic drugs approval process. Realizing this change will mean that new generic drugs will be easily approved, though complying with all required standards. Competition in the market will be stirred as patients will have alternatives to highly priced brand-name drugs. In response, pharmaceutical companies will be forced to standardize their drugs prices to remain competitive in the market.

Specific Aspect of the Issue

The rigorous review process used by the FDA makes it difficult for new generic drug entrants to be approved. Patents also give pharmaceutical companies market exclusivity for a considerable period, a period in which these companies take advantage and come up with outrageous prices considering they have zero competition. A specific aspect to be zoomed in and addressed is the FDA’s process of reviewing generic drugs applications. The FDA ought to review its policies with respect to reviewing generic drugs but must also ensure integrity and quality of these products. It comes down to developing efficiency of this process.

Reducing the time taken for a generic product to be approved and reducing the market exclusivity period given to brand name drugs. Though the exclusivity time given to these drugs is attributed to the intensive investment made by the pharmaceutical company over a long period of time so as to manufacture the drug, it is integral to consider that the government partly or fully finances medical research, and the development of new drugs is at times courtesy of the taxpayers money. On this account, pharmaceutical companies whose researches on drugs were financed by the government ought not to be given a long exclusivity period, but rather, the drugs ought to be sold to the public at low rates. In any case the price remains to be substantially high, the FDA should embrace leniency in reviewing generic products that are to the required standard.

Current programs and Outcomes

In the recent past, other interest groups have been advocating for reduced prescription drug prices in the country. For example, earlier in the year, some of the states embraced change in policies that now require pharmaceutical companies to be transparent to the government and the public regarding their drug pricing process. Some of the states that first approved this legislation are Connecticut and Maryland. In the state of Connecticut, an interest group by the name Universal Health Care Foundation of Connecticut was pivotal in creating advocacy for the transparency legislation. As a result, insures are required to give reports to the state insurance department, elaborating on drugs prices through insure rate review procedure.

In Maryland, Maryland Citizen’s Health Initiative significantly contributed to the approval of the transparency policy whereby pharmaceutical companies are to elaborate the rationale for list prices of drugs. Outcomes associated with the approval of these legislations are promising, as this has brought a sense of pharmaceutical companies being accountable to the state governments and the general public, getting rid of the opacity of the pricing process. In the long run, unreasonable drug prices will be challenged if the rationale behind pricing process is not justifiable. A decrease in drug prices, on account of these new policies, is anticipated, making it easier for patients to access quality prescription drugs.

Recommendations

To further moderate prescription drug prices, the FDA should accelerate its generic drugs approval process so that new entrants can easily create competition in the drug market. The authority also ought to set up regulatory measures to regulate pricing of drugs depending on the authenticity of pricing rationale given by the manufactures. Policymakers both at the state and federal levels should give ear to interest groups, constantly review policies governing health care products and services to ensure quality, service delivery and affordability of these products as offered to the general public.

Conclusion

It is undebatable that U.S. currently has the highest rates on prescription drugs across the globe, making it hard for all citizens to afford the drugs, some at the expense of their lives. One of the possible solutions is to this issue is creating competition in the market. A strategy that can be implemented towards enhancing competition in the drugs market is an accelerated approval process of generic drugs by the FDA. I would like to express my gratitude to the committee for the opportunity to take part in this discussion.

References

Our Team | Patients For Affordable Drugs. (2018). Retrieved from http://www.patientsforaffordabledrugs.org/about/our-team/

McAndrew, C. (2018). 2018 State Legislation on High and Rising Drug Prices. Retrieved from https://familiesusa.org/product/2018-state-legislation-high-and-rising-drug-prices

Gudiksen, K. (2018). Spotlight on 2018 State Drug Legislation: Part 5 – Pricing Transparency Laws – The Source on HealthCare Price and Competition. Retrieved from http://sourceonhealthcare.org/spotlight-on-2018-state-drug-legislation-part-5-pricing-transparency-laws/

Longest, B. B., Jr. (2016). Health policymaking in the United States (6th ed.). Chicago, IL: Health Administration Press. Available from the Bookstore

Pharmaceutical Regulation. (2018). Retrieved from http://ushealthpolicygateway.com/vii-key-policy-issues-regulation-and-reform/l-health-care-regulation/pharmaceutical-regulation/

 

You must proofread your paper. But do not strictly rely on your computer’s spell-checker and grammar-checker; failure to do so indicates a lack of effort on your part and you can expect your grade to suffer accordingly. Papers with numerous misspelled words and grammatical mistakes will be penalized. Read over your paper – in silence and then aloud – before handing it in and make corrections as necessary. Often it is advantageous to have a friend proofread your paper for obvious errors. Handwritten corrections are preferable to uncorrected mistakes.

Use a standard 10 to 12 point (10 to 12 characters per inch) typeface. Smaller or compressed type and papers with small margins or single-spacing are hard to read. It is better to let your essay run over the recommended number of pages than to try to compress it into fewer pages.

Likewise, large type, large margins, large indentations, triple-spacing, increased leading (space between lines), increased kerning (space between letters), and any other such attempts at “padding” to increase the length of a paper are unacceptable, wasteful of trees, and will not fool your professor.

The paper must be neatly formatted, double-spaced with a one-inch margin on the top, bottom, and sides of each page. When submitting hard copy, be sure to use white paper and print out using dark ink. If it is hard to read your essay, it will also be hard to follow your argument.

ADDITIONAL INSTRUCTIONS FOR THE CLASS

Discussion Questions (DQ)

Initial responses to the DQ should address all components of the questions asked, include a minimum of one scholarly source, and be at least 250 words.
Successful responses are substantive (i.e., add something new to the discussion, engage others in the discussion, well-developed idea) and include at least one scholarly source.
One or two sentence responses, simple statements of agreement or “good post,” and responses that are off-topic will not count as substantive. Substantive responses should be at least 150 words.
I encourage you to incorporate the readings from the week (as applicable) into your responses.
Weekly Participation

Your initial responses to the mandatory DQ do not count toward participation and are graded separately.
In addition to the DQ responses, you must post at least one reply to peers (or me) on three separate days, for a total of three replies.
Participation posts do not require a scholarly source/citation (unless you cite someone else’s work).
Part of your weekly participation includes viewing the weekly announcement and attesting to watching it in the comments. These announcements are made to ensure you understand everything that is due during the week.
APA Format and Writing Quality

Familiarize yourself with APA format and practice using it correctly. It is used for most writing assignments for your degree. Visit the Writing Center in the Student Success Center, under the Resources tab in LoudCloud for APA paper templates, citation examples, tips, etc. Points will be deducted for poor use of APA format or absence of APA format (if required).
Cite all sources of information! When in doubt, cite the source. Paraphrasing also requires a citation.
I highly recommend using the APA Publication Manual, 6th edition.
Use of Direct Quotes

I discourage overutilization of direct quotes in DQs and assignments at the Masters’ level and deduct points accordingly.
As Masters’ level students, it is important that you be able to critically analyze and interpret information from journal articles and other resources. Simply restating someone else’s words does not demonstrate an understanding of the content or critical analysis of the content.
It is best to paraphrase content and cite your source.
LopesWrite Policy

For assignments that need to be submitted to LopesWrite, please be sure you have received your report and Similarity Index (SI) percentage BEFORE you do a “final submit” to me.
Once you have received your report, please review it. This report will show you grammatical, punctuation, and spelling errors that can easily be fixed. Take the extra few minutes to review instead of getting counted off for these mistakes.
Review your similarities. Did you forget to cite something? Did you not paraphrase well enough? Is your paper made up of someone else’s thoughts more than your own?
Visit the Writing Center in the Student Success Center, under the Resources tab in LoudCloud for tips on improving your paper and SI score.
Late Policy

The university’s policy on late assignments is 10% penalty PER DAY LATE. This also applies to late DQ replies.
Please communicate with me if you anticipate having to submit an assignment late. I am happy to be flexible, with advance notice. We may be able to work out an extension based on extenuating circumstances.
If you do not communicate with me before submitting an assignment late, the GCU late policy will be in effect.
I do not accept assignments that are two or more weeks late unless we have worked out an extension.
As per policy, no assignments are accepted after the last day of class. Any assignment submitted after midnight on the last day of class will not be accepted for grading.
Communication

Communication is so very important. There are multiple ways to communicate with me:
Questions to Instructor Forum: This is a great place to ask course content or assignment questions. If you have a question, there is a good chance one of your peers does as well. This is a public forum for the class.
Individual Forum: This is a private forum to ask me questions or send me messages. This will be checked at least once every 24 hours.