The Federal Drug Administration (FDA) is the regulatory body that reviews and approves or denies the addition of each new drug submission. The steps for development and marketing new drugs are as follows:

1) Stage 1- Preclinical trials: Discovery and development is the beginning of this phase. Once developed a new drug is tested in vitro or in test tubes and controlled environments outside living organisms or on animals to determine pharmacological activity, therapeutic potential, toxicology, and safety parameters that will become the recommendations for use.  The developing company can file an application for investigational new drug (IND) through the FDA if a therapeutic benefit is discovered to be present. If FDA approves the IND application, the developer can proceed to Clinical Investigation. Stage one generally takes between 1-3 years. 

2) Stage 2- Clinical Investigation: This stage will have at least 3 clinical trials and could take anywhere from 2-10 years. Pediatric and pregnancy testing are not always done in this timeframe. 

a) Clinical Phase I involves testing new compound on relatively small groups of otherwise healthy individuals to determine tolerance, absorption, distribution, metabolism, and excretion of the drug.

b) Clinical Phase II is focused on testing with patients who have a particular disease process to determine safety and effectiveness in these patients who are generally on other medications and may have additional co-morbidities.

c) Clinical Phase III is designed to test drug efficacy when used in specific applications for a targeted group of patients. 

3) Stage 3-Once all phases of clinical trials are completed results are reviewed along with a new drug application (NDA) by the FDA. This process can take anywhere from 2 months to 10 years and the FDA can ask for further information at any point in the process. When it is initially submitted the FDA has 60 days to determine if the NDA meets requirements to be considered for review at all. 

4) Stage 4- Post-marketing studies continue monitoring after the drug has hit the market. This is where processes like adverse reaction reporting can play a role in the further use or removal from the market for new drugs. (Woo and Robinson, 2016)

Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles and is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older. The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The increased effectiveness has not displayed additional side effects other than what is typical with many vaccines. Adverse effects associated with the use of Shingrix may include, but are not limited to, the following: pain, redness or swelling at injection site, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms. Increased effectiveness for a larger number of patients without additional adverse effects indicates that this is a good drug and approval was appropriate.

Shingrix (Zoster Vaccine Recombinant, Adjuvanted). (n.d.)., Federal Drug Administration, Retrieved January 22, 2018, from http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100232/shingrix-zoster-vaccine-recombinant-adjuvanted-

Woo, T. M., & Robinson, M. V. (2016). Pharmacotherapeutics for advanced practice nurse prescribers (4th ed.). Philadelphia, PA: F.A. Davis.

Reflect on Florida’s current health education programs such as Zika Free Florida, Tobacco Free Florida and consider what part the media plays in such disease prevention programs. Identify a specific public health issue that you believe needs to be highlighted in health policy and based on your textbook readings discuss how social media can be used as a health promotion tool to improve public awareness on the selected topic.

posts must be minimum 250 words, references must be cited in APA format, and must include minimum of 2 scholarly resources published within the past 5-7 years.

As their names imply, the honeyguide bird and the honey badger both share an affinity for honey. Honeyguide birds specialize in finding beehives but struggle to access the honey within. Honey badgers are well-equipped to raid beehives but cannot always find them. However, these two honey-loving species have learned to collaborate on an effective means to meet their objectives. The honeyguide bird guides honey badgers to newly discovered hives. Once the honey badger has ransacked the hive, the honey guide bird safely enters to enjoy the leftover honey.

Much like honeyguide birds and honey badgers, nurses and health professionals from other specialty areas can—and should—collaborate to design effective programs. Nurses bring specialties to the table that make them natural partners to professionals with different specialties. When nurses take the requisite leadership in becoming involved throughout the healthcare system, these partnerships can better design and deliver highly effective programs that meet objectives.

In this Assignment, you will practice this type of leadership by advocating for a healthcare program. Equally as important, you will advocate for a collaborative role of the nurse in the design and implementation of this program. To do this, assume you are preparing to be interviewed by a professional organization/publication regarding your thoughts on the role of the nurse in the design and implementation of new healthcare programs.

To Prepare:

• Review the Resources and reflect on your thinking regarding the role of the nurse in the design and implementation of new healthcare programs. 
• Select a healthcare program within your practice and consider the design and implementation of this program.
• Reflect on advocacy efforts and the role of the nurse in relation to healthcare program design and implementation. 

The Assignment: (3 pages)

In a 3-page paper, create an interview transcript of your responses to the following interview questions:

• Tell us about a healthcare program, within your practice. What are the costs and projected outcomes of this program?
• Who is your target population?
• What is the role of the nurse in providing input for the design of this healthcare program? Can you provide examples?
• What is your role as an advocate for your target population for this healthcare program? Do you have input into design decisions? How else do you impact design?
• What is the role of the nurse in healthcare program implementation? How does this role vary between design and implementation of healthcare programs? Can you provide examples?
• Who are the members of a healthcare team that you believe are most needed to implement a program? Can you explain why?

Explore the technology systems offered by Nanthealth, a provider of “telehealth” and health management services via the following link:

http://nanthealth.com/

Prepare a brief (8-10 slides) PowerPoint presentation in which you do the following:

1. Identify at least two technology innovations to connect patients, providers, and insurers across the care continuum.
2. Describe how the technologies work to provide patients and providers with data necessary for health care decision making.
3. Discuss how the real-time data encourages outcome-focused planning.
4. Predict what impact the technology will have on future health care delivery. Provide rationale and examples.

Presentations must include speakers’ notes on each slide, as well as references for the presentation. A minimum of three academic references from credible sources are required for this assignment. The slide count (8-10 slides) does not include the introduction and References slide(s).

Prepare this assignment according to the APA guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.

You are required to submit this assignment to LopesWrite. Refer to the LopesWrite Technical Support articles for assistance.