Discuss how to infiltrate the governing bodies

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Reference no: EM132277869

Create a strategic plan as outlined below.

Strategic Plan-

Compile information into a single document that addresses the following elements:

1. Introduction

2. Background -

Discuss the challenge that oncology clinics currently face with the increased expense of comment based regulations (USP 797 and 800) and the need for evidence based ones. Issue that currently exists is that most community oncology clinics have to adopt USP 800 by Dec 1, 2019 and this will be a huge expense - some clinics will not be able to provide the types of oncology treatments due to this increased cost. If these were evidence based, then the playing field would be more fair and allow for the same standard of care in any therapeutic site.

3. Problem-

Non-evidence based regulations are forcing community oncology clinics to create major changes to their practices based on comments from some of the other treatment arenas and don''t necessarily meet the actual needs for these clinics.

4. Purpose-

To identify evidence based criteria to be used across all oncology sectors to ensure parity amongst all providers and protecting the safety of the patient.

5. Significance of problem or concern

Currently the amount of investment required by the USP 797 and USP 800 regulations is so costly that it could community oncology clinics out of business leaving the hospitals who already comply with these non-evidence based guidance to be the only area a patient can go for treatment. Getting treated in the hospital is always more expensive to the patient, so if evidence based regulations are created and implemented, the community oncology clinics would need to comply. However, today the guidelines may have more rigor that what evidence based regulations would likely have and this would help the community oncology clinics to stay open. (Patients prefer that they get seen in a clinic versus going to the hospital all the time...)

6. Analysis

Create an analysis of pros and cons of each of the non-evidence based (comment-based) and evidence based for each of the stakeholders (Hospitals, Community Oncology Centers, Patients, Manufacturers of the Drugs, and Insurance Companies)

7. Strategic or research plan

Research plan would need to include the Overview of the needs required to provide the level of research for this evidence based criteria, the acquisition of a leader to help deliver the message to the industry after completion of the evidence based information as well as how this could be rolled out to the industry and all relative/potential direct and indirect costs.

8. Plan of action for implementing your problem solution

Discuss how to infiltrate the governing bodies such as the FDA and State Boards of Pharmacy.

9. Defend your conclusion

Discuss the need for evidence based. It is incredibly expensive to implement changes to any practice and they should be evidence based; not based on comments from just industry players. This evidence based look will ensure any changes in oncology practice will be based on the preponderance of the evidence, vs. industry comments and will be much more widely viewed as acceptable to any oncology provider.

10. Timeline associated with the plan of action to implement the solution.

This should be a timeline approach that looks at the acquisition of currently available information in the literature, the acquisition of researchers and a leader in this market, and will probably be a 3-5 year total timeline.

11. Conclusion

Your strategic plan should be no less than 10 pages.

Verified Expert

The report is about evidence-based regulatory framework introduction for oncology treatment as an alternative to Comments based regulatory framework. The report details the strategic plan, research plan and other implementation strategies and concerns. Relative implications to diverse stakeholders also studied in the report. References are given.

Reference no: EM132277869

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