Please conduct a literature search on the new FDA regulations dealing with REMS (Risk Evaluation and Mitigation Strategy).
Scenario: You are the makers of a new pain medication (Relaxicam) which is a controlled substance (CII). The FDA has asked you to develop a REMS program to assure the benefits of the drug outweigh the risks of abuse and misuse.
Write 500 words summary of the elements that you would include and how would you launch the program into the marketplace.
No plagiarism no bullet points please
Introduction:REMS is a drug safety programme that FDA requires for some drugs with serious adverse effects.Chronic pain of vertebral disc prolapse hass a very irritating nagging and threatening effect both on the body and the soul. Use of non steroidal anti inflammatory medications NSAID have some serious adverse effects such as acute gastritis, bone marrow depression peptic perforation etc. Also the drugs like GABA ,extended release and long acting Opiod analgesics fall in the same category. So research work for introduction of drug which can outweigh the adverse effects for the benefit is necessary.
The literature search in the above case can be done by choosing the words
"REMS,' "NSAID 'opioid and FDA,"FDA approval of extended release and long acting Opiod analgesics " "Drugs in the vertebral disc prolapse and FDA" can be given in Medline search or Science direct or in Google.
Please conduct a literature search on the new FDA regulations dealing with REMS (Risk Evaluation and...
Develop a REMS (Risk Evaluation and Mitigation Strategy). for a new pain medication which is a controlled substance (CII). make sure that the benefits of the drug outweigh the risks of abuse and misuse. Include how would you launch the program into the marketplace. 500 words no plagiarism please
No plagiarism or bullet points please Conduct a literature search on the topic "patient compliance" (patient adherence). Write a one page summary of the factors that contribute to poor patient compliance and develop several strategies that you believe will improve medication compliance by patients. How would set out to study the benefits of a new educational intervention on improving medication taking for depression patients? What type of study design? Outcome measures?
Please help edit and ADD to the provided Literature Review Outline. If you use anything from another source be sure to include the citation and reference at the end. Literature Review Outline According to the Center of Disease Control (CDC) by improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the risk of opioid use disorder, overdose, and death. More than 11.5 million Americans, aged...