The nursing process is a tool that puts knowledge into practice. By utilizing this systematic problem-solving method, nurses can determine the health care needs of an individual and provide personalized….
Medication Research: Marinol (dronabinol)
Identify the trade, brand, and chemical name of your drug and its sponsor (manufacturer).
Explain your group’s rationale for selecting or interest in the drug and the indicated uses for the drug.
Provide a thorough description and explanation for the condition/disease state this drug treats or prevents. How prevalent is this condition in the US? How significant of a health issue? What are the common outcomes this drug prevents or mitigates? Is this drug frequently abused? Is it used off label?
Clinical development: Identify and describe:
The clinical pharmacology of the drug- including a brief description of its molecular mechanism of action (if known), its class or classification, the pharmacodynamics (dosing selection), and a description of the pharmacokinetics- absorption, distribution, metabolism, and elimination.
What types of pre-clinical trials were conducted? Describe any toxicology studies, identification of lethal dose. Reproductive issues? What animals were used in non-clinical studies?
The clinical trials (the design, the doses, the population studied); the clinical, safety, and efficacy endpoints and outcomes. What were the results- the clinical indicators and safety effects? Specific data information is helpful. Tables can be used to compare study endpoints, doses, outcomes, etc.
Summarize and describe the NDA application (identify the sections in the review). What was the timeline for review and approval <link is hidden> how long did it take to get approval? Were expedited pathways used? What was the primary indication for your drug’s regulatory approval- indication for use? What was the population for use- adults, children? What are the pregnancy warnings?
What kind of reviewers (what disciplines/specialties) were involved in reviewing the drug?
Are there any supplements to the original NDA (SNDA)
Is there a generic version of the drug? How does the ANDA differ from the NDA? How many generic versions?
Is there a REMS for this drug? Why? What is it?
What kind of advertising has been used to promote your drug? Print, television, media, radio? Are these ads tailored to the patient, family, caregiver? Do you think these reach their target demographic- why or why not? Does marketing mainly target providers or patients?
Is there a patent for your drug product? Who holds the patent?
Include a description of the label/labeling- identify whether changes have been submitted
What are the side effects are described? What are the warnings on the labeling?
Review the <link is hidden> and search for the name of the manufacturer of your drug. How much has this company spent on marketing to hospitals and physicians in the last year. Download the excel file for this year and using the excel sheet- track their expenses for your drug. Look for the column: name_of_drug_or_biological_or_device_or_medical_supply_1