Part A - Research and discuss the process and development of new drugs. Name 2 new drugs and what they are used for. Respond to 2 classmates by adding information to the original postings about your experience with new drugs, or how you feel about the cost of medications.
Part B – Choose one of the following scenarios and discuss the patient’s diagnosis, potential side effects of medications listed and contraindications with other medications and/or foods. Respond to two classmates with ideas for patient education related to side effects and contraindications.
Scenario 1: Patient A has been diagnosed with polymyalgia rheumatica. The physician orders sarilumab 200 mg. injection subcutaneously one dose (following recommended schedule on 1st week, 4th week and then every 12 weeks). Patient is currently taking atorvastatin 10 mg orally daily, losartan 50 mg. orally, daily, and spironolactone 25 mg orally, daily.
Scenario 2: Patient B has been prescribed hydrochlorothiazide 25 mg orally, daily for hypertension. Patient is currently taking Lithium 600 mg orally, twice daily and ibuprofen 200 mg orally, every 8 hours.
Sample Answer
Part A: New Drug Development and Research
The development of a new drug is a high-stakes, multi-year process that transitions from laboratory benches to patient bedsides. Only about 12% of drugs that enter clinical trials eventually receive FDA approval.
The 5 Stages of Drug Development
Discovery and Development: Researchers identify a "target" (like a protein or gene) involved in a disease and search for compounds that can interact with it.
Preclinical Research: Before testing on humans, the drug undergoes in vitro (test tube) and in vivo (animal) testing to assess basic safety and toxicity.
Clinical Research: This is the most critical stage, divided into four phases:
Phase 1: 20–100 healthy volunteers (focus on safety and dosage).
Phase 2: Several hundred people with the condition (focus on efficacy and side effects).
Phase 3: 300–3,000 people (large-scale testing for effectiveness and monitoring of adverse reactions).
Phase 4: Post-market monitoring once the drug is available to the public.
FDA Review: The manufacturer submits a New Drug Application (NDA). FDA experts examine all data to ensure the drug's benefits outweigh its risks.