Reading 7 Flashcards
What is an Inspection?
- “Check Up” that happens for two reason:
- Routine Inspection OR
- Suspicion
Inspected by FDA, DEA, BoP
What inspection does the FDA do?
- Really only look at the places that make the drugs or devices
- Could refuse them but thats a little sus
What inspection does the DEA do?
- Inspect anywhere controlls are kept
- MUST state why, show credentials, & notice of inspection
- Could be refuse but WILL come back with a warrent
What are the rights that the pharmacist has during Notice of Inspection?
- Require a Warrent
- Refuseal [will trigger to get a warrent]
- Anything incriminating will be used againts you
- Get a Copy of the notice
- Withdrawl consent [will trigger to get a warrent]
What are the two types of warrents that can be obtained?
- Administrative Inspection Warrent
- Search Warrent
What is important to know about an Administrative Inspection Warrent?
- Anything of interset could lead to one [VERY broad]
- During business hours
What is important to know about a Search Warrent?
- Must convince a judge that a crime has been committed
- Anytime, even closed
What inspections does the Borad of Pharmacy do?
- CANT BE REFUSED and DONT NEED NO WARRENT
What is the Orange Book?
- Provides equivalency rating for different products
- Helps determine Generic Equivalency
What is the Purple Book?
- Helps with Biological Interchange
What information does the Orange and Purple books provide?
- Shows equivalent Generic/Biologic compared to Prescribed
What products can be substiuted and how are they noted in the Orange Book/
- Must be both Pharmacutical & Therapeutic equivant
- Noted by a RLD rating system
What is the Reference Listed Drug [RLD]?
- Listed drug by the FDA that is seeking approval from the ANDA
What is the two letter rating system that the FDA has for therapeutic equivalence?
- A: ARE bioequivalant
- B: NOT bioequivalant
What are Preclinical Investigations?
- Seeing how good the drug is
- IN INVITRO: not testing on living
- IN VIVO testing on animals
What is a new drug application used for, and what are the components of the approval?
- IND: Company applies for marketing new drug
- Must submit to FDA and wait 30 days then they can do their clinical trials
What is important to know about the Phase 0 or Early Phase 1 Clincial Trails?
- Basically are low doses to help adjust the drug for the main test
What is important to know about Phase 1 Clinical Trails?
- REAL test in Healthy Volunteers
- Shows MOA, Metabolism, Safety
- <100 Patients
What is important to know about Phase 2 Clinical Trials?
- Test with diseases
- Shows side effects, safety, risks
What is important to know about Phase 3 Clinical Trials?
- Basically the same as Phase 2, just more indepth effectiveness data
What is a New Drug Application/
- Application sent to FDA to approve for marketing
- FDA has 6 to 10 months to approve
What is imporant to know about Phase 4 Trials?
- “Post-market Surveillance”
How do supplemental and abbreviated new drug application differ from new drug applications?
- Supplemental: Manufacturer CANNOT change anything about the drug
- Abbreviated: Want to approve therapeutic equivance
What are the requirements for Nonprescription drug approval?
- Direct-to-Nonprescription: NDA to make it OTC
- Prescription-to-Nonprescription: Decide what to make it; then give NDA
What happens if the FDA does not meet the required timelinfe for approval?
- Company can sue the FDA, but that could further the approval
- Most of the time the company will just try to give the FDA more info
What are REMS?
- Risk Evalution and Mitigation Strategy
- Manage serious risk with the drug
Why are REMS used, who makes them, and who approves them?
- FDA MAKES manufacturer make REMS
- REMS show benefits outwieghts risks
- FDA APPROVES REMS
What is important to know about Patient Friendly Labeling in REMS?
- Shows information about the drug or drug class
What is important to know about Communication Plans in REMS?
- Information giving To doctors about the risks
What is important to know about Elements to Assure Safe Use in REMS?
- Done before giving, dispensing, receiving meds
- REQUIRED by doctors [labs, evals, pharmacies [Lab values], patients [Tests, Surveys]
What is important to know about the Implementation System in REMS?
- Measures quality assurance
What are the general requirement of Advertising to Professionals?
- Must have generic name, ingredents, ADRs, contraindications, effectiveness
- CANNOT be misleading
