1
Q
What is an Inspection?
A
- “Check Up” that happens for two reason:
- Routine Inspection OR
- Suspicion
Inspected by FDA, DEA, BoP
2
Q
What inspection does the FDA do?
A
- Really only look at the places that make the drugs or devices
- Could refuse them but thats a little sus
Form: FDA 482
3
Q
What inspection does the DEA do?
A
- Inspect anywhere controlls are kept
- MUST state why, show credentials, & notice of inspection
- Could be refuse but WILL come back with a warrent
4
Q
What are the rights that the pharmacist has during Notice of Inspection?
Notice = DEA Form 82
A
- 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]
5
Q
What are the two types of warrents that can be obtained?
A
- Administrative Inspection Warrent
- Search Warrent
6
Q
What is important to know about an Administrative Inspection Warrent?
A
- Anything of interset could lead to one [VERY broad]
- During business hours
7
Q
What is important to know about a Search Warrent?
A
- Must convince a judge that a crime has been committed
- Anytime, even closed
8
Q
What inspections does the Borad of Pharmacy do?
A
- CANT BE REFUSED and DONT NEED NO WARRENT
9
Q
What is the Orange Book?
A
- Provides equivalency rating for different products
- Helps determine Generic Equivalency
10
Q
What is the Purple Book?
A
- Helps with Biological Interchange
11
Q
What information does the Orange and Purple books provide?
A
- Shows equivalent Generic/Biologic compared to Prescribed
12
Q
What products can be substiuted and how are they noted in the Orange Book/
A
- Must be both Pharmacutical & Therapeutic equivant
- Noted by a RLD rating system
13
Q
What is the Reference Listed Drug [RLD]?
A
- Listed drug by the FDA that is seeking approval from the ANDA
- In order to sub they need to have the same active ingredent, dosage form, strength
14
Q
What is the two letter rating system that the FDA has for therapeutic equivalence?
A
- A: ARE bioequivalant
- B: NOT bioequivalant
15
Q
What are Preclinical Investigations?
A
- Seeing how good the drug is and if it is a good candidate
- IN INVITRO: not testing on living
- IN VIVO testing on animals
16
Q
What is a new drug application used for, and what are the components of the approval?
A
- IND: Company applies for marketing new drug that is not safe and effective yet in humans
- Must submit to FDA and wait 30 days then they can do their clinical trials
17
Q
What is important to know about the Phase 0 or Early Phase 1 Clincial Trails?
A
- Basically are low doses to help adjust the drug for the main test
18
Q
What is important to know about Phase 1 Clinical Trails?
A
- REAL test in Healthy Volunteers
- Shows MOA, Metabolism, Safety
- <100 Patients
19
Q
What is important to know about Phase 2 Clinical Trials?
A
- Test in those with the disease and looks at effectiveness & side effect profiles
- ~ 300 to 1000 people
more so effectiveness
20
Q
What is important to know about Phase 3 Clinical Trials?
A
- The same as phase 2 BUT is looking more into the SAFETY & effectiveness
more so safety
21
Q
What is a New Drug Application/
A
- Application sent to FDA to approve for marketing
- FDA has 6 to 10 months to approve (if it takes longer than the company can sue the FDA but that will just delay it more)
22
Q
What is imporant to know about Phase 4 Trials?
A
- “Post-market Surveillance” and is required for most Rx drugs by the FDA
Really just looking for new indications or serious reactions
23
Q
How do supplemental and abbreviated new drug application differ from new drug applications?
A
- Supplemental: Manufacturer CANNOT change anything about the drug once approved, this is the way to make changes
- Abbreviated: Want to approve therapeutic equivance
24
Q
What are the requirements for Nonprescription drug approval?
A
- Direct-to-Nonprescription: NDA to make it OTC
- Prescription-to-Nonprescription: Decide what to make it; then give NDA
25
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**
26
What are REMS?
- Risk Evalution and Mitigation Strategy
- Manage serious risk with the drug
27
Why are REMS used, who makes them, and who approves them?
- FDA **MAKES** manufacturer make REMS
- REMS show **benefits outwieghts risks**
- FDA **APPROVES** REMS
28
What is important to know about Patient Friendly Labeling in REMS?
- Shows information about the drug or drug class (like medguide or patient package inserts)
## Footnote
i.e; SSRIs, NSAIDs, PPIs
29
What is important to know about Communication Plans in REMS?
- Information giving **TO doctors** about the risks; **NOT** to patients
30
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]
31
What is important to know about the Implementation System in REMS?
- Measures quality assurance
32
What are the general requirement of Advertising to Professionals?
- Must have generic name, ingredents, ADRs, contraindications, effectiveness
- **CANNOT** be misleading
33
# Practice Question 1
Which of the following statements is most accurate regarding pregnacny categoris or information?
## Footnote
a. Lactation information must provide a statement of whether the drug is recommended for ise during breastfeeding
b. The updated pregnancy section should provide a clear indication of which pregnancy category the drug fits into
c. Pregnancy category X drugs can be used if there is not other alternatives and the benefit to the morther is large
d. Pregnancy category B drugs are safe for use during pregnancy
e. Drugs that impact fertility should list information in the females and males of reproductive potential section.
- e. Drugs that impact fertility should list information in the females and males of reproductive potential section.
33
# Practice Question 2
Which of the following is true about inspections?
## Footnote
a. A DEA agent can copy sales records during an inspection
b. A pharmacist can deny admittance to and FDA agent with an administrative inspection warrent
c. A State Board Inspector can be denied entry into the pharmacy if they don't have an administrative inspection warrent
d. A pharmacist can revoke premission to inspect from a DEA inspector who provided a notice of inspection
e. Inspectors cannot view any patient information due to HIPAA
d. A pharmacist can revoke premission to inspect from a DEA inspector who provided a notice of inspection
34
# Practice Question 3
Select all of the following situtations requiring a drug manufacturer to go throught the NDA process.
## Footnote
a. Development of a new molecular entity
b. Development of a previously approved drug in a new dosage form
c. Development of a previously approved drug for a new condition
d. Development of a previously approved drug in a new strength
e. Development of two previously approved drugs into a single combination product
- A, B, C, E
35
# Practice Question 4
A presecription drug used by many patients is found to cause serious decreases in neutrophil count, and through proper monitoring, adverse events can be prevented. Which is the most likely REMS to be required for this medication
## Footnote
a. Medication Guide
b. Communication Plan
c. Elements to Assure Safe Use
d. Implementation Systems
e. No REMS is likely to be required
- c. Elements to Assure Safe Use
36
# Practice Question 5
Select all of the following substututable to ProAir HFA if it's reference listed drug.
## Footnote
a. Albuterol HFA with a rating of AA
b. Albuterol ER capsules with a rating of BC
c. Proventil HFA with a rating of BX
d. Ventolin with a rating of B
e. Albuterol liquid with a rating of BS
- a. Albuterol HFA with a rating of AA
PHRM 871: Law
flashcards
Decks in class (19)
# Cards
-
Reading 118
-
Reading 228
-
Reading 330
-
Reading 430
-
Reading 532
-
Reading 626
-
Reading 737
-
Reading 818
-
Reading 921
-
Reading 1033
-
Reading 1118
-
Reading 1228
-
Reading 1323
-
Reading 1419
-
Reading 1531
-
Reading 1628
-
Reading 17/18 (IC 25-26)61
-
Reading 19/20 (IAC)55
-
Reading 21 (IC, IAC 2, IAC 4, IAC 5, IAC 7, Hormonal Contraceptive Prescribing)12
