Reading 6 & 7 - Federal Acts

Question 1

New pregnancy categories:

Answer 1

-Pregnancy
-Lactation
-Females and Males Reproduction

Question 2

Category B Pregnancy risk

Answer 2

Studies in ANIMALS show no risk

Question 3

Pregnancy Category C

Answer 3

Studies on animals show potential risk
OR
no studies have been conducted

Question 4

Pregnancy Category D

Answer 4

There is evidence of risk to a human fetus bassed on human studies. Weigh risk vs benefit

Question 5

Category X

Answer 5

CONTRAINDICATED
risk outweighs the benefit

Question 6

How can inspect without a warrant in Indiana?

Answer 6

Indiana BoP

Question 7

FDA inspections include:

Answer 7

Manufacturers or compounding of drugs and they MUST show a FDA form 482

Question 8

DEA inspections:

Answer 8

Can request Copy records of CS
Inventory
Storage

MUST show Notice of inspection or DEA form 82

Question 9

What type of warrant is higher threshold for probable cause and involves higher level of evidence?

Answer 9

Search warrant

Question 10

Orange Book

Answer 10

Provides equivalency ratings for pharmaceutical equivalence and therapeutic equivalence

NOT therapeutic substitutions or pharmaceutical alternatives

Question 11

Therapeutic Equivalence A

Answer 11

They are bioequivalent and can be substituted

Question 12

Purple Book

Answer 12

Interchangeable Biological products

Question 13

What is the first step in the new drug approval process?

Answer 13

Submit a Investigational New Drug application (IND) - asking the FDA if they can do a HUMAN clinical trial

Question 14

Phase 1 trials

Answer 14

First introduction into humans === focusing on the safety of the medication
< 100 people

Question 15

Phase 2 trial

Answer 15

First introduction to the disease state === focus on the efficacy
< 1000 people

Question 16

Phase 3 trial

Answer 16

Gathering additional info about risk vs benefit
largest # of patients

Question 17

What is the 2nd application of the new drug approval process to ask the FDA if a drug can enter the market?

Answer 17

New Drug Application (NDA)

Question 18

In order to fill out a ANDA, the drug must be:

Answer 18

therapeutically equivalent
-same strength
-same active ingredient
-same dosage form

Question 19

Risk Evaluation and Mitigation Strategy is included in:

Answer 19

REMS
included in the LABELING

Question 20

The purpose of REMS:

Answer 20

ensure the benefits exceed the risks === SAFETY ==== decrease the risk not stop all risk

***required by the FDA

Question 21

4 different types of REMS

Answer 21

1. patient friendly labeling (MedGuide or PPI)
2. communication of plans by physician or pharmacist
3. Elements to Assure Safe Use (ETASU) === required activites in order to receive the product… evaluates PRIOR to use
4. Implementation system (certification of physicians, frequent monitoring)… applies to both patients and providers

Question 22

A patient must take a pregnancy test before staring a medication. What type of REMS is this?

Answer 22

Elements to Assure Safe Use (ETASU)

Question 23

A patient must obtain LFT labs while on a medication to ensure its safety. What type of REMS is this?

Answer 23

Implementation System

Question 24

PDMA

Answer 24

Prescription Drug Marketing Act designed to protect public health by setting standards for distribution

Question 25

The 3 main parts of the PDMA:

Answer 25

1. Reimportation 2. Preferential Pricing 3. Coupons

Question 26

2 ways to reimport drugs legally:

Answer 26

1. manufacturer may shift drug supply to sell in the US when they realize there is no profit gain 2. emergency use (drug shortage)

Question 27

What is preferential pricing?

Answer 27

bans the sale of a prescription purchased at a reduced hospital or charity price

Question 28

A hospital sells a drug to a retail pharmacy for a profit. What act of the law is this breaking? What component of the act?

Answer 28

Prescription Drug and Marketing Act Preferential Pricing

Question 29

What is the coupon component of the PDMA?

Answer 29

Prohibits the sale while using counterfeit coupons. Requires practitioners to ask for drug samples Prohibits retail pharmacies from having coupons Requires recordkeeping of drug samples for 3 years

Question 30

If you provide information on someone violating the PDMA leading to conviction, what is your reward?

Answer 30

1/2 of the criminal fine is yours but not more than $125,000

Question 31

What Act makes it illegal to conspire to tamper with products or communicating false information that a product was tainted?

Answer 31

Federal Anti-Tampering Act products MUST have: -one or more barriers -distinctive packaging difficult to reproduce -ability to remain intact during handling

Question 32

What procautions to we have now to help us identify when an OTC product has been tampered with?

Answer 32

Sealed cartons Breakable caps Container mouth seals Blister packs

Question 33

Tamper-evident packaging is required for what type of drugs?

Answer 33

OTC drug products that are directly available to the patients

Question 34

What is additional requirement for capsule OTC products to protect against tampering?

Answer 34

SEALED capsules or must use two or more tamper-evident packaging if it cannot be sealed

Question 35

What are the labeling requirements designed from the Federal Anti- Tampering Act?

Answer 35

Packages MUST have a prominently placed statement on the package identifying all the tamper-evident features ***can apply for exemption

Question 36

If an OTC product does not have any barriers to entry and no exemption to the Federal Anti-Tampering Act, we must assume the product is:

Answer 36

Adulterated

Question 37

What OTC products does the FDA not approve?

Answer 37

Dietary Supplements

Question 38

What is required on the labeling of all dietary supplements? What is prohibited on the labeling?

Answer 38

REQUIERED: "Product not evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease" PROHIBITED: - cannot make any claims about a disease

Question 39

Dietary supplements requirements for notifying the FDA:

Answer 39

Must notify the FDA within 30 days of 1st marketing If they have claims on the product, must provide evidence to support

Question 40

What claims can a dietary supplement legally say:

Answer 40

- benefit to classical nutrient deficiency (scurvy, pellagra) and discloses the prevalence - describes the role of affecting the structure or function in humans - mechanism of action to such structure or function - describes wellbeing of consumption

Question 41

Where does the burden of proof fall on when it comes to dietary supplement claims?

Answer 41

FDA

Question 42

What act deals with security and privacy of protected health information?

Answer 42

Health Insurance Portability and Accountability Act (HIPAA)

Question 43

What "covered entities" are required to deal with protected health information (PHI)?

Answer 43

Insurance providers healthcare providers anyone that conducts financial or administrative transactions electronically

Question 44

What is considered PHI?

Answer 44

Protected Health Information - relates to past, present, or future physical or mental health AND payment for the provision of care to the individual - health information that can identify the patient EX: name, address, health plan #, medical record #, prescription, payment records

Question 45

When can you disclose PHI?

Answer 45

TPO - Treatment - Payment - Operation (quality assessments, fruad, audits, etc.) Others: - Directly to the patient or patient representative - public health officers - law enforcement in certain situations - BoP

Question 46

When a PHI breach happens, who needs to be notified?

Answer 46

PATIENT within 60 days