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MPJE > Reading 6 & 7 - Federal Acts > Flashcards

Reading 6 & 7 - Federal Acts Flashcards

1
Q

New pregnancy categories:

A

-Pregnancy
-Lactation
-Females and Males Reproduction

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2
Q

Category B Pregnancy risk

A

Studies in ANIMALS show no risk

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3
Q

Pregnancy Category C

A

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

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4
Q

Pregnancy Category D

A

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

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5
Q

Category X

A

CONTRAINDICATED
risk outweighs the benefit

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6
Q

How can inspect without a warrant in Indiana?

A

Indiana BoP

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7
Q

FDA inspections include:

A

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

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8
Q

DEA inspections:

A

Can request Copy records of CS
Inventory
Storage

MUST show Notice of inspection or DEA form 82

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9
Q

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

A

Search warrant

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10
Q

Orange Book

A

Provides equivalency ratings for pharmaceutical equivalence and therapeutic equivalence

NOT therapeutic substitutions or pharmaceutical alternatives

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11
Q

Therapeutic Equivalence A

A

They are bioequivalent and can be substituted

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12
Q

Purple Book

A

Interchangeable Biological products

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13
Q

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

A

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

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14
Q

Phase 1 trials

A

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

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15
Q

Phase 2 trial

A

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

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16
Q

Phase 3 trial

A

Gathering additional info about risk vs benefit
largest # of patients

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17
Q

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

A

New Drug Application (NDA)

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18
Q

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

A

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

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19
Q

Risk Evaluation and Mitigation Strategy is included in:

A

REMS
included in the LABELING

20
Q

The purpose of REMS:

A

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

***required by the FDA

21
Q

4 different types of REMS

A
  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
22
Q

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

A

Elements to Assure Safe Use (ETASU)

23
Q

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

A

Implementation System

24
Q

PDMA

A

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

25
Q

The 3 main parts of the PDMA:

A
  1. Reimportation
  2. Preferential Pricing
  3. Coupons
26
Q

2 ways to reimport drugs legally:

A
  1. manufacturer may shift drug supply to sell in the US when they realize there is no profit gain
  2. emergency use (drug shortage)
27
Q

What is preferential pricing?

A

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

28
Q

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?

A

Prescription Drug and Marketing Act
Preferential Pricing

29
Q

What is the coupon component of the PDMA?

A

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

30
Q

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

A

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

31
Q

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

A

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

32
Q

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

A

Sealed cartons
Breakable caps
Container mouth seals
Blister packs

33
Q

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

A

OTC drug products that are directly available to the patients

34
Q

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

A

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

35
Q

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

A

Packages MUST have a prominently placed statement on the package identifying all the tamper-evident features

***can apply for exemption

36
Q

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:

A

Adulterated

37
Q

What OTC products does the FDA not approve?

A

Dietary Supplements

38
Q

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

A

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

39
Q

Dietary supplements requirements for notifying the FDA:

A

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

40
Q

What claims can a dietary supplement legally say:

A
  • 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
41
Q

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

A

FDA

42
Q

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

A

Health Insurance Portability and Accountability Act (HIPAA)

43
Q

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

A

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

44
Q

What is considered PHI?

A

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

45
Q

When can you disclose PHI?

A

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

46
Q

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

A

PATIENT within 60 days

MPJE (11 decks)

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