Reading 6 & 7 - Federal Acts Flashcards
New pregnancy categories:
-Pregnancy
-Lactation
-Females and Males Reproduction
Category B Pregnancy risk
Studies in ANIMALS show no risk
Pregnancy Category C
Studies on animals show potential risk
OR
no studies have been conducted
Pregnancy Category D
There is evidence of risk to a human fetus bassed on human studies. Weigh risk vs benefit
Category X
CONTRAINDICATED
risk outweighs the benefit
How can inspect without a warrant in Indiana?
Indiana BoP
FDA inspections include:
Manufacturers or compounding of drugs and they MUST show a FDA form 482
DEA inspections:
Can request Copy records of CS
Inventory
Storage
MUST show Notice of inspection or DEA form 82
What type of warrant is higher threshold for probable cause and involves higher level of evidence?
Search warrant
Orange Book
Provides equivalency ratings for pharmaceutical equivalence and therapeutic equivalence
NOT therapeutic substitutions or pharmaceutical alternatives
Therapeutic Equivalence A
They are bioequivalent and can be substituted
Purple Book
Interchangeable Biological products
What is the first step in the new drug approval process?
Submit a Investigational New Drug application (IND) - asking the FDA if they can do a HUMAN clinical trial
Phase 1 trials
First introduction into humans === focusing on the safety of the medication
< 100 people
Phase 2 trial
First introduction to the disease state === focus on the efficacy
< 1000 people
Phase 3 trial
Gathering additional info about risk vs benefit
largest # of patients
What is the 2nd application of the new drug approval process to ask the FDA if a drug can enter the market?
New Drug Application (NDA)
In order to fill out a ANDA, the drug must be:
therapeutically equivalent
-same strength
-same active ingredient
-same dosage form
Risk Evaluation and Mitigation Strategy is included in:
REMS
included in the LABELING
The purpose of REMS:
ensure the benefits exceed the risks === SAFETY ==== decrease the risk not stop all risk
***required by the FDA
4 different types of REMS
- patient friendly labeling (MedGuide or PPI)
- communication of plans by physician or pharmacist
- Elements to Assure Safe Use (ETASU) === required activites in order to receive the product… evaluates PRIOR to use
- Implementation system (certification of physicians, frequent monitoring)… applies to both patients and providers
A patient must take a pregnancy test before staring a medication. What type of REMS is this?
Elements to Assure Safe Use (ETASU)
A patient must obtain LFT labs while on a medication to ensure its safety. What type of REMS is this?
Implementation System
PDMA
Prescription Drug Marketing Act designed to protect public health by setting standards for distribution
The 3 main parts of the PDMA:
- Reimportation
- Preferential Pricing
- Coupons
2 ways to reimport drugs legally:
- manufacturer may shift drug supply to sell in the US when they realize there is no profit gain
- emergency use (drug shortage)
What is preferential pricing?
bans the sale of a prescription purchased at a reduced hospital or charity price
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?
Prescription Drug and Marketing Act
Preferential Pricing
What is the coupon component of the PDMA?
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
If you provide information on someone violating the PDMA leading to conviction, what is your reward?
1/2 of the criminal fine is yours but not more than $125,000
What Act makes it illegal to conspire to tamper with products or communicating false information that a product was tainted?
Federal Anti-Tampering Act
products MUST have:
-one or more barriers
-distinctive packaging difficult to reproduce
-ability to remain intact during handling
What procautions to we have now to help us identify when an OTC product has been tampered with?
Sealed cartons
Breakable caps
Container mouth seals
Blister packs
Tamper-evident packaging is required for what type of drugs?
OTC drug products that are directly available to the patients
What is additional requirement for capsule OTC products to protect against tampering?
SEALED capsules
or
must use two or more tamper-evident packaging if it cannot be sealed
What are the labeling requirements designed from the Federal Anti- Tampering Act?
Packages MUST have a prominently placed statement on the package identifying all the tamper-evident features
***can apply for exemption
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:
Adulterated
What OTC products does the FDA not approve?
Dietary Supplements
What is required on the labeling of all dietary supplements? What is prohibited on the labeling?
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
Dietary supplements requirements for notifying the FDA:
Must notify the FDA within 30 days of 1st marketing
If they have claims on the product, must provide evidence to support
What claims can a dietary supplement legally say:
- 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
Where does the burden of proof fall on when it comes to dietary supplement claims?
FDA
What act deals with security and privacy of protected health information?
Health Insurance Portability and Accountability Act (HIPAA)
What “covered entities” are required to deal with protected health information (PHI)?
Insurance providers
healthcare providers
anyone that conducts financial or administrative transactions electronically
What is considered PHI?
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
When can you disclose PHI?
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
When a PHI breach happens, who needs to be notified?
PATIENT within 60 days
