Chapter 4 - Pharmacy Law and Ethics

Question 0

What is Constitutional Law?

Answer 0

The first 10 amendments(Bill of Rights)

Most Fundamental Rights

Question 1

What are the 4 types of law?

Answer 1

Constitutional
Statues and Regulations
Administrative Rules and Regulations
Legislative intent

Question 2

Statues

Answer 2

Regulations clarify and explain statues.

Passed by the congress and signed by president.

Question 3

State Law and Regulations?

Answer 3

meet federal and state constitution

provides additional rights

Question 4

What is Legislative intent?

Answer 4

the meaning of law

Question 5

What are the 3 categories of law?

Answer 5

Criminal
Civil
Administrative

Question 6

What is criminal law?

Answer 6

provides community protection.

homicide, drugs, theft, and other antisocial behaviors

Question 7

What is Civil Law?

Answer 7

Any law dealing with the rights of private citizens

Question 8

What is Administrative Law?

Answer 8

Administration agencies that enforce laws

Question 9

What are the 6 regulatory agencies for the practice of pharmacy?

Answer 9

Center of Medicare and Medicaid Services- conducts inspections
Drug Enforcement Administration- regulates trade of narcotics
Food and Drug Administration- Ensures safety of Drugs
Joint Commission on Accreditation of healthcare organizations - evaluates and accredits health systems
Occupational Safety and Health Administration- Protects workers
State Boards of Pharmacy- Registers and Regulates Pharmacy

Question 10

What is required by the FDCA for LABELING of prescriptions?

Answer 10

Pharmacy name and address
serial number (Rx number)
Date of fill
Expiration date
Prescriber name
Patients name
directions for use
cautionary statements

Question 11

What are the FDCA requirements for the LABEL of the drugs?

Answer 11

Est. name and quantity of each active ingredients
Statement of new quantity
Statement of usual dosage
Federal legend
Route of administration
in case of habit forming drugs, federal warning
name of all active ingredients
Unique lot or control number
statement specifying the type of container to be used in dispensing
the name and place of business of the manufacturer
expiration date

Question 12

What additional information does the FDCA require?

Answer 12

in the form of a insert:
Description
clinical pharmacology
indications and usage
Contraindications
side effects and potential safety hazard 
Precautions 
adverse reactions
drug abuse and dependence
dosage
statement as how the drug is supplied
date of most recent revision of the labeling

Question 13

What are the 5 classes of controlled classes?

Answer 13

Schedule 1- herion, LSD, marijuana
Schedule 2- Cocaine, Morphine, Ritalin
Schedule 3- Vicodin, Lortab, Tylenol 3, and anabolic steroids
Schedule 4- Valium and Librium
Schedule 5- Lomotil

Question 14

What are the forms need to register with the DEA?

Answer 14

• Form 225 - to manufacturer or distribute
• Form 224 - to dispense
• Form 363 - to compound or conduct a narcotic treatment program
• Initial Registration is granted for a period of 28-39 months, after which the registration period is every 36 months
• receive a unique number (DEA number)

Question 15

What must prescriptions for controlled substances include?

Answer 15

Full name and address of the patient
Name, address, and registry number of the prescriber
date issued
manual signature of the prescriber

Question 16

What are the requirements for prescribing a controlled substance?

Answer 16

Must be written in ink , with a typewriter, or indelible pen
only valid for 7 days after written
date of initial fill
date of refill

Question 17

How can a pharmacy order schedule 1 and 2 drugs ?

Answer 17

complete a triplicate form (DEA form 222)

DEA controlled substance ordering system (CSOS) electronically

Question 18

What are the record keeping requirements ?

Answer 18

on hand inventory
Biennial inventory
DEA requires exact quantities of schedule 1&2
estimate quantity for schedules 3-5

Question 19

What are the 3 DEA approved filing methods

Answer 19

3 drawers
2 drawers
1 drawer
all substances schedule 3-5 must have a red “C” stamped in the lower right corner

Question 20

How must the register report a theft?

Answer 20

report theft to DEA ( form 41) and local police

Question 21

what can DEA inspect?

Answer 21

records, reports, forms, physical inventories, prescriptions, containers, labels, equipment pertaining to controlled substances, and security systems.