LAWS AFFECTING PRESCRIPTION DISPENSING

Question 1

• Responsible for:
  - Approval of Rx and OTC meds
  - Drug labeling
  - Drug manufacturing standards

Answer 1

Food and Drug Administration (FDA)

Question 2

• regulations for infection control

- Publishes the requirements for vaccinations and immunizations

Answer 2

Centers for Disease Control and Prevention (CDC)

Question 3

• enforce laws and regulation for controlled substances and illegal drugs
  
  • Sets requirements for dispensing and refilling controlled substances

Answer 3

Drug Enforcement Administration (DEA)

Question 4

• requires that manufacturers to prove a drug is safe before being sold
• Before selling manufacturers had to prove a drugs’: Purity, Strength, and Safety

Answer 4

Food, Drug, and Cosmetic Act of 1938

Question 5

• Prohibits misbranding - false labeling, drugs that does not meet FDA standards
  
  • Prohibits adulterations - contaminations, unknown/unsafe contents (contains ingredients not in the labels)

Answer 5

Pure Food and Drug Act of 1906

Question 6

created 2 classes of medications: prescriptions and nonprescription

Answer 6

Durham-Humphrey Amendment of 1951

Question 7

• Cannot be safely used w/o medical supervision
  
  • Can be dispensed directly to the pt by the prescribers
  • Products have “Rx Only” on the product label - tells you prescription is required before you dispense med to the pt

Answer 7

Prescription - Only Drugs (aka Legend drugs)

Question 8

• Typically safe when used correctly
  
  • Labeling is regulated by FDA (1999) and must include:
    
    • Active ingredients
    • Inactive ingredients
    • Purpose/Uses
    • Warnings
    • Dosage instructions

Answer 8

Nonprescription Drugs - OTC drugs

Question 9

standards for packaging meds to protect kids

Answer 9

Poison Prevention Packaging Act of 1970 (PPPA)

Question 10

regularly agency responsible for creating standards for packaging to protect children from accidental poisonings w/ meds.

Answer 10

Consumer Product Safety Commission

Question 11

Child-resistant containers: cannot be opened by __% of children under 5, can be opened by __% of adults

Answer 11

Child-resistant containers: cannot be opened by 80% of children under 5, can be opened by 90% of adults

Question 12

• sublingual form only (sublingual nitroglycerin)
• oral contraceptives and hormonal treatments
• inhalers
• inpatient meds

Answer 12

Meds that are not required to be in a child-resistant containers.

Question 13

What med requires Patient Package Inserts?

Answer 13

• Oral contraceptives (Ortho Tri-Cyclen, Yaz, etc)

- Estrogen-containing products (Premarin, Cenestin, Prempro, vagifem, etc)

Question 14

NDC

Answer 14

National Drug Code

Question 15

HOW MANY DIGITS DOES NDC HAVE?

Answer 15

10

Question 16

(Labeler code): identifies the manufacturer or distributor of the product

Answer 16

First section of NDC

Question 17

(Product code): name, strength, and dosage form

Answer 17

2nd section of NDC

Question 18

(Package code) : size and type of packaging

Answer 18

3rd section of NDC

Question 19

Unique and permanent code of each drug

Answer 19

Drug Listing Act of 1972

Question 20

• Abbreviated new drugs application (ANDA) for generic meds
  
  • Still must prove generis is : safe, effective, and performs like brand name drug
  • Expedite bringing less costly generic drugs to market
• FDA approves ANDAs for generic meds.

Answer 20

Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984)

Question 21

vitamins, minerals, herbs

Answer 21

Dietary Supplements

Question 22

• requires products to be treated more like drugs than food
  
  • must be safe
  • labels can only say the intended effect on the body
  • cannot say that it can treat, prevent, or cure any specific disease or condition
  • loosely regulated by FDA who can intervene if proven to be harmful, unsafe, or mislabeled

Answer 22

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Question 23

a marking or imprint code on the face of the product for both prescriptions and OTC drugs.

Answer 23

Imprint Codes

Question 24

• requires pharmacists to discuss info about meds w/ patients

Answer 24

Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)

Question 25

governs pt’s privacy and sharing of pt’s info.

Answer 25

Health Insurance and Portability and Accountability Act of 1996 (HIPAA)

Question 26

• 1st : Protect patient info
• 2nd : Use and disclose the minimum necessary amount of protected info
• 3rd : Establish the right of pts to approved who has access and use of their medical info

Answer 26

Three Principles of HIPAA privacy rules:

Question 27

Handouts for drugs that pose the most significant and serious public health concerns

Answer 27

Medguides

Question 28

Required to be dispensed w/ many common drugs such as NSAIDs, antidepressants

Answer 28

Medguides

Question 29

WHEN DO I INCLUDE A MEDGUIDE?

Answer 29

• When pt ask: inpatients and outpatients
  
  • New and Refill Rx - outpatients
  • Part of REMS program - inpatient and outpatient
  • Consider misbranding when you don’t dispense them when required.

Question 30

inform pt about benefits and risks associated w/ certain drugs.

Answer 30

package insert

Question 31

protect the health, safety, and welfare of pts.

-Set of laws specific to practice of pharmacy

Answer 31

Board of Pharmacy

Question 32

can differ from federal laws, always follow stricter law

-Uusally state laws are more stricter.

Answer 32

State Laws