Ch 1 Review Flashcards
FDA
Food and Drug Administration
governing body over meds sold in US
FDA
branch of the U.S. Department of Health and Human Services
FDA
Responsible for approval of Rx and OTC meds, drug labeling, and standards for drug manufacturing
FDA
CDC
Centers for Disease Control and Prevention
provides regulations for infection control
CDC
publishes annual vaccination and immunization requirements for children, adolescents, and adults
CDC
DEA
Drug Enforcement Agency
enforce the laws and regulations surrounding controlled substances and illegal substances
DEA
sets requirements for dispensing controlled substances, refills allowed, and product classifications
DEA
first law to regulate meds
Food and Drug Act of 1906
prohibits misbranding (false labeling)
Food and Drug Act of 1906
prohibits adulteration (products contaminated with unknown or unsafe content)
Food and Drug Act of 1906
created amendments to Pure Food and Drug Act of 1906
Food, Drug, and Cosmetic Act of 1938
Expanded role of FDA
Food, Drug, and Cosmetic Act of 1938
created 2 classes of meds
- prescription (legend)
- non-prescription (OTC- over-the-counter)
Durham-Humphrey Amendment of 1951
authorizes the Consumer Product Safety Commission to create standards for packaging to protect children from taking harmful meds
The Poison Prevention Packaging Act of 1970
Created Child resistant containers
The Poison Prevention Packaging Act of 1970
Child resistant containers can’t be opened by what percentage of children under the age of 5 years old
80%
Child resistant containers can be opened by what percentage of adults
90%
Meds that don’t have to be placed in child resistant packaging
- sublingual nitroglycerin
- oral contraceptives and hormones in memory-aid packaging
- inhalers
- drugs dispensed in an inpatient/nursing home setting
If a patient doesn’t want a child resistant packaging for their meds, what must they do?
request that the pharmacy not put meds in child resistant packaging and fill out an authorization form for all meds
Requires each new drug to have a national drug code
Drug Listing Act of 1972
NDC
National Drug Code
How many numbers are in a NDC
10 digits (sometimes 11)
What does the first segment of the NDC number identify?
manufacturer/distributor
What does the second segment of a NDC number identify?
name/strength/dosage form of the product
What does the third segment of the NDC number identify?
size/type of packaging
NDC numbers with 11 digits contain what?
placeholder/leading zero or asterisk
Allows manufacturers to submit abbreviated new drug applications for generic medications
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
ANDA
Abbreviated New Drug Application
Must prove generic is safe and effective, and performs like the brand-name product
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Generic drug can reach the market faster
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
OBRA
Omnibus Reconciliation Act of 1990
requires the pharmacist to discuss information about new and refill Rx with patient
Omnibus Reconciliation Act of 1990
DSHEA
Dietary Supplement Health and Education Act of 1994
requires dietary supplements to be treated more like drugs than food
Dietary Supplement Health and Education Act of 1994
What does dietary supplements include
vitamins, minerals, and herbals
dietary supplements labels can only say the intended effect on the body
Dietary Supplement Health and Education Act of 1994
cannot say the supplement can treat, prevent, or cure a specific disease or condition
Dietary Supplement Health and Education Act of 1994
solid, oral dosage forms must have a marking or imprint code on the face of product
Imprint Code Legislation
help identify individual meds, misfilled orders, and counterfeit drugs
Imprint Code Legislation
HIPAA
Health Insurance Portability and Accountability Act of 1996
protects the privacy of patient information
HIPAA
PHI
Private Health Informtion
uses and disclose the minimum necessary amount of protected info (give and request the minimum amount of info required
HIPAA
establish the rights of patient to approve who has access and use of their medication info
HIPAA
security rule sets standards for ensuring patient info is protected and safe and unauthorized individuals don’t have access
HIPAA
MedGuides
Medication Guide Legislation
FDA approved patient education handouts that inform patients about significant risks of using a med
Medication Guide Legislation
MedGuide is required if one or more of the following exists:
- Patient labeling could help prevent serious adverse effects
- The drug product has serious risks of which patients should be made aware because info concerning the risks could affect the patient’s decision to use, or to continue to use, the product
- The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness
MedGuide standards
- Contain specific, comprehensive, scientifically accurate info based off of package insert
- Be written in non-technical English
- Identify that is is a “Medication Guide” with the name and phonetic spelling of the drug
- Contains certain headings and clear explanations
MedGuide must be dispensed:
- When a patient or patient’s caregiver asks for a MedGuide, in both outpatient and inpatient settings
- with outpatient Rx, including new and refill orders
- When the first dose of a med is dispensed in on an outpatient setting that is to be administered by another health care provider
- When the MedGuide is part of the Risk Evaluation and Mitigation Strategies (REMS) program
pertain to practice of pharmacy
State Laws and Regulations
BOP
Board of Pharmacy
functions to protect the health, safety, and welfare of patients
Board of Pharmacy
