• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about side effects
What is
The Kefauver-Harris Amendment of 1962
These medications are CONTROLLED SUBSTANCES
Only good for 28 days
IN TEXAS most be written on a triplicate
No refills
DATE Sensitive
Must have a DEA number to be valid
What are C-II medications
Instill 1-2 gtts ou qd
10 mL
What is
50 day supply
The drug schedule for Lipitor
WHAT IS
A legend drug
• Enacted to regulate the OTC sales of pseudoephedrine.
• Identity and address of each purchaser to be kept for two years. • Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
What is
Combat Methamphetamine Epidemic Act (2005)
Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement:
Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
What is
The Durham-Humphrey Amendment of 1951
These medication are good for 1 year
Must have a RX from a Physician
Can be refilled 11 times in a year
What is a Legend drug
Instill 2 gtts ou bid
10 mL
What is 25 day supply
What is the Drug Schedule for Ativan
WHAT IS
C-IV
Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
What is Federal Food and Drug Act of 1906
Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.
What is
Federal Food, Drug and Cosmetic Act of 1938
Enacted to regulate the OTC sales of pseudoephedrine.
• Identity and address of each purchaser to be kept for two years. • Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
What is Combat Methamphetamine Epidemic Act (2005)
Instill 1 gtt ou qd
5 ml
What is
50 day supply
What is the generic name for Folvite
WHAT IS folic acid
Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
What is Narcotic Tax Act of 1914
Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
What is
Narcotic Tax Act of 1914
Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions
What is Poison Prevention Packaging Act of 1970
T 1 cap po bid
60 cap
What is 30 day supply
Nurse Wendell will infuse 1 ½ L of NS in over 7 hours; Drop factor: 15 gtt/mL. What flow rate (mL/hr) will nurse Wendell set on the IV infusion pump?
Correct answer:
Formula:
Rationale:
Computation:
Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk of potentially dangerous side effects. It is the strongest warning the FDA can give. It is common in the pharmacy profession to call these warnings “Black Box Warnings” because of their appearance in a drug label; the warning is often enclosed in a black outlined box to draw attention to the content
What is Box Warning
Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
What is
Federal Food and Drug Act of 1906
WHAT ARE XANAX,KLONIPIN,VALIUM,ATIVAN,RESTORIL
C-IV
Benzodiazepines
XANAX(ALPRAZOLAM) ANXIETY
KLONIPIN(CLONAZEPAM)
VALIUM ( DIAZEPAM)
ATIVAN(LORAZEPAM)
RESTORIL ( TEMAZEPAM) SLEEP
480
What is
60 day supply
Nurse Sandra will infuse 1,200 mL of 0.45% Normal Saline at 125 mL/hr. Drop Factor: 12 gtt/mL. How many gtt/min will nurse Sandra regulate the IV? Fill in the blank and round your final answer to a whole number.
Correct answer:
Formula:
Rationale:
Computation:
Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions
What is the Poison Prevention Packaging Act of 1970