Name that Act
LAW/Controlled medications
LAW
Math
Pharmacy history
100
• 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
100
This medication is highly addictive and its one oof the top 10 most prescribed drugs in the United States c
Norco 5/325 (hydrocodone acetaminophen and bitartrate)
100
C-II MEDICATIONS
PRESCRIPTIONS ARE GOOD FOR 28 DAYS
O REFILLS
100
A prescription is brought in for 300 g of 5% coal tar ointment. The pharmacy has in stock 3% coal tar ointment and coal tar.
i. What is the total desired quantity of the new product?
WHAT IS
300 grams
100
A statutory plan passed by Congress or any legislature that is a “bill” until it is enacted and becomes law
What is AN ACT
200
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
200
Pharmacist must counsel patient tov. use a secondary birth control method when taking this medication in combination with birth control
What is birth control
200
C-III -V MEDICATIONS
PRESCRIPTIONS ARE GOOD FOR 6 MONTHS
1 FILL AND 5 REFILLS
200
The pharmacy receives an order for 76% Isopropyl Alcohol, 1L. In stock, the pharmacy has 91% Isopropyl Alcohol, 70% Isopropyl Alcohol, 50% Isopropyl Alcohol, and Distilled Water.
i. What is the desired strength of the new product?
WHAT IS
50%
200
The mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency. Adulteration may cause injury or illness to the consumer
What is Adulteration
300
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
300
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)
300
LEGEND PRESCRIPTIONS
PRESCRIPTIONS ARE GOOD FOR 1 YEAR FROM THE DATE WRITTEN
300
The pharmacy receives an order for 76% Isopropyl Alcohol, 1L. In stock, the pharmacy has 91% Isopropyl Alcohol, 70% Isopropyl Alcohol, 50% Isopropyl Alcohol, and Distilled Water.
WHAT IS
50%; 70%; 91%
300
State board that regulates the practice of pharmacy within the state
What is Board of pharmacy (BOP)
400
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
400
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
400
RED BOOK
The purpose of RED BOOK is to allow comprehensive access to current and accurate drug pricing and description information. RED BOOK covers FDA-approved drug products. It includes prescription drugs, over-the-counter drugs, and nondrug products.
400
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:
- 214 mL/hr
Formula:
Rationale:
- WHAT IS
- Use the IV flow rate formula (ml/hr) above.
- Divide 1,500 ml (total infusion volume) with 7 hours (total infusion time) to get 214.28 mL.
- Finally, round your answer to a whole number to get 214 mL/hr.
Computation:
400
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
500
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
500
XANAX,KLONIPIN,VALIUM,ATIVAN,RESTORIL
C-IV
Benzodiazepines
XANAX(ALPRAZOLAM) ANXIETY
KLONIPIN(CLONAZEPAM)
VALIUM ( DIAZEPAM)
ATIVAN(LORAZEPAM)
RESTORIL ( TEMAZEPAM) SLEEP
500
ORANGE BOOK
The publication Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book
500
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:
- 25 gtts/min
Formula:
Rationale:
- Infusion time on this problem is not explicitly stated. To calculate for the infusion time, divide 1,200 mL (total infusion volume) with 125 mL/hour to get 9.6 hours (infusion time).
- Convert 9.6 hours to minutes by multiplying it to 60 minutes/hour. You’ll get 576 minutes.
- Use the IV flow rate formula for gtts/minute above.
- Multiply 1,200 ml (total infusion volume) with 12 gtts/min (drop factor) to get 14,400 gtts.
- Then, divide 14,400 gtts with 576 minutes (total time of infusion) to get 25 gtts/minute.
Computation:
500
Any drug or other substance that is scheduled I through V and regulated by the Drug Enforcement Administration
What is CONTROLLED SUBSTANCE