Dimensional Analysis
An order for 0.25 g of a medication is received. The medication is available in 125 mg tablets. How many tablets should be given?
2 tablets
Pharmacodynamics
This act set the standard for drug quality and purity in addition to strength and gave birth to the FDA. However, it did not apply to "false claims of therapeutic efficacy"
The Food and Drug Act of 1906
highest drug concentration in the blood
peak
A patient is prescribed 750 mg of amoxicillin. The available tablets are 250 mg each. How many tablets should the nurse administer per dose?
3 tablets
An antibiotic is ordered at 2 g IV every 6 hours. It's available as 500 mg vials. How many vials should the nurse prepare for each dose?
4 vials
Percentage of drug available for activity after administration
Bioavailability
Ensures the safety of a drug before marketing. It is their responsibility to ensure testing for all harmful effects, also requires correct labeling with accurate information and to provide details on the adverse effects
The Federal Food, Drug, and Cosmetic Act of 1938
Drugs that activate receptors and produce a response
Agonist
unintended, unexpected, harmful reactions at normal doses
adverse effect
A patient is to receive 1000 mL of normal saline over 8 hours. The IV tubing has a drop factor of 15 drops/mL. Calculate the drip rate in drops per minute.
31 drips (gtt) per minute
Two drugs given together to produce a substantially greater effect than either alone.
Synergistic Effect
Enacted in 1962, this amendment tightened controls on drug safety, specifically experimental drugs, and required adverse reactions and contraindications be labeled/included in the literature. It also included provisions for the evaluation of testing methods, the process for the withdrawal of approved drugs when safety and effectiveness we doubted, and the establishment of new drugs before marketing
Kefauver-Harris Drug Amendment to the 1938 Act
Strengthened the FDAs ability to safeguard and advance public health by:
1. collecting fees from the industry to fund reviews of drugs with the "breakthrough therapy" designation, medical devices, generic drugs, and biosimilar biologic products
2. expediting development of innovative, safe, and effective products
3. increasing stakeholder engagement in the FDA process
4. Enhancing the safety of the global drug supply chain
FDA Safety and Innovation Act of 2012
drugs that block receptors and prevent responses
antagonist
A physician orders heparin to be administered at 1000 units/hour. The pharmacy supplies a solution of 25,000 units in 250 mL of D5W. The IV pump can be set in 0.1 mL/hr increments.
a) What should the nurse set the pump rate at?
b) How many units of heparin will the patient receive in 24 hours at this rate?
a) Pump rate: 10 mL/hr
b) Units received in 24 hours: 24,000 units
The movement of drugs throughout the body (Absorption, Distribution, Metabolism, Excretion)
Pharmacokinetics
This was designed to remedy the escalating problem of drug abuse ad included several provisions: promoted drug education and research into the prevention and treatment of drug dependence, strengthened the enforcement authority, established treatment and rehabilitation facilities, and designed schedules/categories of controlled substances according to abuse liability
The Controlled Substances Act of 1970 (Also a part of the Comprehensive Drug Abuse Prevention and Controlled Act, Title II)
authorizes the FDA to require that drug manufacturers test certain drugs and biologic products for their safety and efficacy in children, noting "children are not small adults"
Pediatric Research Equity Act of 2003
A patient is prescribed 1000 mL of Lactated Ringer's solution to be infused over 6 hours. The IV tubing has a drip factor of 20 drops/mL. Calculate:
a) The flow rate in mL/hr
b) The drip rate in drops/minute
a) Flow rate: 166.67 mL/hr
b) Drip rate: 56 drops/minute
A patient is to receive vancomycin 1.25 g IV every 12 hours. The medication comes in a 500 mg vial and needs to be reconstituted with 10 mL of sterile water. The hospital policy states that vancomycin should be further diluted in 250 mL of normal saline and infused over 90 minutes. Calculate:
a) How many vials are needed for each dose?
b) What is the final concentration of the infusion in mg/mL?
c) What should the infusion rate be set at in mL/hr?
a) Vials needed: 3 vials
b) Final concentration: 5 mg/mL
c) Infusion rate: 166.67 mL/hr
Large initial dose given to quickly achieve therapeutic concentration
loading dose
Establishes labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices, classified dietary supplements as food
Dietary Supplement Health and Education Act of 1994
Includes 5 provisions:
1. review and use of drug is accelerated
2. drugs can be tested in children before marketing
3. clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions
4. drug companies are required to give information on "off-label" use of drugs (non FDA approved) and their costs
5. drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping production
The FDA Modernization Act of 1997
Length of time a drug produces a therapeutic effect
duration of action