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56 Cards in this Set
- Front
- Back
it prohibits the distribution or sale of adulterated or misbranded foods and drugs.
When was it enacted? |
Food, Drug, and Cosmetic Act(FDCA) - 1906
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This legislation oversees the marketing of all new drugs.
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Food, Drug, and Cosmetic Act(FDCA) - 1906
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the presence of any decomposed substance, packaging under unsanitary conditions, or if the product's strength, quality, or purity is different from what is indicated on the label.
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Adulteration
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false or misleading labeling or when proper warnings and directions are absent.
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Misbranding
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Must be filed to prove effcacy and safety before any drug is available commercially.
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New Drug Application (NDA)
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An amendment to the Food, Drug, and Cosmetic Act(FDCA) separating drugs into 2 categories:
Legend & Non-legend drugs |
Durham-Humphrey Amendment (1951)
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The following info must appear on the label of a drug approved for OTC distribution
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DIM CHoWN
D - directions for use I - Ingredients (active & nonactive) M - Manufacturer name & address C - net contents H - habit forming drugs in product o - omit W - warnings & cautions N - name of product |
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amendment to FDCA that standardized labeling requirements for the manufacturer and dispenser to the patients.
In what year was in established? |
Kefauver-Harris Amendment (1962)
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regulates proper drug advertising and package inserts issued by the manufacturer.
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Kefauver-Harris Amendment (1962)
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Manufacturers must register annually, be inspected at least once every 2 yrs and must report any drug reactions to the agency.
Must also follow standard investigational procedures for drug testing. |
Kefauver-Harris Amendment (1962)
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GMP were established with this legislation
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Kefauver-Harris Amendment (1962)
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THIS FEDERAL LAW WAS ENACTED TO TRY AND REDUCE ACCIDENTAL POISONINGS IN CHILDREN by requiring all pharmacy dispensed meds in child resistant containers.
What year was it established? |
Poison Prevention Packaging Act (1970)
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Exceptions to the PPPA ( 1970)
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EARL
E - emergency medications (nitroglycerin) A - arthritic patients R - requests written from patient/prescriber L - labeled as non-child proof on OTC products |
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contains amendments to the Medicare/Medicaid programs funded by the fed govt.
What year? |
OBRA - Omnibus Budget Reconciliation Act (1990)
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This act requires that only drugs that are approved as safe and effective will be reimbursed
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OBRA (1990)
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This act requires that pharmacists must provide consulting services when dispensing medications.
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OBRA (1990)
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Federal lesiglation regulating the use and distribution of drugs and other substances of abuse.
Year enacted? |
CSA - Controlled Substance Act (1970)
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Agency of the US Dept. of Justice and is responsible w/ the FDA for administering the provisions of the CSA.
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DEA - Drug Enforcement Agency
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Following activities requires registration w/ the DEA
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CRIME-N
C - compounding CS's R - research & activities w/ CS's I - Importing CS's M - manufacturing, distributing, & dispensing CS's E - Exporting CS's N - Narcotic treatment programs |
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Congress established 5 schedules of CS's based on
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abuse potential (mental & phsyical)
accepted medical use |
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Which schedule of drugs has high potential for abuse?
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Schedule I
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Which schedule of drugs have low potential for abuse?
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Schedule V
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To secure (purchase or transfer) a supply of schedule I or II substances, a registrant must complete
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DEA Form 222 triplicate order form
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Who is permitted to sign the order forms?
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Only the person who signed the app for registration w/ the DEA
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In 1990, anabolic steroids were added to which schedule?
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Schedule III
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any drug or hormonal substance, chemically and pharmacologically related to testosterone that promotes muscle growth.
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anabolic steroids
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Why do some states sell controlled substances OTC?
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They contain small amount of CS's (primarily C-V) and the FDA feels that a prescription is not required.
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Which states require prescription for CV Substances?
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Colorado and New York
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guidelines for sale of CV's
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- sale made by pharmacist
- 18yrs + identification - no more than 8 ounces (48 dosage units) in 48 hours for opium containing substances no more than 4 ounces (24 dosage units) for any other controlled substance in any 48 hr period may be dispensed. |
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The pharmacist must maintain record of all such noprescription sales (ex: CV's) in a bound book that contains:
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C-DIP
-name and address of purchaser -name and quantity of controlled substance -date of purchase -initials of dispenser |
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Fed regulations provide for 3 methods for filing prescriptions
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3 sep
-CII -CIII-CV -all others 2 sep -CII-CV; CIII-CV must have red "C" lower left -all others 2 sep -CII only -CIII-CV(must have red "C" stamp lower left) + all others |
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Requires that each pharmacy registrant make a complete and accurate inventory of all controlled substances every 2 yrs.
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Controlled Substance Act (CSA)
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How many months may the biennial inventory be delayed past the biennial date (May 1)
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6 months
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Second letter of the DEA # corresponds to what?
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Prescribers last name
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Two Limitations of pharmacy technicians
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1) recieve oral prescriptions
2) excercise professional judgement |
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If a patient needs additional medication for a CII drug what must happen?
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A new prescription must be issued by the prescriber
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3 safety considerations all pharmacies must have
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PRiM
- number of poision control center in dispensing area - reference guide to toxicities of ingestion or topical exposure -MSDS sheets for hazardous materials |
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How many years must a poison log be kept?
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5 years
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What must a poison log include after a sale?
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DiPPRoN
- Date of purchase -Name and address of purchaser -name and quantity of product -reason for purchase -full name of dispenser |
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All poisonous substances labels must include:
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- the complete name of poison
-the word POISON boldly printed - place of business of the seller - directions for use |
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What 2 things should every pharmacy be stocked with for safety when a toxin is ingested
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One once bottles of syrup of Ipecac
Activated Charcoal |
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Should be used to induce vomitting (emesis) for noncaustic substances only.
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Syrup of Ipecac
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How can you dilute the caustic effects of an ingested toxin?
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Milk or any other suitable substance
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What is the dose of syrup of ipecac and how often should it be taken if vomiting hasn't occurred?
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15ml (1 tbsp)
every 10-15mins |
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Where exposure to the product is not likely to cause adverse health hazard.
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Class III drug recall
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Where exposure to the product will cause a severe health hazard or death.
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Class 1 Drug recall
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ensures a safe and healthful workplace for all employees
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Occupational and Safety Act of 1970
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The Occupational Safety and Health Admin was created to
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- develop job safety standards
- report job related injuries/illnesses - decrease hazards - enforce mandatory standards |
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Standards that relate to pharmacy practice
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- Air contaminants
- Flammable liquids - Eye and Skin protection - Hazard Communication Standard (HCS) |
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Each repackaged drug must contain a label with the following:
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SELDoM-G
-generic name -strength -dosage form -manufacturer name + lot # -expiration date after repackaging |
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A repackaging log must include
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- date of prepacking
-name of drug -manufacturers name -manufacturers expiration date + lot # - quantity of drug repackaged -sig of pharmacist |
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Lists all sources of drug products grouped as pharmaceutical equivalents
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Orange Book
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Orange Book
Drug products with this first letter code are considered therapeutic equivalents |
A
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Orange Book
Drugs products w/ this letter code indicate that the products have a documented therapeutic in-equivalence |
B
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federal agency part of Dept of health and human resources which sets national standards for disease control and prevention.
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CDC (Center for Disease Control)
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Provides statistics and info to health professionals on the treatment of common and rare diseases. Primary function is to issue regulations for infection control.
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CDC (Center for Disease Control)
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