PTU Study Guide Questions with 100%
Correct Answers Graded A+
Credible Drug Information Databases and Websites
Provides access to drug information quickly
Examples of Creditable Drug Info Databases & Websites
‒ Clinical Pharmacology
‒ Lexicomp
‒ Micromedex
‒ GlobalRPh
‒ National Institute of Health (NIH)
Orange Book
Generics are equivalent to which brand name drugs.
- Identical in active ingredients, strength, and dosage form to the brand name
- Absorb and release identically in the body
Therapeutically Equivalent Ratings
Two Parts
- 1st Letter
- 2nd Letter
TE Codes - 1st Letter
Begins with "A" or "B"
‒ "A" = therapeutic equivalence
‒ "B" = not therapeutic equivalence
TE Codes - 2nd Letter
‒ "A" = oral dosage
‒ "B" = bioequivalence
‒ "N" = aerosolization
‒ "P" = Parenteral/injectable
‒ "T" = Topical
Physicians' Desk Reference or Prescribers' Digital Reference (PDR)
Drug information as print version plus FDA safety updates
- Info found on insert packets
United States Pharmacopeia-National Formulary (USP-NF)
•Defines the standards for medications:
‒ Dosage forms
‒ Drug substances
‒ Excipients or inactive ingredients
Also sets standards for strength/purity
Handbook on Injectable Drugs (Trissel's)
Provides information about parenteral meds
, ‒ Intravenous
‒ Intramuscular
‒ Subcutaneous
Natural Medicines (Vitamins)
Provides up-to-date information on dietary supplements, vitamins, minerals, and other natural
remedies
TIRF (Transmucosal Immediate Release Fentanyl) REMS Program
- Actiq, Fentora, Lazanda, & Subsys
- Reduces the misuse, abuse, addiction, and overdose of transmucosal immediate-release fentanyl
products
- Enroll in TIRF program before writing immediate-release fentanyl prescriptions for outpatients
LOTRONEX REMS Program
- Authorized generic, alosetron, for women with severe diarrheapredominant irritable bowel
syndrome
- Ensures prescribers and patients are informed about serious GI effects
- Prescribers are expected to complete training
- Refills are allowed on alosetron prescriptions
- Met guides must be dispensed
Clozapine REMS Program
- Treats schizophrenia and other mental disorder
- Prescribers must become certified in the program before prescribing
- Outpatient pharmacies must obtain a Predispense Authorization (PDA)
- No limits on days' supply or refills
- Blood work every week for at least six months
Food and Drug Administration (FDA)
- Governing body over medications sold in U.S.
- Responsible for approval of prescription and over ‐the ‐counter medications, drug labeling, and
standards for drug manufacturing
- Publishes annual vaccination and immunization requirements for children, adolescents, and adults
The Pure Food and Drug Act of 1906
- First law to regulate medications
- Prohibits falsely labeling pharmaceutical products (misbranding)
- Prohibits sale of contaminated products or those with unknown contents (adulteration)
Food, Drug, and Cosmetic Act of 1938
- Created amendments to Pure Food and Drug Act of 1906
- Requires pharmaceutical manufacturers to prove a drug's purity, strength, and safety before it can
be sold
Durham‐Humphrey Amendment of 1951
- Created 2 classes of medications: prescription (legend) and nonprescription (OTC)
- Prescription = Rx
- OTC labeling must contain active and inactive ingredients
Correct Answers Graded A+
Credible Drug Information Databases and Websites
Provides access to drug information quickly
Examples of Creditable Drug Info Databases & Websites
‒ Clinical Pharmacology
‒ Lexicomp
‒ Micromedex
‒ GlobalRPh
‒ National Institute of Health (NIH)
Orange Book
Generics are equivalent to which brand name drugs.
- Identical in active ingredients, strength, and dosage form to the brand name
- Absorb and release identically in the body
Therapeutically Equivalent Ratings
Two Parts
- 1st Letter
- 2nd Letter
TE Codes - 1st Letter
Begins with "A" or "B"
‒ "A" = therapeutic equivalence
‒ "B" = not therapeutic equivalence
TE Codes - 2nd Letter
‒ "A" = oral dosage
‒ "B" = bioequivalence
‒ "N" = aerosolization
‒ "P" = Parenteral/injectable
‒ "T" = Topical
Physicians' Desk Reference or Prescribers' Digital Reference (PDR)
Drug information as print version plus FDA safety updates
- Info found on insert packets
United States Pharmacopeia-National Formulary (USP-NF)
•Defines the standards for medications:
‒ Dosage forms
‒ Drug substances
‒ Excipients or inactive ingredients
Also sets standards for strength/purity
Handbook on Injectable Drugs (Trissel's)
Provides information about parenteral meds
, ‒ Intravenous
‒ Intramuscular
‒ Subcutaneous
Natural Medicines (Vitamins)
Provides up-to-date information on dietary supplements, vitamins, minerals, and other natural
remedies
TIRF (Transmucosal Immediate Release Fentanyl) REMS Program
- Actiq, Fentora, Lazanda, & Subsys
- Reduces the misuse, abuse, addiction, and overdose of transmucosal immediate-release fentanyl
products
- Enroll in TIRF program before writing immediate-release fentanyl prescriptions for outpatients
LOTRONEX REMS Program
- Authorized generic, alosetron, for women with severe diarrheapredominant irritable bowel
syndrome
- Ensures prescribers and patients are informed about serious GI effects
- Prescribers are expected to complete training
- Refills are allowed on alosetron prescriptions
- Met guides must be dispensed
Clozapine REMS Program
- Treats schizophrenia and other mental disorder
- Prescribers must become certified in the program before prescribing
- Outpatient pharmacies must obtain a Predispense Authorization (PDA)
- No limits on days' supply or refills
- Blood work every week for at least six months
Food and Drug Administration (FDA)
- Governing body over medications sold in U.S.
- Responsible for approval of prescription and over ‐the ‐counter medications, drug labeling, and
standards for drug manufacturing
- Publishes annual vaccination and immunization requirements for children, adolescents, and adults
The Pure Food and Drug Act of 1906
- First law to regulate medications
- Prohibits falsely labeling pharmaceutical products (misbranding)
- Prohibits sale of contaminated products or those with unknown contents (adulteration)
Food, Drug, and Cosmetic Act of 1938
- Created amendments to Pure Food and Drug Act of 1906
- Requires pharmaceutical manufacturers to prove a drug's purity, strength, and safety before it can
be sold
Durham‐Humphrey Amendment of 1951
- Created 2 classes of medications: prescription (legend) and nonprescription (OTC)
- Prescription = Rx
- OTC labeling must contain active and inactive ingredients
