PTU FINAL EXAM ALREADY PASSED!!
Community Pharmacy Technicians
Prepares medications for outpatients
-Retail
Hospital Pharmacy Technicians
Prepares medications for inpatients
Long-Term Care Pharmacy Technicians
Prepares medications for patients in institutional settings such as nursing homes or
assisted living facilities
Mail Order Pharmacy Technicians
Prepare medications for patients receiving prescriptions through the mail
Nuclear Pharmacy Technicians
Prepare radioactive materials used for diagnosing and treating certain conditions
Indications and Usage (Package Inserts)
Lists disease states/conditions the medication is approved to treat
Dosage and Administration (Package Inserts)
Contains recommended doses, dosing schedules, and administration requirements
Contraindications (Package Inserts)
Lists situations when the medication should not be used
Warnings and Precautions (Package Inserts)
Lists situations that require caution when taking the medication
Adverse Reactions (Package Inserts)
Lists reported side affects
Drug Interactions (Package Inserts)
Lists the most significant drug-drug interactions involving the medication
Use in Specific Populations (Package Inserts)
Lists safety concerns when using the drug during pregnancy, while breastfeeding, in
children, adn in the elderly
Drug Abuse and Dependance (Package Inserts)
Lists the drugs controlled substance classification
Overdosage (Package Inserts)
Lists the signs/symptoms and treatment options during an overdose situation
Product Description (Package Inserts)
Lists the chemical name of the medication, structural diagram, active ingredients, and
inactive ingredients
Clinical Pharmacology (Package Inserts)
Contains information on how the medication works, and how the medication is
absorbed, metabolized, and eliminated from the body
Nonclinical Toxicology (Package Inserts)
Lists any cancer and fertility risks from using the medication
Clinical Studies (Package Inserts)
Provides information from the clinical studies showing how well the drug works for its
approved indications
How Supplied (Package Inserts)
, Lists the medications dosage forms, description by color, shape, and markings, and any
special storage and handling instructions
Patient Counseling Information (Package Inserts)
Highlights the important counseling points about the medication for the pharmacist or
prescriber
Orange Book
Created by FDA
Contains ratings that show whether brand and generic drugs are therapeutically
equivalent
Physicians' Drug Reference (PDR)
Contains a compilation of drug inserts
United States Pharmacopeia-National Formulary (USP-NF)
Defines the standards for medications, good reference for compounding medications
Ident-A-Drug
Contains information to identify medications by imprint codes, NDC numbers,
descriptions
Food and Drug Administration (FDA)
Responsible for the approval of prescription and over-the-counter medications, drug
labeling, and standards for drug manufacturing
Centers for Disease Control and Prevention (CDC)
Publishes annual vaccination and immunization requirements for children, adolescents,
and adults
Drug Enforcement Agency (DEA)
Sets requirements for dispensing controlled substances, refills allowed, and product
classifications
The Pure Food and Drug Act of 1906
Prohibits misbranding and adulteration
Misbranding
Falsely labeling pharmaceutical products
Adulteration
Selling contaminated products or those with unknown ingredients
Food, Drug, and Cosmetics Act of 1938
Expanded role of FDA
Addresses safety concerns
Durham-Humphrey Amendment of 1951
Created two classes of medications (Prescription vs OTC)
Class I Recall
Likely to cause serious adverse affects or death
Class II Recall
Likely to cause temporary or reversible side effects
Class III Recall
Unlikely to call adverse effects
Usually due to packaging or labeling
Market Withdrawl
Drug cannot return to market without FDA approval
Therapeutic Equivalent
Community Pharmacy Technicians
Prepares medications for outpatients
-Retail
Hospital Pharmacy Technicians
Prepares medications for inpatients
Long-Term Care Pharmacy Technicians
Prepares medications for patients in institutional settings such as nursing homes or
assisted living facilities
Mail Order Pharmacy Technicians
Prepare medications for patients receiving prescriptions through the mail
Nuclear Pharmacy Technicians
Prepare radioactive materials used for diagnosing and treating certain conditions
Indications and Usage (Package Inserts)
Lists disease states/conditions the medication is approved to treat
Dosage and Administration (Package Inserts)
Contains recommended doses, dosing schedules, and administration requirements
Contraindications (Package Inserts)
Lists situations when the medication should not be used
Warnings and Precautions (Package Inserts)
Lists situations that require caution when taking the medication
Adverse Reactions (Package Inserts)
Lists reported side affects
Drug Interactions (Package Inserts)
Lists the most significant drug-drug interactions involving the medication
Use in Specific Populations (Package Inserts)
Lists safety concerns when using the drug during pregnancy, while breastfeeding, in
children, adn in the elderly
Drug Abuse and Dependance (Package Inserts)
Lists the drugs controlled substance classification
Overdosage (Package Inserts)
Lists the signs/symptoms and treatment options during an overdose situation
Product Description (Package Inserts)
Lists the chemical name of the medication, structural diagram, active ingredients, and
inactive ingredients
Clinical Pharmacology (Package Inserts)
Contains information on how the medication works, and how the medication is
absorbed, metabolized, and eliminated from the body
Nonclinical Toxicology (Package Inserts)
Lists any cancer and fertility risks from using the medication
Clinical Studies (Package Inserts)
Provides information from the clinical studies showing how well the drug works for its
approved indications
How Supplied (Package Inserts)
, Lists the medications dosage forms, description by color, shape, and markings, and any
special storage and handling instructions
Patient Counseling Information (Package Inserts)
Highlights the important counseling points about the medication for the pharmacist or
prescriber
Orange Book
Created by FDA
Contains ratings that show whether brand and generic drugs are therapeutically
equivalent
Physicians' Drug Reference (PDR)
Contains a compilation of drug inserts
United States Pharmacopeia-National Formulary (USP-NF)
Defines the standards for medications, good reference for compounding medications
Ident-A-Drug
Contains information to identify medications by imprint codes, NDC numbers,
descriptions
Food and Drug Administration (FDA)
Responsible for the approval of prescription and over-the-counter medications, drug
labeling, and standards for drug manufacturing
Centers for Disease Control and Prevention (CDC)
Publishes annual vaccination and immunization requirements for children, adolescents,
and adults
Drug Enforcement Agency (DEA)
Sets requirements for dispensing controlled substances, refills allowed, and product
classifications
The Pure Food and Drug Act of 1906
Prohibits misbranding and adulteration
Misbranding
Falsely labeling pharmaceutical products
Adulteration
Selling contaminated products or those with unknown ingredients
Food, Drug, and Cosmetics Act of 1938
Expanded role of FDA
Addresses safety concerns
Durham-Humphrey Amendment of 1951
Created two classes of medications (Prescription vs OTC)
Class I Recall
Likely to cause serious adverse affects or death
Class II Recall
Likely to cause temporary or reversible side effects
Class III Recall
Unlikely to call adverse effects
Usually due to packaging or labeling
Market Withdrawl
Drug cannot return to market without FDA approval
Therapeutic Equivalent
