PHRM 3030 Didactic Exam 1!

what is a drug monograph?

a comprehensive, organized summary of info about a medication for safe and effective administration of a drug

Which Code of Regulations (CFR) deals with content and format of drug labeling?

CFR 21: Food and Drugs

what is the purpose of a drug monograph?

it gives healthcare providers info needed to appropriately prescribe medication

list the info you could find on a drug monograph?

brand name, description, indications/usage, contraindications, warnings, precautions, adverse reactions, dosage + administration, etc.

how are generic names created? how are drugs that are similar in composition considered?

the US Adopted Names Council (USAN) works with manufacturers to establish names

similar drugs tend to have the same stem [ex: ACE inhibitors end in -pril (lisinopril, fosinopril) cholesterol agents end in -statin (atorvastatin, simvastatin)]

how are brand names (aka the “trade name”) created?

pharmaceutical manufacturer proposes a name, then the FDA approves it

what does the indications portion of the drug monograph tell?

answers the question: “why would I use this drug?”

it contains labeled + non-labeled indications that provides necessary clinical data (ex: for insulin drugs, Type 1 diabetes mellitus is a labeled indication)

what does the contraindications of the drug monograph tell?

answers the question: “when should I NOT use this drug?”

tells situations in which the risk of using the drug outweighs any therapeutic benefit

what are absolute contraindications?

“DO NOT USE” if x scenario applies (ex: Isotretinoin use during pregnancy)

what are relative contraindications?

“avoid or use with caution” (ex: aspirin use while on warfarin)

what does the warnings and precautions of the drug monograph tell?

answers the question: “when should I be especially careful?”

describes a set of adverse reactions / potential safety hazards that are severe or have implications for prescribing conditions (ex: Metformin → lactic acidosis in certain instances)

what does the adverse reactions section of the drug monograph tell?

answers the question: “what unwanted effects may occur?”
adverse rxns describe any unwanted effects that the drug may cause due to its pharmacological action

what does the FDA-approved labeling for patients contain?

• Patient Package Inserts (PPI)

• Medication Guides (MGs)

• Patient Instructions for Use (IFU)

• Patient Medication Information (PMI)

describe the info found on a PPI? do they have to be FDA-approved?

tells the patient what the drug is, why they should take it, how to take it, and the risks / side effects; doesn’t have to be FDA-approved to be given

describe the info found on a Medication Guide (MG)?

specifically focuses on info the patient must know to prevent serious adverse effects, but patient adherence to info is crucial; required for REMS

describe the info found on a Patient Instruction for Use (IFU)?

“show me how to use it”

contains step-by-step instructions for products that have complicated or detailed patient use instructions (ex: injection pens, autoinjectors, inhalers / nasal devices, etc.)

describe the info found on a Patient Medical Information (PMI)?

provided for outpatient prescription drugs, contains essential info patients need to know about the prescription drug

describe schedule I drugs

drugs with no current medical use with high potential for abuse + addiction (ex: heroin)

describe schedule II drugs

drugs w/ some medically acceptable use, but still high potential for abuse + addiction; can be obtained via prescription

describe schedule III drugs

low to moderate potential for abuse / addiction, less danger than schedule I or II; obtained via prescription

describe schedule IV drugs

viable medical use and low risk of misuse / abuse

describe schedule V drugs

even lower risk of abuse than schedule IV

What does REMS stand for?

Risk Evaluation and Mitigation Strategies

What is REMS and what’s it used for?

a drug safety program that the U.S. FDA can require for certain medications w/ serious safety concerns to help ensure the medication’s benefit outweighs the risk; focuses on prevention, management, and monitoring

What is the three criteria for boxed warnings?

1. an adverse rxn is so serious in proportion to the drug’s benefit that it must be considered before prescribing the drug

2. there’s a serious adverse reaction that can be prevented / reduced in frequency or severity by appropriate use of the drug

3. FDA approved the drug with restrictions to ensure safe use