Foundations of Pharm. (Ch. 1-2)

2 classification categories for medicine

1. therapeutic

2. pharmacologic

therapeutic medicine

categorizes drugs by their clinical usefulness or the specific disease they treat

pharmacologic medicine

categorizes drugs by their specific mechanism of action at the molecular, tissue, or body system level

3 ways of naming medications

1. chemical

2. generic

3. trade (store name)

what is a prototype drug?

the “lead” drug or model for the representative class of drugs

pharmacology is presented in drug …

classes

most drugs in a singular class have similar _________ and …

response; side effects

prescriptions must have an …

order

OTC

available over the counter without an order

how many stages of approval are there for medications?

4

stage 1 of approval for medications

preclinical investigation

how long does the preclinical investigation stage take

1-3 years

3 parts of the preclinical investigation stage of medication approval

1. lab research

2. cellular biology

3. animal testing

stage 2 of approval for medications

clinical trials

how long does the clinical trials stage of medication approval take

2-10 years

how many phases are there in the clinical trials stage of medication approval

three

phase 1 of the clinical trials stage in medication approval

first on healthy individuals

phase 2 of the clinical trials stage in medication approval

individuals with selected disease

phase 3 of the clinical trials stage in medication approval

evaluation of phase 1 and 2

stage 3 of approval for medications

review of NDA

NDA

new drug application

how long does the review of NDA stage of medication approval take

2 years

stage 4 of approval for medication

postmarketing surveillance

how long does the postmarketing surveillance stage of medication approval take

ongoing

what stage of medication approval do meds usually die off

stage 2, phase 2 and 3

what is a black box warning?

the strictest warning put in the labeling of prescription drugs or drug products that is USUALLY rare but causes serious side effects

controlled substance and drug scheduling drugs are classified (scheduled) according to …

abuse potential

schedule I drugs

highest abuse potential, used for research purposes only

schedule V drugs

lowest abuse potential

controlled substances

need DEA registration

examples of a schedule I drug

marijuana, LSD, heroin

examples of a schedule II drug

most opioids and stimulants (hydromorphone, fentanyl, oxycodone)

examples of a schedule III drug

weaker opioids (oral hydrocodone), typically psych dependance

examples of a schedule IV drug

benzodiazepines (subject to change bc of how addictive they are)

records MUST specify which … interacted with each particular controlled substance, the … used, the … and … of the interaction, the specific … of the substance

staff member, quantity, date/time, destination

daily counts of the controlled substances should be witnessed by …

another staff member

wasting and disposal of controlled substances should also be …

witnessed, with that witness on record

teratogenic risk

risk of causing birth defect

what are the 5 categories of teratogenic risks

1. A

2. B

3. C

4. D

5. X

category A teratogenic risk

safe, no evidence that drug causes harm

category B teratogenic risk

not tested in humans, but no risk in models

category C teratogenic risk

evidence not available for humans and some risk shown in animal models

category D teratogenic risk

fetal abnormalities shown but risk//benefit considerations

category X teratogenic risk

absolutely contraindicated in pregnancy

what is a prescription medication?

medication that requires authorization from a licensed healthcare provider before it can be dispensed to a patient

what is an OTC medication?

over-the-counter medication that can be purchased without a prescription because it is considered safe and effective for self-treatment when used as directed

what is an advantage of prescription medications?

they are prescribed specifically for the patient and involve healthcare provider oversight, which can improve safety and effectiveness

what is a disadvantage of prescription medications?

may be more expensive, require a healthcare provider visit, and can cause adverse effects or drug interactions

what is an advantage of OTC medications?

are easily accessible, convenient, and allow patients to treat minor health conditions without a prescription

what is a disadvantage of OTC medications?

patients may misuse them, take incorrect doses, experience drug interactions, or delay seeking medical care for a serious condition

what is the first stage of the drug approval process?

Preclinical research, where the drug is tested in laboratories and animals to evaluate its safety, toxicity, and potential effectiveness

what happens during Phase I clinical trials?

drug is tested on a small number of healthy volunteers to determine safety, dosage ranges, pharmacokinetics, and adverse effects

what happens during Phase II clinical trials?

drug is given to a larger group of people who have the disease or condition to evaluate effectiveness and continue monitoring safety

what happens during Phase III clinical trials?

drug is tested on a large number of patients to confirm effectiveness, monitor adverse effects, compare it with other treatments, and gather additional safety information.

what happens after successful clinical trials?

manufacturer submits the drug for review and approval by the FDA

what is Phase IV of drug development?

Post-marketing surveillance, which occurs after the drug is approved and monitors long-term safety, effectiveness, and rare or serious adverse effects

why is the drug approval process in the United States long and expensive?

Drugs must undergo years of laboratory research, animal testing, clinical trials, FDA review, and continued safety monitoring to ensure they are safe and effective.

why do many drugs never reach the market?

many drugs fail during development because they are unsafe, ineffective, or cause unacceptable adverse effects

why are large clinical trials expensive?

require many participants, healthcare professionals, facilities, data collection, monitoring, and extensive safety testing

what is drug dependence?

physical or psychological state in which a person relies on a drug and may experience symptoms when the drug is stopped

what is the difference between dependence and addiction?

Dependence means the body has adapted to the drug and may experience withdrawal when it is stopped. Addiction involves compulsive drug use despite harmful consequences.

do Schedule I drugs have an accepted medical use under federal law?

No. Schedule I substances have a high potential for abuse and no currently accepted medical use under federal law.

what is the general pattern of abuse potential from Schedule I to Schedule V?

Schedule I has the highest abuse potential, and the abuse potential generally decreases as you move toward Schedule V.

which schedule generally has the lowest potential for abuse among controlled substances?

Schedule V

what is important to remember about Schedule II drugs?

have a high potential for abuse and may lead to severe psychological or physical dependence

what is important to remember about Schedule III drugs?

have a moderate to low potential for physical and psychological dependence compared with Schedule I or II substances.

what is important to remember about Schedule IV drugs?

have a lower potential for abuse and dependence than Schedule III drugs

what is important to remember about Schedule V drugs?

have the lowest potential for abuse and dependence among the controlled substance schedules

how should a nurse manage a controlled substance?

nurse should follow facility policy, verify the medication order, accurately document administration, secure the medication, and maintain accountability for the medication

what should a nurse do before administering a controlled substance?

nurse should verify the provider's order, identify the patient correctly, perform appropriate medication checks, assess the patient, and follow controlled-substance procedures

what does it mean to “waste” a controlled medication?

Wasting means properly disposing of an unused portion of a controlled medication according to facility policy while maintaining accurate documentation and required witnessing

are the old FDA pregnancy categories A, B, C, D, and X still used on current prescription drug labeling?

No. The FDA replaced the letter categories with the Pregnancy and Lactation Labeling Rule (PLLR), which provides more detailed information about pregnancy, lactation, and reproductive potential

A → B → C → D → X =

increasing concern for fetal risk, with X representing the greatest concern and contraindication in pregnancy