ch 1 - Information Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing

pharmaco-

drug medicine

-ology

study of

pharmacology

study of drugs and their interactions with living cells and systems

history of pharmacology

certain plants were ingested to see how they effected the body

role of the DH in pharmacology

• medication/hh

• medication administration

• emergency situations

• appt scheduling

• nonprescription medication

• nutritional/herbal supplements

3 types of drug names

• chemical name

• trade name

• generic name

which drug name is always capitalized

trade name (Motrin, Advil)

which drug name is always lower case

generic name (ibuprofen)

chemical name

describes drugs’ molecular structure

generic name

• official name chosen by the USAN

• each drug only has 1 of these names

• lower case

trade (brand) name

• name selected by drug company

• can have more than 1 of these names

• capitalized

Drug Price Competition and Patent term restoration act

FDA requires active ingredient of GENERIC product to enter bloodsteam at SAME rate as TRADE name product

chemically equivalent (drug substitution)

2 formulations of a drug meet the chemical and physical standards established by regulatory agencies

biologically equivalent (drug substitution)

2 formulations of a drug produce similar concentrations of the drug in blood and tissues

therapeutically equivalent (drug substitution)

2 formulations of a drug have an equal therapeutic effect

Harrison Narcotic Act

marijuana laws added

Food and Drug Administration (FDA)

• grants approval for drugs marketed in US

• sets standards for quality control

• determines which drugs can be sold by prescription/OTC

• regulates labeling

Federal Trade Commission (FTC)

prohibits false advertising

Drug Enforcement Administration (DEA)

regulates the manufacture and distribution of substances that have a potential for abuse (opiods, stimulants, sedatives)

Omnibus Budget Reconciliation Act (OBRA)

pharmacists must provide pt counseling and a prospective drug utilization review

Clinical eval for new drug

• takes 12 years

• begins with animal studies measure toxicity

phase 1 of clinical studies

• small and the increasing doses to limited # volunteers

• determines biologic effects, metabolism, safe dose range, toxic effects

phase 2 of clinical studies

• larger # of ppl

• adverse reactions reported to FDA

phase 3 of clinical studies

• large # of ppl who have condition meds are meant for

• dosage is determined

phase 4 of clinical studies

• postmarketing surveillance

• toxicity that occurs in pt taking is released and recorded

requirements for prescribing scheduled drugs

DEA number

what schedule drugs require prescription

Schedule II-IV

Schedule II drugs

• must be written in pen or typed

• cannot be sent over telephone

• need new written script to refill

what schedule drugs cannot be refilled more than 5 times in 6 month period

Schedule III-IV

Schedule I

• highest abuse potential

• NO accepted medical use

• for experimental research only

Schedule I drug examples

• Herion

• LSD

• Hallucinogens

Schedule II

• high abuse potential

• written script w provider’s signature required

• no refills

Schedule II drug examples

• Oxycodone

• morphine

• amphetamine

• secobarbital

Schedule III

• moderate abuse potential

• scripts can be telephoned

• pt may not receive more than 5 scripts w/i 6 months

Schedule III drug examples

• codeine (Tylenol 3)

• hydrocodone (Vicodin)

Schedule IV

• less potential for abuse

• scripts can be telephoned

• pt may not receive more than 5 scripts w/i 6 months

Schedule IV drug examples

• dextropropoxyphene forms (Darvon)

• diazepam (Valium)

Schedule V

• least amount of abuse potential

• may be bought OTC

Schedule V drug examples

• some codeine containing cough syrups

• antidiarrheal medications

Package Inserts (PI)

• chemical makeup

• FDA approved indications

• contraindications

• warnings

• adverse reactions

• drug interactions

• dose and administration

• how supplied

Black Box Warning

• Used to draw attentions to safety concerns

• educates both prescriber and pt

Labeled Use

• indicated that the FDA has approved the drug for SPECIFIC USE

• the USE it was INTENDED to have

Off-labeled use

• use outside that stated FDA indications

• use is OUTSIDE main PURPOSE

• ex: Ozempic was meant to diabetes, but off-label use is weight loss

orphan drugs

developed to treat certain RARE medical conditions

(govt helps fund bc the drugs are expensive to make since small population uses them)

drug recall

medications are taken off the market if there is a reasonable probability that use will result in serious adverse health consequences or death

best prescription writing practices

• correct format

• write carefully and legibly

• keep copy of script on pt chart

• avoid latin abbreviations

• keeps script blanks in secure place

• write DEA number only when needed

• follow state laws for duplicates/triplicates

measurement system for prescriptions

metric system

solid drugs are dispensed by weight

mg

liquid drugs are dispensed by volume

mL

qd

once daily

bid

twice a day

tid

3x a day

qid

4x a day

pc

after meals

ac

before meals

po

by mouth

prn

as needed

sig

write (label)

stat

immediately

hs

at bedtime

ud

as directed

q6h

every 6 hours (4 pills)

q4h

every 4 hours (6 pills)

Rx

treatment

hx

history

Dx

diagnosis

qod

every other day

qh

every hour

SOS

if needed

od

once a day

BT

bedtime

BBF

before breakfast

BD

before dinner

Tw

twice a week

SQ

sub cutaneous

IM

intramuscular

ID

intradermal

IV

intravenous

prescription format

• heading (prescriber’s info, pt info, date of script)

• body (RX symbol, drug name and dose, directions)

• RX (drug name # mg, Disp #, sig)

• closing (prescriber’s signature, DEA #, refill instructions)

• substitution

dosage formula

D/H x Q = 1 dose

daily dose formula

number of tabs x times per day

complete prescription formula

daily dose x total days