HOSA: Pharmacology

FDA (food and drug administration)

• approve new drugs to be sold in the US

• process New Drug Applications

• regulate package inserts

• regulate drug advertising

• issue recalls

• federal agency

DEA (Drug Enforcement Agency)

• federal agency

• enforce the CSA (controlled substances act)

• track controlled substances manufactured and sold

• investigates all violations involving controlled substances

• set the DEA Sch. Definitions

• Issue DEA numbers

BOP (Board of Pharmacy)

• regulate licensing of pharmacists

• regulate licensing of pharmacy technicians

• set state laws/requirements

• outline the operating guidelines in the pharmacy

• investigate violations of the operating guidelines

• determine state regulated controlled substances

• state agency

Joint Commission on Accreditation of Healthcare Organizations

• watches over healthcare organizations

• third party auditors/regulators for insurance providers

DEA Schedule 1

• no accepted medical use

• extremely high potential for abuse

• high potential for psychological and physical dependency

• ex. weed, heroin, mdma

DEA Schedule II

• does have medical use

• high potential for abuse

• relative potential for psychological and physical dependency

• ex. oxycodone, codeleine, retalin

• no refills allowed

• cannot be “called in” or transmitted electronically unless it is an absolute emergency

DEA Schedule III

• does have medical use

• moderate abuse potential exits

• ex.) Vicodin and Tylenol w/ codeine

DEA Schedule IV

• abuse potential exists

• ex.) Ambien, darvocet, lorazepam

DEA Schedule V

• lowest abuse potential

• ex.) cough medicine w/ codeine or anti-diarrheas

DEA Form 222

• must be used whenever Sch I or II drugs are bought, sold, or transferred between pharamacies or qualified distributors

DEA number verification

• adds the 1st, 3rd, and 5th digits

• add the 2nd, 4th, and 6th digits —> double it

• add the two totals together (The second digit is the check digit)

• preceded by two letters: first letter represents the type of practice or institution the DEA number is issued to, the second letter represents the first letter of the practitioner’s last name

sig

• tells pharm techs how to dispense it

• also printed on the prescription it is dispensed in but translated into regular words for the patient

expiration dates: DEA Sch II

no expiration

expiration dates: DEA Sch III - V

6 months

expiration dates: legend drugs

12 months

Refills: DEA Schedule II

no refills allowed

Refills: DEA Schedule III - V

• up to five refills

• if a patient can only afford 50 at a time then they will only get 250 total

refill: legend drugs

up to 12 months worth

DEA Controlled Drug Prescriptions must contain at least:

• date of prescription issue

• patient’s name and address

• practitioner’s name, address, and phone number

• drug name

• drug strength

• dosage form and instructions

• exact quantity prescribed

• complete directions for use

• number of refills authorized

• a valid DEA number

Schedule II drug prescription:

• must be manually signed by the practitioner

• may not be faxed or called in, except for a valid emergency

• may not have any refills

FDA Recall Class I

would be used in a case whether is a probability that the use of or exposure to a violative product will caused serious adverse health consequences or death

FDA Recall Class II

would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequence is remote

FDA Recall Class III

may be used in a situation in which use of a violative product is not likely to cause adverse health consequence, but has violate some FDA regulation

FDA Market Withdrawal

appropriate when a product has a minor violation that would be not subject to FDA legal action. the manufacture must remove the product from distribution markets or correct the violation, “a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal”

FDA Medical Device Safety Alert

used only for medical apparatus equipment. this is when a medical device may present an unreasonable risk of substantial harm. in some cases, these situation also are considered recalls

NDA Process: Initial Development - Investigational New Drug Review

• review of pre-clinical trial results

• determination of safety to use on humans

• authorization to ship across state lines

NDA Process: New Drug Clinical Trials - Phase I

• involves 25-100 volunteers

• safety tolerated dosage determined

• identification of major side effects

• emphasis on safety and maximum tolerate dosages

NDA Process: New Drug Clinical Trials - Phase II

• involves 100-300 volunteers

• emphasis on the drug effect against what it’s designed to treat

• effects compared with similar patients receiving different treatments

NDA Process: New Drug Clinicals Trials - Phase III

• involved 300-3000 volunteers

• emphasis on the drugs overall effect

• effected compared with patients taking placebos

• study of different populations and dosages

• testing the drug in combination with other drugs

• final phase before presenting to FDA for approval

NDA Process: New Drug Post Approval Trials - Phase IV

• ongoing/post approval trials

• health-care professionals to report any adverse findings

• lasts eternally, as long as the drug is on the market

NDA Process Time

• can usually take 12-15 years

• patent only last 20 years from the time the application for patent was filled

federal food and drug act of 1906

• known as the Pure Food and Drug Act

• provided authority for federal inspection of meat products and prohibited the sale of adulterated foods

• replaced by the federal food, drug, and cosmetic act of 1938

Narcotic Tax Act of 1914

• known as the Harrison Narcotic Act

• provided authority for the IRS to collect taxes on Opiates thru tax stamps

• required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS

• emphasis on attempting to control the massive flow of opiates in order to protect the public from rising addiction

Federal Food, Drug and Cosmetic Act of 1938

• known as FDCA 1938

• replaced the Food and Drug act of 1906

• provided better clarification about misbranding definitions

• provided better clarification about adulteration definitions

• gave the FDA authority to require adequate testing of new drugs for safety

The Durham-Humphrey Amendment of 1951

• created a distinction between “OTC” and “Legend Drugs”

• required legend drugs to carry the statement: “Caution: Federal law prohibits dispensing without a prescription”

• emphasis on this act was to insure safety through qualified medical supervision

The Kefauver-Harris Amendment of 1962

• known as the “Drug Efficacy Amendment”

• required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval

• required drug advertising to be more closely regulated and disclose accurate information about side effects

The Bureau of Narcotics and Dangerous Drugs (BNDD)

• predecessor agency of the DEA

• BNDD merged into the DEA in 1973

Drug Abuse Prevention/Control Act of 1970

• known as the CSA

• completely replaced the Harrison Act

• required the use of DEA numbers

• required comprehensive record keeping and transaction tracking

• enforced the DEA under the US Dept of Justice

Poison Prevention Packaging Act of 1970

• also known as the PPPA

• designed to reduce the risk of children ingesting dangerous substances

• required locking caps on most prescriptions

Combat Methamphetamine Epidemic Act (2005)

• enacted to regulate the OTC sales of pseudoephedrine

• identity and address of each purchaser to be kept for two years

• daily sales of regulated products no exceed 3.6 grams

• 30 day purchase limit to not exceed 9 grams

• 30 day purchase via mail order not to exceed 7.5 grams

National Drug Code (NDC)

• used to identify legend drugs

• part of the drug listing act of 1972

NDC: ####-xxxx-xx

• identifies the drug’s manufacturer

• number is unique to the maker of repackager of the product

NDC: xxxx-####-xx

• identifies the product

• number unique to the formulation and strength of the product

NDC: xxxx-xxxx-##

• identifies the packaging

• unique to the size and quantity of the product

q

every

qH

every hour

qAM

every morning

qPM

every evening

qHS

every bedtime

qD

everyday

qOD

every other day

qWK

every week

qMO

every month

q_*

every _ hours

q_H

every _ hours

BID

twice a day

TID

three a day

QID

four a day

X_D

times _ days

TDS

3 times a day

C

with

AC

before a meal

PC

after a meal

HS

at bedtime

PRN

as needed

UD

as directed

AA

of each

QS

quantity sufficient

GTT

drop

OD

right eye

OS

left eye

OU

both eyes

AD

right ear

AS

left ear

AU

both ears

PO

by mouth/oral

SL

sub-lingual

NG

naso gastic

BUCCAL

cheek/gum

PR

rectally

PV

vaginally

SUPP

suppository

TAB

tablet

CAP

capsule

IM

intramuscular

SQ

sub-cutaneous

IV

intravenous

IC

intra cardiac

INJ

injection

STAT

immediately

Dosage Form: Enteral Medication

• given orally and pass through the GI tract to be absorbed into the bloodstream and metabolized by the liver

• includes oral, naso-gastric, and rectal routes

Dosage Form: Parenteral medication

• injected or placed into the body tissues and do not pass through the liver before entering the bloodstream

• can include injections, topical, and inhalation reroutes

• generally refers to injection

Dosage Form: Injectable Drugs

• usually in the form of solution or powders

• mixed with a sterile diluent to render an injectable solution

Topical

• applied to the skin surface or a mucous membrane

Tablets

• to form a tablet, the drug is combined with fillers and is them compressed into a hard pellet

• available in fast acting, slow released, control released, enteric coated, film coated, sublingual, chewable, and other formulations

• sublingual tablets are placed under the tongue, wafers are placed on the tongue and buccal tablets are placed between the cheek and gum

Capsules

• to form a capsule, the drug is contained in a cylindrically shaped shell

Caplet

• an oval shaped tablet

oral suspension

• drug is mixed with, but not completely dissolved into a liquid

• needs to be shaken before administration in order to suspend the drug particles evenly

Syrups

• contains a high concentration of sucrose or sugar to sweeten, for ease of use

elixirs

contain between 5-40% alcohol