Hosa Pharmacology

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FDA (food and drug administration)

-approve new drugs to be sold in the US

-process New Drug Applications (NDA)

-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) (each state)

-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 I

-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, codeine, retalin

-no refillls 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 pharmacies or qualified distributors

DEA number verification

-add 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 thru V

6 months

Expiration dates: Legend Drugs

12 months

Refills: DEA Schedule II

no refills allowed

Refills: DEA Schedule III thru V

-up to 5, but only 5 times

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

Refills: 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. no exceptions

-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 where there is a probability that the use of or exposure to a violative product will cause 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 violated 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: Pre Clinical

pre-clinical (animal) testing

NDA Process: Initial Development: Investigational New Drug Review (IND)

-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 tolerated 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

-effets compared with similar patients receiving different treatments

NDA Process: New Drug Clinical Trials: Phase III

-involves 300-3000 volunteers

-emphasis on the drugs overall effect

-effects compared with patients taking placebos

-study of different population and different 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

-required that "secret elixirs" containing ingredients like: cocaine, heroin, morphine and alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages

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