Drug Regulation And Control

Front 1

Health Insurance Portability and Accountability Act (HIPAA)

Back 1

broad and stringent rules to protect patients' privacy

pharmacy technicians legally responsible for privacy and security of protected health information (PHI)

Front 2

Food and Drug Administration (FDA)

Back 2

leading enforcement agency at federal level for regulations concerning drug products

Front 3

Drug Enforcement Administration (DEA)

Back 3

controls distribution of drugs that may be easily abused

Front 4

Food and Drug Act

Back 4

(1906) prohibits interstate commerce in adulterated or misbranded food, drinks, drugs. Gov pre-approval of drugs required

Front 5

Food, Drug and Cosmetic (FDC) Act

Back 5

(1938) new drugs mut be proven safe before marketing

Front 6

Durham-Humphrey Amendment

Back 6

(1951) defines what drugs require prescription by licensed practitioner and requires legend inclusion: "caution: federal law prohibits dispensing without a prescription"

Front 7

Kefauver-Harris Amendments

Back 7

(1962) requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

Front 8

Poision Prevention Packaging Act

Back 8

requires child-proof packaging on all controlled and most prescription drugs dispensed y pharmacists

Front 9

Controlled Substances Act (CSA)

Back 9

(1970) classifies drugs that may be easily abused and restricts distribution

enforced by DEA within Justice Dept.

Front 10

Omnibus Budget Reconciliation Act (OBRA)

Back 10

(1990) requires pharmacists to offer counciling to Medicare patients

(effectively putting common practice into law)

Front 11

prescription drug labels (minimum requirements)

Back 11

name and address of dispenser
name of prescriber
name of patient
prescription serial #
date of prescription or filling
directions for use
cautionary statements

Front 12

NDC # (National Drug Code #)

Back 12

assigned by manufacturer

3 parts:
- manufacturer
- medication, strength, dosage form
- packaging size

Front 13

DEA #

Back 13

# all prescirbers of controlled substances are assigned

(2 letters, 7 digits, eg AB1234567)

Front 14

DEA formula

Back 14

for checking a DEA # on prescription:

sum of 1st, 3rd, 5th digits
+ 2x sum 2nd, 4th, 6th digits
= # whose last digiti is same as last digit of DEA #

Front 15

MedWatch

Back 15

FDA reporting program for healthcare professionals to report adverse effects that occur from use of an approved drug or other medical product.

Medwatch Voluntary Reporting Form 3500

to regulate drugs, biologicals, medical devices, special nutritional and cosmetics

Front 16

Schedule I

Back 16

high potential for abuse
no accepted medical use in US

e.g. heroin, opium derivatives, hallucinogenics

(controlled substances)

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Schedule II

Back 17

high potential for abuse
may lead to physical or psychological dependance
has currently accepted medical use in US

e.g. amphetamines, opium, cocaine, methadone, opiates

(controlled substances)

Front 18

Schedule III

Back 18

potential for abuse less than sched. I and II
currently accepted med. use in US
may lead to moderate or low physical dependence, or high psychological dependence

e.g. anabolic steroids, compunds with limited narcotics (eg codeine)

(controlled substances)

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Schedule IV

Back 19

lower potential for abuse than sched. I-III
may lead to limited physical or psychological dependence
e.g. phenobaribital, sedative chloral hydrate, anesthetic methohexital

(controlled substances)

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Schedule V

Back 20

lower potential for abuse
abuse may lead to limited physical or psychological dependence

e.g. substances containing limited amounts of narcotics, eg codine

Front 21

controlled substances prescriptions

Back 21

greater requirements (fed and state levels), especially schedule II

DEA # must be on form

patient's full street address must be entered

schedule II, form signed by prescriber
-many states: time limits on prescription filling, limited quantities and low refills

schedule III-V may be refilled up to 5 times in 6 months (but see state regulations)

Front 22

"The Orange Book"

Back 22

Approved Drug Products with Theraputid Equivalence Evaluations

provides 2-letter eval code (First letter: A has therapeutic equivalents, B does not)
(Second letter: additional infor on basis of FDA evaluation)

can be found at www.fda.gov/cder/ob/default.htm

Front 23

DEA Form-224

Back 23

application for new registration

Front 24

DEA Form-224a

Back 24

renewal application for registration

Front 25

DEA Form-224b

Back 25

retail pharmacy registration affidavit for chain renewal

Front 26

DEA Form-222

Back 26

U.S. official order forms -- schedule I and II

Front 27

DEA Form-41

Back 27

registrants inventory of drugs surrendered

Front 28

DEA Form-106

Back 28

report of theft or loss of controlled substances

Front 29

DEA Form-363

Back 29

new application registration-- narcotic treatment program

Front 30

DEA Form-363a

Back 30

application for DEA registration-- narcotic treatment program renewal registration

Front 31

DEA Form-510

Back 31

application for registration-- for chemical registration

Front 32

DEA Form-222

Back 32

used to order C-I and C-II substances

copy 1: retained by supplier
copy 2: forwarded to DEA
copy 3: retained by purchaser (e.g. a pharmacy)

Front 33

Class I recall

Back 33

strong likelihood that product will cause serious adverse effects or death

Front 34

Class II recall

Back 34

product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects

Front 35

Class III recalls

Back 35

product is not likely to cause adverse effects

Front 36

Disease State Management Services

Back 36

Programs provide one-on-one pharmacist-patient consultation sessions to help manage chronic diseases or conditions

Front 37

formulary

Back 37

a list of drugs stocked at the hospital which have been selected based on therapeutic factors as well as cost

Front 38

closed formulary

Back 38

requires physicians to order medications from the formulary list

Front 39

non-formulary

Back 39

drugs not on the formulary list

Front 40

Computerized Physician Order ENtry (CPOE)

Back 40

computer system allows physician to enter medication order directly into hospital computer system

Front 41

JCAHO

Back 41

Joint Commission on Accreditation of Healthcare Organizations, accreditation agency for healthcare organizations. Organizations undergo a JCAHO survey every 3 years

(hospital)

Front 42

sharps container

Back 42

needles, etc. (sharp stuff) always thrown away in designated sharps container