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PTCB ch 1 Laws
Pharmacy Law
46
Pharmacology
Undergraduate 1
12/15/2009

Additional Pharmacology Flashcards

 


 

Cards

Term
1906 Federal Food & Drug Act
Definition
prohibits sale of adulterated or mislabeled food, drinks, & drugs
Term
1914 Harrison Narcotic Act
Definition
Limits transport of opium... rx required
Term
1938 Food, Drug, & Cosmetic Act
Definition

Makes Food & Drug Act include cosmetics

Defines "misbranding" & "adulteration"

1. package inserts required

2. label habit forming drugs "may be habit forming"

3. proven safe under FDA guidelines before marketing

Term
1951 Durham-Humphrey Amendment
Definition

Distinguish RX from OTC

1. RX:"Caution: Federal Law Prohibits dispensing without a prescription"

2. Physician supervision for purchase of RX

3. OTC w/o medical supervision must have on label:

a. Product Name

b. Name & Address of Manufacturer/distributer

c. Active Ingredients

d. Qty of certain other ingredients (active or not)


Term
1962 Kefauver-Harris Amendment
Definition

Drugs made after 1938 have to be PROVEN SAFE & EFFECTIVE (b/c of birth defects from thalidomide in Europe)

1. Requires "Good Manufacturing Practice"=GMP

2. Safe & Effective before marketing

3. Federal Trade Commision (FTC) handles drug advertisement

4. Manufacturer must:

a. Register annually

b. Report adverse rxns

c. Be inspected every 2 yrs

Term
1970 Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act-CSA)
Definition

Drug Enforcement Agency (DEA) formed (Justice Dept.)

Controlled Substances: Schedule I-V

Term
1970 Poison Prevention Packaging Act
Definition

Childproof packaging on most drugs dispensed in pharmacy

Exempt:

drugs used in emergency (nitro)

packaged in small qty that wouldn't harm child under 5

Term
1983 Orphan Drug Act
Definition

FDA promotes marketing/research for treatment of rare diseases


Term
1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Ammendment)
Definition

1. Streamlines process for granting approval of generics
2. Gives manufacturers incentive to develop new drugs
3. Generic drug co's rely on safety/efficacy of innovator after patent expiration

Term
1988 Food and Drug Administration Act
Definition

Established FDA as agency of Dept. of Health & Human Services

***Adverse Rxn's/outcomes reported to FDA***


**ALSO in 1988, RX DRUG MARKETING ACT  established.. banned sale, trade, purchase of drug samples.**


Term
1990 Omnibus Budget Reconciliation Act (OBRA)
Definition

REQUIRES pharmacists to ATTEMPT to OFFER to COUNSEL patients on all new RX


*Pharmacists required to give info. on any drug dispenced (name, description, how much to take, side effects, contraindications, interactions, adverse effects, storage, refill info, & what to do if dose missed)

Term
1996 Health Insurance Probability and Accountability Act (HIPAA)
Definition

Rules/Regulations regarding privacy/security of patient health info (PHI)

*Limitations stating who can access, distribute, receive PHI

*Makes health insur portable for employees switching jobs

*Includes provisions making health care more cost effective by standardized electronic transmissions of claim info.

Term
2006 Combat Methamphetamine Epidemic Act (CMEA)
Definition
Limits purchase of psuedodephedrine (pse) products to 3.6g of pse/day AND 9g/30 days
Term

Product Recalls

 

When pharmacy notified of drug recall, ____ & ____ are used to identify the drugs

1. CLASS 1 RECALL:________

2. CLASS 2 RECALL:________

3. CLASS 3 RECALL:________

Definition

lot number & expiration dates

1. Attempt made to NOTIFY PATIENT drug could cause serious harm or death

2. Probability of serious harm NOT LIKELY & effects temporary/reversibe. Does NOT go to customer level & usually due to probs with consistancy of potency

3. Not likely to cause serious effects and Does NOT go to customer level

Term

OTC labeling must contain:

(5)

Definition

1. name of product, address of mfr/packer/distributer

2. net contents of pkg

3. name of ALL active & qty of certain others (active or not)

4. name of habit forming drugs in product & warnings to protect customer

5. adequate directions for use

a. drugs intended conditions for use

b. normal dose used for indication, age, & physical condition

c. frequency & duration of admin. &/or application in relation to meals, onset of sympt., or other time factors

d. route, method, application of administration

e. required preparations for use (if any)

Term

Food, Drug, & Cosmetic Act (FDCA) requires RX labels to contain:

(9)

Definition

1. name, address, phone # of dispensing pharmacy

2. patient & doctor name

3. RX # & date RX filled

4. name of drug, strength, qty, & directions

5. name/initials of dispensing pharm./tech.

6. patient address

7. expiration date, refill info, precautions

8. statement: "FEDERAL LAW PROHIBITS DISPENSING W/O A PRESCRIPTION"

9. pkg insert on selected drugs

Term

Package insert must contain

(7)

Definition

1. Description of drug

2. clinical pharmacology

3. indications and usage

4. contraindications, precautions, warnings, adverse rxns

5. drug abuse, dependence, & overdose info

6. dosage, administration, & how drug is supplied

7. date of most recent labeling revision

(3d iPaw)

Term

Package inserts must be distributed with the following drug classes

(6)

Definition

1. oral contraceptives

2. estrogen-containing & progestational drugs

3. intrauterine contraceptive devices

4. diethylstilbestrol products

5. accutane

6. metered dose inhalers

Term

National Drug Code (NDC)


1. First 5 numbers: ____

2. Next 4 numbers: ____

3. Last 2 numbers: ____

Definition

1.  mfr

2. specific drug

3. pkg size

Term

Schedule Drugs (Controlled Drug Substance- CDS)

 

Schedule 1

Definition

NO accepted medicinal use in United States

Highest abuse potential


*heroin, peyote, LSD, marijuana, mescaline

 

Term

Schedule Drugs (Controlled Drug Substances-CDS)

 

Schedule II

Definition

May not be refilled

ORDERING requires DEA 222 form

RETURNING requires DEA 222 form

High abuse potential: severe physical/psychological dependence

*cocain, morphine, amphetamines, codeine, opium, methadone, oxycodone, hydromorphone, fentanyl, meperidine, methylphenidate, secobarbital

Term

Schedule Drugs (Controlled Drug Substances-CDS)

 

Schedule III

Definition

May be refilled 5 times in a 6 month period

Less potential for abuse/dependence than schedule I or II


*vicodin (hydrocodone/acetaminophen), tylenol #3 (codeine/acetaminophen), marinol (drobabinol), anabolic steroids (testosterone), cough syrups containing hydrocodone


Term

Schedule Drugs (Controlled Drug Substances-CDS)

 

Schedule IV

Definition

May be refilled 5 times in a 6 month period

Less potential for abuse/dependence than schedule II or III

 

*benzodiazepines (alprazolam, diazepam, lorazepam,etc.), phentermine, pentazocine, phenobarbital, diethylpropion

Term

Schedule Drugs (Controlled Drug Substances-CDS)

 

Schedule V

Definition

Less potential for abuse/dependence than schedule II, III, IV

 

*antitussives with codeine, antidiarrheals with opioid

Term

Schedule Drugs (Controlled Drug Substances-CDS)

 

Schedule II-V drugs must have an auxiliary label that states: ____

Definition
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
Term

Filing Schedule and Dangerous Drugs

 

* A controlled substance inventory must be done at least _____, and the records must be kept at least _____


Definition

Once every 2 years

 

2 years

Term

Filing Schedule and Dangerous Drugs

 

Prescription filing methods:

(3)

Definition
*Two File System:
1.  CII-CV, must contain a red C at least one inch high stamped on the lower right hand corner  of rx.
2. all other rx

*Two File System: 

1.  CII only

2. all other rx (non controlled & CIII-CV)  all CIII-CV contain a red C at least one inch high stamped on lower right hand corner of rx

*Three File System:

1. CII only

2. CIII-CV

3. all other rx (non controlled)

Term

Forms for Controlled Drug Substances

 

DEA 222

Definition

Used for purchasing & returning of outdated CII drugs


Comes in 3 copies:

1. BLUE copy: purchaser keeps on file at least 2 years (pharmacy usually purchaser, except when sending back, then becomes seller)

2. Green copy: seller sends to local DEA

3. Brown copy: seller keeps on file

Term

Forms for Controlled Drug Substances

 

DEA 106


Definition

report lost or stolen controlled substances

mandatory when 5% yearly product sold is missing

Term

Forms for Controlled Drug Substances

 

DEA 41

Definition

document destruction of controlled substances

 

The band Sum 41 has a song, "introduction to destruction"

Term

Forms for Controlled Drug Substances


DEA 224

Definition
needed for pharmacy to dispense controlled substances
Term

Forms for Controlled Drug Substances

 

DEA 363

Definition
needed to operate a controlled substance treatment program OR compound controlled substances
Term

Forms for Controlled Drug Substances

 

DEA 225

Definition
needed to manufacture or distribute controlled substances
Term
Verifying the validity of a doctor's DEA number
Definition

2 letters followed by 7 numbers

1st letter: A or B. 2nd letter: 1st letter of doctors last name

Formula: (1st +3rd +5th) + 2(2nd +4th +6th).

The total's last # should = last # of  DEA


EX: AH1264869

1+6+8=15... 2+4+6=12...2x12=24...15+24=39.. last number should be 9.


Term

Pharmacy Resources

 

Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Definition

compares therapeutic equivalency of drugs using A-B rating system.. determines if certain drugs may be substituted in place of others

A rated: bioequivalent: can be substituted

B rated: not bioequivalent: can't be substituted

*Published yearly

*AKA: FDA;s approved drug products publication

Term

Pharmacy Resources

 

USP/NF: Pharmacopoeia/National Formulary

Definition

Book of standards:

contains monographs & chemical characteristics.


published by private organization

Term

Pharmacy Resources

 

USPDI US Pharmacopoeia Dispensing Information

Definition

3 volume set:


Volume 1: Drug info written for health care provider

Volume 2: Drug info written for patients

Volume 3: Therapy equivalency info & pharmacy law

Term

Pharmacy Resources

 

US Pharmacopoeia General Chapter 797

Definition

procedures & requirements for pharmaceutical compounding of sterile preparations

 

usp797.org

 

USP 797.org

Term

Pharmacy Resources

 

Drug Facts and Comparisons

Definition

*listing of drugs & comparative drugs

*organized by therapeutic class & provides general info with a list of monographs

*listing of mfrs with address & phone #

 

*Updated monthly

Term

Pharmacy Resources

 

Drug Topics Red Book

Definition

listing of drugs by PRICING, Strength, Sizes, Mfrs, Brands, & Generics

 

"Gosh!! PMS is BS!!"

Term

Pharmacy Resources

 

Handbook on Injectable Drugs

Definition
lists injectable drug info such as compatability, storage, & dosages
Term

Pharmacy Resources

 

Physician's Desk Reference (PDR)

Definition

*contains packet insert drug info intended for physicians.

*publislhed annually

*color pictures

*list of mfrs, address, phone number

Term

Pharmacy Resources

 

Mosby's Complete Drug Reference


Definition

lists generics in ABC order

contains additional drug info

Term

Pharmacy Resources

 

American Drug Index

Definition

Drugs listed ABC order, provide brand, generic, & chemical names for drug

list of mfrs, address, phone number

Term

Pharmacy Resources

 

The Handbook of Injectable Drugs

Definition

determine compatibility of meds that will be used in an IV bag

Shows compatibility, solubility, & stability of meds

Term

Pharmacy Resources

 

Material Safety Data Sheets (MSDS)

Definition

*info on hazardous materials that may be in pharmacy

*info on disposal, storeage, safe use, & clean up

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