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

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)

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

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

Controlled Substances: Schedule I-V

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

FDA promotes marketing/research for treatment of rare diseases

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

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.**

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)

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.

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:________

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

OTC labeling must contain:

(5)

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)

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

(9)

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

Package insert must contain

(7)

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)

Package inserts must be distributed with the following drug classes

(6)

1. oral contraceptives

2. estrogen-containing & progestational drugs

3. intrauterine contraceptive devices

4. diethylstilbestrol products

5. accutane

6. metered dose inhalers

National Drug Code (NDC)

1. First 5 numbers: ____

2. Next 4 numbers: ____

3. Last 2 numbers: ____

1.  mfr

2. specific drug

3. pkg size

Schedule Drugs (Controlled Drug Substance- CDS)

Schedule 1

NO accepted medicinal use in United States

Highest abuse potential

*heroin, peyote, LSD, marijuana, mescaline

Schedule Drugs (Controlled Drug Substances-CDS)

Schedule II

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

Schedule Drugs (Controlled Drug Substances-CDS)

Schedule III

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

Schedule Drugs (Controlled Drug Substances-CDS)

Schedule IV

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

Schedule Drugs (Controlled Drug Substances-CDS)

Schedule V

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

*antitussives with codeine, antidiarrheals with opioid

Schedule Drugs (Controlled Drug Substances-CDS)

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

Filing Schedule and Dangerous Drugs

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

Once every 2 years

2 years

Filing Schedule and Dangerous Drugs

Prescription filing methods:

(3)

*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)

Forms for Controlled Drug Substances

DEA 222

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

Forms for Controlled Drug Substances

DEA 106

report lost or stolen controlled substances

mandatory when 5% yearly product sold is missing

Forms for Controlled Drug Substances

DEA 41

document destruction of controlled substances

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

Forms for Controlled Drug Substances

DEA 224

Forms for Controlled Drug Substances

DEA 363

Forms for Controlled Drug Substances

DEA 225

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.

Pharmacy Resources

Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

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

Pharmacy Resources

USP/NF: Pharmacopoeia/National Formulary

Book of standards:

contains monographs & chemical characteristics.

published by private organization

Pharmacy Resources

USPDI US Pharmacopoeia Dispensing Information

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

Pharmacy Resources

US Pharmacopoeia General Chapter 797

procedures & requirements for pharmaceutical compounding of sterile preparations

usp797.org

USP 797.org

Pharmacy Resources

Drug Facts and Comparisons

*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

Pharmacy Resources

Drug Topics Red Book

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

"Gosh!! PMS is BS!!"

Pharmacy Resources

Handbook on Injectable Drugs

Pharmacy Resources

Physician's Desk Reference (PDR)

*contains packet insert drug info intended for physicians.

*publislhed annually

*color pictures

*list of mfrs, address, phone number

Pharmacy Resources

Mosby's Complete Drug Reference

lists generics in ABC order

contains additional drug info

Pharmacy Resources

American Drug Index

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

list of mfrs, address, phone number

Pharmacy Resources

The Handbook of Injectable Drugs

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

Shows compatibility, solubility, & stability of meds

Pharmacy Resources

Material Safety Data Sheets (MSDS)

*info on hazardous materials that may be in pharmacy

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