chapter 2 test study

1906 pure food and drug act

one of the first laws to stop the sale of inaccurately labeled drugs and started the misbranding concept

1914 harrison narcotic act

regulated and taxed opiates and cocaine

1938 federal food, drug, and cosmetic act

required drugs to be labeled with adequate directions for safe use and established FDA’s authority / added on to misbranding from 1906 act and added adulteration

1951 The Joint Commission (TJC)

ensures healthcare safety and quality through accrediation

1951 durham-humprhey amendment

required more for labeling, certain drugs needed a physicians order, and made the difference between OTC and prescription drugs

1962 kafauver-harris amendments

required proof of drug effectiveness before FDA approval

1970 comprehension drug abuse prevention and control act

created drug schedules (C-I - C-V)

1970 poison prevention packaging act

required child resistant packaging for most drugs

1971 Occupational safety and health administration (OSHA)

oversees safety in the workplace and created safety data sheet requirements (SDS)

1972 drug listing act

assigned NDCS (National drug codes) to all drugs

1983 orphan drug act

provided support in the creation of drugs for rare diseases

OBRA-87

improved the quality of care in nursing homes

1987 prescription drug marketing act

prevented counterfeit drugs and regulated drug distrubution

1990 omnibus budget reconciliation act (OBRA-90)

required pharmacists to consult medicaid patients

1996 health insurance portability and accountability act (HIPAA)

protected patient health information

2000 drug addiction treatment act

allows practitioners to administer narcotic controlled substances in schedules 3-5 for the purpose of narcotic addiction treatment

2003 medicare modernization act

provided prescription drug coverage for the elderly and gave private health plans

2005 combat methamphetamine epidemic act (CMEA)

regulated the OTC sale of ESE, PSE, and PPA by daily and monthly limits for buying (Pseudophedrine, Phenylpropanolamine, and ephedrine)

2006 dietary supplement and nonprescription drug consumer protection act

requires that labels of a dietary supplement include description of product, address, number, that it is a dietary supplement and more.

2010 patient protection and affordable care act
(ACA)

expanded healthcare coverage and implemented electronic health records

2013 drug quality and security act (DQSA)

established fda tracking for bulk compounding supplies

CLASS 1 RECALL

serious risk or fatal

CLASS 2 RECALL

temporary health issues

CLASS 3 RECALL

minor issues, no serious harm

CONTROLLED SUBSTANCES SCHEDULE 1

illegal, no medical use, HIGHEST abuse potential exs- LSD, Heroin

CONTROLLED SUBSTANCES SCHEDULE 2

High abuse potential, no refills ex- fentanyl, codeine

CONTROLLED SUBSTANCES SCHEDULE 3

lower abuse potential 5 refills in 6 months ex-s acetaminophen/codeine, testosterone

CONTROLLED SUBSTANCES SCHEDULE 4

low abuse potential, up to 5 refills in 6 months exs- diazepam or lorazepam

CONTROLLED SUBSTANCES SCHEDULE 5

lowest abuse potential some refills available OTC in states

filling controlled drugs

schedules 2-5 can be accepted by the pharmacy via written, oral, or fax BUT schedule 2 needs the prescription signed by prescriber and presented before it can be dispensed

emergency filling of c2

only filled in a event of emergency, physician cant give written 5x to pharmacist, only can be enough for the emergency, verify the physician as best as possible, has 7 days to present prescription, and must get all info such as a dea form etc.

partial filling

can be partially filled if pharmacy does not have enough in stock amount must be written on prescription and the remaining amount must be filled in 6 months

transferring controlled drugs

schedule 3-5 can be transferred but schedule 2 cannot since it is only one prescription

dispensing without a prescription for controlled drugs rules

the purchaser must be atleast 18, show id, no more than 240 mL of opium can be sold, no more than 120 mL of any other controlled substance, no more than a 48 hour supply may be sold without a prescription , a schedule 5 log book is kept with the information of patient and quantity sold, date dispensed, and pharmacists initials, the log book must be kept for 2 years etc

DEA FORMS- Form 224

form permits pharmcy to dispense controlled substances / must be renewed every 3 years using form 224A

Form 225

to manufacture or distribute controlled substances

form 363

to manage a controlled substance treatment program or compound controlled substances

form 222

to order or transfer schedule 2 substances

who signs DEA form 222

the pharmacist who signed off on DEA form 224 OR a person who has been legally assigned power of attorney by that same pharmacist

what is form 41

authorization to destroy damaged, outdated, or unwanted controlled substances

INFO FOR FORM 41

retail pharmacies may request the form from the DEA and hospitals request a “blanket destruction” form giving them the ability to destroy controlled substances multiple times a year

reverse distributor

all controlled substances that are unwanted, unusuable, or outdated are returned

drug diversion

loss or misuse of drugs

monographs

package inserts or official prescribing information

boxed warning also known as Black Box warning

drug warning that is placed in the prescribing information of the product and indicates a significant risk for potentially dangerous side effects. strongest warning in the US that FDA gives out.

stringent

strict ex- “more strict”

PREGNANCY CATEGORIES- Category A

safe based on studies

PREGNANCY CATEGORIES- Category B

no risk in animals but not enough studies on humans

PREGNANCY CATEGORIES- Category C

animals studies show risks but not human studies

PREGNANCY CATEGORIES- Category D

proven risk in humans but may be used if no other option

PREGNANCY CATEGORIES- Category X

DO NOT USE during pregnancy

NDC CODE

A 10-digit code that indicates specifics and preparations not included in the USP. specifes the drug manufacturer, drug product, and the package size.

risk evaluation and mitigation strategy - it is to manage a known OR potential risk associated with a drug

REMS

drug utilization evaluation- a program for ensuring that prescribed drugs are used properly

DUE

Obra 87 focused more on nursing home reform while OBRA 90 expanded medicaid eligibility, added patient consultation, educational outreach programs, reimbursement limits, increased taxes on tobacco etc, and more.

what’s the difference between OBRA-87 and OBRA-90

who is exempted from childproof containers

physicians request, certain legend medications, hospitalized patients, and specific request by patient

who created controlled substances?

President Richard Nixon

if there is a error who do you report it to?

the FDA

patient rights for HIPAA

• the right to ask/see and obtain a copy of their health records

• the right to have corrections added to their health information

• the right to get noticed of their info being used/shared

• the right to give their permission before their health info is used/shared

• the right to obtain a report on when and why their health info was shared for certain purposes

What is PSE?

Pseudoephedrine

what is drug class

a group of medications that share similar characteristics

Package inserts

the official prescribing information for a prescription drug provided by manufacturer including side effects, dosage form, indications etc.

Safety data sheets

documents that provide chemical product information

how many prescription filling methods are there

three

inventory

the amount of product a pharmacy has to sale