law midterm

pure food and drug act

adulteration of food and drugs

misbranding

food, drug cosmetic act

safe before marketing

direction of use

warning of habit-forming drugs

durham-humphrey amendment

distinction between prescription and OTC medications

kefauver-harris amendment

safe and effective

good manufacturing practices (GMP)

waxman-hatch amendment

streamline generic drug approval process

prescription drug marketing act

hospitals and healthcare entities prohibited from re-selling drugs

federal anti-tampering act

tylenol contamination event

tamper-resistant

REMS for NDA

patient package insert

communication plan

ETASU

implementation system

REMS for ANDA

package insert

ETASU

implementation system

ETASU requirements

special certifications

specially certified

dispensed certain healthcare settings

dispensed with evidence of safe-use conditions

pt monitoring

pt registry

patient protection and affordable care act

patient access

FDA safety and innovation act

FDA collect fees for NDA, medical devices, generics, biosimilar

adulteration

whole or partly filthy, putrid or decomposed substance

misbranding

distinction between rx and OTC medications

use by date

after drug is moved from original container

product recalls

class i

serious

product recalls

class ii

reversible consequences

product recalls

class iii

not likely to cause adverse consequences

product recalls

voluntary

not determined to cause health issue but manufacturer is urged to recall

pregnancy category x

contraindicated

pregnancy category c

risk can’t be ruled out

pregnancy category a

Human studies show no risk

pregnancy category d

Known fetal risk

pregnancy category b

No demonstrated human fetal risk

medical device

class i

least potential harm

scissors, needles, gloves, toothbrushes

medical device

class ii

moderate - FDA performance standards for safety

insulin syringes, infusion pumps, thermometers

medical devices

class iii

highest - potential injury

pacemakers, heart valve, soft contact lens

lanham trademark act

prohibits false description

allows civil law suits

FDA guidance policy

education separate from drug promotion

manufacturer involvement limited

department of health and human services - office of inspector general

manufacturers no control educational programs or use payments to reward

product claim ads

Drug + Disease + Benefit

Drug X treats hypertension and helps lower blood pressure

Reminder ad

Drug Only

Ask your doctor about Drug X

Help-seeking ad

Disease Only

Do you experience persistent migraines? Talk to your doctor about treatment options

what does FTC and FDA collaborate on?

OTC products and claims regarding food product

INDA

phase i

adverse effects

INDA

phase ii

efficacy and dosage

INDA

phase iii

safety and efficacy in large populations

supplemental new drug application changes

production

manufacturing

labeling

all trail phases must have patient written consent and explain…

risk

benefits

alt courses of therapy

OTC

category i

Safe and effective

OTC

category ii

not safe or effective

OTC

category iii

Not enough information

how should the patient name, brand/generic, directions should appear?

larger font

different color

bolded

expiration date

manufacter date

beyond use date

compounding dispenser

use by date

dispensing pharmacy

sale of emergency contraception

17+ yr → OK

rx: 16yr and younger

do pharmacist have the right to refuse dispensed prescriptions?

yes but needs to give pt alternative

orange book

A: equivalent

B: problems

AB: thought was a problem → is good now

purple book

biosimilars

prescription drug marketing act

No selling drug samples + control of drug distribution + prevention of drug diversion

can you deny drug insepection from…

FDA: NO

BOARD: NO

DEA: YES unless administrative inspection warrant or search warrant

patient records

everything kept 5 years

4 yr retrieve - 2 weeks

1 yr retrieve - 1 day

what kind of rx can be filled in nj?

any U.S territory

• puerto rico

• virgin island

• VA hospital

what should community pharmacies be registered with to used tax paid ethyl alcohol?

ATF

IRS

tax-free alcohol exemptions are generally reserved for..

Hospitals

research laboratories

authorized institutions

Who can request non-child-resistant packaging under the Poison Prevention Packaging Act (PPPA)?

prescriber/pt for individual prescriptions

patients may make blanket requests

computer system downtime

enter within 72 hrs

what happens to pt information after you close the pharmacy?

1 yr store records

differences between label in retail & hospital

retail pharmacy - name of prescriber , prescription #

hospital pharmacy - name of person who prepared the sterile compound

CI

dihydromorphine

marijuana

diethylamide (LSD)

psilocybin

morphine methylbromide

THC

CII

morphine

codeine

fentanyl

levorphanol

hydromorphone

oxycodone

methadone

cocaine

methylphenidate

pentobartibal

CIII

APAP w codiene

chlorphentermine

ketamine

narcotics in CIII may not contain more than

Narcotic	Maximum amount
Codeine or dihydrocodeine	1.8 g per 100 mL or 100 g
Hydrocodone (dihydrocodeinone)	300 mg per 100 mL or 100 g
Ethylmorphine	300 mg per 100 mL or 100 g
Opium	500 mg per 100 mL or 100 g
Morphine	50 mg per 100 mL or 100 g

CIV

tramadol

benzos

DEA registration - midlevel practitioners

CDS prescriptive authorities

animal shelters

certified nurse anesthetists

certified nurse midwives

nurse practitioners

optometrist

PA

new application for registering pharmacy

DEA form 224

renewal application for registered pharmacy

DEA form 224a

who can have the key to the pharmacy?

pharmacist/pharmacist in charge

where should diprenorphine and etorphine HCL be stored?

safe or steel cabinet that is CV container

theft, diversion or loss

notify DEA within 1 business day of significant loss or theft

DEA 106 form → forward copy to NJBOP, record amendment key #

opioid treatment program must be reaccredited and recertified every…

3 years

who is the opioid treatment program enforced by?

substance abuse and mental health services administration

opioid treatment program

maintenance tx

opioid agonist >21 days

combatting methamphetamine epidemic

pseudoephedrine or phenylpropanolamine - behind the counter

purchaser: 18 yr+ and gov ID

quantity limits of

pseudoephedrine or phenylpropanolamine

no > 3.6 gm/day

no > 9 gm/month

no > 7.5gm/month if mail order

CDS DEA registration #

practitioners letter starts with

A,B,F

CDS DEA registration #

mid-level practitioners start with the letter

M

CDS DEA registration #

distributors start with the letter

P or R

CDS DEA registration #

second letter

first letter of PERSON’S last name

if business name begins with a #, the second character of its DEA registration number may be the digit

confirming DEA registration #

add 1st,3rd,5th= x

add 2nd,4th,6th= y

multiply yx2= z

add x+z= D

last digit should be the DEA #

what can’t pharmacist do when correcting a CDS prescription?

pt name

CDS prescribed

prescriber signature

can a pharmacist dispense emergency verbal or faxed CII?

yes only covering emergency period, NO REFILLS

prescriber must send written copy to pharmacist within 7 days

post 7 days - report to DEA office

what if pharmacist is unable to fill partial CII?

notify prescriber after 72 hrs

must fill balance within 72 or new rx is needed

CII partial refill

long term care facility

up to 60 days for terminally ill

dispensing CIII,CIV,CV

refills

no >6m or 5 refills from original date of issue

dispensing CIII,CIV,CV

partial refills

no dispensing occurs after 6m of original issue

CDS inventory record

biennial

CII and CIII-CV must be on separate reports

CI and CII must have separate counts

DEA 222 form

sale or transfer of CDS to another pharmacy (reverse distributor)

DEA form 106

theft

DEA form 41

CDS disposal

DEA 222 form

brown page (page 1)

supplier keeps for records

DEA 222 form

green (page 2)

sent to DEA at the end of the month

DEA 222 form

blue (page 3)

purchaser keeps for records

how long to keep DEA 222 form

state - 5yrs

CSA/DEA - 2 yrs

what happens when DEA 222 forms are lost?

notify DEA and provide serial number of forms

electronic DEA 222 FORM

control substances ordering system

submit to DEA

must have power of attorney to order CDS

when should you report diversion, loss, and theft?

within 24 hrs of discovery

Omnibus Budget Reconciliation Act

patient counseling

drug utilization review (DUR)

patient profiles

HIPPA

4 aspects

Transactions = Standardized billing

NPI = Provider identification

Security = Protect electronic information

Privacy = Protect patient confidentiality