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133 Cards in this Set

  • Front
  • Back
3 Legal Problems a pharmacist should avoid
Regulatory=lose license
Civil law-get sued
Criminal law-go to jail
Who should Emergency B plan approved for
OTC-women 18 and older-stocked behind counter
What started begginning of FDCA and why
1906-with Pure Food and Drug Act, prompted by unsanitary practices in food and drug industries
1906 Pure Food and Drug act required what?
prohibitied adulteration adn misbranding of food and drugs
When was Pure Food and Drug act amended and why
1912-prhibited false and fraudulent EFFICACY claims
What happend after Pure Food and Drug act?
1938 Federal Food, Drug and Cosmetic Act (FDCA)
Why was FDCA enacted?
promopted by 107 deaths from sulfa elixer with (car antifreeze) (diethylene glycol)
What did FDCA require
new drugs must be proven to be SAFE
What happened to drugs enatated before 1938
exempted from safety...(ASA and warfarin)
What in 1951
1951 Durham-Humphrey Amendemnts
What did 1951 Durham-Humphrey Admendment establish
2 classes of drugs:
Rx (prescription and OTC)

also authorized ORAL prescriptions and refills
What happend in 1962
Kefauver-Harris Amendmentby th
What promoted Kefauver-Harris Admendment?
thalidomide diaster in Europe, which causes birth defects
What did 1962 Kefauver-Harris require
drugs must be provent o be EFFECTIVE
What did 1962 Kefauver-Harris do
retro-active to drugs since 1938, adn established GMP
and required "informed consent" of research subjects during trials
What happen in 1997
FDA Modernization ACT
What did FDA modernation act require
prescription labels must contain "RX only", and allow durg manufactor to provide off label use
What are adulterated drugs
drugs that contain filhty, putrid or decomposed material or in unsanitary conditions--, bottle is composed of poisonious substance, quality or strenth reduced by addition of other substances(happens INSIDE bottle)
What are misbranded durgs
labeling false or misleading or inadequte, or statements displayed not easily displaced or understood
Did FDA require registration of phamacies?
no ONLY drug manufactors/processors must be FDA registered
What must maufactuered/distributor inlcude to prevent misbranding
generic name, formuala with each ingredient adn quantity, information on effectiveness, adn side effects and contradiction
What is a drug
article intended for mdtcp prevenion of diesase in humans or aminals
An item is considered a drug if its recognized by
US pharmacopeia, homeopathic parh, or national formulatry
A drug can also be classified by "intent"
-must intent to affect sturuture or fuction, and maufactors intent
What are prohibited acts
adulteration/misbranding of drug
delivery or recptis of adulterated/misbranded drug
How does FDA enforce FDCA
criminal proceding
drug seizure
What are penalties for violating FDCA
1ST offense-1 yr in prison, 1000 fine
2nd offense or fraud: 3 years adn 10,000
What are civil penalties
after 2nd offense, 50,000-1M
WHat must prescription label contain
1. Name and Full address of pharmacy
2 Pt Name, 3. Doc Name
4. Date 5. Rx #
6. Directions
7. Medication Name
8. Cautionary labels
Who regulates compounding
State borad
Regulation of compounding
prepared for 1 pt
immediate demand
no advertising
Are compounding pharmacies exempt from NDA and GMP?
Who regulates manufactoring
FDA inspected and regulated
Can manufactoring make drugs for future demands, adn make inordinate amts
What does 1997 FDAMA allow
compounding as long as pharamy does not advertise compounding of a particular drug
Are Rx from other states honored? another country
YES, illegal to fix an RX from a foriegn country
How many clasess are there of FDA drug recalls
Class I, II, III
What is Class I recall
product causes serious adverse effects or death
What is Class II recall
product causes temporary adverse effects on health
What is Class III recall
product not likely to cause adverse effects on health
What are most Class III recalls
labeling problem
Who is responsbile for employee FDCA violater
empolyeer or responsbile person
What is CSA
controlled substance act
What is purpose of CSA
closed distribution of drugs with potential for addition or abuse
Who enforces Federal CSA
DEA (drug enforcement administration) withn US dept of Justice
What are Schedule I drugs
Drugs with high potential for abuse-AND no ACCEPTED medical use in US
What does Teaxs allow
written uncontrolled from Canada, adn Mexico
Examples of Schedule I
heroin, LSD, peyote, pot, ecstasy, mescaline
What are medical uses of pot
pain reflief, n/v, MS, appetite stimulant, glaucoma, HIV/AIDS,seizures
How many states have legalized medical use of pot
11--including COlorado
What year did pot b/c schedule 1
1937--possion of 1 cigg-1 yr in prison
1 plant is 5 years in prison
What is bottom line of Medical Pot
under federal law, use and distribution of pot illegal
Can pharmcise dispense pot
NO, Doc's cannot issue presciption
What must you have to have pot in state, adn who issues
Medical Marijuana Registry Card, by Colorado Dept of Public Health adn Environment
What does Medical Marijuana card let you do
posess, aquire, grow, use, and transport pot/paraphenali
How much pot can you have with Medical registry card for $110
2oz, usable, and up to 6 plants < 3 mature
What is Measure I-100
persons > 21 can posses up to 1 oz pot, not restircted to medical use
Despite Measure I-100, what will hapeen will you have pot
possession charge under state law--$200 dollars
In summmary Federal Law, adn Colorado state law
possion is illegal CSA
-state-can use if for debilitating medical purposes
What law for City of Denver
Persons 21 and odler can posses up to 1oz pot
What are Schedule II Drugs
High potential for abuse (same as CI) BUT ACCECPTED US medical USE
CII's have what type of physical or psysch dependence potential
What schedule is cocaine
What schedule is "INE's) morphine, codeine, cocaine, methamphetamine, amphetamine, meperidine
What schedule is ONE's and barbial's hydrocodone, oxycodone, oxymorphone, methadone, hyddromorphone
pentobarbital, and amobarbital
What is Tylox and Dilaudid
What changes can pharmacist make to CII
PT address, Drug strenght, Drug quantity, Direction, adn issue
What cannot RPh change
Patient Name, Signature, and DRUG--expect generic
What are Schedule III Drugs
decrease potential for abuse, and accept US medical use
What type of physcial and pyscholog dependence potential does CIII have
moderate to low-physical dependence
and HIGH pysch dependence
Examples of CIII
Tylenol #3, Vicodin, anabolic steroids
What are Schedule IV
Decrease potential for abuse, adn accepted medical use
What type of phsycial and psych dependence does IV have
low to liminited physical adn pysch dependence
Example of Schedule IV
Darvocet, benzo's, adn phenobarb
What are schedule V
LOW potentional for abuse, adn accepted medical use
WHat are type of physcial and psych dependence does V have
EXTREMELY low for both
Example of CV
Elixeris for cold, Lomotil, Robitussin AC adn Tylenol w/ Codeine
Does every pharmacy that dispenses a controlled substance register with DEA
Who must also register with DEA
manufators, distributors, precribers, adn exporter, importers and reserachers
Are SEPARATE registration required for each pharamcy in chain?
How often must pharmacy registered with DEA
every 3 years, adn availabe upon inspection
What changes must you give DEA prior notice of
change of name or address, or going-out-of business
What can interns/hospital empolyyees use for DEA
hopital DEA number + internal code
What to letter in DEA # mean

A--when assigned after or before 1986
Second letter is 1st inital of last name
A Rx for a controlled substance must be issued for
a ligitimate medical purpose!!!!
Is drug addition a ligitmate medical purpose
What is cooresponding duty of pharmacist
to ensure drugs on given on a ligitamte purpose
Can a CS be given to a precriber's office for office USE
What is CSA labeling requirement for CII, CIII and CIV adn NOT CV
Caution: federal law prohbitis the transfer of thsi drug to any person other than the patient for whom it was prescribed
How long must CS records be kept
2 years
Do CS reaquire inverntory on 1st date of activity
What type of info does inventory require
date, time and drug (strenth, form and #)
Do CII require exact count?
What do CII, IV, adn V require
estimated count unless bottle is more than >1000--exact
How often do you being a new CS inventory
every 2 years
What form is need to receipt of CII
form 222--needs to be kept separate from invoices
What does Colorado require for filing RXs
3. All non- CS drugs
What practitioners cannot prescibe CS
military docs, public health substances, adn Bureau of Prison
What addition name must be on a CS RX
Prescirber full name and address
1 Pt address
2 Precribers DEA
3 # of refills
How long do you have to fill CII
one year
How often can CIII-CV be transfered
Who is exception to transfer adn why
Kaiser--keeps prescription # the same
How often can CIII, CIV, CV be filled
5x in 6 months
Exception to hard copy of CII
LTC, hospice, adn home infusion/IV pain, or in emergency sitituation
How can a drug be prescibed for emergency situation?
immediately transcribed to writing
quanlity limited to emergy
GOOD faith effort (authcenticity)
postmarker within 72 hrs
Regulation for partial fills and exceptions
need to pickup with 72hrs
-exception LTC, or "terminally ill on RX" have 60 days
Narcotic can only be written for pain EXCEPT for
narcotic treatment programs
Are script written for NTP
Must all DOC and hospital register with DEA for NTP
Can a non-NTP administer narcotics
yes, but not more than 1 days of meds for MAX 3 days
What is Buprenorphine expection
drug that does not need to be adminstered at NTP
What class and indication is Buprenorphine
for long-term treatment of opioid dependency
What is differance between Subutex adn Suboxone
Subutex--for induction
Suboxone--for long-term
What drugs has naloxone to deter crushing and injecting tablets
Suboxone-long-term treatment
If a doc dispensing Buprenohpine--what special DEA do they have
1st letter is X
What is only way a prescrption can be written for Nacotric dependency
Buprenorphine, and doc's DEA has X
IF there is signigant loss or drug theft who must you IMMEDIATELY notify and form
1. DEA
2. Police
3. State Board,
and form 106 (2 copies to DEA)
Does CS destruction need approval by
DEA or State agency
If you are approved to destroy CS, what else to you need
2 pharmacy witness
or DEA, or DEA-registered distributor
What is max % of CS you can dispense in a calender year
What is differance between Fiorinal and Fioricet?
Pharmacist who dispense CS must be liscened with
Colo Borad of Pharmacy
Who must Pharmacy board notify if your Colorado License is revoked
Is it unlawful to have licence or keep records
Is is against law to not properly label a prescription
Can you sell a CV on an OTC basis
NO--Colorado Law sales NO
Can you have unlimited refills of CV
NO--CIII,CIV,CV only have 5 refills in 6 months
Is it a felony to possess methamphetamis precurose with intent to manufacture CS
What is most PSE you can purchase in 24hrs and age
no more than 3.6 grams/person/day, at least 18
What is PSE max in 30 days
9 grams
What records need to be maintain for selling of PSE
Sale date/time, product name, quantity, and buyers name adn address
When is a photo ID needed
>60 mg sold
Do all retail staff need to be trained