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133 Cards in this Set
- Front
- Back
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3 Legal Problems a pharmacist should avoid
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Regulatory=lose license
Civil law-get sued Criminal law-go to jail |
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Who should Emergency B plan approved for
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OTC-women 18 and older-stocked behind counter
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What started begginning of FDCA and why
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1906-with Pure Food and Drug Act, prompted by unsanitary practices in food and drug industries
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1906 Pure Food and Drug act required what?
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prohibitied adulteration adn misbranding of food and drugs
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When was Pure Food and Drug act amended and why
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1912-prhibited false and fraudulent EFFICACY claims
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What happend after Pure Food and Drug act?
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1938 Federal Food, Drug and Cosmetic Act (FDCA)
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Why was FDCA enacted?
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promopted by 107 deaths from sulfa elixer with (car antifreeze) (diethylene glycol)
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What did FDCA require
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new drugs must be proven to be SAFE
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What happened to drugs enatated before 1938
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exempted from safety...(ASA and warfarin)
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What in 1951
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1951 Durham-Humphrey Amendemnts
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What did 1951 Durham-Humphrey Admendment establish
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2 classes of drugs:
Rx (prescription and OTC) also authorized ORAL prescriptions and refills |
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What happend in 1962
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Kefauver-Harris Amendmentby th
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What promoted Kefauver-Harris Admendment?
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thalidomide diaster in Europe, which causes birth defects
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What did 1962 Kefauver-Harris require
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drugs must be provent o be EFFECTIVE
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What did 1962 Kefauver-Harris do
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retro-active to drugs since 1938, adn established GMP
and required "informed consent" of research subjects during trials |
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What happen in 1997
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FDA Modernization ACT
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What did FDA modernation act require
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prescription labels must contain "RX only", and allow durg manufactor to provide off label use
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What are adulterated drugs
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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)
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What are misbranded durgs
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labeling false or misleading or inadequte, or statements displayed not easily displaced or understood
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Did FDA require registration of phamacies?
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no ONLY drug manufactors/processors must be FDA registered
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What must maufactuered/distributor inlcude to prevent misbranding
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generic name, formuala with each ingredient adn quantity, information on effectiveness, adn side effects and contradiction
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What is a drug
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article intended for mdtcp prevenion of diesase in humans or aminals
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An item is considered a drug if its recognized by
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US pharmacopeia, homeopathic parh, or national formulatry
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A drug can also be classified by "intent"
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-must intent to affect sturuture or fuction, and maufactors intent
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What are prohibited acts
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adulteration/misbranding of drug
delivery or recptis of adulterated/misbranded drug |
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How does FDA enforce FDCA
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injunctions
criminal proceding drug seizure |
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What are penalties for violating FDCA
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1ST offense-1 yr in prison, 1000 fine
2nd offense or fraud: 3 years adn 10,000 |
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What are civil penalties
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after 2nd offense, 50,000-1M
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WHat must prescription label contain
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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 |
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Who regulates compounding
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State borad
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Regulation of compounding
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prepared for 1 pt
immediate demand no advertising |
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Are compounding pharmacies exempt from NDA and GMP?
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YES
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Who regulates manufactoring
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FDA inspected and regulated
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Can manufactoring make drugs for future demands, adn make inordinate amts
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YES
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What does 1997 FDAMA allow
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compounding as long as pharamy does not advertise compounding of a particular drug
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Are Rx from other states honored? another country
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YES, illegal to fix an RX from a foriegn country
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How many clasess are there of FDA drug recalls
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Class I, II, III
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What is Class I recall
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product causes serious adverse effects or death
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What is Class II recall
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product causes temporary adverse effects on health
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What is Class III recall
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product not likely to cause adverse effects on health
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What are most Class III recalls
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labeling problem
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Who is responsbile for employee FDCA violater
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empolyeer or responsbile person
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What is CSA
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controlled substance act
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What is purpose of CSA
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closed distribution of drugs with potential for addition or abuse
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Who enforces Federal CSA
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DEA (drug enforcement administration) withn US dept of Justice
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What are Schedule I drugs
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Drugs with high potential for abuse-AND no ACCEPTED medical use in US
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What does Teaxs allow
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written uncontrolled from Canada, adn Mexico
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Examples of Schedule I
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heroin, LSD, peyote, pot, ecstasy, mescaline
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What are medical uses of pot
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pain reflief, n/v, MS, appetite stimulant, glaucoma, HIV/AIDS,seizures
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How many states have legalized medical use of pot
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11--including COlorado
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What year did pot b/c schedule 1
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1937--possion of 1 cigg-1 yr in prison
1 plant is 5 years in prison |
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What is bottom line of Medical Pot
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under federal law, use and distribution of pot illegal
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Can pharmcise dispense pot
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NO, Doc's cannot issue presciption
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What must you have to have pot in state, adn who issues
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Medical Marijuana Registry Card, by Colorado Dept of Public Health adn Environment
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What does Medical Marijuana card let you do
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posess, aquire, grow, use, and transport pot/paraphenali
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How much pot can you have with Medical registry card for $110
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2oz, usable, and up to 6 plants < 3 mature
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What is Measure I-100
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persons > 21 can posses up to 1 oz pot, not restircted to medical use
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Despite Measure I-100, what will hapeen will you have pot
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possession charge under state law--$200 dollars
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In summmary Federal Law, adn Colorado state law
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possion is illegal CSA
-state-can use if for debilitating medical purposes |
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What law for City of Denver
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Persons 21 and odler can posses up to 1oz pot
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What are Schedule II Drugs
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High potential for abuse (same as CI) BUT ACCECPTED US medical USE
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CII's have what type of physical or psysch dependence potential
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SEVERE
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What schedule is cocaine
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CII
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What schedule is "INE's) morphine, codeine, cocaine, methamphetamine, amphetamine, meperidine
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CII
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What schedule is ONE's and barbial's hydrocodone, oxycodone, oxymorphone, methadone, hyddromorphone
pentobarbital, and amobarbital |
CII
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What is Tylox and Dilaudid
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CII
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What changes can pharmacist make to CII
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PT address, Drug strenght, Drug quantity, Direction, adn issue
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What cannot RPh change
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Patient Name, Signature, and DRUG--expect generic
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What are Schedule III Drugs
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decrease potential for abuse, and accept US medical use
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What type of physcial and pyscholog dependence potential does CIII have
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moderate to low-physical dependence
and HIGH pysch dependence |
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Examples of CIII
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Tylenol #3, Vicodin, anabolic steroids
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What are Schedule IV
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Decrease potential for abuse, adn accepted medical use
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What type of phsycial and psych dependence does IV have
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low to liminited physical adn pysch dependence
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Example of Schedule IV
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Darvocet, benzo's, adn phenobarb
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What are schedule V
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LOW potentional for abuse, adn accepted medical use
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WHat are type of physcial and psych dependence does V have
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EXTREMELY low for both
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Example of CV
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Elixeris for cold, Lomotil, Robitussin AC adn Tylenol w/ Codeine
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Does every pharmacy that dispenses a controlled substance register with DEA
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YES
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Who must also register with DEA
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manufators, distributors, precribers, adn exporter, importers and reserachers
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Are SEPARATE registration required for each pharamcy in chain?
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YES
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How often must pharmacy registered with DEA
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every 3 years, adn availabe upon inspection
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What changes must you give DEA prior notice of
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change of name or address, or going-out-of business
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What can interns/hospital empolyyees use for DEA
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hopital DEA number + internal code
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What to letter in DEA # mean
AU1234563 |
A--when assigned after or before 1986
Second letter is 1st inital of last name |
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A Rx for a controlled substance must be issued for
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a ligitimate medical purpose!!!!
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Is drug addition a ligitmate medical purpose
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NO!!!
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What is cooresponding duty of pharmacist
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to ensure drugs on given on a ligitamte purpose
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Can a CS be given to a precriber's office for office USE
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NO
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What is CSA labeling requirement for CII, CIII and CIV adn NOT CV
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Caution: federal law prohbitis the transfer of thsi drug to any person other than the patient for whom it was prescribed
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How long must CS records be kept
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2 years
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Do CS reaquire inverntory on 1st date of activity
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YES
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What type of info does inventory require
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date, time and drug (strenth, form and #)
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Do CII require exact count?
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YES
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What do CII, IV, adn V require
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estimated count unless bottle is more than >1000--exact
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How often do you being a new CS inventory
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every 2 years
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What form is need to receipt of CII
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form 222--needs to be kept separate from invoices
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What does Colorado require for filing RXs
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1 CII
2. CIII, CIV, CV 3. All non- CS drugs |
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What practitioners cannot prescibe CS
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military docs, public health substances, adn Bureau of Prison
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What addition name must be on a CS RX
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Prescirber full name and address
1 Pt address 2 Precribers DEA 3 # of refills |
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How long do you have to fill CII
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one year
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How often can CIII-CV be transfered
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ONCE
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Who is exception to transfer adn why
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Kaiser--keeps prescription # the same
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How often can CIII, CIV, CV be filled
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5x in 6 months
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Exception to hard copy of CII
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LTC, hospice, adn home infusion/IV pain, or in emergency sitituation
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How can a drug be prescibed for emergency situation?
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immediately transcribed to writing
quanlity limited to emergy GOOD faith effort (authcenticity) postmarker within 72 hrs |
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Regulation for partial fills and exceptions
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need to pickup with 72hrs
-exception LTC, or "terminally ill on RX" have 60 days |
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Narcotic can only be written for pain EXCEPT for
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narcotic treatment programs
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Are script written for NTP
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NO, on ADMINISTRATION
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Must all DOC and hospital register with DEA for NTP
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YES
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Can a non-NTP administer narcotics
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yes, but not more than 1 days of meds for MAX 3 days
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What is Buprenorphine expection
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drug that does not need to be adminstered at NTP
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What class and indication is Buprenorphine
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for long-term treatment of opioid dependency
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What is differance between Subutex adn Suboxone
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Subutex--for induction
Suboxone--for long-term |
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What drugs has naloxone to deter crushing and injecting tablets
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Suboxone-long-term treatment
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If a doc dispensing Buprenohpine--what special DEA do they have
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1st letter is X
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What is only way a prescrption can be written for Nacotric dependency
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Buprenorphine, and doc's DEA has X
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IF there is signigant loss or drug theft who must you IMMEDIATELY notify and form
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1. DEA
2. Police 3. State Board, and form 106 (2 copies to DEA) |
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Does CS destruction need approval by
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DEA or State agency
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If you are approved to destroy CS, what else to you need
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2 pharmacy witness
or DEA, or DEA-registered distributor |
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What is max % of CS you can dispense in a calender year
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5%
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What is differance between Fiorinal and Fioricet?
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Fiorinal--CIII
Fioricet-NON-controlled |
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Pharmacist who dispense CS must be liscened with
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Colo Borad of Pharmacy
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Who must Pharmacy board notify if your Colorado License is revoked
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DEA
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Is it unlawful to have licence or keep records
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YES
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Is is against law to not properly label a prescription
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YES
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Can you sell a CV on an OTC basis
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NO--Colorado Law sales NO
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Can you have unlimited refills of CV
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NO--CIII,CIV,CV only have 5 refills in 6 months
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Is it a felony to possess methamphetamis precurose with intent to manufacture CS
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YES
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What is most PSE you can purchase in 24hrs and age
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no more than 3.6 grams/person/day, at least 18
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What is PSE max in 30 days
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9 grams
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What records need to be maintain for selling of PSE
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Sale date/time, product name, quantity, and buyers name adn address
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When is a photo ID needed
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>60 mg sold
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Do all retail staff need to be trained
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YES
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