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216 Cards in this Set
- Front
- Back
Food, Drug, Cosmetic Act |
-created by the FDA & FCDA
Adulteration -may not be pure Misbranding -must include manufacturer and the number of quantities -failure to warn -failure to provide direction of usage |
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Durham-Humphrey Act
|
-created by the FCDA
-must provide direction of usage unless otherwise stated by the Federal -Legend (prescription) -Non - Legend (non-prescription) -may call fore refills -may fax for new prescription |
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Comprehensive Drug Abuse Prevention and Control Act (1970)
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Drugs with potential drug abuse must be monitored so they'll be divided into 5 categories
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Schedule I
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Not accepted as US mediated drug because of potential drug abuse
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Schedule II
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Highly used US Medicated drug but also has high drug abuse potential with severe psychological & physical dependency
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Schedule III
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Not as high as Schedule II in drug abuse but has potential psychological & physical dependency
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Schedule IV
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Not as high as schedule III but has limited psychological & physical dependency
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Schedule IV
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Not as high as IV with the exception of narcotics
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Drug Enforcement Agency Registration
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-Form 224
-All Drug Facilities must be registered with the DEA -renew license every 3 years |
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Schedule II (Ordering and & receipt)
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-Form 222
-Pharm must sign and date the receipt -Available 60 days from purchase date -Keep in record for 2 years |
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Defective Forms
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-incomplete or illegible
-any forms that show erasure, change, or alternation -keep in record for 2 years |
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Initial Inventory
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-complete and accurate info of all files before the opening
-business day of the pharmacy store |
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Biennial Inventory
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-2 years after initial inventory
-Exact schedule II -Estimate of Schedule III, IV, V -Keep record for 2 years |
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Perpetual Inventory
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Exact unit at a particular time
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Return of Controlled Substance
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-Monitored by the DEA
-Transfer of Schedule II |
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Destruction of Outdated or Damaged Controlled Substance
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Form 41
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Theft of Controlled Substance
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Form 106
Keep a copy for yourself Keep other copy for DEA File a police department |
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Filling of Controlled Substance
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Physician sign ad date prescription with no allowable refills
(within 72 hours) = refills (after 72 hours) = new prescription |
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Emergency Filling of Schedule II Drug Prescriptions
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Limited Supply
Pharm contacted the physician Reduce order to writing Physician need it within 7 days |
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Schedule II Drugs in Long Term Care Facility
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-May fax or original prescription
-Must be labeled as "terminally ill patient" or "Long Term Care Facility Patient -Available for 60 days from the purchase date |
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Schedule III & IV Drugs
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-May Fax or Phone depending on state law
-5 refills within the next 6 months |
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Exempt Narcotics
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-In original package and quantities may not exceed the Federal Law
-Must be at least 18 years old and sign Narcotics Exempt Form -New Prescription after 48 hours (Include the following DNANAPP -Date -Name -Address -Name of Purchase -Address of Purchaser -Price of Transaction -Pharmacist Signature |
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Adderall
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Amphetamine
Destramphetamine |
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Amytal
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amobarbital (II)
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Cocaine
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cocaine (II)
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Codeine
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codeine (II)
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Demerol
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meperidine (II)
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Dexedrine
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dextramphetamine (II)
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Dilaudid
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hydromorphine (II)
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Dolophine
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methadone (II)
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Duragesic
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fentanyl (II)
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Morphine Sulfate
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morphine (II)
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Numorphan
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oxymorphone (II)
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Oxycontin
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oxycodine (II)
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Percocet
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acetaminophan
oxycodone (II) |
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Percodan
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aspirin
oxycodone (II) |
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Ritalin
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methylphenidate (II)
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Seconal
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secobarbital (II)
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Tylox
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acetaminophan
oxycodone (II) |
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Ambien
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zolpidiem (IV)
|
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Anexia
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acetaminophan
hydrocodone (III) |
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Ativan
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lorazepam IV
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Bontril
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phendimetrazine (III)
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Butisol
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butibarbital (IV)
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Capital with Codeine
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acetaminophen with codeine (III)
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Cylert
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pemoline IV
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Dalmane
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flurazepam (IV)
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Darvocet
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acetaminophan and propoxyphene IV
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Empirin with Codeine
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aspirin with codeine III
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Equanil
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meprobamate IV
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Fastin
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phentermine IV
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Fiorcet with Codeine
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acetaminophan
bulbital caffeine codeine IV |
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Fiorinal
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aspirin
bulbital caffeine IV |
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Fiorinal with Codeine
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aspirin
bulbital caffeine codeine IV |
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Halcion
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triazolam IV
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Hycodan
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hydocdan III
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Hycomine Compound
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(to be filled)
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HYcotuss
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guaifenesin
hydrocodan III |
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klonopin
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clonazepam IV
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Librium
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chlorazepoxide IV
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Lomotil
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diphenoxylate & atrophine IV
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Lorcet
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acetaminophan & hydrocodone III
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Lortab
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acetaminophan & hydrocodone III
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Noctec
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chloral hydrate IV
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Phenobarbital
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phenobarbial IV
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Restroil
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temazepam IV
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Robitussin (A-C)
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guaifenesin & codeine IV
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Soma with Codeine
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carisoprodal with codeine III
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Sonata
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zaleplon IV
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Stadol
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butaphanol IV
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Talwin
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pentazocine IV
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Talwin Nx
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pentazocine naloxone IV
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Tenuate
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diethylpropion IV
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Traxene
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chlorazepale IV
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Tussinex
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chlorphenramine
hydrocodone III |
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Tylenol with Codeine
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acetaminophan
codeine III |
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Valium
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diazepam IV
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Vicodan
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aceaminophan
hydrocodone III |
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Vicoprofen
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ibuprofen
hydrocodone III |
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Wygesic
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acetaminophan
propoxyphene IV |
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Xanax
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alprazolam IV
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Facsimile Prescriptions
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-may fax as original prescription (Schedule III, IV, V)
Exceptions: -narcotics under direct administration -Schedule II as controlled drugs -Practitioner under XVIII for Medicare regardless if h/she in a hospital with patient setting |
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Prescription Electronic Reporting Act
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Practitioner controlled sub II< III, IV electronically
IDQPD -patient identifier -drug dispenser -quantity dispensed -prescriber -dispenser |
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Transferring of Controlled Substance for Schedule (II, III, IV, & V)
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-pharmacy share a real live online database to fill max amount of refills
-date, name DEA number of pharmacy or pharmacist |
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Poison Prevention Packaging Act of 1970
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-All OTC & Legend Drugs usually have a child resistant lid
-90% of adults can open -80% of kids under 5 years old can open the lid |
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Exception for Child Resistant Containers
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-One time dispense/settled agreement
-elderly or handicapped (non-compliant size) -must contain no children warning sticker |
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Medication that do not require child resistant containers...
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SKIP
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Drug Listing Act of 1972
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11 Digit (National Drug Code)
5 Digit (manufacturer) 4 Digit (Drug Name) 2 Digit (Packaging) |
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Orphan Act of 1983
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-Less than 200,000 cases
-Tax Incentives |
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Drug Price Competition and Patent Term Restoration Act of 1984
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renew licenses to market more drugs
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Prescription Marketing Act (1987)
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-No imported drug to the US unless if its for license purposes
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Omnibus Budge Reconciliation Act of 1987 (OBRA-87)
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-Extended coverage on Medicaid conditions on long term care facility
-No unnecessary Drugs -Special Condition given to patients with anti-psychotic drug needs |
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Omnibus Budget Reconcillation Act of 1990 (OBRA-90)
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-Lower Price with the average and lowest price in the market
-Pharmacy must mentor patients on drug or lose Medicare funding -Keep patient prof (backed by government) |
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Resource Conservation and Recovery Act
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-EPA (Environmental Protection Agency) state that you must not flush hazardous waste in sewage but instead in proper disposal
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FDA Modernization Act
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Prohibited drug not approved by the Federals are labeled as Rx
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Dietary Supplement Health and Education Act DSHEA of 1994
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-Labeled as a dietary supplement
-Identity plant/plant part -Comply with standards -Follow purity, quality, and compositional specification |
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Health Insurance Portability and Accountability Act (HIPAA) of 1969
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Title 1: Protect families' insurance even if they are unemployed
Title II: Simplification of Code |
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Isotretin (Acutane) Safety and Risk Management Act of 2004
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-Used to treat severe ACNE
-may not use internet, mail, or phone -yearly evaluation -quarterly evaluation after 15 days of deceased patient -monthly blood test -monthly women's test -30 day prescription allotment |
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Anabolic Steroid Act
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-Replace old drug as Schedule III
-59 , different substance total |
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Any Willing Provider's Law
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Pharm can go with whatever prescription benefit program
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Prescription Drug Equity Law
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-Will not mail prescription unless if there's mail insurance
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Medicare Drug, Improvement and Modernization Act (MPPIMA) of 2004
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VPVLCM
-Plan d go up to regional and national level -voluntary prescription benefit plan -prevent elders from getting benefits -lower reimbursement rate for medial equipment -changed Medicare ways to pay for outpatient B |
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Combat Methamphatamine Epidemic Act (2005)
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-Listed as Chemical Drug List for ephinderma, pseudoephedrine, and phenylpropanolamine
3.6g/day 6g/30 days limit mail order prescription |
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Medicaid Tamper Resistant Prescription Act
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-No unauthorized copy of filled or non-filled prescription
-Patient may not change or alter prescription -no counterfeit Sign a pad if there are none available, may fax to another local office |
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USP <79>
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Prevent pharmacy from getting sick from patients' drugs
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Buraeu of Alcohol, Tobacco, and Firearms (ATP)
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Tax free alcohol in hospital/clinic
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Centers for Medicare and Medicaid Services
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-reimbursement
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Drug Enforcement
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-monitor by the DEA, pass out form 222 and 441 to make sure drugs are not damaged (backed by the Department of Justice
-compliance with "Controlled Substance Act" |
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Food and Drug Administration
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-Make sure drugs are pure, effective and sae
-Review by Medwatch |
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Institutional Review Board
|
-Approve Biomedical research in accordance with the FDA
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The Joint Comission
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DEAA
-Deemed status from Medicare Funding -Establishes standards and accredits health care providers -Addresses quality patient care and patient safety |
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National Association of the Boards of Pharm
|
-made up of all state boards of pharm
-Not serious -Come together to discuss about trends |
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State Boards of Pharm (BOP)
|
RED
-regulations of roles, expectations, and duties -made up standards and punish pharmacist or pharm tech for inappropriate behavior |
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United States Pharmacoepia (USP)
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-standard for food or dietary supplement
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Online Adjudication
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-Reimbursement from insurance to pay off profit
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Code A
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equivalent
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AA
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not equivalent
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AB
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bioequivalent
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AO
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injectible oil solution
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AP
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injectible aqueous solution
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AT
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topical equivalence
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B Codes
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not equivalent
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BC Code
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controlled substance such as injectible, tablets, or capsules aka AB bioequivalence
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BD
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dosage form or active ingredient, bioequivalent
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BE
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ENTERIC COATED ORAL DOSAGE FORMS
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BP
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active ingredient and dosage forms
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BR
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suppositories and enemas
(injectibles) |
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BS Code
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Topical Equivalence
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BX Code
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insufficient data
|
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Controlled Sub may only be transferred once
|
pharm or pharm tech may assist
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Theapeutic Equivalence
|
-Orange Book
-Same composition, same effect |
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Theaupeutic Interchange
|
-Diff Composition
-Same effect |
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Epidemic
|
-Control or prescece or non-presence of disease
|
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Elderly Age Groups
|
Young Old 65-74
Medium Old 75-84 Old Old 85 and over |
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Angina
|
Chest Pain from Imbalance of O and demand
|
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Bacterial Infection
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More than 101 F
More than 12,000 White Blood Cells |
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Benign Prostatic Hyperthropy
|
Enlarged Penis
|
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Bronchitis
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cough red or green blood
|
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Congestive Heart Failure
|
Heart Pumping Less Blood
|
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Depression
|
Affected by neurotransmitters
Changes in norepephrine, dolophine, and serotonin |
|
Gestational Diabetes
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Second or third trimester or pregnancy
Cure by Diet and exercise |
|
Type I Diabetes
|
Can't Produce insulin
|
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Type II Diabetes (Adult Onset)
|
Insulin Resistant
|
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Secondary Diabetes
|
Arise from Medications
|
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Emphysema
|
Damaged Lung
|
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Gestational Diabetes
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Second or third trimester or pregnancy
Cure by Diet and exercise |
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Type I Diabetes
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Can't Produce insulin
|
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Type II Diabetes (Adult Onset)
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Insulin Resistant
|
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Secondary Diabetes
|
Arise from Medications
|
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Emphysema
|
Damaged Lung
|
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Hypothroidism
|
damaged thyroid hormone
|
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Myocardial Infaction
|
lack of O in heart disease
|
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Obesity
|
males have more than 30%
females have more than 25% |
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Schizophrenia
|
illusion, hallucination
|
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Stroke
|
Interruption of O in brain by rupture or destruction of pathway (clot)
|
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Tuberculosis
|
array droplets from cough
|
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ulcers
|
excessive secretion of upper GI tract
|
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Urinary Tract Infections
|
caused by bacteria
|
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Viral Infections
|
fever, chill, or headaches
|
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Potentialism
|
One drug will make the other drug have a better lifespan
|
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Synergism
|
Drug of 2 make a more powerful effect
|
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Drug-Disease Interaction
|
Disease might effect the drug in metabolism, absorption, and elimination
|
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Drug nutrient information
|
nutrient affects drug's metabolism
|
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Neonates
|
won't work until baby has organs (1 year)
(BSA) Height, surface area, body weight |
|
Antibiotic aka
-mechanism rxn -common indications -adverse rxn |
sulfonamides: Bacteriostatic
-affects pseudo-amino benzoic acid and folic acid affects bacteria -common indications: urinary tract infection -adverse rxn: photosensitivy to light, kidney, damage |
|
Sulfamethoxazole-trimethroprin
|
Belongs to antibiotics
Brand Name: Bacterium, septra Dosage Forms: Oral suspension, IV, tablet |
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Sulfadiazine
|
Belongs to Anbibiotics
Sulonamides: Bacteriostatic Brand Name: Silvadene Dosage Forms: Cream |
|
Sulfasalazine
|
Belong to Antibiotics
Sulfaonamides: Bacteriostatic Brand Name: Azulfidine Dosaage Forms: Tablet, enteric Coated tablet, oral suspension |
|
Sulfisoxazole
|
Belongs to Antibiotics
Sulfonamide: Bacteriostatic Brand Name: Ganstrin Dosage Forms (TOO): Tablet, oral suspension, ophathalmic (Ointment) |
|
Penicillins
-MOA -common medications -adverse rxn -special consideratios |
MOA: prevent bacteria from forming cell wall
Common Indications: pneumonia, respiratory infections Adverse Rxn: idarrhea Special Considerations: Take it with empty stomache |
|
amoxicillin
|
antibiotics:sulfonaides
Brand Name: Amoxil, Polymox Dosage Forms: Capsule, oral suspension, last 14 days if refrigerated |
|
amopicillin
|
anbibiotics:
Brand Name -Omnipen Dosage Forms -oral suspension -capsule -7 days: laying around -14 days: fridge |
|
cloxacillin
|
antibiotics: sulfonamides
Brand Name: none Dosage Forms: -oral suspension -capsule -powder for injection |
|
dicloxacillin
|
antibiotics: sulfonamides
Brand Name -Dynaphen Dosage Forms -Oral Suspension -Oral Tablet -Chewable Tablet |
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Piperacillin
|
antibiotics:sulfonamides
Brand Name -none Dosage Forms -injectible powder |
|
amoxicillin
|
antibiotics:sulfonaides
Brand Name: Amoxil, Polymox Dosage Forms: Capsule, oral suspension, last 14 days if refrigerated |
|
amopicillin
|
anbibiotics:
Brand Name -Omnipen Dosage Forms -oral suspension -capsule -7 days: laying around -14 days: fridge |
|
cloxacillin
|
antibiotics: sulfonamides
Brand Name: none Dosage Forms: -oral suspension -capsule -powder for injection |
|
dicloxacillin
|
antibiotics: sulfonamides
Brand Name -Dynaphen Dosage Forms -Oral Suspension -Oral Tablet -Chewable Tablet |
|
Piperacillin
|
antibiotics:sulfonamides
Brand Name -none Dosage Forms -injectible powder |
|
ticarcillin- clavulanate
|
antibiotics: sulfonamides
Brand Name -Timentin Dosage Forms IV |
|
Cephalosporins
MOA Indications Adverse Rxns Special Conditions |
MOA: prevent bacteria from forming cell wall
Indications -neumonia Adverse RXn -diarrhea Special Conditions: 10% population is cross sensitive |
|
Cefaclor
|
Cephalosporins
Brand Name -Ceclor Dosage Forms: -capsule -oral suspension -extended release tablet |
|
Cefdinir
|
Cephalosporins
Band Name: -Omnicef Dosage Forms: -capsule -oral liquid |
|
Cefixime
|
Cephalosporins
Brand Name: -Suprax Dosage Forms: -oral suspension -tablet |
|
Cefepime
|
Cephalosporins
Brand Name: -Maxipime Dosage Forms -Injection (IV) |
|
Cefpodoxime
|
Cephalosporins
Brand Name: Vantin Dosage Forms: -oral suspension |
|
Cefadroxil
|
Cephalosporins
Brand Name: Duricef Dosage Forms: -oral suspension -capsule -tablet |
|
Ceftinbuten
|
Cephalosporins
Brand Name -Cedax Dosage Forms -oral suspension -capsule |
|
Cefuroxime
|
Cephalosporins
Brand Name: -Ceftin -Zindacef Dosage Forms -oral suspension -tablet -intramuscular IV |
|
Cephalexin
|
Cephalosporins
Brand Name -Keflex -Keftab Dosage Forms -oral suspension -tablet -capsule |
|
Cephradine
|
Cephalosporins
Brand Name -Velosef Dosage Forms -capsule |
|
Cefprozil
|
Cephalosporins
Brand Name: -Cezil Dosage Forms: -OC -oral liquid -capsule |
|
Carbopenems, Carbocephems, and Monobactams
-indications -adverse rxn |
Indications:
-gram with bacterial -gran without bacteria Adverse Rxn: -same as penicillins and cephalosporins but worse seizures |
|
ertapenem
|
Carbopenems, Carbacephems, and Monobctams
Brand Name -Intranz Dosage Form(s) -Injection IV |
|
imipenem-cilastatin
|
Carbapenems, Carbacephems, Monobactams
Brand Name: -Primaxin Dosage Form(s) -Injection (IV) |
|
loraccarbef
|
Carbapenems, Carbacephems, and Monobactams
Brand Name: Lorabid Dosage Form(s) -capsule -oral liquid |
|
aztreonam
|
Carbaphenems, Carbacephems, and monoBactams
Brand Name: -Azacam Dosage Form(S) IV |
|
Tetracyclines
-MOA -Indications -Adverse Rxn -Special Conditions |
MOA:
bind to ribosomes to block prootein syntehsis Indications: -ACNE -chronic bronchitis Adverse Rxn: -GI -photosensitivity Special Condition: -cannot be mixed with milk -no expired drug -do not give kids under 9 years old of age |
|
Doxyceline Hyclate
|
Tetra cyclines
Brand Name: -Vibramycin Dosage Forms -capsule IV -oral suspension -tablet |
|
Doxycline Monohydrate
|
Teracyclines
Brand Name: Monodose Dosage Forms -Tablet |
|
MInocycline
|
Tetracyclines
Brand Nme -Minocin Dosage Forms: -capsule IV -oral suspension -tablet |
|
Tetracycline
|
Tetracyclines
Brand Name -Achromycin -Salmycin Dosage Forms -Capsule -Oral Suspension -topical |
|
Macrolides
-MOA -Indications -Special Consideration Reconstituinoal Concerns -injection -oral suspension |
MOA: Block ribosomes from protein synthesis
Indications: -pulmonary infections Special Condition: -GI Infection Reconstitutional Concerns: Injection = 24 hours Oral Suspension = 10 days if refrigerated |
|
Azithromycin
|
Microdes
Brand Name: -Azithromax Dosage Forms -oral suspension -capsule |
|
clarithromycin
|
Microlides
Brand Name: -Blxin Dosage Forms -granules for oral suspension -film coated tablet |
|
dirithyromycin
|
Microlides
Brand Name: -Dynabac Dosage Forms -entreric coated tablet |
|
erythromycin base
|
Macrolides
Brand Name -Eryc -E-Mycin -Ery- Tab Doage froms -capsule -tablet -enteric coated tablet -film coated tablet |
|
erythromycin estotate
|
Macrolides
Brand Name -Hosone Dosage Forms -Oral susepnsion -capsule |
|
erythromycin ehtylsuccinate
|
Macrolides
Brand Names: EES Dosage Forms -oral suspension -tablet -chewable tablet |
|
erythromycin stearate
|
Macrolides
Brand Name -Erythrocin Dosage Forms -Film coated tablet -Intramuscular IV |
|
erythromycin sulfisoxazole
|
Macrolides
Brand Name -Pediazole Dosage Forms -oral suspensio IV injection for 8 hours |
|
eryhtromycin lactobinate
|
Macrolides
Brand Nmae -Erythrocin Doage Forms IV IV injection for 8 hours |
|
Ketolides
-MOA -indications -adverse rxn |
MOA:
-stop protein synthesis by stopping ribosomes Indications: -stop bacterial infections to lungs or sinus Adverse Rxn: -blurred vision |
|
telithromycin
|
Ketolides
Brand Name: Ketec Dosage Form -Tablet |
|
Quinolones
-MOA -Indications -Adverse rxns -Special Conditions |
to be continued
|