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B Chapter 2 reveiw

QuestionAnswer
What is the 1906 Federal Food and Drugs act? An act that said manufactures wee required to put truthful information on the label before it could be sold
What is the 1914 Harrison Narcotics Act? A law that made it illegal to get ahold of opium without a prescription and required a registered practitioner also it limited the amount imported and required extensive documentation
What is the 1938 Food Drug and Cosmetics Act? It made adulteration and misbranding an illegal offence giving the FDA legal status along with requiring package inserts with safe use instructions for medications and warning may be habit forming label
What is the 1951 Durham-Humphrey Amendment? Made manufacturers put a federal warning illegal to dispense without a prescription made the initial distention between legend an OTC drugs
What is the 1962 Kefauver-Harris Amendments? Required clinical trials to prove a drugs effectiveness for the intend use and also lets the FDA approve or deny drugs applications and required that side effects be reported to the FDA
What is the 1970 Comprehensive Drug Abuse Prevention and Control Act? DEA was formed to enforce laws related to controlled substances a categorized them based on their addictiveness, intended medical use, and safety
What is the 1970 Poison Prevention Packaging Act? (PPPA) Required childproof caps that at lest 80% of children under the age of 5 couldn't open and at least 90% of adults should be able to open it with the exception of a doctor request, certain legend drug, and patients request
What is the 1983 Orphan Drug Act? Gave incentives to drug companies such as assistants, grants, and 7 year excusive sell rights after FDA approval for diseases that effected less than 200,000 people or 200,000+ if it could be proven that the wouldn't make their money back through sales
What is the 1987 Prescription Drug Marketing Act?(PDMA) Law that made a legal channel for drugs from manufactures to legal distributors also helped curb diversion of drug and knock out counterfeit drugs
What is the 1990 Omnibus Budget Reconciliation Act? (OBRA '90) Addressed problems with nursing homes and set standards, made the pharmacist give council to all Medicare and Medicaid patients on new medications, and required that they have DUEs, if requirements are not met they may not receive reimbursement/be fined
What is the 1996 Health Insurance Portability and Accountability Act?(HIPPA) Also referred to as PHI personal health information I addressed issues of disclosing a patients health data without their permission or knowledge and made it so you could lose your license if you didn't get permission before disclosure
What is the 2000 Drug Addiction Treatment Act? (DATA 2000) Allowed physicians to prescribe scheduled 3-5 drugs to hose individuals suffering from opium addiction for the purpose of upkeep of detoxification to prevent withdrawal symptoms but patient must be in a treatment program that offers additional support
What is the 2003 Medicare Modernization Act? (MMA) Provided low-income families and individuals with a drug discount card to help prevent hospitalization due to high drug cost
What is the 2005 Combat Methamphetamine Epidemic Act? It is a law that is suppose to help lessen the methamphimine problem making It harder to get pseudoephedrine for the preparation of making meth thought it varies from state to state but the pharmacist must approve the sell
What is the 1972 Drug Listing Act; National Drug Code? A law that gave every drug a unique 10 digit code for identification
Anabolic steroids control act was made why? Because of the amount of athletes that abused them
What are the requirements for a class one recall A product that can cause serious of even fatal harm including life saving drugs also contains food with toxins or medications that do not list ingredients that may cause allergies
What are the requirements for a class two recall A product that can cause a temporary health problem or has a slight threat of serious harm
What are the requirements for a class three recall minor defect that wont cause harm to a person but cant be resold such as a faulty cap
What are class one drugs and what are they used for in medicine? LSD, Cocaine, Heroin, and Mescaline they have no accepted medical use in the united states
What makes a drug a class two controlled substance? High potential for abuse and abuse may lead to severe psychological or physical dependence
What Make a drug a class three controlled substance? moderate to low physical dependence and high psychological dependence if abused; most are combination narcotics
What makes a drug a class four controlled substance? Potential for abuse is low and may lead to limited physical or psychological dependence
What makes a drug a class five controlled substance and how does it vary from the other classes? low physical or psychological dependence may occur; also called exempt controlled substances because they can still be sold as OTC medication depending on state law
Tamper-proof prescription pads can have up to how many deterrents? Anywhere from one to eight
What DEA form do you need to distribute or manufacture controlled substances? 225
What DEA form do you need to manage a controlled substance treatment program of compound controlled substances? 363
What one do you need to dispense a controlled substance? 224
What form do you need to transfer a schedule two drug? 222
What form do you need to destroy damaged, outdated, or unwanted controlled substances? Who must witness the destruction? 41
What form is required for the bulk sales of drugs containing pseudoephedrine, phenylpropanolamine, or ephedrine? 510
what form is required for theft or loss of a controlled substance? 106
What are the two ways to order scheduled drugs? DEA form 222 or electronically which includes all but class one and two controlled substances
How long must scheduled 3-5 drug invoices be kept on file? 2 years
DEA requires an inventory or controlled substance be taken when? every two years
What steps must be taken for filling an emergency C-II oral order by the pharmacist? Obtain all information from the physician such as name, strength, dosage form, ROA, and physicians personal info including DEA number. Must make every attempt to verify the physicians authority and can only fill to cover the emergency period.
If you partially fill a controlled substance C-III through C-V how long before the remaining must be dispensed? 6 months
If you partially fill a C-II drug how long before the remainder must be given to the patient? 72 hours
How often do you renew form 224? every three years
How do you renew form 224? 224a
What information is required on the loss or theft of a scheduled drug form? address and name of pharmacy DEA reregistration number, police department notified, type of theft or loss, drug name, and code cost if applicable
What happens if there is any discrepancies in controlled substance inventory? It must be investigated and explained
Who must witness the destruction of controlled substances? A licensed pharmacist, physician, law enforcement officer, or registered nurse must be one of the people.
How many times can a C-II drug be transferred? Zero times cause it has no refills
How many times can you refill a C-II drug? Zero
How many times can you refill a C-III and C-IV drugs Up to five times
How many times can C-V drugs be refilled? As many times as prescribed
How many times can you transfer a C-III,C-IV, and C-V drug? one time
How many sections are there on a drug monograph? seventeen
How many pregnancy categories are there? five
What are the pregnancy categories suppose to do? Inform physician and patient on the risk versus benefits of taking a medication pertaining mainly to possible harm to the fetus
What kind of prescription can a technician not take? Phoned in prescription
What rights does a person have under HIPPA? See and get copies of your health records, have corrections added to health information, have a notice saying they your health information may be used and how, deciding if you health information can be used or shared for certain purposes
What rights do you have if you feel your PHI is not being protected? File a complaint with insurer, file a complaint with the government, authorize or not authorize any sharing of you health data, chance or rescind this permission at anytime
What medications do not require a childproof cap? Betamethasone, Cholestyramine, Colestipol, Erythromycin, Mebendazole, Methylprednisolone, nitroglycerin, Prednisone, and Sodium Fluoride
What is the only medication that doesn't need a child proof cap and has no limit to dose? Nitroglycerin
What are the reasons for non child-proof caps? Patient request, Physician requests, on the exempt list
What year did the MSDS come out and who made it? OSHA in 1989
When was TJC created? 1910
How many health organizations does TJC accredit across the U.S.? more than 16,000
If there are two different laws that over lap Which do you follow? The stricter of the two
Created by: must learn