70 terms

Ch.2 Pharmacy Laws, Ethics, and Regulatory Agencies

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Terms in this set (...)

Morals
Concerning or relating to what is right or wrong and human behavior
Drug utilization evaluation
A process employed to ensure prescribed drugs are used appropriately main outcome is to increase medication related efficacy and safety
Physicians desk reference
Reference book found in pharmacies that contains detailed information on medications
Negligence
A legal concept that describes an action taken without the forethought that should have been taken by a reasonable person of similar competency
Protected health information
A term used to describe a patient's personal health data this information is protected from being shared or distributed without permission
Adulteration
The mishandling of medication that can lead to contamination/impurity, falsification of contents, or loss of drug quality or potency make cause injury or illness to the consumer
Legend drug
Drug that requires a prescription for dispensing
Drug diversion
The intentional misuse of a drug intended for medical purposes
Drug facts and comparisons
One of the many reference books of medications; this reference complies and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals
Controlled substance
Any drug or other substance that is scheduled I through V and regulated by the DEA
Misbranding
Labeling of a product that is false or misleading
Barbiturate
A drug derived barbituric acid; often employed in the treatment of seizures and as sedative and hypnotic agents
Safety data sheet
A document providing chemical product information
Act
A statutory plan passed by Congress or any legislature that is a "bill" until it is enacted and becomes a law
National drug code
A 10 digit number that indicates specifics of a prescription drug or an insulin product
Boxed warning
Warning that is placed in the prescribing information or package insert of the product and indicates a significant risk of potentially dangerous side effects
Narcotic
Nonspecific term used to describe a drug that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses causes stupor, coma, or convulsions, may lead to addiction
Pregnancy category
A system in use by the FDA to describe five levels of assessment of the fetal effects caused by a drug, a required section of current prescription drug labeling
Ethics
The values and morals that are used within a profession
Over the counter
Medication that can be purchased without a prescription non-legend medication
Amendment
A change in the original actor or law
Monograph
Comprehensive information on A medications actions within that class of drugs
Tort
To cause harm or injury to a person intentionally or because of negligence
Pharmacy
The practice of ___________ is governed by a series of laws, regulations, and rules enforced by federal, state, and local government
Pharmacy law
A good understanding of ___________ is necessary to pass the PTCB
Scientific studies
Manufacturers need to prove the effectiveness of the drugs through methods such as ______________.
False
TRUE OR FALSE: The function of the DEA is to encourage the illegal distribution and misused a controlled substance
False
TRUE OR FALSE: Only DEA form 41 is needed by the pharmacy to dispense controlled substances
False (every 2 years)
TRUE OR FALSE: The DEA requires narcotic inventory to be taken every five years
True
TRUE OR FALSE: Prescribers must be registered with the DEA to write prescriptions for controlled substances
True
TRUE OR FALSE: VIPPS is a label indicates to the public at the website from which they are ordering drugs is both legitimate in licensed
False
TRUE OR FALSE: when federal and state law differs the most lenient law is the one you should follow
DEA
Who has the authority to decide under what schedule a drug should be placed?
5 times
A C-III drug can be refilled
6 months or 5 refills
In most states a prescription for a C-IV drug expires after
Literature on the drug
A drug monograph is
Opioid addiction
Methadone is a C-II controlled substance that is commonly used for
Red
When prescriptions for controlled substance is in C-III through C-V will be filed with other non-controlled drug prescriptions, the control drug prescriptions are designated in the pharmacy by stamping with a C that must appear in:
Nitrostat SL tablets
What medication does not require a childproof cap
-amoxicillin chewable tablets
-Nitrostat SL tablets
-mycelex troche
-amoxicillin suspension
Class 1 recall
The highest level of manufacturer recall which indicates that products could cause serious harm or fatality is a
Tort
Causing injury to a person intentionally or through negligence
222
To obtain a schedule II Substance from a distributor which DEA form must be filed out
C-V
What controlled substance schedule drugs can be obtained without a prescription
C-II
Vicodin
C-I
LSD
C-V
Lomotil
C-II
Demerol
C-IV
Valium
C-V
Robitussin AC
C-II
Ritalin
C-IV
Ativan
C-I
Heroin
C-III
Tylenol/Codeine #3
1962 kefavaufer-harris amendment
Ensures the safety and effectiveness of all new drugs on the US market
2005 combat methamphetamine epidemic act
Addresses all areas related to manufacture of enforcement laws pertaining to and sale of pseudophedrine which can be used to create methamphetamine
1983 orphan drug act
Encourages drug companies to develop drugs for rare diseases Beiber fighting research assistance grants and cost incentives to manufactures
1996 health insurance portability and accountability act
Federal act for protecting patients rights establishing national standards for electronic healthcare communication and ensuring the security and privacy of health data
Federal food and drug act of 1906
One of the first laws and acted to stop the sale of an inaccurately labeled drugs
2003 Medicare modernization act
Provides a drug discount card to beneficiaries with low incomes require pharmacy company assistance for obtaining medications
1987 prescription drug marketing act
Helps to avoid counterfeit drugs and ingredients in the supply chain and also helps limit diversion of pharmaceutical samples and prescription drugs
2010 patient protection and affordable care act
Makes preventative care more accessible and affordable bill and afordable for many Americans
1938 food drug and cosmetic act
Important concepts of this act were adulteration misbranding and providing legal status for the FDA
1970 poison prevention packaging act
Requires manufactures and pharmacies to place all medications in containers with childproof caps or packaging including both over the counter and the legend drugs
2000 drug addiction treatment act
Permits physicians to prescribe controlled substances(pre-approved by the DEA) in schedules C-III, C-IV, or C-V two person suffering from opioid addiction for the purpose of maintenance or detoxification treatments
1951 Durham Humphrey amendment
Added more instructions for drug companies, required the labeling "caution federal law prohibits dispensing without a prescription" and made the initial distinction between legend drugs and over the counter medications that do not require a physicians order
2013 drug quality and security act
Gives greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process
1970 comprehensive drug abuse prevention and control act
Formed the DEA to enforce the laws concerning controlled substances and their distribution and introduced a stairstep schedule of controlled substances
1914 Harrison narcotic act
Enacted in the United States in parallel with international treaties to curve the recreational use of opium
1972 drug listing act
Requires every drug to have a unique 10 digit number divided into three segments numbers and identify the labeler, product, and trade package size
1990 Omnibus budget reconciliation act
Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational out reach programs