Ch 2: Pharm Law Flashcards
Adulteration
The mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of quality or potency. Adulteration may cause injury or illness to the consumer
Amendment
A change in the original act or law
Barbiturate
A drug derived from barbituric acid; a barbiturate acts as a central nervous system depressant. Barbiturates are often used in the treatment of seizures and as sedative and hypnotic agents.
Board of pharmacy or BOP
Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk of potentially dangerous side effects. Is the strongest warning the FDA can give. It is common in the pharmacy profession to call these warnings “blackbox warnings” because of their appearance in a drug label; the warning is often enclosed in a black outlined box to draw attention to the content.
Controlled substance
Any drug or other substance that is scheduled one through five and regulated by the Drug Enforcement Administration
Drug diversion
Intentional misuse of the drug intended for medical purposes; the drug enforcement administration usually defines diversions as the recreational use of a prescription or scheduled drug. Diversion can also referred to the channeling a prescription drug supply we from legal distribution into the illegal street market.
Drug enforcement administration or DEA
Federal agency within the US Department of Justice and forces US laws and regulations related to controlled substance is
Drug utilization evaluation or DUE
A process that ensures the prescribed drugs are used appropriately. I mean desired outcome of any DUE program is an increase in medication-related efficacy and safety
Ethics
The value and morals used within the profession
Food and Drug Administration or FDA
The agency within the US Department of Health and Human Services that is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive products.
Health insurance portability and accountability act of 1996 or HIPAA
Federal act that protects patients rights, establishes national standards for electronic healthcare communication, and ensures the security and privacy of health data.
Legend drug
Drug that requires a prescription for dispensing; these drugs carry the federal legend “Federal law prohibits the dispensing of this medication without a prescription”
Medicaid
Federal and state operated insurance program that covers healthcare costs and prescription drugs for though income children, adults, an elderly and those with disabilities
Medicare
Federal and state managed insurance program that covers healthcare costs and prescription drugs for individuals older than 65, persons younger than 65 with long-term disabilities, and individuals with and end-stage renal disease
Misbranding
Labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer; Packer, or distributor; quantity; and weight.
Monograph
Comprehensive information on the medications actions within that class of drugs. Also lists generic and trade names, ingredients, dosages, side effects, adversity facts, how the patient should take the medication, and foods or other drugs (e.g. over-the-counter medications, herbals) to avoid while taking the medication
Morals
Standards concerning or relating to what is right or wrong in human behavior
Narcotic
I nonspecific term used to describe a drug (such as at opium) that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses cause stupor, coma, or convulsions, and may lead to addiction. From the standpoint of US law, opium, opiates (derived of opium), and opioids, in addition to cocaine and cocoa leaves, are “narcotics”
National drug code or NDC
A ten-digit number that indicates specifics of a prescription drugs or an insulin product. The NDC specifies the drug manufacturer, the drug product (drug strength, dosage form, and formulation), and the package size.
Negligence
A legal concept that describes an action taken without the forethought that should’ve been taken by a reasonable person of similar competency
Occupational safety and health administration or OSHA
US government managed agency that oversees safety in the workplace; created safety data sheets or SDS requirements
Omnibus budget reconciliation act of 1990 or OBRA
Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational outreach programs
Over-the-counter or OTC
Describes medication that can be purchased without a prescription; non-legend medications
Physicians desk reference or PDR
One of the many reference books on medications; it compiles and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals
Pregnancy category
A system used by the FDA to describe five levels of assessment of fetal effects caused by a drug; required section of current prescription drug labeling. First to do send 1979, the system is being reevaluated for usefulness and inclusion in the prescription label
Protected health information or PHI
A term used to describe a patient’s personal health data. Under Hippa, this information is protected from being shared or distributed without permission
Safety data sheet or SDS formally known as MSDS sheets
A document providing chemical product information. And STS includes the product name, composition including chemicals in the product, hazards, toxicology, and other information about the proper steps to take with spills, accidental exposure, handling, and storage of the product. Filing of an SDS in the pharmacy or workplace is usually requirement for meeting occupational safety and health administration, or OSHA, standards.
The joint commission or TJC
An independent, nonprofit organization that accredits hospitals and other healthcare organizations in the United States. Accreditation is required to be eligible for Medicare and Medicaid payments.
Tort
An act that causes harm or injury to a person intentionally or because of negligence
United States pharmacopeia or US P
An independent, nonprofit organization establishes documentation on product quality standards, drug quality and information, and healthcare information on medications, over-the-counter products, dietary supplements, and food ingredients to ensure that they have appropriate purity, quality, and strength.
United States pharmacopeia-national formulary or US P-NF
A publication of the USP that contains standards for medications, dosage forms, drug substances, excipients, medical devices and dietary supplements
Pure food and drug act of 1906
Also known as the Wiley act for creator Harvey Wylie, the chief chemist in the division of chemistry at the time the previous name for FDA.
Orphan drug act
Passed in 1983 targeted all rare diseases. Influenced expanded research and availability of new treatments for acquired immunodeficiency syndrome or AIDS, cancer, and genetic diseases. Encouraged drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives to manufactures.
DEA
Drug enforcement administration
Drug listing act
Implemented a 1972 requires national drug code or NDC for every legend drug. The 10 digit code identifies the labeler, product, and trade package size.
Kefauver-Harris amendments
1962: the amendments and acted or groundbreaking in their attempts to ensure the safety and effectiveness of the all new drugs on the US market. Gave the FDA specific authority to approve a manufacturer’s marketing application, firms had to prove safety and provide substantial evidence of effectiveness for the drugs intended use.
“Comprehensive drug abuse prevention and control act”, also known as the “controlled substance act”
Stairstep schedule of controlled substance is was introduced in 1970 based on the drugs intended medical use, the protential for abuse, and safety and dependency concerns. Schedule one is the most restrictive and is defined as drugs with no medically excepted use in the United States. Schedule five drug is less restricted and requires less documentation and that for a schedule two drug.
Omnibus budget reconciliation act or OBRA
With OBRA 1987 there were increasing numbers of elderly entering nursing homes. Great concern arose over substandard care. Personnel to patient ratios, and unhealthy conditions present.
OBRA 90 effected practicing pharmacists and healthcare personnel in general. Outline specifics for pharmacies to participate in Medicaid drug rebate program.
Three important provisions of the Opera 90 include:
- evaluation of drug therapy
- review of drug therapy
- DUE board review
Hippa privacy rule
Hyppa privacy rules specifically prevent certain persons identified by the patient such as family members, or friend, or spouse, to receive information that is directly relevant to their care or payment for healthcare. If the patient does present or is otherwise available before the disclosure and have the capacity to make healthcare decisions, the covered entity may discuss the information with the family and these other individuals if the patient agrees or, when given the opportunity, does not object.
Act
Statutory plan passed by Congress or any legislature that is a “bill” until it is enacted and becomes law.
