Ch 2: Pharm Law

Question 1

Adulteration

Answer 1

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

Question 2

Amendment

Answer 2

A change in the original act or law

Question 3

Barbiturate

Answer 3

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.

Question 4

Board of pharmacy or BOP

Answer 4

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.

Question 5

Controlled substance

Answer 5

Any drug or other substance that is scheduled one through five and regulated by the Drug Enforcement Administration

Question 6

Drug diversion

Answer 6

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.

Question 7

Drug enforcement administration or DEA

Answer 7

Federal agency within the US Department of Justice and forces US laws and regulations related to controlled substance is

Question 8

Drug utilization evaluation or DUE

Answer 8

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

Question 9

Ethics

Answer 9

The value and morals used within the profession

Question 10

Food and Drug Administration or FDA

Answer 10

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.

Question 11

Health insurance portability and accountability act of 1996 or HIPAA

Answer 11

Federal act that protects patients rights, establishes national standards for electronic healthcare communication, and ensures the security and privacy of health data.

Question 12

Legend drug

Answer 12

Drug that requires a prescription for dispensing; these drugs carry the federal legend “Federal law prohibits the dispensing of this medication without a prescription”

Question 13

Medicaid

Answer 13

Federal and state operated insurance program that covers healthcare costs and prescription drugs for though income children, adults, an elderly and those with disabilities

Question 14

Medicare

Answer 14

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

Question 15

Misbranding

Answer 15

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.

Question 16

Monograph

Answer 16

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

Question 17

Morals

Answer 17

Standards concerning or relating to what is right or wrong in human behavior

Question 18

Narcotic

Answer 18

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”

Question 19

National drug code or NDC

Answer 19

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.

Question 20

Negligence

Answer 20

A legal concept that describes an action taken without the forethought that should’ve been taken by a reasonable person of similar competency

Question 21

Occupational safety and health administration or OSHA

Answer 21

US government managed agency that oversees safety in the workplace; created safety data sheets or SDS requirements

Question 22

Omnibus budget reconciliation act of 1990 or OBRA

Answer 22

Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational outreach programs

Question 23

Over-the-counter or OTC

Answer 23

Describes medication that can be purchased without a prescription; non-legend medications

Question 24

Physicians desk reference or PDR

Answer 24

One of the many reference books on medications; it compiles and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals

Question 25

Pregnancy category

Answer 25

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

Question 26

Protected health information or PHI

Answer 26

A term used to describe a patient’s personal health data. Under Hippa, this information is protected from being shared or distributed without permission

Question 27

Safety data sheet or SDS formally known as MSDS sheets

Answer 27

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.

Question 28

The joint commission or TJC

Answer 28

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.

Question 29

Tort

Answer 29

An act that causes harm or injury to a person intentionally or because of negligence

Question 30

United States pharmacopeia or US P

Answer 30

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.

Question 31

United States pharmacopeia-national formulary or US P-NF

Answer 31

A publication of the USP that contains standards for medications, dosage forms, drug substances, excipients, medical devices and dietary supplements

Question 32

Pure food and drug act of 1906

Answer 32

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.

Question 33

Orphan drug act

Answer 33

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.

Question 34

DEA

Answer 34

Drug enforcement administration

Question 35

Drug listing act

Answer 35

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.

Question 36

Kefauver-Harris amendments

Answer 36

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.

Question 37

“Comprehensive drug abuse prevention and control act”, also known as the “controlled substance act”

Answer 37

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.

Question 38

Omnibus budget reconciliation act or OBRA

Answer 38

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:

1. evaluation of drug therapy
2. review of drug therapy
3. DUE board review

Question 39

Hippa privacy rule

Answer 39

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.

Question 40

Act

Answer 40

Statutory plan passed by Congress or any legislature that is a “bill” until it is enacted and becomes law.