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Pharmacy Technician > Pharmacy Law and Regulations > Flashcards

Pharmacy Law and Regulations Flashcards

1
Q

Pure Food and Drug Act of 1906

A

Enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs

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2
Q

Food, Drug and Cosmetic Act of 1938 (FDCA 1938):

A

Requires that all new drugs applications be filed with the FDA
Clearly defined adulteration and misbranding of drugs and food products

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3
Q

Durham-Humphrey Act of 1951:

A

An amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend “Caution: Federal law prohibits dispensing without a prescription.”
It separated drugs into two categories, legend and non legend (OTC). Legend requires a prescription but an OTC drug does not.
Allows verbal prescriptions over the telephone
Allows prescriptions to be called in from physicians office

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4
Q

Kefauver-Harris Amendment of 1962:

A

Requires all medication in the U.S to be pure, safe and effective.
Establishes procedures for both drug applications and investigational drugs
Drug manufacturers are required to be responsible for Good Manufacturing Process

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5
Q

Comprehensive Drug Abuse Prevention And Control Act of 1970

A

DEA was created and placed under supervision of the Department of Justice. Controlled substances are placed in one or five schedules based on a potiental for abuse and accepted medical use in the US.

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6
Q

Schedule 1-5 Drugs

A

Schedule 1: Medications that have no accepted use in the US (ex: weed, heroin, crack etc)
Schedule II: Have medical use but posses a high abuse potential (can be addictive exp: Adderall, codeine, Percocet etc)
Schedule III: Have accepted medical use and the abuse potential is less than I and II drugs (exp: zolpidem, ativan, xanax etc)
Schedule IV: Preparations abuse potential is less tha sch III drugs but may lead to limited physical or psychological dependence.
Schedule V: Medications abuse potential is less than sch IV drugs and exempts narcotics

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7
Q

Drug Enforcement Agency Registration

A

Every facility that dispenses controlled substances must be registered with the DEA.
The pharmacy registersx with the DEA by sumbitting a DEA Form 224.
The pharmacy must renew this registration every 3 years
DEA Form 222 is valid for only 60 days
DEA form 222 is the official document for the transfer of Scheduled II medications

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8
Q

DEA Form 41

A

must be submitted to the DEA indicating the name, strength, and quantities of controlled substances, the date of destruction, the method of destruction and witness present for destruction
Retail Pharmacy may submit one DEA Form 41 each year

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9
Q

DEA Form 106:

A

Must be submitted when there is a theft of controlled substances

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10
Q

Posion Prevention Packaging Act of 1970

A

It was enacted to reduce accidental posioning in children.

The act requires for most OTC and legend drugs be package in child resistant containers.

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11
Q

Occupational Safety and Health Act of 1970 (OSHA):

A

Ensures a safe work place for all employees
OSHA requires use of Safety Data Sheets (SDSs) which are to provided by the seller of a particular product to the purchaser

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12
Q

Drug listing Act of 1972

A

Each drug is assigned a specific 11-digit number to identify it. This number is identified as an NDC number
First five numbers identify the manufacturer
Next four numbers identify drug product
Final two digits represent the package size and packaging

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13
Q

Federal Privacy Act of 1974

A

The Privacy Act of 1974 regulates what personal information the federal government can collect about private individuals and how information can be used.

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14
Q

Orphan Drug Act of 1983

A

Orphan drugs are medications for treatment of diseases or conditions of which are fewer than 200,000 cases in the world
It provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medications

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15
Q

Hatch-Waxman

A

Encouraged the creation of both genetic and new medications by streaming the process for generic drug approval and by extending patient licenses

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16
Q

Prescription Drug Marketing Act of 1987

A

Prohibits the importation of a drug into the United States by anyone except the manufacturer

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17
Q

Omnibus Budget Reconciliation Act of 1987 (OBRA’87

A

Established extensive revisions to Medicare and Medicaid Condition of Participation regarding long-term care

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18
Q

Anabolic Steroid Control Act of 1990

A

Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes

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19
Q

Omnibus Budget Reconcilliation Act of 1990: OBRA’90

A

required states to establish drug use review programs consisting of three essential components (1) prospective drug use review (2) retrospective drug use review (3) educational programs

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20
Q

Food And Drug Administration Safe Medical Devices Act of 1990

A

All medical devices are to be tracked and records maintained for durable medical equipment

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21
Q

Resource Conservation and Recovery Act

A

Resource Conservation and Recovery Act (RCRA) is a U.S. law that provides, in broad terms the general guidelines for the Waste management program envisioned by Congress

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22
Q

Dietary Supplement Health And Education Act of 1994:

A

Herbal products are dietary supplements rather than drugs.

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23
Q

Health Insurance Portability and Accountability Act of 1996

A

The purpose of the Health Insurance Portability and Accountability Act (HIPPA) was to improve portability and continuity of health coverage in the group and individual markets, combat waste, fraud and abuse in health insurance and health care delivery; promote the use of medical savings accounts, improve access to long-term care services and coverage; and simplify the administration of health insurance.

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24
Q

Medicare Prescription Drug Improvement And Modernization Act of 2003

A

Provides for voluntary prescription drug benefit to Medicare beneficiaries

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25
Q

Isotretinoin Safety and Risk Management Act of 2004

A

Isotretinoin (Accutane) Is a very powerful medication to treat acne. The medication has been found to have severe birth defects, induce abortions, and have adverse psychiatric effects (depression, psychosis, suicide attempts etc

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26
Q

Anabolic Steriod Control Act of 2004

A

This act amended the Controlled Substances Act and replaced the existing definition of anabolic steriod with a new definition.

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27
Q

Combat Methamphetamine Epidemic Act of 2005

A

Placed ephedrine, pseudoephedrine and phenylpropanolamine in Controlled Substances Act category “scheduled listed chemical products”

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28
Q

Medicaid Tamper-Resistant Prescription Act

A

Applies to all handwritten prescriptions for covered outpatient drugs; drugs that are transmitted from prescriber to the pharmacy verbally, by fax, or through e-prescribing are not affected by this legislation

29
Q

Clozaril (clozapine) Programs

A

(CNR) was developed in response to an FDA mandate to ensure the safety of patients treated with Clozaril.

30
Q

Thalidomide

A

Thalidomide is indicated for multiple myeloma and certain conditions must be adhered to by the patient

31
Q

Biennial inventory of narcotics

A

Must be maintained in pharmacy

32
Q

Change of pharmacist-in-charge inventory

A

Must be maintained in the pharmacy

33
Q

Controlled Substances Invoices:

A

Must be maintained in pharmacy

34
Q

Exempt narcotic log:

A

Requires name and address of purchaser, name of product and date sold, sellers signature and price of the product

35
Q

Master formula record

A

Work sheets are considered permanent records

36
Q

Safety Data Sheets (SDSs):

A

Documentation required by OSHA, a facility must receive this sheet every time a hazardous chemical is provided to it

37
Q

Medication administration record (MAR)

A

Provides documentation that a drug has actually been dispensed in a hospital or long term facility.

38
Q

Nonsterile compound products

A

All recipe information is copied and show the step-by-step process.

39
Q

Poison log

A

Requires name and address of purchaser

40
Q

Prescription hard copy

A

On the back of the hard copy of the prescription is a copy label with the initials of the pharmacist or technicians who filled the prescription

41
Q

Repackaged medications

A

All repackaged medications must be maintained on log with the following information: date, drug, dosage form, manufacturer, manufacturer’s lot number, manufactures exp. date, pharmacy lot number, pharmacy exp. date, technician and pharmacist

42
Q

United States Pharmacopeia USP <795>

A

provides guidance on applying good compounding practices in the preparation of no sterile compounded formulations for dispensing or administration to humans or animals.

43
Q

United States Pharmacopeia <797

A

It was designed to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.

44
Q

Breakdown room

A

Area where empty or used radiopharmaceuticals are returned and dismantled for reuse.

45
Q

Order entry area

A

Area where prescription orders for radiopharmaceuticals are entered

46
Q

Compounding area

A

Compounding or dispensing area

47
Q

Quality Control Area

A

Quality assurance test are preformed before delivery

48
Q

Packaging Area

A

Finished product is packaged for delivery

49
Q

Storage and disposal area:

A

Storage area for radioactive waste

50
Q

Centers for medicare and Medicaid Services:

A

Oversees Medicare and Medicaid

Establishes conditions for a facility to be reimbursed for services rendered.

51
Q

Department of Transportation

A

Regulates the shipment of hazardous materials that include radioactive materials
Controls the packaging, labeling, and and transportation of radioactive materials

52
Q

Drug Enforcement Agency

A

Enforces compliance with the Controlled Substance Act

Issues DEA Forms 222 and 41

53
Q

Environmental Protection Agency

A

Sets guidelines for the disposal of hazardous waste

54
Q

Food and Drug Administration

A

Ensures that all pharmaceutical products are pure, safe, and effective

55
Q

Class 1-3 Recall

A

Class I recall: A situation in which there is a reasonable probability that the use or exposure to a violatve product will cause serious adverse health consequences or death
Class II recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which use of or exposure to a violative product may cuase temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote
Class III recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

56
Q

Joint Commission (TJC),

A

formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) address the quality of patient care and patient safety.

57
Q

National Association of the Boards of Pharmacy

A

Composed of all of the state Boards of Pharmacy (BOP’s) that meet to discuss the current trends and issues in the pharmacy that affects the practice of pharmacy.

58
Q

State Board of Pharmacy:

A

Regulatory state agency that oversees the practice of pharmacy given in that state. The state boards of pharmacy define, regulations affecting pharmacy and the roles, duties, and expectations of pharmacists and pharmacy technicians in that states

59
Q

United States Pharmacopeia:

A

The USP is an official public standard-setting authority for all prescription and OTC medicines and other health care products manufactured or sold in the United States.

60
Q

Performance Appraisal

A

A process of systematically evaluating performance and providing feedback on which performance adjustments can be made

61
Q

Activity measures

A

A rating system based on an evaluators observation and rating

62
Q

Ranking

A

A comparative technique of performance appraisal that involves rank ordering of each individual from best to worst on each performance dimension

63
Q

Paired Comparison

A

A comparative method of perfomrance appraisal whereby each person is directly compared with every person

64
Q

Forced Distribution

A

A method of performance appraisal that uses a small number of performance categories such as “very good”, “good,” “adequate”, and “very poor”.

65
Q

Graphic rating sales

A

A scale that lists a variety of dimensions thought to be related to high perfomrance outcomes in a given job and that the individual is expected to exhibit

66
Q

Critical incident diary

A

A method of performance appraisal that records incidents of unusual success or failure in a given performance aspect

67
Q

Behaviorally anchored rating scales

A

A performance appraisal approach that describes observable job behaviors, each of which is evaluated to determine good versus bad performance

68
Q

Management by objective

A

A process of joint goal setting between a supervisor and a subordinate

69
Q

360 Evaluations

A

: A comprehensive approach that uses self-ratings, customer ratings, and others outside of the workforce.

Pharmacy Technician (1 decks)

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