Pharmacy Tech Study Guide

Front 1

Pure Food and Drug Act 1906

Back 1

Prohibits the interstate transportation or sale of adulterated and misbranded food or drug

Front 2

Food, Drug, and Cosmetic Act 1938

Back 2

All new drug applications be filed with the FDA.

Adulteration: composed in any part of a decomposed or poisonous substance; prepared under unsanitary conditions; containing unsafe color additives; claiming to be official, but differing in strength, quality, or purity.

Misbranded: labeling that is false.

Front 3

Durham-Humphrey Act 1951

Back 3

An amendment to FDCA requiring all products to have adequate directions for use unless they contain the federal legend "caution: federal law prohibits dispensing without prescription"

Separates legend and nonlegend (OTC)
Allows verbal prescriptions over telephone
Allows refills to be called in from a physician's office.

Front 4

Kefauver-Harris Amendment 1962

Back 4

Requires all medications in the US to be pure, safe, and effective

Front 5

Comprehensive Drug Abuse Prevention and Control Act 1970

Back 5

DEA created and placed under the Department of Justice. Controlled substances are place in five classes (schedules) based on potential for abuse and accepted medical use in the US

Schedule I : No medical use. Extremely high potential for abuse.

Schedule II : Has medical use. Also high potential for abuse with severe psychological or physical dependence.

Schedule III : Has accepted medical use, abuse is less.

Schedule IV : Administration may lead to limited physical or psychological dependence.

Schedule V : Exempt narcotics

Front 6

Poison Prevention Packaging Act 1970

Back 6

Enacted to reduce accidental poisoning in children. Most OTC and legend drugs be packaged into child-resistant containers.

EXCEPTIONS:
-Single time dispensing
-Packages with "Not child resistant"
-Drugs dispensed to institutionalize patients, administered by employee

Front 7

Occupational Safety and Health Act 1970
OSHA

Back 7

Ensure job safety and health standards for employees, maintain a reporting system for job-related injuries and illness, reduce hazards in the workplace, and conduct audits to ensure compliance.

Address air contaminants, flammable and combustible liquids, eye and skin protection, and hazard communication standards.

Front 8

Drug Listing Act 1972

Back 8

Every drug has an 11 digit identification code. The first five digits identify the manufacturer, the next four identify the drug product, and the final two represent the package size and packaging.

Front 9

Orphan Drug Act 1983

Back 9

Medications for treatment of diseases of conditions of which there are fewer than 200k cases in the world. Law provides tax incentives and exclusive licensing of products for manufacturers to develop and market.

Front 10

Drug Price Competition and Patent Term Restoration Act of 1984

Back 10

Encourages the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses.

Front 11

Prescription Drug Marketing Act 1987

Back 11

Prohibits the re-importation of a drug into the US by anyone except the manufacturer. Prohibits the sale or distribution of samples to anyone other than those licensed to prescribe them.

Front 12

Omnibus Budget Reconciliation Act 1987
OBRA

Back 12

Established extensive revisions to Medicare and Medicaid Conditions of Participation regarding long term facilities and pharmacy.

Front 13

Anabolic Steriod Control Act 1990

Back 13

Resulted in harsher penalties for the abuse of steriods and their misuse by athletes

Front 14

Omnibus Budget Reconciliation Act 1990
OBRA-90

Back 14

Requires that manufacturers provide the lowest prices to any customer or Medicaid patient by rebating each state Medicaid agency the difference between its average price and the lowest price.

Requires that an "offer to counsel" is made to every patient.

Authorizes government-sponsored demonstration projects relating to the provision of pharmaceutical care; patient profiles are to be maintained for all patients.

Front 15

FDA Safe Medical Devices 1990

Back 15

Requires all medical devices be tracked and records be maintained for durable medical equipment, such as infusion pumps.

Front 16

Americans with Disabilities Act 1990
ADA

Back 16

Prevents discrimination against potential employees who may possess a disability. Must make a "reasonable accommodation".

Front 17

Resource Conservation and Recovery Act

Back 17

The Environmental Protection Agency produced federal guidelines regarding the disposal of hazardous waste, including controlled substances. Flushing is unacceptable.

Front 18

FDA Modernization Act

Back 18

Federal drug legend "Federal law prohibits the dispensing of this medication without a prescription" is now abbreviated by RX on the container.

Front 19

Dietary Supplement Health and Education Act 1994
DSHEA

Back 19

Herbal products are dietary supplements. Manufacturers are allowed to make claims regarding health, not diseases.

Front 20

Health Insurance Portability and Accountability Act 1996
HIPAA

Back 20

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; simplify the administration of health insurance. Ensures patient confidentiality.

Type I : Insurance Reform

Type II : Admin. Simplification

Front 21

Isotretinoin Safety and Risk Management Act 2004

Back 21

Isotretinoin (Accutane) causes severe birth defects, abortions, etc.

-Mandatory registry of all patients, practitioners, and pharmacists.
-Educations of all risks associated with drug.
-Prescribed only for severe recalcitrant nodular acne.
-Monthly education of patients to avoid pregnancy.
-Certification of medical offices and clinics as treatment centers.
-30 Day prescriptions allotments.
-Female patients have a negative monthly pregnancy testing before prescription is renewed.
-Appropriate blood testing performed during treatment and 30 days after.
-Yearly evals of treatment to ensure compliance.
-Mandatory quarterly reporting of all adverse reactions and mandatory reporting within 15 days of all deaths associated.

Front 22

Anabolic Steroid Control Act 2004

Back 22

Amends the Controlled Substances Act to redefine anabolic steroid to mean any drug or hormonal substance, chemically and pharmacologically related to testosterone Sets forth a list of substances included as anabolic steroids, including tetrahydrogestrinone (THG), androstenedione, and specified related chemicals.

Front 23

Any Willing Provider Law

Back 23

Any pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the term and conditions.

Front 24

Freedom of Choice Law

Back 24

Allows a member of a prescription drug plan to select any pharmacy for his or her pharmacy benefit as long as he pharmacy agrees to the T & C.

Front 25

Freedom of Choice with Regard to Long-Term Care

Back 25

Long-term residents may choose an outside pharmacy for their medications if the pharmaceutical service is not provided under their contract. A LTC facility may refuse admission to a resident if they refuse to use the drug distribution system already in place.

Front 26

Prescription Drug Equity Law

Back 26

Prohibits a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage.

Front 27

Medicare Prescription Drug Improvement, and Modernization Act 2003
MDIMA

Back 27

-Provides for a voluntary prescription drug benefit to Medicare beneficiaries.
-Adds preventative medical benefits to senior citizens.
-Lowers the reimbursement rates for Medicare payment for durable medical equipment.
-Created a national competitive bidding program for DME in 2007.
-Changed the way Medicare pays for outpatient Part B drugs.
-Allowed for a voluntary Medicare-approved discount card program, began in 2004.
-Medicare Part D prescription plan allows beneficiaries to enroll in either regional- or national-based insurance plans.

Front 28

Combat Methamphetamine Epidemic Act 2005

Back 28

Placed ephedrine, pseudoephedrine, and phenylpropanolamine in the Controlled Substances Act category "scheduled listed chemical products".

Front 29

Medicaid Tamper-Resistant Prescription Act

Back 29

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

Must contain all these characteristics.
One or more industry-recognized features designed to prevent:
-unauthorized copying of a completed or blank prescription form.
-the erasure or modification of information written on the prescription pad by the prescriber.
-the use of counterfeit prescription forms.

Front 30

USP <797>

Back 30

Is 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. Contains many procedural training and quality assurance requirements for preparing sterile products.