Obra '90 Omnibus Budget Reconciliation Act of 1990

Congressional act that changed reimbursement limits and mandated drug use evaluation, pharmacy patient consolation, and educational outreach program.

Humanitarian Device Exemption - Safe Medical Devices Act (SMDA)

encourages discovery and use of devices intended to treat patients in treatment and diagnosis of extremely rare diseases

Dietary Supplement Health and Education Act (DSHEA)

This act defines, "Dietary Supplements", Herbs must label themselves correctly and not mislead costumers

Health Insurance Portability and Accountability Act (HIPAA) [and PHI]

Federal Act that protects patient's rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data.

Drug Addiction Treatment Act (DATA 2000)

permits physicians to prescribe controlled substances to patients with opioid addictions for maintenance or detoxification treatments

Medicare Modernization Act (MMA)

(set the stage for MTM) provided a drug discount card to patients with low incomes for any prescriptions

Combat Methamphetamine Epidemic Act (CMEA)

This act amended the Controlled Substance Act. Pseudoephedrine must be sold by trained personnel and manufactures could only sell this drug to retailers under the DEA.

Dietary Supplement and Nonprescription Drug Consumer Protection Act

amends the Federal Food, Drug, and Cosmetic Act to require manufacturers, packers, and distributors of dietary supplements and nonprescription drugs to report serious adverse events associated with their products.

Physician's Labeling Rule (PLR)

one of the many reference books on medication; complies and publishes select manufacturer-provided package inserts and prescribing information for health professionals

Patient Protection and Affordable Care Act (ACA); "Obamacare"

Makes preventative care more accessible

Drug Quality and Security Act (DQSA)

gave FDA greater oversight over bulk pharmaceutical compounding and enhances agency's ability to track drugs through distribution process

Highest level; deals with products that could cause serious harm or death. EX. life-saving drugs and foods that contain toxins

middle level: deals with product found to cause temporary health issues or threat of serious harm. EX. drugs dispensed at lower strength

Lowest level: products with minor defects that will not cause harm but cannot be resold. EX, faulty cap or lack of English on labeling

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10.1.25 aml Rx law

Term	Definition
Obra '90 Omnibus Budget Reconciliation Act of 1990	Congressional act that changed reimbursement limits and mandated drug use evaluation, pharmacy patient consolation, and educational outreach program.
Humanitarian Device Exemption - Safe Medical Devices Act (SMDA)	encourages discovery and use of devices intended to treat patients in treatment and diagnosis of extremely rare diseases
Dietary Supplement Health and Education Act (DSHEA)	This act defines, "Dietary Supplements", Herbs must label themselves correctly and not mislead costumers
Health Insurance Portability and Accountability Act (HIPAA) [and PHI]	Federal Act that protects patient's rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data.
Drug Addiction Treatment Act (DATA 2000)	permits physicians to prescribe controlled substances to patients with opioid addictions for maintenance or detoxification treatments
Medicare Modernization Act (MMA)	(set the stage for MTM) provided a drug discount card to patients with low incomes for any prescriptions
Combat Methamphetamine Epidemic Act (CMEA)	This act amended the Controlled Substance Act. Pseudoephedrine must be sold by trained personnel and manufactures could only sell this drug to retailers under the DEA.
Dietary Supplement and Nonprescription Drug Consumer Protection Act	amends the Federal Food, Drug, and Cosmetic Act to require manufacturers, packers, and distributors of dietary supplements and nonprescription drugs to report serious adverse events associated with their products.
Physician's Labeling Rule (PLR)	one of the many reference books on medication; complies and publishes select manufacturer-provided package inserts and prescribing information for health professionals
Patient Protection and Affordable Care Act (ACA); "Obamacare"	Makes preventative care more accessible
Drug Quality and Security Act (DQSA)	gave FDA greater oversight over bulk pharmaceutical compounding and enhances agency's ability to track drugs through distribution process
Recall Class 1	Highest level; deals with products that could cause serious harm or death. EX. life-saving drugs and foods that contain toxins
Recall Class 2	middle level: deals with product found to cause temporary health issues or threat of serious harm. EX. drugs dispensed at lower strength
Recall Class 3	Lowest level: products with minor defects that will not cause harm but cannot be resold. EX, faulty cap or lack of English on labeling

Created by: alora11

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