PTCB Laws, Programs, and Organizations (Abbreviated Version)

Question 1

DEA

Answer 1

Drug Enforcement Administration: Responsible for the management of controlled substances

Question 2

ISMP

Answer 2

Institute For Safe Medication Practices: Responsible for the prevention of medication errors and promotion of safe medication practices

Question 3

FDA

Answer 3

U.S. Food and Drug Administration: Responsible for determining if a food or drug is safe and effective enough to be sold to the public. Oversees several programs and organizations, including CDER, CBER, and CFSAN

Question 4

CDER

Answer 4

Center for Drug Evaluation and Research: Reviews and ensures the safety of new drugs, generic drugs, and over-the-counter drugs.

Question 5

CBER

Answer 5

Center for Biologics Evaluation and Research: Regulates use of biologics, serums, vaccines, products in bloodstream

Question 6

CFSAN

Answer 6

Center for Food Safety and Applied Nutrition: Regulates the use of food, herbal products, dietary supplements, and cosmetics. (Herbal products do not need FDA approval

Question 7

CAERS

Answer 7

CFSAN Adverse Event Reporting System: FDA Adverse Event Reporting System: Captures any adverse events or complaints related to foods, dietary supplements, or cosmetics

Question 8

CDC

Answer 8

Centers for Disease Control and Prevention: Responsible for the protection of public health and safety through the control and prevention of disease, injury, and disability

Question 9

VAERS

Answer 9

Vaccine Adverse Event Reporting System: Responsible for accepting reports of any adverse reactions after administration of any vaccine

Question 10

FDCA (FFDCA or FD&C)

Answer 10

Federal Food, Drug, and Cosmetic Act: A law that gives authority to the FDA to oversee the safety of food, drugs, medical devices, and cosmetics

Question 11

REMS

Answer 11

Risk Evaluation and Mitigation Strategies: Designed to reinforce medication use behaviors and actions that support the safe use of that medication and to ensure that benefits outweigh risks

Question 12

OSHA

Answer 12

Occupational Safety and Health Administration: A government agency in the Department of Labor responsible for maintaining and enforcing a safe and healthy work environment

Question 13

TJC

Answer 13

The Joint Commission: Responsible for accrediting and evaluating healthcare organizations

Question 14

iPledge

Answer 14

Program set up by FDA to monitor isotretinoin acne treatments

Question 15

NIOSH

Answer 15

National Institute for Occupational Safety & Health: Responsible for conducting research and making recommendations for the prevention of work-related injury and illness

Question 16

ASHP

Answer 16

American Society of Health-System Pharmacists: A professional organization that represents pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings

Question 17

USP

Answer 17

United States Pharmacopeia: An independent, non-profit organization that safeguards public health by developing quality standards for medicines, dietary supplements, and food ingredients

Question 18

HIPAA

Answer 18

Health Insurance Portability and Accountability Act: A federal law protecting the privacy of patient-specific health care information and providing the patient with control over how this information is used and distributed

Question 19

CMS

Answer 19

Centers for Medicare & Medicaid Services: A federal agency within HHS that administers the Medicare program and works in partnership with state governments to administer Medicaid, CHIP, and health insurance portability standards

Question 20

CHIP

Answer 20

Children’s Health Insurance Program: program administered by HHS that provides matching funds to states for health insurance to families with children

Question 21

HHS

Answer 21

Health and Human Services: A cabinet-level executive branch department of the federal government created to protect the health of the U.S. people and providing essential human services

Question 22

CIHQ

Answer 22

Center for Improvement in Healthcare Quality: An organization approved by CMS to accredit both general and long-term acute care hospitals, as well as inpatient rehabilitation facilities

Question 23

USP 795

Answer 23

Standards from USP for compounding NONsterile preparations

Question 24

USP 797

Answer 24

Standards from USP for compounding STERILE preparations

Question 25

USP 800

Answer 25

Standards for handling hazardous drugs, including hazardous non-sterile compounding

Question 26

MERP

Answer 26

Medical Expense Reimbursement Plan: A type of HRA. An employer-sponsored benefit plan that helps employees cover eligible medical expenses. Unlike a traditional HRA, employee contribution is permissible with this type of plan

Question 27

HRA

Answer 27

Health Reimbursement Arrangement: A tax-advantaged plan that employers use to reimburse employees for certain approved medical and dental expenses

Question 28

VERP

Answer 28

Vaccine Errors Reporting Program: Through ISMP, collects information about preventable vaccine administration errors

Question 29

MedWatch

Answer 29

An adverse event reporting system available to everyone. Responsible for monitoring medications, biologics, and medical devices

Question 30

FAERS

Answer 30

FDA Adverse Event Reporting System: A database that contains information on adverse events and medication error reports submitted to the FDA

Question 31

CSA

Answer 31

Controlled Substances Act: A federal law placing all substances already regulated by the federal government into one of five schedules. Scheduling is based on recognized medical use, potential for abuse, and safety or dependence liability

Question 32

DQSA

Answer 32

Drug Quality and Security Act: A law amended to the FDCA allowing the FDA to regulate compounded medications

Question 33

CQA

Answer 33

Compounding Quality Act: Title I of DQSA - Amends regulations concerning compounding drugs

Question 34

DSCSA

Answer 34

Drug Supply Chain Security Act: Title II of DQSA - Established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain

Question 35

PPPA

Answer 35

Poison Prevention Packaging Act: A law requiring certain substances to be packaged in childproof packaging

Question 36

APhA

Answer 36

American Pharmacists Association: The first established professional society of pharmacists in the U.S.

Question 37

CPSC

Answer 37

Consumer Product Safety Commission: An independent agency of the U.S. government. Responsible for promoting the safety of consumer products by addressing unreasonable risks of injury, developing uniform safety standards, and conducting research into product-related illness and injury

Question 38

RCRA

Answer 38

Resource Conservation and Recovery Act: The principle federal law governing the disposal of solid and hazardous waste

Question 39

OBRA 90

Answer 39

Omnibus Budget Reconciliation Act: A law requiring pharmacists to conduct prospective drug use reviews and to provide patient counselling for all Medicaid patients

Question 40

CMEA

Answer 40

Comat Methamphetamine Epidemic Act: A federal law regulating OTC sales of ephedrine, pseudoephedrine, and phenylpropanolamine

Question 41

Durham-Humphrey Amendment of 1951

Answer 41

Defines two categories of drug: Legend (prescription) drugs, and OTC (over-the-counter) drugs

Question 42

Kefauver-Harris Amendment of 1962

Answer 42

Also known as the “Drug Efficacy Amendment”, it requires drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, as well as requiring drug advertising to be more closely regulated and disclose accurate information about side effects