CCP Federal Regulations and Surveys 3 — Questions and Answers
Question 1: The FDA's MedWatch program is primarily designed to facilitate reporting of which of the following?
- Drug shortages to manufacturers
- Adverse events and product problems for marketed drugs (Correct answer)
- Off-label prescribing practices
- Drug diversion in long-term care facilities
Correct answer: Adverse events and product problems for marketed drugs
MedWatch is the FDA's safety information and adverse event reporting program for healthcare professionals and consumers regarding marketed drugs and devices.
Question 2: Under 42 CFR Part 483.45, which category of medication is subject to gradual dose reduction (GDR) requirements in nursing facilities unless clinically contraindicated?
- Antihypertensives
- Antipsychotics (Correct answer)
- Anticoagulants
- Antidiabetics
Correct answer: Antipsychotics
Antipsychotic medications in nursing facilities are subject to GDR requirements under F-tag F758, requiring attempts to reduce doses unless clinically contraindicated.
Question 3: When a Schedule II controlled substance prescription is partially filled in a long-term care facility, the remaining quantity must be dispensed within how many days?
- 30 days
- 60 days (Correct answer)
- 72 hours
- 7 days
Correct answer: 60 days
For LTC patients, a Schedule II prescription may be partially filled, and the remaining portions must be dispensed within 60 days of the original prescription date.
Question 4: What is the primary purpose of the CMS Quality Indicator Survey (QIS) process used in nursing facility inspections?
- To audit financial records for Medicare fraud
- To provide a more structured, computer-assisted survey process using resident outcome data (Correct answer)
- To investigate pharmacist drug regimen review compliance only
- To replace the traditional survey process with telephone interviews
Correct answer: To provide a more structured, computer-assisted survey process using resident outcome data
The QIS is a computer-assisted, two-stage survey process that uses resident outcome data to guide surveyors in identifying potential quality of care concerns.
Question 5: Under the Drug Supply Chain Security Act (DSCSA), which term refers to the electronic system used to track prescription drugs through the supply chain?
- Electronic Prescribing for Controlled Substances (EPCS)
- Track-and-Trace System (Correct answer)
- Drug Diversion Monitoring System
- Pharmaceutical Distribution Security Alliance (PDSA)
Correct answer: Track-and-Trace System
DSCSA requires a Track-and-Trace System using product identifiers and electronic transaction information to verify the legitimacy of drugs throughout the supply chain.
Question 6: Under federal regulations, which of the following must be included in a nursing facility resident's comprehensive care plan?
- A list of all PRN medications only
- Measurable goals and timetables to meet residents' medical, nursing, and psychosocial needs (Correct answer)
- Monthly pharmacy billing codes
- The pharmacist's direct medication orders
Correct answer: Measurable goals and timetables to meet residents' medical, nursing, and psychosocial needs
42 CFR 483.21 requires comprehensive care plans to include measurable goals, timetables, and the services to be provided to meet residents' identified needs.
Question 7: Which federal authority gives the DEA the power to immediately suspend a DEA registration when there is an imminent danger to public health or safety?
- Comprehensive Drug Abuse Prevention Act
- Controlled Substances Act Section 304(a) (Correct answer)
- Combat Methamphetamine Epidemic Act
- FDA Safety and Innovation Act
Correct answer: Controlled Substances Act Section 304(a)
Section 304(a) of the Controlled Substances Act authorizes the DEA to issue an immediate suspension order (ISO) when continued registration poses an imminent danger.
CCP Federal Regulations and Surveys 3
The FDA's MedWatch program is primarily designed to facilitate reporting of which of the following?