CCP Federal Regulations and Surveys 3

Question 1

The FDA's MedWatch program is primarily designed to facilitate reporting of which of the following?

Accepted Answer

Adverse events and product problems for marketed drugs

Answer

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?

Accepted Answer

Antipsychotics

Answer

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?

Accepted Answer

60 days

Answer

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?

Accepted Answer

To provide a more structured, computer-assisted survey process using resident outcome data

Answer

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?

Accepted Answer

Track-and-Trace System

Answer

DSCSA requires a Track-and-Trace System using product identifiers and electronic transaction information to verify the legitimacy of drugs throughout the supply chain.

(CCP) Certified Consultant Pharmacist Practice Test

(CCP) Certified Consultant Pharmacist Practice Test

CCP Federal Regulations and Surveys 3