PTCE Pharmacy Law and Regulations 5

Question 1

Which of the following describes a 'narrow therapeutic index' (NTI) drug from a legal/regulatory standpoint?

Accepted Answer

A drug where small changes in dose or blood level can cause serious adverse effects or therapeutic failure

Answer

NTI drugs have a narrow margin between effective and toxic doses, requiring careful monitoring; many states require pharmacist notification before generic substitution.

Question 2

Under federal law, a DEA Form 222 must be completed to order which class of controlled substances?

Accepted Answer

Schedule I and II only

Answer

DEA Form 222 (or its electronic equivalent, CSOS) is required specifically for ordering Schedule I and II controlled substances.

Question 3

A patient opts out of child-resistant packaging for their prescription. What documentation is required?

Accepted Answer

A signed waiver from the patient or their caregiver on file

Answer

PPPA allows patients or caregivers to request non-child-resistant packaging, but a signed request must be kept on file to document the waiver.

Question 4

Which federal agency oversees the National Provider Identifier (NPI) system?

Accepted Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

CMS administers the NPI system under HIPAA, assigning unique 10-digit identifiers to healthcare providers including prescribers.

Question 5

Under the Omnibus Budget Reconciliation Act (OBRA '90), pharmacists are required to offer counseling to:

Accepted Answer

Medicaid patients only

Answer

OBRA '90 mandates pharmacist counseling offers for Medicaid outpatients; however, most states have expanded this requirement to all patients.

(PTCE) Pharmacy Technician Certification Exam Practice Test

(PTCE) Pharmacy Technician Certification Exam Practice Test

PTCE Pharmacy Law and Regulations 5