PN2002 PACKAGED DEAL 2026 FINAL PAPER
COMPLETE QUESTIONS AND ANSWERS FULL
SOLUTION
◉ 1972 Drug Listing Act.
Answer: Authorized the FDA to compile a list of all legal drugs for
sale in the US. Assigned a unique identifier to all drugs called the
National Drug Code (NDC) 12 digit code. Leading zero on the ones
with only 4 digits in first sequence.
◉ 1983 Orphan Drug Act.
Answer: Created to promote the research and development of drugs
needed for the treatment of rare diseases. (less than 200,000)
◉ 1987 Prescription Drug Marketing Act.
Answer: Enacted to prevent the reimportation of drugs from other
countries. This act banned the sale, trade, or purchase of drug
samples except by those licensed to prescribe drugs.
◉ 1990 Omnibus Budget Reconciliation Act (OBRA 90).
Answer: This act requires a pharmacist to conduct a Drug Utilization
Review (DUR) or offer counsel to patients on all new prescriptions.
Pharmacist must provide name and description of drug, how much
, should be taken, side effects, contraindications, interactions, adverse
effects, storage, refill information, and what to do if a dose is missed.
Administered by State Board of Pharmacies.
◉ 1996 Health Insurance Portability and Accountability Act
(HIPAA).
Answer: This act created rules regarding the privacy/security of
patient health information. This act provides limitations on who can
access, distribute, and receive patient information. This act also
makes health insurance portable for people switching jobs.
Violations punishable by fine up to $250,000.00 per incident
◉ Class I Recall.
Answer: An attempt must be made to notify the patient that the drug
he/she may be taking could cause serious harm or death
◉ Class II Recall.
Answer: The probability of serious harm is not likely and the effects
may be temporary or reversable. This recall does not go to the
customer level and is usually due to problems with consistency of
potency
◉ Class III Recall.
Answer: Not likely to cause any serious adverse effects and does not
go to the customer level
COMPLETE QUESTIONS AND ANSWERS FULL
SOLUTION
◉ 1972 Drug Listing Act.
Answer: Authorized the FDA to compile a list of all legal drugs for
sale in the US. Assigned a unique identifier to all drugs called the
National Drug Code (NDC) 12 digit code. Leading zero on the ones
with only 4 digits in first sequence.
◉ 1983 Orphan Drug Act.
Answer: Created to promote the research and development of drugs
needed for the treatment of rare diseases. (less than 200,000)
◉ 1987 Prescription Drug Marketing Act.
Answer: Enacted to prevent the reimportation of drugs from other
countries. This act banned the sale, trade, or purchase of drug
samples except by those licensed to prescribe drugs.
◉ 1990 Omnibus Budget Reconciliation Act (OBRA 90).
Answer: This act requires a pharmacist to conduct a Drug Utilization
Review (DUR) or offer counsel to patients on all new prescriptions.
Pharmacist must provide name and description of drug, how much
, should be taken, side effects, contraindications, interactions, adverse
effects, storage, refill information, and what to do if a dose is missed.
Administered by State Board of Pharmacies.
◉ 1996 Health Insurance Portability and Accountability Act
(HIPAA).
Answer: This act created rules regarding the privacy/security of
patient health information. This act provides limitations on who can
access, distribute, and receive patient information. This act also
makes health insurance portable for people switching jobs.
Violations punishable by fine up to $250,000.00 per incident
◉ Class I Recall.
Answer: An attempt must be made to notify the patient that the drug
he/she may be taking could cause serious harm or death
◉ Class II Recall.
Answer: The probability of serious harm is not likely and the effects
may be temporary or reversable. This recall does not go to the
customer level and is usually due to problems with consistency of
potency
◉ Class III Recall.
Answer: Not likely to cause any serious adverse effects and does not
go to the customer level
