Federal Pharmacy Laws (ExCPT)

What does HIPAA stand for, and what is its primary purpose?

Health Insurance Portability and Accountability Act; it protects patient health information (PHI) and establishes national privacy standards.

In what year was HIPAA enacted?

1996.

What does PHI stand for under HIPAA?

Protected Health Information.

What types of information are considered PHI under HIPAA?

Patient names, addresses, phone numbers, medical records, prescription history, insurance information, billing information, and any information that identifies a patient.

What does the HIPAA Minimum Necessary Standard require pharmacy employees to do?

Only access or share the minimum amount of PHI necessary to complete a task.

What is the purpose of the HIPAA Notice of Privacy Practices?

To inform patients how their PHI is collected, used, and shared.

What right do patients have regarding their PHI under HIPAA?

They may request copies of their protected health information.

What are Business Associate Agreements (BAAs) under HIPAA?

Contracts required with outside vendors who have access to PHI.

What physical safeguards are required under HIPAA?

Secure storage of records, password-protected systems, locked filing cabinets, and private counseling areas.

Which three situations allow PHI to be disclosed without patient authorization under the HIPAA TPO rule?

Treatment, Payment, and Healthcare Operations.

Besides TPO, what are other situations where HIPAA allows PHI disclosure without patient authorization?

Public health reporting, FDA reporting, and certain law enforcement requests such as court orders or subpoenas.

What is the penalty range for an unknowing HIPAA violation?

$100–$50,000 per violation.

What is the penalty range for a HIPAA violation caused by reasonable cause?

$1,000–$50,000 per violation.

What is the penalty range for willful neglect that is corrected?

$10,000–$50,000 per violation.

What is the minimum penalty for willful neglect that is not corrected?

$50,000 per violation.

What is the maximum annual HIPAA penalty for a violation category?

$1.5 million.

What does FDA stand for?

Food and Drug Administration.

What is the FDA responsible for regulating?

Drugs, biologics, medical devices, and food safety.

hat is the FDA's role in approving medications?

Reviews New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for generics.

What does cGMP stand for, and why is it important?

Current Good Manufacturing Practices; they ensure medications are consistently manufactured safely and with high quality.

What is the purpose of FDA labeling requirements?

To ensure prescription and OTC drugs contain required safety and usage information.

What is MedWatch, and what is it used for?

The FDA's program for reporting adverse drug reactions and safety concerns.

What does a Class I FDA drug recall indicate?

A product may cause serious injury or death.

What is an example of a Class I drug recall?

Drug contamination with a lethal pathogen.

What does a Class II FDA drug recall indicate?

The product may cause temporary or medically reversible health problems.

What is an example of a Class II drug recall?

Incorrect labeling of medication strength.

What does a Class III FDA drug recall indicate?

The product is unlikely to cause adverse health consequences.

What is an example of a Class III drug recall?

Minor labeling errors.

What is the purpose of the National Drug Code (NDC)?

To uniquely identify every drug product.

What is the standard format of an NDC number?

XXXXX-XXXX-XX.

What does the first segment of an NDC number identify?

The manufacturer or labeler.

What does the second segment of an NDC number identify?

The specific drug product, strength, and dosage form.

What does the third segment of an NDC number identify?

The package size.

What is the purpose of the Poison Prevention Packaging Act (PPPA)?

To reduce accidental poisoning by requiring child-resistant packaging.

In what year was the PPPA enacted?

1970.

What standard must child-resistant packaging meet?

It must be significantly difficult for children under five years old to open.

Which patients may request non-child-resistant packaging?

Elderly or disabled patients.

Can a prescriber authorize non-child-resistant packaging?

Yes, with a written order.

Which medications are commonly exempt from child-resistant packaging?

Sublingual nitroglycerin and oral contraceptives in manufacturer packaging.

What documentation is required when dispensing non-child-resistant containers?

The patient's request or prescriber's authorization must be documented.

Who is responsible for safe medication storage when easy-open packaging is requested?

The patient.

What does OBRA-90 stand for?

Omnibus Budget Reconciliation Act of 1990.

Who did OBRA-90 originally apply to?

Medicaid patients.

What is the purpose of Prospective Drug Utilization Review (DUR)?

To identify medication-related problems before dispensing.

What must pharmacists offer patients under OBRA-90?

Patient counseling on new prescriptions.

What information must be maintained in patient profiles under OBRA-90?

Current medications, allergies, and medical conditions.

During DUR, what is therapeutic duplication?

Two medications treating the same condition unnecessarily.

During DUR, what are drug-drug interactions?

Harmful interactions between medications.

During DUR, what is an incorrect dosage?

A dose that is too high or too low.

During DUR, what are drug-disease contraindications?

Medications inappropriate for a patient's medical condition.

During DUR, what are drug-allergy interactions?

Medications that may cause an allergic reaction based on the patient's history.

During DUR, what is clinical abuse or misuse?

Medication use patterns suggesting inappropriate or excessive use.

Can pharmacy technicians perform Drug Utilization Reviews?

No

Can pharmacy technicians provide patient counseling?

No

What are the pharmacy technician's responsibilities under OBRA-90?

Accurately enter patient information, maintain patient profiles, flag concerns for the pharmacist, and document counseling offers according to pharmacy policy.

What is the purpose of the Combat Methamphetamine Epidemic Act (CMEA)?

To prevent methamphetamine production by restricting sales of certain decongestants.

Which medications are regulated under the CMEA?

Products containing pseudoephedrine, ephedrine, and phenylpropanolamine.

Where must CMEA-regulated medications be stored?

Behind the pharmacy counter or in a locked cabinet.

What is the maximum daily purchase limit under the CMEA?

3.6 grams.

What is the maximum 30-day purchase limit under the CMEA?

9 grams (7.5 grams if purchased by mail).

What information must be recorded in the CMEA logbook?

Purchaser's name, address, date and time, product purchased, quantity sold, and purchaser's signature.

How long must pharmacies keep CMEA logbooks?

At least 2 years.

What electronic tracking system is commonly used for CMEA compliance?

NPLEx (National Precursor Log Exchange).

What is the purpose of the Drug Supply Chain Security Act (DSCSA)?

To track prescription drugs through the supply chain and prevent counterfeit medications.

What does T3 stand for under the DSCSA?

Transaction Information, Transaction History, and Transaction Statement.

Which medication requires participation in the iPLEDGE program?

Isotretinoin.

Why was the iPLEDGE program created?

To prevent pregnancy because isotretinoin causes severe birth defects.

Who must register in the iPLEDGE program?

Prescribers, pharmacies, and patients.

How often must females of childbearing potential receive pregnancy tests while taking isotretinoin?

Monthly.

After a negative pregnancy test, how many days does a patient have to receive isotretinoin?

7 days.