Controlled Substances, DEA Regulations, and More

What is the definition of controlled substances?

Drugs with abuse and dependence potential.

What Act regulates controlled substances in the U.S.?

The Controlled Substances Act (CSA).

Who enforces the regulations on controlled substances?

The DEA (Drug Enforcement Administration).

What are the primary roles of pharmacies, prescribers, and distributors in relation to controlled substances?

They must follow regulations to prevent diversion and protect patients.

What are the drug schedule classifications?

Schedule I (CI) to Schedule V (CV).

What is a Schedule I (CI) drug?

A drug with no accepted medical use and high abuse potential.

Provide two examples of Schedule I drugs.

Heroin and LSD.

Can pharmacies stock or dispense Schedule I substances?

No, pharmacies do not stock or dispense Schedule I drugs.

What is a Schedule II (CII) drug?

A drug with accepted medical use but the highest legal abuse risk.

Give examples of Schedule II drugs.

Strong opioids like morphine, oxycodone, and hydromorphone.

Are refills allowed for Schedule II drugs?

No, refills are not allowed.

What is the refilling rule for Schedule III (CIII) drugs?

Up to 5 refills within 6 months from the date written.

List some examples of Schedule III drugs.

Combo products with ≤90 mg codeine, certain anabolic steroids, buprenorphine products.

What is the refilling rule for Schedule IV (CIV) drugs?

Up to 5 refills within 6 months from the date written.

What are examples of Schedule IV drugs?

Benzodiazepines like alprazolam, lorazepam, and diazepam.

What distinguishes Schedule V (CV) drugs from others?

They have the lowest abuse potential.

Can Schedule V drugs have refills?

Yes, refills depend on the prescriber and state law.

What essential warning must carry on Schedule II-CIV prescriptions?

Caution: Federal law prohibits the transfer of this drug to anyone other than the patient.

Who must register with the DEA to handle controlled substances?

Pharmacies, doctors, mid-level prescribers, hospitals, and treatment programs.

What is DEA Form 224 used for?

To register a retail pharmacy with the DEA.

What does DEA Form 222 facilitate?

The ordering or transferring of Schedule I–II drugs.

What is recorded on DEA Form 41?

For destruction of controlled substances.

What does DEA Form 106 report?

Significant theft or loss of controlled substances to the DEA.

What is the format of a DEA number?

Two letters followed by seven digits (e.g., AB1234563).

What does the first letter of a DEA number indicate?

The type of registrant: A/B/F for hospitals/clinics/physicians/pharmacies or M for mid-level practitioners.

How do you verify a DEA number?

Using checksum math with the digits of the DEA number.

What is the requirement for all prescriptions, including controlled substances?

Must include the patient's full name, address, drug name, strength, dosage form, quantity, directions, date, and prescriber info.

What must be included on controlled substance prescriptions aside from standard requirements?

The prescriber’s DEA number.

What is the validity period for a CII prescription as per state law?

Typically valid for a limited time defined by state law.

Can CII prescriptions be transferred between pharmacies?

No, CII prescriptions cannot be transferred.

What is the procedure for partial filling of CII prescriptions?

If out of stock, pharmacies can partially fill and must supply the remainder within 72 hours.

What must happen with emergency CII oral prescriptions?

A follow-up written/electronic prescription must be sent within 7 days with 'Authorization for Emergency Dispensing' noted on it.

How often should pharmacies perform a controlled-substance inventory?

Initial inventory on the first day controlled substances are stocked and biennial inventory at least every two years.

What records must CII substances maintain?

CII records must be kept separate from all other pharmacy records.

What is the proper storage for controlled substances?

Kept in a locked cabinet or dispersed throughout non-controlled stock.

What should techs do if they discover significant loss or theft of controlled substances?

Notify the DEA in writing within 1 business day and sometimes local law enforcement.

What is the process for disposing of controlled substances?

They must be sent to a DEA-registered reverse distributor.

What program ensures the safe use of high-risk medications?

REMS (Risk Evaluation and Mitigation Strategies).

What is the purpose of REMS programs?

To ensure that the benefits of certain high-risk drugs outweigh the risks.

What are some components of REMS?

Medication Guides, communication plans, and elements to ensure safe use (ETASU).

What must a pharmacist do when a recall notice is received?

Identify affected products, remove and quarantine them, and document details.

What are LASA medications?

Look-Alike / Sound-Alike medications that increase the risk of errors.

How can pharmacies reduce LASA errors?

Using tall man lettering, storing LASA drugs separately, and barcode scanning.

What distinguishes a Near Miss in medication errors?

A medication error that was caught before reaching the patient.

What is a Medication Error?

Any preventable event that may lead to wrong drug, dose, patient, time, route, or therapy.

Define Adverse Drug Event (ADE).

Any injury resulting from drug use, whether it occurs with or without medication error.

What is the significance of black box warnings?

They are FDA's strongest safety warnings indicating the risk of serious effects.

What common strategies promote medication safety?

Two patient identifiers, bar-code scanning, and double-check protocols.

What is the purpose of FDA recalls?

To remove or correct products that are defective, contaminated, misbranded, or harmful.

What is the distinction between Quality Assurance (QA) and Quality Control (QC)?

QA is about overall systems to ensure safe care, while QC focuses on specific tasks to meet standards.

What does OBRA-90 require?

Pharmacists to offer counseling for Medicaid patients and requires Drug Utilization Review.

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

To track and trace prescription drug products to combat counterfeiting.

What role do Pharmacy Benefit Managers (PBMs) play?

Process prescription drug claims, manage formularies, and handle prior authorizations.

What is therapeutic duplication?

When a patient is on two or more medications from the same class without justification.

What type of drug forms are common in prescriptions?

Tablets, capsules, solutions, suspensions, creams, ointments, and injectables.

What must be included in a pharmacist’s final check?

Verification of correct ingredients, amounts, mixing, packaging, labeling, and appearance.

What is the minimum required temperature for refrigerated medications?

2 to 8 °C (36 to 46 °F).

Why must some drugs be stored in amber vials?

To protect them from light to maintain efficacy.

What actions must be taken when expired medications are found?

Remove from stock, quarantine, document, and dispose or return according to policy.

What is a black box warning?

The FDA’s strongest warning indicating a risk of serious side effects.

How do you verify a DEA number?

Using checksum math and ensuring the last digit matches the total calculated.

What does the term 'First Expire, First Out' mean in inventory management?

Items with the nearest expiration date are used or sold first.

What specific records must be maintained for controlled substances?

Records must be kept separately from other pharmacy records with strict retention guidelines.

What is required for a CII prescription to be valid?

Must include the prescriber’s DEA number and be filled within the specified time frame.

What are dangerous abbreviations?

Abbreviations that can cause medication errors and are often put on Do Not Use lists.

What qualifies a drug to be on a 'Do Not Use' list?

Abbreviations that can lead to medical errors due to misinterpretation.

What is required of pharmacies in terms of medication disposal?

Medications must be disposed of legally, often through reverse distributors.

Define 'maximum allowable cost' in pharmacy billing.

The maximum amount a plan will pay for a generic drug.

What is the goal of Patient Assistance Programs?

To help patients obtain medications they cannot afford.

What are key elements of infection control in pharmacy settings?

Regular hand washing, cleaning work areas, and proper disposal of sharps and hazardous materials.

What is the definition of a hazardous drug?

A drug that poses a risk of cancer, reproductive toxicity, or organ toxicity.

What is the role of the pharmacy technician in quality control?

To perform checks on specific tasks and ensure quality standards are met.

In what circumstances can a CII prescription be partially filled?

If the pharmacy is out of stock and must supply the remainder within 72 hours.

What happens if a medication error is discovered?

It must be reported internally to analyze and improve systems.

What key information is needed for insurance billing?

Patient's insurance information, including BIN, PCN, Group number, and Member ID.

What is the primary function of PBMs?

To manage and process prescription drug claims on behalf of insurance payers.

What should patients do with old or unused medications?

Return them to the pharmacy or follow local disposal guidelines rather than discard them.

What does REMS stand for?

Risk Evaluation and Mitigation Strategies.

What are common causes of medication errors?

Look-alike/sound-alike names, poor handwriting, and using dangerous abbreviations.

What steps should be taken if a pharmacy receives a recall notice?

Identify, remove, and quarantine affected products and document the actions taken.

What crucial information should a pharmacist document for a medication error?

Details of the event, involved drugs, outcomes, and actions taken.

What is the primary goal of medication reconciliation?

To ensure an accurate list of all medications a patient is taking during transitions in care.

What steps are involved in preparing for a pharmacy audit?

Keep records organized and readily available for inspection.

What procedures should be followed for handling hazardous materials?

Use PPE, follow safety protocols, and dispose of waste correctly.

What does the term 'controlled substances' generally refer to?

Drugs that have restrictions due to their potential for abuse and dependency.

What must be included in the labeling of a compounded medication?

Drug name, strength, quantity, beyond-use date, directions, and storage instructions.

What is a significant responsibility of pharmacy technicians in patient safety?

To report errors, document everything accurately, and follow procedures carefully.

What does 'Caution: Federal law prohibits the transfer of this drug' refer to?

The legal warning required on CII-CIV prescriptions.

What actions must be taken in the event of a medication recall?

Quarantine affected stock and follow manufacturer instructions for return or destruction.

Define 'separate controlled-substance records.'

CII records must be kept distinct from other pharmacy records.

What is the significance of the 'Authorization for Emergency Dispensing' note?

It indicates that a follow-up Rx was issued after an emergency oral prescription.

What are common patient identification methods in pharmacies?

Name, date of birth, and address.

Why is it important to avoid using look-alike/sound-alike abbreviations in prescriptions?

To reduce the risk of medication errors.

What constitutes an Adverse Drug Reaction (ADR)?

An unintended, harmful response to a normal dose of a drug.

What is an example of a high-alert medication?

Warfarin, due to its narrow therapeutic index.

What specific actions should a tech perform during medication order intake?

Verify patient identity, prescription details, and check for allergies.

What is the maximum number of refills allowed for Schedule III drugs within six months?

5 refills.

What class of drug includes codeine phosphate and potent opioids?

Schedule II drugs.

What is necessary when a medication is partially filled?

The remainder must be supplied within 72 hours.

What type of medication must be dispensed in child-resistant packaging as per the Poison Prevention Packaging Act?

Most prescription and over-the-counter medications.