Pharmacy Management and Federal Controlled Substance Law

VOCABULARY flashcards based on the provided lecture notes regarding pharmacy management, labeling, compounding, and federal controlled substance laws (Pages 111-220).

Illegitimate Product

A product that is counterfeit, diverted, stolen, intentionally adulterated, subject of a fraudulent transaction, or unfit for distribution such that it would likely result in serious adverse health consequences or death to humans.

FDA $3911$

The form required to be generated if a product is found to be illegitimate.

Illegitimate Product Sample

The item that must be saved after destroying an illegitimate medication.

Suspected Illegitimate Product Filing

An FDA $3911$ is not required if the product is only suspected and not confirmed to be illegitimate.

HIPAA Record Retention

Forms associated with the Health Insurance Portability and Accountability Act must be kept for $6$ years.

HIPAA Patient Refusal

If a patient refuses to sign HIPAA forms, the pharmacist must document that an attempt was made.

HIPAA Third Party Signatory

A third party is permitted to sign HIPAA forms on behalf of a patient.

HIPAA Privacy Policy Posting

Privacy policies must be posted somewhere accessible within the pharmacy.

Prescription Drug or Device ($2501$)

Anything that may only be dispensed by a pharmacist or licensed practitioner and must bear the 'Rx only' notation or similar text.

Drug Storage Integrity

All areas where drugs are stored must be maintained under environmental conditions per USP or medication labeling to ensure the integrity of the medication.

Misbranded Medications ($2501$)

Medications that are unlawful to possess or dispense.

Adulterated Medications ($2501$)

Medications that are unlawful to possess or dispense.

Expired Medications ($2501$)

Medications that are unlawful to dispense and must be removed from inventory.

Recalled Medications ($2501$)

Medications that must be removed from inventory immediately.

Medication Take Back Quarantine ($2503$)

The process of keeping medication returned by a patient separate from dispensing stock and taking security measures to prevent theft/diversion.

Pharmacy Premises Rule ($2503$)

If a patient has not yet left the pharmacy premises, a medication can be returned to normal stock without quarantine.

Investigational Medicine Protocol ($2505$)

A document that must be kept in the pharmacy for any investigational medication being dispensed.

Investigational Medicine Labeling ($2505$)

Dispensed investigational drugs must carry the label 'for investigation use only'.

Investigational Medicine Storage ($2505$)

Medications that must be stored in the pharmacy but separate from normal medications.

Investigational Medicine Perpetual Inventory ($2505$)

A required record including the name, dosage form, strength, lot number, expiration date, study sponsor info, protocol number, and identification of the dispensing pharmacist.

Veterinary Medication Prescriber ($2507$)

Veterinary medications may only be prescribed by a veterinarian.

Veterinary Rx Label: Patient Identification ($2507$)

The prescription label for a veterinary product must include the client’s name and the patient’s species.

Veterinary Medication Storage Requirement ($2507$)

Veterinary medications must NOT be stored with human medications.

Veterinary Federal Caution Label ($2507$)

'Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian'.

Prescription Device ($2509$)

Any device that says 'rx only' or 'on order of physician' regulated to protect the public and sold only pursuant to a valid prescription.

Syringe Sales Authorization ($2509$)

Authorizes pharmacists, physicians, dentists, veterinarians, podiatrists, embalmers, drug wholesalers, surgical suppliers, and other licensed dealers to sell syringes without a prescription.

Syringe Storage ($2509$)

Syringes must be stored in the pharmacy or other secure area.

Legitimate Medical Need for Syringes ($2509$)

Includes the prevention of the transmission of communicable diseases.

Chart Order ($2511$)

A paper or electronic record for an inpatient or resident of an institutional facility issued by a practitioner or licensed designee.

Chart Order Designee ($2511$)

A nurse, pharmacist, or physician who can write the order and put it in the chart, though a prescriber signature is still needed to make it official.

Prescription Data Elements: Prescriber ($2511$)

Requires the name, licensure designation (e.g. MD), address, and telephone number.

Prescription Data Elements: DEA ($2511$)

Required on the prescription if the drug is a controlled substance.

Toilet Paper Prescription Size ($2511$)

The paper must be $4 \times 5$ inches and have a printed signature line.

Toilet Paper Prescription Refill Slot ($2511$)

A required element for prescriptions written on alternative stationary like toilet paper.

Toilet Paper Prescription Limit ($2511$)

No more than $4$ prescriptions may be written on a single sheet of toilet paper.

DAW Checkbox ($2511$)

The 'Dispense as Written' checkbox required on a prescription written on alternative paper.

Transferred Prescription Format ($2511$)

Prescriptions transferred from other pharmacies may be written on anything and do not have to meet same physical requirements as original orders.

Patient Right to Partial Fills ($2511$)

The right to have partial fills made if they do not exceed the total amount authorized.

Medication Transfer Deadline ($2511$)

Pharmacies must transfer a medication to another pharmacy no more than the close of business the next day.

Authorized Prescribers of Drugs or Devices ($2511 C$)

Practitioners with valid prescriptive authority, agents of the practitioner, or a pharmacist when authorized by law, rule, standing order, or practice agreement.

Pharmacist Adaptation: Quantity ($2511 F$)

A pharmacist may change the quantity if the package size is not available, for dosage form changes, to dispense total authorized amounts, or for med synchronization.

Pharmacist Adaptation: Dosage Form ($2511 F$)

Changing the dosage form of a medication if it is in the best interest of patient care, provided the prescriber did not prohibit adaptation.

Generic Substitution Keys ($2511$)

The patient must be informed, must consent, and the substitution must save money.

Phoned-in Prescription Writing ($2511$)

Must be written down immediately by the pharmacist, intern, or technician.

Phoned-in Prescription Verification ($2511$)

Must be initialed or signed by the person taking the order and by the pharmacist if it was not taken by a pharmacist.

Electronic Prescription Data ($2511$)

Requires prescriber name, licensure designation, address, telephone, and DEA if it is a controlled substance.

Fax Prescription Storage ($2511$)

Faxed prescriptions must be printed on non-fading paper and may be scanned and stored as other written prescriptions.

Fax Machine Location ($2511$)

A fax machine for prescriptions must be located specifically in the pharmacy and in the medical office.

Missing Information Remedy ($2511$)

A technician, intern, or pharmacist may work with the prescriber to remedy missing information or clarify the prescriber's intent.

Accuracy and Authenticity Responsibility ($2513$)

The pharmacist is responsible for verification of authenticity and the accuracy of medications dispensed, even if a technician takes a verbal order.

Internet Based Physicians ($2515$)

Prescriptions from internet-based physicians are not valid if there is doubt about the patient-physician relationship.

6 Steps of Prescription Dispensing: Step $1$ ($2517$)

Receiving and interpreting the prescription.

6 Steps of Prescription Dispensing: Step $2$ ($2517$)

Putting the pills in the right sized bottle.

6 Steps of Prescription Dispensing: Step $3$ ($2517$)

Compounding or mixing if necessary.

6 Steps of Prescription Dispensing: Step $4$ ($2517$)

Sticking a label on the final container.

6 Steps of Prescription Dispensing: Step $5$ ($2517$)

Patient counseling as required.

6 Steps of Prescription Dispensing: Step $6$ ($2517$)

Transfer of possession.

Generic Substitution Medicaid/Medicare Wording ($2517$)

Must be 'Brand necessary' or 'Brand Medically Necessary' for the prescriber to prohibit generic substitution.

Biosimilar Notification Deadline ($2517$)

The pharmacist must notify the prescriber within $5$ business days of dispensing a biosimilar.

Biosimilar Notification Contents ($2517$)

Must include the specific product used, including manufacturer and product name.

Non-Controlled Prescription Refill Life ($2519 A$)

Refills are valid for up to $1 year$ from issuance if not a controlled substance.

CIII through CIV Refill Limit ($2519 A$)

No more than $5$ refills are permitted.

CII Refill Policy ($2519 A$)

No refills are allowed for Schedule II medications.

Autorefill Functionality ($2519 A.3$)

Allowed for monthly refills on a per-prescription basis, but not for the patient's lifetime.

Medication Refill Request Initiation ($2519 A.3$)

The patient must make a specific request; the pharmacy cannot request a refill just because a prescription expired or is out of refills.

Medication Synchronization Quantity ($2519$)

Dispensing quantity and refill schedules can be adjusted as long as they do not exceed the total number of dosage units prescribed.

Emergency Medication Judgment ($2521$)

A pharmacist determination allowed when the prescriber is unavailable and the patient needs medication for an emergency.

Emergency Medication Limit ($2521$)

Up to a $30 day$ supply may be provided in an emergency situation.

Emergency Multiple Dose Container Exception ($2521$)

The $30 day$ emergency supply limit does not apply to unit of use containers like inhalers.

Non-Controlled Transfer Record Retention ($2523$)

Original and transferred prescriptions must be maintained for at least $2$ years after the last refill.

Transfer Giver Requirements ($2523$)

Must invalidate the prescription and record the name/address of the receiving pharmacy, name of receiving pharmacist, date, and name of transferring pharmacist.

Transfer Taker Requirements ($2523$)

Must indicate the prescription is transferred and record patient info, drug info, prescriber info, original dates, refill counts, and original pharmacy details.

Controlled Substance Transfer Professionals ($2523$)

A transfer involving controlled substances may only be completed by a pharmacist.

Controlled Substance Transfer: DEA Recording ($2523$)

The giver must record the taker's DEA number, and the taker must record the giver's and the physician's DEA numbers.

Common Electronic Files ($2523$)

Prescription records stored electronically at a central site, typically used by chain pharmacies to allow multiple stores to fill the same script.

CII Prescription Lifespan ($2525$)

Expires $90 days$ from the original date.

CIII through CIV Prescription Lifespan ($2525$)

Expires $6 months$ from the original date.

CV Prescription Lifespan ($2525$)

Expires $1 year$ from the original date.

Minimum Prescription Label: Prescriber ($2527$)

Requires the name of the practitioner.

Minimum Prescription Label: Pharmacist ($2527$)

Requires the name or initials of the pharmacist.

Minimum Prescription Label: Medication ($2527$)

Requires the name and strength of the drug or device.

Prepackaging ($2529$)

Taking a drug out of a large manufacturer bottle and putting it into a smaller, single-dose container.

Prepackaged Label: Preparer Identification ($2529$)

Requires the pharmacist's initials.

Prepackaged Label: Date of Prep ($2529$)

The date on which the drug was prepackaged.

Prepackaged Label: Expiration ($2529$)

The date of expiration based on USP guidelines.

Prepackaged Label: Batch Identification ($2529$)

Requires the manufacturer's name and the manufacturer's lot or batch number.

Compounding Preparation Definition ($2533$)

A compounded formulation formulated by a compounder.

Class $100$ Environment ($2533$)

A controlled-aire environment, commonly referred to as a clean room.

Cytotoxic ($2533$)

Any pharmaceutical that has the capability of killing living cells.

Sterile Product ($2533$)

Something devoid of viable microorganisms.

Compounding Definition ($2533$)

To prepare, mix, assemble, package, or label something made based on a prescription, a provider relationship, or in anticipation of an order.

Duplicating Commercial Products ($2533$)

Compounding does not include duplicating commercially available products unless the product is not currently available.

Sterile Prep Compounding Standard ($2535$)

Must follow FDCA Section $503 A$ and USP $797$.

Non-Sterile Prep Compounding Standard ($2535$)

Must follow FDCA Section $503 A$ and USP $795$.

Veterinary Compounding Standard ($2535$)

Must follow Section $530$ of Title $21$ of the CFR.

Board Notification for Compounding ($2535$)

The Board of Pharmacy must be notified PRIOR to starting compounding and must approve the pharmacy's request.

Sterile Compounding Training Documentation ($2535$)

Requires recording the name of the person trained, date, topics covered, and the signatures of both the trainee and the trainer.

Sterile Compounding Continuing Education ($2535$)

One hour of CE annually in the field is required for sterile compounders.

Anticipatory Compounding ($2535$)

The practice of making excess product in anticipation of receiving an order; must be labeled with the formula, lot number, and estimated BUD.

Outsourcing Facility ($2535$)

A federal designation for a compounder recognized to provide products to physicians' offices, effectively eliminating a standard compounder's ability to sell to offices.