PTCB Certified Pharmacy Technician (PTCE) flashcards

The Durham-Humphrey Amendment of 1951 is a federal law that established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs, requiring a prescription for drugs that are habit-forming, unsafe for self-medication, or new drugs not yet proven safe for OTC use.

• Defined Rx vs. OTC categories.
• Required 'Rx only' label for prescription drugs.
• Made oral prescriptions and refills legal.

Memory trick: Durham-Humphrey: Differentiated Drugs, Humphrey's Rx is for Me!

Federal law places specific limits on the number and timeframe for refills of controlled substances based on their schedule.

• Schedule II: No refills allowed.
• Schedule III, IV, V: Up to 5 refills within 6 months from the date of issue.
• State laws may impose stricter limits.

Memory trick: Schedule 2 = No Refills; Schedule 3, 4, 5 = Five Refills in Six Months.

Federal regulations require specific and clear directions for use on Schedule II controlled substance prescriptions, including a maximum daily dose and/or duration when 'PRN' is indicated, to prevent misuse and ensure appropriate therapy.

• Directions must be explicit.
• 'PRN' requires specific limits.
• Missing info makes Rx invalid until clarified.

Memory trick: C-II Directions: Clear, Concise, and Complete, especially for PRN.

Federal law dictates strict requirements for Schedule II prescriptions to prevent diversion and abuse.

• Must be written (or e-prescribed) and signed by the prescriber.
• No refills allowed.
• Must include patient's full name and address, prescriber's full name, address, and DEA registration number.
• Must specify drug name, strength, dosage form, quantity, and directions for use (including a specific dosage regimen).

Memory trick: C-II scripts need ALL details: Patient, Prescriber, Drug, Dose, and Regimen.

Federal regulations specify mandatory information that must be present on a Schedule II controlled substance prescription for it to be valid.

• Prescriber's full name, address, and DEA registration number.
• Patient's full name and address.
• Drug name, strength, dosage form, quantity, and directions for use.
• Date issued and manual signature of the prescriber.

Memory trick: DEA's Prescription Rules: Patient, Drug, Doctor, Date, Signature.

Federal law (CMEA) restricts the amount of pseudoephedrine that can be purchased by an individual to combat illicit methamphetamine production.

• Daily limit: 3.6 grams per purchaser.
• 30-day limit (retail): 9 grams per purchaser.
• 30-day limit (mail-order): 7.5 grams per purchaser.
• Requires purchaser ID and signature, and sales log.

Memory trick: Pseudoephedrine: 3.6 daily, 9 monthly, log it!

The classification of a drug as prescription-only (Rx) or over-the-counter (OTC) is determined by federal regulations based on safety, potential for misuse, and necessity of medical supervision.

• Rx drugs require a healthcare professional's authorization.
• OTC drugs can be purchased without a prescription.
• Some drug classes have both Rx and OTC formulations (e.g., lower vs. higher doses).

Memory trick: Rx Requires eXpertise, OTC is Open To Consumers.

Medications that can be purchased without a prescription, generally considered safe and effective for use by the general public when directions are followed.

• Do not require a doctor's order.
• Available directly from pharmacy shelves or other retail stores.
• Examples include many pain relievers, cold remedies, and allergy medications.

Memory trick: Drugs are either RX, OTC, or BTC, each with rules.

Federal law specifies critical information that must be present on every Schedule II prescription for it to be valid and dispensable.

• Patient's full name and address.
• Prescriber's full name, address, and DEA registration number.
• Drug name, strength, dosage form, quantity, and directions for use.
• Date issued and manual signature (or secure electronic signature) of the prescriber.

Memory trick: A C-II Rx needs Patient, Prescriber, Drug Details, and DEA number.

Federal law limits Schedule III, IV, and V controlled substance prescriptions to be valid for 6 months from the date of issue and allows a maximum of 5 refills within that period.

• Applies to Schedules III, IV, and V.
• 6-month validity from issue date.
• Maximum of 5 refills.
• Refills cannot extend beyond the 6-month period.

Memory trick: C3-5: Six months, Five refills, Feel fine.

DEA Form 41, 'Registrants Inventory of Drugs Surrendered', is used to document the destruction of controlled substances by a DEA registrant, or to document the transfer of controlled substances to a reverse distributor for destruction.

• Documents destruction/transfer for destruction.
• Used for all schedules of controlled substances.
• Reverse distributor typically completes it when taking drugs.

Memory trick: Dispose of Controlled Drugs? Form 41, For Fate!

The official federal form required for the ordering of Schedule I and II controlled substances by registrants (e.g., pharmacies).

• Mandatory for all Schedule I and II controlled substance orders.
• Triplicate form: copy 1 (brown) to supplier, copy 2 (green) to DEA, copy 3 (blue) retained by purchaser.
• Must be signed by the DEA registrant or an authorized power of attorney.
• Ensures strict accountability and tracking of highly controlled substances.

Memory trick: DEA Forms: Order C2s, Dispose, Report Loss, Register Pharmacy.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is a federal agency that leads public health efforts to advance the behavioral health of the nation, including regulating and supporting medication-assisted treatment (MAT) for opioid use disorder.

• Oversees buprenorphine prescribing for opioid addiction.
• Requires prescribers to obtain a waiver (X-DEA number).
• Administers the DATA 2000 Act.

Memory trick: SAMHSA Saves Addicts with Medications, ensuring Safe Access.

Federal law (Combat Methamphetamine Epidemic Act of 2005) restricts the sale of pseudoephedrine, ephedrine, and phenylpropanolamine due to their use as precursors in methamphetamine production.

• Requires behind-the-counter placement.
• Mandates ID verification and logbook entry for sales.
• Imposes daily and monthly sales limits.

Memory trick: CMEA: Combat Meth Epidemic, Control Ephedrine, Monitor Sales.

A Risk Evaluation and Mitigation Strategy (REMS) program is an FDA-mandated strategy to manage a drug or biological product with a known or potential serious risk, ensuring that the benefits of the drug outweigh its risks. Clozapine has a REMS due to risks like severe neutropenia.

• FDA-mandated for drugs with serious risks.
• Clozapine REMS requires patient lab monitoring.
• Prescriber and pharmacy must be certified/enrolled.

Memory trick: REMS: Risks Evaluated, Mitigation Strategies enacted, Safe use Ensured.

A specific warning label required by federal law to be affixed to the container of any dispensed Schedule II, III, IV, or V controlled substance.

• Required for all schedules II-V.
• States: 'Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.'
• Ensures patients are aware of legal restrictions.

Memory trick: Labeling Controlled substances: 'Careful! Federal Law Says No Transfer!'

A 1951 amendment to the Food, Drug, and Cosmetic Act that legally established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs.

• Defined drugs that require a prescription.
• Mandated the 'Rx Only' or 'Caution: Federal law prohibits dispensing without a prescription' label.
• Authorized verbal prescriptions and prescription refills.

Memory trick: Food & Drug Acts: Pure, Cosmetic, Durham-Humphrey, Kefauver.

Federal law dictates that prescriptions for Schedule III, IV, and V controlled substances expire 6 months after the date of issue, regardless of the number of refills remaining.

• 6-month validity for CIII-V.
• Maximum 5 refills within that 6-month period.
• Whichever comes first (6 months or 5 refills) causes expiration.
• New prescription required after expiration.

Memory trick: Six months Or Five refills, whichever comes first, the prescription dies.

Federal regulations dictate specific counting methods for controlled substance inventories based on their schedule.

• Schedule I and II: Always require an exact count.
• Schedule III, IV, and V: May be estimated unless the container holds more than 1,000 dosage units.
• Biennial inventory is required at least every two years.

Memory trick: Count carefully: Schedule I/II exact, CIII-CV estimate unless over 1000.

DEA Form 222 is a triplicate form used for ordering and receiving Schedule I and II controlled substances, with specific copies for the supplier, DEA, and purchaser.

• Copy 1 (brown) for supplier.
• Copy 2 (green) for DEA (sent by supplier).
• Copy 3 (blue) for purchaser (pharmacy).

Memory trick: 222: Two copies sent, one kept, all verified.

Federal law requires DEA registrants to report any significant loss or theft of controlled substances to the Drug Enforcement Administration (DEA) using DEA Form 106 within one business day of discovery.

• Requires DEA Form 106.
• Must be reported within one business day of discovery.
• 'Significant' loss is determined by the registrant.

Memory trick: Lost Controlled Drugs? Form 106 to DEA in One Day, No Delay!

The Substance Abuse and Mental Health Services Administration (SAMHSA) is the primary federal agency overseeing the regulations and requirements for prescribers of buprenorphine for opioid use disorder (OUD) treatment.

• Oversees the DATA 2000 Act (Drug Addiction Treatment Act).
• Responsible for X-Waiver (now largely removed) and other buprenorphine prescribing rules.
• Aims to expand access to OUD treatment.
• Works with DEA and FDA, but holds primary oversight for this specific area.

Memory trick: SAMHSA Saves Addicts, Manages Hopeful Solutions for Addiction.

Federal law states that prescriptions for non-controlled legend drugs are valid for refills for up to one year from the date the prescription was written, unless otherwise specified by the prescriber or state law.

• One-year validity period for refills.
• Applies to non-controlled (non-scheduled) drugs.
• State laws may impose shorter limits.

Memory trick: Non-Controlled Rx: One Year to Get Refills, then it's 'Finished'!

Federal law dictates specific refill limits for Schedule III, IV, and V controlled substances to prevent misuse and diversion.

• Applies to Schedule III, IV, and V controlled substances.
• Maximum of five refills.
• Must be refilled within six months from the date of issue.
• No refills are allowed for Schedule II controlled substances.

Memory trick: Refill Five times, Six months, C3-5.

The FDCA of 1938 is the foundational law establishing federal oversight of drug safety and requiring drugs to be adequately labeled, including directions for use for non-prescription products.

• Mandated drug safety prior to marketing.
• Required 'adequate directions for use' on labels.
• Established the FDA's authority to regulate drugs and cosmetics.
• Forms the basis for many subsequent drug laws.

Memory trick: FDCA: First Drug Control Act, Adequate directions.

Federal law allows prescribers to issue multiple prescriptions for a Schedule II controlled substance on the same day for a total extended supply.

• Permitted for up to a 90-day total supply.
• Each separate prescription (after the initial one) must include a 'do not fill before' date.
• Must be for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
• This addresses the 'no refills' rule for C-II drugs.

Memory trick: C-II: No refills, but 90-day supply is possible with staggered 'do not fill before' dates.

Federal regulations require pharmacies to maintain records of all controlled substances received. For Schedule III, IV, and V drugs, this typically involves signing and dating the commercial invoice or packing slip upon receipt.

• Applicable to Schedules III, IV, and V.
• Invoice or packing slip serves as record.
• Must be signed and dated by authorized personnel.

Memory trick: Receiving Controlled Drugs: S-II needs 222, S-III to S-V needs Invoice Sign-Off.

Federal law allows prescriptions for Schedule III, IV, and V controlled substances to be transferred once between pharmacies, unless they share a common electronic database, in which case they can be transferred up to the number of refills authorized.

• C-IIs cannot be transferred.
• CIII-V can be transferred once to another pharmacy.
• If pharmacies share a common electronic database, multiple transfers are allowed up to the number of refills.
• Transfer must be communicated directly between pharmacists.

Memory trick: C3-5: One transfer, unless you're a Twin (common database).

Federal law generally requires a hard copy or e-prescription for Schedule II substances, but allows faxed prescriptions to serve as the original for compounded parenteral C-IIs, C-IIs for LTCF residents, and C-II narcotics for hospice patients.

• Compounded parenteral C-IIs.
• C-IIs for Long-Term Care Facility (LTCF) residents.
• C-II narcotic substances for hospice patients.
• All other C-IIs require original written or e-prescription.

Memory trick: Fax C-II: Hospice, LTCF, Compounded Parenteral - H.L.C.!

Federal regulations dictate the required accuracy of counting controlled substances during inventory, varying by schedule.

• Schedule II substances require an exact count (100% accuracy).
• Schedule III, IV, and V substances require an exact count if the container holds 1,000 units or less.
• Schedule III, IV, and V substances can be estimated if the container holds more than 1,000 units, but an exact count is often preferred for best practice.

Memory trick: C2 Exact, C3-5 Count or Estimate >1000.

DEA Form 222 is the official order form used by pharmacies and other registrants to order Schedule I and II controlled substances.

• Required for all purchases of Schedule I and II drugs.
• Not used for Schedule III, IV, or V drugs.
• Triplicate form, with specific distribution of copies.

Memory trick: Form 222: Only for the 'Double-Two' (Schedule I & II) Drugs, never the others.

Federal law allows a one-time transfer of original prescription information for Schedule III, IV, and V controlled substances for refill purposes between two DEA-registered pharmacies. If pharmacies share a common, real-time electronic database, they can transfer up to the maximum number of refills permitted by law.

• Applies to Schedules III, IV, V.
• Generally, 'one-time' transfer rule.
• Exception: shared electronic databases allow more transfers.
• Schedule II prescriptions cannot be transferred.

Memory trick: Controlled Transfers: S-II is 'No Go', S-III to S-V is 'One Go' (unless Shared Data).

Federal regulations provide specific options for how pharmacies must file controlled substance prescriptions to ensure accountability and accessibility.

• Schedule II: Must be filed separately from all other prescriptions.
• Schedule III, IV, V (Option 1): Filed separately from all non-controlled and Schedule II prescriptions.
• Schedule III, IV, V (Option 2): Filed with non-controlled prescriptions, provided they are readily retrievable and marked with a red 'C' (at least 1 inch high) in the lower right corner.

Memory trick: C-II alone, CIII-CV with non-controls and a Red C, or CIII-CV alone.

Prescriptions for Schedule III and IV controlled substances are valid for 6 months from the date they were written, and patients may receive a maximum of 5 refills within this 6-month period.

• Valid for 6 months from date of issue.
• Maximum of 5 refills allowed.
• No refills can be dispensed after 6 months.

Memory trick: Six Months Max: C-III/IV refills expire, no more than five.

DEA Form 41 is the official document used to record the destruction of controlled substances.

• Required for all registrants destroying controlled substances.
• Documents the method of destruction and substances destroyed.
• Often completed by a reverse distributor when substances are returned to them for destruction.

Memory trick: Each DEA form has a Distinct, Essential Action.

Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated program to ensure that the benefits of certain drugs with serious safety concerns outweigh their risks.

• Required for drugs with significant potential for adverse effects (e.g., teratogenicity).
• May include elements like patient registries, specific training for prescribers/pharmacies, and patient counseling.
• Isotretinoin (for severe acne) is a well-known example.

Memory trick: Risk Evaluation Mitigates Serious (drug) harm.

Federal law (DEA) mandates that pharmacies conduct a complete inventory of all controlled substances at least every two years.

• Initial inventory required upon opening a pharmacy.
• Biennial inventory (every 2 years) is the federal minimum.
• State laws may require more frequent inventories (e.g., annually).
• Inventory must be accurate and include specific details (date, time, drug name, strength, dosage form, quantity).

Memory trick: Inventory is In Two years, not annually.

Federal law allows a faxed prescription for a Schedule II controlled substance to serve as the original written prescription for patients residing in a Long-Term Care Facility (LTCF) or for patients enrolled in a hospice care program.

• Applies to LTCF and hospice patients.
• Faxed copy is considered the original.
• Facilitates timely access to medication.

Memory trick: Faxed C-II: For LTCF or Hospice, it's Fine, No Original Required.

Risk Evaluation and Mitigation Strategy (REMS) programs are FDA requirements for certain medications with serious safety concerns, ensuring that the benefits outweigh the risks.

• FDA-mandated.
• Designed to mitigate serious risks.
• Can include Medication Guides, communication plans, ETASU (Elements to Assure Safe Use).
• ETASU often involve prescriber/dispenser training or patient monitoring.

Memory trick: REMS: Risk Education Means Safety.

When certain foods alter the metabolism of medications, often by inhibiting or inducing cytochrome P450 enzymes in the liver and intestines.

• Can lead to increased drug levels and toxicity or decreased drug efficacy.
• Grapefruit juice is a common inhibitor of CYP3A4.
• Important to counsel patients on specific food restrictions.

Memory trick: Statins and Grapefruit: A Potent Mix, Leading to Muscle Aches and Fix!

Calculations used to determine the appropriate medication dose for children, which are often based on body weight (mg/kg) or body surface area (mg/m²).

• Requires careful attention to units and conversions.
• Always verify against recommended dosing ranges.
• Potential for medication errors is higher in pediatric patients.

Memory trick: Weight to Dose, Dose to Daily, Check the Range, Don't Be Hazy!

When the effects of one drug are altered by the presence of another drug in the body, often due to competition for receptors or changes in physiological response.

• Can result in additive, synergistic, or antagonistic effects.
• May lead to increased toxicity or decreased efficacy.
• Requires careful monitoring and potential dosage adjustments.

Memory trick: Warfarin's a Wimp, Watch What You Mix, or Bleeding's the Blight!

A coarse dispersion in which insoluble solid particles are dispersed in a liquid medium, requiring shaking before use to ensure uniform dosing.

• Used for insoluble drugs or to mask taste.
• Requires a suspending agent to slow settling.
• Must be easily redispersible upon shaking.

Memory trick: Shake It, Don't Break It, for a Dose You Can Take It!

A substance that helps to stabilize an emulsion by forming a protective film around the dispersed droplets and preventing their coalescence.

• Used in emulsions (oil-in-water or water-in-oil).
• Reduces interfacial tension between immiscible liquids.
• Examples include acacia, tragacanth, Tween, Span.

Memory trick: Oil and Water Won't Mix, Unless an Emulsifier Sticks!

The administration of mineral salts to correct deficiencies in the body's electrolytes, which are essential for nerve and muscle function, hydration, and pH balance.

• Commonly replaced electrolytes include potassium, sodium, calcium, magnesium.
• Deficiencies can be caused by diuretics, vomiting, diarrhea, kidney disease.
• Important to monitor levels to avoid hyper- or hypo-states.

Memory trick: Low K? Get KCl!

A compounding technique used to ensure uniform distribution of a small quantity of a potent substance in a larger quantity of a diluent.

• Starts with the smallest quantity ingredient.
• Adds equal amounts of diluent at each step, mixing thoroughly.
• Ensures homogeneity and prevents 'hot spots' of potent drug.

Memory trick: Mix It Right, Mix It Light, for Potent Powders, a Geometric Sight!

A set of procedures used in sterile compounding to prevent contamination of sterile preparations.

• Maintains sterility of compounded sterile products (CSPs).
• Includes hand hygiene, garbing, and disinfection of critical sites.
• Performed within a controlled environment like a laminar airflow workbench.

Memory trick: Clean Hands, Clean Vials, Clean Air, Clean You.

Herbal products can interact with prescription and over-the-counter medications, affecting their efficacy or increasing adverse effects.

• Not regulated by the FDA as drugs; quality and potency vary.
• Patients may not disclose use to healthcare providers.
• Common interactions include altered metabolism (CYP450) or additive pharmacodynamic effects.

Memory trick: Valerian's Veil of Calm, but Watch for Drug Harm!

Medications that contain the same active ingredient, have the same dosage form and strength, and are bioequivalent, thus having the same clinical effect and safety profile.

• Determined by the FDA (e.g., 'Orange Book').
• Generic substitutes must be therapeutically equivalent to their brand-name counterparts.
• Different salts or release mechanisms of the same drug may not be therapeutically equivalent.

Memory trick: Same Drug, Same Dose, Same Effect? Check the Orange Book for the Best.

A common, persistent, dry, non-productive cough that can occur in patients taking Angiotensin-Converting Enzyme (ACE) inhibitors, often leading to discontinuation.

• Caused by accumulation of bradykinin in the airways.
• Can develop weeks to months after starting the medication.
• Usually resolves within 1-4 weeks after discontinuation.

Memory trick: Don't ACE the Cough, Block the Bradykinin's Rough!

Strategies and procedures implemented to reduce the occurrence of mistakes in the medication use process, from prescribing to administration.

• Involves multiple checks and balances.
• Technicians play a critical role in identifying potential errors.
• Always escalate discrepancies to a pharmacist.

Memory trick: See a Glitch? Call the Chief, for Patient Safety, Give Relief!

When compounding non-sterile hazardous drugs (e.g., corticosteroids), essential PPE includes gloves to prevent skin absorption, and potentially gown and eye protection depending on risk.

• Corticosteroids are hazardous drugs
• Gloves prevent skin absorption
• Gowns and eye protection add layers of safety

Memory trick: Hazardous Creams: Hands Must Be Guarded.

The smallest amount of a substance that can be accurately weighed on a given balance, considering its sensitivity and an acceptable error percentage.

• Ensures accuracy in compounding
• Calculated using sensitivity and acceptable error
• Essential for potent substances

Memory trick: Mighty Weighing Quantities Ensure Accuracy.

Extended-release (ER, XR, CD, SR, LA, etc.) dosage forms are designed to release medication slowly over an extended period, and should generally not be cut, crushed, or chewed.

• Maintain consistent drug levels
• Prevent frequent dosing
• Disrupting them causes 'dose dumping'
• Dose dumping can lead to toxicity or subtherapeutic levels

Memory trick: ER = Extended Release, Requires Respect.

The co-administration of Warfarin and Bactrim (sulfamethoxazole/trimethoprim) can lead to a significant increase in Warfarin's anticoagulant effect, greatly elevating the patient's risk of severe bleeding due to metabolic inhibition.

• Bactrim inhibits Warfarin metabolism.
• Leads to higher Warfarin levels in blood.
• Increases risk of hemorrhage.
• Requires close INR monitoring and possible Warfarin dose reduction.

Memory trick: Warfarin + Bactrim = Bleeding Risk, Be Aware!

Percentage strength (w/w, v/v, or w/v) indicates the amount of solute in 100 units of the total mixture. To find the amount of solute, convert the percentage to a decimal and multiply by the total quantity.

• % means 'parts per hundred'.
• For w/w, it's grams of solute per 100 grams of mixture.
• Formula: Amount of solute = (Percentage/100) * Total quantity.

Memory trick: Percent to decimal, then multiply for the part you need.

St. John's Wort can significantly reduce the anticoagulant effect of warfarin by inducing cytochrome P450 enzymes, which metabolize warfarin.

• St. John's Wort is a strong CYP enzyme inducer
• Warfarin's metabolism is increased
• Risk of blood clots increases due to subtherapeutic warfarin levels

Memory trick: Watch Out: St. John's Wort Weakens Warfarin.

The critical area inside a Laminar Airflow Workbench (LAFW) where uncontaminated, HEPA-filtered air flows directly over the compounding activities, ensuring sterility.

• Compounding activities must occur within this zone.
• Typically at least six inches inside the LAFW's front edge.
• Prevents turbulent airflow and introduction of contaminants.

Memory trick: Aseptic means no germs, keep air flowing clean.

A set of practices performed before and during sterile compounding to protect the preparation from microbial contamination.

• Includes proper hand hygiene, garbing, and environmental controls.
• Any breach in technique requires immediate corrective action.
• Goal is to minimize the introduction of pathogens into sterile products.

Memory trick: Tear a glove, trash the glove, wash and new.

The risk of an allergic reaction to other beta-lactam antibiotics (e.g., cephalosporins, carbapenems, other penicillins) in patients with a known penicillin allergy.

• Amoxicillin is a penicillin.
• High risk of cross-reactivity with other penicillins.
• Pharmacist must evaluate and intervene.

Memory trick: Penicillin Allergy? Amoxicillin is a NO-GO, Alert the Pharmacist, Let Them Know!