33 Patient Safety & Quality Assurance Practice Questions & Answers

1. 1. A prescriber orders a 0.5 mg dose. Which way of printing that strength on the label follows safe practice?

   • A.0.50 mg, with a zero added after the five for extra clarity
   • B..5 mg, with the decimal point standing at the front
   • C.0.5 mg, with a zero placed ahead of the decimal point✓ Answer
   • D..50 mg, with the zero at the front of it trimmed off

   A leading zero pulls the eye onto the decimal point; without it, .5 mg is easily read as 5 mg, a tenfold overdose. A trailing zero creates the opposite trap, because 0.50 mg can be read as 50 mg if the decimal is missed.

   Ref QB-ZZMYGDSource: ISMP List of Error-Prone Abbreviations, Symbols and Dose Designations (leading/trailing zeros); Joint Commission Do Not Use ListReport a problem with this question

2. 2. A technician types the directions as "Take 5.0 mg by mouth daily." What specific misreading does that trailing zero invite?

   • A.The decimal may shift and the dose read as 500 mg, a hundred times it
   • B.The figure may be read as a range and the dose taken as 5 to 10 mg
   • C.The zero may be dropped and the dose read as 0.5 mg, one tenth of it
   • D.The decimal may be missed and the dose read as 50 mg, ten times it✓ Answer

   If the decimal point is not seen, 5.0 reads as 50, a tenfold overdose. That is why a trailing zero is never written after a whole number: the correct entry is 5 mg.

   Ref QB-JH6G9FSource: ISMP List of Error-Prone Abbreviations, Symbols and Dose Designations (trailing zero); Joint Commission Do Not Use ListReport a problem with this question

3. 3. Which group of drugs is classified as high-alert medications, and for what reason?

   • A.Antihistamines, laxatives and antacids, because they are dispensed in very large volume
   • B.Insulins, anticoagulants and concentrated electrolytes, because an error often causes severe harm✓ Answer
   • C.Vitamins, minerals and herbal products, because their contents are not reviewed in advance
   • D.Antibiotics, antifungals and antivirals, because resistance follows a single missed dose

   High-alert status reflects the severity of harm when an error occurs, not how often it occurs. These drugs have a narrow margin between a therapeutic and a damaging dose, so independent double checks and separated storage are used.

   Ref QB-KHHTEGSource: ISMP List of High-Alert Medications (community/ambulatory and acute care settings)Report a problem with this question

4. 4. Shelf labels in the pharmacy read predniSONE and prednisoLONE. What does that style of lettering do?

   • A.It stresses the letters that differ so similar names are not mixed up✓ Answer
   • B.It flags the items a technician may pull without a second verification
   • C.It identifies the drugs that are supplied only in unit-dose packaging
   • D.It marks the products that must be stored in the refrigerated section

   Tall man lettering capitalizes the segment of the name that is not shared, so the eye lands on the difference rather than on the identical opening letters of a look-alike, sound-alike pair.

   Ref QB-32CNUFSource: ISMP/FDA Tall Man Lettering List; PTCE Content Outline (error prevention strategies)Report a problem with this question

5. 5. The pharmacy keeps one counting tray used only for penicillins and sulfonamides. What risk does that practice control?

   • A.Penicillin tablets crumble and leave a residue in the plastic tray
   • B.Sulfonamide products count slowly and need a tray with deeper wells
   • C.These two classes stain a tray and make the next count hard to read
   • D.Drug dust on a shared tray could reach a patient allergic to them✓ Answer

   Fine powder from these tablets clings to the tray and transfers to the next drug counted, so a patient with a penicillin or sulfa allergy can react to a trace of a drug that was never prescribed. Trays are also wiped with 70% isopropyl alcohol between uses.

   Ref QB-MHV5MHSource: PTCE Content Outline (hygiene and cleaning standards); ISMP guidance on dedicated counting trays for penicillins and sulfonamidesReport a problem with this question

6. 6. Before counting, a technician scans the barcode on the stock bottle. What does that scan confirm?

   • A.That the counted quantity agrees with the number typed in the record
   • B.That the product taken from the shelf matches the drug code on the order✓ Answer
   • C.That the patient has been offered counseling on the finished product
   • D.That the prescriber holds active authority to write for the product

   The scan compares the National Drug Code on the shelf stock with the code attached to the order, so a wrong drug or wrong strength is caught at the moment of selection, before counting or labeling.

   Ref QB-42QYZGSource: PTCE Content Outline (barcode verification); ISMP guidance on barcode scanning at the point of selectionReport a problem with this question

7. 7. While entering a new prescription, the software flags an interaction with a drug already on the patient's profile. What should the technician do next?

   • A.Override the alert and add a warning sticker to the container
   • B.Cancel the new order and tell the patient to call the prescriber
   • C.Fill the older drug first and hold the new order until later
   • D.Route the order and the alert to the pharmacist before filling✓ Answer

   Resolving a screening alert calls for clinical judgment, which belongs to the pharmacist. A technician does not override the alert, change the therapy or counsel the patient about it, so the order goes forward for review before the fill continues.

   Ref QB-U396X5Source: PTCE Content Outline (issues requiring pharmacist intervention: drug utilization review alerts)Report a problem with this question

8. 8. A profile already lists omeprazole 20 mg daily, and a new prescription for pantoprazole 40 mg daily is entered. What is the technician's part in this?

   • A.Change the new order to the drug already listed on the profile
   • B.Tell the patient to stop one drug and dispense the newer one
   • C.Flag the duplication for the pharmacist and hold the new order✓ Answer
   • D.Delete the older drug from the profile and then process the new one

   Two proton pump inhibitors on one profile is a therapeutic duplication. Recognizing and flagging it is technician work; editing the profile, substituting a therapy or advising the patient are clinical decisions reserved for the pharmacist.

   Ref QB-CKEBH6Source: PTCE Content Outline (therapeutic duplication; issues requiring pharmacist intervention)Report a problem with this question

9. 9. A technician pulls the wrong strength and the pharmacist catches it at verification, before the bag leaves the pharmacy. How is that event classified and handled?

   • A.As a routine correction, left out of the pharmacy's own records
   • B.As an adverse drug event, reported to the product's manufacturer
   • C.As a sentinel event, disclosed to the patient by the pharmacist
   • D.As a near miss, still reported internally so the cause is studied✓ Answer

   An error stopped before it reaches the patient is a near miss, and continuous quality improvement depends on those reports, because the same system weakness would eventually produce an error that does reach a patient.

   Ref QB-V3MG47Source: PTCE Content Outline (event reporting: near miss and good catch); ISMP Medication Errors Reporting ProgramReport a problem with this question

10. 10. After repeated mix-ups between two look-alike names, the pharmacy conducts a root cause analysis. What is the purpose of that review?

    • A.To decide which staff member was at fault in each of the mix-ups
    • B.To trace the system weaknesses that allowed the errors to happen✓ Answer
    • C.To rank the reported events by the harm each one did to a patient
    • D.To predict how a process that is being designed might fail later

    A root cause analysis looks backward at an event that already happened and asks why the system permitted it rather than who erred. Looking forward at a process not yet in use is the job of a failure mode and effects analysis.

    Ref QB-5KXYAWSource: PTCE Content Outline (root cause analysis versus failure mode and effects analysis)Report a problem with this question

11. 11. A patient has a serious, unexpected reaction to a dispensed medication. Where is that reaction reported?

    • A.To the wholesaler, which logs the reaction against the drug lot
    • B.To VAERS, the system that collects reports about given vaccines
    • C.To the state board, which passes reactions to the drug's maker
    • D.To MedWatch, the FDA program that takes drug and device reports✓ Answer

    MedWatch is the FDA safety reporting program for drugs, biologics and devices, and voluntary reports are submitted on Form 3500. Vaccine reactions go to VAERS instead, which is why the two systems are easily confused.

    Ref QB-N356WWSource: FDA MedWatch (Form 3500 voluntary reporting; Form 3500A mandatory); VAERS for vaccine adverse eventsReport a problem with this question

12. 12. In a hospital, which pharmacy product must be removed from open shelving and handled only under strict storage controls because an accidental intravenous push can stop the heart?

    • A.Concentrated potassium chloride injection✓ Answer
    • B.Lactated Ringer's intravenous solution bags
    • C.Prefilled normal saline flush syringes
    • D.Oral potassium chloride supplement tablets

    Undiluted concentrated potassium chloride given by IV push causes hyperkalemic cardiac arrest, which is why ISMP lists it as a high-alert medication and safety standards require it to be sequestered under pharmacy control with warning labels rather than kept in open floor stock. Saline flushes, oral potassium tablets, and Ringer's solution do not carry this immediate lethal-injection risk.

    Ref QB-GJMCDDSource: ISMP List of High-Alert Medications (concentrated potassium chloride injection); PTCE 2026 outline 3.1Report a problem with this question

13. 13. A rheumatoid arthritis prescription for oral methotrexate is entered into the computer as 'take one tablet daily.' Why should this entry raise an immediate safety concern?

    • A.For arthritis it is usually dosed once weekly✓ Answer
    • B.For arthritis it must be given only by injection
    • C.For arthritis it requires a monthly two-week break
    • D.For arthritis it is taken only at bedtime with food

    For non-oncologic conditions such as rheumatoid arthritis, methotrexate is dosed once weekly; accidental daily dosing is a classic and potentially fatal error because toxicity accumulates rapidly. ISMP best practices call for verifying a specific day-of-week schedule and questioning any daily order for oral methotrexate.

    Ref QB-236V5FSource: ISMP Targeted Medication Safety Best Practice 1 (weekly oral methotrexate); PTCE 2026 outline 3.1Report a problem with this question

14. 14. A prescriber orders traMADol 50 mg. When the technician selects the product, which stocked drug name poses the greatest look-alike/sound-alike (LASA) risk?

    • A.TOPiramate
    • B.traZODone✓ Answer
    • C.tiZANidine
    • D.terBINafine

    TraMADol and traZODone share the same beginning and ending letters and similar sound, so ISMP pairs them on its List of Confused Drug Names and applies Tall Man lettering to force attention to the differing middle letters. Confusing an opioid analgesic with an antidepressant can cause serious patient harm.

    Ref QB-HJYPJESource: ISMP List of Confused Drug Names (traMADol/traZODone); PTCE 2026 outline 3.1Report a problem with this question

15. 15. Before handing a filled prescription to a patient at the counter, which pair of identifiers should the technician use to confirm the correct patient?

    • A.Full name and date of birth✓ Answer
    • B.Date of birth and insurance ID
    • C.Room number and prescriber name
    • D.Full name and room number

    Safe practice requires two person-specific identifiers, most commonly full name plus date of birth, because both belong uniquely to the individual. A room number is never acceptable since occupants change, an insurance ID does not verify who is standing at the counter, and the prescriber's name identifies the doctor, not the patient.

    Ref QB-33H7BGSource: The Joint Commission NPSG 01.01.01 (two patient identifiers); PTCE 2026 outline 3.2Report a problem with this question

16. 16. A faxed order includes the abbreviation 'QD.' Under medication-safety rules, how should that frequency appear on the prescription label?

    • A.Converted to 'QOD' for brevity
    • B.Converted to 'QID' for brevity
    • C.Left as 'QD' exactly as received
    • D.Written out as the word 'daily'✓ Answer

    'QD' appears on the ISMP error-prone abbreviations list and The Joint Commission 'Do Not Use' list because it is easily misread as 'QID' (four times daily) or 'QOD' (every other day), multiplying or halving the dose. The safe practice is to spell the frequency out as 'daily' on labels and records.

    Ref QB-JJB2RFSource: ISMP List of Error-Prone Abbreviations; TJC 'Do Not Use' list (QD); PTCE 2026 outline 3.2Report a problem with this question

17. 17. Compared with handwritten prescriptions, which source of error does computerized prescriber order entry (CPOE) with e-prescribing mainly eliminate?

    • A.Misreading of illegible handwriting✓ Answer
    • B.Mislabeling done by the manufacturer
    • C.Miscounting tablets during filling
    • D.Selecting the wrong patient profile

    CPOE transmits the order as typed, structured text directly from prescriber to pharmacy, so no one has to decipher handwriting or re-transcribe a paper order — the classic source of drug-name and dose misreads. It does not prevent picking the wrong profile, counting mistakes at the fill station, or manufacturer labeling defects.

    Ref QB-43VHGHSource: PTCE 2026 outline 3.2 (e-prescribing/CPOE as error-prevention technology)Report a problem with this question

18. 18. A customer asks the technician which cough syrup would be safe to take with his blood pressure medicine. What should the technician do?

    • A.Say that any OTC cough syrup is fine
    • B.Refer the question to the pharmacist✓ Answer
    • C.Recommend a dextromethorphan syrup
    • D.Point to the aisle and let him choose

    Choosing an OTC product for a specific patient — especially one weighing a drug interaction with an antihypertensive — is clinical judgment and counseling, which the law reserves for the pharmacist. The technician's safety role is to recognize the situation and hand it off, never to recommend, guess, or dismiss the question.

    Ref QB-KJPCWGSource: PTCE 2026 outline 3.3 (OTC recommendation requires pharmacist intervention)Report a problem with this question

19. 19. For the second month in a row, a patient tries to refill an oxycodone prescription ten days early. What is the technician's best action?

    • A.Notify the pharmacist of the pattern✓ Answer
    • B.Process the refill to avoid a dispute
    • C.Refuse and block all future refills
    • D.Tell the patient to use another pharmacy

    Repeated early refill requests for a controlled substance are a recognized red flag for misuse or diversion, and suspected misuse is an issue that requires pharmacist intervention. The pharmacist — who holds corresponding responsibility for controlled substances — makes the clinical and legal decision; the technician neither dispenses to avoid conflict nor unilaterally refuses or redirects the patient.

    Ref QB-DZ4D2VSource: PTCE 2026 outline 3.3 (suspected misuse requires pharmacist intervention)Report a problem with this question

20. 20. Minutes after receiving a vaccine at the pharmacy, a patient in the waiting area says she feels lightheaded and itchy. What should the technician do first?

    • A.Offer water and keep on working
    • B.Alert the pharmacist right away✓ Answer
    • C.Advise going home to lie down
    • D.Log a follow-up call for tomorrow

    Lightheadedness and itching within minutes of a vaccination can be the first signs of anaphylaxis, which can become life-threatening rapidly. Post-immunization delivery care requires the pharmacist to assess the patient immediately — epinephrine and emergency services may be needed — so the technician's first duty is an instant hand-off, not comfort measures or delayed follow-up.

    Ref QB-WGAJMVSource: PTCE 2026 outline 3.3 (post-immunization delivery care)Report a problem with this question

21. 21. A patient develops a severe arm reaction after receiving an influenza vaccine at the pharmacy. To which national reporting program should this event be submitted?

    • A.VAERS✓ Answer
    • B.ISMP MERP
    • C.MedWatch
    • D.NIOSH

    The Vaccine Adverse Event Reporting System (VAERS), run jointly by the CDC and FDA, is the national program dedicated specifically to adverse events following vaccination. MedWatch handles adverse events and quality problems for drugs and other medical products, ISMP MERP collects medication-error reports, and NIOSH addresses occupational hazards — none is the vaccine-specific channel.

    Ref QB-CZR2VTSource: VAERS (CDC/FDA vaccine adverse event reporting); PTCE 2026 outline 3.4 (MedWatch vs VAERS distinction)Report a problem with this question

22. 22. Which activity best illustrates continuous quality improvement (CQI) in a pharmacy?

    • A.Disciplining the employee who slipped up
    • B.Running repeated Plan-Do-Check-Act cycles✓ Answer
    • C.Returning one defective lot to the vendor
    • D.Investigating one serious error afterward

    CQI is an ongoing, system-focused cycle — typically Plan-Do-Check-Act — that keeps measuring processes and refining them to prevent errors before they recur. Investigating a single past error is root-cause analysis, discipline is punitive rather than systemic, and returning one lot is a one-time corrective action, not a continuous process.

    Ref QB-VGX7FUSource: PTCE 2026 outline 3.4 (continuous quality improvement; PDCA cycle vs root-cause analysis)Report a problem with this question

23. 23. A technician notices that, in an unopened stock bottle, the oral suspension has turned dark and clumpy well before its expiration date. What is the correct handling?

    • A.Quarantine it and report through MedWatch✓ Answer
    • B.Shake it until uniform and dispense it
    • C.Dilute it with water to fix the texture
    • D.Discard it in the trash with no report

    Visible deterioration before expiry is a product quality/integrity problem: the bottle must be quarantined so it cannot be dispensed, and the defect reported to the FDA through MedWatch so the lot can be evaluated. Dispensing or altering a degraded product endangers patients, and silent disposal destroys the evidence needed to catch a defective lot.

    Ref QB-BZDQPSSource: FDA MedWatch (product quality problem reporting); PTCE 2026 outline 3.4Report a problem with this question

24. 24. A prescription reads digoxin 0.125 mg daily, but the label is typed as digoxin 1.25 mg daily. How is this error best classified?

    • A.An incorrect patient on the profile
    • B.An incorrect dose, tenfold too high✓ Answer
    • C.An incorrect route in the directions
    • D.An incorrect quantity in the count

    The drug, patient, and route are all unchanged; what shifted is the decimal point, making the labeled strength ten times the prescribed dose — the definition of an incorrect-dose error. Tenfold decimal errors with narrow-margin drugs like digoxin are exactly what leading-zero rules, barcode scanning, and independent double checks exist to catch.

    Ref QB-UGKV9TSource: PTCE 2026 outline 3.5 (incorrect dose; tenfold/decimal-point errors)Report a problem with this question

25. 25. The sig reads 'take one tablet by mouth twice daily' for a 30-day supply, but 30 tablets are dispensed. What type of prescription error is this?

    • A.An incorrect-drug error
    • B.An incorrect-quantity error✓ Answer
    • C.An incorrect-route error
    • D.An incorrect-dose error

    Twice-daily dosing for 30 days requires 60 tablets, so dispensing only 30 means the count in the vial does not match what the sig calls for — the definition of an incorrect-quantity error. The drug itself, the dose per administration, and the oral route are all correct, which rules out the other classifications.

    Ref QB-AZ2DHRSource: PTCE 2026 outline 3.5 (incorrect quantity; count vs sig mismatch)Report a problem with this question

26. 26. Ofloxacin otic solution is dispensed with a label reading 'instill 4 drops in the affected eye twice daily.' What type of error does this represent?

    • A.Incorrect patient identification
    • B.Incorrect route of administration✓ Answer
    • C.Incorrect quantity of solution
    • D.Incorrect strength of the product

    The product is an otic (ear) preparation, but the directions send it into the eye, so the site of administration on the label is wrong — an incorrect-route error. Otic solutions are not formulated to be sterile or buffered for ocular tissue and can injure the eye, which is why ear-versus-eye mix-ups are a classic route-error scenario.

    Ref QB-TG8J4SSource: PTCE 2026 outline 3.5 (incorrect route of administration)Report a problem with this question

27. 27. According to CDC infection-control guidance, what is the single most effective measure pharmacy staff can take to prevent the spread of infection?

    • A.Practicing consistent hand hygiene✓ Answer
    • B.Wearing gloves for every task
    • C.Taking preventive antibiotics
    • D.Wiping counters once per week

    The CDC identifies hand hygiene — washing with soap and water or using an alcohol-based rub — as the single most effective way to prevent transmitting infection, because hands are the main vehicle carrying pathogens between people and surfaces. Gloves supplement but never replace clean hands, prophylactic antibiotics promote resistance, and weekly counter wiping is far too infrequent.

    Ref QB-9ZP2CQSource: CDC Hand Hygiene Guidelines; PTCE 2026 outline 3.6Report a problem with this question

28. 28. Which agent is the standard choice for routinely cleaning counting trays and countertops in the pharmacy?

    • A.Full-strength bleach
    • B.Plain tap water alone
    • C.70% isopropyl alcohol✓ Answer
    • D.Scented ammonia spray

    Isopropyl alcohol at 70% is the pharmacy standard because it kills most surface microorganisms and evaporates completely, leaving no residue on surfaces that contact medication. Undiluted bleach is corrosive and leaves residue, plain water cleans but does not disinfect, and scented ammonia products can deposit fragrance and chemical residue on drug-contact surfaces.

    Ref QB-SGV7XQSource: Standard pharmacy cleaning practice (70% isopropyl alcohol); PTCE 2026 outline 3.6Report a problem with this question

29. 29. When donning personal protective equipment (PPE), which item is put on first and which is put on last?

    • A.Mask first, goggles last
    • B.Gown first, gloves last✓ Answer
    • C.Goggles first, mask last
    • D.Gloves first, gown last

    The CDC donning sequence is gown, then mask or respirator, then goggles or face shield, then gloves — so the gown goes on first and gloves go on last, allowing the glove cuffs to cover the gown's wrists for a sealed barrier. When doffing, gloves come off first because they are the most contaminated item.

    Ref QB-896WUZSource: CDC Sequence for Donning PPE (gown, mask, goggles/face shield, gloves); PTCE 2026 outline 3.6Report a problem with this question

30. 30. A prescription is written for a brand-name extended-release product whose Orange Book therapeutic equivalence code is AB1. The pharmacy stocks two generics of the same strength: one rated AB1 and one rated AB2. Which may be dispensed as a generic substitution?

    • A.Either of the two generics
    • B.Only the generic rated AB2
    • C.Only the generic rated AB1✓ Answer
    • D.Neither of the two generics

    When two reference listed drugs of the same strength are not bioequivalent to each other, FDA adds a digit to the AB code (AB1, AB2, AB3), and products are therapeutically equivalent only when they share the same three-character code. The AB2 generic is equivalent to a different reference product, so the fact that both codes start with A does not make it interchangeable with an AB1 brand. The AB1 generic may be substituted, subject to state substitution law and the absence of a dispense-as-written instruction.

    Ref QB-QRYQ9ZSource: FDA Orange Book Preface, Section 1.7 Therapeutic Equivalence Evaluations Codes (AB1/AB2/AB3 multiple-reference-drug coding)Report a problem with this question

31. 31. A prescription for atorvastatin 20 mg daily arrives. The patient asks the technician to fill rosuvastatin instead because a friend said it works better. No institutional substitution protocol applies. What should the technician do?

    • A.Dispense rosuvastatin, since statins are interchangeable
    • B.Substitute it if the Orange Book rates it AB to atorvastatin
    • C.Refer it to the pharmacist; the prescriber must authorize the change✓ Answer
    • D.Make the switch now and fax the prescriber a notice afterward

    Swapping one statin for another changes the active ingredient, so it is therapeutic substitution, not generic substitution. The Orange Book rates only pharmaceutical equivalents (same active ingredient, strength, dosage form and route), so it never gives an AB rating between two different statins. Without an approved protocol, the change needs prescriber authorization before dispensing, and a technician cannot make it. Telling the prescriber after the fill does not count as authorization. The technician refers the request to the pharmacist, who can contact the prescriber.

    Ref QB-79TJPYSource: FDA Orange Book Preface, Section 1.2 (therapeutic equivalence applies only to pharmaceutical equivalents); PTCE Content Outline 2026, Knowledge Area 3.3 (therapeutic substitution requires pharmacist intervention)Report a problem with this question

32. 32. A prescription for Lasix 40 mg tablets has 'Dispense as Written' marked by the prescriber. The pharmacy stocks AB-rated generic furosemide 40 mg, and the patient says she would prefer the cheaper generic. What may be dispensed?

    • A.Generic furosemide, because the patient prefers it
    • B.Generic furosemide, because the Orange Book requires it
    • C.Brand Lasix, unless the prescriber approves a change✓ Answer
    • D.Either product, as DAW applies only to controlled drugs

    A prescriber's 'Dispense as Written' or 'brand medically necessary' instruction blocks generic substitution, and the patient's preference does not override it. The pharmacy dispenses the brand unless the pharmacist gets the prescriber's authorization for the generic. The Orange Book only advises which products are therapeutically equivalent. It never requires substitution, which is governed by state law. A DAW instruction is not limited to controlled substances and applies to any prescription drug.

    Ref QB-PRMD4YSource: FDA Orange Book Preface, Section 1.1 (evaluations are advisory; substitution is governed by state law); PTCE Content Outline 2026, Knowledge Area 3.3Report a problem with this question

33. 33. A kidney-transplant patient has received tacrolimus capsules from the same manufacturer for a year. This month the only stock on hand is an AB-rated tacrolimus from a different manufacturer. What should the technician do?

    • A.Dispense it unflagged, since an AB rating rules out any concern
    • B.Refuse the fill, since federal law bars switching for NTI drugs
    • C.Substitute a different immunosuppressant that is in stock today
    • D.Flag the manufacturer change to the pharmacist before dispensing✓ Answer

    Tacrolimus has a narrow therapeutic index, so small changes in exposure can cause rejection or toxicity. Switching manufacturers on a stabilized patient therefore deserves a flag, so the pharmacist can decide whether the prescriber or patient should be told and blood levels watched. The AB rating does mean FDA considers the product substitutable, and no federal law bans the switch, because substitution is a matter of state law. Moving to a different immunosuppressant would be therapeutic substitution, which needs prescriber authorization and is never a technician decision.

    Ref QB-69F8HXSource: FDA Orange Book Preface, Sections 1.1 and 1.7 (AB code = therapeutically equivalent; substitution governed by state law); PTCE Content Outline 2026, Knowledge Area 3.3 (issues requiring pharmacist intervention)Report a problem with this question

Practice questions based on the PTCB exam content outline. Not affiliated with the PTCB, and not medical advice. About the PTCE →