PTCB Pharmacy Technician (PTCE) — All Questions

Which drug is placed in Schedule II (C-II), the schedule with an accepted medical use but the highest abuse potential of any prescribable controlled substance?

• a.Ketamine
• b.Hydromorphone✓
• c.Pregabalin
• d.Alprazolam

Hydromorphone is a C-II opioid; other common C-II agents include oxycodone, fentanyl, methylphenidate, and amphetamine. Alprazolam is C-IV, pregabalin is C-V, and ketamine is C-III, so all three carry a lower federally assigned abuse potential. Schedule II drugs have accepted medical use but the greatest abuse and dependence risk among drugs that may still be prescribed.21 CFR 1308 (DEA schedules)

Under the Controlled Substances Act, which statement correctly describes Schedule I substances such as heroin and LSD?

• a.They have a high abuse potential and no currently accepted medical use in the United States, so they cannot be prescribed.✓
• b.They may be dispensed on a written prescription, but that prescription may never be refilled.
• c.They have a low potential for abuse and may be sold over the counter without a prescription.
• d.They may be dispensed with up to 5 refills within 6 months of the date it was written.

The defining feature of Schedule I is a high potential for abuse combined with no currently accepted medical use in the United States, which is why these substances are not dispensed on an outpatient prescription at all. A written prescription that may not be refilled describes Schedule II, and up to 5 refills within 6 months of the date written describes Schedules III and IV. Over-the-counter sale is impossible for any controlled substance in Schedule I, whose lawful handling is limited to registered research and other DEA-authorized activity.21 CFR 1308 (DEA schedules)

What is DEA Form 222 (or its electronic CSOS equivalent) used for?

• a.Registering a new pharmacy with the DEA for the first time
• b.Reporting a significant theft or loss of controlled substances
• c.Documenting the destruction of expired controlled substances on site
• d.Ordering or transferring Schedule II controlled substances between DEA registrants✓

DEA Form 222, or an electronic order placed through the Controlled Substance Ordering System (CSOS), is required for every purchase or transfer of a Schedule II substance between registrants. Schedules III through V may be ordered on an ordinary invoice, which must still be retained. A significant theft or loss is reported on Form 106, destruction is documented on Form 41, and an initial pharmacy registration is made on Form 224.21 CFR 1305 (DEA Form 222 / CSOS)

A pharmacy destroys a quantity of expired Schedule II tablets on site. Which DEA form documents this disposal?

• a.DEA Form 106
• b.DEA Form 224
• c.DEA Form 41✓
• d.DEA Form 222

DEA Form 41 is the registrant's record of controlled substances that have been destroyed, and it must be retained with the pharmacy's controlled substance records. Form 106 is reserved for theft or significant loss, Form 222 is for ordering Schedule II drugs, and Form 224 is the pharmacy's DEA registration application. Destruction records are kept for at least 2 years under federal law; some states are stricter.21 CFR 1307 (DEA Form 41 destruction)

During a routine count the pharmacy discovers that a sealed bottle of oxycodone is missing and suspects diversion. Which action does federal law require?

• a.Notify the DEA and submit DEA Form 106 for the theft or significant loss✓
• b.Submit a new DEA Form 222 to replace the lost stock
• c.Complete DEA Form 41 to document the missing product
• d.Record the shortage on the next biennial inventory only

A theft or significant loss of controlled substances must be reported to the DEA, and Form 106 is the report used to document the circumstances and quantities involved. Form 41 records product that was intentionally destroyed, not product that disappeared, and Form 222 only orders Schedule II stock. Simply noting the discrepancy at the next inventory does not satisfy the reporting duty; state boards often require notification as well.DEA

How often must a DEA registrant take a complete inventory of all controlled substances on hand?

• a.Every 5 years
• b.Every 2 years✓
• c.Every 12 months
• d.Every 6 months

Federal law requires a biennial inventory, meaning a complete count of controlled substances on hand at least every 2 years, in addition to the initial inventory taken when the registrant begins handling controlled substances. Annual, semiannual, and five-year cycles are not the federal standard, although some states require inventories more often. Schedule II records must be kept separate from all other records and all controlled substance records must be readily retrievable and kept at least 2 years; this is a federal minimum and some states are stricter.21 CFR 1304 (controlled substance records)

A patient presents a written prescription for a Schedule IV benzodiazepine. What is the federal refill limit?

• a.No refills are permitted
• b.Up to 3 refills within 12 months of the date written
• c.Up to 5 refills within 6 months of the date written✓
• d.Unlimited refills for 12 months from the date written

Schedule III and Schedule IV prescriptions may be refilled a maximum of 5 times and only within 6 months of the date the prescription was written, whichever limit is reached first. The no-refill option describes Schedule II, which may not be refilled at all, and neither unlimited refills for a year nor a 3-refill cap matches the federal rule for C-III and C-IV. This is a federal minimum; some states are stricter.21 CFR 1306 (controlled substance prescriptions)

A manufacturer recalls a sterile injectable after finding particulate matter that could cause fatal embolism. How does the FDA classify this recall?

• a.Class IV
• b.Class II
• c.Class I✓
• d.Class III

A Class I recall applies when there is a reasonable probability that use of the product will cause serious adverse health consequences or death, which fits a contaminant capable of causing a fatal event. Class II covers products that may cause temporary or medically reversible harm, and Class III covers products unlikely to cause any adverse health consequence, such as a minor labeling defect. There is no Class IV in the FDA recall classification system.21 CFR 7 (FDA recall classification)

Which statement best describes a Risk Evaluation and Mitigation Strategy (REMS)?

• a.A manufacturer's voluntary copay assistance program that lowers the amount a commercially insured patient pays for a specialty drug
• b.A USP compounding standard that sets the beyond-use dates and the sterile air quality requirements that apply to compounded preparations
• c.An FDA-required safety program that may mandate prescriber certification, patient enrollment, pharmacy certification, or laboratory monitoring before a drug is dispensed✓
• d.A DEA quota program that limits how much of a controlled substance a pharmacy may order and keep in stock in a given month

A REMS is imposed by the FDA when a drug's serious safety risks require controls beyond standard labeling, and its elements can include certifying prescribers and pharmacies, enrolling patients in a registry, and documenting laboratory results before dispensing. Familiar examples are iPLEDGE for isotretinoin, absolute neutrophil count monitoring for clozapine, and the restricted program for thalidomide. Beyond-use dating and air quality standards for compounding come from USP, quotas for controlled substances are set by the DEA at the manufacturing level rather than per pharmacy, and manufacturer copay assistance carries no regulatory safety role at all.FDA REMS (FDAAA 2007)

Which standard governs compounded sterile preparations, including ISO-classified air, garbing, and assignment of beyond-use dates?

• a.21 CFR 1304
• b.USP <800>
• c.USP <795>
• d.USP <797>✓

USP <797> sets the practice standards for compounded sterile preparations, covering ISO-classified engineering controls, personnel hand hygiene and garbing, environmental monitoring, and beyond-use dating. USP <795> applies to nonsterile compounding such as creams and oral suspensions, while USP <800> addresses handling of hazardous drugs regardless of whether the preparation is sterile. 21 CFR 1304 concerns controlled substance recordkeeping and has nothing to do with compounding technique.USP <797>

A technician will compound a chemotherapy agent in a negative-pressure containment room while wearing a chemotherapy-rated gown and two pairs of chemotherapy-rated gloves. Which standard drives these requirements?

• a.USP <795>
• b.USP <797>
• c.USP <800>✓
• d.Drug Supply Chain Security Act (DSCSA)

USP <800> governs the receipt, storage, compounding, and disposal of hazardous drugs in order to protect personnel, patients, and the environment, and it specifies containment engineering controls such as negative pressure rooms plus chemotherapy-rated PPE. Drugs subject to <800> are identified from the NIOSH hazardous drug list. USP <795> and <797> address nonsterile and sterile compounding quality rather than worker exposure, and the DSCSA deals with tracing product through the supply chain.USP <800>

Which action by a pharmacy technician violates the HIPAA Privacy Rule?

• a.Faxing a refill history to the prescribing physician who is managing the patient's therapy
• b.Providing patient records to the pharmacist for an internal medication error review
• c.Telling the patient's neighbor which medications the patient picked up that morning✓
• d.Submitting a claim with the patient's medication details to the patient's insurer

Protected health information may be used or disclosed without separate patient authorization for treatment, payment, and health care operations, and disclosures must be limited to the minimum necessary for the purpose. Billing the insurer is payment, faxing the prescriber is treatment, and an internal error review is health care operations, so all three are permitted. Disclosing a patient's medications to a neighbor serves none of these purposes and is a privacy violation.HIPAA Privacy Rule (45 CFR 164)

Under the Combat Methamphetamine Epidemic Act, what is the federal daily purchase limit of pseudoephedrine base for a single buyer?

• a.3.6 g✓
• b.2.4 g
• c.9 g
• d.7.5 g

The CMEA caps a single purchaser at 3.6 g of pseudoephedrine base per day and 9 g in a 30-day period, so 9 g is the monthly limit rather than the daily one and 2.4 g and 7.5 g are not federal thresholds. Products must be kept behind the counter or in a locked case, and the buyer must show photo identification and sign a written or electronic logbook that is retained for 2 years. These are federal minimums; some states are stricter and require a prescription.Combat Methamphetamine Epidemic Act (CMEA)

Which federal law required pharmacies to offer counselling and to carry out a prospective drug utilization review for Medicaid patients?

• a.The Health Insurance Portability and Accountability Act of 1996
• b.The Omnibus Budget Reconciliation Act of 1990✓
• c.The Drug Quality and Security Act of 2013
• d.The Poison Prevention Packaging Act of 1970

The Omnibus Budget Reconciliation Act of 1990 tied federal Medicaid funding to a prospective drug utilization review and an offer to counsel, and the states then extended both duties to patients generally. The privacy statute is the closest wrong answer, because it also governs what happens at the counter, but it controls the use and disclosure of health information rather than requiring any counselling offer. Child-resistant packaging comes from the 1970 packaging law, and drug supply-chain track-and-trace requirements from the 2013 statute.

Under the federal Controlled Substances Act, which of these prescription products is placed in Schedule V?

• a.Methylphenidate tablets for attention-deficit disorder
• b.Diphenoxylate with atropine tablets for diarrhea✓
• c.Alprazolam tablets for anxiety
• d.Buprenorphine film for opioid use disorder

Diphenoxylate combined with a subtherapeutic amount of atropine is a Schedule V product; the atropine is added specifically to discourage abuse of the opioid. Buprenorphine is the closest trap because it is also an opioid used in low doses under tight control, but it is Schedule III. Alprazolam is Schedule IV and methylphenidate is Schedule II.21 CFR 1308.15

Which statement correctly describes how Schedule III differs from Schedule IV under the Controlled Substances Act?

• a.Schedule III substances may be refilled five times, while Schedule IV substances may not be refilled
• b.Schedule III substances must be ordered on a DEA Form 222, while Schedule IV substances need no order form
• c.Schedule III substances have a greater potential for abuse than Schedule IV substances✓
• d.Schedule III substances have no currently accepted medical use in the United States

The schedules are ranked by abuse potential and dependence liability, so Schedule III sits above Schedule IV. Both have accepted medical uses, both are limited to five refills within six months, and only Schedule I and II substances require a DEA Form 222 or a CSOS order. Testosterone and acetaminophen with codeine are typical Schedule III products; alprazolam and zolpidem are Schedule IV.21 USC 812

While preparing a paper DEA Form 222 for a Schedule II order, a technician writes the wrong number of packages on one line. What does federal regulation require?

• a.The technician may line through the entry and initial the change, provided the pharmacist signs the form afterward
• b.The form must be voided and a new one prepared, because a supplier may not fill an order form that shows any alteration or erasure✓
• c.The line may be left as written, and the correct quantity noted on the packing slip when the order is received
• d.The entry may be corrected in ink and initialed if the supplier is telephoned before the form is mailed

A supplier is forbidden to fill an order form that is incomplete, illegible, or that shows any alteration, erasure or change, so the only remedy is to void the defective form and execute a fresh one; the voided form is retained with the pharmacy's Schedule II records. Crossing out and initialing is the tempting answer because that is how most other pharmacy records are corrected, but on an order form it is exactly what makes the document defective.

A pharmacy orders Schedule II products electronically through the Controlled Substance Ordering System (CSOS) instead of on paper. What does federal law require of the person who signs those orders?

• a.The signer must enter the pharmacy's shared CSOS password, which the wholesaler reissues each year
• b.The signer must be the pharmacist-in-charge listed on the pharmacy's DEA registration
• c.The signer must hold an individual CSOS digital certificate issued by the DEA✓
• d.The signer must fax a paper DEA Form 222 to the supplier

A CSOS digital certificate is issued by the DEA to a named individual — the registrant, or a person who holds power of attorney for ordering — and that certificate, not a shared store password, signs the electronic order. Naming the pharmacist-in-charge is tempting because that person usually does hold the power of attorney, but the rule is about who holds a certificate, not about the title. No paper form accompanies a CSOS order.

A pharmacy destroys expired Schedule II tablets on site and records the destruction on DEA Form 41. What does the DEA require about how that destruction is carried out?

• a.A DEA diversion investigator must be present in the pharmacy during the destruction
• b.The pharmacist-in-charge may destroy the drugs alone if their acquisition cost is under five hundred dollars
• c.A licensed reverse distributor must take possession before any Schedule II drug may be destroyed
• d.Two authorized employees must witness the destruction and sign the record✓

The destruction must render the substance non-retrievable, and the Form 41 record is witnessed and signed by two employees the registrant has authorized. Sending expired stock to a licensed reverse distributor is the tempting answer because it is what most community pharmacies actually do, but it is one lawful option rather than a requirement — a registrant may destroy on site and document it on Form 41.

A pharmacy confirms that a significant quantity of controlled substances has been stolen. In addition to completing DEA Form 106, what does federal regulation require?

• a.Written notice to the DEA field division office within one business day of discovering the loss✓
• b.Completing an internal audit first and notifying the DEA once the exact missing quantity is known
• c.Written notice to the DEA field division office within thirty days of discovering the loss
• d.Notifying the local police only, since Form 106 itself serves as notice to the DEA

On discovering a theft or significant loss the registrant must notify the DEA field division office in writing within one business day, and Form 106 follows. Waiting for the audit is the tempting answer, because Form 106 does ask for exact quantities and the pharmacy usually cannot state them on day one — but the notification clock runs from discovery, not from the completed count.21 CFR 1301.76

When a pharmacy takes its biennial controlled substance inventory, how must the quantities on hand be counted?

• a.Schedule II items must be counted exactly; Schedule III through V items may be estimated✓
• b.Every schedule may be estimated as long as a pharmacist signs and dates the inventory record
• c.Only Schedule II items are inventoried; Schedule III through V items are counted when ownership changes
• d.Every schedule must be counted exactly, including opened Schedule V syrups

Federal rules require an exact count of every Schedule II substance on hand. For Schedule III through V an estimated count is acceptable, except that a container holding more than 1,000 tablets or capsules must be counted exactly. Estimating everything is the tempting answer because it is true for most of the shelf, but it fails on the Schedule II requirement.21 CFR 1304.11

Federal law sets a minimum period for keeping controlled substance records at the registered location. What is that period, and how do state requirements interact with it?

• a.Two years, and a state board may require a longer period✓
• b.Two years, and no state may require longer because federal law preempts state record rules
• c.Five years in every state, because HIPAA extended the federal period
• d.Seven years, matching the federal retention period for business tax records

The federal floor is two years, and the records must be kept at the registered location and be readily retrievable. Federal law does not preempt stricter state rules here: many boards of pharmacy require three, five or more years, and the pharmacy follows whichever period is longer. HIPAA governs privacy documentation and does not set the retention period for controlled substance records.21 CFR 1304.04

Federal regulations govern how a pharmacy files the paper prescriptions it has dispensed. How must Schedule II prescriptions be filed?

• a.Interfiled with Schedule III through V prescriptions in one controlled substance file
• b.In a separate file that holds Schedule II prescriptions and nothing else✓
• c.In any arrangement the pharmacy chooses, provided the records can be produced within 72 hours of a DEA request
• d.Interfiled with non-controlled prescriptions and stamped with a red C

Schedule II prescriptions must be maintained in a file separate from every other prescription record. The red C answer describes the alternative available for Schedule III through V prescriptions, which may be kept in their own file or interfiled with non-controlled prescriptions if marked with a red C at least one inch high — an option that does not extend to Schedule II. Pharmacies using an electronic system that makes the records readily retrievable are excused from the red C marking.21 CFR 1304.04

A prescriber telephones an emergency oral prescription for a Schedule II drug and the pharmacist dispenses only the amount needed for the emergency period. What must happen next under federal regulations?

• a.The prescriber must deliver a written, signed prescription to the pharmacy within seven days✓
• b.The pharmacist must obtain a written prescription before the patient leaves the pharmacy
• c.The prescriber must deliver a written, signed prescription to the pharmacy within seventy-two hours
• d.No further paperwork is required once the oral order is entered in the profile

The prescriber has seven days to deliver the written, signed prescription covering the emergency oral order, and if it does not arrive the pharmacist must notify the DEA. Seventy-two hours is the closest wrong answer because that figure does appear in the Schedule II rules — it is the window for supplying the balance of a partially filled prescription, a different situation.21 CFR 1306.11

A pharmacy can supply only part of the quantity written on a Schedule II prescription because of a stock shortage. Under federal rules, what applies to the remaining quantity?

• a.It may be supplied whenever the wholesaler delivers, since the prescription is already on file
• b.It must be supplied within 72 hours, or the pharmacist must notify the prescriber✓
• c.It must be supplied within 30 days of the date the prescription was issued
• d.It requires a new prescription, since Schedule II prescriptions may not be partially filled

When the pharmacist cannot supply the full quantity, the balance may be dispensed within 72 hours; if that passes, the pharmacist must notify the prescriber and no further quantity may go out on that prescription. The 30-day answer is genuinely close, because a partial fill requested by the patient or the prescriber does allow the remainder to be filled up to 30 days after the prescription was written — but that is a requested partial fill, not a stock shortage.21 CFR 1306.13

A resident of a long-term care facility has a Schedule II prescription that the pharmacy dispenses in small amounts as the resident needs them. For how long do federal rules allow that prescription to be partially filled?

• a.Up to 72 hours from the first partial fill, as in a community pharmacy
• b.Up to 90 days from the date it was issued, matching a typical maintenance supply
• c.Up to six months from the date it was issued, as with Schedule III refills
• d.Up to 60 days from the date it was issued✓

For a patient in a long-term care facility, and for a patient the prescriber has documented as terminally ill, a Schedule II prescription may be partially filled for up to 60 days from the issue date unless it is terminated sooner. The 72-hour answer is the tempting one because that limit does govern partial fills in a community pharmacy that is simply out of stock; the long-term care provision is a separate, longer allowance.21 CFR 1306.13

Under federal law, how long after it is written may a Schedule II prescription still be filled?

• a.Federal rules set no fixed limit, and many state boards impose one of their own✓
• b.Federal rules allow six months, as with Schedule III refills
• c.Federal rules allow 90 days when the prescription is for a chronic condition
• d.Federal rules allow 30 days, after which the prescriber must write a new prescription

The DEA has not set a federal expiration date for filling a Schedule II prescription; it must be presented within a reasonable time and the prescriber's intent must still be current, but no number of days appears in the federal rule. Many state boards do set a limit, commonly 30, 60, 90 or 180 days, and the pharmacy follows its own state's rule. The six-month figure belongs to Schedule III through V refills, not to filling a Schedule II.

A patient asks a pharmacy to transfer the remaining refills on a Schedule IV prescription to a different pharmacy. What does federal law allow?

• a.Unlimited transfers, provided both pharmacists record the date and their initials
• b.No transfer at all, since prescriptions for any controlled substance may never be transferred between pharmacies
• c.One transfer of the remaining refills, unless the two pharmacies share a real-time online database✓
• d.Transfers back and forth between the pharmacies as often as the patient asks

Refill information for a Schedule III, IV or V prescription may be transferred one time only, and both pharmacists must document the transfer. Where the two pharmacies share a real-time, online database, transfers may be made up to the maximum number of refills authorized. The blanket no-transfer answer describes Schedule II prescriptions, which carry no refills to transfer in the first place.21 CFR 1306.25

Federal regulations permit certain Schedule V products that are not prescription drugs to be sold at retail without a prescription. What does federal law require of that sale, and what may a state do?

• a.A pharmacist must make the sale to a buyer at least 18 years old; a state may forbid it✓
• b.Any pharmacy employee may make the sale once the buyer signs the pseudoephedrine logbook and shows a photo ID
• c.Any pharmacy employee may make the sale to a buyer at least 21 years old, and no state may forbid it
• d.A pharmacist must make the sale, and only to a buyer already known to the pharmacy

Federal rules let a pharmacist personally sell a limited quantity to a purchaser at least 18 years of age, obtain identification from a purchaser not known to the pharmacist, and record the sale in a bound book. Federal law is only a floor here: many states require a prescription for these products, and where the state is stricter the state rule controls. Requiring the buyer to be already known to the pharmacy inverts the identification rule, which exists precisely for buyers who are not known.21 CFR 1306.26

A customer buys a pseudoephedrine product under the Combat Methamphetamine Epidemic Act. What does federal law require of the record of that sale?

• a.A logbook entry with photo identification, kept until the end of the calendar year
• b.A logbook entry signed by the pharmacist who made the sale, kept six months
• c.A logbook entry with photo identification, kept for two years✓
• d.An electronic record transmitted to the DEA within one business day of each sale

The seller records the product, the quantity, the purchaser's name and address and the date and time of sale, verifies photo identification, obtains the purchaser's signature, and keeps the logbook for at least two years after the last entry. Nothing is transmitted to the DEA at the point of sale, and federal law does not require a pharmacist to ring up the sale, although several states are stricter on that point.

A patient asks that all of her prescriptions be dispensed in easy-open containers because she has arthritis. Under the Poison Prevention Packaging Act, what may the pharmacy do?

• a.Honor the request for one prescription at a time, with a new request at each fill
• b.Refuse, because federal law waives child-resistant packaging only for named exempt drugs
• c.Honor a standing request from the patient that covers all of her prescriptions, and keep it on file✓
• d.Honor the request only if the prescriber writes a waiver on each prescription

The Act, enforced by the Consumer Product Safety Commission rather than the FDA, allows the patient to give a blanket request covering all of her prescriptions, and the pharmacy documents it. A prescriber's request is the narrower one — it applies only to the prescription on which it appears. Exempt products such as sublingual nitroglycerin are a separate provision and do not limit the patient's right to ask.

A manufacturer recalls several lots of a tablet because the outer carton misspells the company's mailing address. The drug itself and the directions for use are unaffected. How does the FDA classify this recall?

• a.Class III, a defect that is not likely to cause an adverse health consequence✓
• b.Class II, a defect that may cause temporary or medically reversible health harm
• c.Class I, since any labeling error creates a reasonable probability of serious harm
• d.A market withdrawal, since the FDA does not regulate carton printing

Class III covers situations where use of the product is not likely to cause any adverse health consequence, which fits a cosmetic misprint that does not touch the drug, its strength or its directions. Class II is the closest wrong answer and would apply if the labeling error could lead to a temporary or reversible harm, such as a wrong strength on the carton. A market withdrawal involves a minor issue that is not a violation the FDA would act on, and printed labeling is very much regulated.

Under the Drug Supply Chain Security Act, a pharmacy receives transaction information and a transaction statement with each shipment of prescription drugs. What must the pharmacy do with those records?

• a.Keep them for six years from the date of the transaction and produce them on request✓
• b.Keep them for two years, which is the period that applies to controlled substance records
• c.Return them to the wholesaler once the shipment has been checked in
• d.Keep them only for the products that are controlled substances

A dispenser must retain the transaction information and transaction statement for at least six years from the date of the transaction and be able to produce them, particularly when investigating a suspect or illegitimate product. The two-year answer is tempting because it is a real retention period in a pharmacy — it is the DEA's period for controlled substance records, a different law with its own clock. The Act covers prescription drug purchases generally, not only controlled substances.

A health plan telephones a pharmacy to ask about one patient's claim for a single medication. Which principle of the HIPAA Privacy Rule governs how much the technician may disclose?

• a.The patient authorization requirement, which bars disclosure without a signed release
• b.The treatment exception, which permits disclosure of the entire medication profile
• c.The minimum necessary standard✓
• d.The public health exception, which permits disclosure to any payer

Disclosures for payment are permitted without patient authorization, but they are limited to the minimum information necessary for the purpose — here, the single claim in question rather than the patient's whole medication history. The authorization answer is the tempting one because a signed authorization really is required for uses such as marketing; it is not required for payment activities.45 CFR 164.502

A patient reports high fever and extensive arm swelling that began the day after receiving an influenza vaccine at the pharmacy. Which federal system is used to report this event?

• a.The FDA MedWatch program, which receives reports on every FDA-regulated product
• b.The Vaccine Adverse Event Reporting System✓
• c.The state board of pharmacy, which forwards vaccine reports to the CDC
• d.The DEA field division office, using its adverse event report form

Adverse events following immunization go to VAERS, which the FDA and the CDC run jointly, and federal law requires health care providers to report certain post-vaccination events. MedWatch is the closest wrong answer because it genuinely does collect adverse events for drugs, biologics and devices, but vaccine events are routed to VAERS instead. The DEA has no role in adverse event reporting.

A pharmacy technician's duties include assisting with immunizations, so the OSHA Bloodborne Pathogens Standard applies. What must the employer make available?

• a.Hepatitis B vaccination at a cost shared equally by the employer and the employee
• b.Hepatitis B vaccination, but only after a documented needlestick injury
• c.Hepatitis B and hepatitis C vaccination at no cost to the employee
• d.Hepatitis B vaccination at no cost to the employee✓

The employer must offer hepatitis B vaccination free of charge, within 10 working days of the employee's initial assignment to work with occupational exposure; an employee who declines signs a declination form and may still accept the vaccine later. The needlestick answer inverts the rule, since the point of the standard is protection before an exposure occurs, and there is no hepatitis C vaccine to offer.29 CFR 1910.1030

The OSHA Hazard Communication Standard covers the hazardous chemicals a pharmacy keeps, such as disinfectants and compounding chemicals. What does it require of the safety data sheets?

• a.They must be kept in a locked cabinet with the pharmacist-in-charge holding the key
• b.They must be requested from the manufacturer only when an exposure occurs
• c.They must be readily accessible to employees on every shift✓
• d.They must be mailed to OSHA each year

Safety data sheets must be available to employees in their work area throughout each work shift, without having to ask permission or wait for someone with a key, which is why locking them away fails the standard even though the sheets are on the premises. Requesting a sheet only after an exposure defeats the purpose, since the sheet is what tells the employee how to respond.29 CFR 1910.1200

A drug's Risk Evaluation and Mitigation Strategy includes elements to assure safe use (ETASU). What does that add beyond a medication guide?

• a.The manufacturer must supply the drug to any pharmacy that orders it and pay for all patient monitoring
• b.Prescribers, pharmacies and patients may have to be certified or enrolled before dispensing✓
• c.The FDA reviews each individual prescription before it may be filled
• d.The drug is placed in a DEA schedule matching the seriousness of the risk it carries

ETASU can require prescriber certification, pharmacy certification, patient enrollment in a registry, documented laboratory monitoring, or dispensing only in certain settings, so a pharmacy that is not certified simply cannot dispense the product. A REMS is an FDA requirement and has no connection to DEA scheduling, and the FDA does not review individual prescriptions.

Two products carry the same AB therapeutic equivalence code in the Orange Book. What determines whether the pharmacy may actually dispense one in place of the other?

• a.The FDA's approval letter, which names the products that may be dispensed in place of the brand
• b.The wholesaler's purchasing contract, which lists the products a pharmacy may interchange
• c.The AB rating by itself, which authorizes substitution in every state
• d.State substitution law, since the AB rating by itself does not authorize a substitution✓

An AB code tells the pharmacy that the FDA considers the products therapeutically equivalent, but the authority to dispense one for the other comes from state substitution law, which varies on points such as patient notification, prescriber consent, and whether substitution is mandatory or permissive. The AB rating is a necessary condition in most states rather than the permission itself, which is why relying on the rating alone is the tempting error.