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Pharmacy Management
| Question | Answer |
|---|---|
| How frequently are pharmacies required by federal law to inventory controlled substances? | Every 2 years |
| What is the term for an error that occurs when a task is performed incorrectly, such as dispensing the wrong medicine? | Error of commission |
| What is an Error of commission | An error of commission occurs when an action is performed incorrectly — for example, dispensing the wrong medicine to a patient. These errors increase the risk of medication errors in pharmacies. |
| What is an Error of Ommission | By contrast, an error of omission occurs when something necessary is left undone — for instance, failing to dispense a medicine that the patient should have received. |
| What is the 10-digit identifier assigned to healthcare providers for transmitting healthcare information? | A National Provider Identifier (NPI) is a unique 10-digit number assigned to healthcare providers by the Centers for Medicare and Medicaid Services (CMS). |
| Which law established the protocol that drugs could be identified and reported using the NDC? | Drug Listing Act |
| Which USP chapter sets standards in hazardous drug handling for patients, healthcare workers, and the environment? | USP 800 sets standards in hazardous drug handling for patients, healthcare workers, and the environment. |
| Which law was passed to ensure that medicines are developed in a child protected form? | Poison Prevention Packaging Act |
| Under the Drug Supply Chain Security Act (DSCSA), pharmacies are required to maintain product tracing documentation for how long? | The DSCSA requires pharmacies to retain all product tracing documentation — Transaction Information (TI), Transaction History (TH), and the Transaction Statement (TS) — for a minimum of 6 years from the date of the transaction. |
| Which organization is responsible for accrediting and certifying healthcare organizations in the United States? | TJC – or The Joint Commission – is responsible for accrediting and certifying healthcare organizations in the United States. |
| The Orphan Drug Act was passed to promote research and development of drugs that affect which of these categories? | “Orphan drugs” are those manufactured to treat rare diseases. Enacted in 1983, the Orphan Drug Act offers financial incentives to pharmaceutical companies to research and manufacture these medicines. |
| Material Safety Data Sheets (MSDS) were mandated after which legislation was passed? | Occupational Health and Safety Act |
| Which legislation placed prescription drug advertising under FDA supervision and required drug manufacturers to register and permit inspections of manufacturing sites? | Enacted in 1963, the Kefauver-Harris Amendment placed prescription drug advertising under FDA supervision. |
| Enacted in 1990, which law requires pharmacies that fill orders for Medicaid patients to obtain, record, and maintain basic patient information? | Omnibus Budget Reconciliation Act |
| What term refers to the total cost of maintaining inventory? | The term used to describe the total cost of keeping items in stock is carrying cost or holding cost. |
| Which legislation classified medicines as either prescription or over-the-counter (OTC) drugs? | The 1951 Durham-Humphrey Amendment formally established the distinction between prescription drugs and over-the-counter (OTC) drugs. |
| Which section of a prescription provides instructions on how to take the medicine? | The signature (sig) section of a prescription provides instructions on how the patient should take the medicine. |
| For both prescription and OTC medicines, which serves as the product identifier? | The NDC number (National Drug Code) is a 10-digit identifier assigned to every medicinal product. |
| The passing of which legislation required that all new prescription drugs be shown to be both safe and effective before being marketed? | The Kefauver-Harris Amendment (1962) was passed after the thalidomide tragedy in Europe. It requires manufacturers to provide proof of both safety and effectiveness before a drug can be approved by the FDA. |
| Form 41 must be submitted to the DEA within what timeframe? | Pharmacies are not required to submit Form 41 within a designated timeframe. Instead, the form must be submitted when specifically requested by the DEA. Note that Form 41 is used to request permission from the DEA to destroy controlled substances. |
| A patient is prescribed hydralazine for hypertension, but the pharmacy technician almost selected hydroxyzine. This type of medication error is classified as which of these? | SALAD = Soundalike-Lookalike Drugs In this case, hydralazine and hydroxyzine have a similar sounding / looking name, meaning there is a higher risk of choosing the wrong medicine to dispense to the patient. |