PTCE key terms

The study of how the body handles a drug over time: absorption, distribution, metabolism, and excretion. It explains why doses and dosing intervals differ between patients and between products.

The fraction of an administered dose that reaches the bloodstream unchanged and is available to act at the site of action. A drug given intravenously is considered fully bioavailable.

The time it takes for the amount of drug in the body, or its blood concentration, to decrease by half. It guides how often a dose is given and how long a drug's effects last.

A ratio comparing the dose of a drug that causes harm with the dose that produces the desired effect. A narrow index means small changes in dose or blood level can cause toxicity.

A medication that has little or no activity as administered and must be chemically converted by the body into its active form before it can produce a therapeutic effect.

An inactive ingredient added to a dosage form to provide bulk, stability, flavor, preservation, or other physical properties. Some excipients, such as certain dyes or lactose, can still cause patient reactions.

The physical form in which a drug is manufactured for administration, such as a tablet, capsule, solution, cream, patch, or injection. The form affects how the drug is given and absorbed.

A liquid dosage form in which solid drug particles are dispersed throughout a liquid but are not dissolved. Particles settle on standing, so the label directs the patient to shake well before each dose.

The determination that two products contain the same active ingredient in the same amount and dosage form and can be expected to produce the same clinical effect. Reference books rate these products with two-letter codes.

A medication that federal law requires to be dispensed only on a prescription because it is not safe for use without professional supervision. Its label carries the statement Rx only.

A drug regulated under the Controlled Substances Act because it has potential for abuse or dependence. Drugs are placed in one of five schedules, with Schedule II carrying the strictest prescribing and recordkeeping rules.

The official order form a registrant uses to purchase Schedule I or Schedule II controlled substances from a supplier. Each form is serially numbered, and copies must be kept with the controlled substance records.

The report a DEA registrant files to document the theft or significant loss of controlled substances. It must be submitted to the DEA when the loss is discovered, with a copy retained.

A complete count of all controlled substances on hand that a DEA registrant must take every two years. The date and time are recorded, and the inventory record is kept on file.

A federal law requiring most oral prescription medicines to be dispensed in child-resistant containers. Some products are exempt, and patients may request easier-to-open packaging.

A Risk Evaluation and Mitigation Strategy, an FDA-required safety program for drugs with serious risks. It may require special certification, training, patient registries, or limited distribution before dispensing is allowed.

The Drug Supply Chain Security Act, which requires an electronic, interoperable system to trace prescription drugs through the supply chain. Pharmacies must verify transaction information and quarantine suspect product.

The FDA program and form for reporting serious adverse events, product quality problems, and medication errors involving drugs, biologics, and devices. Health professionals and consumers may submit reports.

The most serious FDA recall category, used when a defective product is reasonably likely to cause serious injury or death. Class II and Class III recalls cover less severe risks.

A drug that has a heightened risk of causing significant patient harm when used in error. Insulin, heparin, and concentrated electrolytes are examples, and extra checks or independent double-checks are used.

Look-alike/sound-alike, meaning drug names or packaging that can be easily confused and lead to wrong-drug errors. Pharmacies separate storage, add alerts, and use auxiliary labels to reduce mix-ups.

A labeling convention that capitalizes part of a drug name to highlight the difference from a similar name, such as hydrOXYzine versus hydrALAZINE. It helps staff catch look-alike names.

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient, or consumer.

Harm experienced by a patient related to a medication, whether or not the drug was used correctly. It includes adverse drug reactions and injuries resulting from medication errors.

A structured team review that looks past the individual who made a mistake to find the system failures that allowed the error. The goal is to redesign the process so the error cannot easily happen again.

The classic administration checklist: right patient, right drug, right dose, right route, and right time. Many organizations add right documentation, right reason, and right to refuse.

The date after which a compounded or repackaged preparation must not be used. It is calculated from the preparation date and reflects chemical stability and the risk of microbial contamination.

The United States Pharmacopeia chapter that sets standards for sterile compounding, including cleanroom classifications, environmental monitoring, and staff training. It is intended to prevent contamination and infection from compounded sterile products.

The USP chapter on safe handling of hazardous drugs, covering receipt, storage, compounding, administration, and disposal. It requires engineering controls and personal protective equipment to limit occupational exposure.

The part of a prescription that gives the directions for use, telling the patient how much to take, how often, and by what route. Clear, complete SIGs help prevent dosing errors.

The number of days a dispensed quantity will last at the prescribed dose. It is calculated for insurance claims and determines when the next refill may be dispensed.

A number entered on a pharmacy claim explaining why a specific brand product was dispensed instead of a generic. The code affects whether the claim pays and how much the patient owes.

The list of medications that a health plan or hospital prefers or covers, often arranged in cost tiers. Drugs not on the list may require prior authorization or cost the patient more.

Approval a prescriber must obtain from the payer before a particular drug will be covered. Without it, the claim may be denied and the patient may be charged the full price.

The National Drug Code, a number that identifies a drug's labeler, product, and package size. Pharmacy systems and claims use it to select the exact product dispensed.

A calculation method used to combine two or more preparations of different strengths to make a mixture of a desired in-between strength. It is commonly used in compounding.

The speed at which an IV solution is delivered, commonly expressed in milliliters per hour or drops per minute. It is calculated from the total volume ordered and the infusion time.

Preparing a liquid dose by adding a specified diluent to a powder medication according to the manufacturer's directions. The resulting concentration and beyond-use date must be noted on the label.

Documentation of a compounded preparation listing ingredients, quantities, lot numbers, equipment used, and the person who prepared it. It supports quality checks and tracing if a problem is found later.