NPC D.Pharm key terms

An official book of drug standards issued by a recognised authority, giving mandatory tests, assays and specifications that a substance or preparation must meet before it may be legally supplied.

A single official entry in a pharmacopoeia that describes one drug substance or preparation, listing its name, description, solubility, identification tests, limits and assay method.

The quantitative procedure used to determine how much of the active ingredient is present in a sample, usually expressed as a percentage of the labelled or stated content.

A semi-quantitative test that confirms an impurity is present only below a permitted maximum, rather than measuring its exact amount, and is commonly used for chloride, sulphate and heavy metals.

A volumetric analysis in which a standard solution is added from a burette until the reaction with the analyte is complete, allowing the concentration to be calculated from the volume consumed.

The point during a titration at which the indicator changes colour or the instrument signals completion, ideally coinciding with the equivalence point of the reaction.

The process of comparing an instrument's readings against a known standard across its working range so that results can be traced to accepted reference values and corrected if necessary.

Documented evidence that a method, process or system consistently performs as intended for its stated purpose, covering accuracy, precision, specificity, linearity, range, detection and quantification limits.

The fraction of an administered dose of a drug that reaches the systemic circulation unchanged, together with the rate at which it does so; intravenous dosing is taken as 100 percent.

The absence of a significant difference in bioavailability between two pharmaceutical products containing the same active ingredient, assessed by comparing plasma concentration-time curves and their confidence intervals.

Loss of drug during absorption and its first passage through the gut wall and liver before reaching the systemic circulation, which reduces oral bioavailability and may make parenteral dosing necessary.

An apparent volume relating the amount of drug in the body to its plasma concentration; a large value indicates extensive tissue distribution rather than concentration in blood.

The volume of plasma from which a drug is completely removed per unit time by all eliminating organs combined, determining the maintenance dose rate needed to sustain a target concentration.

The time taken for the plasma concentration of a drug to fall by half during elimination; it governs how long dosing takes to reach steady state and how quickly a drug is cleared after stopping.

The condition reached when the amount of drug absorbed per dose equals the amount eliminated between doses, so plasma concentrations fluctuate around a stable average, typically after four to five half-lives.

An initial larger dose given to reach a therapeutic plasma concentration rapidly, calculated from the volume of distribution rather than from clearance.

Measurement of plasma drug concentrations at defined times to individualise dosing for drugs with narrow therapeutic ranges, poor correlation between dose and effect, or unpredictable pharmacokinetics.

A property of drugs whose toxic and effective concentrations lie close together, so small changes in dose, absorption or clearance can cause treatment failure or serious toxicity and require careful monitoring.

A drug that binds a receptor and activates it to produce a biological response, mimicking the action of the body's own signalling molecule.

A drug that binds a receptor without activating it, blocking the effect of agonists; competitive antagonists can be overcome by raising agonist concentration, non-competitive ones cannot.

A drug that binds and activates a receptor but produces a smaller maximal response than a full agonist, and can therefore act as a net antagonist when a full agonist is present.

A protein molecule, often on the cell surface or in the nucleus, that specifically recognises a chemical messenger and converts binding into a cellular response, forming the basis of selective drug action.

A harmful or unintended response to a medicine occurring at doses normally used for prophylaxis, diagnosis or treatment, excluding therapeutic failure and accidental overdose.

The science and activities concerned with detecting, assessing, understanding and preventing adverse effects or any other medicine-related problem, chiefly through spontaneous reporting systems.

The structured judgement of how likely a medicine caused an observed adverse event, using scales such as WHO-UMC or Naranjo that weigh timing, plausibility, dechallenge and rechallenge information.

A product marketed after the innovator's patent or exclusivity expires, containing the same active ingredient in the same dose form, shown to be bioequivalent and usually sold under a non-proprietary name.

A national or WHO-maintained register of medicines selected because they satisfy priority health needs, are proven safe and effective, and should be available at all times in functioning health systems.

A continually updated list of medicines approved for use within a hospital or health system, usually with prescribing guidance and therapeutic alternatives, maintained by a pharmacy and therapeutics committee.

Prescribing and dispensing that matches the patient's clinical needs, at doses meeting individual requirements, for an adequate period, at the lowest cost to the patient and community.

A written, electronic or verbal lawful order from a registered prescriber for a medicine to be dispensed to a named patient, which must contain specified particulars before a pharmacist may supply it.

The professional act of interpreting a prescription, checking its legality and safety, preparing and labelling the medicine and counselling the patient before the supply is completed.

A structured, two-way conversation in which the pharmacist helps the patient understand the medicine, its purpose, correct use, expected effects and what to do about problems.

The extent to which a person's behaviour in taking medicines, following diets or changing lifestyle matches the agreed recommendations of the prescriber.

Planned communication aimed at improving health literacy and behaviour, delivered by pharmacists through advice, leaflets, screening campaigns and community programmes on topics such as immunisation and hygiene.

Any preventable event that may cause or lead to inappropriate medication use or patient harm, occurring during prescribing, transcribing, dispensing, administration or monitoring.

A medicine whose possession, supply, storage and record-keeping are restricted by law because of abuse or dependence potential, requiring special registers, secure storage and prescription formalities.

A legal classification that groups medicines according to the restrictions placed on their sale and supply, determining who may prescribe or dispense them and what records are required.

A registered health professional responsible for the safe and effective preparation, dispensing, storage and use of medicines, and for advising patients and prescribers on their correct application.

The branch of pharmacy practice concerned with the procurement, storage, compounding, distribution and clinical use of medicines within a hospital, including ward services and drug information.