NPC B.Pharm key terms

The national law that establishes the Nepal Pharmacy Council, defines who may practise pharmacy, and sets registration, discipline and professional conduct requirements for pharmacists and pharmacy assistants.

The statutory regulatory body created under the Pharmacy Act to register pharmacy professionals, set educational and practice standards, and take disciplinary action against practitioners who breach professional obligations.

The formal entry of a qualified person's name on the Council's register after verification of academic qualification and internship, which is the legal prerequisite for practising and using the protected title of pharmacist.

The supervised practical training period a pharmacy graduate must complete in an approved hospital or community pharmacy before being eligible for full registration and independent practice.

Structured learning activities that registered pharmacy professionals undertake throughout their career to maintain and update knowledge, often counted in credit hours and required for licence renewal.

The set of professional conduct principles binding registered pharmacists, covering patient confidentiality, avoidance of conflicts of interest, honesty in promotion, and refusal to dispense unsafe or illegal medicines.

The regulatory approval process by which a manufacturer obtains authorisation from the national drug authority to market a specific pharmaceutical product after assessment of quality, safety and efficacy.

The structured submission of data on chemistry, manufacturing, pharmacology, toxicology and clinical studies that a manufacturer files to support approval of a medicine for sale.

The set of quality-assurance requirements ensuring medicines are consistently produced and controlled according to quality standards, covering premises, personnel, documentation, validation and complaint handling.

Practice standards describing the minimum level of care a pharmacy should provide, including correct dispensing, patient counselling, storage conditions, record keeping and referral of patients when needed.

The demonstration that two pharmaceutical products containing the same active ingredient reach the systemic circulation at comparable rate and extent, usually judged by AUC and Cmax within accepted confidence limits.

The science of detecting, assessing, understanding and preventing adverse effects or any other medicine-related problems, mainly through spontaneous reporting and periodic safety review after marketing.

A spontaneous adverse-drug-reaction reporting system in which health professionals submit a standard form to the national pharmacovigilance centre describing a suspected reaction and the implicated medicine.

The legal grouping of medicines by the level of control over sale, such as prescription-only, pharmacy-only or over-the-counter, which determines who may supply them and under what record-keeping conditions.

The legal and professional elements a valid prescription must contain, including prescriber details and signature, patient identification, drug name, strength, dosage form, dose, route and duration, without which dispensing is improper.

The special legal regime for medicines with abuse potential, imposing licence requirements, secure storage, prescription limits and mandatory record keeping to prevent diversion and misuse.

The process of removing a medicine from distribution because of a defect or safety concern, classified by severity from class I for serious harm to class III for minor problems, with defined retrieval and reporting steps.

The fraction of an administered dose of unchanged drug that reaches the systemic circulation, and for orally given drugs the rate at which it does so, expressed relative to the intravenous route.

Presystemic elimination of a drug in the gut wall or liver before it reaches the systemic circulation after oral dosing, reducing bioavailability and often requiring a higher oral dose.

The time taken for the plasma concentration of a drug to fall by half during elimination, used to estimate dosing interval and the time needed to reach steady state.

The apparent volume relating the amount of drug in the body to its plasma concentration, indicating how widely a drug distributes into tissues and guiding loading-dose calculation.

The volume of plasma from which a drug is completely removed per unit time, reflecting the combined activity of hepatic metabolism and renal excretion and determining maintenance dose rate.

The condition during repeated dosing when the amount of drug entering the body equals the amount eliminated, so plasma concentrations fluctuate within a stable range around a mean value.

Measurement of plasma drug concentrations to individualise dosage for drugs with narrow therapeutic indices, such as digoxin, lithium, phenytoin and aminoglycosides, where clinical response is hard to judge.

A property of drugs whose effective and toxic concentrations lie close together, so small changes in dose or blood level can cause treatment failure or serious toxicity.

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

A change in the effect of one medicine caused by another medicine, food or substance, acting through pharmacokinetic mechanisms such as enzyme induction or inhibition, or pharmacodynamic mechanisms at the same target.

Blocking of hepatic metabolising enzymes by a drug, slowing the breakdown of co-administered substrates and raising their plasma levels, as seen with macrolides, azoles and ritonavir.

A drug that binds a receptor and activates it to produce a biological response, having both affinity and intrinsic activity, in contrast to a blocker at the same site.

A drug that binds a receptor with affinity but no intrinsic activity, preventing the natural ligand or an agonist from producing a response; it may be competitive or non-competitive.

A ligand that binds a receptor and produces a submaximal response even at full occupancy, so it can act as an agonist or blunt the effect of a full agonist depending on context.

The ratio of the dose producing toxicity to the dose producing the desired effect in a population, a large value indicating a wide margin of safety.

The structured conversation in which a pharmacist explains how to take a medicine, expected effects, precautions and what to do about missed doses, checking the patient's understanding afterwards.

The extent to which a patient's actual medicine-taking behaviour matches the agreed prescription, influenced by regimen complexity, side effects, cost, beliefs and quality of counselling.

The responsible provision of drug therapy to achieve definite outcomes that improve a patient's quality of life, involving identification, resolution and prevention of medication-related problems.

A preventable mistake made during the dispensing process, such as wrong drug, strength, form or label, or an omitted warning, which may or may not reach and harm the patient.

Documented evidence that a manufacturing process, equipment or analytical method consistently produces results meeting predetermined specifications, established before routine use.

The testing and sampling activities performed on starting materials, intermediates and finished products to confirm they meet specification, including assay, dissolution, uniformity and microbial limits.

An analytical separation technique in which a sample is pumped through a packed column and detected by UV, fluorescence or mass spectrometry, widely used for assay, impurity and dissolution testing of medicines.

A plot of detector response against known concentrations of an analyte, used to quantify unknown samples and to establish linearity, sensitivity and the working range of an analytical method.

An in-vitro test measuring how quickly an active ingredient is released from a dosage form into a specified medium under controlled agitation, used as a quality and bioequivalence indicator.

A formulation designed to release drug slowly over an extended period, reducing dosing frequency and flattening peak-trough fluctuations, often using matrices, coatings or osmotic systems.

Any inactive substance in a dosage form, such as a diluent, binder, disintegrant, lubricant, preservative or colourant, included to aid manufacture, stability or patient acceptability.

The combination of design, aseptic technique, filtration or terminal sterilisation and environmental monitoring that ensures a product is free from viable micro-organisms, expressed as a probability of contamination.

The study of medicines derived from natural sources, covering the botany, chemistry, cultivation, standardisation and biological activity of plant, animal and mineral drugs.