Fachapotheker/in FPH Spital key terms

Swiss federal law governing medicinal products, covering their development, manufacture, distribution, dispensing and surveillance. It is the legal basis for market authorisation, pharmacy operation, pharmacovigilance duties and sanctions for non-compliant handling of drugs.

The Swiss agency for therapeutic products. It authorises medicines, inspects manufacturers against GMP, supervises clinical trials, runs the national pharmacovigilance system and enforces narcotics and blood product regulation within the HMG framework.

Swiss ordinance on narcotics (Betäubungsmittelverordnungs-Verordnung) regulating handling of controlled substances: prescribing restrictions, special prescription forms, record-keeping, secure storage and reporting obligations that hospital pharmacies must operationalise in daily dispensing.

The hospital's approved list of medicines with standardised prescribing information, maintained by a formulary committee. It guides prescribing, procurement and substitution, and is a core governance instrument balancing evidence, cost and local logistics.

Interprofessional body, usually including pharmacists, physicians and nursing, that evaluates applications for drug inclusion, reviews therapeutic class strategy and decides on deletions. It applies evidence criteria, budget impact and safety data to produce binding local policy.

Policy allowing substitution of a prescribed drug with a therapeutically equivalent formulary alternative, typically under agreed protocols. It requires equivalence evidence, prescriber communication and monitoring to avoid unintended clinical consequences during the switch.

Prescribing an authorised medicine outside its approved indication, dose, population or route. In hospitals it requires documented rationale, patient information where appropriate, liability awareness and often local policy approval, especially for high-risk or expensive therapies.

Access to an unapproved medicine for a seriously ill patient outside a clinical trial, under defined regulatory conditions. It involves Swissmedic or ethics notification, informed consent, supply documentation and systematic safety reporting throughout treatment.

Structured process of obtaining and verifying a complete medication history at admission, transfer and discharge, then comparing it with current orders. Discrepancies are resolved with the prescriber, reducing omissions, duplications and dosing errors across care transitions.

A systematic history built from at least two sources, such as patient interview, community pharmacy records and referral documents, to establish what the patient actually takes. It is the foundation on which reconciliation and drug therapy review are performed.

A structured pharmacist assessment of indication, effectiveness, safety and adherence for each medicine, considering comorbidities and patient goals. Findings are prioritised and communicated to the care team as concrete recommendations rather than a simple list of problems.

A documented, patient-specific plan listing identified drug-related problems, agreed interventions, monitoring parameters, responsible persons and review dates. It makes pharmaceutical contributions visible and traceable within the interprofessional record.

Regular interprofessional bedside visit where the care team reviews the patient's status and adjusts therapy. Pharmacist participation enables real-time advice on dosing, interactions, therapeutic duplication and switching from intravenous to oral therapy.

Structured patient education before leaving hospital covering purpose, dose, timing, side effects and adherence of each medicine. Combined with a reconciled discharge list sent to the next provider, it reduces post-discharge errors and readmissions.

Measurement of drug concentrations in blood to individualise dosing for medicines with narrow therapeutic ranges or variable pharmacokinetics. Interpretation requires sampling time, dosing history and patient factors, and results guide dose adjustment rather than acting alone.

Description of what the body does to a drug over time: absorption, distribution, metabolism and elimination. Parameters such as clearance, volume of distribution and half-life allow prediction of concentrations and dose adjustments in organ dysfunction.

Apparent volume relating the amount of drug in the body to its plasma concentration. It indicates how extensively a drug distributes into tissues and predicts loading dose, while low values suggest mainly intravascular distribution.

An initial larger dose given to reach therapeutic concentration quickly rather than waiting for accumulation. It depends mainly on volume of distribution and is often unchanged in renal impairment, unlike maintenance dosing.

Modification of dose or interval for drugs cleared by the kidney, based on estimated glomerular filtration rate. It requires choosing an appropriate estimation formula, accounting for acute kidney injury and avoiding both underdosing and accumulation toxicity.

Individualising vancomycin therapy by targeting the area under the concentration-time curve relative to the minimal inhibitory concentration, rather than trough alone. It improves efficacy while limiting nephrotoxicity and typically requires two concentration samples or Bayesian estimation.

Method combining a population pharmacokinetic model with a patient's measured concentrations and covariates to estimate individual parameters and propose the next dose. It supports sparse sampling and is widely used in hospital TDM software.

A harmful and unintended response to a medicine at normal doses. Classification by mechanism (type A dose-related versus type B idiosyncratic) and causality assessment guide reporting obligations and preventive strategies.

The science and activities relating to detection, assessment, understanding and prevention of adverse effects or other drug-related problems. Hospital pharmacists contribute through systematic collection, causality assessment and reporting to the national authority.

Swiss spontaneous reporting system for suspected adverse drug reactions, submitted to Swissmedic and the regional pharmacovigilance centre. Reports are mandatory for serious suspected reactions and new drugs, and quality depends on completeness of clinical detail.

Any preventable event that may cause or lead to inappropriate medication use or patient harm, occurring at prescribing, transcribing, dispensing, administration or monitoring. Analysis focuses on system failures rather than individual blame.

Drugs carrying a heightened risk of significant harm when used in error, such as anticoagulants, insulin, concentrated electrolytes and cytotoxics. They require independent double checks, clear labelling, restricted storage and specific administration safeguards.

Medicines whose names or packaging resemble each other, creating selection and dispensing errors. Mitigation includes tall-man lettering, physical separation, barcode scanning and alerts in electronic systems.

Prospective team method that maps a process step by step, identifies ways it could fail, and scores severity, occurrence and detectability to prioritise risk reduction. It is commonly applied to hospital medication processes before implementation.

Retrospective structured investigation after a serious incident, tracing contributing factors across tasks, equipment, environment, team and organisation. Its output is an action plan addressing system weaknesses, not individual punishment.

Safe preparation, transport, administration and waste disposal of hazardous antineoplastic drugs. Controls include biological safety cabinets or isolators, closed system transfer devices, validated cleaning, protective equipment and staff health surveillance.

Compounding of sterile products using techniques that prevent microbial contamination, performed in controlled environments with validated processes, trained personnel and documented release checks. It applies to parenterals, eye drops and other sterile dosage forms.

A closed barrier enclosure with gloves and controlled internal positive pressure that separates the operator from the sterile workspace. Used for cytotoxic and other hazardous sterile compounding, it requires validated decontamination and environmental monitoring.

Quality system ensuring products are consistently produced and controlled according to quality standards. For hospital manufacturing it covers premises, equipment qualification, documentation, validation, personnel training and quality control release of compounded batches.

Documented evidence that equipment and processes perform as intended: installation, operational and performance qualification. Validation of processes such as sterilisation or aseptic filling demonstrates consistency before routine use and after significant changes.

Official standard defining identity, purity, assay and testing methods for a substance or preparation. Monographs from the European or Swiss pharmacopoeia are binding references for compounding and quality control in hospital manufacturing.

The date after which a compounded preparation must no longer be used, assigned from stability data, preservative considerations and contamination risk. It differs from the manufacturer's expiry date and depends on storage conditions and container type.

Electronic storage and dispensing unit on wards that controls access, records transactions and supports restocking and inventory control. Configuration, user rights and override monitoring are essential for safety and narcotics accountability.

Regular documented comparison of controlled substance stock records with physical counts and dispensed amounts, investigating discrepancies. It fulfils legal accountability duties and deters diversion within hospital distribution systems.

Bedside scanning of patient identification and medicine barcode before administration, with electronic verification against the order. It intercepts wrong-patient, wrong-drug and wrong-dose errors and generates data for safety monitoring.

Systematic evaluation of prescribing patterns against criteria to identify overuse, underuse, misuse or costly alternatives. Results feed formulary decisions, quality improvement projects and prescriber feedback.

Explicit screening tools listing potentially inappropriate medicines for older adults (STOPP) and commonly omitted beneficial therapies (START). They support structured medication review but require clinical judgement for each individual patient.

Planned, supervised reduction or withdrawal of medicines whose harms now outweigh benefits, such as in frailty or limited life expectancy. It involves patient discussion, tapering where needed and monitoring for withdrawal or disease recurrence.

The extent to which a patient's behaviour matches agreed recommendations on timing, dose and duration. Assessment uses non-judgemental interview, refill data and pill counts, and improvement relies on simplification, education and shared decision-making.

Planned transition from parenteral to oral therapy once the patient is clinically stable and absorption is adequate. It shortens hospital stay, reduces line-related infection and cost, and requires explicit criteria and documentation.

The reciprocal of absolute risk reduction, expressing how many patients must be treated for one additional benefit. It translates trial results into clinical effort and depends heavily on baseline risk, so it should be reported with confidence intervals.

The arithmetic difference in event rates between control and treatment groups. Unlike relative risk reduction, it reflects actual clinical impact and is the basis for calculating number needed to treat.

A range of values consistent with the observed data at a stated probability, usually 95 percent. It conveys precision of an estimate; wide intervals indicate uncertainty and should temper strong conclusions from small studies.

Experimental study allocating participants randomly to interventions, minimising selection bias and supporting causal inference. Appraisal considers allocation concealment, blinding, completeness of follow-up and whether outcomes are patient-relevant.

Structured synthesis of all relevant studies addressing a defined question, using explicit search, selection and appraisal methods, often with meta-analysis. Its strength depends on review quality and heterogeneity of included studies.

Coordinated teamwork in which pharmacists, physicians, nurses and other professions share goals, information and accountability for patient outcomes. It depends on role clarity, mutual respect, structured communication and shared documentation.

Structured approach to implementing organisational change, addressing stakeholder engagement, communication, training and resistance. In hospital pharmacy it underpins adoption of new technologies, formularies or safety protocols.

A quantifiable measure tracking progress toward a defined operational or clinical objective, such as dispensing turnaround time or reconciliation completion. Effective KPIs are specific, attributable and reviewed regularly with corrective action.