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edited by AIFA’s Office of Osmed and HTA


Services provided by medical specialists who generally do not have first contact with patients (e.g., cardiologists, urologists, dermatologists). This can happen by a self-referral by patients for these services, or patients must first seek care from primary care providers and are then referred to secondary and/or tertiary providers, as needed.
Self-medication is the treatment of common health problems with medicines especially designed and labelled for use without medical supervision and approved as safe and effective for such use. Medicines for self-medication are often called “non-prescription” or “over-the-counter” (OTC) and are available without a doctor's prescription through pharmacies. In some countries OTC products are also available in supermarkets and other outlets. [Source: World Self-Medication Industry website]
An unexpected occurrence at a health care facility involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The event is called “sentinel” because it sends a signal or sounds a warning that requires immediate attention. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
A single social health insurance institution. In some countries there are several sickness funds operating (Austria) or even competing each other (Germany). Some sickness funds are operating on a regional basis whereas others are limited to specific professional groups like farmers or self-employed persons. [Source: PPRI Glossary]
SINGLE-CHANNEL SYSTEM Distribution system at wholesale level. A wholesaler has the exclusive right to distribute medicines – usually all products – of one manufacturer. In a single-channel system, there are usually only a few wholesale companies operating on the market.
Social health insurance is a type of health care provision, often funded through insurance contributions by employers and employees as well as state subsidies. In many countries there are obligatory schemes for (employed) persons whose income does not exceed a certain amount/limit (= insurance obligation) in place. Social health insurance is often organised in different sickness funds - in some countries allowing the patient to select a sickness fund (Germany) whereas in others the membership is determined mandatory, e.g. depending on the type of occupation (e.g. Poland, Austria). In some social health insurance countries persons with higher income as well as self-employed persons may opt for substitutive private health insurance. In addition to social health insurance in some countries voluntary health insurance, covering e.g. out-of pocket payments or allowing for free choice of doctors, is very popular. [Source: PPRI Glossary]
A person or organisation with a legitimate interest in a topic related to health care. Stakeholders may be:  pharmaceutical manufacturers  equipment suppliers  patient organisations  organisations representing health care professionals  other health care organisations  covil society organisations. [Source: adapted from NICE Glossary]
A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance.
Pricing system, where medicine prices are set on a regulatory basis (e.g. law, enactment, decree). [Source: PPRI Glossary]
A pharmaceutical product free of organisms and pyrogens. [Source: Global Conference on the Future of Hospital Pharmacy]
Management of medicine stocks in a hospital or any other step of a delivery chain. Good distribution practices suggest the following principles for stock-taking:  Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.  All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.  FEFO (First Expiry/First Out): A distribution procedure that ensures the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used; EEFO (Earliest Expiry/First Out) shall have a similar meaning.  FIFO (First In/First Out): A distribution procedure to ensure that the oldest stock is distributed and/or utilised before a newer and identical stock item is distributed and/or utilised.
The storing of pharmaceutical products up to the point of use. [Source: WHO. Good distribution practices (GDP) for pharmaceutical products]
The legal basis for the summary of product characteristics is contained in Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004. It is stated that in order to obtain a marketing authorisation, an application must contain a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC. For decisions concerning centralised marketing authorisations, the SmPC forms part of the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP). According to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorisation Holder. In accordance with Directive 2001/83/EC, when the marketing authorisation is issued the competent authorities of the Member States concerned shall inform the Marketing Authorisation Holder of the SmPC that was approved. The SmPC is part of the Product Information (PI) which comprises of the SmPC, the manufacturing authorization holder responsible for batch release, conditions of the marketing authorization, labeling and Package Leaflet (PL). The Package Leaflet (PL) is drawn up in accordance with the SmPC. The SmPC has two defined roles. In the first instance, it sets out the position of the medicinal product as agreed during the course of the assessment process of the marketing authorisation application. As such, the content of the SmPC cannot be changed except with the approval of the CHMP. In a second instance, the SmPC also forms the basis of information for healthcare professionals on how to use the medicinal product safely and effectively, and relates specific advice on aspects concerned with the treatment or its side effects on the patient. It is not the remit of the SmPC to give general advice on the treatment of particular medical conditions or general advice on administration procedures. Further information on the SmPC can be found in the SmPC guideline that provides advice on the principles of presenting information in the SmPC:
SPC gives original products a complementary period of market exclusivity beyond patent expiry to compensate for delays of marketing in the pharmaceutical sector. SPC are available in EU countries but such complementary protection exists in other countries. [Source: PPRI Glossary]
Persons or company providing medicines on request. Suppliers include manufacturers, distribution actors and (parallel) traders. [Source: adapted from WHO. Good distribution practices (GDP) for pharmaceutical products]
All elective invasive therapies provided, under general or local anaesthesia, to day care patients whose post-surveillance and convalescence stay requires no overnight stay as an in-patient. [Source: OECD. A System of Health Accounts]
All types of medical interventions involving an incision with instruments mostly performed in an operating theatre which normally involves anaesthesia and/or respiratory assistance. Surgical procedures can be performed either as in-patient cases, day cases or out-patient cases. The procedure can be performed on a hospital stay, day case or out-patient basis. [Source: EUROSTAT. Definitions and data collection specifications on health care statistics (non-expenditure data)]
A biomarker that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiological, therapeutic, pathophysiologic, or other scientific evidence. Surrogate endpoints are a subset of biomarkers. Although all surrogate endpoints can be considered biomarkers, it is likely that only a few biomarkers will achieve surrogate endpoint status. The term surrogate endpoint applies primarily to endpoints in therapeutic intervention trials; however, it may sometimes apply in natural history or epidemiological studies. It is important to point out that the same biomarkers used as surrogate endpoints in clinical trials are often extended to clinical practice in which disease responses are similarly measured. The use of biomarkers as surrogate endpoints in a clinical trial requires the specification of the clinical endpoints that are being substituted, class of therapeutic intervention being applied, and characteristics of population and disease state in which the substitution is being made. The term surrogate literally means “to substitute for”; therefore use of the term surrogate marker is discouraged because the term suggests that the substitution is for a marker rather than for a clinical endpoint. [Source: Biomarkers Definitions Working Group] See also: biological marker, clinical endpoint
The capacity to meet the needs of the present without compromising the ability to meet future needs. [Source: WHO Regional Office for Europe. Terminology – A glossary of technical terms on the economics and finance of health services. Regional Office for Europe, 1998]
Reclassification of prescription-only medicines to over-the-counter medicines. [Source: PPRI Glossary]
The System of Health Accounts provides for health accounting an economic framework and accounting rules which are methodologically compatible with the System of National Accounts, 1993 Revision (SNA 93).
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