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edited by AIFA’s Office of Osmed and HTA

Glossary

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EFFECTIVENESS
EFFECTIVENESS Effectiveness is the extent to which an intervention does more good than harm when provided under the usual circumstances of health care practice. Relative effectiveness can be defined as the extent to which an intervention does more good than harm compared to one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of health care practice. [Source: European Union Pharmaceutical Forum. Core principles on relative effectiveness]
EFFICACY
Efficacy is the extent to which an intervention does more good than harm under ideal circumstances. Relative efficacy: can be defined as the extent to which an intervention does more good than harm, under ideal circumstances, compared to one or more alternative interventions. [Source: European Union Pharmaceutical Forum. Core principles on relative effectiveness]
EFFICIENCY
An ability to perform well or achieve a result without wasted energy, resources, effort, time or money thus the extent to which objectives are achieved by minimising the use of resources (i.e. obtaining the best possible value for the resources used). Greater efficiency is achieved where the same amount and standard of services are produced for a lower cost, if a more useful activity is substituted for a less useful one at the same cost or if needless activities are eliminated. Efficiency can be measured in physical terms (technical efficiency) or terms of cost (economic efficiency). Technical efficiency means producing the maximum possible sustained output from a given set of inputs. Allocative efficiency is when resources are allocated in such a way that any change to the amounts or types of outputs currently being produced (which might make someone better off) would make someone worse off. [Source: World Bank]
ELIGIBILITY SCHEME(S)
There are, in general, 4 types of eligibility schemes: * product-specific reimbursement * disease-specific reimbursement, * population-group-specific reimbursement, * consumption-based reimbursement [Source: PPRI Glossary]
ELIGIBILITY SCHEME(S)
There are, in general, 4 types of eligibility schemes: * product-specific reimbursement * disease-specific reimbursement, * population-group-specific reimbursement, * consumption-based reimbursement [Source: PPRI Glossary]
EMERGENCY
Sudden unexpected onset of illness or injury which requires the immediate care and attention of a qualified physician, and which, if not treated immediately, would jeopardise or impair the health of the individual.
EMERGENCY UNIT
The section of a health care facility for providing rapid treatment to victims of sudden illness or trauma.
END USERS OF PHARMACEUTICAL (END USERS)
End users can be patients, consumers, or professional who directly use the pharmaceutical product on patients/consumers. [Source: WHO. IMPACT. Principles and elements for national legislation against counterfeit medical product]
ESSENTIAL MEDICINES
Essential medicines are those that satisfy the priority health care needs of the population. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. The concept of essential medicines is forward-looking. It incorporates the need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure medicine quality; and the need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns. [Source: WHO. Essential medicines]
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
The European Public Assessment Report (EPAR) is a scientific report made available on the EMEA website which reflects the scientific evaluation, discussion and conclusion reached by the Committee for Medicinal Products for Human Use (CHMP) at the time of opinion of a centralised procedure for a marketing authorisation application. The legal basis for the EPAR is contained in Article 13(3) of Regulation (EC) No 726/2004 and it is made available for information to the general public, after deletion of commercially confidential information. The EPAR is updated regularly throughout the marketing lifecycle of a product as changes to the original terms and conditions of the authorisation (i.e. variations, pharmacovigilance issues, specific obligations) are made. The EPAR is accompanied by a summary EPAR, which provides a short description of the main attributes of the product and is written in lay language that is understandable to the general public.
Euroqol-5D:
EQ-5D self-report questionnaire (EQ-5D) is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care. The EQ-5D essentially consists of two pages comprising the EQ-5D descriptive system and the EQ VAS (EQ-visual analogue scale). The EQ-5D descriptive system includes the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into 3 levels: no problems, some problems, severe problems. A total of 243 possible health states is defined in this way. Two further states (unconscious and death) are included in the full set of 245 EQ-5D health states. Most of the EQ-5D weights have been obtained using a representative sample of the general population, thereby ensuring that they represent the societal perspective. [Source: Euroqol group]
EX-FACTORY PRICE
The manufacturer’s posted price. Discounts or other incentives offered by manufacturers result in an effective price that is lower than the ex-factory price. [Source: OECD. Pharmaceutical Pricing Policies in a Global Market]
EXCIPIENT
A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to: - aid in the processing of the drug delivery system during its manufacture; - protect, support or enhance stability, bioavailability, or patient acceptability; - assist in product identification; or - enhance any other attribute of the overall safety and effectiveness of the drug during storage or use
EXCIPIENT
A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to: - aid in the processing of the drug delivery system during its manufacture; - protect, support or enhance stability, bioavailability, or patient acceptability; - assist in product identification; or - enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
EXTEMPORANEOUS PREPARATION
A product which is dispensed immediately after preparation and not kept in stock. [Source: Global Conference on the Future of Hospital Pharmacy]
EXTERNAL PRICE REFERENCING (INTERNATIONAL PRICE COMPARISON)
The practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country. [Source: adapted from PPRI Glossary]
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