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edited by AIFA’s Office of Osmed and HTA


Method by which medicines are divided, according to their annual usage (unit cost times annual consumption) into class A items (the 10 to 20 percent of items that account for 75 to 80 percent of the funds spent), class B items (with intermediate usage rates), and class C items (the vast majority of items with low individual usage, the total of which accounts for 5 to 10 percent of the funds spent). ABC analysis can be used to give priority to Class A items in procurement, inventory control, and port clearing. [Source: Quick et al. Managing Drug Supply, 2nd ed. Kumerian Press: 1997; 181]
The patient's ability to obtain medical care and a measure of the proportion of a population that reaches appropriate health services. The ease of access is determined by such components as the availability of medical services and their acceptability to the patient, the location of health care facilities, transportation, hours of operation and cost of care. Barriers to access can be financial (insufficient monetary resources), geographic (distance to providers), organisational (lack of available providers) and sociological (e.g., discrimination, language barriers). Efforts to improve access often focus on providing/improving health coverage. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
Initiative in which a payer provides temporary or interim funding for a particular technology or service to facilitate the collection of information needed to reduce specific uncertainties around a coverage decision. [Source: Stafinski T, McCabe C, Menon D: Funding the unfundable – mechanisms for managing uncertainty in decisions on the introduction o new and innovative technologies into healthcare systems. Pharmacoeconomics 2010; 28:113-42.] See also: managed entry agreements
An evaluative process in which a health care organisation undergoes an examination of its policies, procedures and performance by an external organisation (accrediting body) to ensure that it is meeting predetermined standards. For facilities, accreditation standards are usually defined in terms of physical plant, governing body, administration, and medical and other staff. Accreditation is often carried out by organisations created for the purpose of assuring the public of the quality of the accredited institution or program. The State can recognise accreditation in lieu of, or as the basis for mandatory approvals. Public or private payment programs often require accreditation as a condition of payment for covered services. Accreditation may either be permanent or may be given for a specified period of time.
Ingredient that alone or in combination with one or more other ingredients is considered to fulfil the intended activity of a pharmaceutical. [Source: European Committee for Standardisation. ENV 12610 – Medical informatics-Medicinal product identification]
Umbrella term for persons and entities which comprises authorities, market player and stakeholder.
A type of health care in which a patient is treated for an acute (immediate and severe) episode of illness, for the subsequent treatment of injuries related to an accident or other trauma, or during recovery from surgery. Acute care is usually given in a hospital by specialised personnel, using complex and sophisticated technical equipment and materials. Unlike chronic care, acute care is often necessary for only a short time. [Source: NHS Quality Improvement Scotland – Raising Health care standards]
Acute care beds are beds accommodating patients where the principal clinical intent is to do one or more of the following: - manage labour (obstetric) - cure illness or provide definitive treatment of injury - perform surgery - relieve symptoms of illness or injury (excluding palliative care) - reduce severity of illness or injury - protect against exacerbation and/or complication of an illness and/or injury which could threaten life or normal functions - perform diagnostic or therapeutic procedures. [Source: 2001 Data Collection on Education Systems: Definitions, Explanations and Instructions, UNESCO, OECD, Eurostat, page 45] See also: Hospital beds
Adherence to long term therapy is defined as the the extent to which a person’s behaviour – taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. [Source: WHO Report, 2003]
Advanced therapy medicinal products are based on manufacturing processes focussed on various gene transfer-produced bio-molecules, and/or biologically advanced therapeutic modified cells as active substances or part of active substances. They include: Gene therapy medicinal product: a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell. Somatic cell therapy medicinal product: it means the use in humans of autologous (emanating from the patient himself), allogeneic (coming from another human being) or xenogeneic (coming from animals) somatic living cells, the biological characteristics of which have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect through metabolic, pharmacological and immunological means. Somatic cell therapy medicinal products include:  Cells manipulated to modify their immunological, metabolic or other functional properties in qualitative or quantitative aspects;  Cells sorted, selected and manipulated and subsequently undergoing a manufacturing process in order to obtain the finished medicinal product;  Cells manipulated and combined with non-cellular components (e.g. biological or inert matrixes or medical devices) and exerting the principle intended action in the finished product;  Autologous cell derivatives expressed in vitro under specific culture conditions;  Cells genetically modified or otherwise manipulated to express previously unexpressed homologous or non-homologous functional properties. Tissue engineered product means a product that contains or consists of engineered cells or tissues, and is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices. Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition. [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007]
A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function. Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use] Type A adverse reactions are those that are the result of an exaggerated but otherwise predictable pharmacological effect of the medicine. They tend to be common, dose-related, and less serious than Type B reactions Type B adverse reactions are those that are aberrant effects of the medicine. They tend to be uncommon, not dose-related, and unpredictable. [Source: Strom, Kimmel. Textbook of pharmacoepidemiology] Synonyms: ADVERSE REACTIONS
The extent to which medicines and further health care products are available to the people who need them at a price they / their health system can pay. [Source: adapted from WHO. A model quality assurance system for procurement agencies]
Dispensation of a medicine (often generic) by the pharmacist with a different active ingredient (or combination product) but the same therapeutical effect instead of the product prescribed by the physician. Cf. also generic substitution. [Source: PPRI Glossary]
A classification system of pharmaceuticals where the active ingredients are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties. Pharmaceuticals are classified according to the main therapeutic use of the main active ingredient, on the basic principle of only one ATC code for each route of administration. Immediate and slow release tablets will normally have the same ATC code. A pharmaceutical can be given more than one ATC code if it is available in two or more strengths or routes of administration with clearly different therapeutic uses. Different pharmaceutical forms for topical and systemic use are also given separate ATC codes. [Source: WHO Collaborating Centre for Drug Statistics Methodology – Guidelines for ATC classification and DDD assignment]
Authorities are Government entities responsible for the regulatory framework.
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