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edited by AIFA’s Office of Osmed and HTA


Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient. [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]
A clinically coherent group of International Classification of Diseases (ICD) diagnoses by major organ system or etiology that is used as the first step in assignment of most diagnosis related groups (DRGs). MDCs are commonly used for aggregated DRG reporting.
An arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximize their effective use, or limit their budget impact. [Source: Klemp, M Frønsdal KB, Facey K. What principles should govern the use of Managed Entry Agreements? International Journal of Technology Assessment in Health Care. 2011 Jan;27(1):77-83.] Types of managed entry agreements: • Access with evidence development (AED)Conditional coverageConditional treatment continuation (CTC)Coverage with evidence development (CED)Only in research (OIR)Only with researchOutcome guaranteesPatient access scheme (PAS)Pattern or process carePerformance based agreementPerformance based health outcome reimbursement schemesPerformance-linked reimbursementPrice volume agreementsRisk sharing schemes Please consult definitions in this PHIS Glossary in alphabetical order.
Natural or legal person with responsibility for the manufacturing of a product. Manufacturing includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabeling, quality control, release, storage, and distribution of active pharmaceutical ingredients (APIs) and related controls. [Source: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use]
The percentage margin is the percentage of the selling price that is profit. The wholesale margin is the gross profit of wholesalers, expressed as a percentage of the wholesale price. The pharmacy margin is the gross profit of pharmacies expressed as a percentage of the pharmacy retail price. [Source: adapted from PPRI Glossary]
Increase or decrease in costs as the result of one more or one less unit of output. Determining marginal cost is important in deciding whether or not to vary a rate of production. [Source: J.P. Friedmann. Dictionary of business terms]
The mark-up is the percentage of the purchasing price added on to get the selling price. A mark-up is added on to the total cost incurred by the producer of a good in order to create a profit. The wholesale mark-up is the gross profit of wholesalers, expressed as a percentage add-on to the ex-factory price. The pharmacy mark-up is the gross profit of pharmacies expressed as a percentage add-on to the wholesale price (or pharmacy purchasing price). [Source: adapted from PPRI Glossary]
Actors with a commercial interest in the pharmaceutical system. These include pharmaceutical manufacturers, distribution actors and equipment suppliers.
A licence issued by a medicines agency approving a medicine for market use based on a determination by authorities that the medicine meets the requirements of quality, safety and efficacy for human use in therapeutic treatment. There are four application procedures possible in the European Union: Centralised procedure (CP): Way of approval of medicines valid in all Member States. The CP is administered by the European Medicines Agency (EMEA) in London. It consists of a single application which, when approved, grants marketing authorisation for all markets within the European Union. This procedure is available to all new, innovative medicines, and is obligatory for 1. biotechnology-derived products, 2. new active ingredients for treating AIDS, cancer, diabetes and "neuro-degenerative illnesses" as well as 3. orphan medicines. Under certain conditions the CP can be limited for one year. If the medicine is important for public health (especially therapeutic innovations) the appraisal period can be abbreviated. Mutual recognition procedure (MRP): The MRP is the most common marketing authorisation procedure in the EU. It states that the marketing authorisation granted in one EU Member State (the so-called "Reference Member State") being "mutually recognised" as valid in other Member State (the "Concerned Member State") upon request. The legal basis is Directive 2001/83/EC, as amended by Directive 2004/27/EC, and further guidance is given in the Notice to Applicants, which forms Chapter 2 of the Rules Governing Medicinal Products in the EU. Decentralised procedure: The decentralised procedure came into operation in late 2005. It is applicable in cases where a marketing authorisation does not yet exist in any of the EU Member States. Identical dossiers are submitted to all Member States where a marketing authorisation is sought. A Reference Member State, selected by the applicant, will prepare draft assessment documents within 120 days and send them to the Concerned Member States. They, in turn, will either approve the assessment or the application will continue into arbitration procedures. The new decentralised procedure will involve concerned Member States at an earlier stage of the evaluation than under the MRP in an effort to minimise disagreements and to facilitate the application for marketing authorisation in as many markets as possible. National procedure: Independent national marketing authorisation procedures are still applicable during the initial stage of the mutual recognition procedure in the country that is to act as Reference Member State. They are also applicable in situations in which the mutual recognition procedure is not compulsory, namely: 1. Bibliographical applications for medicines with a well-established medicinal use for which no reference product is available in the EU. 2. Line extensions of nationally registered medicines for which no harmonised product information is available within the EU. Although some changes to dossiers for nationally registered medicines (such as a change in the strength, pharmaceutical form or route of administration) require the submission of a new marketing authorisation application, these changes are considered as variations to a nationally issued marketing authorisation. Registration: For herbal medicines, homeopathic medicines and medical devices no authorisation but a registration procedure is necessary. [Source: PPRI Glossary]
In exceptional circumstances and following consultation with the applicant, a marketing authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only for objective, verifiable reasons and must be based on one of the assumption that the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:  The indications for which the product in question is intended are encountered so rarely that the  applicant cannot reasonably be expected to provide comprehensive evidence, or  In the present state of scientific knowledge, comprehensive information cannot be provided, or  It would be contrary to generally accepted principles of medical ethics to collect such information. In these cases a marketing authorisation may be granted subject to certain specific obligations. These obligations may include the following:  The applicant shall complete an identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,  The medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radio-pharmaceutical, by an authorised person,  The package leaflet and any medical information shall draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects. [Source: CHMP Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances] See also: marketing authorisation, conditional marketing authorisation
This term is used in a different way in different countries: e.g. in some countries it is the maximum amount which is reimbursed (cf. reference price system), in others it is the maximum share that is refunded by third party payers expressed as percentage of the reimbursement basis. [Source: PPRI Glossary]
A me-too medicine is approved after a pioneering product and is defined as comparable or similar but not clinically superior. [Source: PPRI Glossary]
A medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. A distinction is made between device and ‘accessory’, which is an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device. [Source: Council Directive 93/42/EECof 14 June 1993concerning medical devices]
Documentation of treatment of the patient. [Source: Global Conference on the Future of Hospital Pharmacy]
Services provided by a health care system to a population. They include:  Hospital medical services aimed at curing, restoring and/or maintaining the health of a patient: surgical services, medical services, gynaecological and obstetrical services, rehabilitation services, psychiatric services, other hospital services (medical, pharmaceutical and paramedical services, nursing services, laboratory and technical services including radiological and anaesthesiological services, etc), military hospital services; prison hospital services  General medical services: services consisting of the prevention, diagnosis and treatment by doctors of medicine of physical and/or mental diseases of a general nature, such as consultations, − physical check-ups, etc. These services are not limited to specified or particular conditions, diseases or anatomical regions. They can be provided in general practitioners’ practices and also delivered by out-patient clinics, clinics attached to firms, schools, etc.  Specialised medical services: consultation services in paediatrics, gynaecology-obstetrics, neurology and psychiatry, and various medical services; surgical consultation services; treatment services in out-patients clinics, such as dialysis, chemotherapy, insulin therapy, respirator treatment, X-ray treatment and the like; • functional exploration and interpreting of medical images (X-ray photographs, electrocardiograms, endoscopies and the like).  Dental services: orthodontic services, e.g. treatment of protruding teeth, crossbite, overbite, etc., including dental surgery even when given in hospitals to in-patients; services in the field of oral surgery; other specialised dental services, e.g. in the field of periodontics, paedondontics, endodontics and reconstruction; diagnosis and treatment services of diseases affecting the patient or aberrations in the cavity of the mouth, and services aimed at the prevention of dental diseases.  Deliveries and related services, nursing services, physiotherapeutic and para-medical services: services such as supervision during pregnancy and childbirth; supervision of the mother after birth; services in a field of nursing care (without admission), advice and prevention for patients at home, the provision of maternity care, children’s hygiene, etc.; services provided by physiotherapists and other para-medical persons (including homeopathological and similar services); physiotherapy and para-medical services are services in the field of physiotherapy, ergo therapy, occupational therapy, speech therapy, homeopathy, acupuncture, nutrition, etc. These services are provided by authorised persons, other than medical doctors.  Ambulance services: services involving transport of patients by ambulance, with or without resuscitation equipment or medical personnel.  Residential health facilities services other than hospital services: combined lodging and medical services provided without the supervision of a medical doctor located on the premises.  Other human health services n.e.c.: services provided by medical laboratories; services provided by blood, sperm and transplant organ banks; dental testing services; medical analysis and testing services; other human health services n.e.c. [Source: OECD. A System of Health Accounts]
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
Medication persistence may be defined as “the duration of time from initiation to discontinuation of therapy”. Continuing to take any amount of the medication is consistent with the definition of persistence. This definition can be operationalised in both prospective and retrospective assessments by determining the initiation of treatment, or a point in time during chronic treatment, to a point in time defined as the end of the observation period. By definition, persistence is reported as a continuous variable in terms of number of days for which therapy was available. Persistence may also be reported as a dichotomous variable measured at the end of a predefined time period (e.g. 12 months), considering patients as being “persistent” or “non persistent.” [Source: ISPOR. Medication Compliance and Persistence: Terminology and Definitions]
The process of comparing a patient’s medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions. [Source: Global Conference on the Future of Hospital Pharmacy]
Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. [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] See also: advanced therapy medicinal product, biological medicinal product, herbal medicinal product, homeopathic medicinal product Terms to be avoided: drug unless in well established terms like ADR.
An estimate of the proportion of a population that dies during a specified period. The numerator is the number of persons dying during the period; the denominator is the number in the population exposed to the risk of dying, usually estimated as the midyear population. [Source: European Health Expectancy Monitoring Unit. Glossary]
Distribution system at wholesale level. Medicines of a manufacturer are distributed and supplied in parallel via different wholesalers
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