Definitions
• Active ingredient (Active Substance, Compound, Active Pharmaceutical Ingredient)
Ingredient that alone or in combination with one or more other ingredients is considered to fulfil the intended activity of a medicine.
• Acute care (what is. Acute care)
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.
• Adherence (what is Adherence)
The extent to which a person’s behaviour – taking medication, following a diet, and/or executing life-style changes, corresponds with agreed recommendations from a health care provider.
• Adverse reaction (what is Adverse reaction)
A response to a reaction which is noxoious 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.
• Batch (Lot) (what is Batch (Lot) )
A specific quantity of material produced in a process or series of processes so that it is expected to be homogenous within specified limits. In the case of continuous
production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
• Bioavailability (what is Bioavailability)
It is defined as, “the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical form and becomes available at the site of action”.
• Bioequivalence (what is Bioequivalence )
Two medicines are bioequivalent if they are pharmaceutically equivalent or
pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essentially the same.
• Biological marker (Biomarker)
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
• Biological medicine
It is a product, the active substance of which is a biological substance.
• Bio-similar
It is defined as, “a biological medicine that is developed to be similar to an existing biological medicine (the “reference medicine”)”. Biosimilar medicines can only be marketed following the patent expiry of reference medicine.
• Brand Name (Innovator’s Name/Proprietary Product Name/Medicine Speciality Product Name/Medicinal Product Speciality Name)
It is the name given for marketing purposes to any ready-prepared medicine placed on the market under a special name and in a special pack. A brand name may be a protected trade mark.
• Bulk product (what is Bulk products)
It is defined, “as any product that has completed all processing stages up to, but not including, final packaging”.
• Burden of disease (what is Burden of disease)
It is a measurement of the gap between a population’s current health and the optimal state where all people attain full life expectancy without suffering major ill-health.
• Chronic care (what is Chronic care)
The ongoing provision of medical, functional, psychological, social, environmental and spiritual care services that enable people with serious and persistent health and/or mental conditions to optimize their functional independence and well-being, from the time of condition onset until problem resolution or death.
• Chronic condition (Chronic Disease)
A disease which has one or more of the following characteristics: is permanent; leaves residual disability; is caused by no reversible pathological alteration; requires special training of the patient for rehabilitation; or may be expected to require a long period of supervision, observation or care.
• Disability-Adjusted Life Years (DALYs)
It is defined as, “a measure of the burden of the disease on a defined population and the effectiveness of the intervention”. DALYs are advocates as an alternative to Quality Adjusted Life Years (QALY) and claimed to be a valid indicator of population health.
• Disease
A failure of the adaptive mechanisms of an organism to counteract adequately, normally or appropriately to stimuli and stresses to which the organism is subjected, resulting in abdisturbance in the function or structure of some part of the organism.
• Dispensing
To supply a clinically appropriate medicine to a patient or care giver, usually against a written prescription, for self-administration by another professional, and to advise on safe and effective use.
• Drug utilisation research
It is defined as, “the research on marketing, distribution, prescription, and use of medicines in a society, with special emphasis on the resulting medical, social and economic consequences”.
• Effectiveness
It is the extent to which an intervention does more good than harm when provided under the usual circumstances of health care practice.
• Efficacy
It is the extent to which an intervention does more good than harm under ideal circumstances.
• 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.
• Essential medicines
These are the medicines that satisfy the priority healthcare needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety,
and comparative cost effectiveness.
• Excepient
A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a medicine delivery system to:
o Aid in the processing of the medicine delivery system during its manufacture;
o Protect, support or enhance stability, bioavailability, or patient acceptability;
o Assist in product identification; or
o Enhance any other attribute of the overall safety and effectiveness of the medicine during storage or use.
• Fixed dose combination (FDC) product
It is defined as, “a combination of two or more active substances in a fixed ratio of
doses”. It may be administered as single entity products given concurrently or as a finished pharmaceutical product.
• Generic (Generic medicine)
A pharmaceutical product (medicine) which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicine, and whose bioequivalence with the reference medicine has been demonstrated by appropriate bioavailability studies.
• Generic substitution
Practice of substituting a medicine, whether marketed under a trade name or a generic name (branded or unbranded generic), with a less expensive medicine (e.g. branded or unbranded generic), often containing the same active ingredient(s).
• Good clinical practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and the reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
• Good distribution practices (GDP)
This is that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the numerous activities which occur during the distribution process.
• Good manufacturing practices (GMP)
This is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation.
• Haemovigilance
It is defined as, “a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients of blood products, and the epidemiological follow-up of donors”.
• Health
It is defined as, “a state of complete physical, social and mental well-being, and not merely the absence of disease or infirmity”.
• Herbal medicine
It is defined as, “any medicine, exclusively containing as active ingredients, one or more herbal substances or one or more herbal preparations, or one or more such herbal
substances in combination with one or more such herbal preparations”.
• Herbal substances
They are defined as, “whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form, but sometimes fresh”. Certain exudates that are not being subjected to a specific treatment are also considered to be herbal substances.
• Herbal preparations
They are defined as, “preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation”. These include comminuted or powdered herbal
substances, tinctures, extracts, essential oils, express juices and processed exudates.
• Home care
It comprises medical and paramedical services delivered to patients at home.
• Homeopathic medicines
Any medicine prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the Pharmacopoeias currently used officially in the Member
States.
• Hospice (Hospice care)
It is defined as, “a facility or a programme providing care for the terminally ill”.
• Hospital pharmacists
Health care professionals who provide services to patients and health care professionals in hospitals are called as hospital pharmacists.
• Hospital pharmacy
It is the health care service, which comprises the art, practise, and profession of choosing, preparing, storing, compounding and dispensing pharmaceuticals and medical devices, advising health care professionals and patients on their safe, effective and efficient use.
• Illness
A person’s own perceptions, experience and evaluation of a disease or condition, or how he or she feels is called as illness; e.g. an individual may feel pain, discomfort, weakness, depression or anxiety, but a disease may or may not be present.
• Infusion
Administration, from a syringe or other rigid or collapsible container e.g. plastic bag, of a volume of sterile solution of an injectable medicine directly into a tissue, organ, vein or artery, at a constant rate, under gravity or by means of an electronic or mechanical pump or other means of rate control, over a defined period usually of at least 10 minutes is called as infusion.
• In-patient care
An in-patient is a patient who is formally admitted (or hospitalised) to an institution for treatment and/or care and stays for a minimum of one night in the hospital or other institution providing in-patient care. In-patient care is delivered in hospitals, or in nursing and residential care facilities or in other establishments.
• International Non-proprietary Name (INN, Generic name)
The shortened scientific name based on the active ingredient is called as INN. WHO is responsible for assigning INNs to pharmaceutical substances. INN is a unique name that is globally recognised and is public property.
• Internet pharmacy (Online pharmacy)
It is an umbrella term for retailers of prescription-only medicines (POM) and Over-the- Counter (OTC) medicines who sell their products via World Wide Web.
• Life expectancy
A statistical abstraction based on existing age-specific death rates is termed as life
expectancy.
• Medical device
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 its manufacturer to be used for human beings for the purpose of:
o Diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
o Investigation, replacement or modification of the anatomy or of a physiological process;
o Control of conception, and which does not achieve its principle 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.
• Medication error
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, is termed as medication error.
• Medicine (Pharmaceutical, Pharmaceutical product, Medication, Medicinal product)
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) 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 is termed as medicine.
• Mortality rate
An estimate of the proportion of a population that dies during a specified period is called as mortality rate.
• Out-patient
An out-patient is a person who goes to a health care facility for a consultation/
treatment, and who leaves the facility within several hours of the start of the consultation without being admitted to the facility as a patient.
• Out-patient care (Ambulatory care, Community care)
It comprises of medical and para-medical services delivered to out-patients.
• Palliative care
The active total care offered to a person and that person’s family when it is recognised that the illness is no longer curable, in order to concentrate on the person’s quality of life and the alleviation of distressing symptoms is called as palliative care.
• Patent
It is a set of exclusive rights granted by a state (National Government) to an inventor or their assignee for a limited period of time in exchange for public disclosure for its invention.
• Pharmaceutical alternatives
Medicines are pharmaceutical alternatives if they contain the same active moiety but differ in chemical form (salt, ester etc.) of that moiety in the dosage form or strength.
• Pharmaceutical care
It is the responsible provision of medicine therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life. These outcomes are:
o Cure of a disease
o Elimination or reduction of a patients’ symptomatology
o Arresting or slowing of a disease process; or
o Preventing a disease or symptomatology.
• Pharmaceutical equivalence
Medicines are pharmaceutically equivalent if they contain the same amount of the same active substance(s) in the same dosage forms that meet the same or comparable standards.
• Pharmacovigilance
It is the process and science of monitoring the safety of medicines and taking action to reduce risks and increased benefits from medicines. It comprises of:
o Collecting and managing data on safety of medicines,
o Looking at the data to detect signals (any new or changing safety issue), evaluating the data and making decisions with regard to safety issues,
o Acting to protect public health (including regulatory action); communicating with stakeholders,
o Audit, both the outcomes of action taken and of the key processes involved.
• Polypharmacy
The administration of many medicines at the same time or the administration of
excessive number of medicines is called as polypharmacy.
• Quality-Adjusted Life Years (QALYs)
It is a measure of health outcome which looks at both length of life and quality of life.
QALYs are calculated by estimating the years of life remaining for a patient following a particular care pathway and weighing each year with a quality of life score (on a zero to one scale). One QALY = one year of life in perfect health, or two years at 50% health, and so on.
• Rational use of medicines
It requires that, patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.
• Reference product (Reference medicine)
A medicine which has been granted a marketing authorisation by a country or by the regulatory authority on the basis of submitted quality, pre-clinical and clinical data, to which the application for marketing authorisation for a generic or a bio-similar product refers.
• Risk
The probability that an event will occur, e.g., that an individual will become ill or die within a stated period of time or by a certain age.
• Risk-benefit balance
An evaluation of the positive therapeutic effects of the medicine in relation to its risks (any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health and any risk of undesirable effects on the environment) is called risk-benefit balance.
• Self-medication
It 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.
• Therapeutic benefit (Therapeutic value)
The effect conveyed on a patient following administration of a pharmaceutical which restores, corrects or modifies a physiological function(s) for that patient is called as therapeutic benefit.
• Therapeutic equivalence
Two pharmaceutical products are considered to be therapeutically equivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and after administration in the same molar dose, their effects, with respect to both efficacy and safety, are essentially the same when administered to patients by the same route under the conditions specified in the labelling.
• Therapeutic group
A group of medicines according to their indications of use are called as a therapeutic group.
• Tertiary care
Services provided by highly specialised providers (e.g. neurosurgeons, thoracic surgeons, intensive care units), usually in in-patient facility is called as tertiary care.
• Vulnerable groups
Groups within a society facing higher risks of poverty and social exclusion compared to the general population are called as vulnerable groups; e.g. people with disabilities, isolated elderly people, children, migrants, ex-prisoners and drug addicts.
