7.9.1.1 drug: any chemical compound that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiologic condition (Dorlands Illustrated Medical Dictionary 27th edition).
7.9.1.2 medical device: something contrived for or used in the diagnosis (vascular catheters), treatment (thermotherapy units) or prevention of disease or other abnormal condition, for the relief of pain or suffering or to control or improve any physiologic condition, including instrumentation and implanted devices (prosthetic cardiac valves, pacemakers, hip prostheses)
7.9.1.3 product: a drug or medical device.
7.9.1.4 non-proprietary (generic) name: drug name that are not protected by a trademark, usually descriptive of its chemical structure; sometimes called a public name. In the US, most generic drug names are assigned by the US Adopted Name Council (USAN). Other generic names in common use are the National Formulary (NF) and the US Pharmacopoeia (USP) names. Figure 7-3 lists other available drug coding systems.
7.9.1.5 trade (brand) name: proprietary names that are registered to protect the name for the sole use of the manufacturer holding the trademark.
7.9.1.6 adverse event/adverse experience:
Pre-marketing: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Post-marketing/European Union: Any undesirable experience occurring to a patient treated with a pharmaceutical product whether or not considered related to the medicinal product.
Post-marketing/US: Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose; an adverse event occurring from drug withdrawal; and any failure of expected pharmacologic action.
WHO: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this product.
7.9.1.7 adverse drug reaction:
Pre-marketing: All noxious and unintended responses to a medicinal product related to any dose.
Post-marketing/WHO: A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function
Post-marketing/European Union: A reaction which is harmful and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis, or treatment of disease or the modification of physiological function.
Post-marketing/US: Any undesirable effect reasonably associated with the use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable.
7.9.1 8 causation: an exposure which truly does increase or decrease the probability of a certain outcome.
7.9.1.9 causal relationship: when an event occurs a product may be suspected as causing the event but rarely can it be proven particularly at an early stage of the products life. Certain information about the relationship between the product and the event can reinforce the believe in a causal relationship between the product and the event while others can decrease the probability that there is a causal relationship.
7.9.1.10 regulatory agency: many geopolitical entities have established agencies/authority responsible for regulating products used in health care. The agencies are collectively referred to as regulatory agencies.
7.9.1.11 Product manufacturer: the organization which is responsible for the manufacture of a product. This will usually be the entity which hold the marketing authorization for the product.
7.9.1.12 Holder of marketing authorization (HMA): the organization which holds the authority to market a product. This will often be the organization which manufactures the product.
7.9.1.13 Serious adverse product reaction: an adverse product reaction which:
is fatal (results in death)
is life threatening
requires hospitalization or prolongation of a hospitalization
results in persistent or significant disability/incapacity
results in a congenital anomaly/birth defect.
Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also be considered serious.
7.9.1.14 Expected adverse product reaction: expected events are those which prior experience has demonstrated to be probabilistically linked to the product and are generally included in product labeling.
Pre-marketing: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigators Brochure for an unapproved investigational product).
Post-marketing/European Union: This relates to an adverse reaction which is not mentioned in any ECsummary of product characteristics (SPC). In the absence of any European SPC, an international document prepared by the marketing authorization holder containing all relevant safety information which the marketing authorization holder considers should be listed for the medicinal product in all countries where the medicinal product is marketed (Care Data Sheet).
Post-marketing/US current: Unexpected means an adverse drug experience that is not listed in the current labeling for the drug product and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling but differs from the event because of greater severity or specificity.
Post-marketing/US (proposed): The applicants core safety data sheet shall be a document prepared by the applicant that contains all relevant safety information, including adverse drug experiences, which the applicant believes should e listed for the drug in all countries where the drug is marketed. It may be used by the applicant as the reference document by which an adverse drug experience is judged to be expected or unexpected for purposes of this post-marketing periodic report.
Post-marketing/WHO: An adverse reaction, the nature or severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug.