Significant adverse drug reaction definition

Significant adverse drug reaction means a drug-related incident that may result in serious harm, injury, or death to the patient;
Sample 1Sample 2Sample 3
Significant adverse drug reaction means a drug‑related incident that may result in serious harm, injury, or death to the patient.
Sample 1Sample 2Sample 3
Significant adverse drug reaction means any reaction which requires any medical treatment beyond a consultation between Pharmacist/patient, Pharmacist/Prescriber, patient/prescriber or Pharmacist/patient/Prescriber; and
Sample 1Sample 2

More Definitions of Significant adverse drug reaction

Significant adverse drug reaction means an unexpected adverse drug experience that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. A medical event may also be considered a significant adverse drug reaction when, based on appropriate medical judgment, the medical event places the patient at a significant risk of experiencing any of the outcomes listed above. An adverse drug reaction is unexpected if it has not previously been observed, rather than a reaction that is not anticipated from the pharmacological properties of the pharmaceutical product.
Sample 1Sample 2
Significant adverse drug reaction means an unexpected adverse drug experience that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or
Sample 1

Related to Significant adverse drug reaction

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Material Adverse Event means any circumstance or event that, individually or collectively with other circumstances or events, may reasonably be expected to have a material adverse effect on the financial condition or Business of the Borrower, as now conducted or as proposed to be conducted.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Adverse decision means any decision by a review agent not to certify an admission,

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Adverse employment action means an action that affects an em- ployee ’s compensation, promotion, transfer, work assignment, or performance evaluation, or any other employment action that would dissuade a reasonable employee from making or supporting a report of abuse or neglect under Family Code 261.101.