SERIOUSNESS ASSESSMENT - Pharmacovigilance-Material

SERIOUSNESS ASSESSMENT

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:

•       Results in death.

•       Is life-threatening.

•       Requires inpatient hospitalization or prolongation of an existing hospitalization.

•       Results in a persistent or significant disability or incapacity.

•       Is a congenital anomaly or birth defect.

•       Is an important medical event.

Important Medical Events

•       AEs that may not result in death, be life-threatening, or require hospitalization, may be considered serious AEs when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

•       Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in hospitalization; or the development of drug dependency or abuse or the diagnosis of cancer.

Reports that should be considered serious:

•       Any suspected transmission via a medicinal product of an infectious agent should be considered a serious adverse reaction and should be assessed under the category of medically important in the absence of other seriousness criteria.

•       Any organism, virus or infectious particle (e.g. prion protein transmitting Transmissible Spongiform Encephalopathy), pathogenic or non-pathogenic, is considered an infectious agent.

•       Medicinal products used for the treatment of life-threatening diseases, vaccines and contraceptives are examples of classes of medicinal products where lack of efficacy should be considered as cases requiring expedited reporting.

Hospitalisation

•       Hospitalisation is an admission to any hospital, casualty center, emergency room, or health care centre as an inpatient as opposed to an examination and/or treatment on an outpatient basis.

•       There is no universal definition or understanding of ‘admission’ to a hospital or what constitutes as ‘in-patient’. Even if the patient is admitted (kept overnight, e.g.), this does not necessarily mean that the event is indeed medically serious or that the

•       admission was medically justified; on the other hand, the consequences of hospitalisation to the patient and his/her family make it an important (if not strictly a ‘serious’) event.

•       The focus should always be on the adverse event and it’s treatment, not necessarily where the patient is treated or if he/she is an ‘in-patient’. When in doubt, the case should be considered as serious!

Life Threatening

•       Life-threatening refers to immediate risk of death as the event occurred per the reporter.

•       A life-threatening experience does not include an experience that, had it occurred in a more severe form, might have caused death but as it actually occurred did not create an immediate risk of death.

•       For example, hepatitis that resolved without evidence of hepatic failure would not be considered life-threatening even though hepatitis of a more severe nature can be fatal.

•       Similarly, an allergic reaction resulting in angioedema of the face would not be life-threatening, even though angioedema of the larynx, allergic bronchospasm or anaphylaxis can be fatal.

Disability

•       Disability is defined as a substantial disruption in a person's ability to conduct normal life functions.

•       If there is any doubt whether the information provided constitutes a serious AE, local Medics can be a valuable source in the event the case is urgently required for expedited reporting.