Anzeige
Erschienen in:
01.05.2012 | Editorial
Adverse events in nuclear medicine – cause for concern?
Erschienen in: European Journal of Nuclear Medicine and Molecular Imaging | Ausgabe 5/2012
Einloggen, um Zugang zu erhaltenExcerpt
In the public arena, nuclear medicine has struggled with the widely held perception of the risk associated with radiation exposure from the administration of radionuclides for diagnostic imaging. In the media and in public debate, and even among medical professionals, this risk has been highly exaggerated compared to the risks associated with other diagnostic and therapeutic interventions, obviously due to confusion with the risks associated with nuclear power plants and nuclear weapons. On the contrary, nuclear medicine has been characterized by the rare occurrence of acute and chronic adverse events. In the period 1980–2000 fewer than 50 reports were registered annually in Europe [1]. Hesslewood, in a survey of adverse reactions to radiopharmaceuticals in Europe, found a frequency of 11 events per 105 administrations with no serious, life-threatening events [2]. Data from the US [3] and more recently from Japan [4] show even lower figures: 2.3 and 1.3 per 105 administrations, respectively. These figures, including all adverse events and no single serious adverse event in the data associated with radiopharmaceutical drugs, should be compared with the overall incidence of serious adverse drug reactions of 6.7% and fatal adverse drug reactions of 0.32% in hospitalized patients, reported found a meta-analysis in 1998 [5]. It should be borne in mind, however, that under-reporting of adverse reactions is a significant problem [6], in part due to the mild and transient nature of most reactions. There are other confounding factors for collection of proper statistical data including confusion in terminology. The comprehensive WHO definitions include several different terms including adverse/side reactions/effects/events/experiences, as shown in Table 1.
Table 1
WHO definitions [7]
|
Term
|
WHO definition
|
|---|---|
|
Adverse drug reaction
|
A response to a medicine which is noxious and unintended, and which occurs at doses normally used in man. In this description it is of importance that it concerns the response of a patient, so that individual factors may play an important role.
|
|
Unexpected adverse reaction
|
An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorisation, or expected from characteristics of the drug.
|
|
Side effect
|
Any unintended effect of a pharmaceutical product occurring at doses normally used by a patient, which is related to the pharmacological properties of the drug.
|
|
Adverse event or experience
|
Any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment. The basic point here is the coincidence in time without any suspicion of a causal relationship.
|
|
Serious adverse event
|
Any event that Is fatal, life-threatening, permanently/significantly disabling, requires or prolongs hospitalization, causes a congenital anomaly, requires intervention to prevent permanent impairment or damage.
|