Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability

Safety of Biological Preparations and Small Molecules. Are There Any Differences?

“…It is true that the overall average BP and SM observation time does not significantly differ in these stages: 7.4 years (2.5-11.4 years) and 5.0 years (2.5-10.0 years), respectively [16]. Type A adverse reactions, characterized by the 1-10% rate of manifestations, are revealed in this stage [13]. However, there are several factors that do not allow doing this to the full extent on the preregistration stage exactly in respect of biopharmaceuticals.…”

“…It has historically been established that AR are classified into 4 types -A, B, C and D. This classification has a range of restrictions and is criticized more and more [13]. The conducted studies showed that the most frequent adverse phenomena were of type B (immunoallergic reactions) and type C (infections).…”

“…We used the classification of adverse phenomena, which distinguishes between 4 types: A, B, C and D [13].…”

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

“…In contrast to the liver specific core elements of the original and updated CIOMS scale (Tables 1 and 2) [4, [21][22][23][24] , numerous causality algorithms are liver unspecific [4,24,76,79,80] , including the Naranjo scale [81] , the World Health Organization (WHO) global introspection method as the WHO method in short [82] , and the KL method of Karg and Lasagna [83] . Particularly intensive discussions focused on the Naranjo scale [4,24,25,[84][85][86][87] , the WHO method [4,24,84,87] , and the KL method [24,25] .…”

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

“… the identification of previously unrecognized Adverse Drug Reactions (ADRs, novel by virtue of nature, frequency and/or severity);  the identification of subgroups of patients at particular risk of adverse reactions;  the continued surveillance of a product throughout the duration of its use, to ensure that the balance of its benefits and harms are and remain acceptable;  the description of the comparative adverse reactions profile of products within the same therapeutic class;  the detection of inappropriate prescription and administration;  the further elucidation of a product's pharmacological and toxicological properties and the mechanism(s) by which it produces adverse effects; Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS) 269  the detection of clinically important drug-drug, drug-herb/herbal medicine, drug-food, and drug-device interactions;  the communication of appropriate information to health-care professionals;  the confirmation or refutation of false-positive signals that arise, whether in the professional or lay media, or from spontaneous reports (see below for definition of a "signal") [12]. Therefore, PhV is becoming a holistic discipline embracing overall risk/benefit assessment, which necessarily takes place both at the individual patient level and at the population level (epidemiological perspective).…”