Title : General and local anaesthetic agents: An analysis of their safety data
Abstract:
General and local anaesthetics are widely used during surgical interventions. These drugs have usually associated with mild and reversible local adverse drug reactions (ADRs), but also with more severe and systemic ADRs, including respiratory and cardiovascular depression and anaphylaxis. In light of their peculiar safety profiles, we carried out a descriptive analysis on safety data of general or local anaesthetics contained in the Italian pharmacovigilance database and deriving from Campania Region (Southern Italy) in the last two decades. For this aim, we described their overall characteristics, focusing on the ADRs seriousness and distribution by System Organ Class (SOC) and Preferred Term (PT).
In this descriptive analysis, among relatively few Individual Case Safety Reports (ICSRs) related to general or local anaesthetics, the ADRs occurred in patients with a median age of 48 years and in a slightly higher percentage of men. Almost all ICSRs were sent by healthcare professionals with poor contribution by patients. Most ADRs were classified as not serious and with a favorable outcome. In terms of distribution of ADRs by SOC and PT, both general and local anesthetics were associated with general and cutaneous disorders, with common ADRs that included lack of efficacy, rash, and erythema. Additionally, general anesthetics were associated with the occurrence of respiratory ADRs, instead, local anesthetics were associated with the occurrence of nervous ADRs.
In conclusion, even though a limited number of ICSRs documenting anesthetics-induced ADRs were retrieved from the Italian spontaneous reporting database in the Campania region, we believe that the continuous monitoring of these drugs is highly recommended, especially among the frail population.
Audience Take Away Notes:
- Post-marketing data on general and local anaesthetics did not show an increase in adverse drug reactions.
- The lack of efficacy observed with general and local anaesthetics, which could represent the consequence of clinical errors (e.g. misidentification of ampoules, vials, and syringes), underlines the need of more attention in the anaesthetic procedure/administration by healthcare professionals.
- Since general and local anaesthetics are widely used, more Pharmacovigilance activities focused on their safety profiles should be promoted via educational campaigns and addressed to both healthcare professionals and patients.
