A prospective analysis of the preventability of adverse drug reactions reported in Sweden

Abstract

+46 10 103 43 26Conflict of interest, summary: Henrik Lövborg declares that his wife is an employee of a company (MEDAC) whose products are part of this study (as is the case for many other companies). We believe a statement is not necessary to publish since this type of study includes all drugs on the market, thereby limiting the risk of conflict of interest. AbstractPurpose Adverse drug reactions (ADRs) are a major patient safety issue and a substantial proportion of ADRs are in fact preventable. The aim of this study was to describe the proportion and pattern of preventable ADRs in spontaneously reported suspected ADRs and to study the feasibility of using data from an ADR reporting system for this purpose.Methods All reports of ADRs, except those where a vaccine was the suspected drug, submitted to the regional pharmacovigilance centre of south eastern Sweden between 2008 and 2009 were analysed. Causality between the suspected ADR and the medication was assessed using WHO criteria and preventability was assessed using Hallas criteria.Results During the study period 1290 ADRs were received and 1255 were classified as having at least a possible causality between a reaction and a drug. Of these 172 (14%) ADRs were considered preventable, 35 (20%) were classified as definitely preventable and 137 (80%) as possibly preventable. Of all preventable ADRs, 96 (56%) were related to issues relating to prescribing, 35 (20%) to administration of drugs and 41 (24%) to clinical and laboratory monitoring of treatment. Warfarin, oxycodone and ioversol were the most common drugs with preventable ADRs. ConclusionsThis study found that a substantial part of reported ADRs are preventable. Most of these are related to drug prescription suggesting that interventions aiming to reduce preventable ADRs should focus on this process. Moreover, systems for ADR reporting may be useful in the mission of reducing the unsafe use of drugs.

Severe cutaneous adverse reactions due to inappropriate medication use

“…A failure to take a previously documented allergy to a drug into account was one of the main causes of avoidable SCARs. This finding is consistent with previous studies showing that 10% of adverse drug reactions were linked to unintentional rechallenge . As in our study, these errors are mostly associated with the prescription of antibiotics, in particular β‐lactam antibiotics .…”

“…This finding is consistent with previous studies showing that 10% of adverse drug reactions were linked to unintentional rechallenge. 34,35 As in our study, these errors are mostly associated with the prescription of antibiotics, in particular b-lactam antibiotics. 36 Inappropriate rechallenge in patients with a previous known allergy to a drug often occurs because prescribers are not aware of the patient's allergy history or because physicians neglect the risk of cross-allergy.…”

Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool

“…ADRs are a major patient safety issue and they can have significant consequences both for the patient and health care system [1]. A recent systematic review of ADRs in children reported incidences of ADRs in hospitalised children ranging from 0.6 to 16.8% among studies [2].…”

Adverse Drug Reactions in a Tertiary Care Emergency Medicine Ward - Prevalence, Preventability and Reporting

“…Also in line with our data, a systematic review found, drugs accountable for preventable drug-related hospital admissions to be aspirin (16%), diuretics (16%), NSAIDs (11%) and anticoagulants (8%) [ 39 ]. In a Swedish study on reported ADRs, a high number of preventable ADRs was found for CNS-active, cardiovascular and antithrombotic drugs, but not for cancer-related drugs [ 40 ].…”