![]() No differences between patient-controlled and PRN groups were reported for adverse events. However, there was little difference in administration of psychotropic medicines. More analgesia was administered in the patient-controlled than the PRN arms but pain reduction was similar. Studies compared patient-controlled or routine administration with PRN and one trial assessed the effect of a practice guideline on implementation of PRN administration. Patient populations, interventions and outcomes varied. The included studies were RCTs with one exception, a pre-test post-test experimental design. Title, abstract and full-text appraisals yielded 5 articles. The authors independently assessed titles, abstracts and full-texts of retrieved studies based on inclusion criteria and risk of bias. We included all randomized controlled trials (RCTs) and studies with comparison groups, comparing PRN prescription and administration with scheduled administration, where safety issues and adverse events were reported. Electronic databases including Scopus, PubMed, Embase, Cinahl, Web of Science and ProQuest were systematically searched to retrieve articles published from 2005 to 2017. The aim of this systematic review was to explore safety issues and adverse events arising from PRN prescription and administration. PRN is the acronym for 'pro re nata,' written against prescriptions whose administration should be based on patients' needs, rather than at set times. Well-designed RCTs are needed to identify any safety issues and adverse events associated with PRN administration. Variations in the interventions, outcomes and clinical areas make it difficult to judge the overall quality of the evidence. This systematic review suggests that PRN safety issues and adverse events are an under-researched area of healthcare practice. The PRN practice guideline improved PRN patient education but non-documentation of PRN administration increased. Selection criteria: we included all randomized controlled trials (RCTs) and studies with comparison groups, comparing PRN prescription and administration with scheduled administration, where safety issues and adverse events were reported. In conclusion, as-needed use is a feasible, patient-centred approach that engages patients with alcohol dependence in the active management of their illness. Sixty-eight percent of the nalmefene-treated patients (78% of the study completers) adhered to the as-needed treatment regimen on at least 80% of the study days. In each treatment group medication intake appeared to vary according to patients' needs in that intake correlated with the baseline drinking pattern. Nalmefene was taken on approximately half of the study days placebo was taken more often than nalmefene (52.8 vs. Adherence was defined as alcohol consumption and medication intake, or no alcohol consumption (with or without medication intake). ![]() A pooled analysis of 'as-needed medication use' data from 1,276 patients in two randomised, double-blind, placebo-controlled, parallel-group trials of nalmefene in the treatment of alcohol dependence was performed to explore whether an 'as-needed' regimen is an acceptable and feasible strategy in patients seeking help for alcohol dependence.
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