Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values.

BACKGROUND: Adverse drug reactions (ADRs) contribute significantly to patient morbidity and mortality, as well as to costs for healthcare systems. Our aim was to evaluate the type and incidence of ADRs in a paediatric hospital population, comparatively ascertained by two different methodological approaches. METHODS: Our prospective study enrolled all patients admitted to two of the general children wards (46 beds) and the paediatric intensive care unit (6 beds) at the HELIOS Klinikum Wuppertal teaching hospital in Germany, over the study period of 3 months. We used two methods to detect ADRs. The intensified surveillance system relied on a trained physician conducting ward rounds and assessing patient charts. The computer-assisted screening of pathological laboratory parameters used values slightly below or above the age-specific normal range as a trigger signal for a potential ADR, which was subsequently assessed by trained personnel. RESULTS: By applying both methods simultaneously we observed that 14.1% of children experienced an ADR while they were hospitalised and 2.7% of children were admitted to hospital because of the ADR. Intensified surveillance resulted in the detection of 101 ADRs in 11.9% of patients, predominantly presenting with gastrointestinal symptoms, skin and CNS disorders; computer-assisted screening identified 45 ADRs in 5.7% of patients, mainly with drug-induced blood dyscrasia and liver damage. Furthermore, the ADRs detected by the intensified method were more severe, affected younger children and showed a closer causal attributability to the reaction than the ADRs observed by the computerised method. The spectra of drugs involved were similar, with the anti-infectives being suspected most frequently. The sensitivities of the intensified surveillance system and the computerised surveillance screening came to 67.2% and 44.8%, respectively, with computer-assisted screening having a specificity of 72.8%. The mean positive predictive value of the pathological laboratory values under surveillance by computer-assisted screening was 18.6%. Approximately 25% of ADR-related drugs administered were used for off-label indications. CONCLUSION: Using the published literature for comparison, we found that ADRs occur as frequently in paediatric patients as in adult patients. Intensified surveillance and computerised surveillance applied in the paediatric setting show substantial differences in their detection specificities. A higher number of and more severe ADRs can be detected by intensified surveillance than by computerised surveillance, but require higher personnel resources.

The epidemiology of preventable adverse drug events: a review of the literature.

BACKGROUND: A growing amount of data suggests that adverse drug events (ADEs) in hospital settings are frequent and result in substantial harm. Even though prevention is where efforts must be directed, only a few studies have reported on the preventability of these events. The objective of this article is to review the literature of ADEs and their preventability, and to report on their incidences, characteristics, risk factors, costs and prevention strategies. METHODS: We systematically searched Medline and Embase for literature published between 1980 and June 2002. All articles reporting primary data on the incidences of ADEs and their preventability in hospital settings were included. RESULTS: In the 8 articles retrieved the incidences of ADEs were between 0.7% and 6.5% of hospitalized patients; in up to 56.6% these events were judged to be preventable. Furthermore, ADEs accounted for 2.4% to 4.1% of admissions to inpatient facilities; preventability was stated in up to 69.0% of these events. A substantial body of preventable ADEs, the so-called medication errors, occur in the process of ordering, transcribing, dispensing and administrating the drugs. Further investigations into medication errors at the ordering stage reveal their occurrence in up to 57.0 per 1,000 orders. Between 18.7% and 57.7% of those errors have the potential for harm, but only in about 1% they result in preventable ADEs. IMPLICATIONS: The detection of errors having only the potential for harm by means of computerized surveillance has shown to be a useful technique in order to understand and prevent ADEs. Apart from the use of sophisticated computer techniques the participation of pharmacists in the drug prescribing process results in a tremendous error reduction. The greatest task in changing the health care system into a system with safety as its first priority is to create a culture of constant learning from mistakes among health care professionals. The appreciation of the health care teams' ideas and perceptions for improvement, and their implementation through small improvement cycles, may represent the leading strength in error reduction and health care improvement.

The epidemiology of medical errors: a review of the literature.

BACKGROUND: Medical errors are one of the most important quality problems in health care today. The best insight into the incidences and characteristics of medical errors is through studies on adverse events (AEs) since a considerable fraction of AEs are results of errors and as such preventable. Even though prevention is where effort should be directed to, only a few studies report on the preventability of AEs. Our aim is to give an overview of the literature reporting on AEs and their preventability. METHODS: We systematically searched Medline and Embase for literature published between 1980 and June 2002. All articles reporting primary data on incidences of AEs and their preventability were included. RESULTS: The 8 articles retrieved were divided into two categories. 1) Four large scale retrospective studies: They reported incidences of AEs between 2.9% and 16.6% of all hospitalizations that were judged as preventable in 48.0-69.6% and negligent in up to 32.3%. 2) Four prospective studies: The reported rates of AEs vary remarkably (0.0037-39.0%) because of different detection methods used, different definitions applied and different health care settings studied. One prospective observational study identified AEs in 39.0% of hospitalized patients with a preventability of 18.0%. Two other studies, using process oriented incidence reporting detected rather low rates of AEs (4.2-5.4%) which were preventable in up to 62.5%. One prospective study in the outpatient setting, using voluntary incidence reporting detected only about 3.7 events per 100,000 clinic visits of which a high fraction was judged to be preventable (83.0%). IMPLICATIONS: Incidence, medical outcome and costs of AEs warrant this issue to be high on any countries health care agenda. The U.S., Australia and Britain have adopted this challenge by creating a centre for quality improvement and patient safety within the health service and by enacting new laws. But real improvement of patient safety will need a fundamental change in medicine from a culture of individual blame and guilt to a culture of learning, system thinking and executive responsibility.