Medication safety in children

Background: The issue of medication safety has received considerable attention in the last few years. Especially drug related problems (DRP) are a major safety issue. Hospital pharmacists are best placed to oversee the quality of the entire drug distribution, preparation and administration chain and can fulfil an important role in improving medication safety. Despite the awareness that children are at increased risk for DRPs, little is known about the epidemiology of these problems and where the gaps remain in our present knowledge. We undertook three studies to help provide a better understanding of (1) acute kidney injury (AKI) as a possible adverse drug event, (2) prescribing errors, which are considered as a subgroup of medication errors and (3) high drug exposure as an important medication safety issue.
Methods: First, we performed a retrospective case-control study in a paediatric intensive care unit (PICU). Cases were patients who developed AKI during PICU stay. Patients without AKI served as controls and were matched to cases on age category and gender in a one to one ratio. Secondly, we performed therefore a prospective observational study to determine the number and type of medication prescribing errors in critically ill children in a PICU. Prescribing errors were prospectively identified by a clinical pharmacist. Lastly, a retrospective observational study was performed to determine the number and profile of drugs and their association with socio-demographic, diagnostic and severity of illness parameters. Number of drugs was defined as the number of different drugs that a study subject received during the first 24 hours.
Results: 100 case-control pairs were included. Cases were not statistically different from controls with regard to median weight and main diagnoses, but differed with regard to the need of mechanical ventilation, the severity of illness, and the median length of PICU stay. Multivariate models revealed a statistically significantly higher risk of developing AKI for patients treated with Metamizol, Morphine, Paracetamol and Tropisetron. A similar risk could be shown for medication groups, namely glucocorticoids, betalactam antibiotics, opioids and non-steroidal anti-inflammatory drugs.
In the second study a total of 1’129 medication orders were analysed. There were 151 prescribing errors, giving an overall error rate of 14% (95% CI 11 to 16). The medication groups with the highest proportion of medication prescribing errors (MPEs) were antihypertensives, antimycotics and drugs for nasal preparation with error rates of each 50%, followed by antiasthmatic drugs (25%), antibiotics (15%) and analgesics (14%). 104 errors (70%) were classified as MPEs which required interventions and/or resulted in patient harm equivalent to 9% of all medication orders (95% CI 6.5 to 14.4). 45 MPEs (30%) did not result in patient harm.
In the third study 1751 medication orders in the first 24 hours were included. The patients received a median of 4 (range 1; 25) different drugs. The most frequently prescribed drug groups were analgesics without opioids (19%), opioids (12%), betalactam antibiotics (12%) and cardiac stimulants (7%). There was a statistically significant association between the number of drugs and age, some diagnosis and the severity of illness parameters, respectively. Socio-economic status and sex was not associated with numbers of drugs. Three medication groups (cardiac stimulants, opioids and analgesics without opioids) showed a statistically significant association with the severity of illness parameters.
Conclusion:
Our studies reveal different risk factors associated with the administration of drugs in children. With a view to reduce these risk factors and improve patient safety, the data presented here help us to prevent errors before they occur. In addition, prevention of DRPs requires a team approach, where clinical pharmacists play an important role in optimizing drug therapy in critically ill children. Careful evaluation of each drug, precise prescription and the awareness of the most vulnerable population may improve patient’s outcome.