Lecturer of Clinical Pharmacy
Professor of Clinical Pharmacy
Department of Pharmacy
Robert Debré Hospital APHP
Faculté de pharmacie
René Descartes University MP5
Medication errors have become a major public health concern.(1,2) The goal of a zero drug error rate should be sought, with systems in place aiming to eliminate the effects of human error.(3) In contrast to nonpreventable adverse drug reactions, medication errors occur as a result of human mistakes or system flaws. A medication error is defined as any preventable event that occurs, regardless of whether an injury occurred or the potential for injury was present. Errors are possible at any step of the medication use system, from medication selection and ordering to order transcription and drug formulation, dispensing and administration.(4)
Clinical pharmacists in children’s hospitals deal daily with the special medication needs of paediatric and neonatal patients of various weights (400g to 80kg). Because the dosing of most drugs is based on weight, there is potential for a 200-fold dosing error. In adult patients, a twofold dosing error is usually the maximum encountered, as pharmaceutical manufacturers provide medications in adult unit-dose packaging.(5) Young children do not have the communication skills to warn clinicians about potential mistakes in medication administration or about the adverse effects that they may experience. Moreover, few drugs are available from manufacturers in ready-to-administer paediatric or neonatal unit doses or dosage forms. Paediatric pharmacists and nurses are routinely required to prepare dilutions, repackage or compound dosage forms.(5)
A study by the US Pharmacopeia Medication Errors Reporting Program, carried out from 1995 to 1999, demonstrated a significant increase in medication error rates, resulting in more harm or death in paediatric patients (31%) than in adults (13%).(6)
Error prevention strategies
An improved understanding of the nature of medication error and of the people who contribute to it is required to design and prioritise the implementation of error prevention strategies. Many guidelines for preventing medication errors have been published.(3,7–9) The American Academy of Pediatrics is committed to decreasing medication errors in the treatment of children and to developing systems designed to identify and learn from errors.(4) They published actions and/or guidelines for policy, education and communication to help decrease the rate of paediatric medication errors for hospital systems, physicians, pharmacies, nurses, patients and families.
Tenfold or decimal point errors result in 10-, 100- or 1,000-fold errors in medication dosing and are a well-recognised risk to children. Lesar identified and quantified the characteristics of 10-fold medication dosage prescribing errors.(10) Two hundred 10-fold prescribing errors were detected between 1 July 2000 and 4 January 2002 in a 631-bed tertiary-care teaching hospital. Errors in paediatric patients were detected at a rate of 0.53 errors per 100 total admissions and 0.98 per 1,000 total patient days, compared with a rate of 0.52 per 100 total admissions and 0.77 per 1,000 total patient days in adults. The majority of errors in paediatric patients were associated with dose calculation, unit conversion, or both factors. They listed some recommended strategies for preventing 10-fold medication dose errors concerning policies and individual processes and broad healthcare organisation processes.
Infants should be weighed, verbal orders avoided, prescription legible without abbreviations or trailing zeros. Verbal ordering of drugs is a process susceptible to error. Therefore, if a phoned prescription is absolutely necessary, it has to be ordered to two different nurses. For any prescription, the indication, route and duration of treatment should be specified. Computerised physician order entry (CPOE) could help reduce these errors.(3) CPOE is somewhat more difficult to implement in the paediatric setting, where individualised dosage calculations, rapid fluctuations in weight and certain laboratory values, as well as changing physiological parameters over the paediatric age spectrum, require more sophisticated software. Although the computerisation of ordering is more challenging to develop, it may be especially beneficial in paediatrics.(9)
Drug preparation, purchase and dispensing
In paediatric units, prescribed drugs are either unlicensed (7–10%) or used off-label (18–64%), with a particularly high proportion of these drugs used in newborns and preterm infants.(11–13) Data on safety, therapeutic effect and dosage of medications used in children are often inadequate, and drug presentations are frequently ill-suited to the needs of paediatric patients.(14) The need to prepare dilutions, crush tablets or open capsules may increase the risk of error in drug administration.(15)
The production of commercial, clearly labelled formulations for children only,(14) the purchase of commercial products (approved or imported) rather than those prepared by pharmacies, and the avoidance of continual switching between generic and brand-name products in order to cut costs are sensible options.(3) General interventions, such as optimising pharmacy work environments, introducing computerised medication use systems and establishing a coordinated interdisciplinary reporting and quality control service, are worth pursuing(3) (see Table 1 for pharmacy recommendations(4)).
Unit-dose drug distribution and a limited floor stock medication have to be implemented to reduce the risk of error. Increased pharmacist presence in the clinical setting (for example, on work rounds or with physicians as they write orders) would likely have a greater impact on medication errors reduction, as they would incorporate real-time feedback and teaching into the order-writing process. Having pharmacists at the point of care may lead to more informed clinical decisions by physicians and a greater chance of intercepting erroneous orders before they are implemented.(9) The presence of pharmacists on the ward facilitates communication between clinical staff and the pharmacy. In addition, clinical pharmacists assist nurses with drug preparation and administration, and monitor drug preparation, storage and distribution systems.(16)
The pharmacist can also promote information technologies that help prevent errors, such as computerised medication administration records, robots dispensing medications and barcoding of medications.(9)
A drug administration error is defined as any discrepancy between printed or handwritten physicians’ orders and drug delivery to the patient. Administration errors are classified into 10 categories: timing errors (more than one hour delay), omission, unordered drug, wrong generic drug, dosage, formulation, route, deteriorated drug, technical error in preparation or administration, and supernumerary dose. The “five rights” warn the nurse about giving the right drug to the right patient at the right dose by the right route at the right time. Anderson et al noted that this does not take into account drug omissions or errors in rate and method of intravenous administration.(3) Bedside technology, which reminds nurses of when a dose is due and alerts them to check for the drug type using a barcode system, decreases administration errors, and especially time errors and administration to the wrong patient.
To help minimise preventable drug administration errors in infancy, parents should also be educated about their children’s medication. Latin abbreviations on pill bottles are unsatisfactory, and easy-to-understand information should be supplied. Therapy is more effective if children understand their treatment and actively participate in it. Illustrations can play an important role in stimulating children to learn, by making the leaflet more inviting and easier to read.(17) Improved communication between healthcare practitioners, especially physicians, pharmacists and nurses, has a significant impact on potential error prevention.(9) Specialty-based, anonymous or nonpunitive reporting by caregivers identifies a broad range of medication errors and promotes multidisciplinary collaborative learning.(17)
Errors are common and, without appropriate error prevention and detection processes, they present a significant risk to patients, particularly children. Implementation of a number of commonly recommended medication safety strategies is likely to reduce patient risk from errors.
Awareness of potential problems, re-education and adherence to medication protocols and hospital policies must be included in any system designed to reduce the number of errors in drug administration.(3)
Additional resources should be allocated to studies that aim to prevent and reduce medication errors. Hospitals, health systems, insurance companies and state and federal governments must invest in making the healthcare system safer, especially for children.
- Committee on Quality of Health Care in America, Institute of Medicine. To err is human: building a safer health system. Kohn LT, Corrigan J, Donaldson MS (Eds) Washington (DC): National Academy Press; 2000.
- Fontan JE, et al. Arch Pediatr 2004;11:1173-84.
- Anderson BJ, Ellis JF. Common errors of drug administration in infants: causes and avoidance. Paediatr Drugs 1999;1:93-107.
- Stucky ER. Prevention of medication errors in the pediatric inpatient setting. Pediatrics 2003;112:431-6.
- Poole RL, Benitz WE. Medication errors in children. JAMA 2001;286:915; author reply 915-6.
- Crowley E, et al. Medication errors in children: a descriptive summary of medication error reports submitted to the United States Pharmacopeia. Curr Ther Res 2001;26:627-40.
- ASHP. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm 1993;50:305-14.
- Crane VS. New perspectives on preventing medication errors and adverse drug events. Am J Health-Syst Pharm 2000;57:690-7.
- Fortescue EB, et al. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics 2003;111:722-9.
- Lesar TS. Tenfold medication dose prescribing errors. Ann Pharmacother 2002;36:1833-9.
- Avenel S, et al. Incidence des prescriptions hors autorisation de mise sur le marché en réanimation néonatale. Arch Pediatr 2000;7:1437.
- Turner S, et al. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998;316:343-5.
- Combeau D, et al. Analyse du livret thérapeutique d’un hôpital pédiatrique. J Pharm Clin 1999;18:5-10.
- Roberts R, et al. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA 2003;290:905-11.
- Koren G, Haslam RH. Pediatric medication errors: predicting and preventing tenfold disasters. J Clin Pharmacol 1994;34:1043-5.
- Kaushal R, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114-20.
- Prot S, et al. Antiretroviral instruction leaflets for children. Neonatal and Paediatric Pharmacists Group; 2003; Cardiff, UK.
- Suresh G, et al. Voluntary anonymous reporting of medical errors for neonatal intensive care. Pediatrics 2004;113:1609-18.
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Available at: www.jcajo.com (accessed October 2004).