Patient safety should be at the forefront of all care and decisions. Whether through the oath of Hippocrates or the golden rule, or most lessons taught by your mother – “first, do no harm.” When we look at the history of medicine in general and particularly of neonatal care, this has certainly not always been the case.
Harm has never been the intention but it requires great care to ensure harm does not come to the tiniest and most fragile patients. There have been some improvements in medication safety over the past year but many are still in process, particularly in the neonatal population. Many measures recommended to increase safety don’t work or don’t work the same in the NICU. For instance, last time you received a medication, or got blood drawn for labs or any other medical procedure, you were asked your name and possibly date of birth. Of course, infants’ cannot participate in this identification or question when or why a medication is being given. While, in some hospitals parents are encouraged to do this, they often are not present 24/7 and may not be as informed about the infant’s medications. At the same time, it is well documented that the risk of medication errors is higher in intensive care settings and particularly in the neonatal unit at three times greater than in an adult intensive care unit.1 When considering all patients in intensive care units, they are generally less likely to be able to participate in their own safety, more intravenous medications are given and these have been shown to be more prone to error, and medications requiring dilution are certainly more common in neonates.2
There are several difficulties in the study of medication errors to determine where specific improvements may be helpful. The definition of medication errors vary from one report to another. A medication error is defined by the National Coordinating Council for Medication Error Reporting and Prevention as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer” (www.nccmerp.org). However, many practitioners have defined medication errors in a more focused context for purposes of quality improvement. Stavroudis et al reported on an extensive analysis of medication errors in the NICU and found that 24% were classified as near misses, where no actual error occurred but one was prevented, 55% were errors that occurred but did not reach the patient, while 12% were errors that reached the patient and required monitoring to confirm that there was no harm.3 Fortunately, only 4% of medication errors resulted in serious harm and 0.4% in death. Suresh et al found that about 8% of neonatal medication errors had a harmful or serious outcome.4 Because few of the medication errors actually result in harm, which is commonly recognized amongst clinician’s, certain medication errors may not be taken with such seriousness as others. However, there is much to be learned from a near miss in many cases. This may highlight a problem in the system that, with the next error, could result in patient harm or worse, death.
Most reports of the incidence of medication errors comes from anonymous reporting of the error. It is, however, common knowledge that this results in under-reporting of medication errors. In a typically busy shift in the NICU, if the medication error is considered to be “minor” by the person discovering it or is caught and corrected prior to reaching the patient, the added few minutes it may take to report the error may be time not easily justified. Therefore, we have to consider that the reported errors are simply the tip of the iceberg and representative of overall processes in need of improvement. Various studies have determined the area of highest incidence and varies from dose errors to dispensing errors to IV rate errors.2 Larsen et al only addressed one category of error, that related to continuous infusion drips.5 Measures like standard concentrations and smart pumps have been effective in decreasing the incidence of errors in this category.5 Dose errors are the most common category of error and have been decreased through the use of computerized physician order entry but is more complex in the neonatal population since doses are almost always calculated based on body weight and sometimes change in various gestational age neonates or as maturation occurs.1 Bar coding of medications for bedside validation has been discussed for some time now and has been implemented in some settings, including in the NICU. However, in the adult population, the medication itself usually comes from the manufacturer with the bar code which can then be scanned with the patient identification to verify the correct medication. However, IV medications as often used in the NICU are dosed according to weight and therefore, need to be re-packaged prior to appearing at the bedside. This requires the pharmacy to place a patient bar code on the syringe/package for final validation, another step in the process and potential for error. Sauberan et al provides a case study in which an incorrect medication was dispensed for a patient.6 The bedside nurse scanned the bar code on the outside of the plastic baggy in which the syringe of medication was placed (instead of the label in the syringe itself). This provided a match but fortunately, the nurse visually verified the syringe label and determined it was not correct. In another case, the bar codes did not match, a visual check was done with another nurse per the unit policy and both agreed that, in spite of the bar code not matching, it was the correct medication, which it was not! The incorrect neuromuscular blocker was given but fortunately, the patient had no adverse outcome.
There are several inherent challenges in medication safety for neonates. One review article from the Netherlands sites that 45-60% of medications used in the NICU are used off-label in the UK, Australia and Israel and 10-16% are unlicensed.2 The off-label use is estimated at 65% in the U.S. Ongoing and re-occurring drug shortages compound this problem. Just when you get used to seeing a drug in a familiar concentration and container, it is changed because of a shortage or, if your pharmacy is like most hospital pharmacies, the buyers get medications from various sources, depending on price. Names and containers may be different. Several years ago, we were asked to only use generic names of medications to prevent issues with different brand names of the same drug. However, if it is a drug we have commonly referred to by the trade name, you may not be very familiar with generic names. As we use the generic names more and more, hopefully this familiarity will increase.
The importance of combating medication errors, particularly in this high risk population is obvious. These infants are at higher risk of a medication error which is more likely to have a detrimental effect. So, what is your unit doing to prevent medication errors, and what are you doing personally? Hopefully, at the very least, you are reporting near-misses and risky situations that you may discover.
1. Sorrentino E & Alegiani C. Medication errors in the neonate. The Journal of maternal-Fetal and Neonatal Medicine. 2012;25(54):91-93.
2. Chedoe I, Molendijk HA, Dittrich TAM, et al. Incidence and nature of medication errors in the neonatal intensive care unit with strategies to improve safety: A review of the current literature. Drug Safety. 2007; 30(6):503-513.
3. Stavroudis TA, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR. NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. J Perinatol 2010;30:459–468.
4. Suresh G, Horbar JD, Plsek P, Gray J, Edwards WH, Shiono PH, Ursprung R, et al. Voluntary anonymous reporting of medical errors for neonatal intensive care. Pediatrics 2004;113:1609–1618.
5. Larsen GY, Parker HB, Cash J, et al. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. Pediatrics 2005 Jul;116 (1): e21-5
6. Sauberan JB, Dean LM, Fiedelak J, et al. Origins of and solutions for neonatal medication-dispensing errors. American Journal of Health-System Pharmacists. 2010; 67:49-57.
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