David R Upton
Medication Safety Pharmacist
ALARIS Medical Systems UK Limited
Adverse drug events (ADEs) continue to be associated with considerable human and financial costs. Preventable ADEs are estimated to cost $2 billion per year in the USA alone, a figure that does not include malpractice claims.(1) Intravenous (IV) administration of drugs has been identified as the route most commonly involved with errors.(2) This is a worrying figure, as up to 80% of patients admitted to hospital receive IV therapy.(3) In addition, the potential for litigation is high. In the UK, by the end of 2000 the medical negligence bill totalled £400 million, with potential clinical negligence claims rising to almost £4 billion.(4) Unsurprisingly, drug error reduction is a government health target in both the UK(5) and the USA.(6)
The incidence of ADEs
A recent study conducted in Germany and the UK investigated the incidence and severity of IV drug preparation and administration errors in three different pharmacy services.(7) Administration error rates varied between 27 and 49%, but the majority of errors were likely to be of “moderate” to “severe” outcome. The authors recommended changes in practice to make IV therapy safer for patients.
Another UK-based study monitored IV drug preparation and administration in a university teaching hospital and in a nonteaching general hospital.(8) Ten wards were selected with high, medium and low usage of IV drugs. For the 1,042 observations carried out during the investigation, the researcher had to intervene 12 times to prevent an error reaching the patient. Of 430 IV drug doses, 49% contained one or more errors, with administration errors accounting for 36% of these. Analysis of the data indicated that the two weak points in the process were drugs that require multiple-step preparation and administration of doses as a bolus. Measures to ensure the correct administration of bolus doses and reduce mistakes in multiple-step drug preparations will therefore have the greatest effect on error rates.(8) The authors maintain that further staff training could improve awareness, but also that technical solutions could be employed, such as devices that could prevent the fast administration of bolus doses.
The importance of reporting incidents in order to learn from past adverse incidents was stressed by the UK Department of Health.(9) Many hospitals, however, rely on staff to report potential and actual adverse events, which may not always be the best option. Staff may be fearful of being held accountable and potentially having to face disciplinary action, despite efforts across the NHS to establish a “fair blame” culture.
One way of bypassing this problem is to use technology that not only helps prevent ADEs but also automatically collects data on the occurrence of potential errors. As most adverse incidents are caused by a variety of factors, however, this is not always straightforward. Additionally, there is still relatively little in the way of automatic safeguards at the point of care, despite the fact that mistakes that occur during drug administration are less likely to be picked up and corrected than those occurring earlier in the process. One study in the USA showed that administration errors account for 38% of medication errors; of these, only 2% are intercepted.(10)
The design of some infusion pumps, for example, allows for “single button press” mistakes. Heparin for infusion is typically dispensed from the pharmacy in 500ml bags containing 25,000 units, an amount sufficient to provide a therapeutic dose for 24h. In one case, the nurse programmed the “volume to be infused” as 500ml and then accidentally also programmed the rate as 500ml/h, rather than the ordered 14ml/h. The device infused for 1h as programmed, resulting in the patient receiving
1.5 times the 24-h dose in a 1-h time period.
Smart device technology
The Emergency Care Research Institute (ECRI) recently evaluated general-purpose infusion pumps,(11) indicating that the factors that distinguish one pump from another are not performance issues but safety considerations. Many of the older models do not offer the same level of safeguard as newer models. Thus, only pumps that featured what the ECRI termed a “dose error reduction system” and free-flow protection were classed as “Preferred”, and those that lacked one or both features were classed as “Not Recommended” or “Unacceptable”.
IV technology with a dose error reduction system has now been implemented on a hospital-wide basis by Clarian Health Partners, a 1,400-bed healthcare system in Indianapolis (USA).(12) After assembling a “wish-list” of essential features and assessing several systems from a number of manufacturers, Clarian purchased a system from ALARIS Medical Systems that features Guardrails(®) Safety Software. This software can help prevent IV medication errors by incorporating dosing limits established by the hospital.(13)
Guardrails Safety Software provides a “test of reasonableness” at the point of care, before medication delivery and customisation, to overcome the “one size fits all” approach. The hospital can configure the software to accommodate up to 10 unique sets of operating parameters, programming options and drug libraries. Each profile is developed to meet the infusion requirements for a particular patient type or patient care area. Using the software, the hospital can also predetermine drug libraries for the patient care area selected. For each patient area, the drug library contains institution-defined medication lists and standard concentrations, preset dosing units and minimum and maximum dose limits. These limits are formatted as “hard” (cannot be overridden) and “soft” (can be overridden at the clinician’s discretion). If an alert is overridden, the system displays a constant reminder that drugs are being infused at doses outside the institution’s recommended limits.(13) The Guardrails CQI Software also records any near-misses such as programming errors; these data can help to identify ways of improving the safety of IV medication administration. The value of this technology was illustrated using a Harm Assessment Index, which indicated that, in a 350-bed hospital, Guardrails Safety Software averted an IV medication error that may have been life-threatening every 2.6 days.(14) At one of the Clarian hospitals a potentially serious error was averted on the first day of system use, and initial data suggest that use of the system will result in 4,000 reprogramming events annually due to Guardrails Alerts.(12)
Although some potential users may express concerns over the possible cost issues of implementing new systems with safeguards such as Guardrails Safety Software, the initial costs are not important when measured against potential savings if ADEs are averted. The ECRI believes that the higher costs of pumps that incorporate dose error reduction systems are likely to be offset by the long-term savings associated with their use and strongly encourages hospitals to adopt the technology.(11) If this technology is combined with training and protocols to produce efficient and safe working methods, hospitals will be better equipped to tackle the problem of ADEs.
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- Bates DW, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997;277:307-11.
- Bates DW, et al. Consensus Development Conference Statement on the safety of intravenous drug delivery systems: balancing safety and cost. Hosp Pharm 2000;35:150-5.
- Workman B. Peripheral intravenous therapy management. Nurs Stand 1999;14:53-60.
- National Audit Office. Handling claims for clinical negligence. May 2001.
- Department of Health. Building a safer NHS for patients. London: Stationery Office; 2001.
- Kohn LT, et al, editors. To err is human. Building a safer health system. Committee on Quality of Health Care in America. Institute of Medicine. Washington (DC): National Academic Press; 2000.
- Wirtz V, Taxis K, Barber ND. An observational study of intravenous medication errors in the United Kingdom and in Germany. Pharm World Sci 2003;25:104-11.
- Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. BMJ 2003;326:684-8.
- Department of Health. An organisation with a memory. Report of an Expert Group on Learning from Adverse Events in the NHS. Chaired by the Chief Medical Officer. London: The Stationery Office, 2000.
- Leape LL, et al. Systems analysis of adverse drug events. JAMA 1995;274:35-43.
- General-purpose infusion pumps. ECRI. Health Devices 2002;31:353-87. 12. Eskew JA, et al. Using innovative technologies to set new safety standards for the infusion of intravenous medications. Hosp Pharm 2002;37:1179-89.
- Eskew JA, et al. Using innovative technologies to set new safety standards fpr the infusion of intravenous medications. Hosp Pharm 2002;37:1179-89.
- Vanderveen TW. The Guardrails™ Safety Software– an innovative safety solution to address infusion medication errors. ALARIS Medical Systems; 2002.
- Crass R. Improving intravenous (IV) medication safety at the point of care: retrospective analysis of pooled data using an innovative IV harm assessment index. ALARIS Medical Systems; 2003.