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Medication safety: prevention of error with high alert medications


Organisational leadership and change are some of the key elements contributing towards better patient safety not only from medication errors but from all adverse events in healthcare

Lecturer in Nursing
Lecturer in Nursing/
Research Fellow
Sandra Fleming
Lecturer in Nursing

Medication management has been repeatedly identified as an area of healthcare practice where the incidence of errors and resultant adverse events, ranging from short term effects to death, is high.[1,2] Accordingly, medication errors that cause death or serious disability including the wrong drug, wrong dose, wrong patient, wrong preparation or wrong route of administration, or product or device adverse events pertaining to medication management are described as “Serious Reportable Events” by the National Quality Forum (2008).[3]The literature also identifies that medication errors are not caused by the individual alone but are also caused by wider organisational issues.[4]

Medication errors in the delivery of controlled substances, as one of five groups of high-alert medications, are a particular concern for risk management in healthcare. The ramifications of mistakes associated with such substances may have catastrophic effects for patients. Narcotics, as one group of controlled substances, are being used increasingly in all healthcare settings for a variety of pain syndromes. This provides challenges for healthcare professionals with medication safety for this group of drugs, ranging from safe administration to managing the pharmacogenetics of such medications. Opioid analgesics are one of the therapeutic categories most closely associated with harmful or fatal errors in intravenous (IV) medication administration (ASHP, 2008).[5]

Research findings have emphasised specific issues in the use of controlled drugs. Hankin et al. (2007) investigated the medical device events using the established Manufacturer and User Facility Device Experience (MAUDE) data base in order to characterise the nature and type of adverse events associated with Intravenous Patient Controlled Analgesia (PCA) pumps in the USA over a 2 year period.[6] They found a total of 2009 largely preventable events over a 2 year period Jan 2002-Dec 2003, further categorising them as device safety (1590, 79%); operator errors (131, 6.5%); adverse reaction to opioids (25,1.2%); patient related events (12, 0.6%) and indeterminate causes (235, 11.7%). They concluded that device malfunction is a major attributable cause of problems with PCAs. However the consequences of medical device events associated with operator error were most serious as they often resulted in drug overdosage with 6 deaths, 2 respiratory arrests and 50 episodes of respiratory depression necessitating treatment with Naxloxone recorded in this category over the period of the study. The primary cause (80%) of operator errors occurred as a result of mistakes in programming. In particular they recommended that strategies be adopted to standardise devices so that there is consistency as to device default settings across manufacturer, models and healthcare organisations. Parashuram et al. (2007) conducted a simulated observational study of 118 healthcare professionals (nurses, doctors and pharmacy staff) as they prepared 464 morphine infusions.[7] The study found drug volume calculation errors in 58 (4.9% 95% CI, 3.7-6.2%) and that one third (161, 34.7% 95% CI 30.4-39%) of infusions prepared were inaccurate resulting in drug concentration outside the anticipated pharmaceutical standard. The attributed causes were multifactorial but in particular increased years of experience, fatigue, and recent infusion experience in practice were found to be associated with errors in accuracy. The study also found a greater propensity for larger magnitude errors associated with fatigue and in the preparation of small volumes usually for children or infants. Researchers recommended the production of paediatric strength preparation and strategies to reduce healthcare professional fatigue in the workplace to reduce the rate of errors. The findings of both of these studies emphasise the impact of medication errors with controlled drugs.

Managing medication errors and adverse events
A variety of strategies have been utilised to reduce medication errors and the associated adverse events in hospitalised patients. These include electronic systems for reporting adverse events, root cause analysis, staff training and development, computerised prescriber order entry, automated dispensing machines and bar-code point-of-care technology. However, it has also been identified that such strategies may or may not have achieved the desired outcomes in terms of detecting adverse events. An online adverse event reporting system identified a pattern of unrecognised, widespread, low-frequency adverse event with patient controlled analgesia (PCA).[8] The adverse events related to issues including PCA programming in this report resulted in over and under dosing, equipment problems and ordering problems. Identification of the reasons for adverse events assisted with implementing action to reduce failures including standardising dosage prescribing protocols and order sets and implementing a double check policy for registered nurses (RN’s). Rickrode et al. (2007) emphasised how a hospital error reporting system failed to identify events within the pharmacy department.[9] A paper based internal error-reporting system was introduced. Over a nine month evaluation period, 1385 total pharmacy events were documented using the internal system, whereas 203 pharmacy reporting errors were reported using the hospital system. Of the 1385 events, 204 involved high-alert medications. The authors conclude that the internal error-reporting system increased staff reporting, and identified errors within the medication distribution process that might not have be identified through the hospital system. Therefore the systems that have been developed to manage medication errors may or may not achieve what they have been designed and implemented for. This emphasises the need to evaluate the efficacy of the systems that are utilised to address patient safety.

How can we improve medication safety?
The National Quality Forum (2009) identifies medication management as one of seven functional categories where patient safety can be improved.[10] Pivotal in their recommendations is creating and sustaining a culture of safety. Thirty-four areas of safe practice are delineated. Many of these areas impact on medication safety, for example identification and mitigation of risks and hazards. Areas that specifically relate to medication management are medication reconciliation, pharmacist leadership structures and systems and safe anti-coagulant therapy. They advocate that “Pharmacy leaders should have an active role in the administration leadership team that reflects their authority and accountability for medication management systems performance across the organisation” (National Quality Forum, 2009: viii).


A number of strategic approaches can be implemented to prevent medication errors and improve the quality and safety of medication-use systems within healthcare. Examples of these are the establishment of institutional interdisciplinary medication safety mittees and interprofessional education and training as advocated by the Summit on Preventing Patient Harm and Death from IV Medication Errors (2008) and frameworks such as the High-Performance Pharmacy Practice Framework (HPP).[11] However, whilst it is generally acknowledged that interdisciplinary collaboration and interprofessional education and strategic frameworks are components in total quality care and lead to the provision of better care the literature also identifies organisational cultural issues as one of the barriers in relation to implementing safe medication practices. It identifies that improvements or reduction in medication errors are attainable through establishing a culture of trust, honesty and open interdisciplinary communication. Whilst cultivating such a culture is not without its challenges to organisational and clinical leaders its development is only possible if it is inculcated and supported by organisational and clinical leadership,[11] and human resource management. In some cases this approach may necessitate a paradigm shift within organisational/ departmental design.

The issue of organisational leadership and governance in patient safety is paramount. Botwinick et al (2006) have delineated leadership steps to achieve patient safety and high reliability in organisations.[12]

Sandrick (2007) highlights the role that leaders and boards can play in achieving quality and safety in their organisations.[13] The hospital she cites as an example, addresses quality and safety at board level, and executive bonuses relate to quality and safety achievements, not to financial ones. The leadership steps in Table 1 delineate how organisational leadership and change can address the issues of patient safety, thereby facilitating the implementation of organisational wide initiatives that impact on each aspect of care management, to reduce patient harm, not only from medication errors with high-alert medications including controlled drugs, but from all adverse events in healthcare.

1. Brady A-M, Redmond R, et al. Journal of Nursing Management 2009a. 17:155–164.
2. Brady A-M, Malone A-M et al. Journal of Nursing Management 2009b. 17:679–697.
3. National Quality Forum. Serious Reportable Events (SRE’s) Transparency & Accountability are Critical to Reducing Medical
Errors Fact Sheet. 2008. Available at: http://www. 2008/10/Serious_ Reportable_Events. aspx. Last accessed on 3 December 2009.
4. Anderson JG, Ramanujam R, et al. International
Journal of Medical Informatics 2006.75:809–817.
5. American Journal Health-System Pharmacists 2008 65:2367–2379.
6. Hankin CS, Schein J, et al. American Journal of Health System Pharmacy 2007.64:1492–1498.
7. Parshuram CS, To T, et al. CMAJ 2007 178:42–48.
8. Weir VL. Nursing Management 2005 36(9):24–30.
9. Rickrode GA, Williams, et al. Am J Health-Syst Pharm 2007 64:1197–1202.
10. National Quality Forum. Safe Practices for Better Healthcare-2009 Update A Consensus Report Executive Summary. 2009 Available at: Safe_Practices_for_Better_hcare%e2%80%932009_ Update.aspx. Last accessed on 3 December 2009.
11. Vermeulen LC, Rough SS, et al. American Society of Health-System Pharmacists 2007. 64:1699–1710.
Botwinick L, Bisognano M et al. IHI Innovation Series white paper Cambridge, MA: Institute for Healthcare Improvement. 2006. (Available on
13. Sandrick K. Quality Exponential: The Journey from 100,000 to 5 Million Lives. Trustee. 2007. 60(10):14–16,17.

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