WHO Collaborating Centre for Patient Safety Solutions Aide Memoire

Control of Concentrated Electrolyte Solutions

Patient Safety Solutions

| volume 1, solution 5 | May 2007

▶ Statement of Problem and Impact: ▶ Associated Issues:

Concentrated potassium chloride has been identified as a high- Removal of concentrated electrolyte solutions, specifically po-
risk medication by organizations in Australia, Canada, and the tassium chloride, from patient care units has had a marked posi-
United Kingdom of Great Britain and Northern Ireland (UK) tive impact on the reduction of death and disabling injury associ-
(1-8). In the United States of America, ten patient deaths from ated with these agents. Several forcing functions are inherently
misadministration of concentrated potassium chloride (KCl) so- implemented when these agents are removed from patient care
lution were reported to the Joint Commission in just the first two units; namely, the drug must be prescribed and ordered; it must
years of its sentinel event reporting programme: 1996–1997 (1). be properly prepared (e.g. diluted), packaged, and labeled; and
In Canada, 23 incidents involving KCl mis-administration oc- it must be administered with appropriate care and expertise. By
curred between 1993 and 1996 (2). There are also reports of not having these products on the patient care unit, they cannot
accidental death from the inadvertent administration of concen- simply be reached for, drawn up, and injected.
trated saline solution (3). While some might suggest that such procedures impede rap-
While all drugs, biologics, vaccines, and contrast media have a id-action to meet patient care needs in case of emergency, it
defined risk profile, concentrated electrolyte solutions for injec- is important to know that plans and procedures for such even-
tion are especially dangerous. Reports of death and serious inju- tualities can be put in place to make concentrated electrolytes
ry/disability related to the inappropriate administration of these safely available in such cases. Collaborative efforts in this regard
drugs have been continuous and dramatic. Most of the time, it between physicians, nurses, and pharmacists are recommended.
is not clinically possible to reverse the effects of concentrated Institutional and cultural change may be required to ensure that
electrolytes when not administered properly (e.g. not properly fail-safe systems are in place in order to avoid death or disabling
diluted, confused with another drug, etc.), and hence, patient injury associated with the inappropriate use of concentrated
death is usually the observed outcome. In short, these agents electrolyte solutions.
are deadly when not prepared and administered properly. Although concentrated KCl is the most common medication
It is especially critical that the availability, access, prescribing, implicated in electrolyte administration errors, potassium phos-
ordering, preparation, distribution, labeling, verification, ad- phate concentrate and hypertonic (>0.9%) saline also have lethal
ministration, and monitoring of these agents be planned in such consequences if improperly administered. Until recent concerns
a way that possible adverse events can be avoided, and, hope- prompted revised practices, it was common to find concentrated
fully, be eliminated. Standardizing the dosing, units of measure, electrolyte solutions in the unit/clinic stock located in close prox-
and terminology are critical elements of safe use of concen- imity to other less hazardous, similarly packaged and labeled so-
trated electrolyte solutions. Moreover, mix-ups of specific con- lutions. This situation, coupled with the practice of having ward
centrated electrolyte solutions must be avoided (e.g. confusing or clinic staff prepare the intravenous solution, increased the
sodium chloride with potassium chloride). These efforts require possibility of inadvertent administration of concentrated elec-
special attention, appropriate expertise, inter- professional col- trolytes, leading to fatalities in some cases. Fortunately,
laboration, processes of verification, and several forcing func- such catastrophic errors can be eliminated by adopting
tions that would ensure safe use. simple precautionary measures.
▶ Suggested Actions: ▶ Looking Forward:
The following strategies should be considered by WHO Member states recommend that:
Member States.
1. Concentrated electrolyte solutions be purchased by
1. Ensure that health-care organizations have systems the health-care organization only in standardized and
and processes in place wherein: limited drug concentrations.
a. The promotion of safe practices with potassium 2. The health-care organization purchases and uses only
chloride and other concentrated electrolyte solu- premixed parenteral solutions.
tions is a priority and where effective organization
risk assessments address these solutions. 3. The organization petitions the drug manufacturing in-
dustry to utilize HIGH RISK WARNING labels on all
b. Potassium chloride is treated as a controlled sub-
concentrated electrolyte solutions.
stance, including requirements that restrict or-
dering and establish storage and documentation 4. Regulatory agencies and drug manufacturers should
requirements. be engaged to improve the safety of manufacturing
c. Ideally, removal of concentrated electrolyte solu- these types of concentrated electrolyte solutions.
tions from all nursing units is accomplished, and
these solutions are only stored in specialized ▶ Strength of Evidence:
pharmacy preparation areas or in a locked area. ▶ Expert consensus.
Potassium vials, if stored in a specialized patient
care area, must be labeled individually with a vis- ▶ Applicability:
ible florescent warning label that states MUST BE
▶ Hospitals, ambulatory care facilities, ambulatory surgical
DILUTED.
centers, dialysis centers, and any other facilities that use
d. When a pharmacist or pharmacy preparation area and administer concentrated electrolyte solutions.
is not available to store and prepare these solutions,
only a trained and qualified individual (physician, ▶ Opportunities for Patient and
nurse, pharmacy technician) prepares the solutions.
Family Involvement:
e. After solution preparation, there is independent
▶ Ask what medications are being given and why they are
verification of the electrolyte solution by a second
being given.
trained and qualified individual. The organization
should establish a checklist that is used for the in- ▶ Learn to recognize that potassium chloride solutions and
dependent verification. Checklist items should in- other high concentration electrolyte solutions may create
clude concentration calculations, infusion pump dangerous situations. Ask for clarification regarding their
rates, and correct line attachments. need and route of administration if they are to be given.
f. The prepared solution is labeled with a HIGH RISK ▶ Ensure positive identification before receiving
WARNING label prior to administration. medication.
g. An infusion pump is used to administer concentrat-
ed solutions. If an infusion pump is not available, ▶ Potential Barriers:
other infusion devices, such as buretrol administra- ▶ Some organizations have limited pharmacy services.
tion tubing (tubing with an inline receptacle that
limits the volume that will flow into the patient), ▶ Perceived need to have electrolyte concentrates im-
may be considered for use, but infusions of con- mediately available—especially for urgent or emergent
centrated solutions must be monitored frequently. situations.

h. An organizational safety infrastructure supports ▶ Economics (current low cost of pharmaceutical produc-
the training of qualified individuals through tion of concentrated products—having pre-mixed KCL
policies, procedures, best practices, and annual bags will increase cost).
recertification.
▶ Lack of technology required for safe administration
i. Physician orders include the rates of infusion for (e.g. infusion devices).
these solutions.
▶ Lack of staff awareness of the risk.
▶ Insufficient generally accepted research, data, and 7. Medication Safety Recommendations from the Institute of
economic rationale regarding cost-benefit analysis Medicine’s To Err Is Human: Building a Safer Health System:
or return on investment (ROI) for implementing these [Link]
recommendations. 8. Medication Safety Taskforce of the Australian Council
for Safety and Quality in Healthcare. Intravenous po-
▶ Risks for Unintended tassium chloride can be fatal of given inappropriately.
October 2003.
Consequences: 9. NPSA Alert on potassium chloride concentrate solutions:
▶ Unacceptable delays in obtaining needed electrolyte [Link]
solutions from the pharmacy. [Link]
10. National Quality Forum Never Events: [Link]
▶ Gradual stockpiling of unused solutions on the nursing
[Link]/pdf/news/[Link]
units for future use.
11. Stevenson T. The National Patient Safety Agency. Archives of
Disease in Childhood, 90: 2005.
▶ References: 12. Tisdale JE, Miller DA. Drug-induced diseases: prevention,
1. Medication error prevention—potassium chloride. Sentinel Event
detection and management. Bethesda, MD, American
Alert,Issue1,[Link].[Link]
Society of Health-System Pharmacists, 2005
[Link]/SentinelEvents/SentinelEventAlert/sea_1.htm.
13. Wright v. Abbott Lab, Inc. Nurse’s act intervenes to preclude
2. Alert on potassium chloride solutions. National Patient Safety
manufacturer liability. 10th Circuit. 6 August 2001.
Agency (United Kingdom), 23 July 2002.
14. United States Department of Defense. Patient Safety
3. DiPaulo M et al. Accidental death due to erroneous intravenous in-
Program, Patient Safety Center Alert. Concentrated
fusion of hypertonic saline solution for hemodialysis. International
electrolyte solutions and high dose epinephrine.
Journal of Artificial Organs, 2004, 27(9):810–812.
21 November 2003.
4. High-alert medications and patient safety. Sentinel Event Alert,
Issue 11, 19 November 1999. Joint Commission. [Link]
[Link]/SentinelEvents/SentinelEventAlert/sea_11.htm.
5. Intravenous potassium chloride can be fatal if given inappropri-
ately. Safety and Quality Council (Australia) Medication Alert,
October 2003.
6. Update on the implementation of recommended safety controls
for potassium chloride in the NHS. National Patient Safety Agency
(United Kingdom), 6 November 2003.
7. More on potassium chloride. ISMP Canada Safety Bulletin, 3(11),
November 2003.
8. Concentrated potassium chloride: a recurring danger. ISMP © World Health Organization 2007
Canada Safety Bulletin, 4(3), March 2004. All rights reserved. Publications of the World Health Organization can be ob-
tained from WHO Press, World Health Organization, 20 Avenue Appia, 1211
Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail:

▶ Other Selected Resources: bookorders@[Link] ). Requests for permission to reproduce or translate WHO
publications – whether for sale or for noncommercial distribution – should be
1. American Iatrogenic Association. Fatal errors: hospitals addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail:
permissions@[Link] ).
learn lessons the hard way, 1997. The designations employed and the presentation of the material in this publica-
2. Brown TR. Institutional pharmacy practice, 4th ed. Bethesda, tion do not imply the expression of any opinion whatsoever on the part of the
World Health Organization concerning the legal status of any country, territory,
MD, American Society of Health-System Pharmacists, 2006 city or area or of its authorities, or concerning the delimitation of its frontiers or
boundaries. Dotted lines on maps represent approximate border lines for which
3. External Patient Safety Review. Calgary Health Region. June there may not yet be full agreement.
2004. The mention of specific companies or of certain manufacturers’ products does not
imply that they are endorsed or recommended by the World Health Organization
4. ISMP Canada potassium chloride safety recommendations in preference to others of a similar nature that are not mentioned. Errors and
omissions excepted, the names of proprietary products are distinguished by initial
summary: [Link] capital letters.
[Link] All reasonable precautions have been taken by the World Health Organization
to verify the information contained in this publication. However, the published
5. Joint Commission Sentinel Event Alert, High-Alert Medications material is being distributed without warranty of any kind, either expressed or
andPatientSafety,November19,1999,Issue11:[Link] implied. The responsibility for the interpretation and use of the material lies with
the reader. In no event shall the World Health Organization be liable for damages
[Link]/SentinelEvents/SentinelEventAlert/sea_11.htm arising from its use.
6. Manasse HR, Thompson KK. Medication safety: a guide for This publication contains the collective views of the WHO Collaborating Centre
for Patient Safety Solutions and its International Steering Committee
health care facilities. Bethesda, MD, American Society of and does not necessarily represent the decisions or the stated policy
Health-System Pharmacists, 2005 of the World Health Organization.