Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 4 (Dec. 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Clear Liquids May Place Patients at Risk T hese reports to PA-PSRS highlight the hazards of using unlabeled or mislabeled clear liquids, such as Domeboro solution, in the provision of healthcare: and in preterm infants with underdeveloped renal function.4,5 Symptoms of aluminum toxicity include anemia, de- A patient noted that the solution in the oxy- mentia, bone disease, impaired neurologic develop- gen humidifier was Domeboro solution in- ment, encephalopathy in uremic patients, impaired stead of sterile water. The container was calcium metabolism that can lead to osteoporosis, labeled incorrectly. impaired kidney function, colic, gastrointestinal prob- lems, headaches, liver dysfunction, forgetfulness, A patient accidentally drank a large gulp of extreme nervousness, and memory loss.1,2,5-7 Domeboro solution. This was an external treatment for the patient’s foot. Patient Inadvertent ingestion/inhalation of Domeboro solution thought it was water. may increase the risk of aluminum toxicity, particularly in renal compromised patients. Treatment for toxicity Domeboro solution has been used for more than 50 may even require the use of chelating agents to rid years in health applications such as swimmers ear, the body of aluminum,8,9 which has no biologic role in athlete’s foot, foot odor, insect bites, poison ivy/ humans.6 sumac, eczema, skin rashes, herpetic lesions, and wound care.1 When Domeboro powder or tablets are Other Examples dissolved in water, the ingredients calcium acetate As suggested by the PA-PSRS reports above, both and aluminum sulfate produce a chemical reaction healthcare workers and patients can confuse Dome- that results in aluminum acetate.2 This acidic astrin- boro solution with other liquids. However, Domeboro gent solution reduces itching, and soothes and dries solution is just one example of many clear liquids that weeping wounds/lesions. Ordinarily, the solution is are used in healthcare, each of which carries the po- used as a soak with compresses or wet dressings or tential for confusion with another product. in a bath. Any unused portion can be stored for up to 7 days in a clean, capped/covered container, at room Sources outside of PSRS have reported the following temperature.1 scenarios in which liquids have been confused: It is at this point of storage that patient safety may be • A 100 ml bottle of sterile water and an identi- compromised. Because Domeboro solution is clear, it cal bottle containing Dakin’s solution were can easily be mistaken for other clear liquids, if ac- stored next to each other on a counter in a tions are not taken to reduce risks of accidental expo- patient’s room. Instead of using the sterile sure. Moreover, leaving unused Domeboro solution at water to dilute crushed medications for ad- the bedside for recurrent soaks/treatments may in- ministration to the patient, the Dakin’s solu- crease the risk of confusion with other liquids. tion was used. Fortunately, the mistake was identified prior to administration.10 Domeboro solution is not innocuous. It can cause irritation, redness, and itching upon skin exposure, • In an OR, it was discovered that housekeep- resulting in contacting the physician if irritation devel- ops. When in contact with eyes, Domeboro can cause eye irritation: tearing, stinging, reddening, requiring This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. flushing the eyes with water for 15 minutes and con- 4—Dec. 2005. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as tacting a physician. If ingested, it may produce nau- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). sea and vomiting, and contacting the regional poison control center or a physician immediately is advised. Copyright 2005 by the Patient Safety Authority. This publication may be re- If inhaled, the person should be provided with fresh printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their air.3 entirety and without alteration provided the source is clearly attributed. Additionally, there is the risk of aluminum toxicity, par- To see other articles or issues of the Advisory, visit our web site at ticularly in patients with chronic severe renal failure www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 4 (Dec. 2005) Clear Liquids May Place Patients at Risk (Continued) ing personnel obtained sterile sodium chlo- • Routine assessment7 by a multidisciplinary ride irrigation solution bottles, added a disin- team of facility departments to identify prac- fectant concentrate to the containers, and tices that increase the risk of inadvertent ad- placed a label provided by the manufacturer ministration of non-drug/healthcare sub- over the irrigation solution label. This practice stances. was discovered before any patients were af- fected.7 Education • Antibiotic solutions have inadvertently been • Heightening awareness of both clinical and reconstituted with 10% formalin solution and non-clinical staff concerning this issue (food administered, resulting in patient hospitaliza- services, housekeeping, central supply, laun- tion.7 Non-pharmacists working in pharmacy dry, etc) and explaining the dangers of adding used empty gallon containers of distilled wa- non-drug items into drug, irrigation, or IV con- ter to prepare the formalin solution. The for- tainers. malin containers were accidentally placed with distilled water containers. • Educating patients/family about the purpose of solutions left at bedside. • Almost 4,000 patients were exposed to surgi- Storage cal instruments that were inadvertently washed with used elevator hydraulic fluid in- • Not leaving the solution at bedside. stead of detergent. The used hydraulic fluid • Segregating patient treatment products from was placed in empty detergent barrels. These products used by patients for cleanliness/ barrels were mistakenly shipped to two hospi- hygiene purposes. tals that used the product as a detergent, as the barrel labels indicated.11 • Designating separate spaces for patient treat- ment products and items intended for inges- The common theme in these examples is that con- tion (e.g., not placing patient treatment prod- tainers of one liquid were re-used to hold another, ucts on the overbed table, where water and dramatically different, liquid. Applying a new label to food trays are placed). the container that accurately indicates the new prod- uct may not be sufficient to solve this problem. The • Considering storing unused solutions in a original label may be inadvertently left on the con- central storage area, away from the patient tainer, as well. Furthermore, the relabeling step could room. be forgotten, or the new label might not be placed • Installing shelves in patient rooms dedicated over the original label but on the opposite side of the solely to patient treatment products. container.7 The shape, color, or location of the con- tainer may lead a person to assume that the container holds the original product/liquid, overlooking a clear Labeling label to the contrary—an example of confirmation bias. • Standardizing labels for each solution that are unique in size, lettering, color and that are Risk Reduction Strategies different from other labels, such as for sterile The following risk reduction strategies may be appro- water. priately applied to any clear solution that is used in • Preparing unique labeling to clearly differenti- healthcare. ate between irrigation/wound care products Assessment from those that might be used orally or par- enterally. • When conducting the admission assessment and subsequent assessments, evaluating the Containers patient’s mental status and ability to under- stand the use of products left at the bedside. • Providing a visual cue by standardizing con- tainers for different types of solutions that are • If any assessment so indicates, removing a different shape/color/size.10 patient treatment products from the patient’s bedside/room. • Poking holes into empty plastic containers to prevent reuse.7 Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 4 (Dec. 2005) Clear Liquids May Place Patients at Risk (Continued) Preparation 5. Nursing uses a function in the pharmacy computer system to reorder Domeboro solu- • Having the Pharmacy Department mix stan- tion from Pharmacy. dard, extemporaneously prepared solutions used for healthcare,10 rather than mixing such No reports of incorrect use of Domeboro solution solutions on the patient care unit. have been reported by the facility to PA-PSRS since Discarding this process was implemented. • Discarding unused solutions immediately af- Notes ter a treatment is provided. 1. Domeboro FAQ’s. [web site]. [cited 2005 Sep 2]. Morristown (NJ): Bayer Health Care LLC. Available from Internet: http:// • Discarding any unlabeled containers or con- www.bayercare.com/htm/domefaq.htm. tainers with more than one label. 2. Domeboro astringent solution powder packets. [web site]. [cited 2005 Sep 2]. Morristown (NJ): Bayer Health Care LLC. Available Policies/Procedures from Internet: http://bayercare.com/htm/domepackets.htm. 3. Bayer Health Care LLC. Material Safety Data Sheet. Domeboro • Developing written protocols that support the ® powder packets [fact sheet]. Product code: 2324, 2322. 1997 Jul above risk reduction strategies and prohibit 31. container reuse for other solutions.7 4. Bishop NJ, Morley R, Day JP, et al. Aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. N Engl J Lesson Learned Med 1997;336:1557-61. In response to occurrences of incorrect use of Dome- 5. Klein GL. Nutritional aspects of aluminum toxicity. Nutr Res Rev 1990;3:117-41. boro solution, one Pennsylvania facility developed a 6. Aluminum. PDRhealth [online]. [cited 2005 Nov 7]. Available procedure for handling of Domeboro, which places from Internet:http://www.pdrhealth.cm/drug_info/nmdrugprofiles/ the responsibility on Pharmacy for mixing and labeling nutsupdrugs/alu_0020.shtml. all topical medicated solutions used for nursing care. 7. Institute for Safe Medication Practices. Involving non-clinical departments in patient safety discussions can reduce risk of seri- Elements of the policy include the following: ous errors. Medication Safety Alert! 2002 Sep 4;7(18):1. 8. Barnet B, Edwards MR. Toxicity, aluminum. Emedicine [online] 2002 Nov 26 [cited 2005 Nov 7]. Available from Internet:http:// 1. When the order for Domeboro is entered in www.emedicine.com/med/topic113.htm. the pharmacy computer system, an alert ap- 9. Domingo JL. The use of chelating agents in the treatment of pears to the pharmacist concerning how to aluminum overload. J toxicol Clin Toxicol 1989;27(6):355-67. enter the order for dispensing, specifying that 10. Institute for Safe Medication Practices. Separate innies and Domeboro tablets are not sent to the nursing outies. Medication Safety Alert! 2004;9(25):2-3. unit and that pharmacy prepares all Dome- 11. Thompson E. Duke health system under fire after hydraulic fluid used to clean instruments at two hospitals [press release online]. boro solutions for soaks or compresses. 2005 Jun 14 [cited 2005 Nov 4]. Available from Internet: http:// 2. Pharmacy mixes a standard solution of 1:20 abcnews.go.com/Health/wireStory?id=849639. dilution by adding four effervescent tablets to 1000 cc of water for irrigation. 3. Pharmacy labels the solution with: a) A computer-generated label from the pharmacy computer system b) For External Use Only c) Discard After: _________ [time speci- fied] d) Any other warning labels considered appropriate 4. Pharmacy enters the order for Domeboro so- lution with a route that ensures that it appears on the medication summary for nursing to verify, but it does not appear on the active worklist in the medication administration Kardex for charting. ©2005 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 4 (Dec. 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. Page 4 ©2005 Pennsylvania Patient Safety Authority