Abstract
These medication errors have occurred in health care facilities at least once. They will happen again—perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them at your inservice training programs.
Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below.
Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at
Error Prevention Strategies for Strong Iodine Solution
Our sister organization in Canada, ISMP Canada, recently published a safety bulletin on oral dosing errors associated with Lugol's solution (potassium iodide and iodine), also referred to as strong iodine solution. 1 The organization had recently received 3 reports involving incorrect oral dosing of Lugol's solution. A quick search of the Quantros MedMarx and ISMP National Medication Errors Reporting Program (ISMP MERP) databases showed that a dozen oral dosing errors have been reported in the United States in the past 6 years.
Most dosing errors have involved prescribing, dispensing, or administering milliliter doses of Lugol's solution when just a few drops were indicated. One contributing factor may be that oral liquid medications for adults and young children are typically dosed in milliliters, while drops are typically reserved for infants. Thus, an adult dose expressed in drops is uncommon. Another factor is that the product is used relatively infrequently and may be prescribed during an emergency. Thus, unfamiliarity with the drug has been linked to many dosing errors.
Lugol's solution contains 100 mg/mL of potassium iodide and 50 mg/mL of iodine. Given orally, the product (a) reduces thyroid vascularity (used to reduce blood loss during thyroid surgery); (b) temporarily inhibits thyroid hormone synthesis and secretion (used in treating thyrotoxic crisis and in reducing the risk of thyroid storm post thyroid surgery); and (c) blocks thyroidal uptake of radioactive isotopes, thereby reducing the risk of thyroid cancer (used in a radiation emergency or therapeutic/diagnostic exposure of radioactive iodine). Lugol's solution is also approved for use as a topical antiseptic.
Of the 3 errors reported to ISMP Canada, one was described in detail in the bulletin. 1 This event involved an adult patient with Grave's disease who was admitted to the hospital with thyroid storm. The physician prescribed 4 drops of Lugol's solution to be given orally every 8 hours. The intended dose of 4 drops would require approximately 0.2 mL of Lugol's solution. But this patient was accidentally given an entire 100 mL container of the solution in a single dose, which amounted to a total of 5 g of free iodine. Acute toxicity of Lugol's solution is related to its iodine content, 1 although the high potassium concentration can cause extreme irritation of the mucosal membranes. 2 Patients with an iodine overdose can experience metabolic acidosis, renal failure, hypotension, circulatory collapse, and death. This patient received more than a potentially lethal adult dose of free iodine (2 to 4 g). 1 Although his condition deteriorated and required intervention to manage the overdose, the patient recovered.
In the Quantros MedMarx database, one error involved a correct prescription for 5 drops of Lugol's solution per dose, but the pharmacy dispensed the product with directions to administer 5 mL of the solution for each dose. In 2 other cases, the physician prescribed Lugol's solution in the correct dose, pharmacy dispensed the drug in the smallest volume bulk bottle (15 mL) with the correct instructions for use, but nursing staff administered the entire bottle, believing it contained a single unit dose of the drug. In both cases, the pharmacist had included a dropper for administration, but the device was overlooked. Both patients recovered.
A similar error reported to ISMP more than a decade ago resulted in a tragic outcome - the death of a young infant. 2 A doctor had ordered 0.05 mL (approximately 1 drop) of Lugol's solution 3 times daily for this infant with hyperthyroidism. Because the dose was so small, the pharmacist decided not to dispense the drug in an oral syringe. Instead he dispensed a 15 mL bottle of Lugol's solution to the unit, with directions for administering each dose on the label. He also dispensed an oral syringe for measuring and diluting the drug and showed the evening-shift nurses how to measure and administer the drug. The doses were administered correctly the first day. The following night, a nurse, who had been off the night before, assumed the bottle of Lugol's solution contained a single dose and tried to administer the entire bottle to the infant. After receiving 5 mL, the infant vomited, aspirated, went into respiratory arrest, and died. An autopsy revealed esophageal erosion from the high potassium concentration in the Lugol's solution (0.6 mEq/mL). 2
In the ISMP MERP and Quantros MedMarx databases, there are several errors in which drops of Lugol's solution were prescribed for oral administration, but the solutions were thought to be eye drops and were instilled into the eye, causing burning and tearing. One of the errors reported more than a decade ago involved an order to administer 10 drops of Lugol's solution mixed with OJ (orange juice), but nurses misinterpreted OJ as OD (right eye). The patient received several doses of Lugol's solution in his right eye. The error was identified when the patient complained to the physician about how painful the eye drops were.
The potential for harmful errors with the oral administration of Lugol's solution suggests the need to review current prescribing, dispensing, administration, and storage of this product and other iodine solutions to identify vulnerabilities in existing processes and to implement safeguards.
Establish protocols. Ensure that protocols include information about managing acute hyperthyroidism, protecting the thyroid during exposure to radioactive iodine, and preoperative use of iodine solutions. The protocols should be readily accessible and include treatment and dosing information.
Do not Use an Insulin Pen for Multiple Patients
A single pen device is never suitable for use with multiple patients due to the risk of cross-contamination and transmission of blood-borne diseases. Air bubbles and pathogenic contaminants can enter the cartridge after injection while the needle is still attached to the pen, even for short periods of time. In 2009, ISMP cooperated with the US Food and Drug Administration (FDA) on a Patient Safety News video (www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=86#9) that discusses how contamination can happen. The video was prompted by incidents in 2009 at 2 US Army hospitals in which 2,114 insulin-dependent diabetic patients were placed at risk because insulin pens were used for multiple patients.
Last year, an incident in Wisconsin required notification of more than 2,000 potentially exposed patients due to inappropriate sharing of insulin demonstration pens used during patient training. Repeated event reports suggest that an alarming and widespread misunderstanding that sterility can be maintained between patients by affixing a fresh needle on a pen device continues even today, despite warnings from ISMP, the Centers for Disease Control and Prevention (CDC), FDA, and pen device manufacturers.
In December 2011, we received 2 reports in which nurses knowingly used the same insulin pen for multiple patients. Both nurses thought the practice was acceptable because they changed the needle between patients. In one case, it was later determined that the original patient had human immunodeficiency virus (HIV). Follow-up exposure treatment and testing are being conducted on the affected patient. The nurse involved in the event reported that sharing insulin pens after changing the needle was routine practice at another hospital where she had worked. In the other case, 2 pens were used to administer insulin to 3 patients, even though each pen had a patient-specific label. One of the pens was borrowed from another patient while the nurse was waiting for pharmacy to dispense an insulin pen for her new patient. Insulin pen cartons state that the pens are intended for “single patient use only”; however, labels on the pens do not include this warning, and the cartons are rarely dispensed to patient care units.
According to the CDC, evidence continues to mount that this dangerous practice is affecting thousands of patients (www.cdc.gov/injectionsafety/blood-glucose-monitoring.html). In January 2012, CDC released a “clinical reminder” stating that the agency has increasingly become aware of reports of improper use of insulin pens, which places individuals at risk of infection (www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html).
Insulin pens are convenient and offer the possibility of improving safety when viewed from the perspective of reducing dosing errors, particularly errors that occur when drawing the correct volume into a syringe and the addition of several extra steps in administration. The dose preparation step is simpler and involves turning a dial to the prescribed dose and affixing a special needle to the device before injection. However, keep in mind that insulin pens were originally designed for home use by diabetic patients, and less so for inpatient use.
To reduce the risk of cross-contamination, insulin pens used in inpatient settings should be assigned to individual patients and labeled accordingly. Unfortunately, space is lacking on the pen for application of a patient label, so pharmacists must affix a “flag” label, taking care to attach the label to the body of the pen, not the cap, without covering the drug name. If the label is on the cap, once the cap is removed, the pen is no longer labeled.
Safety can only be ensured through timely education and ongoing monitoring. Unfortunately, hospitals may find education and monitoring difficult to accomplish due to staff turnover and time constraints. If ongoing education and continuous monitoring cannot be accomplished, hazardous conditions may persist, and hospitals may need to take a long, hard look to determine whether dispensing vials of insulin or prefilled syringes would be safer for the patients. Another option is allowing patients to bring their own pens to the hospital for use, but this is only acceptable if the hospital has effective procedures in place to verify, label, and securely store the pens.
Here are some other safety efforts already reported to us by hospitals that use insulin pens: (a) develop staff orientation and continuing education programs on the proper use of pen devices, (b) include warnings about proper pen use on computer-generated and electronic medication administration records, and (c) create screen savers and posters about the risk of sharing pens that can be displayed in medication areas. ISMP also recommends conducting a failure mode and effects analysis on pen device use to determine the scope of risk, plan an effective risk-reduction action plan, implement the plan, and measure its effectiveness.
Pen manufacturers also need to step up their efforts. Manufacturers should prominently label the pens with a bold statement such as, “Warning! For Single Patient Use ONLY.” Space must also be devoted on the pen body for a patient label so that a patient's name can be specified on each pen. FDA oversight is needed to ensure that pen manufacturers communicate with hospitals, outpatient pharmacies, physician offices, and ambulatory centers about the risks associated with pen sharing.