ISMP Quarterly Action Agenda - july and september 2007

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One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and use that information to prevent similar problems at your practice site. To promote such a process, the following selected agenda items have been prepared for your senior leaders and an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. These agenda topics appeared in the ISMP Medication Safety Alert!® between July and September 2007. Each item includes a brief description of the medication safety problem, recommendations to reduce the risk of errors, and the issue number in parentheses to locate additional information as desired. Look for our high-alert medication icon under the issue number if the agenda item involves one or more medications on the ISMP List of High- Alert Medications. Many product-related problems can be viewed in the ISMP Medication Safety Alert!® section of our website. The Action Agenda is also available for download in a Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda0704.doc) that allows expansion of the columns in the table designated for organizational documentation of an assessment, actions required, and assignments for each agenda item. Continuing education credit is available for nurses at: www.ismp.org/Newsletters/acutecare/actionagendas.asp.

Key:   — ISMP high-alert medication

Fatal 1,000-fold overdose of zinc in TPN due to confusion between mcg and mg (18)
Problem:A fatal 1,000-fold overdose of zinc sulfate contained in a TPN solution was administered to a preterm neonate. A calculation was made to convert zinc, prescribed in mcg/100 mL, to mcg/kg, which was required for the automated compounder software. The calculation was correct, but it was entered incorrectly into the pharmacy computer as mg, not mcg. Several system failures contributed to the error, including nonstandard ways of prescribing electrolyte additives in TPN and inadequate check systems 
Recommendation: Standardize the way zinc sulfate (and other electrolytes) is prescribed. Ensure that the prescribed dosing method matches the dosing method required for order entry into pharmacy software. Add low-volume trace elements to TPN admixtures manually. Build and heed dose warnings in automated compounders and pharmacy software. Develop comprehensive education modules and validate the competency of individuals involved in TPN. See the full article with additional recommendations at: www.ismp.org/Newsletters/acutecare/articles/20070906.asp.

Inappropriate prescribing of FENTORA (fentanyl buccal tablets) (19)
Problem: Fentora has been linked to serious adverse outcomes, including death, when prescribed for the management of acute pain in patients who are not opiate tolerant. Prescribers are also cautioned that mcg-to-mcg conversions between fentanyl patches and other forms of fentanyl products, including ACTIQ (fentanyl transmucosal lozenges)
or buccal fentanyl tablets, are not safe.
Recommendation: Make FDA's Healthcare Professional Sheet
(www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora) available to practitioners who
prescribe, dispense, or administer fentanyl products. Validate each patient’s opiate tolerance
before use and require personnel who dispense or administer these products to verify that the patient meets prescribing criteria.

World Health Organization (WHO): Dilute vincristine in a minibag (15)
Problem: Humapen Memoir is a pen device that was recently launched for use with HUMALOG (insulin lispro injection [rDNA origin]). This product may be confused with Humira Pen used to treat immune-related disorders. The brand names look and sound very similar
Recommendation: Dilute vincristine and other vinca alkaloids in a minibag rather than a syringe so it looks dissimilar to drugs that are given intrathecally. For more on preventing fatal vincristine errors, view the free FDA Patient Safety Video at: www.accessdata.fda.gov/psn/transcript.cfm?show=68#7.

Lack of standard dosing methods contributes to IV errors (17)
Problem:A large variety of IV drug dosing methods exist in hospitals. For example, the same drug might be administered within the same facility using the dosing methods of mcg/kg, mcg/kg/min, or mcg/kg/hour concentrations. Lack of standardization makes recognition of dosing errors difficult, even when using smart pumps.
Recommendation: Define and standardize adult (and if applicable, pediatric) dosing methods to be used for each drug administered IV in your organization. Employ smart pumps and program them using the endorsed dosing method. The dose on the prescriber's order, the MAR, and the drug label should match the dosing method required to program the infusion pump.

IV fluorouracil infused in 4 hours instead of 4 days (19)
Problem:A patient undergoing treatment for advanced carcinoma received a fatal dose of fluorouracil, given over 4 hours instead of 4 days. Two nurses miscalculated the infusion rate, forgetting to divide the daily dose by 24 hours. The pharmacy label listed the mL/24 hour rate of infusion first, then the mL/hour rate. The nurses saw the mL/24 hour infusion rate and thought their erroneous calculations were correct. Failed double-check systems and pump design flaws also contributed to the error.
Recommendation: Display information needed to program infusion pumps in a standard way. The mL/hour rate, not the mL/24 hour rate, should be prominent. Minimize the need for calculations at the bedside. Use checklists to structure task workflow. Use chemotherapy certification processes to validate that staff possess and maintain an appropriate level of skills, knowledge, and abilities before working independently. See the full article for details at: www.ismp.org/Newsletters/acutecare/archives/Sep07.asp#20.

Confusion with SYMLIN (pramlintide acetate) dosing (17)
Problem:Symlin may be prescribed for insulin-dependent diabetic patients to enhance glucose control. It is prescribed in mcg, not units. Patients may confuse the "mcg" dose of Symlin with the"unit" dose markings on the insulin syringes used to administer the dose, leading to potentially serious dosing errors.
Recommendation: Teach patients how to draw up the correct dose of Symlin using an insulin syringe, and validate understanding by observing a return demonstration. Also validate that the patient knows how to measure doses in general in case the dose is changed. Instruct the patient not to mix Symlin and insulin in the same syringe.

New ROCEPHIN (ceftriaxone) warning (14)
Problem:FDA and Roche published an advisory about a potential problem when Rocephin is used concomitantly with calcium or calciumcontaining products within 48 hours, especially
in neonates.
Recommendation: A second advisory (www.fda.gov/medwatch/safety/2007/Rocephin_HCP_august2007.pdf) stresses that Rocephin and calcium-containing solutions, including parenteral nutrition, should not be mixed or co-administered within 48 hours to any patient, even via different infusion lines at different sites. Computer alerts or smart pumps can help warn clinicians about such conditions.

Insulin CONCENTRATE U-500 (15)
Problem:With use of U-500 insulin products in hospitals on the rise, reports of mix-ups between U-100 and U-500 insulin are also increasing. The way insulin products are listed on computerized order-entry screens is often a causative factor in erroneously selecting U-500 insulin when entering orders. Access to concentrated insulin on patient care units also increases the likelihood of an inadvertent overdose.
Recommendation: Evaluate how insulin is listed on order entry screens; if the concentration appears at the far right of the drug information, the risk of selecting the wrong product increases. Drug information vendors have agreed to incorporate the word "CONCENTRATED" to U-500 insulin entries. Consider adding a hard stop on U-500 insulin orders to require prescriber and pharmacist verification before proceeding. Segregate the storage of these two strengths of insulin.

Failure to cap IV tubing and disinfect IV ports place patients at risk (15)
Problem: Leaving the distal end of IV tubing uncapped between intermittent infusions and failing to disinfect IV ports on needle-free valves before access increases the likelihood that patients will acquire a healthcare-associated infection. Meticulous attention to aseptic technique including proper disinfection of IV access devices is not the observed norm in many organizations.
Recommendation: Organizational policies and procedures should detail the expectations related to maintenance of aseptic technique including disinfection of vascular access lines and ports. Teach these expectations to individuals who administer medications and conduct rounds on patient care units to document baseline compliance and measure improvement.

Preventing mix-ups between various formulations of amphotericin B (18)
Problem:Several reports of fatal mix-ups between conventional and lipid-based formulations of amphotericin B were recently published in the United Kingdom. Alerts issued by ISMP since 1997 have called attention to mix-ups between the lipidbased and conventional formulations of drugs.
Recommendation: Communicate orders for drugs with liposomal and conventional forms using both the proprietary and complete generic name (e.g., AMBISOME [amphotericin B liposomal]). Restrict the preparation and dispensing of amphotericin B products to the pharmacy. Separate the storage of different formulations. Additional recommendations can be found at: www.ismp.org/Newsletters/acutecare/articles/20070906_1.asp.

BYETTA (exenatide) barcode scanning inconsistencies (16)
Problem:Two formulations of Byetta are distributed in pen injectors, one delivering 5 mcg/injection and one delivering 10 mcg/injection. The wrong strength may be dispensed because both pens have similar NDC numbers. Only the final digits of the NDC numbers are different, and the barcodes for both products may not include these final digits.
Recommendation: Manual double-checks of Byetta products are warranted to ensure the correct strength is dispensed, especially in community settings where erroneous dispensing could lead to repeated dosing errors.

Another problem with Byetta (exenatide) (16)
Problem:A nurse reported administering the full contents (1.2 mL) of a Byetta prefilled pen to a patient instead of the intended dose of 5 mcg (0.02 mL), a 60-fold overdose. The nurse saw the prescribed dose of 5 mcg on the pen's label but no directions on the pen itself. She missed the concentration and total volume listed on the pen in fine print. She'd never used Byetta and was unsure how to activate it, so she withdrew the entire contents from the pen into a separate syringe and administered the full amount to the patient.
Recommendation: Review educational processes that are used when new products are introduced in your organization. Do not assume that all pen injector devices operate similarly; evaluate the steps necessary to ensure that a dose is delivered successfully and accurately each time a new product is considered. Ensure that nurses receive adequate, hands-on education with pen injector devices before introducing new products into patient care areas.

Potential problem with EXACTACAIN spray (benzocaine 14%, butamben 2%, tetracaine 2%)  (14)
Problem: Some Exactacain applicator straws have been"popping off into patients' throats." Recent product changes to the spray release button necessitated re-sizing applicator straws. Straws for use with the original Exactacain spray release button are not compatible with newly designed spray release button and will pop off during use.
Recommendation: Use only the straws packaged with each Exactacain container, not leftover straws from the older container. Discard leftover straws when starting a new container. For more information, view a free FDA Patient Safety Video on this topic at: www.accessdata.fda.gov/psn/transcript.cfm?show=68#6.

Updated: ISMP's List of High-Alert Medications (16)
Problem: High-alert medications are drugs that bear a heightened risk of causing significant patient harm when used in error. Special safeguards may reduce the risk of error. 
Recommendation: Based on a 2007 practitioner survey and review by ISMP and other medication safety experts, ISMP's List of High-Alert Medications has been updated (www.ismp.org/Tools/highalertmedications.pdf). Organizations are strongly encouraged
to evaluate the error potential for each high-alert drug, and take proactive measures to reduce risk.

Talc given IV (17)
Problem: A patient died after a talc suspension was administered IV instead of being instilled through a chest tube during a pleurodesis (causes the membranes around the lung to stick together to prevent fluid buildup in the space between the membranes). The nurse misinterpreted the word"in" amid the order for "talc in saline" as "IV." The product was dispensed in a parenteral syringe with "IV additive product" listed on the label.
Recommendation: Drugs used for pleurodesis should be delivered to the unit immediately prior to the procedure; they should be prepared in a catheter-tipped syringe (not a parenteral syringe) which is labeled “for chest tube instillation only." Use a pre-procedure "time out" to confirm patient identity, clarify the plan of care, and ensure that appropriate equipment
and medications have been brought to the bedside.