ISMP Quarterly Action
Agenda - april - june 2011
From the July 27, 2011 issue
One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent similar problems at your practice site. To promote such a process, the following selected items from the April -June 2011 ISMP Medication Safety Alert! have been prepared for an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. Each item includes a description of the medication safety problem, recommendations to reduce the risk of errors, and the issue number 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. The Action Agenda is also available for download in a Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda1103.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.
Key: — ISMP high-alert medication
Dosing confusion with colistimethate sodium for injection (13)
Problem: ISMP and ASHP sent a warning through the National Alert Network (NAN) about dosing errors involving colistimethate sodium for injection, a prodrug of colistin with a high potential to induce nephrotoxicity and neurotoxicity. The drug is used to treat multidrug-resistant organisms. The strength of colistimethate sodium is labeled in terms of the colistin base, not the prodrug. Recently, a physician ordered the dose as the prodrug, but the dose was dispensed as colistin base, which resulted in an overdose.
Recommendation: Dose colistimethate sodium ONLY as colistin base, with a dosage reduction for renal insufficiency. Consider restricting ordering to infectious disease specialists or intensivists. Use pre-approved guidelines or order sets with colistin base dosing only. Dose limits should be established with immediate investigation required for doses outside hospital guidelines. The full NAN alert can be accessed at: www.ismp.org/sc?k=nanalerts.
Parenteral nutrition-related deaths and a cluster of bacterial endophthalmitis call for compounding pharmacy oversight (7, 8, 13)
Problem: Nineteen patients received parenteral nutrition (PN) containing Serratia marcescens. Nine patients died. All of the PN came from the same compounding pharmacy. A shortage of commercial amino acid solutions this winter led the pharmacy to use amino acid powder. A failure in the sterilization process caused the contamination. Also, a cluster of bacterial endophthalmitis occurred related to intravitreal injections of bevacizumab obtained from another compounding pharmacy. Not using masks, talking during preparation of the injections, and no vertical barrier were suspected to be sources of contamination.
Recommendation: The use of compounding pharmacies for com-plex solution preparation should not cease as a result of these outbreaks. Compounding pharmacies are often better equipped to employ and monitor compliance with USP <797>. Hospitals should use commercially available solutions when possible. If solutions are outsourced, regularly monitor the external vendor using ASHP’s new Outsourcing Sterile Products Preparation: Contractor Assessment Tool (www.ashpfoun dation.org/MainMenuCategories/ PracticeTools/SterileProductsTool.aspx). Better FDA and licensing oversight for these pharmacies are also needed.
Broselow tape for chemical warfare may be confused with the emergency tape (9)
Problem: Broselow Pediatric Antidotes for Chemical Warfare Tape (www.ismp.org/sc?k=broselow) resembles the Broselow Pediatric Emergency Tape. There could be confusion between the two tapes during a pediatric emergency.
Recommendation: Make staff aware that both tapes exist. Guard against confusion by underlining the words “Chemical Warfare” and storing this tape on carts in the emergency department only, in a different part of the cart than the emergency tape.
Safe practices in pharmacy sterile compounding areas (11)
Problem: A recent pharmacy compounding error involved a small volume injectable preparation in which a woman in labor received succinylcholine instead of ePHEdrine after a technician with multiple drugs under the hood during preparation of the medication syringes mixed up the two products. Another error involved an IV admixture in which an infant received a highly concentrated solution of sodium chloride after a technician pulled what he thought was a 250 mL bottle of sterile water to use as a base solution, but it was actually a bottle of 23.4% sodium chloride.
Reccomendation: Limit in-house preparation of injectables and solutions to products not available commercially. Separate the storage of concentrated bulk solutions, particularly concentrated electrolytes, amino acids, and dextrose. Have a pharmacist pull the necessary ingredients prior to preparation to give to technicians. Use an automated compounder when possible. Place the ingredients of only one product under the hood at a time. Establish a standard procedure for verifying products, preferably checking additives before mixing high-alert medications.
Final Acute Care Guidelines for Timely Administration of Scheduled Medications posted on ISMP website (10)
Problem: Nurses who responded to an ISMP survey made it clear that changes in the drug administration system have made the long-standing Centers for Medicare & Medicaid Services (CMS) “30-minute rule” error prone. Nurses reported taking shortcuts to comply with the rule, which have led to errors, some harmful. Examples include skipping pre-medication assessments and double checks, pre-pouring medications, borrowing medications, and failing to use available bar-coding technology. ISMP has been working towards documentation of what we believe represents best practices associated with timely administration of scheduled medications.
Recommendation: ISMP has posted the final Acute Care Guidelines for Timely Administration of Scheduled Medica-tions at: www.ismp.org/tools/guidelines/acutecare/tasm.pdf. The guidelines suggest that hospitals should define a short list of time-critical scheduled medications that should be administered within 30 minutes of the scheduled time. For non-time-critical medications, administer daily, weekly, or monthly medications within 2 hours of the scheduled time, and drugs prescribed more frequently than daily (but not more often than every 4 hours) within 1 hour of the scheduled time. For now, hospitals will still be held accountable to CMS for the “30-minute rule,” although we anticipate that changes will be forthcoming.
Benzocaine risk of methemoglobinemia (9)
Problem: FDA continues to receive reports of methemoglobinemia (www.fda.gov/Safety/MedWatch/Safety Information/SafetyAlertsforHumanMedicalProducts/ucm250264.htm), a serious and potentially fatal adverse effect associated with topical benzocaine products, including sprays used to numb mucous membranes before procedures and over-the-counter gels and liquids used to relieve pain from teething, canker sores, and gum irritation.
Recommendation: Screen patients who may receive topical benzocaine for risk factors (e.g., G6PD deficiency). Avoid sprays of longer duration than recommended on the label. When possible, use metered-dose sprays. Monitor patients who receive benzocaine sprays for signs of methemoglobinemia during the procedure and for 2 hours post-application. Additional recommendations can be found at the FDA link to the left.
Overreliance on a barcode scanner beep can lead to errors (13)
Problem: Regardless of whether a correct or incorrect product or patient has been scanned, audible barcode scanners produce the same beeping sound. The nurse must confirm whether he/she scanned the correct patient/medication by reading the actions on the electronic medication administration record (eMAR) or hand-held scanner screen. Some nurses have mistakenly relied on the sound of the beep alone to signal verification of the patient and medication.
Recommendation: Identify and remedy conditions that may result in absent or poor visibility of the full eMAR during the entire medication administration process, including the scanning process. Scanners that incorporate their own self-contained internal logic may be employed so nurses can view alerts associated with scanning, although the entire eMAR may not be viewable. Educate users not to rely on the audible beep to verify the patient/medication.
Barcode scanning after drug administration has little value (13)
Problem: The purpose of barcode scanning is defeated when it occurs after drug administration—a practice called back scanning, which is one of the observed workarounds used to reduce workload during the drug administration process. Employing this workaround increases the risk of wrong drug, wrong dose, wrong time, wrong route, and wrong patient errors.
Recommendation: Hospitals should monitor for back scanning practices, identify the causes if it occurs, and make the necessary system changes to avoid this practice, including but not limited to educating nurses about the risks associated with back scanning. If a drug must be given under urgent conditions, the safest method is to scan the patient and medication barcodes, and create a new task on the electronic medication administration record (eMAR) to document the drug administration, which must be later verified.
Parenteral nutrition (PN) calcium dose entered as sodium dose, leading to infant’s death (8)
Problem: An infant died after receiving a PN solution that contained 60 times more sodium than prescribed. A pharmacy technician entered the dose of calcium (“982” mg) into the mEq field for sodium instead of the correct dose of 14.7 mEq. A sodium dose warning did not appear while entering the order because it had either been entered into a non-PN template without dose limits or entered using an adult template. A free-text label that listed the sodium content as 14.7 mEq was placed over the compounder label, contributing to a failure to detect the error during product verification.
Recommendation: Synchronize the order and format of ingredients listed in PN order sets, the pharmacy computer system, the compounder software, and the PN label to help prevent errors. If your PN software supports dose warning limits, fully implement them but do not rely on them only. Define and install more restrictive weight-based dosing limits applicable to specific patient populations. Use product labels that include the actual dose/ strength of the base solution and each additive. Conduct verification processes in the pharmacy to ensure appropriateness and accuracy of the PN order, additives, and the final PN product, including the expected versus actual weight.
PENTACEL (Diphtheria and Tetanus Toxoids, Acellular Pertussis, Poliovirus, Haemophilus b conjugate vaccine [DTaP-IPV and ActHIB]) (10)
Problem: Numerous infants did not receive the Haemophilus influenzae type b component of PENTACEL, a two-part vaccine packaged in cartons containing vials of liquid DTaP-IPV and vials of lyophilized Haemophilus influenzae. Nurses administering the two-part vaccine failed to use the DTaP-IPV component to dilute and mix with the lyophilized ActHIB powder component of the vaccine.
Recommendation: Pharmacies should dispense the two vials together using a rubber band or by placing the two vials in a ziplock bag. Affix an auxiliary label to the carton to remind staff to use both vials. To confirm administration of both components, staff should document the NDC number for each vial in the vaccine log before administration. Documenting the actual administration of the vaccine should always occur after it is given.
Inconsistent use of smart pump libraries may lead to legal concerns (9)
Problem: Clinicians sometimes view the dose checking feature of smart pumps as an option that can be turned off, or they may bypass alerts without consideration. Serious errors may result. From a legal perspective, when this technology is available but not used, litigation could be successful in finding fault with nurses (Harding AD, et al. Nurses’ risk without using smart pumps. JONAS Healthc Law Ethics Regul. 2011;13(1):17-20).
Recommendation: Available smart pump technology should be fully maximized and employed consistently, and alerts issued by the technology should be addressed before administering parenteral therapy. For assistance with these formidable tasks, see ISMP guidelines for safe implementation and use of smart pumps at: www.ismp.org/Tools/guidelines/smartpumps/default.asp
Serious interaction between simvastatin and ketoconazole demonstrates a series of latent failures (9)
Problem: A serious interaction between simvastatin and ketoconazole harmed a patient. Concomitant use of these drugs increases the risk of rhabdomyo-lysis. The interaction was not detected due to a series of latent failures including inactive prescriptions that were refilled and a temporary suspension of the pharmacy computer alert system during transition to an electronic record system.
Recommendation: Ensure that pharmacy computer systems warn about this serious interaction and require action on the part of the pharmacist if both drugs remain on the patient’s profile. Encourage practitioners who investigate events to always look for multiple latent system failures and multiple human errors (active failures) that might have occurred.
Mix-ups between risperiDONE (RISPERDAL) and rOPINIRole (REQUIP) (13)
Problem: A medication error occurred when a public health nurse, intending to administer a tuberculin (PPD) skin test, mistakenly administered 0.1 mL of injectable inactivated polio vaccine (IPV). The polio vaccine had been placed accidentally in the PPD carton, and the PPD vial had been incorrectly placed in the polio vaccine carton.
Recommendation: Require practitioners to document the vaccine in the vaccine log, including lot number of the drug vials, prior to administration. (Actual administration should be documented after administration.) Store PPD in its original carton since it is light sensitive. For products that aren’t light sensitive, discard cartons once the products are opened.
RAPAFLO (silodosin) and RAPAMUNE (sirolimus) mix-up (1)
Problem: FDA recently alerted the public about mix-ups between risperiDONE and rOPINIRole, some involving patients who required hospitalization. The causes of confusion include: name similarity; illegible written prescriptions; similar product strengths, dosage forms, and dosing intervals; storage next to each other; and appearance together in computer listings.
Recommendation: When prescribing either drug, the drug name should be printed, and the purpose of the drug should be listed. In pharmacies, the products should not be stored near each other, and tall man letters should be used for storage labeling and computer listings.
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