Bridging the gap…between the business of medicine and the practice of medicine.
Doctor’s Digest’s ISMP Med/Hazard Alerts
- Change in Anzemet indication
Dolasetron mesylate (ANZEMET) injection should no longer be used to prevent chemotherapy induced nausea and vomiting (CINV) in adult or pediatric patients. Sanofi-aventis recently informed health professionals of the occurrence of dose-dependent QTc, PR, and QRS interval prolongation, and that revisions to the prescribing information have been made. While labeling for both injection and tablets has changed, the tablets continue to be indicated for the prevention of CINV and postoperative nausea and vomiting (PONV) because the cardiac risk is less than that seen with the injection form. The letter sent to healthcare professionals and label changes are detailed at: www.ismp.org/sc?k=anzemet.
- Parenteral nutrition deaths tied to drug shortage
The Alabama Department of Public Health (ADPH) continues its investigation of an outbreak of Serratia marcescens bacteremia in hospitalized patients who received contaminated parenteral nutrition (PN) made by a compounding pharmacy. Nine patients have died and a total of 19 patients from six hospitals were adversely affected (www.ismp.org/Newsletters/acutecare/articles/20110407.asp). ADPH has determined that bacteria in 12 of the hospitalized patients has the same genetic fingerprint as the organism isolated from a container and stirrer used to mix powdered amino acids, from the tap water spigot used to rinse the container, and from the PN solution (http://adph.org/news/assets/110407.pdf). We contacted ADPH and learned that a shortage of commercial amino acid solutions this past winter led the pharmacy to compound the PN using amino acid powder. A failure in a step of the sterilization process, possibly at the filtration stage during cold sterilization, was most likely the cause of contamination. We’ll continue to follow this case closely and report any new findings.
- Injury from dislodged wall-mounted IV pole
A tragic hospital accident recently left an ICU patient in critical condition when a wall-mounted IV pole became dislodged as the bed was being raised. The top of the headboard lifted the pole from its housing, and an infusion pump that was clamped to it fell onto the patient’s head, causing an intracranial bleed. According to press accounts, the patient is not expected to survive. The hospital has now removed all wall-mounted IV poles and is using only floor-based IV poles. An electric bed capable of lifting patients that weigh 100 kg or more has the power to easily shear off wall-mounted equipment if it catches onto it as the bed rises.
Nurses have recounted similar incidents in which an IV pole on a bedframe dislodged a light fixture on the wall when the bed was raised, nearly falling on the patient. In fact, almost any piece of equipment attached high on a pole (e.g., a monitor) could potentially harm a patient if it falls. Standing IV poles can also tip easily if they hold more devices than recommended by the manufacturer or heavy fluid bags (e.g., 3 liter parenteral nutrition bags). These heavy objects, when raised high on IV poles, may dramatically shift the center of gravity, making it more likely to tip. Standing IV poles also risk tipping if the wheels are close together or if a wheel does not spin freely, sometimes due to debris (e.g., tape) that collects on the wheels. In light of the above tragedy, please examine the possibility of a similar accident, even if you don’t have wall- or bed-mounted units.
- Insulin pen teaching device used in error
We recently learned about an error involving Lilly insulin pens. The event happened at a clinic that dispenses insulin pens to patients for use at home. The pen devices were stored on a cabinet shelf while the Lilly HUMALOG insulin cartridges that are used with the pen devices were stored in the refrigerator. Several days after dispensing a pen device to a patient, the patient was in the emergency department (ED) with an elevated blood sugar. As part of their evaluation, ED personnel examined the insulin pen device brought in by the patient. After opening the pen to determine if the insulin cartridge was empty or defective, staff found that the pen contained a teaching cartridge filled with saline. When a teaching cartridge is put in the pen device, you cannot see the drug name or banded colors that differentiate the teaching cartridges from actual insulin cartridges. The HumaLOG insulin cartridge has red bands on both ends with red lettering whereas the saline cartridge has black bands with black lettering. The manufacturer provides the pens in an unsealed box, which means that a teaching pen with a saline cartridge could accidentally be placed in the box. Fortunately, the patient received insulin in the ED and was able to return home without any further consequences. The clinic was not sure how the training pen got into their supply. To improve safety, clinic staff now open every box of pen devices they receive for a visual check, and then they recheck each pen before dispensing it to the patient. They also add a seal using colored tape after they inspect the contents. Lilly was contacted, and suggestions were made by clinic staff to avoid similar occurrences at other locations, such as supplying the pens in sealed boxes. Staff said they would also like to see different markings on teaching pens and cartridges to help distinguish them. Perhaps a different color could also be used and/or prominent labeling that differentiates teaching devices from insulin-containing devices.
- Triaminic brand name extension could be dangerous to kids
A community pharmacist wrote to us about a concern he has regarding acetaminophen marketed under the Triaminic brand name, TRIAMINIC FEVER REDUCER. This product contains only acetaminophen. (Triaminic acetaminophen infant drops [80 mg/0.8 mL], similar to Tylenol Infants’ Drops, is also available.) Since the brand name Triaminic has been used for many years as a decongestant-antihistamine combination product, most consumers probably associate “Triaminic” with a cough and cold medicine. The pharmacist had noticed a woman trying to purchase a bottle of store brand acetaminophen liquid along with a bottle of Triaminic Fever Reducer. After speaking with the woman, the pharmacist learned she had no idea that both products contained acetaminophen; she just knew that she wanted something for her child’s fever and “Triaminic” for his cold symptoms. The label on the Triaminic product noting “fever reducer,” and the yellow highlighted “acetaminophen” was not enough to signal that this Triaminic product was different than the one she’d come to know. Had the pharmacist not intervened, the woman would have given both products to her children, risking toxicity.
FDA has some difficulties regulating over-the-counter (OTC) brand name extensions, even when the actual product ingredient is completely different from ingredients in the original product that uses the brand name. For OTC “monograph” drugs, a new drug application or abbreviated new drug application does not have to be filed. Monograph drugs are designated OTC drugs that have not been approved by FDA by direct application but are legally marketed under regulations referred to as “OTC monographs” established through the FDA’s OTC Drug Review. According to FDA, monograph drugs are “generally recognized as safe and effective” for their intended uses. Thus, companies are able to market certain OTC products, like Triaminic Fever Reducer, without prior FDA approval of the product name. FDA has occasionally acted when name confusion has led to errors, as it did last year when MAALOX TOTAL RELIEF, which contained only bismuth subsalicylate. The company was asked to change the name but instead took the product off the market. Perhaps it would be safest for pharmacies to avoid stocking Triaminic Fever Reducer.
- Wrong Patient Errors
When you think of “wrong patient” medication errors in inpatient settings, the most common scenario that comes to mind is a nurse walking into a patient’s room and administering medications intended for one patient to another patient—often a roommate. However, “wrong patient” medication errors can occur for a variety of reasons at any point in the patient encounter or during any phase of the medication use process. Read about hazards, near misses, actual “wrong patient” errors and what to do to prevent this troublesome type of medication error: http://www.ismp.org/Newsletters/acutecare/articles/20110310.asp
- Electrolyte Shortages
The national shortage of common electrolyte solutions in certain strengths and sizes has forced many pharmacists to replace their standard injectable solutions with a different product. The electrolyte solutions, sizes, or concentrations in short supply include: concentrated sodium chloride 14.6% and 23.4%; potassium phosphate injection; potassium acetate injection; zinc chloride injection; calcium gluconate injection; and calcium chloride injection. As a result, it’s critically important to follow a formal verification process, not only for purchasing alternative products and making inventory adjustments, but also for ensuring that necessary changes are made within computer software that drives various medication use systems, such as IV compounders and robots, automated dispensing cabinets, computer order entry systems, smart pumps, and any other affected technology. Please take a moment to ensure that a workable, standard process exists and is well understood by practitioners for making these adjustments with all due care. Omitting this important step could easily result in a serious error.
- Mix-ups between heparin and Hespan (hetastarch)
Since October 2010, we have received four reports of mix-ups between B. Braun’s heparin and HESPAN (hetastarch) products. One case occurred in the operating room (OR); heparin was nearly administered in error to treat hypotension. Fortunately, the anesthesiologist noticed the incorrect solution before it was administered. He said he had a difficult time distinguishing between the two products because they both had red and blue lettering. Also, the names heparin and Hespan share several letter characters in the same sequence—“H-E,” “P-A,” and “N.” The hospital has since changed to a different manufacturer for hetastarch.
We’ve written about the problem with these look-alike products on 10 separate occasions since 1998! These latest cases should serve as yet another warning that action is needed to prevent this potentially fatal mix-up.
We’ve communicated with FDA and the manufacturer about this problem, but substantial changes to differentiate these products have not occurred, so we are re-doubling our efforts.
Since other companies now manufacture generic hetastarch, for now, consider using one of the generic alternatives to Hespan, and refer to hetastarch products by the generic name. Bar-coding technology will also help prevent packaging or container mix-ups.
- Medication errors during code blues
Cardiac and/or respiratory resuscitation is an extremely stressful situation during which healthcare practitioners have little time for discussion and verification of the patient’s treatment plan, including medications. During these medical emergencies—often referred to as a code blue—every second counts and every errant action or inaction can result in patient harm or death. Two facts are clear: Patient harm from medication errors during code conditions is high and serious errors are often missed, even if the patient died or is harmed, because there was no suspicion that the drugs actually caused or contributed to the morbidity or mortality. We provide a list of strategies to decrease the risk of medication errors during codes. The list can be used to assess current practices and establish an action plan with high-leverage strategies that are more likely to reduce the risk of errors during codes. http://www.ismp.org/Newsletters/acutecare/articles/20110210.asp
- Standard NICU drug infusion concentrations
Few would disagree that standardizing the concentrations of drug infusions has enormous potential for increasing safety, especially in neonatal care. But imagine the benefits if drug concentrations could be standardized for neonates beyond just one hospital’s four walls. Some regional efforts have accomplished standardizing drug concentrations in adult medicine (Eastham JH, Rizos A, Gama JA, et al. Reduction in variation of intravenous drug administration in seventeen San Diego hospitals with standardized drug concentrations and dosage units. Hosp Pharm. 2009;44:150–158).
For neonates, standardization would help reduce risk when critically-ill babies are transferred from one facility to another. It would also stimulate the development of standardized infusion device drug libraries and could even provide a level of demand necessary for manufacturers to offer commercially-prepared solutions, thus reducing the risk of extemporaneous compounding errors within local facilities.
Such an effort to standardize neonatal drug infusion concentrations nationally is well underway through a joint effort of ISMP and the Vermont Oxford Network (VON), a non-profit voluntary collaboration of healthcare professionals dedicated to improving the quality and safety of medical care for newborn infants. ISMP and VON collaborated with representatives from NICUs across the country during the past 2 years to develop standard concentrations, and the list is now available on the ISMP website at: www.ismp.org/Tools/NeonatalConcentrations.
We urge all NICUs to review the list and consider full adoption if possible. Your efforts can help reduce the risk of medication errors when treating our tiniest patients.
- A Rapaflo Rapamune mixup
On the first day of a patient’s hospital admission, medication reconciliation was completed and the patient’s attending physician wrote orders for all the patient’s home medications. Nephrology was consulted since the patient had chronic renal disease. At home, the patient had been taking RAPAFLO (silodosin) 8 mg PO daily for an overactive bladder. In the hospital, Rapaflo was a nonformulary drug and not in the computer system. The central order-entry pharmacist received the order, misread it, and profiled RAPAMUNE (sirolimus), an immunosuppressant on the hospital formulary, to be given 8 mg PO daily.
The error was also missed by nurses and the attending physician, and the wrong drug was erroneously given for 5 days. On day 6 of hospitalization, the nephrologist asked why the patient was on sirolimus since the patient had no history of transplant and did not need an immunosuppressant. The drug was immediately discontinued. Fortunately the patient did not experience any adverse effects from the medication error but serious adverse events may well have occurred from such a mix-up.
Think about adding this drug name pair to your list of look-alike product names. (We plan to add the name pair to our list during its next revision.) Nonformulary drugs are more likely to be unfamiliar to staff, and unfamiliar drug names are more likely to be misinterpreted as a more familiar drug name.
Prescribers can help prevent possible mix-ups by including the drug’s purpose when ordering medications, regularly
- Error prevention during a recurring Tamiflu shortage
Similar to what happened last year during the flu season, Genentech announced last week that TAMIFLU (oseltamivir phosphate) Oral Suspension is on backorder again due to high demand. However, oral capsules remain available.
Although supplies of the suspension may currently be available at your local pharmacy, the company is unable to estimate when it will be available again for shipment. Therefore, when children need Tamiflu or when adults cannot swallow capsules, a compounded suspension may need to be prepared from the capsule powder.
When this occurred last year during a similar shortage, dosing errors were reported to us because the FDA-approved procedure in the product labeling for preparing the pharmacy compounded oral suspension from capsule powder (www.tamiflu.com/hcp/resources/hcp_resources_pharmacists.jsp) results in a concentration (15 mg/mL) that differs from the commercially available product (12 mg/mL).
Unless prescribers specify the patient’s dose in mg, a dosing error is still possible. As done last year, we are advising prescribers to communicate suspension doses in mg rather than by volume. Patients should be given an oral syringe to measure and administer the dose.
In hospitals with computerized prescribing, only the available concentration should be listed on computer drug selection screens. Otherwise, direct communication is necessary between the prescriber and pharmacist to assure the intended dose reaches the patient. As an alternative to compounding suspensions, the package insert states that capsule contents can be opened, emptied, and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
- ISMP releases QuarterWatch Q2 2010
QuarterWatch™ is an ISMP program that monitors all serious, disabling and fatal adverse drug events (ADEs) in the US reported to the FDA by drug manufacturers and through its MedWatch reporting program.
For the second quarter (Q2) of 2010, we analyzed computer excerpts from 33,068 reports. Overall, the steady increase in reports continued, up 12% compared to the same quarter (Q2) in 2009. While reports to FDA from manufacturers increased by 24%, reports directly to FDA from consumers and health professionals were 25% fewer than the same quarter in 2009, and a downward trend has now extended across the last four quarters (Q3 and Q4 in 2009, and Q1 and Q2 in 2010).
Limited physician reporting. Despite more than 800,000 active physicians in the United States, FDA received only 425 reports of serious adverse events directly from physicians in Q2 2010. Physicians were much more likely to report adverse events through drug company channels, which accounted for 28% of all the expedited reports submitted to FDA from drug manufacturers. Physician reports to drug manufacturers make a valuable contribution to drug safety, as the manufacturers, in turn, report the events to FDA. However, the physician is clearly in a better position to describe how the drug affected the patient and to provide important clinical details about the patient’s condition to FDA than drug company staff. Given the new era of information systems, it should be possible to make physician reporting simple, accurate, and timely.
FentaNYL (DURAGESIC) maladministrations. Maladministrations with fentaNYL patches were one of the most frequently reported (447 cases) drug safety issues in Q2 2010. These problems were reported 12.6 times more frequently than expected, given the total number of reports for the drug. For comparison, only 10 reports were received indicating maladministration of nicotine products—also widely used in patch form. Specific problems included adherence issues in which the patch fell off, improper placement on the body which affected drug absorption, and application at the wrong time. With a potent opioid, these problems can lead to potentially lethal overdoses or opioid withdrawal symptoms.
QUEtiapine (SEROQUEL)?and diabetes. Reports identifying QUEtiapine as suspect in inducing diabetes greatly outnumber reports for all other newer antipsychotic drugs that also carry a warning about diabetes risk. While QUEtiapine is one of the most widely used drugs in its class, reports regarding diabetes were received 16.5 times more often than expected, given the total number of reports for the drug. Glucose monitoring is recommended for patients who take this and other drugs in this class.
InFLIXimab (REMICADE)?and skin cancer. A cluster of 154 new reports of non-melanoma skin cancers were reported with this drug. Many drugs that immobilize important components of the immune system carry an increased risk of infection and certain cancers. This new cluster of reports, approximately 101.3 times more than expected, suggests the possibility of a broader cancer risk and a need to monitor patients’ skin carefully.
Alendronate (FOSAMAX) and lower limb fractures. In March 2010, scattered reports began to appear suggesting a new safety issue for alendronate and other bisphosphonate drugs used to treat osteoporosis. The new reports suggested that while bone density was preserved, bones might become more brittle over time and fracture easily—notably at the hip and femur. From April to June 2010 (Q2 2010), FDA received 126 reports of lower limb fractures associated with alendronate—50.4 times more frequently than expected given all reports for this drug—together with additional but fewer reports for other bisphosphonate drugs. Merck believes the increase in reports may be due in part to media attention to the issue. In October 2010, FDA announced it was going to require a warning (http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm) regarding the possibility of atypical fractures for all bisphosphonates used to treat osteoporosis; however, label changes had yet to be implemented by January 2011. A Medication Guide will also be required to be given to patients when they pick up their prescription.
Exenatide (BYETTA) and pancreas inflammation. In 2007, FDA issued a public health alert about 30 reported cases of an inflamed pancreas associated with exenatide, urging discontinuation of the drug if the problem occurred. FDA updated this warning in August 2008, identifying six more cases of hemorrhagic or necrotizing pancreatitis, leading to two patient deaths. In Q2 2010, we identified 118 new reported cases of this medical disorder, reported 32.5 times more frequently than expected. Eli Lilly and Amylin Pharmaceuticals told us they observed an increase in the cases reported following the two FDA alerts (www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor
HumanMedicalProducts/ucm079781.htm). We also identified the signal for a second serious adverse effect: 31 cases of renal failure or impairment, also the subject of a previous FDA public health alert in November 2009 (www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor
PatientsandProviders/ucm113705.htm). We believe these signals are of sufficient concern to require a more systematic study on the incidence of this drug’s adverse effects on the pancreas and kidneys.
The report includes additional information about Varenicline (CHANTIX), Levofloxacin (LEVAQUIN) and Dronedarone (MULTAQ). http://www.ismp.org/Newsletters/acutecare/articles/20110127.asp
- Pradaxa caps expire 30 days after bottle opened
Bottles of Pradaxa (dabigatran etexilate mesylate) contain 60 capsules. The usual dosage of 75 mg or 150 mg is given twice a day. A statement in product labeling notes that capsules expire 30 days after the bottle is opened. Therefore, patients must be made aware that prescriptions for more than a month’s supply (e.g., 60 days or 90 days) require that they open only one container at a time.
When the supply of capsules from the first container is exhausted, the second container may be opened, etc. To complicate matters, the bottles are not sealed with a tamper evident seal. The cap contains dessicant. Patients or their pharmacists should mark the bottle in some way (e.g., bottle #1, bottle #2, etc) to indicate which bottle is the one from which to remove capsules until supply is exhausted. The container should then be discarded and the second container started.
We are aware of one patient who began to take capsules from each container and therefore had to discard unused capsules from both bottles before the end of month one.
Also, there is a medication guide that goes along with the prescription.
- Caution! Samples of Angeliq mistakenly provided as birth control
Angeliq, a combination product containing progestin and estrogen, is a relatively new medication intended to relieve symptoms associated with menopause. It is available in the US and Canada. Our Canadian counterpart, ISMP Canada, has been alerted to 2 incidents in which physicians gave samples of this product to patients instead of oral contraceptives (birth control). In both cases, the error was discovered when the patient went to fill her prescription for Angeliq at a community pharmacy, after completing the samples received several months before.
The dose of the progestin component used for hormone replacement therapy (i.e., in drugs like Angeliq) is substantially lower than the dose of progestin used in oral contraceptives. Similarly, the potency or effective dose of estrogen used for hormone replacement therapy is less than that used in oral contraceptives. If a woman who has not yet reached menopause uses Angeliq instead of an oral contraceptive, she could become pregnant, and the consequences of the mixup could be devastating. These 2 reports suggest that labeling, packaging, and patient information for Angeliq could be improved.
Full information can be seen here: http://www.ismpcanada.org/download/safetyBulletins/ISMPCSB2010-10-Angeliq.pdf
- Eyelids stuck together with Super Glue? Relax, it won’t be permanent
You may have read this week that Zsa Zsa Gabor’s husband, Prince Frederic Von Anhalt, accidentally used his wife’s nail glue in his eyes, mistaking the container for his eye drops. This is similar to several other cases reported to us, including one this fall where a woman accidentally glued her eye shut when she mistook super glue (cyanoacrylate) for eye drops. Associated Press wire services reported that the woman had cataract surgery a year ago. She was reaching for what she thought was one of a half-dozen eye medications she uses but picked up the super glue instead.
In fact, we have written about a nearly identical incident in our November 29, 2000 newsletter. In that case, a woman instilled super glue into one of her eyes instead of eye drops, and also glued her eyelids together. She was treated at a hospital where the glue was carefully removed. Fortunately, she suffered no permanent damage. A literature search confirmed that this has happened numerous times.
The bond formed by super glue is extremely strong. In fact, anyone who’s used cyanoacrylates has probably gotten their fingers stuck together or stuck to whatever was being glued. This is such a common problem that the manufacturer of super glue, the Super Glue Corporation, has a page on its website (www.supergluecorp.com/removingsuperglue.html) devoted to removal of the glue from body parts.
As for fingers sticking together or sticking to whatever you’re gluing, that’s easy to fix. A small amount of nail polish remover applied with a Q-tip will do the trick. Be sure the nail polish remover contains acetone, which breaks down cyanoacrylate glues.
Obviously, you do not want to use acetone near your eyes since that could damage your vision. In the event that eyelids are stuck together or bonded to the eyeball, Super Glue Corporation recommends that you wash thoroughly with warm water and apply a gauze patch. The eye will open without further action within 1-4 days. The good news is that the manufacturer says there has never been a documented case of adhesive in the eye causing permanent damage.
Any non-ophthalmic substance packaged in bottles or tubes that look like eye drops or ointments might pose a problem, particularly if the products are left in areas where ophthalmic medications are stored. At one time, super glue products came in containers that were nearly identical to eye drop containers, but changes have been made to reduce confusion. Still, those using ophthalmics should be warned not to purchase super glue in a container that looks like an eye medication, and they should store the glue far away from medications.
- Perilous infection control practices with needles, syringes, and vials
A recent online survey of 5,446 healthcare practitioners reveals an alarming lapse in basic infection control practices associated with the use of syringes, needles, multiple-dose vials, single-use vials, and flush solutions. Survey respondents primarily included registered nurses (89.5%) who worked in hospitals. While the majority of nurses and other healthcare practitioners appear to follow infection control practices consistent with current recommendations, some survey respondents clearly place patients at risk for transmission of blood-borne diseases.
- Nearly 1% of respondents admitted to sometimes or always reusing a syringe for more than one patient after only changing the needle
- 6% of respondents admitted to sometimes or always using single-dose/single-use vials for multiple patients
- 15% of respondents reported using the same syringe to re-enter a multiple-dose vial numerous times; of this group, about 7% reported saving these multiple-dose vials for use with other patients
- 9% of respondents sometimes or always use a common bag or bottle of IV solution as a source of flushes and drug diluents for multiple patients.
Each of these unsafe practices has been associated with disease transmission and is explicitly prohibited by the Centers for Disease Control and Prevention (CDC).
Complete information can be accessed at: http://www.ismp.org/Newsletters/acutecare/articles/20101202.asp
- Cover applied without the medicated Catapress TTS patch
CATAPRES-TTS (transdermal therapeutic system) is a square, tan, reservoir-type adhesive patch containing cloNIDine. These patches, manufactured by Boehringer Ingelheim, are packaged with an optional white, round adhesive cover to place over the drug patch to prevent it from coming loose. So, each "dose" typically contains two types of pouches: one pouch with the medication patch and one pouch with the optional cover.
Although the pouch for the cover includes a warning that it does not contain active medication, we have received several reports in which just the cover was applied without the actual patch that contains cloNIDine. The most recent report involves a float nurse in a long-term care facility who applied just the optional overlay cover to her patient’s arm for several weeks in a row. Nurses who worked at the long-term care facility typically checked all medication patches each shift to monitor placement and adherence. However, the round, white cover is larger than the tan, square medication patch, so it’s hard to tell whether the patient’s patch is under the cover. Further, the patch with the medication is not labeled with the drug name, and although a warning appears on the outer packaging of the cover, stating it contains no medicine, the warning is not on the cover itself.
The company has no plans to change the product labeling. They advise not to write directly on the patch because it might affect the delivery of the medication. However, the optional cover can be labeled before application. If the cover is placed over the Catapres-TTS patch, it’s best to label it with the drug name and strength, and to also leave a small edge of the patch uncovered so other caregivers can assure that the cover was not applied without the medication patch. Another strategy is to place each patch/cover pair into an individual plastic bag and seal the bag with a label reminding practitioners to apply the medication patch as well as the adhesive cover. In 2007, we spoke to the manufacturer regarding our concerns with not listing the drug name on the patch as well as the risk of applying just the cover without the medicated patch.
- Thumb injected despite EpiPen redesign
Dey Pharma has redesigned its EPINEPHrine autoinjector, EPIPEN, to make it less likely to accidentally inject into a thumb or finger. Initial use of the new device requires activation of a blue safety release at the end of the pen farthest from the needle. Once activated, an orange tip at the needle end of the syringe is placed firmly against the outer thigh (the autoinjector is designed to work through clothing) for approximately 10 seconds while the drug is delivered intramuscularly.
We recently received a report in which a nurse injected her thumb using the new device. She was administering an EpiPen injection for the first time. She was not familiar with the device and apparently had not been taught how to use it properly. She was, however, familiar with the use of a NOVOLOG (insulin aspart) FLEXPEN, which has an orange push button that is pressed to inject the insulin. Although the EpiPen’s orange end is clearly marked with the warning "Never put thumb, fingers, or hand over orange tip," the nurse incorrectly assumed that, since it was a pen and had an orange tip, it operated the same way as the NovoLOG FlexPen. She held her thumb against the orange tip at the EpiPen needle end, expecting the needle to exit the opposite end once she activated the safety release. But when she pushed down on the orange end, she drove the needle through her thumb.
While injecting EPINEPHrine into a thumb or finger may pose a risk (restricted tissue perfusion) to the individual attempting to administer the drug, the greater harm and risk is to the patient who needed the drug if treatment is delayed. In fact, the situation could be quite serious if only a single pen is available in the field. As noted in our November 30, 2006 article, PEN injectors: Technology is not without imPENding risks (www.ismp.org/Newsletters/acutecare/articles/20061130.asp), more and more medications are available in prefilled pens, but the various pen devices are activated differently. EpiPens have been around for some time but many clinicians have never used one or have yet to become familiar with the newly designed device. Generic epinephrine pens are also available.
Instructions for proper use of EpiPens, and a picture of the newly designed pen, can be found at: www.epipen.com/page/how-to-use-epipen-auto-injector-index. If you are using EpiPens or similar generic EPINEPHrine delivery devices in emergency departments, assure that all staff know how to use them properly. We did notify Dey Pharma about the reported mishap.
- Update on metal in drug patches
An updated list of transdermal drug delivery systems (e.g., patches) with a metallic component was recently published (Hong I, Gabay M, Lodolce A. Safety Concerns Involving Transdermal Patches Magnetic Resonance Imaging [MRI]. Hosp Pharm. 2010;45(10):771-778) and is available at: http://thomasland.metapress.com/content/lh6x4h1g68815272/?p=6a2ede3d480d4ad3bbc5d4e1d095586b&pi=6.
Serious burns may occur in patients undergoing MRI who have transdermal patches with metallic content applied to their skin since the metal acts as a conductor of radiofrequency pulses, inducing electric current that causes intense heat and burns. FDA and ISMP issued an alert about burns from medication patches known to contain a metallic component in 2004 (www.ismp.org/Newsletters/acutecare/articles/20040408.asp). In 2009 the FDA issued a public health advisory regarding removal of drug patches prior to MRI (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149537.htm).
The latest review, by a team of pharmacists from the University of Illinois at Chicago, provides information related to the metallic content of available transdermal patches and also provides recommendations regarding reapplication of transdermal therapy after a scan.
- New TAXOTERE concentration and preparation
A new one-vial Taxotere (docetaxel) in a double concentration is replacing the current two-vial Taxotere packaging.
Ever since the drug became available, Taxotere has been provided in a two-vial package, with active drug in liquid form along with a vial of required diluent. The product required two dilutions prior to administration. First the diluent had to be added to the concentrated Taxotere. Then the product had to be diluted in an infusion bag. Reconstitution errors occurred due to confusion regarding overfill in the vials. The final dose could be miscalculated if the total volume of the initial diluted solution is added to the infusion bag rather than withdrawing the appropriate volume from the vial based on the 10 mg/mL concentration. These problems should end when the new one-vial form replaces the current two-vial packaging. The new one-vial packaging of Taxotere does not require reconstitution and can be injected directly into the IV infusion solution without further dilution. Importantly, the product is now twice the concentration. The new one-vial concentration is 20 mg/mL compared to the previous two-vial preparation, which was 10 mg/mL. The new formulation is available in both 20 mg/mL and 80 mg/4 mL vials (see Figure 1 in PDF version of the newsletter). For additional information, see a letter from sanofi-aventis posted on our website at: www.ismp.org/sc?k=taxotere. Please make sure all staff involved with preparing Taxotere are aware of the concentration change
- Lab change may affect CARBOplatin dosing
The FDA has alerted the oncology community about a potential dosing problem with CARBOplatin due to changes in the way labs are measuring serum creatinine. By the end of 2010, all clinical laboratories in the US will use the new standardized Isotope Dilution Mass Spectrometry (IDMS) method to measure serum creatinine. The IDMS method appears to underestimate serum creatinine values compared to older methods when the serum creatinine values are relatively low (e.g., about 0.7 mg/dL). Measurement of serum creatinine by the IDMS-method could result in an overestimation of the glomerular filtration rate (GFR) in some patients with normal renal function. If the total CARBOplatin dose is calculated based on IDMS-measured serum creatinine using the Calvert formula, CARBOplatin dosing could be higher than desired and could result in increased drug-related toxicity. To avoid potential toxicity, FDA recommends capping the dose of CARBOplatin for desired exposure (area under the curve [AUC]) if a patient’s GFR is estimated based on serum creatinine measurements using the IDMS method. Specific recommendations appear on the FDA website at: www.fda.gov/AboutFDA/CentersOffices/CDER/ucm228974.htm
- Null sign can be misread or misunderstood
Misidentification of alphanumeric symbols in handwritten and computer-generated information is a well known issue. For example, the numeral 0 (zero) looks very much like an upper or lower case letter O. One way to avoid misinterpreting this alphanumeric look-alike pair is to express a zero with a slash though it, also known as the null sign, to differentiate it from the letter O. A nurse who read this recommendation told us about a medication error that happened in her hospital that was caused in large part by a misinterpreted null sign.
A physician had handwritten a null sign next to a dose prompt for a basal rate on a patient controlled analgesia order form. Two nurses misread the null sign as the number 4. The patient received a basal infusion of morphine 4 mg/hour and became unresponsive. The patient was found in cardiac arrest; resuscitation efforts ensued but the patient suffered anoxic brain injury.
During investigation of the event, several other orders with a null sign revealed that the symbol could be mistaken as a number 4 or 9, especially if the tail of the hash mark through the circle is long, or a 6, especially if the circle is not closed above the hash mark through the circle.
We thank the nurse who reported this error. We have added the null sign to ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations (www.ismp.org/Tools/errorproneabbreviations.pdf).
- Electronic prescribing vulnerability. Height and weight mix-up leads to dosing error
Electronic prescribing with clinical decision support is widely accepted as a means to improve safety in the medication-use process. However, these early warning systems are not error-proof, as demonstrated by an event in which a patient’s height and weight were transposed into an electronic chemotherapy prescribing system. An event published by ISMP Canada brings attention to this particular electronic prescribing system vulnerability. The alert may be accessed at http://www.ismp.org/Newsletters/acutecare/articles/20100826.asp
- Drug vial caps and closures for cautionary statements only
USP has finalized a standard that allows only cautionary statements intended to prevent life-threatening situations to be printed on drug vial caps and ferrules (the metal bands that hold the stopper to the vial). This area of the vial must remain blank if the medication contained does not need a cautionary statement. Thus, it prevents company logos, names, and other such information from being printed in this location.
The new requirements are intended to make it more likely for doctors, nurses, pharmacists, and other healthcare practitioners to better see and act on labeling statements on injectable products. These labeling statements convey important safety messages critical for the prevention of life-threatening situations that may result from the misadministration of a product. According to FDA, manufacturers will need to provide a rationale to the agency if they want to include a cautionary statement in this location. Under the new requirements, other information will still be permitted elsewhere on the medication vial.
- Adding drugs to hanging IV bags poses many risks
We heard from a pharmacist who met with resistance recently when he proposed a policy prohibiting the addition of medications to hanging parenteral nutrition solutions or IV bags of any type. We first wrote about risks associated with doing this in 1997. Besides the obvious infection control concerns, some individuals adding drugs to IV bags may not recognize how important adequate mixing is to gain a uniform concentration of the drug in solution. Without proper mixing, instead of receiving an infusion over time, patients might inadvertently be subjected to a bolus of the drug. An experiment with potassium chloride concentrate injection that was died blue with food coloring can easily demonstrate this problem. (In practice, potassium chloride should never be added to an IV bag already in use.) Until the bag is removed from the IV pole and inverted vigorously several times, the blue-colored potassium chloride will pool near the bottom of the bag where the IV set is attached. Long ago, the medical literature described severe hyperkalemia and even death that occurred as a result of drug pooling when additions were made to hanging IV bags [Williams RHP. Potassium overdosage: A potential hazard of non-rigid parenteral fluid containers. Brit Med J. 1973;1:714-15. 2. Lankton JW, Siler JN, Neigh JL. Hyperkalemia after administration of potassium from nonrigid parenteral-fluid containers. Anesthesiology. 1973;39:660-61]. Also, without knowing exactly how much fluid remains in the container, it’s not possible to identify what the drug’s concentration will be when a new product is added to the remaining fluid, which in some cases might not be safe. The container would also be mislabeled unless the drug strength and fluid volume were revised on the bag label. For example, adding oxytocin (PITOCIN) to a hanging IV bag on a patient in labor could lead to more than the expected amount of oxytocin being delivered. Without testing, no one knows for sure whether or not other drugs are at similar risk of pooling and overdose.
- Limit nimodipine liquid preparation only to the pharmacy
FDA reminded healthcare professionals recently that nimodipine capsules should be given only by mouth or through a feeding tube. Since some patients are incapable of swallowing capsules, the drug often needs to be given via a feeding tube as a liquid dosage form. Recommendations from the alert and product labeling state that nimodipine can be prepared extemporaneously by puncturing the capsule with an 18 gauge needle, extracting the liquid contents with a syringe labeled Not For IV Use, removing the needle, emptying the contents into the patient’s feeding tube, and flushing with 30 mL of 0.9% sodium chloride. Unfortunately, no mention was made about restricting the preparation of the drug to the pharmacy. Not only is it unlikely that a Not For IV Use label will be applied, but the recommended process involves placing an oral liquid in a parenteral syringe with a needle attached. This is a set up for exactly what the labeling and FDA alert seek to prevent—accidental IV administration!
We strongly recommend liquid nimodipine be prepared ONLY in the pharmacy and be dispensed ONLY in an oral syringe labeled WARNING: For Oral Use Only. Assure feeding tubes have a port that will only accommodate oral syringes so a transfer of the drug to a parenteral syringe isn’t necessary. Nimodipine liquid extracted from capsules, stored in amber oral syringes, and placed in light-protected bags is stable at room temperature for 31 days (Green AE, et al. Stability of nimodipine solution in oral syringes. Am J Health-Syst Pharm. 2004;61:1493-6). A commercial oral liquid version would be welcomed; until then outsourcing the product from a reliable compounding pharmacy is also an option.
- Follow up to needlestick injury due to label issue with Lovenox unit dose injection
At the request of sanofi aventis, the manufacturer of LOVENOX (enoxaparin sodium) injection, and as a public service, the Institute for Safe Medication Practices (ISMP) has agreed to distribute the attached letter regarding recent reports of label adherence issues with Lovenox 30 mg and 40 mg prefilled unit dose syringes. The letter provides information about avoiding needle sticks when using the syringe, including the need to inspect syringes when removing them from the bubble pack, then assuring the label properly adheres to the syringe before use. The company is taking the required steps to address the issues that were identified in a previous alert on Practice Rx. The letter can be accessed at: www.ismp.org/newsletters/nursing/articles/lovenox.pdf
- Report of drug name confusion
A community pharmacist was transferring a prescription to another pharmacy by telephone. The verbal transmission sounded like the antidepressant PARoxetine (Paxil), but the transferred prescription was for the nonsteroidal anti-inflammatory drug piroxicam. Both drugs are available in the prescribed 20 mg strength, contributing to the confusion. The prescription was filled and dispensed as PARoxetine. Fortunately, the patient’s wife recognized that a mistake had been made and called the pharmacy before her husband took the wrong drug. The prescription was clarified and the correct drug was dispensed.
While this mix-up was caused by the sound-alike nature of the two drug names, PARoxetine and piroxicam could also look very similar when handwritten. PARoxetine is on ISMP’s List of Look-Alike Drug Name Sets With Recommended Tall Man Letters (http://www.ismp.org/tools/tallmanletters.pdf) due to its potential for confusion with FLUoxetine.
Once we complete our current Survey on Tall Man Lettering to Reduce Drug Name Confusion (please participate in this important survey at: www.surveymonkey.com/s/ismp), we will determine whether this new name pair should be included and whether changes are in order for the tall man letters currently used with PARoxetine. We will take into consideration that PARoxetine could also be confused with pyridoxine and paclitaxel.
- Acetaminophen study yields worrisome results
The July/August issue of the Annals of Pharmacotherapy contains a University of California Davis study on prescription and nonprescription acetaminophen use among Medi-Cal patients during a 1 year period in 2004-2005. Among the group, 769 consumers were potentially exposed to at least 16 g of acetaminophen for at least 1 day, and 2,664 were potentially exposed to at least 4 g a day for at least 100 days. Sixty-one patients with claims of 4 g per day or greater for more than 100 days had a diagnosis of primary liver or renal dysfunction, which the study team found to be alarming.
FDA is currently considering FDA Advisory Panel recommendations to reduce the acetaminophen total dose per 24 hours and to make the maximum single dose for adults no more than 650 mg.
- Air embolism risk with pressurized sprayers
Surgical staff should be aware that air or gas embolisms have occurred during or immediately after application of fibrin sealants (hemostatic drug or biological products) using air- or gas-pressurized sprayers. FDA has identified cases that appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. Although rare, the reports describe air embolisms that were life threatening and include one fatality—a 22-year-old patient who died from an air embolism likely caused by the method of product administration. In some reports the device was used at a higher than recommended pressure or at a distance too close to the surface of the bleeding site.
All manufacturers of US?licensed fibrin sealants (EVICEL, TISSEEL, and ARTISS), which are human derived, have updated the Warning and Precautions section of their product labels to emphasize the risk of air embolism and proper use of the product. Evicel and Tisseel are used as hemostats while Artiss is used for adhering autologous skin grafts in burn patients. Labeling of the spray devices and non-fibrin hemostatic or biological products also includes information on recommended pressures and distances. More information can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218530.htm.
- Unprecedented number of drug shortages wreaking havoc
While drug shortages have long been a problem in healthcare, the number experienced in the past few months is unprecedented, particularly with high use medications, including emergency drugs, pain medications, and anesthetic agents. Shortages include hydromorphone, propofol, certain high alert emergency drugs in prefilled syringes, and many others.
Frustrations are high as healthcare providers experience frequent stock depletion of critical drugs, often without prior notice, and then scramble to devise acceptable and safe alternatives. But using alternative medications, dosage strengths, or dosage forms often requires different dosing, preparation, and administration considerations, which only adds to the complexity of care. This increases the risk of serious errors, especially when the drugs in short supply are high-alert medications.
Whatever the cause, drug shortages have become a key patient safety concern in healthcare today. The urgency of this situation suggests that the current “business as usual” approach is woefully inadequate in every respect; this issue requires a disaster-type response. ISMP and ASHP are interested in co-convening a public meeting and inviting key stakeholders representing FDA, the pharmaceutical industry, healthcare practitioners, regulatory authorities, and medication safety experts to explore and articulate the scope of this problem, and to develop a plan to reduce the occurrence of drug shortages and better manage them when they occur.
In preparation for this meeting, we’re interested in hearing from doctors, pharmacists and nurses who’ve experienced this problem. Please tell us how the situation is affecting you and your patients. http://tiny.cc/f7pgm We will publish the results in September and advocate for necessary changes via FDA and the pharmaceutical industry. Thank you!
- Needlestick injury due to label issue with Lovenox Unit Dose injection
ISMP received a report about a nurse at a large health system who was stuck by a needle on a commercially-prepared LOVENOX (enoxaparin) prefilled syringe (sanofi-aventis). The manufacturer’s label that was placed around the barrel of the syringe did not fully adhere. The needlestick occurred after the nurse had given the patient the injection. Upon removal of the needle from the patient’s skin and just before the built-in safety shield could be engaged, the adhesive caught the nurse’s glove and twisted the syringe, allowing the needle to stick her.
The reporter told us that additional loose labels have been found on other syringes, while still in their original blister packaging. Syringes from four different lots of Lovenox 40 mg and two lots of 30 mg shipped to the hospital were involved. Some additional Lovenox syringes purchased from a wholesaler or received directly from the company were also affected. ISMP has also learned that the label problem has been identified at other hospitals.
We have contacted the manufacturer, sanofi-aventis. At this time, the company will only acknowledge that they are aware of the reported needlestick due to the label issue. They said they are currently investigating and will take required steps to address any issue that is identified during the investigation. For questions regarding Lovenox, please contact sanofi-aventis Medical Information Services at 1-800-633-1610. Please report any similar findings to the company.
Because of the serious nature of potential needlestick injuries, we feel it is necessary to forward this alert without delay. As a temporary measure, the hospital mentioned above has created an auxiliary warning label for the outer package to caution nurses about this problem. Nursing leadership at the hospital has been made aware of the situation so they can follow up with staff.
For hospitals and other healthcare settings where unit dose syringes of Lovenox are used, ISMP is recommending that pharmacy and nursing staff be made aware of the situation so that syringes can be examined in order to identify any loose labels prior to removing syringes from the packaging. We expect that further word will be forthcoming from the manufacturer.
- DTaP-Tdap mix-ups now affecting hundreds of patients
Our database of reported medication errors now contains hundreds of cases of accidental mix-ups between adult and pediatric products used to immunize patients against diphtheria, tetanus, and pertussis (whooping cough). Several reports involve errors that affected numerous patients. In one report alone, 80 clinic patients were given the wrong vaccine. In all, these mix-ups may be affecting thousands of patients given that not all cases are reported to ISMP. Read more about this at: http://www.ismp.org/Newsletters/acutecare/articles/20100701.asp
- Dangerous abbreviations BIW and TIW
A prescription written for chlorambucil (LEUKERAN) with directions to give “one tablet BIW” (tablet strength unspecified by the reporter) led to a pharmacist typing “one tablet twice daily” when the prescriber’s intention was for the patient to take one tablet twice a week. The error was caught by a second pharmacist who did a visual check of the completed prescription prior to dispensing.
Similar errors have occurred with the abbreviation “TIW” in which patients received the medication three times daily instead of the intended three times a week.
“BIW” or “TIW” should never be used in prescriptions—either handwritten or electronic (“BIW” and “TIW” should not be a selection for dose frequency). Both abbreviations are on the ISMP List of Error-Prone Abbreviations (http://www.ismp.org/Tools/errorproneabbreviations.pdf). Write or have electronic systems print “twice a week” or “three times a week” instead.
- Twice a Week or Twice a Month?
In American parlance, the word “biweekly” is sometimes used to indicate once every 2 weeks. The word “bimonthly” usually means once every 2 months. However, there can be another meaning for each of these words that is likely to cause confusion. According to available online and print dictionaries, “biweekly” is also loosely used to mean twice-a week or semiweekly, and “bimonthly” can also rightly indicate twice a month. So, for clarity purposes when ordering medications, it seems obvious that these words should be avoided. Instead, it is best to use terms such as “twice a week,” “every other week” (or “every 2 weeks”), or “every other month” (or “alternate months”).
- A National Alert Network (NAN) message is being issued
A National Alert Network (NAN) message is being issued by the American Society of Health-System Pharmacists (ASHP) and ISMP regarding the EPINEPHrine 1 mg/10 mL (0.1 mg/mL) prefilled syringe shortage.
The message will also be distributed to members of the National Coordinating Committee on Medication Error Reporting and Prevention, for further distribution to their own constituents.
The message (PDF file) can be downloaded at: www.ashp.org/patientsafety
- Painful eye injuries with improper use of Clear Care solution
People who wear contact lenses may assume that all multipurpose cleaning and disinfecting solutions used for rinsing and soaking lenses are the same. After all, they are stored side by side on supermarket and pharmacy shelves. But they are not all the same, particularly regarding how they are used, and serious injuries can occur if these products are used improperly.
Recently, a young woman who was staying at a friend’s house noticed a bottle of contact lens solution in the bathroom. She removed her contacts, placed them in her flat contact lens case, and added the solution found in her friend’s bathroom. The solution was CLEAR CARE (CIBA VISION, a Novartis Company), a cleaning and disinfecting product. To the woman, the product (see picture in the PDF version) looked like any other contact lens cleaning solution. The label had a picture of a contact lens on it, and it seemed to be the same shape and size as other contact lens solutions. The following morning, the woman put one of the contacts in her right eye and experienced excruciating pain and burning. Her eye clenched shut, delaying removal of the contact lens. The problem was discovered when the woman called her ophthalmologist, mentioned the product she had used, and described how she had soaked her lenses with the solution in her flat contact lens holder.
The woman’s physician pointed out that Clear Care is 3% hydrogen peroxide, which will cause severe burning if used directly in the eyes or as a soaking agent in typical contact lens cases. The Clear Care case has a built-in neutralizer—a ring of platinum that reacts with hydrogen peroxide—that causes effervescence and changes hydrogen peroxide into water. The process takes about 6 hours, and only the special accompanying lens case can be used to neutralize the hydrogen peroxide. After the disinfecting and neutralizing step is completed, the lenses can be removed from the case and placed in the eyes. Contacts must never be rinsed with the hydrogen peroxide solution and placed directly into the eye. The entire disinfecting and neutralizing step must be completed. As hundreds of Internet descriptions and FDA MedWatch reports demonstrate, not doing so can cause pain, burning, and chemical injuries to the eye, including epithelial tissue injuries. Almost all cases have occurred when patients confused Clear Care or a generic product with other cleaning and disinfecting solutions, including saline, despite manufacturer labeling with warnings that are intended to help avoid misuse.
With ongoing reports, we encourage healthcare providers to warn consumers about this risk, and we urge manufacturers of these products and FDA to do more to assure safe use if they remain on the market. One required improvement should be better design and placement of the warnings. In the case of Clear Care, a red band at the top of the container (see picture in PDF version) states, “Use only lens case provided. Do not rinse lens with Clear Care prior to insertion.” You must turn the container to see the entire statement, and if read, the statement may not be a clear warning. Some will think, “Why use the special lens case when I have my own case.” As for the statement about not rinsing lens with the solution prior to insertion, no doubt some will misinterpret this statement to simply mean they need not rinse the lenses that have been soaking in the solution prior to insertion. Those who do not routinely rinse their lenses with saline prior to insertion may simply ignore this statement, thinking it doesn’t apply to them.
Warnings should be printed in their entirety on the product’s front label panel near the product name, as well as in other locations so it can be seen no matter how the product is oriented. Consumers might not turn the product to look for a warning if they don’t know the warnings are present. With Clear Care, there is also a red paper ring on the neck of the bottle that reads, “Use only lens case provided,” “Do not put Clear Care directly into the eye,” and “Do not rinse lens with Clear Care prior to insertion.” However, again, the bottle or ring must be turned to read all the statements, and to some users, these may not seem important. The ring may also be removed (see picture in PDF version) or come off if the paper gets wet, as it might if the product is used near the bathroom sink.
We’d also like to see much stronger warnings on both the bottle and the carton panels and flaps. The words “WARNING” or “DANGER” should precede a statement about the consequences of not following directions. It should also be noted that some people might not be able to read label instructions without their contacts in place. A different container shape would also be helpful so people won’t see this product as just another multipurpose cleaner and disinfectant. Human factors testing is also in order.
For an overview on the application of warnings, see our August 24, 2006, newsletter article at: www.ismp.org/Newsletters/acutecare/articles/20060824.asp.
- Questionable safety with continuous inhalation albuterol
Some facilities have pharmacy staff add albuterol inhalation solution to an IV bag; the solution is intended for respiratory therapy use with an infusion pump for continuous administration into a nebulizer and face mask for patients with status asthmaticus. In order to use this mixture with an infusion pump, the 100 mL bag is spiked with IV tubing, and the distal end of the tubing is cut off just above the Luer connector. This allows the end of the tubing to be jury-rigged so it connects to the nebulizer, which is attached to a face mask. One concern with placing albuterol in an IV bag is the risk of accidental IV infusion of the bag contents. But another concern has also surfaced. Recently a nurse discovered that a patient’s IV methylPREDNISolone and famotidine were being infused into the “Y” port on the IV tubing that was connected to the nebulized albuterol rather than the intended IV line. As a result, this patient did not receive his systemic steroid or H2 antagonist, and he likely received diluted albuterol when these medications were injected into the tubing connected to the nebulizer.
After identifying the error, the patient’s treatment was changed to intermittent albuterol via the nebulizer—where the medication is added directly to the nebulizer cup prior to each treatment—and oral corticosteroids. His condition improved once he began receiving his medications as intended. The hospital has recently changed its delivery method and is now adding albuterol inhalation solution directly into a nebulizer cup, instead of employing the more risky continuous infusion from an IV bag.
- Errors with Insulin
In reported events in Pennsylvania (PA) involving insulin products, 52% led to situations in which a patient may have received or did receive the wrong dose or an omitted dose of insulin. Visit the PA Patient Safety Authority’s Web site to download a sample tool with outcome and process measures that can be used to identify and monitor problems with the use of insulin. ISMP is contracted through ECRI Institute to provide analysis and recommendations on medication-related reports submitted to the PA Patient Safety Authority (through the PA Patient Safety Reporting System).
- Invanz or IV Vanc?
A handwritten recommendation in the progress notes for “Invanz 1 g q 24h” was misread by a physician as “IV vanc (vancomycin) 1 g q 24h;” vancomycin 1 gram IV every 24 hours was subsequently prescribed. Although a 1 g dose every 24 hours may be appropriate in patients with renal insufficiency, the error was identified by a pharmacist prior to reaching the patient because the dose was too low for this patient without renal impairment. Both are antibiotics. Vancomycin is sometimes improperly referred to as “vanc” or “vanco,” increasing the risk of errors if after this incident was reported, an annual review of the hospital’s sound- and look-alike drug names list occurred at a pharmacy and therapeutics meeting. A physician raised the issue of confusion, mentioning a similar event in the past. In fact a May 15, 2002 article in the ISMP Medication Safety Alert! carried a Safety Brief about the exact same type of error, which led to a patient receiving vancomycin in error. As a result of the above error, pharmacists in this health system were notified via email of the potential for confusion. Awareness of this error, electronic medical records, computer alerts, printed antibiotic order sheets, and prohibiting the use of drug name abbreviations may be helpful in preventing this mix-up.
- Confusion between Casodex and Kapidex
There have been reported instances of medication errors due to name confusion between KAPIDEX (dexlansoprazole) and CASODEX (bicalutamide). Both written and verbal prescriptions have been dispensed in error. Kapidex is indicated for healing of erosive esophagitis, maintenance of healed erosive esophagitis, and treatment of symptomatic nonerosive gastroesophageal reflux disease (GERD). It is available as 30 mg and 60 mg delayed-release capsules for oral administration. Casodex is indicated for use in combination herapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of stage D2 metastatic carcinoma of the prostate. Casodex is available as 50 mg tablets for oral administration.
Patients who receive either drug in error could be unnecessarily subjected to unintended effects and/or adverse events. Specifically, Casodex is contraindicated in women. To reduce the potential for medication errors, please take time to verify written or verbal orders and build an alert in your computer system. If you are a prescriber, please include the drug’s purpose on prescriptions.
- Confusion between Kapidex and Capadex
In addition to an alert posted today about mix-ups between Kapidex and Casodex, we also heard from a pharmacist who received a prescription from a doctor’s office via telephone for Kapidex. The office nurse had misspelled the drug as “Capadex,” probably because she heard the doctor pronounce the drug name and then transcribed it phonetically. When the pharmacist tried to enter the medication into the computer, he could not find “Capadex.” The pharmacist asked others in the pharmacy if the prescribed drug could be Casodex. Meanwhile, one of the pharmacists searched “Capadex” using Google to see if it was an actual product. He saw many listings for “Capadex” as well as a listing for Kapidex. But “Capadex” is a foreign product containing acetaminophen and propoxyphene (similar to available in Australia and New Zealand, and online.) At least one site advertises that no prescription is needed.
We’ve notified FDA about this new issue associated with the brand name “Kapidex.” Given that the name is being confused with Casodex and could lead to dangerous confusion with the foreign product Capadex, this might be a case where a name change is appropriate.
- Baclofen programming error with SynchroMed II pump -
Facility not made aware of company’s software updates
A recent error while programming a Medtronic SynchroMed II implantable pump led to a significant baclofen overdose in a patient with muscle spasticity, causing persistent weakness in his lower extremities. A few months earlier, the pump had been implanted to deliver baclofen intrathecally, which achieves cerebrospinal fluid drug levels up to 30 times higher than those achieved with oral doses while maintaining low serum concentrations to minimize the drug’s side effects.(1)
On the day of the error, the patient visited his physician for a pump programming change. Because the patient’s symptoms from his disease were worse in the mornings, the physician wanted to reprogram the pump to deliver an extra bolus dose of baclofen over 1 hour each morning. A small, portable N’Vision Clinician Programmer (http://professional.medtronic.com/devices/synchromed-II-for-pain/programmers-and-accessories/index.htm) was used to reprogram the pump. The programmer is equipped with a touch screen display for data entry, a telemetry head that must be placed as close as practical to the implanted pump, and a port through which communication can be established with compatible printers. A therapy application card that contains application-specific software is supplied separately.
Various programming options exist with the SynchroMed II pump, including a “flex mode,” which allows practitioners to program a sequence of independent dosing intervals to deliver more or less drug at scheduled times each day when patients experience increased or decreased symptoms. In this case, the physician accidentally programmed the small bolus dose intended for each morning in a manner that changed the overall delivery to a 60 mcg dose every hour throughout the day, rather than 60 mcg per day.
Shortly after arriving home, the patient experienced increasing weakness and called his physician, who suspected that a programming error had occurred. The physician asked the patient to return to the office immediately. For undetermined reasons, the patient failed to return to the physician’s office but presented in the emergency department (ED) 5 hours later and was admitted to the intensive care unit. The patient was hospitalized for 13 days until strength in his legs was adequate for safe ambulation at home.
During discussion of this event at the hospital, another physician familiar with Medtronic implantable drug delivery and neurostimulation devices recalled that she had heard elsewhere that the company had made software updates to the N’Vision Clinician Programmer to help reduce the risk of errors. After an investigation, it was determined that a letter or notification about the software updates was never communicated to this provider.
Medtronic had issued a letter (currently on our Web site at: www.ismp.org/docs/medtronics.pdf) to healthcare providers in February 2009 to alert SynchroMed II and SynchroMed EL pump users to reports of under- and overdoses that resulted when programming the pumps, particularly bolus doses. The letter informed providers that modifications had been made in the software application card used with the N’Vision Clinician Programmer. For example, changes were made to: the navigation screens for priming bolus doses and bridge bolus doses (to clear old drug from the fluid pathway when changing the drug or concentration); the summary screen, which, along with the total dose, now includes the percent of the dose increase or decrease from the prior setting; and the confirmation screen, which now recaps the total dose.
In the February 2009 letter, Medtronic noted that errors while programming the pumps can lead to serious patient injury, including death, and that the company wanted to ensure that customers were always using the most current version of the programmer software. However, it is not clear whether all potential healthcare providers who use the N’Vision Clinician Programmer are aware of the possibility of errors and the software update. One day after the adverse event, a Medtronic representative updated the software on two of the hospital’s N’Vision Clinician Programmers. The following day, the hospital called the company to learn why they had not heard about the software update in February 2009. A company representative told the hospital that the letter was not mailed directly to all healthcare providers; rather, the letter was often left behind in hospitals after sales representatives visited them to update the software.
If inpatient or outpatient providers in your organization care for patients with implanted SynchroMed pumps and program these pumps, please check that the latest software updates for the N’Vision Clinician Programmer have been provided by the company. The model 8870 versions AAG and AAJ software application cards should be replaced by version AAH or newer. If you have questions, contact your Medtronic representative or call Medtronic technical services at: 1-800-707-0933.
Also, advise ED staff to be aware of implantable drug pump-related adverse events, and to ask patients when the last refill and/or programming change occurred. If this has occurred within a few days of admission, there is an increased likelihood that an error occurred. For example, patients receiving intrathecal baclofen therapy might exhibit signs of an overdose—somnolence, respiratory depression, seizures, rostral progression of hypotonia, loss of consciousness, coma—or baclofen withdrawal (from a subtherapeutic dose)—pruritis without rash, diaphoresis, hyperthermia, hypotension, sudden increase in muscle spasticity and rigidity.2
1) Gaffen A, Nesic M, Coleman G. Intrathecal baclofen (Lioresal): suspected adverse incidents associated with implantable drug pump system. Canadian Adverse Reaction Newsletter. October 2005;15(4):1-2.
2) Medtronic. SynchroMed II programmable pumps implant manual (8637). 2003. Available at: http://professional.medtronic.com/downloads/itb/M221311A_a_014.pdf.
- Order by metric weight, not volume
A pharmacist who manages an electronic database for a health system told us that he frequently receives requests to use mL as the ordering unit with oral liquids (versus metric weight [e.g., mg, g]). The pharmacist wanted to know if we had a position that agreed with his, which is to prescribe oral liquid medications using metric weight. In the ISMP book, Medication Errors, we noted that, in most cases, it is un-acceptable to express doses or quantities in terms of dosage form or volume alone. Volume may be used along with a strength or concentration; for example, it is acceptable to prescribe 5 mL of a solution of 100 mg/5 mL (though unnecessary if the dose in mg is prescribed). It is also acceptable to prescribe by volume when: 1) there is no strength due to a combination of many ingredients, or no active ingredient (e.g., cola syrup); 2) when the active ingredient is available only as a liquid in a single strength (e.g., paregoric); and 3) when prescribing certain external-use items such as creams, lotions, and drops (e.g., “add 10 drops to vaporizer water”).
Usually, however, prescribing by volume alone presents a hazard. For example, Fer-In-Sol (ferrous sulfate) contains 15 mg of iron per mL while generics contain 15 mg of iron per 0.6 mL (25 mg/mL). The brand product contains 40% less elemental iron per mL than generics. If Fer-In-Sol is prescribed in terms of mL and generic substitution is allowed, the patient would receive nearly twice as much iron as intended. Healthcare providers should specify the dose in mg and alert parents when multiple concentrations are available.
- “UD” - ambiguous and dangerous abbreviation
A serious medication error resulted when a nurse did not know what “UD,” a medical abbreviation derived from Latin, meant. A pharmacist had added it to directions on an electronic nursing medication administration record (eMAR). The rate of infusion for an IV diltiazem solution was not yet known in the pharmacy, so the pharmacist who entered the prescription into the computer entered “UD” (ut dictum or “as directed”) from a drop-down list used to populate the rate field. The nurse, upon seeing the notation on the eMAR, thought it meant that the 125 mg infusion was a “unit dose” injection. The nurse proceeded to give the diltiazem at 125 mg/hour and infused the entire dose over 1 hour (the rate should have been 5 mg/hour). The nurse then requested and received another diltiazem drip from the pharmacy and administered the entire 125 mg infusion again over 1 hour. Pharmacy staff did not question why another bag was needed so soon. The patient later expired.
At a subsequent meeting to review the event, it was revealed that the majority of nursing staff thought “UD” meant “unit dose.” This is a great example of why pharmacists and doctors should NOT use Latin abbreviations that others may not understand. We agree with the hospital, which asked their computer system vendor to eliminate the ability to enter “UD” in the rate field. While some pharmacists and doctors are familiar with the abbreviation as learned in pharmacy school, it is as archaic as the apothecary system of measurement and should not be used because it’s too easily confused with “unit dose.”
We plan to add “UD” (for ut dictum) to our list of dangerous abbreviations posted on our website (www.ismp.org). We would also recommend that you help make other healthcare professionals in medicine, nursing, and pharmacy aware of this incident. Thank you.
- Safer catheter connectors in the UK
The National Patient Safety Agency (NPSA), a patient safety oversight government agency that is part of the National Health Service in the United Kingdom (UK), has just published an alert to ensure that as of April 1, 2011, all spinal (intrathecal) bolus doses and lumbar puncture samples will be performed using syringes, needles, and other devices that will not connect with IV Luer connectors. Further, as of April 1, 2013, all epidural, spinal, and regional infusions and boluses must be delivered with devices that will not connect with IV Luer connectors or IV infusion spikes. Currently, standard medical connectors (Luer connectors) are used in a wide variety of systems including the administration of IV, spinal, and other injections. Their wide use has exposed patients to the risk of accidentally delivering spinal and epidural medicines IV, and vice versa, with fatal results.
A full range of devices with safer connectors are not yet available. However, some new products are commercially available (www.neurax.co.uk) and representative industry groups and other key stakeholders support this initiative. It is believed that this move will stimulate additional manufacturers to develop safer connectors that will not allow a Luer connection. Copies of the Patient Safety Alert (being issued in two parts because there are two implementation dates), together with supporting information, are on the National Reporting and Learning Service (NRLS) website at: www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=65259.
- Lithium safety alert
In recognition of patient harm that sometimes occurs in patients taking lithium, the National Patient Safety Agency (NPSA) in England and Wales has released an alert on safer lithium therapy. The alert, sent to all healthcare organizations where lithium therapy is initiated, prescribed, dispensed, and monitored, requests compliance with safe treatment practices established by the National Health Service. These include informing patients of the known side effects or symptoms of lithium toxicity and scheduling regular blood tests, which are important as a basis for dose adjustments when appropriate. Clinically significant alterations in lithium blood levels may occur with commonly prescribed and over-the-counter medicines. The blood level of lithium is dependent on kidney function, and lithium has the potential to interfere with kidney and thyroid functions. The NPSA has developed supportive material for health professionals as well as a patient information booklet, lithium alert card, and a record book for tracking blood tests. The complete alert and links to the associated materials can be found at: www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=65426.
- Danger of withdrawing insulin from pen cartridge
A pharmacist received a call from a nurse who was concerned that a patient’s insulin pen did not deliver the correct dose of insulin. To identify the problem, the nurse took a standard insulin syringe, dialed the pen to 10 units, and injected the insulin into the syringe to measure how much would reach the patient. She found that the insulin syringe only contained 5 units. This was repeated twice with the same results. The pharmacist went to the nursing unit, repeated the experiment, and also got just 5 units. When laying the pen down on the table, the pharmacist noticed that an air bubble was visible. Knowing how that could affect insulin delivery from the pen, he obtained a new pen from stock and repeated the previous experiment. This time 10 units were measured in the syringe. The problem was traced to nurses using the pen cartridges as “mini” insulin vials by drawing the dose out of the pen cartridge with an insulin syringe. It’s a practice we’ve warned against because it’s known to lead to inaccurate dose measurement (www.ismp.org/Newsletters/acutecare/articles/20080508.asp).
When nurses are not sure how to use a pen, or encounter problems when using it, they may remove the pen cartridge and use it as if it was a vial. This can accidentally introduce air into the cartridge. Once any amount of insulin is withdrawn from the cartridge, it may no longer deliver the amount of insulin listed on the dispensing dial (and may also risk contamination of the remaining medication). In this instance, the patient was subjected to several injections and less effective blood glucose control because the pen was used in an unintended manner.
- Cetacaine bottles with Luer connector
While Cetacaine liquid (benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) continues to be available in spray and gel forms, the widely used local anesthetic is now also available in a bottle with a dispenser cap that is compatible with any Luerlock syringe. The product catalog can be viewed at: www.cetylite.com/pdf/productcatalog.pdf
The new presentation allows dentists and other practitioners to draw up small amounts (liquid in excess of 0.4 mL is contraindicated) and attach a special applicator tip to reach periodontal pockets to provide local anesthesia for scaling and root planing, without need for an injectable local anesthetic.
Cetacaine liquid is not suitable for injection. Given the potential for mix-ups with unlabeled syringes, the ability to draw the liquid into a parenteral syringe should be cause for concern in any patient care area where systemic injections might be administered. See our October 22, 2009 issue http://www.ismp.org/Newsletters/acutecare/archives/Oct09.asp#22 - for a related article about accidental injection of oral products.)
In marketing materials, the manufacturer, Cetylite Industries, mentions that the liquid can be used for “other procedures requiring site-specific topical anesthesia to accessible mucous membrane.” This may place the product into an area where systemic injections are administered.
We’ve contacted the company to express our concern and suggest the use of a non-Luer connector, with directions to use the product with a nonparenteral syringe (oral or topical syringe). We also suggested including “Topical Use Only” labels with the product to facilitate proper labeling. Our best advice, though, would be to avoid this form of Cetacaine if there’s any chance it might wind up in area where patients may receive systemic injections.