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Practitioners' Reporting NewsSummary of August 2004 CasesIssued September 30, 2004 The following summaries are a sample of reports submitted to USP's Medication Errors Reporting Program during the month of August 2004.
Copy Prescription Function Error description: A patient called in a refill request for Ultram®. The refill request was submitted to the physician and then canceled because the patient brought in a new prescription for Ultram®. Rather than enter a new prescription, the pharmacist used the "copy prescription function" on the computer to generate a new prescription from the previous prescription. The pharmacist failed to update the physician and also failed to update the directions. This error occurred during the morning shift of the first week of the month, which tends to be a busier than usual time. The patient noticed the error when reading the label and confirmed the correct usage of the medication with the pharmacist. Reporting pharmacist's recommendations: More complete review of prescription data fields after using copy prescription function on pharmacy software programs. Possibly develop a policy of having pharmacy technicians do all the computer entry and eliminate the use of the "copy prescription function."
Vicodin® or Vytorin™? USP received 2 reports on this potential name confusion. Take measures now in your facility to prevent this error from occurring. Potential error: Two separate practitioners informed USP that Merck/Schering-Plough announced that the Food and Drug Administration (FDA) approved the product Vytorin, a combination product containing the cholesterol-lowering agents ezetimibe and simvastatin. These practitioner's foresaw mix ups with Abbott's Vicodin, a combination product containing the pain medications acetaminophen and hydrocodone, because these brand names sound very similar when spoken. Reporting practitioner's recommendation: Change the name Vytorin before any patients are harmed.
And How About Voltaren® or Vytorin? Potential error: Be careful with the sound-alike names Vytorin and Voltaren (an anti-inflammatory). A pharmacist was speaking with a sales representative and could not get the product Voltaren out of his mind as the sales representative was talking about the product Vytorin. Reporting pharmacist's recommendation: The reporting pharmacist alerted all the facilities pharmacists via e-mail to be on the lookout for these products. The facility will most likely not add Vytorin to the formulary, but because there is a chance that patients can be admitted on this drug, a note of caution was issued.
No Salt Form on Haloperidol Vial Potential error: Novaplus' haloperidol injection is loaded in an automatic dispensing device in this reporting pharmacist's facility for use on the nursing units. A nurse removed a vial from the automatic dispensing machine to administer to a patient and was concerned because the label indicated "For IM use only." The nurse consulted the clinical pharmacist on the unit, who explained that although FDA approval was for IM use, haloperidol could be administered IV, but that it was only safe to do so for certain formulations. The pharmacist asked to see the vial to ensure that it was the lactate and not the decanoate salt. A review of the vial's label determined that the salt form of the medication was not listed on the label (see photo). Although Novaplus' labeling "For Immediate Release" does suggest IV use, only the package insert can verify this. When the pharmacist went back to the pharmacy to retrieve the package insert, he discovered that the drug was in fact the lactate salt. The package insert states, "Each mL of haloperidol injection USP contains 5 mg haloperidol (as the lactate)." Reporting pharmacist's recommendation: Their pharmacy is in the process of procuring a different brand of haloperidol injection to ensure that the salt will be identified on the label. Inservice education to pharmacy and nursing staff will also be conducted. Novaplus should make changes to include the salt on the label.
Pentostam—Misleading Labeling Error description: A patient received a 10x overdose of Pentostam, while being treated for cutaneous leishmaniasis (a parasitic disease spread by the bite of infected sand flies). Pentostam is an orphan drug with limited use and is not currently approved by the FDA. This drug was obtained as a non-formulary item through the Centers for Disease Control and is manufactured in England by Wellcome Pharmaceuticals. The pharmacy technician miscalculated that he needed 150 mL of solution, rather than 15 mL. Two vials of Pentostam were used to obtain 150 mL. Once mixed with 50 mL of 5% dextrose, there was a 200 mL solution ready for infusion. The pharmacist checked the admixture before it was dispensed, but did not catch the technician's error. The reporting nurse believes that the concentration printed on the label of the multi-dose vial is misleading. The emphasis is on the total volume in the vial. The strength per mL (100 mg/mL) is in much smaller type font and is buried in a text message, rather than clearly showing the concentration. In large part, this was a confirmation error by the technician, who prepared the admixture, and the pharmacist responsible for double checking the IV bag following preparation. Both parties looked at the 100 mL designation printed directly under the drug name, and thought the vial contained 100 mg of Pentostam. The patient experienced facial tingling at the time of infusion and numbness at the end, which resolved, and the patient was discharged. The error was discovered when the pharmacists were discussing an inadequate supply of Pentostam. The patient was contacted regarding the medication error and was transported to the nearest hospital for observation. After ensuring that the patient was stable, the patient was returned to the original facility, where the patient was vigorously hydrated with IV fluids. The patient's condition remained stable and he was discharged the next afternoon. The patient is being monitored on an outpatient basis. Reporting nurse's recommendation: With the return of military personnel from Iraq and Afghanistan, we will see more cases of cutaneous leishmaniasis. Therefore, it is important to disseminate the information experienced by this facility so that others can avoid a similar mistake.
Don't Dispense Desiccants to Patients! Error description: When picking up a prescription at the pharmacy, a patient was dispensed one prescription at the wrong dose. After complaining to the pharmacist, the patient decided to inspect her other prescriptions. When the pharmacy technician opened the stapled bag and handed the amber vial to the patient, both the technician and the patient noticed that there was an unusual looking capsule inside that was a different color and shape than the other capsules. When the technician poured out the vial's contents, it was discovered that a DriCap® desiccant cartridge had been counted and dispensed as one of the capsules. The reporting consumer believes that this is a patient safety issue, especially for the elderly or those who have poor vision. Patients could accidentally consume the cartridge, thinking it was the medication. Although the DriCap cartridge is nontoxic, patients could choke on it or it could result in the patient not receiving the required dose of the medication.
Another Abbreviation Error with QD vs. QID Error description: A physician used the abbreviation "QD" in an order for Flomax®. The "QD" when handwritten looked like "QID." Fortunately, the pharmacist interpreted the order correctly as "QD" during order entry. These error-prone abbreviations can easily be confused for one another. View USP's Abbreviations List.
Two Different Products, Same Lot Number? Potential error: The reporting pharmacist noticed that two different products from the same manufacturer contained the same lot number and expiration date. The medications are Cytoxan® 2 grams, National Drug Code (NDC) 00015-0506-41, and the Ifex®/Mesnex® 3 gram kit, NDC 00015-0557-41. Both contain the lot number KAD03 and the expiration date Jan 2007. The pharmacist contacted the manufacturer, Bristol-Myers Squibb, for clarification and was informed that this is a valid practice and that both drugs are safe to use. The pharmacist believes that this practice is not only confusing to healthcare professionals, but an unsafe practice in the event of a recall or other event requiring the tracking of either product. NOTE: USP's Center for the Advancement of Patient Safety (CAPS) contacted the Food and Drug Administration about this practice. While the regulations do not explicitly address this specific situation, CAPS has learned that this practice is uncommon among manufacturers and is not recommended. 21 CFR 211 requires firms to establish a system that allows for ready determination of the distribution of each lot of drug product to facilitate its recall if necessary, as well as labeling issuance and operational controls to prevent mix ups during manufacture or use.
Depakote® & Depakote® ER—Confusing Names, Now Similar Labeling Error description: Depakote® ER 250mg unit-dose tablets and Depakote® 250mg unit-dose tablets were found mixed in the same bin in an automated dispensing station during an inspection of a nursing unit by a pharmacist. The mix up was not discovered by the pharmacy technician who filled it, the pharmacist who checked it, or the pharmacy technician who delivered it. On investigation, the staff involved checked the two products unit-dose labeling, which are nearly identical in appearance and size. However, they did not turn over each unit-dose packet to check the tablet appearance-Depakote ER 250 mg is a white oval tablet with an imprint code of Abbott's logo and the letters HF, while Depakote 250 mg is a peach elliptical tablet with an imprint code of Abbott's logo and the letters NR.
This error did not reach a patient, but the reporting pharmacist believes it easily could have.
Similar Labeling: Timolol and Prednisolone Error description: Timolol 0.5% ophthalmic solution (15 mL bottle) was dispensed to a patient instead of prednisolone 1% ophthalmic suspension (10 mL bottle). Both of the products involved in this incident are manufactured by Pacific Pharma. The packaging is nearly identical—both boxes have a vertical blue stripe down the left-hand side and a pale yellow box toward the bottom of the package (timolol's yellow box contains the concentration, while prednisolone's yellow box contains the total volume). The practitioner reported that the look-alike packaging was significant enough to cause this error. Even though these products were stored separately at the time of the incident, both of these medications were relatively high-volume prescriptions for this pharmacy so the staff may have used visual cues to pull these products off the shelf. However, the reporting practitioner recognized that the error could have been prevented by checking the NDC number, as the middle three digits are dissimilar (801 vs. 119). Coincidentally, the patient had an appointment with their ophthalmologist immediately after picking up the prescription from the pharmacy and had the eye drops in hand. The physician noticed the wrong medication had been dispensed and intervened before the patient had the opportunity to administer any doses. Reporting practitioner's recommendation: These products are now tagged with a look-alike alert label and continue to be stored separately. The look-alike alert labels were also attached to the inventory boxes where these products are stored in the pharmacy, prompting staff to double check the NDC number. Look-alike alert messages will also print out on the label the pharmacist uses to check a prescription to alert them to the potential for confusion with these products. In addition, the reporter would find it extremely helpful if the manufacturer could better differentiate between the packaging of their various eye drops.
Lyophilized Cytoxan® Discontinued—BE CAREFUL: New Formulation has Different Reconstitution Instructions! Potential error: Bristol-Myers Squibb has recently discontinued the lyophilized formulation of Cytoxan (cyclophosphamide) injection. According to the reporting pharmacist, the company has not yet communicated this change despite the fact that the new product is being actively distributed and includes new instructions for reconstitution. The new formulation does not contain mannitol and, as a result, there is a significantly smaller amount of powder in each vial for reconstitution. The pharmacy IV technicians questioned the small amount of powder in the vial, which lead to further investigation. The only difference in the new label is the removal of the word "Lyophilized" above the brand name. The lyophilized product was reconstituted with sterile water, while the new formulation requires that it be reconstituted with 5 mL of normal saline. The package insert states, "CYTOXAN solution in water is hypotonic." Pharmacies that prepare Cytoxan for direct IV infusion should recognize this difference and change their preparation to include the use of normal saline. Reporting pharmacist's recommendation: Information was sent to all staff including nursing staff in the outpatient oncology clinic. The products images were also sent to help staff visualize the difference between the two products.
Preprinted Order Sheets—Only Good if People Use Them Error description: A patient received 80 units of insulin in a total parenteral nutrition (TPN). The patient became hypoglycemic and the TPN was held. A drop in blood glucose alerted the physician to check the TPN to determine the insulin amount that was added. The physician called the pharmacy to say that he actually ordered 8 units of insulin. The cause of this error was due to two factors. First, the physician did not use the appropriate section of the preprinted order sheet to write the insulin dose, which leaves a space for the number of units (i.e., ____ units/day). Instead, the physician wrote under the "Additional Additives" section. Second, the physician wrote the order as "Insulin reg 8Units." Since there was no space between the letter "U" and the number 8, the pharmacist misinterpreted the dose as 80 units rather than 8 units. It is also important to note that using "units/Units" vs. "U" is not foolproof either. It is essential to stress that a space must be left between the number and the word units. Reporting pharmacist's recommendation: Some changes that will occur due to this event: 1) the preprinted TPN order form will be revised to bring it up-to-date and allow additional room for writing numbers and include all potential additives on the form to avoid handwriting issues, and 2) if any additives are written on the form, a telephone verification with the physician is required to confirm the handwritten additive drug and dose. There was discussion of giving potential guidelines/parameters for adding insulin to the TPN, such that doses that are outside a specified range would be questioned before adding. That range could vary, so more discussion is needed to facilitate a workable solution.
Repackaging Can Lead to Errors... Potential error: A facility repackaged a bottle of bupropion hydrochloride 150 mg sustained release tablets by Watson (generic equivalent for Zyban®). In small red letters in the upper right-hand corner of the manufacturer's label is printed, "As an aid to smoking cessation treatment." This information was not included on the facilities repackaged product. Watson also distributes a bupropion hydrochloride which is equivalent to Wellbutrin SR® without the statement in red font. The NDC number on the Zyban equivalent is 0591-0867-60 and the Wellbutrin SR equivalent is 0591-0839-60. In addition to the facilities repackaging being similar, the tablets themselves look identical to one another, except that the imprint codes on the tablets are different (839 is stamped on the Wellbutrin generic and 867 is stamped on the Zyban generic.  Photo of facility's similar repackaging and Watson's similar bupropion sustained release 150 mg tablets**
An Extended Release Conundrum Potential error: A major concern was expressed over the generic bupropion products that have been appearing on the market (specifically Watson, Teva, and Eon). As you may know, Wellbutrin® (immediate release) and Wellbutrin SR (sustained release) have been on the market for some time. Wellbutrin XL™ (extended release) is also available, which is a once-daily dosage form. Now, generic versions for Wellbutrin SR have been approved. The concern is that some of these generics say "Sustained Release," some say "Extended Release," and one product (by Teva) says "Budeprion™ SR Extended-Release." Wellbutrin SR is labeled sustained release, but the generics that are supposed to be equivalent to it are labeled extended release. This would not be a problem if Wellbutrin XL had not hit the market. There is a real potential for medication errors to occur (i.e., pharmacists dispensing the generic "extended release" bupropion for Wellbutrin XL). This will become even more of a problem if/when Wellbutrin XL loses its patent and once-a-day generics appear on the market. This labeling issue can cause wide-spread confusion for pharmacists, doctors, and nurses, resulting in the wrong medication, dose, and time intervals. Eon Labs product is labeled as twice-a-day, but this may just be a band-aid and does not fix the problem. Note: Practitioners should be aware that for compendial purposes, USP considers "extended release" to encompass all prolonged release rates, except for delayed release. Reference USP 27–NF 22, General Chapters <1151> Extended Release Tablets, pg. 2589:"Extended release tablets are formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. Expressions such as 'prolonged action,' 'repeat action,' and 'sustained release' have also been used to describe such dosage forms. However, the term 'extended-release' is used for Pharmaceutical purposes, and requirements for Drug release typically are specified in the individual monographs."Therefore, the current USP–NF monograph for bupropion hydrochloride requires that generic manufacturer's label their products as extended release, even though they are equivalent to the innovators product Wellbutrin SR. USP and the FDA are aware of the complications this labeling poses and are working together to resolve this problem.
Bar-Code Technology—Did You Scan the Right Product? Error description: Two products, both manufactured by Able Laboratories, have similar packaging and strengths—prochloperazine 25mg suppositories and promethazine 25mg suppositories. To complicate the matter, the beginning and ending portions of the names are the same (i.e., "pro" and "azine"). A pharmacy technician, not noticing the difference between these two products, put them together in the refrigerator (prochlorperazine does not require refrigeration, only promethazine does). During dispensing, the two different products were mixed in the same order. Although the product's bar code was scanned before a label was printed (a very effective mechanism in reducing medication errors where the wrong medication is labeled) this error occurred because two packages were used to fill the order. The correct package was scanned, which produced the correct label, but the second package used to complete the order was incorrect. Reporting pharmacist's recommendation: Educated all staff about the difference between these two products, that only promethazine suppositories require refrigeration, and that these two products should be stored separately. Also, pharmacists have put these two medications on a "triple-check list."
Relafen® vs. Robaxin® Mix Ups From February-August 2004, USP has received 3 reports on this particular mix up. In all 3 cases, the error reached the patient. Error description: A customer brought in a new prescription for Relafen (nabumetone) 750 mg. It was filled with methocarbamol (Robaxin) instead. At the time, the facility's computer could not substitute the generic (nabumetone) for Relafen. The pharmacist mistakenly thought that the generic for Relafen was methocarbamol. The error was discovered when the patient called another pharmacy to refill the generic Relafen and the pharmacist could not find it on file to transfer the prescription. Reporting pharmacist's recommendation: Computers are now able to substitute the generic for the brand for this medication, and special notice is taken when prescriptions for these medications are being filled. Reports can be submitted online at www.usp.org/patientSafety/mer/ or by requesting a form at 1-800-23-ERROR (1-800-233-7767). *Photos provided courtesy of the reporter or the Institute for Safe Medication Practices.
†Image reprinted with permission from the Lexi-Comp Online™ Drug Identification database. © 2004
Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices. |
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