March 2016 Volume 15 Issue 3

Do not let “Depo-”medications be a depot for mistakesPROBLEM: Several longstanding medications are available on the market with namesthat begin with the prefix “Depo-,” meaning they are administered via a depot injectionthat deposits the drug into localized tissue from which it is gradually absorbed by sur-rounding tissue. These injections, typically subcutaneous, intramuscular (IM), or intra-articular, allow the active compound to be released consistently over a longer period oftime. Many of these medications with the prefix “Depo-” have been on the market for30 to 50 years, some even longer. Misadministration of these medications and confusingone “Depo-” medication with another has been consistently reported throughout theyears. More recently, mix-ups between different strengths and volumes of containers ofa “Depo-” drug have occurred. The “Depo-” medications most often involved in outpatientwrong route, wrong drug, or wrong strength/volume errors can be found in Table 1.

Examples of error reports submitted to the US Food and Drug Administration (FDA) Ad-verse Event Reporting System (FAERS) and/or the ISMP National Medication Errors Re-porting Program (MERP) are provided below.

Depo-Provera vs. Depo-MedrolIn early 2015, FAERS received a report involving a 44-year-old man with shoulder pain (non-impingement)who received an intra-articular injection of Depo-Provera instead of Depo-Medrol. A box of Depo-Proverahad been stored inadvertently in the bin where Depo-Medrol was usually kept in a medication cabinet. Otherthan size, the medication cartons do not look similar,but both drug names start with “Depo-” and appear inthe same black font (Figure 1). The physician perform-ing the shoulder injection reached into the bin and re-moved a box of the correct medication, Depo-Medrol,and read the label and concentration. He set that carton aside, and a moment later, heinadvertently reached back into the bin and removed another box, but this one contained

Confusing warfarin tablet color.We’ve received two recent reportsabout confusion regarding warfarintablet colors. One report specificallynoted a problem with the 2.5 mgtablet color used by Exelan Pharma-ceuticals. Although brand and genericwarfarin tablet manufacturers seemto have standardized the green tabletcolor for the 2.5 mg tablets, the Exelangeneric 2.5 mg product is a lightshade of blue, which is not far off fromthe COUMADIN or JANTOVEN4 mg tablet, which also is a shade ofblue (Figure 1). In fact, we’ve also

noticed someother color dif-ferences amongtablet strengthsbetween vari-ous warfarinmanufacturers.H e a l t h c a r epract i t ionersand patientshave becomeso accustomedto standard col-ors for the vari-ous strengths ofwarfarin tablets,

that any color difference raises con-cerns, as happened here when pa-tients and health professionals raisedquestions. The blue color of the Exelantablet could also contribute to dis-pensing errors if confused with blueJantoven or Coumadin 4 mg tablets.We contacted Exelan to ask them totry to match the green color used byother manufacturers for the 2.5 mgtablets.

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Figure 1. Both “Depo-” products havebeen mixed up, despite dissimilarcarton labels.

Figure 1. Exelanwarfarin 2.5 mg (top),Coumadin 2.5 mg(middle), and Jantoven2.5 mg (bottom).

Brand Name Generic Name Route DescriptionDepo-ProveraDepo-Provera Contra-ceptive InjectionDepo-SubQ Provera 104

medroxyPROGESTERoneacetate

IM Subcu-taneous

A progestin used as acontraceptive, or to treat endometriosis orendometrial carcinoma

Depo-Medrol methylPREDNISoloneacetate

IMIntra-articular

An anti-inflammatory orimmunosuppressive corticosteroid

Depo-Testosterone testosterone cypionate IM An androgen used totreat male hypogonadism

Table 1. “Depo-” medications most often involved in outpatient medication errors.

March 2016 Volume 15 Issue 3 Page 2

Depo-Provera. Believing he had previously confirmedthe drug and concentration, the physician withdrewthe desired amount of an opaque white liquid similarin appearance to Depo-Medrol (Figure 2). The physi-cian injected about three-quarters of the 1 mL volumehe had withdrawn into the syringe (about 112 mg ofDepo-Provera). A medical assistant discovered the errorwhile cleaning up after the patient had left the office.Within 3 days of injection, the patient experienced alack of libido and had erectile dysfunction, which re-quired prolonged use of testosterone and CIALIS(tadalafil). Since making the error, the physician learnedthat others have made the same error, mixing up Depo-Medrol and Depo-Provera.

Depo-Medrol vs. Depo-ProveraSeveral years ago, ISMP received a report of a similar mix-up, again leading to patientharm, but in this case, the patient was supposed to receive Depo-Provera but receivedDepo-Medrol in error. A 19-year-old woman went to a clinic to receive an injection ofDepo-Provera for contraception, which was to be repeated every 12 weeks. After providinga negative pregnancy test, the young woman was mistakenly given an intramuscularinjection of Depo-Medrol. The lot number of the vial of medication was recorded in hermedical record. The woman returned in 12 weeks and reported a positive home preg-nancy test. An ultrasound confirmed the preg-nancy, with an estimated date of conception about3 ½ weeks after her first injection. The error wasuncovered when the documented lot number wasfound to be associated with Depo-Medrol.

In this case, Depo-Medrol and Depo-Provera hadpreviously been stored in separate cabinets. How-ever, a few days before the event, the medicationcabinets had been consolidated, and the medica-tions were stored alphabetically in bins. The stockin the consolidated cabinet had been labeled withDepo-Provera and Depo-Medrol, which werestored next to each other. Working with only averbal order for the drug, the clinic staff had acci-dentally selected a vial of Depo-Medrol insteadof the intended Depo-Provera.

Wrong strength Depo-TestosteroneISMP has received reports regarding potential errors with Depo-Testosterone for whichthe wrong strength or volume of the drug might be administered to patients. This drugis available in two strengths: 100 mg/mL and 200 mg/mL. The 200 mg/mL strength isavailable in a 1 mL vial and a 10 mL vial. However, the vial sizes are extremely hard todifferentiate when looking at the medication cartons (Figure 3).

Aggregate reportsAnalysis of aggregate data regarding mix-ups between Depo-Medrol and Depo-Proverabetween 1999 and 2015 identified 5 additional cases reported to FAERS and 4 more re-

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Safety opportunities with NY e-Rx re-quirement. Beginning March 27, 2016,prescribers in New York (NY) Statemust utilize electronic prescribing (e-Rx) or face fines, license revocation,or even prison. Except in emergenciesor a few other exceptions, handwrittenand printed prescriptions will soon be-come a thing of the past in NY (www.ismp.org/sc?id=1697). Other states willlikely follow suit. Minnesota alreadyhas such a rule, although without con-sequences for noncompliance. The NYlaw requires a secure, encrypted, orencoded system for electronic trans-mission from prescriber to pharmacy,computer to computer. Emailed pre-scriptions are not allowed; a faxed pre-scription for non-controlled drugs isallowed under certain circumstances.

This is a well-intentioned rule that willlikely reduce errors due to poor hand-writing and will hopefully provide pre-scribers with clinical decision support.However, as with most changes, un-intended consequences couldemerge. For example, the risk is ele-vated for errors due to selecting thewrong medication among look-alikedrug names from a drop-down list.This type of error would be hard todetect without knowing the intendedpurpose of the prescribed medication.Strategies that would help, such ascommunicating each medication’s pur-pose and counseling patients, are notmentioned in the legislation. We hopehealthcare practitioners will keepthese strategies in mind. We also hoperegulations will be written to assistpractitioners in understanding and im-plementing this legislative mandate.

Also missing is a provision for ensur-ing that patients receive a printout atthe prescriber’s office that lists newlyprescribed medications. Otherwise,how will patients know what they’resupposed to receive? The prescriber

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Figure 2. Vials look dissimilar except forthe “Depo-” part of the drug name andthe opaque white liquid inside the vial.

Figure 3. Can you see the difference? Thelabeling on cartons of Depo-Testosteronemakes it difficult to notice that one containsa 1 mL vial (L) and the other a 10 mL vial (R).

March 2016 Volume 15 Issue 3 Page 3

ported to the ISMP MERP, for a total of 11 reports. One of the events occurred as recentlyas December 2015, although no harm occurred when the patient received an injectionof Depo-Medrol instead of Depo-Provera. The reported errors were distributed evenlyfrom 1999 through 2015; therefore, we did not find any trends in the occurrence of theerrors over time. In most (n = 7) of the cases, Depo-Provera was the intended drug andDepo-Medrol was administered instead. The errors occurred in a variety of settings, so itis difficult to associate patterns of error within a specific clinical setting. Five of thereports identified the Pfizer Depo-Medrol 80 mg/mL vials, and 2 involved the PfizerDepo-Provera 150 mg/mL vials (both distributed by Pharmacia & Upjohn, a division ofPfizer). In four of the 11 cases, both products were available as unit stock. This may havecontributed to errors due to the similarities in the names. For example, confusion mayhave occurred if staff misread the correct drug name when stocking the drug product(i.e., stocked in the wrong bin) and then the wrong drug was selected prior to adminis-tration, leading to a medication error. Other than name similarity, none of the reportsidentified container labels or carton labeling similarities as a contributing factor.

The recent close calls associated with Depo-Testosterone (n = 2) were both caused byvolume or strength confusion due to look-alike labeling and packaging.

SAFE PRACTICE RECOMMENDATIONS: Today, the “Depo-” naming convention would bea concern for FDA based on its proprietary name review criteria (www.ismp.org/sc?id=423). However, when these drugs were first approved, the risk associated withthis prefix was not considered. It would be very difficult to change the names of theseproducts today—it may even make the risk of errors greater since these drug names arewidely recognized. However, there are steps manufacturers, regulatory agencies, andhealthcare practitioners can take to reduce the risk of potentially harmful mix-upsbetween these medications, strengths/container volumes, and routes of administration.

Manufacturers and regulatory agenciesClarify labeling.Address the look-alike labels and packages of Depo-Testosterone assoon as possible. Most people look at the 1 mL and 10 mL vials and fail to realize thatthey are not the same.

Enhance warnings. Make warnings against intravenous (IV) use of depot productsmore prominent. The warnings should be clearly visible on the front label panel ofcartons and vials, not on the back.

Healthcare practitionersKeep vials apart.Separate the storage of the “Depo-” medication vials in the pharmacyand in all clinical settings where these drugs are stocked. Store only one medication ineach bin or other storage container. Evaluate whether all of these drugs need to bestocked in patient care areas.

Differentiate the products. Consider stocking Depo-Provera in prefilled syringes forsingle patient use instead of single-dose vials. Depo-SubQ Provera 104 is available insingle use 0.65 mL (104 mg) prefilled syringes for subcutaneous injections, and Depo-Provera 1 mL (150 mg) is available in prefilled syringes for intramuscular injections.Since Depo-Medrol is not supplied in prefilled syringes, this may increase differentiationbetween the two products, but only if staff know to expect Depo-Provera in a syringe.Thus, staff awareness is a necessary component of this differentiation strategy. This isimportant at the physician office or clinic as well as at the pharmacy since many com-munity pharmacies may dispense these products to office practices and clinics.

doesn’t always communicate thename, strength, and directions for us-ing the prescribed medication; if theydo, patients sometimes forget. Ideally,with e-prescribing, the prescribershould give the patient verbal instruc-tions, offer an opportunity to ask ques-tions, and provide the patient with acorresponding printout that lists theprescribed medication, dose, and di-rections for use. As long as the print-out isn’t on official NY State prescrip-tion paper, once the e-Rx is sentelectronically, the law does not pro-hibit a printout of current medications.This is a practice that should be en-couraged, and not just in NY! Phar-macists should encourage patients toask prescribers for a record of whatwas prescribed so they can know whatto expect, read about the drugs, andformulate any questions they mayhave for their pharmacists, or contacttheir physicians if they have concernsabout taking the medications.

Ambiguous abbreviation.One readercontacted us about a near miss. Anurse transcribed an order forNOVOLOG (insulin aspart) FLEX-PEN 20 units with the frequency ofadministration as “c B-L-D”. Thepharmacist initially misread the “B-L-D” as “BID,” but upon further reviewprior to submitting the order, noticedthe hyphens placed between the let-ters and requested clarification. Ap-parently, the nurse had written theabbreviation “B-L-D” to mean withbreakfast, lunch, and dinner.

This is the first time we have receiveda report involving this abbreviation.Even so, if not already done, thiswould be a good time to ban this ab-breviation and put out a reminder topractitioners that B-L-D should neverbe used in handwritten or electronicprescriptions. Ambiguous abbrevia-tions should be avoided when com-municating drug and patient informa-

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March 2016 Volume 15 Issue 3 Page 4

Limit access.Attempt to limit inventory of Depo-Testosterone to a single strength andvial size. Also evaluate which “Depo-” medications need to be stocked in clinics, andlimit access to those that can be dispensed as needed from a pharmacy.

Include auxiliary labels. Highlight or circle important information on labels to drawattention to it, or add an auxiliary label if necessary. For example, given the small font ofthe warning on Depo-Medrol vials, an auxiliary label that states, “IM Use Only” or “In-tra-articular Use Only” may be required. For Depo-Testosterone labels, circle or point anarrow toward the total volume in each vial.

Express generic names safely. Use tall man letters when expressing the genericnames of Depo-Medrol and Depo-Provera (i.e., methylPREDNISolone, medroxyPROG-ESTERone) to prevent confusion. When expressing generic names for Depo-Medroland SOLU-MEDROL (methylPREDNISolone sodium succinate), include the form ofmethylPREDNISolone (i.e., acetate, sodium succinate) to help differentiate the drugs.

Use barcode scanning. Implement barcode scanning to verify medications when dis-pensing medications. Explore the possibility of using barcode scanning prior to drugadministration at the bedside in clinic and procedural areas as a method to help mitigateconfusion that may lead to wrong drug medication errors. When used at the bedside,this technology confirms not only the drug but also the patient’s identity, dose, time,and dosage form of the medication being delivered. Track scanning compliance toensure that staff is using the technology.

Increase staff awareness.Assess staff understanding of the term “depot,” and increasetheir understanding regarding why “Depo-” medications should not be administeredIV. Be sure staff know the risk of confusion between “Depo-” products with similarnames, such as mix-ups between Depo-Provera and Depo-Medrol, or the risk of errorsrelated to labeling and packaging similarities with Depo-Testosterone.

If you would like to subscribe to this newsletter, visit: www.ismp.org/sc?id=386

ISMP Medication Safety Alert! Community/Ambulatory Care (ISSN 1550-6290) © 2016 Institute for Safe Medication Practices(ISMP). Subscribers are granted permission to redistribute the newsletter or reproduce its contents within their practice site or facilityonly. Other reproduction, including posting on a public-access website, is prohibited without written permission from ISMP. This is a peerreviewed publication.

Report medication and vaccine errors to ISMP: Call 1-800-FAIL-SAF(E), or visit www.ismp.org/MERP or www.ismp.org/VERP. ISMPguarantees the confidentiality of information received and respects the reporters’ wishes regarding the level of detail included in publications.

ismp.org consumermedsafety.org twitter.com/ISMP1 facebook.com/ismp1 medsafetyofficer.org

Editors: Michael Gaunt, PharmD; Michael Cohen, RPh, MS, ScD (hon), DPS (hon); Judy Smetzer, BSN, RN, FISMP; Ann Shastay, MSN, RN, AOCN. ISMP, 200 LakesideDrive, Suite 200, Horsham, PA 19044. Email: ismpinfo@ismp.org; Tel: 215-947-7797; Fax: 215-914-1492.

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tion. Pharmacists should not dispensedrugs until ambiguities are clarifiedwith the prescriber.

Health literacy toolkit. Only 12 percentof US adults have the health literacyskills needed to manage and navigatethe complexities of the US healthcaresystem. Patients’ ability to absorb anduse health information can be com-promised by stress or illness. Expertsrecommend assuming that everyonemay have difficulty understanding inorder to create an environment inwhich all patients can thrive. To ac-complish this, healthcare profession-als should implement universal pre-cautions to address health literacybecause they have no way of knowingwhich patients are challenged by lim-ited health literacy.

The Agency for Healthcare Researchand Quality (AHRQ) recently pub-lished the second edition of its healthliteracy universal precautions toolkit.The AHRQ Health Literacy UniversalPrecautions Toolkit, Second Edition(www.ismp.org/sc?id=1701) can helppharmacies and primary care prac-tices reduce the complexity of healthcare and enhance support for patientsof all health literacy levels. We took alook at the tools and found them tohave been done very well, particularlythe slide sets with the speaker’s notes.We encourage practitioners to putthese tools into practice and forhealthcare professional schools to in-corporate them into the curriculum forstudents about to go on rotations.

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