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Educating the Healthcare Community About Safe Medication Practices ISMP Medication Safety Alert! ® Community/Ambulatory Care Edition Volume 13, Issue 1 January 2014 QuarterWatch™ (Special Report) Adverse drug events in children less than 18 years old QuarterWatch™ is an ISMP surveillance program that monitors serious, disabling, and fatal adverse drug events (ADEs) reported to the US Food and Drug Administration (FDA) by manufacturers, healthcare professionals, and the public. The goal of QuarterWatch™ is to improve patient safety through the identification of signals that may represent important drug safety issues. The term signal means evidence judged to be substantial enough to warrant publication but which requires further investigation to determine its frequency of occurrence and establish a causal relationship to the suspect drug. The latest QuarterWatch™ examines ADEs in children less than age 18 that have been reported to FDA during a 5-year span between 2008 and 2012. Reporting Totals During these 5 years, 45,610 ADEs were reported in children less than 18 years old. Of these, approximately 64% (29,298) involved reports of a serious injury. The number of reports in children grew substantially over time—from 6,320 in 2008 to 11,401 in 2012. The rate of increase in pediatric reports (80%) was the same as the rate of increase for adult reports during that time. The 5-year totals included 2,935 (6%) deaths, 10,032 (22%) cases that required hospitalization, 774 (2%) cases that required intervention, 1,430 (3%) cases considered life-threatening, and 816 (2%) cases of disability. A U-shaped curve of the data revealed that the greatest number of cases occurred in the first year of a child’s life, then declined and leveled off until adolescence, when cases again rose rapidly. Comparison of Reported and Actual Events The 45,610 ADEs in children reported to FDA likely represent just a portion of the actual events, according to a 2009 FDA study.1 Data from various years and sources reveal that a mean of about 586,000 children visit the doctor’s office or other outpatient facility for treatment of ADEs, mostly involving mild rashes or gastrointestinal (GI) distress.2 More severe ADEs account for an additional 160,000 emergency room visits per year, mostly to treat unintentional overdoses and allergic reactions.3 More serious ADEs in children that cause hospital admissions are difficult to estimate. Published data suggest that approximately 1 to 2 per 100 children experience an ADE requiring medical treatment per year.1-3 Overall, improvements are needed to expand active surveillance and spontaneous reporting of ADEs in children.1 cont’d on page 2 Table 1. Most frequent suspect drugs in serious ADEs reported in children, 2008-2012 Rank Drug name Brand name* Cases Medical use* Psych** Most frequent ADE Second most frequent ADE 1 2 3 4 5 6 7 8 9 10 11 inFLIXimab montelukast somatropin baclofen ISOtretinoin methylphenidate lamoTRIgine lisdexamfetamine ARIPiprazole ibuprofen etanercept Remicade Singulair Nutropin Lioresal Claravis Concerta LaMICtal Vyvanse Abilify Motrin Enbrel 1,772 944 606 579 447 418 335 314 297 242 231 No Yes No No Yes Yes Yes Yes Yes No No atomoxetine QUEtiapine levETIRAcetam risperiDONE Strattera SEROquel Keppra RisperDAL 227 210 206 195 Crohn’s disease Suicidal ideation Serious headache Hypertonia Suicidal ideation Sudden death Seizures Suicidal ideation Weight increased Hypersensitivity Serious injection site pain Suicidal ideation Weight increased Seizures Aggression Ulcerative colitis Aggression Seizures Drug ineffective Depression Aggression Stevens-Johnson syndrome Aggression Dystonia Acute renal failure Vomiting 12 13 14 15 Crohn’s disease Asthma GH deficiency Muscle spasticity Acne ADHD Epilepsy ADHD Bipolar disorder Pyrexia Juvenile idiopathic arthritis ADHD Bipolar disorder Epilepsy Bipolar disorder Yes Yes Yes Yes Chest pain Tardive dyskinesia Drug ineffective Weight increased ISMP Medication Safety Alert! ® 15 Most Frequently Reported Drugs To identify signals of potential safety problems in children, a subset of serious adverse event reports that resulted from normal or expected use of the drugs was identified. These more restrictive criteria captured 16,992 reports involving 741 different drugs between 2008 and 2012. Just 15 (2%) of the 741 drugs accounted for 41% of all reports in this category during the 5-year period (Table 1 on page 1). Although only 6 of the 15 drugs have intended psychotropic effects, psychiatric adverse events were prominent for 10 of the 15 drugs. They included suicidal ideation (n=714), aggression (n=686), and abnormal behavior (n=580). Suicidal behaviors were not limited to thoughts of suicide but also included 274 completed suicides, 159 attempted suicides, and 100 cases labeled “self-injurious behavior.” Also reported were various forms of psychosis, including hallucination (n=276), psychotic disorder (n=124), and paranoia (n=74). QuarterWatch™ (cont’d from page 1) Highlights of the List Three drugs used to treat ADHD. Psychiatric side effects, particularly suicidal behaviors, aggression, hallucinations, and other manifestations of psychosis, were predominant for methylphenidate (CONCERTA, RITALIN), lisdexamfetamine (VYVANSE), and atomoxetine (STRATTERA), three medications often used to treat attention deficit hyperactivity disorder (ADHD). Atomoxetine shares a suicidal behavior warning in official prescribing information similar to antidepressants. The two central nervous system stimulants, lisdexamfetamine and methylphenidate, are not required to warn about suicidal behaviors, even though such events were reported in 26% and 14% of all cases, respectively, in the data we analyzed. Previously, FDA studied the incidence of hallucinations and other forms of psychosis when taking the stimulants and required a warning about these potential adverse effects.4 FDA should also assess the need for a warning for the more frequently reported suicidal thoughts and behaviors. Non-psychiatric adverse effects were also reported with these three drugs. The most frequently reported adverse event for methylphenidate was 37 cases of sudden death; the prescribing information currently contains a warning about this, but the literature is mixed.5-6 Cardiac effects were also reported for atomoxetine, including chest pain (n=16), syncope (n=11), and prolonged QT interval (n=10). Movement disorders were reported for lisdexamfetamine, including dyskinesia (n=17), tics (n=16), and tremor (n=9). Weight loss or arrested growth was also reported for all three drugs. January 2014 page 2 Safety Briefs Review your “bagging” procedures. A patient came to the community pharmacy to pick up a completed prescription; however, the patient’s bag could not be located. Both the pharmacy computer system and the pharmacy robot’s computer system confirmed that the prescription had been completed. Pharmacy staff then checked all the bags in the will-call area. The patient’s medication was found in another patient’s bag. Both patients had the same last name. This is certainly not the first time we have heard of this type of error. We wrote about a similar event in our February 2009 newsletter. We have also seen this happen during observations in pharmacies. This error prompts us to call on pharmacies to review their current “bagging” procedures because, once in the will-call area, the chances are high that a bagging error will reach the patient. For example, pharmacies should consider using baskets or trays to keep labeled containers and receipts for one patient together through the production process until final verification. It is also important to strengthen strategies at the point-of-sale to catch any bagging errors that make it to the will-call area. Staff should consistently use 2 patient identifiers at the point-of-sale. Ask the person picking up the prescription to provide the patient’s name and date of birth. Compare the answers to the information listed in the computer system or printed on the prescription receipt and vial. Also, staff should check each prescription vial at the point-of-sale, even if this requires opening the bag. Involving the patient can provide an additional check. Present each prescription vial to the patient to verify that each medication is correct. While this will require some additional time at the point-of-sale, this step can help make sure the right patient receives the right medication. If your site is working to prevent bagging errors, please share your ideas by emailing us at: [email protected]. Unsafe frequency notation. Staff at a community pharmacy told us that they are receiving prescriptions from ophthalmologists that list administration times as “1xd,” “2xd,” and “3xd” to indicate once, twice, and three times daily dosing respectively. However, these designations can be misinterpreted as 1 dose, 1 day, or once daily. When the pharmacy receives prescriptions with these designations, the pharmacist must contact the cont’d on page 3 cont’d on page 4 Free customized medication safety alerts for consumers and caregivers. Details at: www.ConsumerMedSafety.org. ISMP Medication Safety Alert! ® Topical anesthetics for teething infants Lidocaine viscous is indicated for use as a topical anesthetic for irritated or inflamed mucous membranes of the mouth and pharynx and to reduce gagging when taking X-rays of the mouth or performing dental impressions. The US Food and Drug Administration (FDA) has not approved this product for use in children who are teething. Nevertheless, we recently learned about a tragic event involving twin 1-year-old infants who were prescribed lidocaine viscous for that reason. The first infant suffered a seizure at home, followed by cardiac arrest. She was successfully resuscitated by emergency medical services personnel and transferred to a hospital. Since the infant had been playing with toy beads, the initial impression was asphyxiation. Just two days later the second twin also had a seizure and arrested. Tragically, this twin could not be resuscitated. Upon hearing of the demise of the second twin, concern for toxic exposure and/or ingestion in the home was raised. Toxicology results for the first twin indicated toxic levels of lidocaine. It was learned that the infant’s primary care provider had prescribed lidocaine viscous 2% for teething/irritability. Toxic levels of lidocaine were also identified in the second infant. It’s unclear how the infants received an overdose of the medication. Although parents may like to rub topical anesthetics on their baby’s gums to treat teeting-related discomfort, the directions for use and potential for toxicity with these products are often not clear to parents and, sometimes, not even to their doctors. One issue is that the anesthetic effects may be short-lived, resulting in well-meaning parents using the product more often than recommended by the doctor or the product label. Parents have also been known to put the topical anesthetic into the infant’s formula, or to soak a pacifier in the solution and then put that in the baby’s mouth. This is a dangerous practice since it is difficult to determine the amount of medication the infant receives. Also, a portion of the medication often ends up being swallowed. When that happens, the mucous membranes of the throat may become anesthetized,1 which can affect the gag reflex and make it difficult to sense liquids during swallowing, increasing the risk of choking or aspiration. As for anesthetic products like ANBESOL and ORAJEL that contain benzocaine, the same can occur, plus methemoglobinemia is a risk.2 Methemoglobinemia can occur within minutes after exposure, even the first time the product is used. It isn’t very common overall, but children under 2 years of age appear to be at particular risk. In 2011, FDA issued an January 2014 page 3 prescriber to clarify the order. Luckily, no errors have been detected yet. It makes sense to avoid these administration time formats all together. Safety Briefs (cont’d from page 2) FDA compounding guidances. In response to the 2012 meningitis outbreak involving compounded drugs, the US Food and Drug Administration (FDA) is taking a more aggressive stance in regulating compounding activities, including those conducted at traditional pharmacies. In December 2013, FDA issued three draft guidance documents (www.ismp.org/sc?id=294) that carry out the newly signed Drug Quality and Security Act (DQSA). A key provision of one of the guidance documents, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (www.ismp.org/sc?id=295), is that a drug product which is compounded should be in compliance with the United States Pharmacopoeial Convention (USP) chapters (i.e., USP Chapters <795> and <797>) on pharmacy compounding. These USP standards provide guidance for both non-sterile and sterile compounding. FDA expects state boards of pharmacy to continue their oversight and regulation of the practice of pharmacy, including traditional pharmacy compounding. FDA also intends to continue to cooperate with state authorities to address pharmacy activities that may violate the Federal Food Drug and Cosmetic Act. For more details about USP Chapters <795> and <797>, consult the USP/NF. alert (www.ismp.org/sc?id=292) about the risks of over-thecounter benzocaine gels and stated that these products should not be used except under the advice and supervision of a healthcare professional. The American Academy of Pediatrics discourages topical anesthetic use (www.ismp.org/sc?id=293) and instead suggests using a rubber teething ring that’s been chilled in the refrigerator (not the freezer). One can also gently rub or massage the child’s gums with a finger. Pain medications like acetaminophen and ibuprofen can also be useful when given in conjunction with advice from a healthcare professional. The bottom line is lidocaine viscous is not approved by FDA for use as a treatment for teething. For safety reasons, lidocaine viscous and benzocaine gels or liquids should not be used for this purpose. References 1) Cohen MR, Levinsky WJ. Topical anesthesia and swallowing. JAMA. 1976; 236(6):562. 2) Moore TJ, Walsh CS, Cohen MR. Reported adverse event cases of methemoglobi-nemia associated with benzocaine products. Arch Intern Med. 2004;164(11):1192-6. ISMP Medication Safety Alert! ® Three antipsychotic drugs. The full spectrum of antipsychotic adverse drug effects that occur in adults was also reported in children for ARIPiprazole (ABILIFY), QUEtiapine (SEROQUEL), and risperiDONE (RISPERDAL). Suicidal behaviors were reported for all three drugs, accounting for 25% of QUEtiapine cases, 19% of risperiDONE cases, and 10% of ARIPiprazole cases. Reports of dyskinesia, tics, weight gain, and sexual organ adverse effects were seen for ARIPiprazole, QUEtiapine, and risperiDONE. The reports occurred in children being treated for a wide range of disorders but most frequently depression or bipolar disorder. QuarterWatch™ (cont’d from page 2) Asthma and acne drugs. Montelukast (SINGULAIR) for asthma and allergies, and ISOtretinoin (CLARAVIS) for acne, are notable examples of drugs with numerous reported psychiatric effects but no intended psychotropic action. Montelukast produced a high number of serious adverse event reports, predominantly psychiatric effects including suicidal behaviors, aggression, and depression. Reports surged in 2008, and then tapered off substantially. For ISOtretinoin, suicidal behaviors number among other prominent adverse effects, including birth defects, warranting consideration prior to use of this medication for severe and resistant acne. Other major reported adverse effects included depressed mood (n=101) and colitis (n=20). Analgesic and anticonvulsant drugs. Among the over-thecounter (OTC) and prescription analgesics used in children, ibuprofen produced an unexpectedly large number of cases (n=32) of severe hypersensitivity and skin reactions, notably Stevens-Johnson syndrome and toxic epidermal necrolysis. These skin reactions were seldom reported for acetaminophen and naproxen. Severe skin reactions were even more numerous for another top-15 drug, the anticonvulsant lamoTRIgine (LAMICTAL) (n=66), which currently carries a warning about this adverse effect in its official labeling. Its first-line use as adjunctive therapy for seizures should be reevaluated. Two anti-TNF agents. Reports for two anti-tumor necrosis factor (anti-TNF) agents showed that adverse events occurred in two different populations. InFLIXimab (REMICADE) events (n=1,772) primarily affected the GI tract and occurred in patients treated for GI tract disorders including Crohn’s disease and ulcerative colitis. The largest group of adverse events suggested treatment failures, which the manufacturer attributed to disease flares despite an overall benefit of treatment. Etanercept (ENBREL) adverse events (n=231) were primarily reported in patients treated for juvenile idiopathic January 2014 page 4 arthritis and psoriasis and were frequently related to infection and infusion site reactions. Because of differences in juvenile patient populations and likely differences in exposure (inFLIXimab has more indications for treatment in children), the 7-fold difference in the number of reported serious ADEs does not necessarily imply higher relative risks for inFLIXimab compared to etanercept. However, the results in both children and adults continue to show that anti-TNF agents are high-risk treatments requiring vigilance. Where Cases Were Few Three of the most widely used drugs in children accounted for few reported serious adverse events in our analysis. For example, 28 million pediatric patients out of a population of 74 million were prescribed amoxicillin and/or azithromycin in 2010.7 However, azithromycin accounted for only 51 reports over 5 years, and amoxicillin only 41 reports. Albuterol, another drug often used with children, was prescribed to about 7% of all children7 but accounted for only 56 serious adverse events in our primary analysis group. The low volume of reports for these medications may not only attest to the safety of these widely used drugs, but also reflect shortterm or intermittent use as well as very low reporting rates. Read the full report at: www.ismp.org/QuarterWatch. References 1) Johann-Liang R, Wyeth J, Chen M, et al. Pediatric drug surveillance and the Food and Drug Administration’s adverse event reporting system: an overview of reports, 2003-2007. Pharmacoepidemiol Drug Saf. 2009;18(1):24–7. 2) Bourgeois FT, Mandl KD, Valim C, et al. Pediatric adverse drug events in the outpatient setting: an 11-year national analysis. Pediatrics. 2009;124(4):e744–50. 3) Cohen AL, Budnitz DS, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. J Pediatr. 2008;152(3):416–21. 4) Mosholder AD, Gelperin K, Hammad TA, et al. Hallucinations and other psychotic symptoms associated with the use of attention-deficit/hyperactivity disorder drugs in children. Pediatrics. 2009;123(2):611–6. 5) Olfson M, Huang C, Gerhard T, et al. Stimulants and cardiovascular events in youth with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012;51:147–56. 6) Winterstein AG, Gerhard T, Kubilis P, et al. Cardiovascular safety of central nervous system stimulants in children and adolescents: population based cohort study. BMJ. 2012;345:e4627. 7) Chai G, Governale L, McMahon AW, et al. Trends of outpatient prescription drug utilization in US children, 2002-2010. Pediatrics. 2010;130(1):23–31. ISMP Medication Safety Alert! Community/Ambulatory Care Edition (ISSN 1550-6290) ©2014 Institute for Safe Medication Practices (ISMP). Permission is granted for duplication only for internal distribution at your practice site. Other reproduction is prohibited without permission by ISMP. Report medication errors to the ISMP National Medication Errors Reporting Program (ISMP MERP) at: www.ismp.org. ISMP is a federally certified patient safety organization (PSO). Institute for Safe Medication Practices, 200 Lakeside Drive, Suite 200, Horsham, PA 19044. Tel: 215-947-7797; Fax: 215914-1492. Email: [email protected]. This is a peer-reviewed publication. Three Unique Fellowship Programs The Institute for Safe Medication Practices (ISMP) is now accepting applications for Three 2014-2015 Fellowships ISMP Safe Medication Management Fellowships (Two Positions) FDA/ISMP Safe Medication Management Fellowship ISMP Safe Medication Management Fellowships (Two Positions) One Position Supported by Express Scripts Location and Term: The 12-month Fellowship commences summer 2014 at the Pennsylvania (near Philadelphia) office of ISMP. Relocation to the Philadelphia area is required. Description: The Fellowship offers a nurse, pharmacist, or physician with at least 1 year of postgraduate clinical experience an unparalleled opportunity to learn from and work with some of the nation’s experts in medication safety. Now in its 22nd year, the Fellowship allows the candidate to work collaboratively with practitioners in various healthcare settings to assess and develop interdisciplinary medication error-prevention strategies. FDA/ISMP Safe Medication Management Fellowship Location and Term: The 12-month Fellowship commences summer 2014. The Fellow will spend 6 months at the Pennsylvania (near Philadelphia) office of ISMP and 6 months at the Maryland (near Washington, DC) office of the US Food and Drug Administration (FDA). Relocation to the Philadelphia and Washington, DC, area is required. Description: The Fellowship, open to a healthcare professional with at least 1 year of postgraduate clinical experience, is a joint effort between ISMP and FDA’s Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, and Division of Medication Error Prevention and Analysis. The Fellowship allows the candidate to benefit from ISMP’s years of experience devoted to medication error prevention. At FDA, valuable regulatory experience is gained by working with the division focused on medication error prevention. A competitive stipend, 2 weeks paid vacation, and full health benefits are provided with all Fellowship Programs. How to Apply Information and applications can be found at: www.ismp.org/profdevelopment/. Applications can also be requested by calling 215-947-7797. Speak to ISMP’s Current Fellows Please join us on February 5, 2014, at 2:00 p.m. ET for a special, live conference call about the Fellowship programs. Current and past Fellows will describe their Fellowship experiences as well as plans for their post-Fellowship careers. They will also be available to answer any questions you may have about the Fellowship. To attend, please send an email to [email protected]. The application deadline for all Fellowship Programs is March 31, 2014. September-December 2013 ISMP AmbulatoryCare ActionAgenda One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent similar problems at your practice site. To promote such a process, the following selected agenda items have been prepared for you and your staff to stimulate discussion and collaborative action to reduce the risk of medication errors. These agenda topics appeared in the ISMP Medication Safety Alert! Community/Ambulatory Care Edition between September 2013 and December 2013. Each item includes a brief description of the medication safety problem, recommendations to reduce the risk of errors, and the issue to locate additional information. The Action Agenda is also available for download in a Word format at: www.ismp.org/Newsletters/ambulatory/actionagenda.asp. To learn how to use the ISMP Ambulatory Care Action Agenda at your practice site, visit www.ismp.org/newsletters/ambulatory/How_To_Use_AA.asp. Problem Issue Recommendation Organization Assessment Action Required/Assignment Date Completed Breath mints or melatonin 09/13 ISMP recently learned about an incident where a child shared what were thought to be breath mint film strips with other children at a school, but they turned out to be melatonin film strips. The packaging of these products are similar making it easy to mix-up the products. Also, both products are advertised in various flavors. Pharmacies should evaluate their over-thecounter (OTC) inventory for these products and consider not selling them. If these products are sold, evaluate how and where they are placed on the shelves and add a sign to alert people that these are dietary supplements. Consider placing these products behind the counter. QuarterWatchTM 2012 Annual Report: Anticoagulants, anti-TNF drugs, fentaNYL patches and alendronate ©2014 10/13 ISMP ISMP’s QuarterWatchTM 2012 Annual Report identified adverse drug events (ADEs) frequently reported to FDA. Anticoagulants, including dabigatran and warfarin, ranked highest in serious or fatal adverse events. Antitumor necrosis factor (TNF) agents ranked highest in regards to manufacturers’ expedited reports. Safety issues were also identified with fentaNYL patches including prescribing errors, patient self-administration errors, and accidental exposure to the patch. It was also identified that alendronate was 186 times more likely to be associated with bone and joint injuries compared to all other drugs after adjusting for the volume of reports. For patients on anticoagulants, ensure that proper follow-up monitoring is in place. Ensure patients taking anti-TNF agents are aware of the risks associated with taking these medications. Provide proper counseling to patients who are prescribed fentaNYL patches, including education to keep patches out of reach of children. If using alendronate, confirm patients are aware the FDA warns “optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.” See the full QuarterWatchTM report at: www.ismp.org/QuarterWatch/ pdfs/2012Q4.pdf. ZERIT (stavudine) – ZYRTEC (cetirizine) mix-up 09/13 An error occurred when taking a patient’s medication history. The antiretroviral agent stavudine was recorded instead of the antihistamine cetirizine. The brand names Zerit and Zyrtec are similar and when pronounced the generic names stavudine and cetirizine can sound similar. January 2014 Confirm an HIV diagnosis for any patient taking stavudine. When performing medication histories, ensure that all medications have an appropriate indication. ISMP MedicationSafetyAlert! Ò Community/Ambulatory Care Edition ACAA 1 September-December 2013 ISMP AmbulatoryCare Problem Issue Recommendation ActionAgenda Organization Assessment Action Required/Assignment Date Completed Low health literacy, a Rx for error 09/13 According to an American Medical Association report on health literacy, 50% of adults read at or below the 6th grade level and only 20% of adults can read at or above the 9th grade level. Patients unable to understand the instructions on how to properly take medications are more likely to experience unsuccessful management of treatment plans. Use the health literacy tools (www.ismp.org/ sc?id=296) developed for pharmacy by the Agency for Healthcare Research and Quality (AHRQ). Included is an assessment for pharmacies to use, a training program for staff, a script to be used for automated telephone prescription reminders, and a pill card that patients can use. Double-checking bingo cards 10/13 ©2014 ISMP A community pharmacy that serves retail clients, assisted living facilities, group homes, and rest homes recently delivered the wrong medication to a group home patient. A pharmacy technician inadvertently filled a bingo card with propranolol 40 mg instead of pantoprazole 40 mg. The patient received 4 doses of the wrong medication but did not exhibit any negative outcomes. Ensure the original medication stock bottle accompanies the completed prescription all the way to the verification pharmacist so a visual comparison of the tablets in the bingo card and the stock bottle can be made. Add a description of the medication to the bingo card label to better enable nurses or other staff to serve as a final check and identify when the incorrect medication has been placed in the bingo card. Influenza vaccine – shake well 12/13 An immunization-certified pharmacist was not aware that all influenza vaccine products had to be shaken before use. The vaccine cartons are labeled “shake well.” But the vial and syringe labels of influenza vaccine that we’ve looked at are not so labeled. Ensure staff who vaccinate patients with the flu vaccine are aware that all influenza vaccines need to be shaken before use, whether packaged in a single dose or multiple dose vial, or a prefilled syringe. Since most pharmacies process vaccines as a prescription and print a label, it may be helpful to include “SHAKE WELL BEFORE ADMINISTRATION” on the label. Possible cross-contamination with insulin vials 10/13 A nurse accidentally injected a hepatitis C positive patient with an empty insulin syringe before she realized she hadn’t filled it with insulin. She then used the same syringe and needle to withdraw insulin from a vial. That vial was later used to prepare doses for other patients, exposing more than 70 patients to hepatitis C. January 2014 Keep this event in mind for education of staff if you service nursing homes, prisons, or other facilities. Using 3 mL insulin vials would expose fewer patients if the vial becomes contaminated. In institutional settings, preparation of patient-specific insulin doses by pharmacy would greatly reduce the risk of cross-contamination. ISMP MedicationSafetyAlert! Ò Community/Ambulatory Care Edition ACAA 2 September-December 2013 ISMP AmbulatoryCare Problem Issue Recommendation ActionAgenda Organization Assessment Action Required/Assignment Date Completed Identify your patients 11/13 A pharmacy dispensed prescriptions to wrong patients who had the same first name but different last names. Both patients were to receive the same medication, metoprolol tartrate 25 mg; however, the directions for use were different. In a second report, a patient received another patient’s amitriptyline and ended up being treated in the emergency department after taking upwards of 30 tablets in an apparent suicide attempt. Both patients had the same last name. Standardize and monitor the processes in place at the point-of-sale. Require pharmacy personnel to ask the person picking-up the completed prescription to supply the patient’s name and date of birth. Open the prescription bag at the point-of-sale so the medication can be reviewed with the patient to verify that the medication and directions for use are correct. Also, consider employing technology at the point-of-sale that would guide or “force” the patient identification process. Contamination of topical antiseptic products 11/13 ©2014 ISMP The US Food and Drug Administration (FDA) is receiving reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation. Most often, contamination of these products occurs when organisms are introduced into the product by users. Examples of affected antiseptic ingredients include alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium. FDA recommends healthcare practitioners use the products according to the directions on the label, apply the contents of single-use containers only one time to one patient, avoid diluting antiseptic products after opening them, and discard applicators and any unused solution after the single application. To read the complete MEDWATCH Safety Alert, go to: www.ismp.org/sc?id=275. Caution! Error-prone dose designations 11/13 A pharmacist expressed a safety concern regarding the labeling of ferrous sulfate tablets distributed by Qualitest Pharmaceuticals. The carton expresses the strength of each tablet in three different ways—325 mg of ferrous sulfate, 5 grains of ferrous sulfate, and 65 mg of elemental iron. The unit dose blisters are only labeled with 5 gr. Check your inventory and consider removing this product. Manufacturers should avoid using the apothecary system and clearly express dosage strengths in terms of both elemental iron and the ferrous salt form on package labels. When questions arise, verify 09/13 A physician ordered LORazepam 2 mg/mL injection for a hospice patient. However, pharmacy staff immediately thought of the oral concentrate; they were familiar with its common use in hospice and the hospice services’ preference for patient comfort to avoid injections. The oral concentrate was dispensed without consulting the prescriber. January 2014 Educate staff to never make assumptions when interpreting prescriptions. When questions arise, the prescriber should be contacted to verify what he or she intended. ISMP MedicationSafetyAlert! Ò Community/Ambulatory Care Edition ACAA 3