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1 September 25, 2014 Volume 19 Issue 19 h Report: Quarters 2 and 3, 2013 Signals for Chantix, Xyrem, Gilenya, and Tecfidera The new issue of ISMP s (see Box below) on adverse drug events (ADEs) reported to the US Food and Drug Administration (FDA) focuses on safety signals involving four drugs. The report examines cases of homicidal, self-injurious, and suicidal ideation for varenicline (CHANTIX); multiple adverse effects on the brain with sodium oxybate (XYREM); cardiac, ocular, infection, and pregnancy risks with fingolimod (GILENYA); and severe gastrointestinal (GI) toxicity and hypersensitivity associated with dimethyl fumarate (TECFIDERA). Varenicline (Chantix): Thoughts of suicide/self-injury and homicide In October 2014, FDA will move the smoking cessation drug varenicline back into the drug safety spotlight. The agency has scheduled a joint public meeting of two advisory committees to review the current Boxed Warning and Medication Guide. Thus far, FDA has revealed little about why it scheduled this special meeting. The inaugural issue of continued on page 2 > What is? is an ISMP surveillance program that monitors serious, disabling, and fatal adverse drug events reported to the FDA by manufacturers, healthcare professionals, and the public. The goal of 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. This report examines data from Quarter 2 and 3 in 2013, during which FDA received a total of 95,620 reports. DOCEtaxel product has unusual concentration Unlike DOCEtaxel solution products that do not require reconstitution before adding to an infusion container, there is a Sun Pharmaceutical/Caraco product known as DOCEFREZ that is available in 20 mg and 80 mg amounts as a lyophilized powder along with a diluent for reconstitution. While DOCEtaxel solutions are available from various manufacturers in either a 10 mg or 20 mg per ml concentration, it is important to recognize that the 20 mg Docefrez product results in a 25 mg/ml (20 mg/0.8 ml) concentration after reconstitution using instructions provided with the diluent. The 80 mg product results in a 24 mg/ml (20 mg/0.833 ml) concentration after reconstitution. This information is listed on the lyophilized powder container label and the Figure 1. Docefrez 80 mg vial label. product insert, but it is not promicontinued on page 5 DOCEtaxel > Tragic vaccine diluent mix-ups in Syria have also happened here. You may have seen news reports last week about a terrible tragedy in Syria where 15 children died after being vaccinated against measles. The diluent turned out to be atracurium. Don t think that something similar couldn t happen here. It has, many times. Apparently in the Syrian incident, the manufacturer shipped vials of vaccine as a lyophilized powder along with separate glass ampuls of diluent. Somehow, a mixup occurred either before shipment from the manufacturer or at the central area where the vaccines and diluents were stored in a refrigerator, prior to distribution to other areas. The diluent ampuls were confused with look-alike ampuls of atracurium, a neuromuscular blocking agent, which is also refrigerated. Of 75 children given vaccine, at least 15 died when the vaccine was accidentally reconstituted with the neuromuscular blocker. The neuromuscular blocker dose is weight based, so the children who died were 18 months old or younger. Older children survived. Below are several similar incidents that have previously been reported by ISMP. A US hospital emergency department (ED) nurse administered pancuronium instead of influenza vaccine to several patients. The vials were the same size, and the labels were quite similar. The look-alike vials had been stored next to each other in the refrigerator. The patients experienced dyspnea and respiratory depression but, fortunately, sustained no permanent injuries. A nurse mixed up measles vaccine and bacille Calmette-Guerin (BCG) continued on page 2 SAFETY briefs > Provided by Novation to members of VHA, UHC, Provista and Children s Hospital Association.

2 September 25, 2014 Volume 19 Issue 19 Page 2 > continued from page 1 in 2008 featured an unexpectedly large number of serious psychiatric and other ADEs for this drug. We thought it was troubling that an alternative to nicotine replacement products was the primary suspect in more reported cases of serious injury than toxic chemotherapeutic agents, potent opioids, or powerful immunosuppressant drugs. In response, the Federal Aviation Administration banned the use of Chantix by airline pilots, the Department of Transportation limited its use among truck drivers, and the Department of Defense prohibited its use by aircraft and missile crews. Also, more than 3,000 patients sued Pfizer, the manufacturer, related to the drug s psychiatric adverse effects, and thousands were compensated. The FDA required the company to add a Boxed Warning to the package insert and to provide more information in the Medication Guide in In light of the October meeting, we reassessed selected varenicline ADE data collected since drug approval 7 years ago, using as endpoints thoughts of suicide, self-injury, or homicide. These new data show that varenicline continues to account for more cases of suicidal, self-injurious, or homicidal thoughts than any other therapeutic drug from 2007 through 2013 Q3 (Table 1) more than 3 times as many as the second-ranked Table 1. Leading suspect drugs in suicidal/self-injurious and homicidal ideation cases, 2007 to 2013 Q3 Rank Drug name Disease target Number Pct. (%) 1 varenicline Smoking cessation montelukast Asthma PARoxetine Major depression QUEtiapine Schizophrenia venlafaxine Major depression interferon beta Multiple sclerosis ISOtretinoin Resistant acne DULoxetine Major depression pregabalin Neuropathic pain bupropion Major depression drug. For varenicline reports, thoughts of suicide and self-injury also correlated with attempted and completed suicides. Since 2007, varenicline was the primary suspect drug in 293 cases of completed suicide and 490 cases of attempted suicide. Varenicline stands out even more prominently in the subset of homicidal ideation, with a 5-fold margin over second-ranked QUEtiapine. If examining only the reports for 2011 to 2013, the margin by which varenicline cases outnumbered all others was reduced. That reduction was consistent with the 73% decline in dispensed outpatient prescriptions since its peak in Of note, based on IMS Health data for 2013 Q3, eight of nine other drugs in Table 1 had a much wider patient exposure, ranging from pregabalin (4.2 times higher than varenicline) to montelukast (14.4 times higher than varenicline). Only ISOtretinoin (CLARAVIS) had fewer prescriptions (47% of the total for varenicline). Current FDA warnings about suicidal behavior are reasonably clear in the varenicline Boxed Warning. However, warnings about homicidal thoughts, hostility, aggression, psychosis, and violence need to be strengthened. In addition, the promotional language about smoking cessation benefits should be removed from the Boxed Warning, and the indications section should explicitly state that use is not recommended for sensitive occupations such as pilots, air traffic controllers, deployed military personnel, police, fire fighters, and emergency medical care professionals. Sodium oxybate (Xyrem): High adverse event report rate Sodium oxybate, also known as gamma hydroxybutyric acid (or GHB), is an extremely fast-acting sedative and central nervous system (CNS) depressant. It was once a continued on page 3 > Bottom line: To ensure safety with neuromuscular blocking agents, review our article, Paralyzed by mistakes. Preventing errors with neuromuscular blocking agents (www.ismp.org/sc?id=413). Use this to think through safety changes that might be needed. For example, consider use of prefilled vaccine syringes whenever possible. Eliminate or restrict the storage of paracont d from page 1 vaccines with pancuronium and administered the drug to healthy infants. One infant died after experiencing seizures and respiratory arrest. The pancuronium vial looked very similar to a vial of sodium chloride injection, the diluent for these vaccines. In Taiwan, atracurium was administered subcutaneously instead of hepatitis B vaccine to seven infants. The infants developed respiratory distress within 30 minutes. Five infants recovered, one sustained permanent injury, and another died. Neuromuscular blocking agents had never been available as floor stock in the nursery. For convenience, an anesthesiologist from a nearby operating room had placed the vial of atracurium in the unit refrigerator near vaccine vials of similar appearance. In Mexico, 14 patients presented with hypotonia, cyanosis, and dyspnea 5 minutes following immunization with measles vaccine. One patient died. Succinylcholine and pancuronium vials were found stored with the vaccine and diluent. In Kenya, 6 infants immunized with measles vaccine had convulsions and became floppy. Pancuronium was found stored with the vaccine. In Lesotho, 5 neonates collapsed a few minutes following immunization with BCG and oral polio vaccine. The vaccine was diluted with a neuromuscular blocker. One infant died. continued on page 3 SAFETY briefs >

3 September 25, 2014 Volume 19 Issue 19 Page 3 > continued from page 2 widely available addictive drug of abuse and one of the first known daterape drugs. The drug is available as sodium oxybate to treat daytime sleepiness and catalepsy manifestations of narcolepsy. It is classified as a Schedule III controlled substance. Illicit use is subject to Schedule I penalties. The drug is only available under a restricted distribution program from one central pharmacy, and prescribing doctors and patients must complete an education program. The drug acts so fast that patients are warned to take the evening dose in or near a bed, and it is metabolized so rapidly that patients are instructed to set an alarm to take a second dose 2.5 to 4 hours later. Jazz Pharmaceuticals, the manufacturer, published an optimistic safety overview of sodium oxybate in 2009 in a medical journal and gave a similar portrayal at a 2010 FDA meeting. However, in 2011, Jazz revealed that it had included only 21 of 103 reported patient deaths. The problem was traced to inadequate coordination of reporting procedures with the central pharmacy that distributed the prescriptions. Thus, this issue provides the first published overview of a fully reported ADE profile. We identified an unexpectedly high number of serious ADEs reported for the drug given its use by a small patient population of approximately 9,000 in Sodium oxybate accounted for more reported serious ADEs than other drugs taken by millions of patients. According to the reports, the drug was suspect as causing adverse effects on motor control (e.g., falls, bedwetting), the extrapyramidal motor system (e.g., dystonia, Parkinsonism, akathisia), memory and alertness (e.g., blackout, memory loss), and mood and behavior (e.g., depression, psychosis, hostility, suicidal behaviors). Serious reported ADEs involved 15% of the exposed population, measured in patient years. Close follow-up with patients and manifestations of the disease itself could account for the high total of reported events. There are also safety concerns associated with the off-label use of sodium oxybate, which was illegally promoted by Jazz s predecessor company for use in insomnia and various psychiatric disorders, leading to civil and criminal penalties in In recent data, we found that off-label use was documented in at least 19% of the reported ADEs, including fibromyalgia, insomnia, and unspecified sleep disorders. Given the risks now seen in the current adverse event reports, questions remain whether the drug s benefits justify its unusually high risks, and whether off-label use has been or could be controlled. Fingolimod (Gilenya): Cardiac, ocular, infection, and pregnancy risks Two years ago, first reported early safety signals for fingolimod, the first oral immunosuppressant treatment for multiple sclerosis (MS), which received expedited FDA approval. Meanwhile, postmarket data continue to highlight four important safety risks. First, because fingolimod has the capacity to disrupt normal heart rhythm, initiating treatment requires that the patient be observed for the first 6 hours in a medical setting. ADE reports for the most recent 12 months show that this cardiac risk is neither rare nor hypothetical. We identified 473 cases of heart rhythm disturbances, primarily bradycardia and heart block, including 13 deaths, 11 life-threatening cases, and 141 cases resulting in hospitalization. Next, a large group of cases (348) reported macular edema or less specific ocular adverse effects. (Vision disturbances are also an early symptom of MS.) Because of the known risk of macular edema, baseline and follow-up eye exams are recommended, and reminders should be sent to patients. A third concern was increased risk of infection due to fingolimod s effect on lymphocytes. continued on page 4 > cont d from page 2 lyzing agents by sequestering the products (e.g., in a sealed box with a breakaway lock or rapid sequence intubation [RSI] kit), and affix WARNING PARALYZING AGENT labels to the vials and storage container. Review refrigerated storage areas regularly to consider the potential for mix-ups, and limit or eliminate the storage of neuromuscular blockers whenever possible. ISMP is calling upon federal regulators and product vendors to work toward improving vaccine packaging to eliminate tragedies like these, worldwide. Many vaccines that require a diluent could be packaged in a dual chamber container (for the powder and liquid) to assure only the proper diluent is always used. Our May 22, 2014, issue discussed this and other issues with diluents for vaccines (www.ismp.org/newslet ters/acutecare/showarticle.aspx?id=80). Caution when prescribing Xarelto to first-time patients. The recommended dose of XARELTO (rivaroxaban) for treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), is 15 mg twice a day with food for the first 21 days, followed by 20 mg once daily for at least 60 days. This requires two different tablet strengths, two different frequencies, and two different prescriptions for first-time patients. Recently, a patient with a DVT was discharged from a hospital with two prescriptions for Xarelto one for 15 mg and another for 20 mg. Neither the prescription directions nor the discharge instructions given to the patient made it clear that the 20 mg tablets were not to be started until the 15 mg tablets were finished. The prescriptions were dispensed together at the patient s community pharmacy, but the pharmacist did not clarify any instructions for the patient or investigate the potential for duplicate therapy. The prescription benefit plan (insurance company) agreed to pay for both prescriptions on the same date. The patient mistakenly took the two prescriptions concurrently (50 mg total per day). continued on page 4 SAFETY briefs >

4 September 25, 2014 Volume 19 Issue 19 Page 4 > continued from page 3 In the 12 months of data, we identified 172 cases of reported viral infections, mostly herpes simplex and zoster. Finally, pregnancy risks were a substantial concern based on animal studies linking the target fingolimod receptor to vascular malformations in rodents as well as human fetal abnormalities in clinical studies. In the 12 months of ADE data for this issue, we identified 3 additional cases in postmarket surveillance with an outcome of birth defect. While the drug is currently classified with a Pregnancy Category C risk profile, FDA and the manufacturer should now consider reclassifying fingolimod as Pregnancy Category X, clearly identifying it as a drug not suitable for women who may become pregnant. The large number of serious injury reports (2,716) shows that fingolimod remains a high-risk drug with multiple toxicities. This underlies the critical importance of observation during administration of the first dose, follow-up eye exams, and prohibitions during pregnancy. Dimethyl fumarate (Tecfidera): GI side effects and hypersensitivity Approved in March 2013, the product launch for dimethyl fumarate the third orally administered immunosuppressant for MS was so successful that the manufacturer, Biogen Idec, reported that it was the leading oral disease-modifying MS therapy in the US after only 6 months. However, during this time, adverse event reports showed a marked signal for severe GI disorders and hypersensitivity. Additional safety questions arise from animal studies. In premarket testing, dimethyl fumarate produced toxic effects in multiple animal species at both clinically relevant and higher exposures. The primary target organs were the kidneys, stomach, and testes. The postmarket ADE reports also include GI reactions (202) that were often severe and required hospitalization, and hypersensitivity reactions (125). More than half (55%) of the hypersensitivity cases also involved GI reactions. Important questions about the safety of dimethyl fumarate remain unanswered, particularly related to possible damage to the kidneys and testes. In fact, the toxic effects on the kidney were so pervasive in animal studies that the toxicology reviewer recommended against FDA approval. However, human clinical studies did not provide evidence of adverse effects on the kidneys. But one FDA reviewer thought the slow kidney deterioration seen in a 1-year monkey study might not be evident. Adverse effects on the testes were also seen in three animal species. The severe hypersensitivity and GI adverse effects associated with dimethyl fumarate show the need to re-evaluate these risks, provide clear warnings for physicians, develop guidelines for optimal treatment, and conduct robust postmarketing analysis. For the full report with references, visit: ISMP webinar Join us on October 23, 2014, for Smart Pump Integration: A Giant Step for IV Infusion Safety. This webinar will describe how smart pump integration can improve safety by linking the medication order directly to the infusion device and prepopulating the pump with infusion parameters contained in the order, thereby eliminating programming errors. Efficiencies are also gained as a 17-step manual programming process is reduced to 7 steps with integration. For details about the webinar, visit: al/webinars.asp. cont d from page 3 At a follow-up visit with the primary care provider 10 days later, the mistake was discovered. The patient was very fortunate to not have any serious bleeding but did report vision changes and was referred to an ophthalmologist for further evaluation. That also turned out to be unremarkable. The proper instructions were discussed with the patient, and he verbalized understanding, at which point proper therapy resumed. Although the FDA-approved dose for DVT calls for two different strengths and directions, and although it may be more convenient for prescribers and patients to have both prescriptions issued and dispensed at the same time, the safety of this practice is in question unless clear directions are provided and understood by the patient. Prescribers should include prescription instructions for the 20 mg tablets to begin after the 15 mg tablet prescription supply is exhausted (after 21 days). The statement, Begin taking after [date] should be included in the Xarelto 20 mg directions. Unfortunately, too many pharmacists fail to provide proper patient education when dispensing new prescriptions. Therefore, it s time for the boards of pharmacy in all states, whose role it is to protect the public from medication harm, to mandate patient education by pharmacists for selected highalert drugs, such as anticoagulants. If computer alerts were issued when prescribing and dispensing, they were apparently overlooked or disregarded. Again, for certain high-alert drugs and drug classes, stepped-up computer warnings that aren t easy to bypass are required. Payer systems should also have an automated method to decline payment for prescriptions that may cause an overdose, like with this case. ISMP has contacted the manufacturer of Xarelto, Janssen, to ask the company to consider providing patient education regarding this potential problem. A Starting Dose Pack and Continuing Dose Pack that illustrate for the patient how to take the drug properly would also be helpful.

5 September 25, 2014 Volume 19 Issue 19 Page 5 > DOCEtaxel continued from page 1 nent and can easily be overlooked since it appears several lines below the total mg amount in each vial (Figure 1 on page 1). The unusual final concentration of Docefrez led to a medication error recently when the solution that the hospital normally used was on backorder by the pharmacy s wholesaler. A pharmacy purchaser saw the 80 mg Docefrez product as an alternative listing. Believing it was similar to the product the hospital normally used, he ordered it after checking with a clinical oncology pharmacist specialist. When a dose of 145 mg was later ordered for a patient, a pharmacy technician retrieved the Docefrez product and had a pharmacist check the set-up prior to preparation. Label instructions were to add 4 ml of diluent to the 80 mg vial, which seemed like it would yield 20 mg/ml, the same as the hospital pharmacy computer system listed for the solution that they normally use. Since the ordered dose was 145 mg, the computer calculated that 7.25 ml was needed, based on a 20 mg/ml final concentration. The final solution of drug was then approved by a second pharmacist and added to an infusion container. What all parties missed was that reconstituting the 80 mg vial with 4 ml does not yield a 20 mg/ml concentration but rather a 24 mg/ml concentration. The patient received a dose of 174 mg (20% more) instead of 145 mg, which can be a dangerous dose for this drug. Fortunately the patient was monitored and did not experience harm. To help reduce the risk of an error if Docefrez should it be needed due to a manufacturer backorder of the normal DOCEtaxel product the hospital uses, the pharmacy computer system will now list the Docefrez product along with the concentration after reconstitution. There s now also a step during purchasing where the package insert must be reviewed by a pharmacist whenever alternative products are ordered, to determine if there are any inherent risks or potential for errors that need to be communicated to staff. ISMP has spoken to the manufacturer, Sun Pharma USA, who has agreed to revise the label. There are currently several other DOCEtaxel manufacturers and, as above, various concentrations are listed for purchase in computer systems. Keep in mind, when ordering replacement products for any injectable drug on backorder or during a drug shortage, it is the amount of drug by weight that is most important to consider, not the volume. If hospitals or clinics aren t able to get the product they normally use, it could be a set-up for a medication error. There must be a process in place to review any new products brought into the hospital to make sure people are aware of the new product and that systems (including strengths and concentrations in IT systems) can be adjusted as necessary for safe use ISMPFellows ISMP welcomes Ivyruth Andreica, BSN, PharmD, the ISMP Safe Medication Management Fellow sponsored by Express Scripts Foundation. Ivy is from Massachusetts General Hospital in Boston, where she practiced as a clinical pharmacist at the hospital s Level- 1 Trauma emergency department (ED) as well as the ED short stay units. She graduated first with her Bachelor of Science in Nursing from Texas Woman s University. While working as a critical care nurse, she decided to pursue pharmacy and attended Massachusetts College of Pharmacy and Health Sciences. Upon graduation, Ivy first worked at a small community hospital with an ambulatory oncology and infusion clinic, and then transitioned to a large academic medical center. ISMP also welcomes Ariane Conrad, PharmD, BCACP, CDE, FASCP, the FDA/ISMP Safe Medication Management Fellow. Ariane joins us from New Orleans, where she worked as a clinical assistant professor at Xavier University of Louisiana and as an ambulatory care pharmacist with the Interim Louisiana State University Public Hospital. Her primary areas of clinical practice include diabetes, obesity, and hypertension. Ariane earned her Doctor of Pharmacy degree from Xavier University and completed a pharmacy practice residency with the Central Arkansas Veterans Healthcare System in Little Rock, AR. She also earned the designations of Board Certified Ambulatory Care Pharmacist (BCACP) and Certified Diabetes Educator (CDE). Ariane will spend 6 months at ISMP followed by 6 months at the FDA. If you would like to subscribe to this newsletter, visit: ISMP Medication Safety Alert! Acute Care (ISSN ) 2014 Institute for Safe Medication Practices (ISMP). Permission is granted to subscribers to reproduce material for internal communications. Other reproduction is prohibited without permission. Report medication errors to the ISMP National Medication Errors Reporting Program (ISMP MERP) at FAIL-SAF(E) or online at Unless noted, published errors were received through the ISMP MERP. ISMP guarantees confidentiality of information received and respects the reporters' wishes as to the level of detail included in publications. Editors: Judy Smetzer, RN, BSN, FISMP; Michael R. Cohen, RPh, MS, ScD; Russell Jenkins, MD. ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA Tel: ; Fax: This is a peer reviewed publication.

6 September 25, 2014 Volume 19 Issue 19 Page 6 News & Resources 17 th Annual Cheers Awards ISMP s annual Cheers Awards dinner will be held on December 9 in Anaheim, CA at the Astor Classics Event Center Automotive and Communications Museum. The Cheers Awards shine a national spotlight on safety leaders please consider attending the dinner or making a donation to enable ISMP to continue its lifesaving work in preventing medication errors. For more information, visit: MSI Workshops You can fast-track your medication safety program by attending one of ISMP s 2014 Medication Safety Intensive (MSI) workshops, but hurry only two sessions remain. Professionals with real-world experience will give you the tools to promote successful safety improvements. For more information or to register, visit: The remaining 2014 MSI workshops are scheduled for: October 2 and 3 Nashville, TN December 5 and 6 Anaheim, CA (immediately preceding ASHP Midyear Meeting) Data Analysis and Coaching Your organization may be collecting medication safety data, but are you capturing the best information and using it to the best advantage? ISMP can help you define metrics, perform advanced analysis, and use data to reduce risk of patient harm. The Institute offers onsite evaluation/ assistance, data analysis workshops at ISMP headquarters, and remote coaching. For more information, visit: Annual Fund Launched This year is ISMP s 20 th anniversary, and the Institute has created an Annual Fund to ensure that it will be able to continue its lifesaving work for another 20 years. Please consider making a charitable donation to help keep ISMP an important part of the fight against medication errors. For more information, visit: ISMP Webinar Bundles Save on multiple presentations that address hot topics in medication safety. Visit: NOW AVAILABLE

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