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Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected — sometimes life-threatening — side effects or complications, according to a new analysis in the Journal of the American Medical Assn. Researchers looked at potential problems that cropped up during the routine monitoring that's done once a medicine has been approved by the Food and Drug Administration and is on the market. The results, published Tuesday, covered all 222 prescription drugs approved by the FDA from 2001 through 2010. The 71 drugs that were flagged included top sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death. “The large percentage of problems was a surprise,” and they included side effects not seen during the review process, said senior author Dr. Joseph Ross, an associate professor of medicine and public health at Yale University. While most safety concerns were not serious enough to prompt recalls, the findings raise questions about how thoroughly drugs are tested before approval, said drug safety expert Thomas Moore. But Ross said the results suggest that the FDA “is kind of doing a great job” at scrutinizing drugs after approval. New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness. “We know that safety concerns, new ones, are going to be identified once a drug is used in a wider population. That's just how it is,” Ross said. “The fact that that's such a high number means the FDA is working hard to evaluate drugs, and once concerns are identified, they're communicating them.” The researchers analyzed online FDA data on new drugs and the agency's later safety announcements. Problems surfaced on average about four years after approval. The FDA said in a statement that it performs post-market monitoring “to identify new safety information that may impact product labeling.” The agency said it would review the study findings but declined to comment further. The study counted black-box warnings for dozens of drugs. These warnings involved serious problems including risk of death or life-threatening conditions linked with the drugs. There were also alerts for less serious potential harms related to dozens of drugs. Among them: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner. Three drugs were withdrawn because of the potential for death or other serious harm. They were Bextra, an anti-inflammatory medicine, because of incidence of heart problems; Raptiva, a psoriasis drug, which is linked to a rare nervous system illness; and Zelnorm, a bowel illness drug, which has been connected to heart problems. Safety issues were most common for psychiatric drugs and biologic drugs — made from living cells rather than chemicals — than for older drug types. Drugs brought to market through “accelerated” approval were slightly more likely to have later safety issues than those approved through conventional channels, a link seen in some previous research. In recent years, there has been increasing pressure on the FDA from consumers and others to speed up its regulatory review process to get new drugs to the market sooner, Ross said. Moore, a senior scientist for drug safety and policy at the Institute for Safe Medication Practices, said the new results raise concerns about whether new drugs are being extensively tested before approval. He noted that since 2011, drugs have increasingly been approved based on studies in small numbers of patients amid public criticism questioning whether the FDA is keeping potential cures away from patients. “The answer is, you can't know whether they're valuable and life-saving treatments unless you test them” adequately, Moore said. The Pharmaceutical Research and Manufacturers of America, a drug industry trade group, is reviewing the study, said spokeswoman Holly Campbell. In a statement, she said the industry is committed to post-market surveillance of new medicines, but added, “Even with rigorous clinical studies and regulatory review it may be impossible to detect certain safety signals until several years after approval, once the medicine is in broader use.” Scientists are on alert after the latest changes at the EPA To live a long life in America, it helps to be born in the right county Another way humans are polluting the environment: Too much noise

For the complete analysis, download the CBS Report, Medication-related Malpractice Risks, available online as a PDF. Every medical malpractice case presents unique circumstances, but a collection of similar cases can reveal a common story of what goes wrong. This Report analyzed medical malpractice claims from CRICO Strategies' Comparative Benchmarking System (CBS)—a database of deeply coded medical malpractice claims representing more than $25 billion in reserves and losses. CBS reflects the medical professional liability experience of more than 400 hospitals and health care entities and 165,000 physicians from commercial and captive insurers nationwide, representing approximately 30 percent of all US medical malpractice claims. Mark E. Reynolds, president and CEO of CRICO said, "The national Comparative Benchmarking System enables us to examine thousands of cases, providing credible findings that can be considered for all caregivers who prescribe, administer, or manage medications. Our analyses are powered by information captured directly from the patient's medical record as well as legal documents, extracting a broad range of systemic and human factors underlying each case." Each step in a medication process—ordering, dispensing, administering, and managing—presents unique risks to providers and their patients, and the 11 percent of cases in which the patient experienced failures in multiple steps demonstrate how intertwined the process can become. Says Heather Riah, chief operating officer of CRICO, "In between getting everything right and having something go terribly wrong, patients and providers are encountering a vast array of medication-related errors. Most will not trigger a lawsuit, but all have short or long-term consequences for patients and providers." National leaders in patient safety who contributed to the Report include, Frank Federico, RPH, Vice President, Institute for Healthcare Improvement, Michael Cohen, RPh, President, Institute for Safe Medication Practices, David Bates, MD, Senior Vice President & Chief Innovation Officer, Brigham & Women's Hospital, and Argin Srinivasan, MD, FSHEA, Associate Director for Healthcare Associated Infection Prevention Programs, Centers for Disease Control and Prevention. CRICO Strategies is a division of The Risk Management Foundation of the Harvard Medical Institutions Incorporated, a CRICO company. The CRICO insurance program is a group of companies owned by and serving the Harvard medical community, with an established reputation as a leader in evidence-based risk and claims management. Established in 1998, Strategies extends CRICO's patient safety mission through broad dissemination of products and services designed to reduce medical errors and malpractice exposure. For more information, visit www.rmf.harvard.edu/Strategies. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/opportunities-to-reduce-patient-safety-risks-related-to-medication-error-identified-in-new-crico-strategies-report-300461377.html

Publisher ByYourSide Studios announced the release of Dave’s Subs Book Club edition. A facilitator’s guide and a member’s guide allow managers to learn the key concepts for creating a more accountable workplace culture. Each page contains questions covering key concepts that will take a group of managers to a deeper level of reflection, learning, and action. Disastrous events are seemingly inevitable. From major embarrassment to loss of life: the Oscars announce the wrong winner, Volkswagen cheats on emissions tests, Wells Fargo creates fake customer accounts, a news organization covers for its headliner, an airline crashes an airplane, a hospital inadvertently kills its patient. Yet, most leaders don’t have the tools to deal with disasters like these, particularly when it comes to managing the employees involved. Until now. It’s a business book and a management tool. The fictional Dave’s Subs faces a lawsuit over an employee mistakenly giving a gluten-filled bread roll to a woman – who happens to be an attorney – for whom gluten is life threatening. In the midst of a media storm and legal onslaught that threatens the shop’s very existence, the owner chooses not to fire his employee. A noble choice but one that leaves the shop manager, Milo, to operationalize the decision. It’s an instructional tale for every CEO, director or manager who’s had to learn how to hold employees accountable – and for every employee who wants to be treated fairly. David Marx is widely known as the father of the Just Culture movement. Just Culture is at the forefront of a revolution in workplace accountability has been underway within high consequence industries. The Joint Commission (healthcare’s accreditor), the International Civil Aviation Authority (ICAO), the American Nurses Association (ANA), the Federal Aviation Administration (FAA), medical schools and many others are endorsing and incorporating new notions of accountability into their operations, to create workplace cultures where employees are judged based on the quality of their choices rather than solely on the severity of the outcome of their actions. A sought after speaker, Mr. Marx provides a compelling vision into how workplace accountability should address our inescapable human fallibility. Both an engineer and attorney, Marx brings a unique perspective to workplace accountability that is rapidly becoming the standard across high consequence industries. Drawing on his system engineering, human factors, and legal expertise, Marx published Patient Safety and the “Just Culture”: A Primer for Health Care Executives in 2001 for the National Institutes of Health. For his work in Just Culture, Mr. Marx received the 2016 Lifetime Achievement Award from the Institute for Safe Medication Practices. Marx’s first book on the subject, Whack-a-Mole: The Price We Pay for Expecting Perfection, was released in September 2009.

Moore T.J.,Institute for Safe Medication Practices | Moore T.J.,George Washington University
JAMA Internal Medicine | Year: 2014

IMPORTANCE TheUS Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. OBJECTIVE To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. DESIGN Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. MAINOUTCOMESAND MEASURES Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. RESULTS In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P =.05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P =.003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. CONCLUSIONS AND RELEVANCE For new drugs approved bythe FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed. Copyright 2014 American Medical Association. All rights reserved.

News Article | November 10, 2016
Site: www.marketwired.com

Editors: An online press kit is available at www.NCCN.org/justbagit As part of its mission to improve the quality, effectiveness, and efficiency of cancer care so that patients can live better lives, the National Comprehensive Cancer Network® (NCCN®) today announced the launch of Just Bag It: The NCCN Campaign for Safe Vincristine Handling. This campaign encourages health care providers to adopt a policy to always dilute and administer vincristine in a mini IV-drip bag to prevent a deadly medical error. Vincristine is a chemotherapy agent, widely used in patients with Leukemia or Lymphoma, which should be administered intravenously, or directly into the patient's vein. When it enters the blood, it is highly effective at blocking the growth of cancer by preventing cells from separating. However, vincristine is a neurotoxin that causes peripheral neuropathy when given intravenously and profound neurotoxicity if given into the spinal fluid, which flows around the spinal cord and brain. Many patients who receive vincristine have a treatment regimen that includes other chemotherapy drugs that are administered intrathecally, or injected into the spinal fluid with a syringe. If vincristine is mistakenly administered into the spinal fluid, it is uniformly fatal, causing ascending paralysis, neurological defects, and eventually death. In 2005, NCCN Chief Executive Officer Robert W. Carlson, MD, a medical oncologist, witnessed such a tragedy with a 21 year-old patient with Non-Hodgkin's Lymphoma named Christopher Wibeto. Wibeto was transferred to Carlson's care after receiving incorrectly administered vincristine at another hospital. Carlson watched the young man go from having a likely curable condition to deteriorating and dying within four days. Motivated by this tragic experience, Carlson spearheaded a national effort to address this deadly error when he arrived at NCCN, enlisting the help of its Best Practices Committee, which is dedicated to improving cancer treatment protocols. To ensure that vincristine is always administered properly, NCCN has issued guidelines advising health care providers to always dilute and administer vincristine in a mini IV-drip bag and never use a syringe to administer the medication. This precaution renders it impossible to accidentally administer the medication into the spinal fluid and greatly decreases the chances of improper dosage. All 27 NCCN Member Institutions have adopted policies in line with these guidelines, which are also recommended by the Institute for Safe Medication Practices, the Joint Commission, the World Health Organization, and the Oncology Nursing Society. "We are proud of this achievement and grateful for the support and participation of our Member Institutions in reaching this goal," Carlson said. "Our efforts will not stop here. We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again." Surveys issued by the Institute for Safe Medication Practices (ISMP) show that over time, more hospitals have adopted a policy to always bag vincristine. According to ISMP data, the number of hospitals that have fully implemented the policy across their practice nearly doubled between February 2014 and February 2016. Earlier surveys indicated a similar increase between 2005 and 2012. Still, only about half of all respondents indicated that they have implemented the policy in all treatment settings, indicating that there is a long way to go. With 125 known cases of accidental death in the U.S. and abroad since the inception of vincristine use in the 1960s, this error is relatively rare. Still, it is unique in its level of mortality. Improvements in practice over the years, including manufacturer- and pharmacist-issued warning labels, have reduced the number of deaths, but the error continues to occur. Diluting vincristine into a mini IV-drip bag may entail a change in practice for some providers, but it is well worth the outcome of avoiding preventable deaths, according to Michael Cohen, RPh, MS, FASHP, President of ISMP. "One more life taken is one too many," Cohen said. "We are glad an organization of NCCN's influence has stepped up to bring this issue to national attention. Ending this devastating error should be a priority for all of us who care for and advocate on behalf of patients and their families." Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, or the leaking of a chemotherapy drug into the tissue surrounding the intravenous administration site. But research shows that the risk of extravasation is extremely low. [1] "The Just Bag It campaign is the latest of NCCN's long-standing efforts to improve the safe use of drugs in cancer care," said F. Marc Stewart, MD, Medical Director of the Seattle Cancer Care Alliance and Member of the Fred Hutchinson Cancer Research Center, Professor of Medicine at University of Washington, and Co-Chair of the NCCN Best Practices Committee. "For more than 15 years, the Best Practices Committee has worked to ensure the highest standards of safety for patients." In 2008, the Best Practices Committee led the charge for NCCN to begin publishing Chemotherapy Order Templates (NCCN Templates®), which detail the most common regimens for many cancers and highlight safety parameters. These resources enable practitioners to standardize patient care, reduce medication errors, and anticipate and manage adverse events. There are more than 1,500 NCCN Templates® for 86 cancer types, and they are used by more than 10,000 subscribers. For more information about Just Bag It: The NCCN Campaign for Safe Vincristine Handling, or to report that a medical facility has adopted a vincristine policy, visit www.NCCN.org/JustBagIt. The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT. [1] ISMP. Death and neurological devastation from intrathecal vinca alkaloids: Prepared in syringes = 120; Prepared in minibags = 0. ISMP Medication Safety Alert! 2013;18(18):3. The following files are available for download:

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today the immediate availability in the United States of Heparin Sodium Injection (5,000 USP units per mL) in the company’s Simplist™ ready-to-administer prefilled syringe. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. Fresenius Kabi offers U.S. customers a broad range of Heparin presentations which now includes the Heparin 5,000 USP units per mL ready-to-administer prefilled syringe for subcutaneous and intravenous bolus injections. “Delivering the right drug at the right dose is always important, particularly with High-Alert medications such as Heparin,” said John Ducker, president and chief executive officer of Fresenius Kabi USA. “Fresenius Kabi Simplist ready-to-administer prefilled syringes help promote safe practices and can minimize medication errors by reducing drug preparation steps and vial-to-syringe transfers.” All Simplist ready-to-administer prefilled syringes, including the new Heparin presentation, are designed to offer clear and consistent labeling, individual bar coding on both packaging and syringes, require no assembly or point-of-care preparation and have a 24-month shelf life. According to the Institute for Safe Medication Practices (ISMP), High-Alert medications are defined as “drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.” For full prescribing information, including more information about all the Simplist ready-to-administer prefilled syringes exclusively from Fresenius Kabi, please visit www.simplist-us.com. Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.

Moore T.J.,Institute for Safe Medication Practices | Moore T.J.,George Washington University | Glenmullen J.,Harvard University | Mattison D.R.,University of Ottawa
JAMA Internal Medicine | Year: 2014

IMPORTANCE: Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia. OBJECTIVES: To analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to assess the relationship of these case reports with the 6 FDA-approved dopamine receptor agonist drugs. DESIGN, SETTING, AND PARTICIPANTS: We conducted a retrospective disproportionality analysis based on the 2.7 million serious domestic and foreign adverse drug event reports from 2003 to 2012 extracted from the FDA Adverse Event Reporting System. MAIN OUTCOMES AND MEASURES: Cases were selected if they contained any of 10 preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) that described the abnormal behaviors. We used the proportional reporting ratio (PRR) to compare the proportion of target events to all serious events for the study drugs with a similar proportion for all other drugs. RESULTS: We identified 1580 events indicating impulse control disorders from the United States and 21 other countries: 710 for dopamine receptor agonist drugs and 870 for other drugs. The dopamine receptor agonist drugs had a strong signal associated with these impulse control disorders (n = 710; PRR = 277.6, P < .001). The association was strongest for the dopamine agonists pramipexole (n = 410; PRR = 455.9, P < .001) and ropinirole (n = 188; PRR = 152.5, P < .001), with preferential affinity for the dopamine D3 receptor. A signal was also seen for aripiprazole, an antipsychotic classified as a partial agonist of the D3 receptor (n = 37; PRR = 8.6, P < .001). CONCLUSIONS AND RELEVANCE: Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings. Copyright 2014 American Medical Association. All rights reserved.

News Article | December 12, 2016
Site: www.eurekalert.org

About 1 in 6 adults in the United States reported taking psychiatric drugs at least once during 2013, according to a new research letter published online by JAMA Internal Medicine. Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Alexandria, Va., and Donald R. Mattison, M.D., M.S., of Risk Sciences International, Ottawa, Canada, used the 2013 Medical Expenditure Panel Survey to calculate percentages of adults using three classes of psychiatric drugs: antidepressants; anxiolytics, sedatives and hypnotics; and antipsychotics. The use of psychiatric drugs also appeared to increase with age, with 25.1 percent of adults 60 to 85 reporting use compared with 9.0 percent of adults 18 to 39 years of age. Women also were more likely to report using psychiatric drugs than men, according to the results. The authors note that the use of psychiatric drugs may be underestimated because the prescriptions were self-reported. For more details and the study findings, please visit the For The Media website. Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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