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AMERICAN PAIN SOCIETY TO SUPPORT PAIN RESEARCH FORUM PAPERS OF THE WEEK
The American Pain Society (APS) announced on June 23 that it had begun a collaboration with the Pain Research Forum (PRF) in which APS will provide grant support for PRF's “Papers of the Week” website postings of new papers in pain research, which are published in peer-reviewed journals covering pain, neuroscience and related disciplines.
“We are grateful for the generous support from the American Pain Society for the Pain Research Forum, a unique and valuable resource for the pain research community. Papers of the Week, has become one of the most popular services of the Pain Research Forum to help researchers and clinicians stay current with new studies in the field of pain research”, said PRF Executive Editor Neil Andrews.
“As the leading professional society devoted to pain science and pain research, the American Pain Society supports the mission of Pain Research Forum to provide an active online community for pain researchers worldwide to exchange information and ideas”, said APS President Gregory Terman, M.D. “Our support for Papers of the Week encourages our members to rely on this valuable service to stay on top of the latest published science in pain”.
Pain Research Forum was launched in June 2011. Its mission is foster discussion and collaboration that will speed the acquisition of new knowledge and its translation into novel treatments for chronic and neuropathic pain. The site was developed and is maintained by editorial staff at the Harvard NeuroDiscovery Center, in collaboration with the MassGeneral Institute for Neurodegenerative Disease Informatics group, with guidance from an international advisory board of top pain researchers. All PRF news and discussion content, research resources and member services are free to researchers, clinicians and others interested in the problem of chronic pain. PRF members can request to receive email alerts when new editions of Papers of the Week are published online every Friday.
MONTEFIORE AND EINSTEIN TO EDUCATE CLINICIANS WHO PRESCRIBE OPIOIDS
On June 11, 2014, the Center for Continuing Medical Education (CCME) at Montefiore Medical Center and Albert Einstein College of Medicine of Yeshiva University in The Bronx, New York, announced receipt of a $2 million grant from the Extended-Release/Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Program Committee. The purpose of this grant is to develop a continuing medical education (CME) program to help educate clinicians who prescribe ER/LA opioids for patients with chronic pain about using them safely and effectively, and to ensure the benefits of these medications outweigh the risks for patients. The U.S. Food and Drug Administration (FDA) requires all manufacturers of ER/LA opioid analgesics to collaborate and provide education for prescribers of these medications. This grant will fund the development of CME programming that follows guidelines outlined by the FDA. An estimated 100 million Americans experience chronic pain, according to the Institute of Medicine, and ER/LA opioids are often utilized as part of the treatment plan. Unfortunately, the misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose and death.
“We see a need for training clinicians in appropriate prescribing of ER/LA opioids, awareness of their role in chronic pain treatment plans and recognition of negative outcomes associated with inappropriate prescribing”, said Victor Hatcher, PhD, research director, Montefiore Medical Center, and associate dean for CME and Research Administration and professor of Medicine and Biochemistry, Einstein. “Globally, opioid prescribers face the dual challenge of emerging epidemics of undertreated pain and prescription opioid abuse and misuse. Safe and effective pain management requires clinical skill and knowledge of treatments and effective assessment of risks associated with abuse and addiction”.
CCME's PainEDU REMS Education Program will be disseminated on a national level to prescribers through a virtual patient simulation and skill-building training for treating chronic pain in non-cancer patients with ER/LA opioids safely and effectively. The program can be found on the nationally known pain education website, PainEDU.org or at Rems.PainEdu.org, which was developed and maintained by Inflexxion, a healthcare technology company that provides solutions for collecting clinical data, analyzing data and providing educational content and resources in the field of pain management.
In addition to the internet-based course, Montefiore will deliver an in-person pilot course, led by Naum Shaparin, MD, director, Pain Service, in appropriate opioid dissemination for physicians and residents and will measure how this approach elevates treatment within the healthcare system.
“When we have completed the national education effort and Montefiore pilot study, we will evaluate their effectiveness, focusing on increased prescriber knowledge and how the program changed provider attitudes and behavior”, said Dr. Hatcher. “Ultimately, our goal is to improve methods of prescribing these pain medications and enhance overall patient outcomes”.
Founded in 1976, CCME at Montefiore and Einstein is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CCME has produced hundreds of CME activities and offers CME credit to thousands of practitioners.
PALLIATIVE CARE TOOLKIT AND RESOURCE GUIDE TO IMPROVE CARE OF SERIOUS ILLNESS
With increasingly wide recognition of the need to improve quality of care for those with serious illness, one of the major strategies is implementation of palliative care. Multiple studies have shown that palliative care services result in less symptom distress and longer patient survival, as well as better patient and family quality of life. These improvements in quality result in the reduced need for crisis interventions and hospitalizations, thus enabling patients to spend more time enjoying what matters most to them. At the same time, palliative care also markedly reduces spending. To improve access to this high-value care, payers, providers and communities are working together to find new ways to deliver and finance palliative care. This toolkit –accessible at: http://www.capc.org/payertoolkit/toolkit.pdf is meant to serve as a reference guide for organizations that lead the financing of health care (including commercial insurers, self-funded employers and federal and state government agencies) and for providers working in shared risk arrangements.
The Toolkit:
Defines palliative care and demonstrates its importance to improving value in health care
Identifies opportunities to integrate palliative care into payer programs and products
Highlights case examples from industry leaders that demonstrate what payers are already doing to advance palliative care initiatives
Provides tools, check lists and action plans to get you started
Offers resources for payers, employers and providers, including palliative care quality standards and best practices, and checklists to support opportunities and action within payer organizations
The toolkit will help you learn how payers and providers can collaborate to help an aging population with complex care needs. The imperative to help our sickest, most costly and most vulnerable patients has never been greater, but solutions are within reach.
LITTLE BENEFIT FROM CORTICOSTEROID INJECTIONS FOR COMMON CAUSE OF SPINE-RELATED PAIN
The addition of a corticosteroid to epidural injections of an anesthetic does not enhance pain reduction in patients with lumbar spinal stenosis, a common cause of lower back and leg pain, according to a paper entitled A Randomized Trial of Epidural Steroid Injections for Spinal Stenosis, published in the July 3 issue of New England Journal of Medicine. The findings come from the first major clinical trial comparing epidural injections of anesthetic with and without corticosteroids for spinal stenosis. Researchers studied patients 6 weeks after treatment and found those whose lidocaine anesthetic was supplemented with a corticosteroid –a steroid medication often used to relieve swelling –experienced minimal to no additional benefit compared with patients who received injections of anesthetic alone.
Epidural injection of anesthetic with corticosteroid is a common treatment for lumbar spinal stenosis. The combination has been hypothesized to relieve pain by reducing nerve swelling and increasing blood flow. It is estimated that more than 2.2 million lumbar epidural steroid injections are performed each year among Medicare patients. Rates and associated costs of the procedure have increased nearly 300% over the last two decades.
This study, the Lumbar Epidural steroid injections for Spinal Stenosis (LESS) trial, was led by Janna L. Friedly, MD, Assistant Professor of Rehabilitation Medicine at the University of Washington in Seattle. It was conducted at 16 hospitals in the United States and included 400 patients aged 50 and older with evidence of lumbar stenosis and at least moderate pain. Half of the patients in the trial received epidural injections of anesthetic with corticosteroid, the other half received injections without corticosteroid. The researchers found that patients combining corticosteroids and lidocaine were more likely to report side effects, and were more likely to absorb the corticosteroid into their bloodstream. Taken over time, corticosteroids can result in reduce bone density, increased risk of bone fracture and immunosuppression.
“This is the first large, multicenter randomized trial to look at epidural steroid injections for spinal stenosis, and we found that injection with corticosteroids and lidocaine provided these patients with minimal or no additional benefit over lidocaine injections”, Dr. Friedly said. “If patients are considering an epidural injection, they should talk to their doctor about the benefits and risks of the options available”.
NIH ANNOUNCES LAUNCH OF A DATABASE FOR PAIN RESEARCH
The National Institutes of Health has launched a federal pain database, called the Interagency Pain Research Portfolio (IPRP).
“This database will provide the public and the research community with an important tool to learn more about the breadth and details of pain research supported across the federal government. They can search for individual research projects or sets of projects grouped by themes uniquely relevant to pain”, said Dr. Linda Porter, Policy Advisor for Pain at the National Institute of Neurological Disorders and Stroke, in the statement. “It also can be helpful in identifying potential collaborators by searching for topic areas of interest or for investigators”.
The database will give users access to over 1200 projects, organized in a tiered system, with the first tier comprising basic, translational (research concerning particular diseases) and clinical research projects. The second tier will cover 29 different areas of pain, from biobehavioral and psychosocial mechanisms to chronic overlapping conditions.
The database is the product of a collaboration between six federal agencies, including the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality and the Food and Drug Administration. In all, the database is expected to provide people with a diverse range of content in which the contributions from the federal agencies “reflect their unique missions and the populations they serve”, Porter said in the statement. “For the first time, this information has been collected into a single database that can be mined to ensure that federal research efforts are not redundant and to identify opportunities to collaborate and share resources across agencies”.
AMERICAN PAIN SOCIETY GUIDELINE ON METHADONE SAFETY
Measures can be taken to promote safer user of methadone, including better physician education and patient counseling about methadone safety and cardiac monitoring to identify patients at high risk for these problems, a new Clinical Practice Guideline on Methadone Safety from the American Pain Society (APS) concludes. The safety of methadone, a synthetic opioid used to treat opioid addiction and chronic pain, has been questioned in recent years, as deaths from methadone overdoses have jumped from 800 in 1999 to 4900 in 2008, the authors note. The increase in deaths has been substantially higher than for any other opioid medication and is attributed to a sharp rise in prescribing methadone for chronic pain, they point out. The guideline is published in the April 2014 issue of The Journal of Pain. The new document is based on a systematic review of the evidence on methadone safety performed by an interdisciplinary panel, commissioned by the APS and CPDD, in collaboration with the Heart Rhythm Society, under the direction of the Oregon Evidence-based Practice Center. The panel identified “numerous research gaps” and note that most recommendations are based on low-quality evidence and none are based on high-quality evidence.
Among the key recommendations:
Patient assessment: Perform an individualized medical and behavioral risk evaluation to assess risks and benefits of methadone. Use the results to stratify patients according to their risk for substance abuse and consideration that the long and variable half-life of the drug could cause reactions with other prescription medications and possible arrhythmias. “Proper patient selection is critical when considering the use of any opioid, whether for chronic pain or treatment of addiction”, the authors say.
Education and counseling: Counsel patients about potential risks and benefits before initiating methadone therapy. Advise patients to take methadone as prescribed and comply with recommended follow-up and monitoring. Notify caregivers about risks for respiratory depression; include instructions to withhold additional doses of methadone and contact the prescriber if signs of respiratory depression or somnolence occur.
Baseline electrocardiogram (ECG): Obtain an ECG before initiating methadone therapy in patients with risk factors for prolonged corrected QT interval (QTc), any prior ECG demonstrating a QTc greater than 450 ms, or a history suggestive of prior ventricular arrhythmia. Consider obtaining an ECG before starting methadone in patients not known to be at higher risk for prolonged QTc. Recent data suggest that methadone is the most common drug-related cause of ventricular arrhythmia, the panel notes.
Alternative medications: Consider buprenorphine as an option for patients being treated for opioid addiction who have risk factors for prolonged QTc.
Low beginning dose: Start methadone at low doses (no more than 30 to 40 mg daily) and titrate slowly. This recommendation is based on the drug's long and variable half-life, which can be as long as 120 hours. Slow titration may reduce the risk for unintended drug accumulation and accidental overdose, the panel says.
Urine drug testing: Perform urine drug testing before starting methadone therapy and at regular intervals for patients treated for opioid addiction.
CONSENSUS STATEMENT ON PRN OPIOID RANGE ORDERS IN THE MANAGEMENT OF PAIN
In the June issue of Pain Management Nursing, the American Society of Pain Management Nurses and APS published a consensus statement regarding the use of as-needed (PRN) range orders for opioids, which enables necessary and safe adjustments in doses based on individual responses to treatment. The position statement affirms that effective pain management requires careful individual titration of analgesics. The statement further provides recommendations for writing PRN range orders and a review of evidence supporting the need for such individualized dosing.
AMERICAN PAIN SOCIETY TO PAIN RESEARCH FORUM'S “PAPERS OF THE WEEK”
The American Pain Society (APS) announced on June 23 that it had begun a collaboration with the Pain Research Forum (PRF) in which APS will provide grant support for PRF's “Papers of the Week” website postings of new papers in pain research, which are published in peer-reviewed journals covering pain, neuroscience and related disciplines.
“We are grateful for the generous support from the American Pain Society for the Pain Research Forum, a unique and valuable resource for the pain research community. Papers of the Week, has become one of the most popular services of the Pain Research Forum to help researchers and clinicians stay current with new studies in the field of pain research”, said PRF Executive Editor Neil Andrews.
“As the leading professional society devoted to pain science and pain research, the American Pain Society supports the mission of Pain Research Forum to provide an active online community for pain researchers worldwide to exchange information and ideas” said APS President Gregory Terman, M.D. “Our support for Papers of the Week encourages our members to rely on this valuable service to stay on top of the latest published science in pain”
Pain Research Forum was launched in June 2011. Its mission is foster discussion and collaboration that will speed the acquisition of new knowledge and its translation into novel treatments for chronic and neuropathic pain. The site was developed and is maintained by editorial staff at the Harvard NeuroDiscovery Center, in collaboration with the MassGeneral Institute for Neurodegenerative Disease Informatics group, with guidance from an international advisory board of top pain researchers. All PRF news and discussion content, research resources and member services are free to researchers, clinicians and others interested in the problem of chronic pain. PRF members can request to receive email alerts when new editions of Papers of the Week are published online every Friday.
DEA RESCHEDULES HYDROCODONE COMBINATION PRODUCTS
On August 22, 2014, the U.S. Drug Enforcement Administration (DEA) published in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA's own evaluation of relevant data. This Final Rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle or propose to handle HCPs. It goes into effect in 45 days. The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.) HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin.
“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents”, said DEA Administrator Michele Leonhart, “Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available”.
When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II. The current analysis of HCPs by HHS and the DEA shows they have a high potential for abuse, and abuse may lead to severe psychological or physical dependence. Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential. The many findings by the DEA and HHS and the data that support these findings are presented in detail in the Final Rule on the website. Data and surveys from multiple federal and non-federal agencies show the extent of abuse of HCPs. For example, Monitoring the Future surveys of 8th, 10th, and 12th graders from 2002 to 2011 found that twice as many high school seniors used Vicodin®, an HCP, nonmedically as used OxyContin®, a Schedule II substance, which is more tightly controlled.
In general, substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations. Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health or on the petition of any interested party. (Detailed information on the scheduling and rescheduling process can be found beginning on page 8 of Drugs of Abuse on the DEA's website at http://www.justice.gov/dea/pr/multimedia-library/publications/drug_of_abuse.pdf.)
The rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, the U.S. Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II by a vote of 19 to 10. Consistent with the outcome of that vote, in December of 2013 HHS sent such a recommendation to the DEA. Two months later, on February 27, the DEA informed Americans of its intent to move HCPs from Schedule III to Schedule II by publishing a Notice of Proposed Rulemaking in the Federal Register, outlining its rationale and the proposed changes in detail and soliciting public comments on the proposal, of which almost 600 were received. A small majority of the commenters supported the proposed change.
FDA APPROVES NEW EXTENDED-RELEASE OXYCODONE WITH ABUSE-DETERRENT PROPERTIES
On July 23, 2014, U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product's abuse-deterrent properties consistent with the FDA's 2013 draft guidance for industry, Abuse-Deterrent Opioids –Evaluation and Labeling.
Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.
“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.”, said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain”.
Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given Targiniq ER's risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.
The safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3000 people with Targiniq ER. Data from in vitro (in a laboratory) and in vivo (testing with people) abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting). The most common side effects of Targiniq ER are nausea and vomiting.
The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death associated with long-term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.
In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage and disposal of ER/LA opioids.
DEA RECLASSIFIES TRAMADOL AS A CONTROLLED SUBSTANCE
The federal Drug Enforcement Administration (DEA) published its Final Rule in the Federal Register on July 2nd placing tramadol into Schedule IV effective August 18, 2014. Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under the name “Ultram”. Since then, the FDA has approved for marketing generic, combination and extended release versions. The DEA follows in the path of a number of states that have already taken this step such as Arkansas, Mississippi, and New York. By making tramadol a Schedule IV controlled substance, the DEA makes it easier for the pharmaceutical industry to develop consistent policies and procedures nationwide for how this drug is handled.
Acknowledging that changes such as these take time to implement, the DEA extended the usual effective date for this type of change from 30 to 45 days to provide what it considers to be “reasonable time for registrants to comply with handling requirements for a schedule IV” drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders. Though in the past the DEA has allowed for additional time for compliance or staggered the implementation process, it specifically chose to forgo staggered dates here to avoid confusion and inconsistent application of the new requirement.
It is important to note that as of August 18, 2014, manufacturers are required to print the designation “C-IV” onto every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation. The DEA believes that the 45 day window between July 2nd and August 18th will “provide a reasonable time for distributors to sell existing stock” without the designation and to stock inventory with the proper designation. Also, August 18th will be a busy day, as on August 18th every DEA registrant possessing tramadol must take an inventory of all tramadol stock in compliance with 21 C.F.R. § 1304.11(d). Anyone who does not want to handle controlled substances, but that currently stocks tramadol, must surrender the stock according to § 1307.21 or must transfer the stock to a DEA registrant before August 18th.
IASP NAMES SIX HONORARY MEMBERS
The International Association for the Study of Pain (IASP) Council has named six outstanding pain researchers and clinicians Honorary Members. All will be recognized before the IASP General Assembly of the 15th World Congress on Pain in October in Buenos Aires.
Honorary membership is the highest recognition the association awards its members. These individuals have made substantial contributions in pain-related fields and have advanced the mission of the association. They join 34 living honorees. The committee reviewed more than a dozen nominations, basing its selections on the nominee's contributions in pain education, pain research and/or pain management; involvement and service to IASP; and exceptional contributions to pain issues at national and international levels.
Following are the 2014 IASP Honorary Members:
Gary J. Bennett is Canada Senior Research Chair, Department of Anesthesia and Faculty of Dentistry at McGill University in Montreal, Canada. Dr. Bennett has devoted his career to improve our understanding of the underlying mechanisms of neuropathic pain, ultimately enhancing care provided to people suffering with these complex syndromes.
Marshall Devor is a laboratory head in the Institute of Life Sciences, Hebrew University of Jerusalem and incumbent to the first endowed chair in pain research in Israel. Dr. Devor's extensive publications in the field, using a wide variety of experimental approaches, have contributed considerably to our understanding of the neurobiological basis of neuropathic pain.
George Mendelson is Foundation Fellow, Faculty of Forensic Psychiatry, the Royal Australian and New Zealand College of Psychiatrists. Dr. Mendelson's significant contributions in pain management cover the fields of pain medicine, psychiatry and the law and compensation for chronic pain.
Robert Andrew Moore is Senior Research Fellow, Nuffield Department of Anaesthetics at the University of Oxford. Dr. Moore has supported and developed the thinking of many clinical and non-clinical “pain leaders” around the world, owing to his prodigious contributions to the knowledge and literature of pain and anesthesia.
Donald D. Price is Professor of Oral and Maxillofacial Surgery, Department of Oral Surgery and Neuroscience, at the University of Florida College of Medicine. Dr. Price has contributed substantially to the treatment of pain by his tireless and passionate advocacy for adequate pain assessment and by developing scales that allow clinicians to measure the pain their patients communicate.
Manoel Jacobsen Teixeira is Professor of Neurosurgery in the Medicine School of the University of São Paulo, Brazil. A pioneer who expanded the study of pain in Brazil and throughout Latin America, Dr. Teixeira created the Residency Program in Chronic Pain in Neurology and Neurosurgery at the university, the first program of its kind in the country. He also founded the original League Against Pain, a model for 20 similar organizations in Brazil that educate students on the practical aspects of the assistance to chronic pain patients.
MANY PATIENTS IN CANCER CENTERS MAY NOT EXPERIENCE A DIGNIFIED DEATH
A study that surveyed physicians and nurses in hospitals within cancer centers in Germany suggests that many patients there do not experience a dignified death. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study indicates the need for cancer centers to invest more in palliative care services, adequate rooms for dying patients, staff training in end-of-life care and advance-care-planning standards.
Previous research has shown that hospitals are often ill-prepared to provide care for dying patients. To investigate whether the circumstances for dying on cancer center wards allow for a dignified death, Karin Jors, MA, of the University Medical Center Freiburg, and her colleagues surveyed physicians and nurses in 16 hospitals belonging to 10 cancer centers in Baden-Württemberg, Germany. The survey addressed topics regarding end-of-life care including structural conditions such as rooms and staff, education/training, working environment, family/caregivers, medical treatment, communication with patients and dignified death.
Among 1131 survey respondents, 57% believed that patients could die with dignity on their ward. Half of the survey staff members indicated that they rarely have enough time to care for dying patients, and 55% found the rooms available for dying patients unsatisfactory. Only 19% of respondents felt that they had been well-prepared to care for dying patients (and only 6% of physicians felt so). Palliative care staff reported much better conditions for dying patients than staff from other wards, with 95% of palliative care staff indicating that patients die with dignity on their wards. Generally, physicians perceived the circumstances for dying patients much more positively than nurses, especially regarding communication and life-prolonging measures. While 72% of physicians reported that patients can usually die a dignified death on their ward, only 52% of nurses shared this opinion.
“In our aging society, it is predicted that the number of hospital deaths will continue to rise in the coming years, and many of these deaths will be attributable to cancer. For this reason, it is particularly important that cancer centers strive to create a comfortable, dignified experience for dying patients and their families”, said Jors. “Above all, this requires that staff members are provided with the adequate resources to care for these patients”.
The investigators encourage the integration of palliative care into standard oncology care, beginning as early as diagnosis. They also note that physicians and nurses would benefit from increased education and training in end-of-life care. To promote the development of standards for end-of-life care, establish a comprehensive palliative care curriculum for health care staff, and to encourage further research in this field, the Palliative Care Center of Excellence in Baden-Württemberg (KOMPACT) was established in 2014. “This center combines the expertise of five academic, specialist palliative care departments. We believe that this cooperation is a valuable tool for improving patient care in the end-of-life setting”, said Jors.
PHARMACY SCHOOL LAUNCHES STATEWIDE OD PREVENTION WEBSITE
With funding from the Pennsylvania Commission on Crime and Delinquency, the University of Pittsburgh School of Pharmacy's Program Evaluation and Research Unit (PERU) has launched a statewide overdose prevention website called OverdoseFreePA. A pilot application is being developed for OverdoseFreePA that will allow the public to browse close-to-real-time overdose death statistics by categories such as gender, age, race and type of drug. The pilot will begin by using the overdose death statistics from Allegheny County. Collaborators on the project include the Pennsylvania Department of Drug and Alcohol Programs, the Allegheny County Medical Examiner's Office, and the Single County Authorities of Allegheny, Butler, Bucks, Blair, Dauphin, Delaware and Westmoreland counties. OverdoseFreePA provides presentations and educational curricula that are evidence-based and tailored to a number of target audiences, including the public, substance use disorder (SUD) treatment professionals, criminal justice system personnel, healthcare providers and more. The website also will include documents that describe how to effectively link high-risk individuals to SUD treatment and recovery, and strategies for building and maintaining community coalitions that address overdose prevention locally.
“Data from the National Center for Health Statistics indicate that drug-related deaths have skyrocketed across the nation in recent years, especially in Pennsylvania”, said PERU Director Janice Pringle. “The new website could help show Pennsylvanians the true effect of overdoses within their community and provide resources for increasing public awareness of the overdose risk and strategies for reducing this risk”.
“These are deaths that didn't have to happen”, she noted. “We can prevent them using compassionate approaches to addiction treatment and education, and by creating a unified front from which to approach the problem”.
The website can be accessed at: http://www. overdosefreepa.pitt.edu/
CAMBIA FOUNDATION AWARDS $ 1.8 MILLION TO ADVANCE PALLIATIVE CARE
The Cambia Health Foundation announced in September the first 10 recipients of its Sojourns Scholar Leadership Program, which recognizes leadership in palliative care, an increasingly important field of health care that relieves suffering and improves quality of life for people facing serious illness. The inaugural Sojourns Scholar Leadership Program provides emerging palliative care leaders with a 2 year, $180,000 grant to support research, clinical, educational or policy projects. The national program will leverage the previous success of the Sojourns Awards, a regional program designed to recognize established leaders in the field of palliative care. The focus of the enhanced grant program is to strengthen the palliative care work force by creating a learning community of emerging palliative care leaders.
The 2014 award recipients span the country and areas of focus, with projects that focus on individuals who are recovering from strokes, those with dementia, seriously ill veterans, infants and children and the aging population. The Sojourns scholars are located in California, Maryland, New York, North Carolina, Washington and Wisconsin.
There is a significant need to increase, enhance and support the palliative care workforce on a national level. Today, there is approximately one palliative care medical professional for every 1200 people facing serious illness. And as the baby boomer population ages, there will be a greatly increased need for palliative care both for patients and their families. In addition to solidifying the future palliative care workforce, the Sojourns program also has the potential to increase general awareness for palliative care. As Americans are diagnosed with serious and chronic illnesses, many do not know what palliative care is or how to access it.
“We created the Sojourns Scholar Leadership Program to recognize and support future innovators and leaders in the field of palliative care, the outstanding doctors and nurses who are really making a difference for patients and families”, said Peggy Maguire, President and Board Chair of the Cambia Health Foundation. “These award recipients are already actively working to advance the field of palliative care, and we hope that our investment will allow them to become the next generation of leaders who will help to improve quality, access and understanding at a crucial time in our nation's health care landscape”.
The $180,000 grant will help to advance the work of each winning physician or nurse and allow them to influence and advance system and policy changes in palliative care. Originally slated to award up to six grants, the Sojourns Scholar Award advisory committee received a significant number of extremely promising proposals from doctors and nurses in the palliative care field. As a result, the advisory committee elected to award 10 recipients, increasing Cambia Health Foundation's investment to $1.8 million.
“The Sojourns Scholar grant proposals demonstrated both growth and promise in the palliative care field”, said Dr. Diane Meier, Director of the Center to Advance Palliative Care and one of the five national palliative care experts on the advisory committee that selected the winners. “These physicians and nurses bring experience and perspective that will certainly influence the palliative care workforce for years to come. After spending a significant amount of time with each award recipient, we feel that the future of palliative care is in good hands”.
The Award recipients are:
From California:
Wendy Anderson, MD, MS, University of California, San Francisco, palliative care training and systems for critical care nurses and physicians
Anne Kinderman, MD, San Francisco General Hospital and the University of California, San Francisco, community-based palliative care services
From Maryland:
Renee Boss, MD, the Johns Hopkins University School of Medicine and Berman Institute of Bioethics, palliative care for chronically ill infants and their families
From New York:
Abraham A Brody, RN, PhD, GNP-BC, New York University College of Nursing, palliative care for dementia patients and their caretakers
Elizabeth Lindenberger, MD, Icahn School of Medicine at Mount Sinai, palliative care for older and seriously ill patients
From North Carolina:
Arif Kamal, MD, Duke University, palliative care quality measures and research
From Washington:
Claire Creutzfeldt, MD, University of Washington, palliative care needs for stroke patients
Caroline Hurd, MD, University of Washington, palliative care curriculum and training in Pediatric and Internal Medicine
Lynn F. Reinke, PhD, ARNP, Department of Veteran Affairs, VA Puget Sound Healthcare, palliative care for patients with multi-morbidity
From Wisconsin:
Toby Campbell, MD, MSCI, University of Wisconsin School of Medicine and Public Health, palliative care for older adults facing high-risk surgery decisions
INSTITUTE OF MEDICINE ON DYING IN AMERICA
In September 2014, the Institute of Medicine released a 500-page report, titled “Dying In America” which suggests that the first end-of-life conversation could coincide with a cherished American milestone: getting a driver's license at 16, the first time a person weighs what it means to be an organ donor. Follow-up conversations with a counselor, nurse or social worker should come at other points early in life, such as turning 18 or getting married. The idea, according to the IOM, is to “help normalize the advance care planning process by starting it early, to identify a health care agent, and to obtain guidance in the event of a rare catastrophic event”.
The IOM plans to spend the next year holding meetings around the country to spark conversations about the report's findings and recommendations. “The time is now for our nation to develop a modernized end-of-life care system”, said Dr. Victor Dzau, president of the IOM.
The 21-member IOM committee that authored the report grappled with the fact that most Americans have not documented their wishes for end-of-life care. A national survey in 2013 found that 90% of Americans believed it was important to have end-of-life care discussions with their families, yet less than 30% had done so. Those who have had the discussions tend to be white, higher-income, over 65 and have one or more chronic condition.
In response to these statistics, the IOM offers a new “life-cycle model of advance care planning” that envisions people having regular planning conversations as part of their primary care, and at the diagnosis of any chronic illnesses or genetic conditions. The conversation would continue at various turning points of a disease, when spiritual counseling might be offered, and then again in the final year of expected life.
The report also found that the American health care system is poorly equipped to care for patients at the end of life. Despite efforts to improve access to hospice and palliative care over the past decade, the committee identified major gaps, including a shortage of doctors proficient in palliative care, reluctance among providers to have direct and honest conversations about end-of-life issues, and inadequate financial and organizational support for the needs of ailing and dying patients.
“We all share in common one reality: We're all going to die”, said Dr. Philip Pizzo, co-chair of the committee, at the public release of the report Wednesday. “We have the ability to accomplish [a strong end-of-life care system], but we have a long way to go”.
Just talking about death and dying can ignite fear and controversy: Five years ago, the health law's proposal for Medicare to reimburse doctors for counseling patients about living wills and advance directives became a rallying cry for Republican opponents of the law who warned about so-called “death panels”. The reimbursement provision was removed from the Affordable Care Act before it passed.
The IOM argues that the country cannot afford to wait any longer to have a less heated conversation, especially as the number of elderly Americans continues to grow with the aging of the baby boom generation.
“At a time when public leaders hesitate to speak on a subject that is profoundly consequential for the health and well-being of all Americans, it is incumbent on others to examine the facts dispassionately, assess what can be done to make those final days better, and promote a reasoned and respectful public discourse on the subject”, write Dzau and Dr. Harvey Fineberg, the former president of the IOM, in a forward.
The report also addresses how to make palliative care –care that focuses on quality of life and pain control for people with serious illnesses –more prevalent and available to all patients. Over the past decade, palliative medicine has become a widespread specialty. But while 85% of hospitals with more than 300 beds now have palliative care services, many patients still may not have access to a specialist, including those who are not hospitalized or who live in rural areas. To address the shortage, the committee writes, all clinicians regardless of specialty “should be competent in basic palliative care, including communication skills, interprofessional collaboration and symptom management”. Medical schools are currently required to cover end-of-life care as part of their curriculum, but they offer an average of just 17 hours of training over all 4 years. And end-of-life care is not one of the crucial 15 topic areas for Step 3 of the medical licensing exams, the final step to becoming a practicing physician.
The committee calls for medical schools, accrediting boards and state regulatory agencies to bolster their end-of-life training and certification requirements. Some private insurance plans have already started adopting some of the practices recommended in the report. “It's not entirely altruistic”, said David Walker, co-chair of the committee. Private payers have the data to know that palliative and hospice care can save money at the end of life.
FDA APPROVES NALOXEGOL (MOVANTIK)) FOR OPIOID-INDUCED CONSTIPATION
On September 16, 2014, the U.S. Food and Drug Administration (FDA) approved naloxegol (Movantik) tablets as the first once-daily oral peripherally acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. I tis a Schedule 2 controlled substance.
“The FDA approval of Movantik provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy”, said Dr. Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. “We are pleased to provide physicians and their patients with a once-daily oral treatment supported by a robust clinical programme”.
The FDA approval of Movantik was based on data from the KODIAC clinical program, which is comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4 and KODIAC-8 was a 52 week open label, long-term safety study.
The medication is expected to be available to patients in the first half of 2015. Movantik is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the New Drug Application, the FDA evaluated the abuse potential and the approved labeling indicates that Movantik has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of the drug to the U.S. Drug Enforcement Administration (DEA) in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request. Results from KODIAC-4 and -5 were published in the New England Journal of Medicine on June 19, 2014. Naloxegol is also under regulatory review by the European Medicines Agency (EMA).
CHRONIC PAIN MANAGEMENT IN SICKLE CELL DISEASE RECOMMENDATIONS FROM THE NIH
The National Heart, Lung, and Blood Institute (NHLBI) recently released new recommendations for managing chronic pain in people with sickle cell disease (SCD).
The 142 page report is available online at: http:// www.nhlbi.nih.gov/health-pro/guidelines/sickle-cell-disease-guidelines/sickle-cell-disease-report.pdf. The recommendations are part of NHLBI's “Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014” guidelines, which were developed for health care professionals to “address the care of infants, children, adolescents, and adults with sickle cell disease, with the goal of facilitating high-quality and appropriate care for all individuals with this disease”.
The report states that there are no current comprehensive, systematically reviewed, evidence-based guidelines in the United States to assist health care professionals in the management of individuals with SCD, which affects an estimated 70,000 to 100,000 Americans. Therefore, a team of methodologists, librarians and research staff conducted a systematic review of two randomized controlled trials, six observational studies and 13 case reports to evaluate the efficacy of current management practice for chronic pain. Chronic pain in SCD was defined as lasting for more than 3 months, is of unclear etiology and is associated with neuropathic pain. The researchers found no significant difference between combining massage therapy with progressive muscle relaxation and massage therapy alone. They also found a statistically significant difference in favor of transcutaneous sodium salicylate iontophoresis for hip pain versus parenteral analgesics. The investigators noted that the quality of the available evidence was low and additional research is needed to provide better data.
The 12 recommendations featured in the report are an adaptation of the guidelines published by the American Pain Society in collaboration with the American Academy of Pain Medicine. An overview of the chronic pain recommendations from the report can be found in the Box. The recommendations are:
Determine the cause and type of chronic pain.
Use a combination of the patient's treatment response to guide long-term use of opioids.
Encourage use of nonpharmacologic interventions (e.g., deep tissue/deep pressure massage therapy, muscle relaxation therapy, self-hypnosis).
Use opioids (long- and/or short-acting) when pain is not controlled by nonopioids.
Assess chronic pain at least annually, or as needed.
Use a partnership agreement as a basis for the development of a written, individualized treatment plan.
Appoint one to two physicians to write biweekly/monthly long-term opioid prescriptions. Avoid refills without patient follow-up, and evaluate patients on chronic opioid therapy every 2 to 3 months.
Document all patient encounters (e.g., medical history, physical exam, diagnosis, management plan).
Encourage patients on opioid therapy to increase fluid intake and maintain dietary intake per current recommendations; use stool softeners and stimulant laxatives as needed.
Listen to patient reports and optimize therapeutic outcomes based on them.
Refer patients for mental health professional evaluations as needed.
Assess non-SCD pain (e.g., postoperative, trauma, iatrogenic, comorbid conditions).
METHYLNALTREXONE APPROVED FOR OPIOID-INDUCED CONSTIPATION IN NON-CANCER PAIN
On September 29, 2014, Salix Pharmaceuticals Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of methylnaltrexone bromide (Relistor) injection for use in patients experiencing opioid-induced constipation who are receiving opioids for chronic pain unrelated to cancer. Relistor was first approved in 2008 to treat opioid-induced constipation in severely ill patients who did not respond to laxatives.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.