NEWS AND INNOVATIONS

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PAIN EXHIBIT LAUNCHES WEB SITE IN SPANISH

On October 28, 2013, PAIN Exhibit, Inc., a nonprofit organization, announced that it has launched its Web site in Spanish at PainExhibit.org/es. The site features art from people with chronic pain with their art expressing some facet of the pain experience. The mission of the PAIN Exhibit is to educate health care providers and the public about chronic pain through art and to give a voice to the many who suffer in silence. Purdue Pharma L.P. provided a generous donation for the creation of the new Spanish Web site. The U.S. Census Bureau estimates that the Hispanic population in America in 2010 was 50.5 million, and currently in California the number of Hispanics equal that of whites. Moreover, Hispanics are both the largest minority in the United States and the fastest growing. According to a recent report from the Institute of Medicine, there are approximately 100 million American adults affected by chronic pain at an estimated annual cost of $600 billion. Chronic pain is poorly treated in the United States and worldwide, resulting in increased suffering. The scientific literature provides some insight into Hispanics and pain. The data suggest that about a third of Hispanic adults have chronic pain; and significantly fewer Hispanics seek medical care for pain, and are more likely to feel isolated and that pain had ruined their lives as compared with whites and African Americans. In addition, Hispanics who seek pain treatment are less likely to receive adequate pain medication to relieve their pain as compared with whites. Chronic pain is often invisible and what is not seen is not believed. Art makes the invisible visible and communicates pain far better than words. PainExhibit.org/es features 106 pieces of art divided amongst 11 galleries. Examples of these galleries include “Portraits of Pain,” “Isolation and Imprisonment,” “But You Look So Normal,” “Mental Health,” “Unconditional Love,” and “Hope and Transformation.”

OREGON HOSPITALS TO USE NEW TOOL TO PREVENT PRESCRIPTION MEDICATION ABUSE

Fifty hospitals in Oregon will take part in the new Emergency Department Information Exchange to give emergency department physicians “a new tool to assess patients’ needs and prevent them from ‘shopping’ around for narcotics prescriptions.” The exchange, a collaboration between the Oregon Chapter of the American College of Emergency Physicians, the Oregon Health Authority, the Oregon Health Leadership Council, and the Oregon Association of Hospital and Health Systems, “links participating hospitals through an online system giving doctors access to a patient's real-time clinical and utilization data.” It is hoped the new exchange will help lower Oregon's rate of prescription medication abuse, currently the highest in the United States.

FDA APPROVES EXTENDED-RELEASE, SINGLE-ENTITY HYDROCODONE PRODUCT

The U.S. Food and Drug Administration approved Zohydro ER (hydrocodone bitartrate extended-release capsules) on October 25, 2013, for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids. Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.

The approved labeling for Zohydro ER conforms to updated labeling requirements for all ER/LA opioid analgesics announced by the FDA on September 10, 2013.

The new class labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications. These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices. Zohydro ER is the first opioid to be labeled in this manner.

The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks. These studies will also be required for other ER/LA opioid analgesics. The safety of Zohydro ER is based on clinical studies of more than 1100 people living with chronic pain. The efficacy of Zohydro ER is based on a clinical study that enrolled over 500 patients with chronic low back pain and showed significant improvement in chronic pain compared with placebo. Zohydro ER will be part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the ER/LA Opioid Analgesics REMS 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.

The most common side effects of Zohydro ER are constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting, and itching (pruritus).

Zohydro ER is manufactured by San Diego–based Zogenix, Inc.

GUIDE TO PAIN MANAGEMENT IN LOW-RESOURCE SETTINGS NOW AVAILABLE IN SPANISH

The International Association for the Study of Pain (IASP) has published a Spanish translation of Guide to Pain Management in Low-Resource Settings. The 393-page book, available free, addresses such topics as physiology and psychology of pain, principles of palliative care, and management of patients with specific pain problems, including various types of cancer, acquired immunodeficiency syndrome (AIDS), sickle cell anemia, neuropathic pain, back pain, and visceral pain. Case reports provide illustrations of typical cases in the low-resource (often rural) setting in developing countries. Dr. Alfredo Covarrubias-Gómez and Lic. Fernando Ruiz García devoted many hours to the translation, under the auspices of IASP's Mexico chapter, Asociacion Mexicana para el Estudio y Tratamiento del Dolor. IASP President Fernando Cervero hailed their effort as a “great service to our Spanish-speaking members and colleagues and a tribute to the contribution of the Mexican chapter to the work of IASP.” The original publication was edited by Andreas Kopf and Nilesh B. Patel and first published in 2009.

IASP SPONSORS GLOBAL YEAR AGAINST OROFACIAL PAIN

The Global Year against Orofacial Pain launched on October 21, 2013, bringing global attention to pain that is perceived in the face and/or oral cavity, caused by diseases or disorder of regional structures, by dysfunction of the nervous system, or through referral from distant sources. Sponsored by IASP, the 12-month campaign focuses on education for health care professionals and government leaders as well as public awareness.

Treatment of orofacial pain is a specialty in dentistry in many parts of the world and an emerging area of specialization in others. One organized diagnostic approach categorizes orofacial pain into four groups based on the underlying pain mechanisms—namely, musculoskeletal, neuropathic, neurovascular, and psychogenic pain. Led by IASP's Special Interest Group on Orofacial Pain, the initiative will mobilize IASP's 8000+ members and 90 national chapters, and forge partnerships with other organizations, to do the following:

• Disseminate information about orofacial pain worldwide

• Educate pain researchers and health care professionals who see the issues associated with orofacial pain firsthand in their interactions with patients

• Increase awareness of orofacial pain among government officials, members of the media, and the general public worldwide

• Encourage government leaders, research institutions, and others to support policies that result in improved pain treatment for people with orofacial pain

As part of the Global Year Against Orofacial Pain, IASP offers a series of fact sheets for clinicians and health care professionals that cover specific topics related to orofacial pain. These fact sheets are translated into multiple languages and available for free download. Also available is a page of resources that includes links and free posters promoting the Global Year. IASP and its chapters will sponsor meetings, symposia, media interviews, publications, and other efforts throughout the coming year to promote education on issues surrounding orofacial pain. For more information, visit www.iasp-pain.org/GlobalYear/ orofacialpain.

JOHNS HOPKINS LAUNCHES NEW BIOETHICS FELLOWSHIP PROGRAM

The Johns Hopkins Berman Institute of Bioethics has announced a new bioethics postdoctoral fellowship program intended to help launch the careers of the next generation of bioethics scholars, creating 2-year funded research positions for at least 10 fellows over the next decade. In an announcement inviting applicants for the September 2014 cohort of fellows, the Berman Institute states that the Hecht-Levi Fellowship Program in Bioethics will include “considerable protected time for research and publication” and can be coordinated with clinical duties at Johns Hopkins’ Schools of Nursing or Medicine.

“We are very excited about the launch of this new fellowship program, which has already begun to bring some of the most promising young bioethics scholars to our community, and will drive inquiry into some of the most pressing issues for the future,” says Ruth Faden, PhD, MPH, director of the Berman Institute. The inaugural cohort of fellows began work at the Berman Institute in September 2013. The program is made possible through a grant from the Hecht-Levi Foundation, longtime supporters of bioethics, medicine, and scholarship at Johns Hopkins, as well as urban renewal and the arts in Baltimore.

“Fellowship training has been a centerpiece of the Berman Institute from its inception, and we are so grateful to the Hecht-Levi Foundation for the opportunity to continue this wonderful tradition,” says Faden.

According to Faden, fellows will be selected for their promise as future leaders in the field of bioethics, and for research interests that will benefit from the expertise available among the Berman Institute's faculty. Fellows will receive one-on-one mentoring and take part in seminars and events hosted by the Berman Institute, attend courses offered across Johns Hopkins University, and take advantage of the proximity to policy-making within state and federal governments. A relevant doctoral or professional degree is required for the fellowship, though specific experience in bioethics is not. All fellows must reside in the Baltimore area for the 2 years of the fellowship. Robert H. Levi graduated from the Johns Hopkins School of Arts and Sciences in 1936 and went on to become a trustee of both the university and hospital. Today, his son, Alex Levi, is chair of the Berman Institute's National Advisory Board.

“We are honored that the Levi family shares and supports our vision for training the next generation of scholars in our field. We owe them a great debt of gratitude for making this fellowship program a reality,” says Jeffrey Kahn, PhD, MPH, the Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy at the Berman Institute, a professorship also endowed by the Hecht-Levi Foundation. The Hecht-Levi fellowship program replaces the Greenwall Fellowship Program in Bioethics and Health Policy, which the Berman Institute hosted by from 1997 to 2012. The Greenwall Fellowship Program trained scholars who have gone on to become thought leaders at academic centers around the country, including nine faculty members at the Berman Institute.

PRESCRIPTION OPIOID ANALGESICS INCREASE THE RISK OF DEPRESSION

A report by Scherrer JF, Dragan M, Svrakic DM, et al., entitled “Prescription opioid analgesics increase the risk of depression,” appeared online in the October 2013 issue of the Journal of General Internal Medicine. It associated opioid use with depression. The abstract of the report follows.

Prescription opioid analgesic use has quintupled recently. Evidence linking opioid use with depression emanates from animal models and studies of persons with co-occurring substance use and major depression. Little is known about depressogenic effects of opioid use in other populations. The purpose of this study was to determine whether prescription opioids are associated with increased risk of diagnosed depression. This was a retrospective cohort study, new user design. Medical record data from 49,770 US Department of Veterans Affairs (VA) health care system patients with no recent (24-month) history of opioid use or a diagnosis of depression in 1999 and 2000. Propensity scores were used to control for bias by indication, and the data were weighted to balance the distribution of covariates by duration of incident opioid exposure. Cox proportional hazard models with adjustment for painful conditions were used to estimate the association between duration of prescription opioid use and the subsequent risk of development of depression between 2001 and 2007. Of 49,770 patients who were prescribed an opioid analgesic, 91% had a prescription for <90 days, 4% for 90–180 days, and 5% for >180 days. Compared to patients whose prescription was for <90 days, the risk of depression increased significantly as the duration of opioid prescription increased (HR  =  1.25; 95% CI: 1.05–1.46 for 90–180 days, and HR  =  1.51; 95% CI:1.31–1.74 for >180 days). The authors concluded that in this sample of veterans with no recent (24-month) history of depression or opioid analgesic use, the risk of development of depression increased as the duration of opioid analgesic exposure increased. The potential for depressogenic effect should be considered in risk-benefit discussions, and patients initiating opioid treatment should be monitored for development of depression.

KENYA SETS PALLIATIVE CARE STANDARDS

A report in Research Africa describes the following new Kenyan Palliative Care Standards. Kenya has moved to standardize its training of health care providers on palliative care services through the introduction of training manuals and guidelines covering different aspects. The documents launched recently in Nairobi include

• National Palliative Care Guidelines 2013

• National Palliative Care Training Curriculum for HIV/AIDS, Cancer and Other Life Threatening Illnesses 2013

• National Palliative Care Training Curriculum for HIV/AIDS, Cancer and Other Life Threatening Illnesses—Trainer's Manual 2013

• National Palliative Care Training Curriculum for HIV/AIDS, Cancer and Other Life Threatening Illnesses—Trainees’ Manual 2013

Speaking at the launch of these documents, Health Cabinet Secretary James Macharia said that the training of health care providers would ensure appropriate or suitable care is provided to people with terminal illnesses.

“The curriculum document we are launching today should be put to use so that any nurse, doctor, pharmacist or any health worker has the skills and knowledge to provide palliative care no matter where they are working,” he said.

Kenya Hospices and Palliative Care Association (KEHPCA) director Dr. Zipporah Ali said that the manuals will be important in providing training for health professionals.

“There has been a lot of training on palliative care without specific curriculum for the education, we hope these documents will address this challenge,” she said.

Palliative care in Kenya has gained much ground. It is now being offered in 41 government hospitals compared with the initial 11 that began offering this service in 2011. The ministry of health is in the process of ensuring that appropriate pain-controlling drugs are available at recommended levels of pain management. Dr. Ali noted that despite efforts to create cancer awareness, the majority of cancer patients still go to hospitals when it is too late to intervene.

“Most of cancer patients seek medication when it is too late, a lot of work is needed to educate people and create more awareness” she said.

The ministry of health has, however, lagged behind in the creation of National Cancer Institute, which according the Cancer Prevention and Control Act 2012 should deal with all matter of awareness creation and education.

Head of noncommunicable diseases at the Ministry of Health Dr. Joseph Kibachio says the process of establishing the institute was derailed by the March 4 elections but efforts are on track to operationalize it.

OPIOID PRESCRIBING: A SYSTEMATIC REVIEW AND CRITICAL APPRAISAL OF GUIDELINES FOR CHRONIC PAIN

An evaluation of available opioid prescribing guidelines was published online in the Annals of Internal Medicine on November 12, 2013. The paper revealed great variability on the quality of available documents. The authors are Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, and Chou R. The abstract of the original paper follows.

Deaths due to prescription opioid overdoses have increased dramatically. High-quality guidelines could help clinicians mitigate risks associated with opioid therapy. To evaluate the quality and content of guidelines on the use of opioids for chronic pain. MEDLINE, National Guideline Clearinghouse, specialty society Web sites, and international guideline clearinghouses (searched in July 2013) were the data sources. Guidelines published between January 2007 and July 2013 addressing use of opioids for chronic pain in adults were selected. Guidelines on specific settings, populations, and conditions were excluded. Guidelines and associated systematic reviews were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument and A Measurement Tool to Assess Systematic Reviews (AMSTAR), respectively, and recommendations for mitigating opioid-related risks were compared. Thirteen guidelines met selection criteria. Overall AGREE II scores were 3.00 to 6.20 (on a scale of 1 to 7). The AMSTAR ratings were poor to fair for 10 guidelines. Two received high AGREE II and AMSTAR scores. A majority of the guidelines recommend that clinicians avoid doses greater than 90 to 200 mg of morphine equivalents per day, have additional knowledge to prescribe methadone, recognize risks of fentanyl patches, titrate cautiously, and reduce doses by at least 25% to 50% when switching opioids. Guidelines also agree that opioid risk assessment tools, written treatment agreements, and urine drug testing can mitigate risks. Most recommendations are supported by observational data or expert consensus. Exclusion of non–English-language guidelines and reliance on published information was a limitation. The authors concluded that despite limited evidence and variable development methods, recent guidelines on chronic pain agree on several opioid risk mitigation strategies, including upper dosing thresholds; cautions with certain medications; attention to drug–drug and drug–disease interactions; and use of risk assessment tools, treatment agreements, and urine drug testing. Future research should directly examine the effectiveness of opioid risk mitigation strategies.

The primary funding source was the California Department of Industrial Relations and California Commission on Health and Safety and Workers’ Compensation.

THE PAINS OF CHRONIC OPIOID USAGE

The federal Agency for Healthcare Quality and Research (AHRQ) publishes a Research Update every 2 months. The November–December 2013 issue contains three clinical case reports, one of which, entitled “The pains of chronic opioid usage,” is accessible at: http://www.ahrq.gov/news/newsletters/research-activities/13nov-dec/111213RA23.html. We reprint it as information for our readers.

The spotlight case of AHRQ's September Web M&M is that of a 42-year-old man with a history of asthma and chronic lower back pain, who was admitted to the hospital with community -acquired pneumonia and an asthma exacerbation. His primary care physician (PCP) had been prescribing high doses of long­acting morphine (MS Contin), oxycodone, and gabapentin for his low back pain. He was marginally housed and often slept in shelters.

On admission to the hospital, he was treated with nebulizers, antibiotics, and prednisone. Due to some odd behavior and suspicion for substance abuse, a urine toxicology test was sent on admission and was positive for benzodiazepines, methadone, and opiates. The hospitalist confronted the patient who admitted selling his prescribed opiates and buying diazepam and methadone on the street, because they could “control [my] pain better.”

The hospital's pain service changed his medication s to methadone, hydromorphone, clonazepam, and venlafaxine. The morphine and oxycodone were discontinued. With this regimen, the patient had reasonable pain relief at the time of discharge. He was discharged with a prescription for a 2-week supply of medication s and had a follow-up appointment with his PCP 10 days after discharge. Unfortunately, as it was a weekend the discharging hospitalist was not able to speak directly with the PCP but sent her an email with the medication changes. Five days after discharge, the patient was found unconscious at a subway station and pronounced dead at a local hospital following unsuccessful resuscitation. Based on the clinical presentation and details at the scene, the cause of death was likely from unintentional opiate/benzodiazepine overdose.

In reviewing his medications, the patient had refilled his long-acting morphine and oxycodone one day before admission. Unfortunately this information was not available to the discharging hospitalist, and the patient stated that he had not gotten any recent refills of his opiates. The patient filled the new prescription for methadone, hydromorphone, and clonazepam on the day of discharge.

It is unclear whether the patient's unexpected death could have been prevented, but the scenario acts as a powerful reminder of the risks of opioid prescribing, notes the accompanying commentary by Laxmaiah Manchikanti, MD, medical director of the Pain Management Center of Paducah, Paducah, KY, and clinical professor of anesthesiology and perioperative medicine at the University of Louisville, KY, and Joshua A. Hirsch, MD, vice chief of interventional care at Massachusetts General Hospital and associate professor at Harvard Medical School.

They suggest the first error was prescribing both long-acting morphine and oxycodone in a patient with comorbid respiratory disorders, and who was marginally housed and lacked support systems. It might have been more appropriate to start with a single short-acting agent to determine adherence and tolerance. This patient had significant abuse pattern s and should have been considered as high risk and, consequently, should never have been initiated on high-dose opioid therapy, should have been appropriately monitored, and should have been weaned off opioids or referred to addiction management.

PALLIATIVE CARE POLICY COURSES OFFERED AT ONLY A FEW U.S. PUBLIC HEALTH SCHOOLS

Researchers from the George Washington University in Washington, DC, and the University of Chicago investigated current courses offered by accredited schools of public health about palliative and end-of-life care from a public health and policy perspective and reported their findings in Journal of Palliative Medicine. For the academic years ending in 2012 and 2013, the researchers found only 3 of the 49 schools offered a full course discussing public health perspectives in palliative care, and 6 schools offered some palliative care content in related courses, such as gerontology policy. The authors concluded that the schools “are not preparing future policy experts with a basic knowledge of the components and systems of palliative care and hospice. Development and dissemination of appropriate curricular material to address the public health and policy aspects of palliative care is needed to address this gap.”

AMERICAN PAIN SOCIETY NAMES 2014 ANNUAL AWARD RECIPIENTS

Each year, the American Pain Society (APS) recognizes excellence in the field of pain management and research by presenting awards for career achievement, pain scholarship, education and public service, advocacy on behalf of children, outstanding service to APS, and early career achievement. APS is pleased to announce the 2014 recipients. They are the following:

• John and Emma Bonica Public Service Award— Dennis C. Turk, PhD and Robert H. Dworkin, PhD

• Wilbert E. Fordyce Clinical Investigator Award— Mark P. Jensen, PhD

• Frederick W. L. Kerr Basic Science Research Award—Michael J. Iadarola, PhD

• Jeffrey Lawson Award for Advocacy in Children's Pain Relief—Anna Taddio

• John C. Liebeskind Early Career Scholar Award— Claudia M. Campbell, PhD

• Elizabeth Narcessian Award for Outstanding Educational Achievements—Joanna Girard Katzman, MD MSPH

• Distinguished Service Award—David A. Williams, PhD

The APS Future Leaders in Pain Research Grant program was established in 2005 to fund pain research projects of doctoral-prepared investigators who have not yet attained National Institutes of Health R01-level funding. The purpose of this grant is to encourage research in pain that will add to the existing body of knowledge and to allow investigators to develop pilot data to help them secure additional major grant funding for continued pain research. APS is pleased to announce the 2013 recipients:

• Jessica Fales, PhD, Seattle Children's Research Institute—The Nature and Significance of Peer Victimization Among Youth with Chronic Pain

• Erica Schwartz, PhD, University of Pittsburgh— Nociceptive and Inflammatory Mediators of CP/CPPS

• Qing Yang, MD MS, The University of Texas Health Science Center at Houston—Novel Target for Preventing & Ameliorating Paclitaxel-Induced Neuropathic Pain

SURVEY REVEALS THAT ONE IN TEN TEENS HAS MISUSED PRESCRIPTION PAINKILLERS

About 1 in 10 American teens and young adults says they have misused a prescription painkiller or sedative, a new study finds. Researchers conducted a confidential survey of more than 2100 people aged 14 to 20 who visited University of Michigan Health System emergency departments for any reason in 2010 and 2011. The results showed that 10.4% of the participants admitted to misusing a prescription painkiller or sedative at least once in the last year. This included taking drugs to get high, taking more than the recommended amount of a drug that was prescribed to them, and taking drugs prescribed to someone else.

Most of the drug misuse was illegal. The vast majority of patients who admitted misuse had no prescriptions for these drugs on their medical records, according to the authors of the study published online October 28, 2013 in the journal Pediatrics. The findings raise the possibility that emergency room visits, for any reason, could be a good opportunity to detect and treat prescription drug problems among young people, Dr. Lauren Whiteside, who led the study during her University of Michigan Injury Center postdoctoral research, said in a university news release. She is now at the University of Washington. Whiteside also noted that it's important for emergency physicians to be aware that some patients who come to the ER could be seeking drugs for misuse or to give to other people. The study also identified several risk factors associated with misuse of prescription painkillers and sedatives. For example, patients who misused painkillers were more likely to receive an intravenous opioid painkiller during their emergency room visit. And patients who misused prescription drugs were significantly more likely to have also abused alcohol and nonprescription drugs such as cough medicine or to have used marijuana in the past year. They were also more likely to have been in a vehicle with a drunken driver.

Declaration of interest: The author reports no conflicts of interest. The author alone is responsible for the content and writing of the paper.