Rosene D. Pirrello

New opioids: expensive distractions or important additions to practice?

Russell K. Portenoy, M.D.: I have been involved in doing a lot of the studies with the new rapid-onset fentanyl formulations, including the very first one that was on the market, oral transmucosal fentanyl citrate. These formulations have all been developed in response to the view that breakthrough pain is an unmet need largely because the time course of a typical breakthrough pain is much shorter than the timeaction relationship of a typical oral short-acting drug like oxycodone or morphine. The vast majority of breakthrough pain, when evaluated in these epidemiologic studies, last less than 1 hour and have a time to maximum intensity of 10 minutes or less. When you compare that to the time-action relationship of an oral drug like morphine, you can see that there is a mismatch. Oral transmucosal fentanyl was commercially successful. The second formulation, fentanyl buccal citrate, has also been successful for the pharmaceutical company. This success has induced other companies to formulate new products and get them on the market. The Holy Grail with these drugs has been to try to have a time-action relationship that almost approximates an intravenous bolus, with the goal of translating a rapid effect into clinical benefit by addressing the mismatch I mentioned. Interestingly, there has been very, very little research comparing the standard oral agents, like morphine or oxycodone, with any of the rapid-onset fentanyl formulations. Although the very few studies that have been done have had methodological concerns, they have found greater satisfaction and greater pain control with the fentanyl formulations. This cannot be viewed as definitive, however, because of the methodological issues and the need for replication in broader clinical populations and real world settings. Right now on the market we have the oral transmucosal fentanyl citrate, the fentanyl buccal tablet, and the new bioerodible mucoadhesive patch, which just got approved. Coming on the market in relatively short order will be a sublingual dissolvable tablet, intranasal formulations, and possibly aerosolized formulations that will be inhaled. These drugs all will have company-initiated Risk Evaluation and Mitigation Strategies (REMS), which the U.S. Food and Drug Administration has been required by law to put into place. In the case of the patch and with others coming, these REMS programs appear to add some burden to doctors to make sure that they are aware of risks, including drug abuse and unintentional overdose, and the management guidelines to minimize them. Doctors are going to have to get used to the concept of REMS and be willing to spend an extra few minutes to review guidelines, document that they are knowledgeable about the risks, and be entered into a registry. To the extent that REMS affects the newer rapid onset fentanyl formulations before affecting other opioid formulations, they may slow down the uptake of the new products as they come on the market.

Strategic planning by the palliative care steering committee of the Middle East Cancer Consortium.

High quality comprehensive palliative care is a critical need for millions of patients and families, but remains only a dream in many parts of the world. The failure to do a strategic planning process is one obstacle to advancing education and pain prevention and relief. The Middle Eastern Cancer Consortium Steering Committee attendees completed an initial strategic planning process and identified “developmental steps” to advance palliative care. Underscoring the multi-disciplinary nature of comprehensive palliative care, discipline-specific planning was done (adult and pediatric cancer and medicine, pharmacy, nursing) in a separate process from country-specific planning. Delineating the layers of intersection and differences between disciplines and countries was very powerful. Finding the common strengths and weaknesses in the status quo creates the potential for a more powerful regional response to the palliative care needs. Implementing and refining these preliminary strategic plans will augment and align the efforts to advance palliative care education and pain management in the Middle East. The dream to prevent and relieve suffering for millions of patients with advanced disease will become reality with a powerful strategic planning process well implemented.

Opioid Consumption in Patients With Advanced Illnesses (S722)

Opioid Consumption in Patients With Advanced Illnesses (S722) Frank Ferris, MD, The Institute for Palliative Medicine at San Diego Hospice, San Diego, CA. Simon Schrick-Senasac, DO MS, Rush University Medical Center, Chicago, IL. Rosene Pirrello, BPham RPh, The Institute for Palliative Medicine at San Diego Hospice, San Diego, CA. (All authors listed above had no relevant financial relationships to disclose with the following exception: Ferris is on the speakers’ bureau and receives an honorarium from Salix Pharmaceuticals.)

A Whirlwind Tour: Psychopharmacologic Management of Depression, Anxiety, Delirium, and Insomnia in Children—A Palliative Care Perspective (308) (Advanced): Pediatric

1. Discuss a major palliative and end-of-life care research initiative in Canada, funded through the Canadian Institutes of Health Research (

Initial experiences with subcutaneous recombinant human hyaluronidase.

16.5 million). 2. Discuss the world’s first PhD strategic training program in palliative and end-of-life care, funded by the Canadian Institutes of Health Research. The Palliative and End-of-Life Care (PELC) initiative was developed by the Canadian Institutes of Health Research’s Institute of Cancer Research in collaboration with 18 funding partners. The objectives of the initiative were to support infrastructure development, enhance interdisciplinary research collaboration, encourage the development of early career researchers, and attract trainees to this emerging area. Since 2004, the PELC initiative has supported 19 pilot projects, ten new emerging team grants, one career transition award, and a strategic training program. With a total investment of

Clarifying Delirium Management: Practical, Evidenced-Based, Expert Recommendations for Clinical Practice

16.5 million over six years, the Initiative is the largest research investment in PELC research in the world. This presentation will provide highlights of the initiative including impacts on the Canadian research agenda, research productivity and quality, and on research capacity. Lessons learned will be shared.