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Online Resources

With Cancer, Let's Face It: Words Are Inadequate
New York Times column by Dana Jennings.
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When the Only Hope Is a Peaceful Ending
New York Times column by Jane Brody on her husband's death from lung cancer.
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In Cancer Fight, Teenagers Don't Fit In
New York Times article.
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The last hours of living:  practical advice for clinicians
Emanuel L, et al.  From Medscape Nurses.  (free registration required)
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Sexuality and cancer: A guide for people with cancer
From the Canadian Cancer Society.
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Keep-A-Breast Foundation
An organization dedicated to raising awareness of breast cancer in young women.
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Planet Cancer
Information, resources, and support for young adults with cancer.
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Center for the Advancement of Cancer Survivorship, Navigation and Policy (caSNP)
A new initiative of the GW Cancer Institute, George Washington University.
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Sisters Network, Inc.
A national African American breast cancer survivorship organization.
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Resources
for Patients


The Eighth Annual Cancer Survivorship Series: Living With, Through & Beyond Cancer.  CancerCare. 
All workshops take place from 1:30 to 2:30 pm Eastern Time. (SWCE).  Free, no telephone charges, but pre-registration required.
Learn More >>

April 13
Trouble Sleeping? Sleep Better to Feel Better: Tips You Can Use

May 18
Communicating with Your Health Care Team After Treatment: Making the Most of Your Visit


June 22
Survivorship and Workplace Transitions


July 13
Survivors Too: Communicating With and Among Family, Friends and Loved Ones


Continuing Education


Yale/YNHH

Yale Bioethics Center
End of Life Issues group
All meetings 5:00 - 7:30pm (CME)

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April 6
John D. Lantos, MD
Extreme Prematurity
Cohen Auditorium, Child Study Center, 230 Frontage Road, New Haven, CT



Schwartz Rounds; 12:00 Noon
YNHH 9th floor East Pavilion conference room.
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April 19
Too Young to be Dying


April 21
4th Annual Yale Cancer Survivorship Symposium:  Sexuality and Survivorship
New Haven Lawn Club.  (CME, CNE)
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Connecticut

April 9 & 16; 7:30am-4:30pm
ONS Chemotherapy & Biotherapy Course
Hospital of St. Raphael (CNE) Pre-registration required: (203) 789-3391

April 17
Oncology Nurses Connecting in Connecticut
3rd Annual Oncology Symposium. The Oakdale Theatre. 95 South Turnpike Road, Wallingford, CT.  Registration details to follow.
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April 23
Continuing the Conversation . . . Addressing Barriers to End-of-Life Care
Annual Spring Conference of Connecticut Coalition to Improve End-of-Life Care.   Albertus Magnus College, New Haven.
Learn More >>
 



Elsewhere
July 12 - 16  2010
Spirituality & Health Care Summer Institute
George Washington University, Washington, DC
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Novmber 5 - 6
Quality of life for the Children
4th Annual Pediatric Palliative Care Conference.  Washington, DC.
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Online
April 14, 1:00pm
"Bereaved Children and Adolescents: Lessons from Research." 
Webinar sponsored by Hospice Foundation of America.  (fee)
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ONS Webcourse
Symptom Management. (CNE)

Optimizing Chronic Pain Management in Elderly Persons: Integrating Pharmacokinetics & Pharmacodynamics
(Pain.com) (CME, CNE, CPE).
(See pain-topics.org for many other pain-related continuing education programs.)
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Upcoming Meeting


Connecticut Cancer Partnership

Palliative Care/Hospice Committee
April 8; 10:30 AM - Noon
Yale University School of Nursing
For more information, contact Phyllis Osterman

April  2010          Volume 4 No 3

Medication Safety Regulations:  Risk Evaluation and Mitigation Strategy (REMS)
Thomas Quinn, APRN, MSN


A defining consideration in the approval of any drug by the Food and Drug Administration is that the benefit of the drug must outweigh its risks.  Certain drugs or classes of drugs are considered to be at particularly high risk, including many used for cancer treatment and supportive care.  In the case of opioids, abuse potential and the consequent concerns for public health are receiving increased attention in the review process for new drugs, while new regulations are being considered for some drugs already marketed.  

In February of 2008, a new federal law gave the Food and Drug Administration (FDA) expanded power to regulate both new and established medications.  One of the provisions authorizes the FDA to require that a drug manufacturer submit a Risk Evaluation and Mitigation Strategy (REMS).  REMS is the latest in the long evolution of systematic steps that the FDA has taken to ensure that approved drugs are safe.  Over 100 drugs had REMS by March 2010.  Of importance in cancer care, chemotherapy agents, hematopoietic growth factors and other biologics, and opioids are included.  REMS typically include patient and prescriber education.  For many of these, a patient-directed "Medication Guide" and supplemental prescriber information are the only requirements.  Others may require restricted distribution through specified pharmacies; certification that patients, prescribers, and pharmacists have completed mandated education; and that registries of approved prescribers and patients be maintained.  The most restrictive requires that a courier deliver the prescription to the approved pharmacy, and also deliver the medication to the patient.

Manufacturers of methadone and all extended release opioids were informed in early 2009 that they would be required to develop a REMS for each of their products.  A "Draft Guidance" document for opioid REMS' has been published but a final rule is unlikely before 2011.  In the meantime, individual product REMS will be required for any newly-approved opioid analgesics.

The REMS approach for opioid analgesics is controversial.   Patient advocacy groups and professional societies have endorsed the goals of safe use and avoidance of abuse and diversion.  However, they have expressed concerns about the potential unintended consequence of decreased access to appropriately prescribed opioids.  In addition, they have cited cost, widespread use of an untested system, lack of consensus on measuring outcomes, and confusion in the face of product-specific (rather than opioid class-specific) REMS.  There have also been concerns expressed about lack of standardization in REMS development.  Patient education concerns, in the form of information overload and health literacy, have also been raised.  In addition, a very strong objection to the "stigmatizing" effects of patient registration has been expressed.  A further concern is that some prescribers may find the multiple diverse educational and registration requirements so burdensome that they opt out of prescribing all opioid analgesics.

There is broad consensus that patient and public safety must be considered at all levels of opioid development, approval, and clinical use.  It will be some time before either positive or negative outcomes of opioid REMS are known.

REMS references >>

In the News

The Connecticut Challenge
Registration is open for the 2010 Connecticut Challenge bicycle ride on Saturday July 24 in Fairfield.  The Challenge raises funds for survivorship programs throughout Connecticut, including the pediatric and adult survivorship clinics at Yale Cancer Center.
 
This year they are making a concerted effort to include more survivors among the riders.  They are offering free training/coaching (face-to-face or virtual) to survivors who register to ride.
Learn More >>


New Editions Recently Published
Oxford Textbook of Palliative Medicine (4th edition)
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Oxford Textbook of Palliative Nursing (3rd edition)
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New Site Launched
The Collaborative to Advance Funding for Palliative Care (CAFPAC) has launched www.FundPalCare.org as part of a new initiative to share palliative care grant making concepts and success stories, and to stimulate higher levels of funding in palliative care.
Learn More >>


New York Times Article
After Cancer, Removing a Healthy Breast
A procedure gains popularity but doesn't improve survival odds.
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Alternative to Actiq Now Available
Oral Transmucosal Fentanyl Citrate, a generic alternative to Actiq, should be available in pharmacies this month.  Note that there are critical safety considerations in the use of any of the potent transmucosal fentanyl products now on the market.  Safety information for each product must be reviewed carefully and explicit warnings and instructions given to the patient and family.
Learn More >>


Stay In The Game CT
A new initiative of the Department of Public Health to increase colorectal cancer screening. Connecticut currently ranks 13th in the nation for colon cancer rates in men and 11th in women. It is the 3rd leading cause of death in Connecticut men and women.  
Learn More >>


New Connecticut Chapter
Connecticut now has its own chapter of the Hospice and Palliative Nurses Association: The Charter Oak Chapter.  Learn More >>

Journal Watch

Barnett ML, et al.  Nurses' Knowledge, Attitudes, and Practice Patterns Regarding Titration of Opioid Infusions at the End of Life.  J Hosp Palliat Nurs.  2010;12(2):81-88.
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Bennett MI.  Cancer pain terminology: Time to develop a taxonomy that promotes good clinical practice and allows research to progress.  Pain. 2010 Feb 25.
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Bokhari F, Sawatzky JA.  Chronic neuropathic pain in women after breast cancer treatment.  Pain Manag Nurs. 2009 Dec;10(4):197-205.
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Boland BA, et al.  Chemotherapy-induced peripheral neuropathy in cancer survivors.  Oncology Nurse Edition.  2010;24(2):33-38,42-43.  Free full text. (free registration required)
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Dusek JA.  The Impact of Integrative Medicine on Pain Management in a Tertiary Care Hospital.  J Patient Saf.  2010;6(1):48-51.
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Helf PR, Cavanaugh MK.  The Complexity of Reproductive Decisions for Patients with Advanced Cancer: Ethical and Communicative Dimensions.  J Support Oncol.  2010;8(1):45-48. Free full text.
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Henderson TO, et al.  Physician preferences and knowledge gaps regarding the care of childhood cancer survivors: a mailed survey of pediatric oncologists.  J Clin Oncol. 2010;28(5):878-83.
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Holland JC, Alici Y.  Management of distress in cancer patients.  J Support Oncol.  2010;8(1):4-12. Free full text.
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Lipshultz SE, Adams MJ.  Cardiotoxicity After Childhood Cancer: Beginning With the End in Mind.  J Clin Oncol.  2010;28(8):1276-1281.
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Liu Y, et al.  Accuracy of Perceived Risk of Recurrence Among Patients With Early-Stage Breast Cancer.  Cancer Epidemiol Biomarkers Prev. 2010 Feb 16
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"Thank you" to Christian McEvoy of the Connecticut Challenge for blogging on this article.


Ragheb AM, Sabanegh ES.  Male fertility-implications of anticancer treatment and strategies to mitigate gonadotoxicity.  Anticancer Agents Med Chem. 2010;10(1):92-102.
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Schnur J.  Radiotherapy-induced skin changes and quality of life.  Lancet Oncol.  2010;11(3):212.
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Stoner M, et al.  Patients With Cancer: Experiences of Medication Management.  J Hosp Palliat Nurs.  2010;12(2):99-104.
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Wagner LI.  Coping with 'chemobrain.'  Oncology Nurse Edition.  2010;24(2):50-54.  Free full text. (free registration required)
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Wohlgemut J.  Going Gentle.  CMAJ.  2010;182(4):412. (On palliative care in family practice).
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