As part of an FDA-required Risk Evaluation and Mitigation Strategy, or REMS, only health care providers, pharmacies, and patients registered with the FOCUS program will be able to prescribe, dispense, and use the medicine.

The FOCUS program will:

• Provide training and educational materials to health care providers and pharmacists about the drug’s risks and appropriate uses.
• Make a counseling call to patients to be sure they have receive proper education about the drug’s use.
• Only allow prescriptions to be filled by pharmacies that send the drug directly to the patient’s home.

Onsolis delivers fentanyl through an absorbable film that sticks to the inside of the mouth.  It can only be prescribed for patients who are already taking another opiate medicine around the clock, considered tolerant to opiates and can safely take high doses of fentanyl.

The drug has a boxed warning that it should not be used for migraines, dental pain, or pain after surgery or by patients who only use it on an as-needed basis. It also warns that it must be kept out of the reach of children and not substituted for other fentanyl products.

Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER) said,

Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death. For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.

In other headlines, both patients and doctors liked virtual, computer videoconferencing visits, and the FDA reports that shortages of fentanyl patches have been resolved.

Research Reports

• Finding cancer at a late stage is more common in Illinois cities than in rural areas. Colorectal, breast, prostate, and lung cancers — are more common in the most densely populated areas of Chicago and follow a pattern of reduced risk as the area population decreases. There was a small increased risk in the most remote rural areas. Researchers used data from Illinois State Cancer Registry from 1998 through 2002. Even after accounting for socioeconomic differences and access to nearby health care facilities, the disparities between city and rural remained. Writing in the early view edition of Cancer published May 11, 2009, geographer Sara McLafferty, Ph.D. said, “The observed pattern of urban disadvantage emphasized the need for more extensive urban-based cancer screening and education programs.”
• Telephone calls and personally tailored printed diet and exercise information reduced the rate of functional decline in older, overweight long-term cancer survivors.  They lost weight and their physical activity, diet, and quality of life improved.  At the beginning of the year-long program both the group in the program and a control group had functional abilities averaging 75.7 on a 100 point scale.  During the year, overall scores declined 2.15 points for survivors in the program compared to a 4.84 loss for the control group.  Leg strength increased,while the control group’s leg function declined further. Program participants were over 65 and had survived cancer for more than five years. Miriam C. Morey, Ph.D. at Duke University reported the results of the study in the May 13, 2009 Journal of the American Medical Association.
• The caregivers of cancer patients show very real changes over time in blood markers of inflammation — both those that promote inflammatory changes and those that protect against it.   Family members caring for patients with a very aggressive form of brain cancer had blood and saliva tested.  A matched group of controls, similar in age and background but free of major life stresses, were also tested.   Psychological tests showed the caregivers were more stressed than the average population and had more depression.  Excess inflammatory response left them vulnerable to heart disease and other illnesses that are triggered by chronic inflammation.  Nicolas Rohleder and  his team from the University of British Columbia published their work in an early online edition of the Journal of Clinical Oncology on May 11, 2009.

Other Headlines

• Virtual visits with a doctor rated well with both patients and doctors.  Patients found talking with a doctor via desktop videoconferencing satisfactory in the time spent with the doctor, personal aspects, and ease of the interaction.  Patients in a study conducted at the Massachusetts General Hospital saw two different doctors, one via teleconferencing and one face-to-face.  They had similar evaluations for both encounters.  Another group saw two different doctors face-to-face without use of telemedicine.  The two doctors agreed on diagnosis 84 percent of the time in the first group, using both teleconferencing and face-to-face visits and 80 percent of the time when they both saw the patient only in their office.   Doctors Ronald Dixon and James Stahl wrote about their study in the Journal of Telemedicine and Telecare.
• The FDA  has announced that the shortage of fentanyl patches has been resolved and that the market is being supplied by five different firms.