Late Breaking News
Most Hospitals and Doctors Plan to Adopt Electronic Records
Four-fifths of the nation’s hospitals, and 41% of office-based physicians, currently intend to take advantage of federal incentive payments for adoption and meaningful use of certified electronic health records (EHR) technology, according to survey data released last month by the Office of the National Coordinator (ONC) for Health Information Technology. The survey information was released as the registration period opened for the Medicare and Medicaid EHR Incentive Programs. The data comes from surveys commissioned by ONC and carried out in the course of regular annual surveillance by the American Hospital Association and the CDC’s National Center for Health Statistics (NCHS).
The AHA survey found that 81% of hospitals plan to achieve meaningful use of EHRs and take advantage of incentive payments. About two-thirds of hospitals (65%) responded that they will enroll during Stage 1 of the Incentive Programs, in 2011-2012.
The NCHS survey found that 41% of office-based physicians are currently planning to achieve meaningful use of certified EHR technology and take advantage of the incentive payments. Four-fifths of these, or about a third of all office-based physicians (32.4%), responded that they will enroll during Stage 1 of the programs. Only 14% of respondents said they were not planning to apply for meaningful use incentives.
Additional survey data from NCHS show that significantly increasing numbers of primary care physicians have already adopted a basic EHR, rising by 50% from 19.8% of primary care physicians in 2008 to 29.6% in 2010. Basic EHRs provide a beginning point for use of electronic health records in physician offices, but most physicians would need to further upgrade their EHR systems or their use of the systems in order to qualify for meaningful use incentive payments.
Incentive payments for the adoption and meaningful use of certified EHR technology were authorized in the Health Information Technology Economic and Clinical Health Act (HITECH) in 2009. Incentive payments will be made through the Medicare and Medicaid programs. High rates of adoption and meaningful use could result in as much as $27 billion in incentive payments over 10 years.
Non-hospital-based physicians and other eligible professionals can obtain incentive payments of as much as $44,000 under Medicare or $63,750 under Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.
Provider registration for the Medicare EHR Incentive Program and some Medicaid EHR Incentive Programs opened January 3, 2011. Most states will allow provider registration to begin for their Medicaid EHR Incentive Programs during the spring and summer of 2011.
FDA Asking for Limits on Acetaminophen
The FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule. The agency also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.
Acetaminophen, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and OTC products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine®), oxycodone (Percocet®), and hydrocodone (Vicodin®). OTC acetaminophen products are not affected by the action.
The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and FDA does not expect it to create a shortage of pain medication. Patients and healthcare professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.
FDA officials noted that there is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their healthcare provider. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.
Acetaminophen is also widely used as an OTC and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.
Because of continued reports of liver injury, FDA is proposing that boxed warnings, the agency’s strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.
An FDA advisory committee discussed the issue at a meeting in June 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.
Opioid Analgesic Approved with Strict Controls
FDA has approved Abstral® (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed. Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use.
Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, and overdose. Under this program, pharmacies, distributors, and healthcare professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense, and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.
“This approval is also a significant step toward reducing the burden on the healthcare system of implementing REMS programs,” said John Jenkins, MD, director of FDA’s Office of New Drugs. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”
The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from one to 405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.
Common adverse reactions include nausea, constipation, drowsiness, and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.
Possible Gene Target Found for Treating Lymphoma
Researchers have identified a mutation in a gene that could lead to targeted therapies for certain lymphoma patients whose cure rates are currently poor. Mutation of the MYD88 gene was found to be one of the most frequent genetic abnormalities in a form of cancer known as diffuse large B cell lymphoma. MYD88 encodes a protein that is crucial for the normal immune response to invading microorganisms. New experiments show a mutation in the MYD88 protein sequence can cause uncontrolled cellular signaling, leading to survival of malignant cells. The study, led by researchers from NCI, appeared online in Nature, December 22, 2010.
Louis M Staudt, MD, PhD, and colleagues at the Metabolism Branch of the Center for Cancer Research at NCI have worked to identify proteins that play a role in the development of the ABC subtype because these proteins may provide targets to improve the treatment of patients with this form of lymphoma. To identify these critical proteins, the researchers performed a genetic screen in which thousands of genes were inactivated. They found that ABC lymphoma cells were killed when they inactivated the genes encoding MYD88 and IRAK1, another cell signaling protein that works with MYD88.
The scientists then looked for genetic mutations that might explain why the ABC lymphoma cells were so dependent upon MYD88. Sequencing of the MYD88 gene in 382 lymphoma biopsy samples revealed that 29% of ABC lymphoma samples had the same mutation, which altered a single amino acid in the MYD88 protein, but this mutation was rare or absent in other lymphoma subtypes. The mutant form of MYD88 sustained the survival of the ABC lymphoma cells but the non-mutated version did not, suggesting that mutations in the MYD88 gene could play an important role in the development of ABC diffuse large B cell lymphomas.
To understand how MYD88 might promote ABC lymphoma cell survival, the researchers examined proteins that interact with MYD88 in the lymphoma cells. The mutant form of MYD88 spontaneously assembled a protein complex that included IRAK1, identified in the genetic screen, and a related protein, IRAK4. In this protein complex, IRAK4 functioned as an enzyme to modify IRAK1, which was required for the mutant MYD88 protein to promote lymphoma cell survival. This particular finding may have direct therapeutic implications since pharmaceutical companies are developing IRAK4 inhibitors for use in inflammatory and autoimmune diseases, according to the scientists.
Three High-Risk Populations Targeted for Suicide Prevention Efforts
The National Action Alliance for Suicide Prevention has added three new task forces to address suicide prevention efforts within high-risk populations: American Indians/Alaska Natives; youth who identify as lesbian, gay, bisexual, or transgender; and military service members and veterans. This brings to six the number of task forces formed by the Action Alliance, the public-private partnership forged in September this year to advance the National Strategy for Suicide Prevention.
In the US, suicide claims over 34,000 lives annually—the equivalent of 94 suicides per day, or one suicide every 15 minutes. State and local prevention efforts are having a positive impact as rates of suicide have been falling among teenaged and elder males, two of the hardest hit groups. Suicides are increasing among other groups, however, such as AI/AN youth and military members.
Studies from organizations such as the Suicide Prevention Resource Center report that lesbian, gay, and bisexual youth are from 1.5 to seven times more likely to report having attempted suicide than their non-LGBT peers, transgender youth are believed to have higher rates of suicidal behavior as well. Co-leading the LGBT Youth Task Force are Kevin Jennings, assistant deputy secretary of the Office of Safe and Drug-Free Schools, US Department of Education, and Charles Robbins, executive director of The Trevor Project, a leading national organization focused on crisis and suicide prevention efforts among LGBT youth.
“This task force will bring together the best minds in the country to combat suicide and make sure that every LGBT youth has the opportunity to grow up in a supportive, accepting community and to enter adulthood safely,” Robbins said.
Cancer Costs Projected to Reach $158 Billion in 2020
Based on growth and aging of the US population, medical expenditures for cancer in the year 2020 are projected to reach at least $158 billion (in 2010 dollars) — an increase of 27% over 2010, according to an NCI analysis. If newly developed tools for cancer diagnosis, treatment, and follow-up continue to be more expensive, medical expenditures for cancer could reach as high as $207 billion, said the researchers. The analysis appeared online, January 12, 2011, in the Journal of the National Cancer Institute.
The projections were based on the most recent data available on cancer incidence, survival, and costs of care. In 2010, medical costs associated with cancer were projected to reach $124.6 billion, with the highest costs associated with breast cancer ($16.5 billion), followed by colorectal cancer ($14 billion), lymphoma ($12 billion), lung cancer ($12 billion), and prostate cancer ($12 billion).
If cancer incidence, survival rates, and costs remain stable and the US population ages at the rate predicted by the US Census Bureau, direct cancer care expenditures would reach $158 billion in 2020, the report said.
However, the researchers also did additional analyses to account for changes in cancer incidence and survival rates and for the likelihood that cancer care costs will increase as new technologies and treatments are developed. Assuming a 2% annual increase in medical costs in the initial and final phases of care—which would mirror recent trends—the projected 2020 costs increased to $173 billion. Estimating a 5% annual increase in these costs raised the projection to $207 billion. These figures do not include other types of costs, such as lost productivity, which add to the overall financial burden of cancer.