This roundup includes the following news briefs:
Two doses of the human papillomavirus, or HPV, vaccine were as effective as the recommended three-dose series after four years of follow-up, according to a recent study(jnci.oxfordjournals.org) published by the Journal of the National Cancer Institute.
The study was conducted by researchers from the National Cancer Institute, which is part of the National Institutes of Health, using the HPV vaccine marketed as Cervarix. The researchers found that two doses of the vaccine conferred the same protection against persistent infection with HPV 16 and 18 as the full three-dose regimen after four years.
Aimee Kreimer, Ph.D., lead author and investigator in the National Cancer Institute's Division of Cancer Epidemiology and Genetics, said in a news release(www.nih.gov) that it was unclear whether the duration of protection from two doses is adequate compared to three doses.
It also is not known whether the same results would be obtained with the other FDA-approved HPV vaccine, which is marketed as Gardasil, because the vaccines have different formulations. Gardasil is the more commonly administered HPV vaccine in the United States, according to the NIH.
The FDA is warning the public that serious allergic reactions, including anaphylaxis, have been reported with the use of the antipsychotic medication asenapine maleate, which is marketed as Saphris.
The agency said in a Sept. 1 safety announcement(www.fda.gov) that the drug's label has been revised to include information about this risk and to inform physicians that the medication should not be used in patients with a known hypersensitivity to the drug.
The FDA said it has received more than 50 reports of Type I hypersensitivity reactions with the drug, which was approved in 2009. In several cases, such reactions occurred after the first dose.
The agency issued the following information for physicians:
- in addition to anaphylaxis, reported hypersensitivity reactions have included angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash;
- patients should be educated to recognize these signs and symptoms and be advised to contact a health care professional immediately if they experience any of these symptoms; and
- adverse events involving asenapine maleate should be reported to the FDA's MedWatch program(www.accessdata.fda.gov).
Patients would have direct access to their laboratory test results under a proposed rule issued by HHS on Sept. 12. The proposed rule(www.gpo.gov) in the Sept. 14 Federal Register would modify the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996. These two statutes limit the release of test results directly from laboratories to patients in states that do not have laws allowing test results to be given to patients directly.
Nearly 40 states prohibit a laboratory from releasing a test report directly to the patient or prohibit the release without the consent of a physician or another health care provider. The proposed rule would allow patients or their designated representatives to access test results directly, thus preempting state laws, according to HHS. The proposed rule is an attempt to give patients easier access to health care information.
HHS also unveiled a voluntary Personal Health Record Model Privacy Notice(healthit.hhs.gov), which creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about personal health record products. The new template is designed to improve transparency and consumer understanding about data practices, according to HHS.
The FDA is informing health care professionals(www.fda.gov) that the boxed warning section of the product labels for the entire class of tumor necrosis factor-alpha, or TNF-alpha, blockers has been updated to include the risk of infection from the bacterial pathogens Legionella and Listeria.
The affected drugs are infliximab, which is marketed as Remicade; etanercept, which is marketed as Enbrel; adalimumab, which is marketed as Humira; certolizumab pegol, which is marketed as Cimzia; and golimumab, which is marketed as Simponi. These medications are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and juvenile idiopathic arthritis.
Because TNF-alpha blockers are immunosuppressants, patients treated with these agents are at increased risk for developing serious infections due to bacterial, mycobacterial, fungal, viral, parasitic or other opportunistic pathogens. These infections can involve multiple organ systems and sites and may lead to hospitalization or death.
The agency had these recommendations for health care professionals:
- the risks and the benefits of TNF-alpha blockers should be considered before initiating therapy with these agents in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection;
- patients older than 65 years and those taking concomitant immunosuppressants may be at greater risk of infection;
- before initiating TNF-alpha blockers and periodically during treatment, patients should be evaluated for active tuberculosis and tested for latent infection;
- patients should be monitored for signs and symptoms of serious infections while taking TNF-alpha blockers;
- empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness;
- health care professionals should encourage patients to read the accompanying medication guide for any TNF-alpha blocker prescribed for them; and
- adverse events involving TNF-alpha blockers should be reported to the FDA's MedWatch program(www.accessdata.fda.gov).
North Carolina has launched a public/private partnership that will enable the state's largest employers to tap into the network of patient-centered medical home, or PCMH, practices that was created for the state's Medicaid population.
The partnership, known as First in Health(www.communitycarenc.org), will use a state-wide infrastructure of physician-led networks and medical homes created by Community Care of North Carolina, or CCNC, to provide access to medical homes for members of the partnership. First in Health encompasses a broad mix of public and private entities, including CCNC; GlaxoSmithKline or GSK; the State Health Plan of North Carolina; Kerr Drug, a local pharmacy chain; SAS, a business analytics company; and Blue Cross and Blue Shield of North Carolina.
GSK will start offering its North Carolina employees the option of joining a medical home in January 2012, by adding the First in Health benefit to its existing health benefits. GSK will waive copayments for primary care physician visits for employees choosing this option and will pay participating physicians a per-member, per-month fee for each GSK employee assigned to a medical home.
In addition, the state of North Carolina will start offering employees access to the First in Health program this fall, and the State Health Plan of North Carolina plans to offer the option to 40,000 enrollees in 100 North Carolina counties within two years via a cooperative agreement with Active Health Management.