This roundup includes the following news briefs:
The FDA has expanded its approval of Merck & Co. Inc.'s quadrivalent human papillomavirus, or HPV, vaccine, which is marketed as Gardasil, to include use of the vaccine to prevent anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages 9-26 years.
In October 2009, the agency approved use of the vaccine to prevent genital warts in boys and men ages 9-26 years. During that same month, the CDC's Advisory Committee on Immunization Practices recommended against routine use of the vaccine to prevent genital warts in boys and young men. The committee instead voted to support "permissive use" of Gardasil for this indication, leaving decisions on whether to immunize males ages 9-26 years who request the vaccine up to their physicians.
HPV vaccine is recommended for girls and women aged 11-26 years for the prevention of cervical, vulvar and vaginal cancer and associated precancerous lesions.
The American Cancer Society estimates that more than 5,000 Americans are diagnosed with anal cancer each year. The FDA said in a Dec. 22 news release(www.fda.gov)
that HPV is associated with 90 percent of anal cancer. The agency said that in a clinical trial, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia.
Pfizer is recalling one lot -- about 19,000 bottles -- of 40 mg tablets of atorvastatin calcium, which is marketed as Lipitor. The company said in a Dec. 22 news release(www.fda.gov) that it had received a consumer report of an uncharacteristic odor related to bottles in lot 0836050.
This is the fourth time in five months that Pfizer has recalled the cholesterol drug -- including pulling 190,000 bottles from the market in October -- in response to complaints of an uncharacteristic odor. The odor is consistent with the presence of 2, 4, 6 tribromoanisole, a degradant of 2,4,6-tribromophenol, which is a fungicide and flame retardant used to treat wooden pallets.
The same contaminant and odor problem was responsible for a massive recall of OTC products by McNeil Consumer Healthcare last year.
Pfizer said it has taken action to address the problem, but the latest recalled lot was packaged and shipped before its changes took effect. The company, which now has recalled 18 lots of atorvastatin calcium, said it does not anticipate a drug shortage resulting from the recalls.
Pfizer said the odor is not likely to cause adverse events, but patients who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist.
The percentage of females matriculating at U.S. allopathic medical schools is up substantially since 1990. More entering students have never been married. Fewer decided to become physicians before high school, making the career decision during the first two years of college. These are some of the results of the Association of American Medical Colleges, or AAMC, 2010 Matriculating Student Questionnaire(www.aamc.org).
According to the report's executive summary, women comprised 47 percent of all matriculants in 2010, up from 46 percent in 2000 and 39 percent in 1990. The percentage of never-married students was 86 percent in 2010, versus 81 percent in 2000 and 79 percent in 1990.
Although more than half -- or 52 percent of new medical students in 1990 and 54 percent in 2000 -- said they decided to study medicine before they entered college, these early deciders dropped to 49 percent in 2010.
Cumberland Pharmaceuticals Inc. is recalling six lots of its acetylcysteine product -- which is marketed as Acetadote Injection -- after particulate matter was found in vials.
Acetadote is used in emergency rooms to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. It is the only injectable product approved in the United States to treat acetaminophen overdose.
Cumberland said in a Dec. 30 news release(www.fda.gov) that it was unaware of any adverse medical events associated with the product. However, the company is recalling the affected lots as a precautionary measure.
The product being recalled is Acetadote Injection, 20% solution (200 mg/mL) in 30 mL single-dose glass vials. The following product lots are affected by the recall:
- 090602 and
The FDA said in a Jan. 1 safety alert(www.fda.gov) that physicians should report adverse events associated with the product to the agency's MedWatch program(www.fda.gov).
A significant number of primary care practices in Connecticut are adopting various elements of the patient-centered medical home, or PCMH, model according to a recent report(www.csms.org) in Connecticut Medicine.
The report, which is based on a survey of 498 primary care physicians in the state, found that 57 percent of physicians were using open or advanced-access scheduling, and 39 percent had an electronic health record, or EHR, system. More than 30 percent had a registry of patients with chronic diseases, the report said.
The survey also found that adoption of various PCMH elements varies by specialty. For example, internists used the least amount of open scheduling, and pediatricians had the lowest rates of EHR use. The report concluded "the adoption of the medical home among Connecticut primary care physicians remains in its infancy."
The Patient Protection and Affordable Care Act makes substantial investments in the nation's primary care infrastructure that are likely to improve care, lower costs, and lead to higher satisfaction rates among physicians and patients. That's according to a new report(www.commonwealthfund.org) issued by the Commonwealth Fund on Jan. 4.
The report points out that the health care reform law "temporarily increases Medicare and Medicaid payments for primary care, puts a premium on innovation in health care delivery, enhances support for primary care providers and invests in the continued development of the primary care workforce." The report also lists the impact of selected provisions on patients and their physicians.
- Fifty million Medicare beneficiaries in 2011 will have free access to currently covered preventive service, such as high blood pressure screening, alcohol misuse counseling and colon cancer screening.
- As many as 40 million people in 2011 and 90 million by 2013 will no longer have to make a copayment for recommended preventive screenings, including cancer screenings.
- A 10 percent bonus will be paid to primary care physicians who see Medicare patients.
- Payment rates for primary care physicians who see Medicaid patients will be increased.
- Starting in 2011, as many as 10 million Medicaid patients who have at least one chronic condition could have a "health home" to help them manage their condition. An estimated 8 million newly eligible Medicare beneficiaries with at least one chronic condition could have a health home by 2014.
- The Affordable Care Act and the American Recovery and Reinvestment Act will together support the training of more than 16,000 new primary care physicians and other health care professionals during the next five years.
Blue Cross and Blue Shield of Rhode Island, or BCBSRI, the largest insurance carrier in Rhode Island, and Coastal Medical, one of the state's largest primary care practices, have formed a partnership to create a statewide patient-centered medical home, or PCMH, initiative.
BCBSRI covers more than 600,000 members, and Coastal Medical provides care to more than 105,000 patients, 35 percent of whom are BCBSRI members, according to a BCBSRI press release(www.bcbsri.com). Coastal Medical is the fifth primary care practice in the state to enter into a medical home agreement with BCBSRI, which now has PCMH agreements with more than 25 percent of the primary care physician networks in Rhode Island.
The initiative calls for BCBSRI to pay physicians based on outcomes and the value of care delivered, in addition to current fee-for-service payments. The project with Coastal Medical will stress the use of electronic health records, or EHRs, by rewarding the practice for improving how it shares patient information with hospitals and subspecialists through its EHR system.
A recent Analysis in Brief(www.aamc.org) from the Association of American Medical Colleges, or AAMC, examines the relationship of students' socioeconomic status to medical school completion.
According to the AAMC study, less than 3 percent of medical students do not complete their medical degrees, and they typically drop out during the first two years of medical school.
However, students with parents who do not have college degrees are more likely to withdraw from medical school within the first two years regardless of their scores on the Medical College Admission Test.
The study says that if medical schools can understand the relationship of socioeconomic status to medical school completion, they can tailor support mechanisms for struggling students and maintain diversity.