US Readies for Massive H1N1 Vaccination Program
The FDA has approved 4 new vaccines to fight the H1N1 virus, and at press time, the vaccines were expected to be distributed nationally to states after initial lots become available in early-tomid October. The FDA-approved injectable vaccines are manufactured by CSL Biotherapies and Novartis Vaccines and Diagnostics (both approved for use in adults aged 18 and older) and Sanofi Pasteur (approved for those 6 months of age and older). The fourth—an intranasal vaccine—is manufactured by MedImmune and is approved for individuals 2 to 49 years of age.
The National Institutes of Health also reports that preliminary data from clinical studies of the H1N1 vaccine indicate that a single (15-mcg) dose of the vaccine induces a robust immune response in most healthy adults in about 8 to 10 days, as is the case with the vaccine for regular, seasonal flu. Previously, it was expected that the H1N1 vaccine would need to be administered in 2 doses, spaced approximately 4 weeks apart. The Centers for Disease Control and Prevention (CDC) is not forecasting a shortage of H1N1 flu vaccine, but the agency notes that vaccine availability and demand can be unpredictable and that initial distribution will be to priority groups identified by its Advisory Committee on Immunization Practices: pregnant women; household contacts and caregivers for infants younger than 6 months; health care workers and emergency medical services personnel; individuals 6 months to 24 years of age; and patients 25 through 64 years of age with underlying health conditions.
Each week the CDC releases its surveillance figures on influenza activity. At the end of last month, the agency reported that visits to doctors for influenza-like illness were higher than expected and had increased for 6 consecutive weeks. Almost all of the influenza viruses identified were H1N1, and these viruses remained similar to those chosen for the recently approved H1N1 vaccines; the viruses also remained susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception, according to the CDC. Officials are reminding individuals that they must also get vaccinated against seasonal flu. Health professionals can find more information on both the H1N1 and seasonal flu vaccines at www.fda. gov/BiologicsBloodVaccines/.
An Aspirin a Day May Keep Colon Cancer Away
For patients genetically predisposed to colon cancer, a daily dose of aspirin might be all it takes to reduce their risk of developing the disease, according to recent research from Newcastle University in Britain. The study tracked 1071 patients with Lynch syndrome, a genetic mutation that makes individuals more susceptible to a number of cancers, including that of the colon. Participants were randomized to receive either aspirin or placebo. After a decade, tests revealed that fewer patients in the aspirin group developed colon cancer—6, compared with 16 in the placebo group. Notably, when tested after 29 months, the patients showed no difference in cancer rates, but after 4 years, the researchers observed that fewer of the patients who took aspirin had developed colon cancer. Although the patients stopped taking daily aspirin after 4 years had passed, the positive effects of the drug continued. The researchers have yet to pinpoint just how aspirin staves off cancer, but the study’s lead author, John Burns, contends that it may speed up the destruction of cancerous stem cells. Future research will explore varied aspirin dose effects.
Many Obtaining Internet Antibiotics Illegally
Antibiotics are easily obtained via the Internet, without a prescription, by those patients who determine on their own that they need them. As researchers stated in a paper in the September/ October issue of the Annals of Family Medicine, the practice is illegal and could ultimately have very serious health implications—by contributing to an overuse of antibiotics that is known to create resistant bacteria, which, in turn, can cause life-threatening infections. Arch G. Mainous III, PhD, lead author of the paper, and coauthors performed an Internet search using the words “purchase antibiotics without a prescription” on both Yahoo! and Google, on only English-language sites, and came up with 138 different sites that sold antibiotics without a prescription.
Some of these sites were linked with servers at well-known educational institutions, like Dartmouth College, Carnegie Mellon University, and the University of Pittsburgh, without the knowledge of the institutions. The researchers found an interesting point when they actually ordered different antibiotics—the mean delivery time was 8 days, at which time the buyer should have already recovered from his or her illness. The researchers concluded that US regulatory agencies need to strengthen their enforcement efforts of existing laws in order to curb this potentially dangerous practice.
“Thinking Outside the Pillbox” to Improve Adherence
The cost of patients not taking their medications is estimated to be $290 billion in avoidable medical spending every year, and a new report from the New England Healthcare Institute (NEHI) offers some ideas to help clinicians address this growing problem. In its report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence, NEHI notes that one third to one half of all patients do not take their medications properly. Patients with chronic diseases are particularly susceptible to uneven adherence practices that leave them vulnerable to otherwise unnecessary hospitalizations and additional medical risks.
The report cites several innovations that foster adherence and has identified 4 which show the most promise: (1) creating health care teams of nurses, care managers, pharmacists, and other clinicians to offer repeated checks on adherence as patients move through the health care system; (2) counseling by pharmacists and primary care providers to ensure that patients understand their disease and the important role of their medication in improving their condition; (3) realigning reimbursement incentives away from rewarding volume and toward rewarding good outcomes; and (4) using health information technology to ensure accurate medication data, including medication fill and refill rates, are shared among all parties.
Pharmacists Offered Greater Role in Diabetes Education
The National Community Pharmacists Association (NCPA) and the American Association of Diabetes Educators (AADE) will step up community pharmacists' role in educating patients about diabetes while also creating a way for them to be compensated by Medicare and other insurers. Community pharmacists will be trained to provide comprehensive diabetes education classes to patients. The 16 hours of training required before taking the certification exam will be conducted by AADE and NCPA-in person and online. Training also will be provided for applying to become accredited as a Diabetes Self-Management Education/ Training program, which is required in order to receive reimbursement for diabetes education. Visit www.ncpanet.org/ calendarncpa/2009convention.php or call 866-575-4134 for more information.
New Immunization Guidelines Issued
An Expert Panel of the Infectious Diseases Society of America (IDSA) has prepared new evidence-based guidelines for immunization of infants, children, adolescents, and adults. Significant improvements have been made in the ability to prevent more infectious diseases since the previous IDSA clinical practice guideline for quality standards for immunization were published in 2002. The complete list of the updated guidelines is available in the September 15 issue of Clinical Infectious Diseases.
Since 2002, new vaccines have been licensed, including human papillomavirus vaccine; live, attenuated influenza vaccine; meningococcal conjugate vaccine; rotavirus vaccine, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine; and zoster vaccine. Several new combination vaccines have become available, including measles, mumps, rubella, and varicella vaccine; tetanus, diphtheria, and pertussis and inactivated polio vaccine; and tetanus, diphtheria, and pertussis and inactivated polio/Haemophilus influenzae type b vaccine. Hepatitis A vaccines are now universally recommended in young children. Influenza vaccines are recommended annually for all children aged 6 months through 18 years and for adults aged ≥50 years. A second dose of varicella vaccine is now included in the routine childhood and adolescent immunization schedule. Many of these amendments and additions have resulted in an expansion of the adolescent and adult immunization schedules.
The updated guidelines also focus on removing barriers to immunization, eliminating racial/ethnic disparities, addressing vaccine safety issues, and financing recommended vaccines. In addition, the guidelines provide specific recommendations for immunizing specific groups, including health care providers, immunocompromised individuals, pregnant women, international travelers, and internationally adopted children. The guidelines include 46 standards that, if followed, should result in optimal disease prevention through vaccination in multiple population groups while sustaining high levels of safety.
Examples of the updated vaccine recommendations include:
- Infants, children, adolescents, and adults should receive all age-appropriate vaccines recommended by the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American Academy of Pediatrics.
- Any vaccine dose not administered at the recommended age should be administered at any subsequent medical encounter when indicated and feasible without reinitiating the series.
- Recommendations for the minimum interval between doses for people who have delayed immunizations or who want to accelerate their schedule should be followed.