CDC Updates Measles, Mumps, Rubella, Varicella Vaccination Recommendations
The Centers for Disease Control and Prevention (CDC) recently published updated recommendations for the use of the combination measles, mumps, rubella, and varicella (MMRV) vaccine versus use of the MMR vaccine plus the varicella vaccine. When it was first licensed in 2005, the MMRV vaccine was preferred by the CDC's Advisory Committee on Immunization Practices (ACIP) for both the first and second vaccine doses. However, the ACIP issued updated recommendations in February 2008 that stated no preference for which vaccines to use after preliminary data showed an increased risk of fever and febrile seizures five to 12 days after vaccination among children 12 to 23 months of age who had received their first dose of the MMRV vaccine compared with those who received separate MMR and varicella vaccines. Data from postlicensure studies do not suggest a similar risk in children four to six years of age receiving a second dose. Thus, for the first dose at 12 to 47 months of age, the CDC recommends using the MMR and varicella vaccines unless parents express a preference for the MMRV vaccine. For the second dose at 15 months to 12 years of age, and for the first dose in children four years or older, use of the MMRV vaccine generally is preferred, but children with a personal or family history of seizures should generally be vaccinated with the MMR and varicella vaccines only. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100512mmrv-updt.html and http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5903a1.htm.
FDA Recommends That Physicians Resume Use of Rotavirus Vaccinations
The U.S. Food and Drug Administration (FDA) has revised its recommendations for rotavirus vaccines, advising physicians to resume using Rotarix (manufactured by GlaxoSmithKline) or continue using Rotateq (manufactured by Merck and Co.). In March 2010, the FDA called for a temporary halt to the use of Rotarix after DNA from porcine circovirus type 1 (PCV1) was found in the vaccine. Subsequent tests found that DNA from PCV1 and PCV2 were present in Rotateq. The FDA's Vaccines and Related Biological Products Advisory Committee met May 7, 2010, to discuss the issue. The FDA found no evidence that PCV1 and PCV2 pose a safety risk to humans, and that the known benefits of the vaccines, which have strong safety records, outweigh the risks. The FDA said it is working with GlaxoSmithKline and Merck to update the labeling for the vaccines. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100517rotavirus-vacc.html.
FDA Investigating McNeil Consumer Healthcare After Product Recalls
Prompted by McNeil Consumer Healthcare's most recent recall of its children's and infants' liquid pain-relief products, the FDA is conducting an investigation to determine if there are similar problems throughout McNeil's drug manufacturing practices. On April 30, 2010, McNeil announced it was recalling all unexpired lots of certain brand-name over-the-counter children's and infants' liquid medications—including more than 40 variations of Tylenol, Motrin, Zyrtec, and Benadryl products—because of manufacturing deficiencies that could affect quality, purity, or potency. The most recent incident marks the second time this year, and the third time in less than nine months, that McNeil has recalled children's and infants' liquid pain-relief products. In a May 1, 2010, news release, the FDA said that some of the recalled products may contain higher concentrations of active ingredients than specified, whereas others may contain foreign particles or inactive ingredients that may not meet internal testing requirements. McNeil subsequently closed the Fort Washington, Pa., facility where the recalled products were made and said it would not reopen that plant without notifying the FDA. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20100518fdaandmcneil.html and http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM212243.pdf.
Study Shows No Effect on Patient-Physician Communication with Ask Me 3 Program
A patient education program designed to help patients understand health instructions failed to achieve its desired results, according to a recently published study conducted by the American Academy of Family Physicians' (AAFP's) National Research Network (NRN) and published in the March/April issue of Annals of Family Medicine. The program, known as Ask Me 3, encourages patients to ask three questions during each visit with their physicians: “What is my main problem?”, “What do I need to do?”, and “Why is it important for me to do this?” However, the NRN study found that patients at 10 primary care practices that promoted Ask Me 3 were no more likely to ask those specific questions than were patients at 10 practices that did not promote the program. NRN director James Galliher, PhD, said the study may have been addressing the wrong population. Galliher said patients in the practices studied already asked their physicians questions at a high rate and also demonstrated high levels of adherence to physician advice. He said a study of patients with low health literacy is needed to fully evaluate whether Ask Me 3 is effective. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100510ask-me-3.html.
FDA Launches Program to Crack Down on Misleading Drug Promotions
The FDA announced in May 2010 that it is launching its Bad Ad Program, in which physicians and others can help prevent the misleading or inaccurate promotion of prescription medications. The FDA said examples of common violations include omitting or downplaying the risks associated with a product, overstating a product's effectiveness, promoting off-label uses of products, and making misleading drug comparisons. The program aims to ensure that promotional information is accurate, balances the risks and benefits of a product, is consistent with prescribing information approved by the FDA, and includes only information that is supported by strong evidence from clinical studies. Physicians are encouraged to report potential violations related to drug promotions by e-mailing BadAd@fda.gov or calling 877-793-3622. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20100512fda-bad-ad.html and http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm.
Study Shows Primary Care Physicians in Religious Hospitals Face Ethical Conflicts
About one in five primary care physicians who have practiced in religiously affiliated hospitals have experienced conflicts deriving from those institutions' religion-based patient care policies, according to a recent study conducted by researchers at the University of Chicago. The study, which was published online in April 2010 in the Journal of General Internal Medicine, showed that the conflicts most commonly involved hospital policies governing reproductive health care and end-of-life care. If a patient needs a medical intervention that is prohibited by the hospital, most physicians surveyed for the study said they would refer the patient to another institution. However, physicians practicing in medically underserved communities could find such referrals difficult because these areas typically offer fewer health care facility options, said the study's authors. AAFP member and study author Debra Stulberg, MD, added that patients may not benefit from referral to another hospital in instances involving time-sensitive treatments, such as emergency contraception or certain procedures for an ectopic pregnancy. The study's authors suggest that hospital administrators involve physicians in the policy-making process more fully or communicate policies more clearly to reduce such conflicts, and that physicians inform patients about religiously based institutional policies if an admission is not urgent and other hospital choices are available. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100511hosp-ethics.html.
Early Study Results Show AIM-HI Works; AAFP News Now Posts Obesity Resources
Preliminary results from the AAFP's Americans In Motion-Healthy Interventions (AIM-HI) research project indicate that the program can help patients increase physical activity, make healthier choices, lose weight, and maintain those lifestyle changes. The study, conducted by AAFP's NRN, involved nearly two dozen primary care practices that used AIM-HI, which offers physicians three tools to use with their patients: a fitness inventory, a fitness prescription, and a food and activity journal. In May 2010, AAFP News Now launched “Encouraging Healthy Lifestyles: A Special Report on Overweight and Obesity,” which offers resources for family physicians to encourage healthy changes in their patients. For more information, visit https://www.aafp.org/news-now/obesity/20100517aim-hi.html and https://www.aafp.org/news-now/obesity.html.
FamilyDoctor.org Launches Patient Information on Supplements, Vitamins
On May 14, 2010, the AAFP added new content on dietary supplements and vitamins to its consumer Web site FamilyDoctor.org. The content includes patient handouts on a variety of topics, including antioxidants, calcium, cholesterol, dietary fats, dietary supplements, special diets, osteopenia, varicose veins, and vitamin D. Point-of-sales data from Nielsen Inc. indicate that U.S. consumers increased their use of vitamins and supplements by 31 percent from 2005 to 2009. The new FamilyDoctor.org content is a result of general underwriting support from the AAFP's newest Consumer Alliance Program partner—Nature Made, a manufacturer of vitamins, minerals, and other dietary supplements that is owned by Pharmavite LLC. Neither FamilyDoctor.org nor the AAFP endorse any specific brands, products, or services. For more information, visit https://www.aafp.org/news-now/inside-aafp/20100514pharmavite.html.
— AFPandAAFP NEWS NOWstaff