House Bills Would Strengthen Federal Regulations for Compounding Pharmacies
Two bills have been introduced in the U.S. House of Representatives that would strengthen federal regulations of compounding pharmacies. The Verifying Authority and Legality in Drug (VALID) Compounding Act contains several provisions, including a measure to give the U.S. Food and Drug Administration (FDA) the authority to regulate pharmacies as drug manufacturers if the pharmacies are operating as drug manufacturers. The legislation would also require compounded drugs to be labeled as such to ensure that recipients know the drugs have not been tested for safety or effectiveness. The other bill, known as the Safe Compounding Drugs Act, would require compounding pharmacies to register with the FDA and would give the FDA the authority to set minimum production standards and impose new labeling restrictions on compounded drugs. These bills were introduced in response to the fungal meningitis outbreak that occurred as a result of tainted steroid injections from a compounding pharmacy in Massachusetts. For more information, go to https://www.aafp.org/news-now/news-in-brief/20121212wklynewsbrfs.html#NewsArticleParsys77801.
HHS Launches Initiative and Online Tools to Protect Patient Privacy on Mobile Devices
The U.S. Department of Health and Human Services (HHS) launched an education initiative and online tools to help health care professionals and organizations protect their patients' health information when using mobile devices. The initiative, called “Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information,” offers education resources such as videos, downloadable fact sheets, and posters to promote best practices for safeguarding patient health information. The initiative is available online at http://www.HealthIT.gov/mobiledevices. For more information, go to http://www.hhs.gov/news/press/2012pres/12/20121212a.html.
Quality Improvement Interventions May Improve Vaccination Rates
A meta-analysis in Annals of Family Medicine showed that implementing quality improvement interventions could produce a modest increase in vaccination rates. The researchers concluded that three quality improvements (team change, patient outreach, and clinician reminders) are effective for improving rates of both influenza and pneumococcal vaccinations. The analysis also noted that few of the interventions improved vaccination rates enough to meet policy targets in North America. For more information, go to: https://www.aafp.org/news-now/health-of-the-public/20121211teamvacratesstudy.html.
Study Shows Patients Utilize More Services When Allowed Online Access to Physicians
Results of a study published in the Nov. 21 issue of the Journal of the American Medical Association, titled “Association of Online Patient Access to Clinicians and Medical Records With Use of Clinical Services,” showed that patients who have online access to their physicians and other health care professionals increased their use of in-person and telephone clinical services. The study was conducted at Kaiser Permanente Colorado, a health care delivery system in the Denver-Boulder-Longmont area that provides services to more than 500,000 patients. This health system has used an electronic health record system since 2004, and added an online feature called MyHealth-Manager in 2006 that allows patients secure online access to their health records and lets them schedule and cancel appointments, request medication refills, and send and receive messages to and from physicians and other health care professionals. For more information, go to https://www.aafp.org/news-now/practice-professional-issues/20121210onlineaccessstudy.html.
MedWatch: FDA Issues Updated Safety Review on Varenicline (Chantix)
The FDA has issued an updated safety review on the risk of cardiovascular events associated with the tobacco-cessation drug varenicline (Chantix). A meta-analysis comparing patients receiving Chantix with patients receiving a placebo showed an increased, although not statistically significant, occurrence of major adverse cardiovascular events in those receiving Chantix, according to the FDA. Based on results of this study, the FDA advises physicians to weigh the risks and benefits before prescribing Chantix. For more information, go to https://www.aafp.org/news-now/news-in-brief/20121212wklynewsbrfs.html#NewsArticle Parsys67394. The MedWatch Online Voluntary Reporting Form is available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
— AFP and AAFP NEWS NOW staff