FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation.

FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.

There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.

Additional information, including information for healthcare professionals and parents, is provided in the document below.

[03/22/2010 - Update on Rotarix Vaccine¹ - FDA]

    

Important information from the FDA; please disseminate!

Keep Pharmacy-Related Provisions in the Final Version of Health Care Reform Legislation

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Senate Bill 1046 RSS feed for this bill

Relating to prescriptive authority for licensed psychologists; declaring an emergency.

Authorizes Oregon Medical Board to issue certificate of prescriptive authority to certain licensed psychologists and sets forth requirements and procedure for issuance of certificate.

This bill has passed the House and the Senate. Please contact Oregon Governor Kulongoski to express your concerns with this bill: http://governor.oregon.gov/Gov/contact_us.shtml

Under pressure from out-of-state interests, our Legislature is about to consider passage of Senate Bill 1046, enabling psychologists to prescribe medication. This bill would jeopardize the safety of our citizens while creating unnecessary costs. The work group proposing the bill held only five sessions, without public testimony. Remarkably, one member of the work group was from California (and required a temporary Oregon license to participate) and heads a distance-learning post-doctoral psychology training program in clinical psychopharmacology that stands to benefit from the bill's passage. I hope that the Legislature will defer judgment on such an important issue to a regular session during which full and open testimony can be offered.

I am not in favor of this kind of legislation, which I think sets a dangerous precedent. I agree with the author of this editorial that it would be interesting to see if this actually expands care into rural and undeserved populations.

Instead of increasing the scope-of-practice for this profession, I feel a better option would be to encourage the expansion of professionals already credentialed to provide medication therapy.

Pfizer announced today results of a survey the company recently sponsored that shows physicians are more likely to report side effects through an electronic health records (EHR) system, as compared to traditional paper methods. Nearly 60 percent of physicians who responded to the survey also agreed that adverse event reporting through an EHR system would improve patient care.

“Patient safety continues to be a top priority at Pfizer,” said Freda Lewis-Hall, MD, Pfizer’s chief medical officer. “This survey furthers our understanding about how we can best use electronic health records systems to collect critical information about the safe and appropriate use of our products so that we can improve patient safety.”

Of the 300 physicians surveyed, two-thirds utilized some form of an EHR system and one-third used a paper-based system. Half of all respondents and 60 percent of fully-functional EHR users reported that they would be much more likely to submit information about adverse events using an EHR system. Of those still using paper-based systems, 80 percent cited cost as a deterrent to investing in an EHR system.

Ipsos conducted the survey online among primary care physicians in the United States who were categorized as basic electronic health record users, fully functional electronic health record users or paper health record users. The research was conducted during September and October 2009.

As part of the company’s ongoing efforts to improve patient safety, Pfizer is collaborating with Brigham and Women’s Hospital, Partners Healthcare, CDISC, an international standards group, and CRIX International to improve the quality of data in safety reports. Earlier this year, the group conducted a pilot known as the ASTER (Adverse Drug Event Spontaneous Triggered Event Reporting) study, allowing physicians to use electronic health records to report adverse events directly to the Food and Drug Administration (FDA). By exploring a combination of standards, technology and a new business model, the group intends to help physicians better recognize and report adverse events.

“These survey results confirm what we saw in the Partners Healthcare ASTER study,” said Jeffrey A. Linder, MD, MPH, FACP an internist at Brigham and Women's Hospital in Boston. “The system we used in that study was well accepted by the participating physicians, who felt the adverse event reporting was unobtrusive and who saw the public health potential of this type of reporting. While most of the participating clinicians submitted no reports in the year prior to the study, they submitted hundreds of detailed reports during the five months of the study period."

Interesting and somewhat surprising, not that providers prefer and electronic method for submitting ADE reports, but that providers saw the tool as "unobtrusive."

As the FDA hones in on a pharmacovigilance strategy, they should certainly consider standardizing integration with EHRs (or make it a requirement for vendors).

World Cancer Day 2010, led by UICC, its members and with the support of the World Health Organization (WHO), will raise awareness of cancer prevention. 

Each year, over 12 million people receive a cancer diagnosis and 7.6 million die of the disease.

The good news is that approximately 40% of cancers are potentially preventable. We invite you to join us in marking World Cancer Day on 4 February by promoting our exciting new campaign and spreading the message that cancer can be prevented too.

This coming February, UICC will launch the campaign “Cancer can be prevented too”, focussing on how the risk of developing cancer can significantly be reduced through simple measures:

• Stop tobacco use and avoid exposure to second-hand smoke
• Limit alcohol consumption
• Avoid excessive sun exposure
• Maintain a healthy weight, through eating healthily and exercising regularly
• Protect against cancer-causing infections

February 4, 2010 is World Cancer Day. Please educate and share!

Philanthropists Bill Gates and Melinda Gates said Friday they would spend $10 billion to develop and deliver new vaccines over the next decade, highlighting growing concerns that the global recession and competing government priorities will stifle efforts to control diseases in developing countries.

"Hopefully we'll have some breakthroughs," Mr. Gates said in an interview this week, pointing to funding from his foundation aimed at finding a vaccine for malaria.

The money, combined with a call by Mr. Gates for continued investment in vaccines from other donors, comes amid growing worries at the World Health Organization and other health groups that funding shortfalls will stifle the distribution of promising new vaccines and allow diseases like polio to spread in new areas.

Those worries are particularly acute as health officials start rolling out new vaccines that prevent rotavirus, a cause of severe diarrhea, and pneumococcal disease. The new vaccines are fueling concerns in developing countries, many with decrepit primary health care systems, already struggling with how to deliver existing vaccines.

Many African countries, for instance, lack the refrigeration, or "cold chain," needed to keep vaccines fresh while they are being stored and transported.

Amazing. I wonder if Mr. Gates will be remembered more for his impact on technology or his humanitarian efforts?

Supplements try to reduce food "to a single component, such as one nutrient or one antioxidant," said Marion Nestle, a professor of nutrition at New York University, but no study or test has proved what exactly makes food, such as fruits and vegetables, so healthy. "It may not be one thing; maybe it's the combination."

Others see dietary supplements as a type of insurance: "There is a big discrepancy between what people think they eat and what they actually are eating," said Kelly Dorfman, a nutritionist in North Potomac. "Taking nutrients just makes good sense."

And for certain medical conditions, such as diabetes, supplements are highly recommended. Benjamin Caballero, a professor at the John Hopkins Bloomberg School of Public Health, said he does not think any "healthy person with a healthy diet" should take dietary supplements, with a few exceptions: "pregnant woman; children under the age of 6 months who are being breast-fed, as breast milk is not rich in vitamins A, C, and D; and people with gastrointestinal problems." And, in those cases, he believes a doctor would have already been consulted.

This is an interesting - but thin - opinion piece to which I believe there are some grains of truth. Diet should be the foundation of any desire for health. However, I think the point that the quoted experts in this article are missing, is that from a population-level Americans are not getting the nutrients they need from our diets (there is a reason the SAD is the acronym for the Standard American Diet). Secondly, would most providers know how to assess a patient's diet, their need for functional nutrients and their need to supplement with macro/micronutrients and herbs? Doubtful. That kind of training and education is missing from standard biomedical curriculum. Naturopathic Physicians (http://www.aanmc.org/) are well-placed to provide patient care in this arena. And hopefully, we'll continue to see outcomes-based literature providing evidence for some of these interventions.

Food for thought.