Health and Medical News and Resources

General interest items edited by Janice Flahiff

Patients Feel More Control of Their Health When Doctors Share Notes

 

From the 1 October 2012 article at Science Daily

Patients with access to notes written by their doctors feel more in control of their care and report a better understanding of their medical issues, improved recall of their care plan and being more likely to take their medications as prescribed, a Beth Israel Deaconess Medical Center-led study has found…

“Open notes may both engage patients far more actively in their care and enhance safety when the patient reviews their records with a second set of eyes.”

“Perhaps most important clinically, a remarkable number of patients reported becoming more likely to take medications as prescribed,” adds Jan Walker, RN, MBA, co-first author and a Principal Associate in Medicine in the Division of General Medicine and Primary Care at BIDMC and Harvard Medical School. “And in contrast to the fears of many doctors, few patients reported being confused, worried or offended by what they read.”…

..

Of 5,391 patients who opened at least one note and returned surveys, between 77 and 87 percent reported open notes made them feel more in control of their care, with 60 to 78 percent reporting increased adherence to medications. Only 1 to 8 percent of patients reported worry, confusion or offense, three out of five felt they should be able to add comments to their doctors’ notes, and 86 percent agreed that availability of notes would influence their choice of providers in the future.

Among doctors, a maximum of 5 percent reported longer visits, and no more than 8 percent said they spent extra time addressing patients’ questions outside of visits. A maximum of 21 percent reported taking more time to write notes, while between 3 and 36 percent reported changing documentation content…

Walker suggests that so few patients were worried, confused or offended by the note because “fear or uncertainty of what’s in a doctor’s ‘black box’ may engender far more anxiety than what is actually written, and patients who are especially likely to react negatively to notes may self-select to not read them.”..

 

 

 

 

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October 4, 2012 Posted by | health care | , , , | Leave a comment

Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements

 

Dietary supplements

Dietary supplements (Photo credit: Andrei Z)

 

From the 2 October 2012 report by the Office of the Inspector General, US Department of Health and Human Services

 

Summary

WHY WE DID THIS STUDY

The Government Accountability Office and public interest groups have raised concerns about a specific type of claim-called a structure/function claim-that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. FDA lacks authority to review or approve these claims before products enter the market. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims, and a product label must include a disclaimer stating that FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.

HOW WE DID THIS STUDY

We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.

WHAT WE FOUND

Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.

WHAT WE RECOMMEND

We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.

 

 

October 4, 2012 Posted by | Nutrition | , , , , | 2 Comments

   

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