Jump to content

Many Federal Drug Risk Alerts Fail to Achieve Recommended Changes in Prescribn


Barbarannamated
 Share

Recommended Posts

Many Federal drug risk alerts fail to achieve the recommended changes in prescribing

Agency for Healthcare Research and Quality, October 2012

http://www.ahrq.gov/research/oct12/1012RA3.htm

 

Drug safety alerts issued by the U.S. Food and Drug Administration (FDA) after a drug is on the market can have mixed results, according to a new review of studies. After approval of a new drug by the FDA, additional information on safety often comes to the Agency once a drug is marketed. This postmarketing surveillance can lead to identification of a new safety concern for a specific subpopulation or requirement of additional clinical or laboratory monitoring for patients taking the drug. The researchers completed a systematic review and identified 49 studies of 16 drug classes or individual pharmaceuticals that evaluated the impact of FDA regulatory actions on prescription drug use.

 

Nearly half of the studies focused on three drugs or drug classes:

antidepressants,

glitazones (that target insulin resistance), and

cisapride (used to treat symptoms of nighttime heartburn).

 

An additional two studies looked at both antidepressant and antipsychotic drugs.

 

Recommendations for additional clinical or laboratory testing, such as monitoring patients taking antipsychotic drugs for hyperlipidemia or diabetes, had minimal or only temporary effects. In contrast, warnings against coprescribing drugs due to their interactions were effective in changing clinical practice, but often months or years after the warning was issued.

Recommendations against use of a drug or use of a drug category in a subpopulation of patients (such as against using antipsychotic drugs in elderly dementia patients) often resulted in large decreases in use among the targeted population but also in modest decreases in use in subpopulations not at risk (i.e., spillover effects).

 

These findings demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, note the researchers. The review was funded in part by the Agency for Healthcare Research and Quality (HS18996).

 

More details are in "Impact of FDA drug risk communications on health care utilization and health behaviors," by Stacie B. Dusetzina, Ph.D., Ashley S. Higashi, M.P.H., E. Ray Dorsey, M.D., M.B.A., and others in the June 2012 Medical Care 50(6).

Pristiq tapered over 8 months ending Spring 2011 after 18 years of polydrugging that began w/Zoloft for fatigue/general malaise (not mood). CURRENT: 1mg Klonopin qhs (SSRI bruxism), 75mg trazodone qhs, various hormonesLitigation for 11 years for Work-related injury, settled 2004. Involuntary medical retirement in 2001 (age 39). 2012 - brain MRI showing diffuse, chronic cerebrovascular damage/demyelination possibly vasculitis/cerebritis. Dx w/autoimmune polyendocrine failure.<p>2013 - Dx w/CNS Sjogren's Lupus (FANA antibodies first appeared in 1997 but missed by doc).

Link to comment
Share on other sites

  • Moderator Emeritus

Many Federal drug risk alerts fail to achieve the recommended changes in prescribing

Agency for Healthcare Research and Quality, October 2012

http://www.ahrq.gov/research/oct12/1012RA3.htm

 

More details are in "Impact of FDA drug risk communications on health care utilization and health behaviors," by Stacie B. Dusetzina, Ph.D., Ashley S. Higashi, M.P.H., E. Ray Dorsey, M.D., M.B.A., and others in the June 2012 Medical Care 50(6).

 

Very informative. I wonder why I'm not surprised?

As always, LISTEN TO YOUR BODY! A proud supporter of the 10% (or slower) rule.

 

Requip - 3/16 ZERO  Total time on 25 years.

 

Lyrica: 8/15 ZERO Total time on 7 or 8 yrs.

BENZO FREE 10/13 (started tapering 7/10)  Total time on 25 years.

 

Read my intro thread here, and check the about me section.  "No matter how cynical you get, it's almost impossible to keep up." Lily Tomlin

 

 

Link to comment
Share on other sites

 Share

×
×
  • Create New...

Important Information

Terms of Use Privacy Policy