Health and Medical News and Resources

General interest items edited by Janice Flahiff

Communicating Health Risk Is A Risky Task For FDA

 

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Communicating Health Risk Is A Risky Task For FDA

From the 23 January Medical News Today article

The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been “varied and unpredictable,” according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.

Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care. …

…The FDA has several standard tools to disseminate new evidence about drug safety. These include “Dear Healthcare Provider” letters to prescribers*, “public health advisories” and “Safety Alerts” targeting the general public, and “black box warnings”** added to a label when a drug’s risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications….

[Article summarizes the effectiveness of 4 categories of communication]

…Part of the problem, the authors emphasize, is the challenge of communicating complex risk messages to a large, diverse audience. “The most effective communications were the simplest, those that were specific, where alternatives were available, and where the messaging was reinforced over time,” said Stacie Dusetzina, PhD, lead author from Harvard Medical School.

 

Read the entire Medical News Today article

*No direct links to “Dear Healthcare Provider” letters at http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/default.htm
However, individual letters can be found through using search engines, as a recent one for the drug Promacta

**Recent black box warnings are listed at Drug Safety Communications . If a drug has a black box warning, it will be part of its label. Drug information by name of drug is located at Drugs@FDA.

January 30, 2012 Posted by | Consumer Health | , , , , , , | Leave a comment

Excessive Heat Can Harm Medications, Expert Says

 HealthDay news image
Don’t travel with meds in your car trunk or leave them in a parked car, she advises
 
From the 20 August 2011 Health Day news article
 

SATURDAY, Aug. 20 (HealthDay News) — Medications can be harmed by high temperatures, say pharmacists.

Although just a handful of drugs have been tested at temperatures above 86F, all medications could be altered by extreme heat, they warn.

According to Dr. Amy Peak, clinical pharmacist and director of Drug Information Services at Butler University, several medications have been tested at high temperatures. She outlined some of the changes the researchers found:

  • Albuterol inhalers: The container could burst at temperatures above 120F. Moreover, when stored at high temperatures, there may be a decrease in the amount of medication inhaled.
  • Concentrated epinephrine: Cyclical heating could reduce 64 percent of the medication’s potency.
  • Diazepam: Concentration of this drug dropped 25 percent when stored at 98.6F.
  • Formoterol (capsules that are placed in inhalers): Following four hours of exposure to 158F heat, the amount released from the capsules was less than half the normal amount.
  • Lorazepam: When stored at 98F, concentration decreased 75 percent.
  • Mometasone (formoterol inhalers): Temperatures above 120F may cause the container to burst.

Peak says several more medications may be susceptible to excessive heat, including:

  • Insulin: Excessive heat could make the insulin less effective. It could also cause the insulin vials to explode.
  • Thyroid hormones: Thyroid hormones could be altered by excessively high temperatures, resulting in inconsistent doses.
  • Any medications in aerosolized canisters could burst when exposed to temperatures above 120F.

Although the United States Pharmacopeia Convention Inc. recommends that medications be protected from excessive heat, only a few drugs are actually tested at temperatures above 86F, Peak pointed out.

Nevertheless, she noted there are a number of steps people can take to ensure the quality of their medications during heat waves, including:

  • Be aware that temperatures inside cars can top 160 F. When driving, be sure to keep medications out of the trunk and in the climate-controlled passenger compartment.
  • Never leave medications in a parked car.
  • During heat waves, have medications shipped overnight in special cooled containers.
  • Request a one-time replacement from your insurance company or drug manufacturer for any medication that may have been affected by excessive heat.

SOURCE: Butler University, news release, August 2011

August 22, 2011 Posted by | Consumer Health | , , , , | Leave a comment

   

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