Staying Healthy this Halloween

SRxA’s Word on Health wishes all of our readers a Happy and Healthy Halloween.  For the 50 million or so people living on the Atlantic Seaboard of America affected by Mondays’ Frankenstorm we hope you are staying safe and recovering from the devastation wreaked by Sandy.

Although the United States experiences hurricanes almost every year and most people have a rudimentary knowledge of the dangers, there are a number of health risks that people seem to forget about in every storm. And frequently, it’s these things that cause unnecessary deaths, injuries, and illnesses.

While many people believe that high winds are the greatest risk from a hurricane, that’s simply not true. According to Ready.gov the majority of deaths are from flooding.   Flooding deaths often result from people trying to wade or drive through moving water or water of unknown depth.  Six inches of water will stall most vehicles – a foot of water may float a vehicle. Sadly, many flood deaths happen as a result of misadventure. Victims who chose to ignore warnings and drive around barricades set up to restrict travel in flood danger areas.

Other deaths happen when people walk or drive through flood water and discover that the ground has been washed away or the water is too deep to cross. Falling trees and tree limbs are another cause of hurricane deaths and injuries. Wait until the storm passes to begin any work on these hazards, even if they have fallen on a house or car. And even then take extreme care.  The Centers for Disease Control (CDC) warns that tree parts can move without warning by a mistaken cut of a saw.  If in doubt call your local fire department or check out the CDC’s advice on preventing chain saw injuries.

High winds and flood produces power outages and electrical dangers. Electrical providers suggest that all downed wires should be considered as live. Stay ten feet away, at minimum. And remember don’t touch tree limbs, fences or other objects that a power line is touching since they can conduct electricity, sometimes for hundreds of feet.

Flooded homes and flooded appliances inside homes represent another electrical hazard. Don’t use power outlets or lights in a building that was flooded until the electrical system has been inspected by an electrician. Carbon monoxide poisoning is another oft overlooked danger after a hurricane. Carbon monoxide is colorless and odorless and exposure can be deadly. Please remember that generators, charcoal grills, hibachis and other similar cooking methods should only be operated outside.

And even when the worst of the storm is over, as things start to dry out, those that got wet in the flooding will begin to mold. The CDC offers a web page about how to reenter a flooded home and another on dealing with the dangers of mold. You should also keep in mind that any surface that was flooded, especially basements may be contaminated with sewage.

Also consider the dangers from food spoiled by loss of power. If the power is out for less than 2 hours, then the food in your refrigerator and freezer should be safe to consume. However, if the power is out for longer than 2 hours, then you should remember the following:

A freezer that is half full will only hold food safely for up to 24 hours. A full freezer will hold food safely for 48 hours. Beyond that you will need to toss the contents.

So whether you hunkering down, bailing out or trick-or-treating today, please stay safe and healthy.

FDA Criticized by the Government Accountability Office

Normally, it’s  pharmaceutical companies that come under the scrutiny of the FDA.  However, in an interesting twist of fate, the FDA  itself is now under fire for not enforcing its own rules.

Physicians have an innate tendency to trust governing medical entities such as the American Medical Association (AMA), Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Maintaining a reproducible and sustainable standard for reporting clinically relevant pharmaceutical data for new and established drugs has always been a priority for the FDA.

In December 2000, the  FDA issued a call to improve the professional labeling of drug  package inserts and other accredited drug information sources i.e.  the Physician Drug Reference (PDR). In 2006, the standard format for package inserts was modified in an attempt to make it more user-friendly and to serve as an efficient resource tool for patients, physicians, and researchers.

In today’s fast-changing challenging healthcare environment, physicians tend to accept this reported data, and the lack of it, as this is all there is available to them.

However, many would like to know more. For example, how to manipulate a drug dose for a patient with renal failure based on given elimination half life.  Although vital to the management of such patients, all too often, such information is not yet an option for many of FDA approved drugs.

The United States Government Accountability Office (GAO) recently concluded that the FDA lacks a clear and effective process for postmarket drug safety issues. The GAO  also observed that there is a lack of criteria for determining what safety actions to take and when to take them.

This finding is supported by research from  Wesley College, Delaware.   Using the commercially available KnowItAll^® informatics platform from Bio-Rad Laboratories, researchers built a Cancer Drug Database containing 85 chemotherapy drugs.  They found that the  reporting of important biological properties such as bioavailability (BIO), plasma protein binding (PPB), elimination half-life (t_1/2), volume of distribution (V_D), and water solubility were found to be markedly deficient.

According to Malcolm J. D’Souza, Ph.D “The evidence is so compelling that the apparent laxity in enforcing reporting regulations for many of these pharmaceuticals is alarming.”

Perhaps the real impact of this research is the red flags it raises.  The FDA guidelines need to be revisited with emphasis on vigilance in reporting all parameters that directly or indirectly affect patient care.

Until the FDA has its house in order, we wonder how much, and for how long either physicians and pharma will continue to trust their own regulatory bodies.  Let us know what you think.