Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, March 13, 2014

Antibiotic Resistance

When I was a child, antibiotics were still thought to be a miracle drug and saved my hearing in my right ear and maybe my life. Billions of microscopic bacteria normally live on the skin, in the gut, and in our mouths and throats. Most are harmless to humans, but some are pathogenic and can cause infections in the ears, throat, skin, and other parts of the body. In the pre-antibiotic era in the first half of the 20th century, people had no medicines against these common germs and as a result were often made quite ill, had severe complications or even died from bacterial infections. It has been less than 75 years that we have had antibiotics to fight these bacterial infections. Now, that miracle may be ending helped along by our excessive use and overuse of antibiotics.
Clostridium difficile, Enterobacteriaceae and Neisseria gonorrhoeae currently pose an urgent threat in the US


Less than a decade after antibiotics came into common use in medicine it began to be widely used as a feed additive in agriculture. It was discovered that antibiotics fed to young animals caused them to increase weight and grow faster on less food. To this day we don’t know exactly why that happens. Thumb through any farm supply catalogue and you are likely to see for sale medicated feet that “boosts the growth of poultry and livestock.” However, you are likely to find that medicated feed is out of stock. At the end of last year, the Food and Drug Administration (FDA) began implementing a voluntary plan with industry to phase out the use of certain antibiotics for enhanced food production. This action was taken as part of a coordinated program to preserve the effectiveness of antibiotics used to treat human illness and reduce the spread of antibiotic resistant bacteria.

Antibiotic resistant bacteria are a rapidly growing problem in the United States and the world. In 2012 at least 2 million people in the United States alone became infected with bacteria that are resistant to antibiotics and at least 23,000 of those people died as a direct result of these infections. Many more people died from other conditions that were complicated by antibiotic-resistant infections. Almost 250,000 people in 2012 required hospital care for Clostridium difficile commonly known as C. difficile. At least 14,000 people died that year in the United States from C. difficile infections including the son of an acquaintance of mine who died in San Francisco despite the availability of excellent medical care. Antibiotic use is a major contributing factor to the spread of these infections. Many of these infections could have been prevented.

As antibiotic resistance grows, the antibiotics used to treat infections do not work as well or at all. The loss of effective antibiotic treatments will not only cripple the ability to fight routine infectious diseases but will also undermine treatment of infectious complications like C. difficile in patients with other diseases. Many of the wondrous advances in modern medicine—joint replacements, organ transplants, cancer therapy, and treatment of chronic diseases such as diabetes, asthma, rheumatoid arthritis—are dependent on the ability to fight infections with antibiotics. If that ability is lost, the ability to safely offer modern medical wonders will be lost with it.

Antibiotics are among the most commonly prescribed drugs used in human medicine. However, up to 50% of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed. Antibiotics are also commonly used in food animals to prevent, control, and treat disease, and to promote the growth of food-producing animals. The use of antibiotics for promoting growth in livestock is not necessary, and the practice should be phased out. Guidance from the FDA at the end of last year plots a path towards this goal. According to the FDA it is difficult to directly compare the amount of drugs used in food animals with the amount used in humans, but there is evidence that more antibiotics are used in food production. The Pew Foundation reports that 70% of antibiotics manufactured in the United States are used in food production (though I could not identify their methodology for calculating this). The primary danger from antibiotic over use in animal feeding is from antibiotic resistant bacteria that survive to enter the food chain, not from human exposure to antibiotics in meat; however, there might be human health impact from broad low level exposure or changes in gut bacteria colonies.
from FDA


Antibiotic resistance infections have left the confines of hospitals and begun appearing in our communities without any connecting factors to the hospital population. Antibiotic-resistant infections outside of the hospital setting were rare until recently. Today, resistant infections that appear in the community include tuberculosis and respiratory infections caused by Streptococcus pneumoniae, skin infections caused by methicillin-resistant Staphylococcus aureus, and sexually transmitted infections such as gonorrhea. Right now the biggest of these threats in the United States are Streptococcus pneumoniae (pneumococcus) and MRSA infections. Multidrug-resistant and extensively drug-resistant tuberculosis (MDR and XDR TB) infections are an increasing threat outside of the United States and could spread very quickly because of the ways the disease is spread. Now the FDA and the CDC are developing a group of strategies to fight back against antibiotic resistance.

There are four core actions:
  1. Preventing infections. Avoiding infections in the first place prevent infection and the spread of antibiotic resistant bacteria. There are many ways that drug-resistant infections can be prevented: immunization, safe food preparation, hand washing, and using antibiotics as directed and only when necessary. Streptococcus pneumoniae (pneumococcus) can cause serious and sometimes life-threatening infections and can persist in a medical facility for years, so preventing infection in the first place is essential.
  2. Tracking. The CDC gathers data on antibiotic-resistant infections, the causes of infections and whether there are particular risk factors that caused some people to get a resistant infection. With more information, scientists can develop specific strategies to prevent those infections and prevent the resistant bacteria from spreading.
  3. Improving the way we use antibiotics. The most important action needed to greatly slow down the development and spread of antibiotic-resistant infections is to change the way antibiotics are used. Most antibiotic use is unnecessary and inappropriate and makes everyone less safe. Stopping the inappropriate and unnecessary use of antibiotics in people and animals would help greatly in slowing down the spread of resistant bacteria. This requires a commitment from all of us to only use antibiotics when necessary and appropriate and also to reserve the broad spectrum antibiotics (the big guns) for the most dire bacterial infections.
  4. Finally, new diagnostic tests and new antibiotics must be developed. Antibiotic resistance occurs as part of the natural process in which bacteria continually evolve. The process of developing resistance can be slowed but not stopped. Therefore, we will always need new antibiotics to fight resistant bacteria as well as new diagnostic tests to determine the most effective treatment and track the development of resistance.

Thursday, April 11, 2013

Safely Dispose of Drugs in Prince William County April 27th 2013


The 6th National DEA Prescription Drug Take-Back Day will be held on Saturday, April 27, 2013; from 10:00 am to 2:00 pm.  Prince William County is again participating in the program. Simply bring your prescription drugs to the collection sites at Prince William Hospital, Heathcote Health Center and Sentara Lake Ridge between 10 am to 2:00 pm to safely dispose of unused and old drugs such as powerful narcotic, pain relievers and other controlled substances that carry FDA instructions for flushing the remainder or excess down the toilet to reduce the danger of unintentional use or overdose and illegal abuse. Any other pills or capsules you wish to dispose of will be accepted-prescription and over the counter tablets. Intravenous solutions, injectables such as insulin, and needles will not be accepted. The service is free and anonymous, and though no questions will be asked- Illicit substances such as marijuana or methamphetamine will also not be accepted.

According to the Food and Drug Administration (FDA), most drugs can be thrown in the household trash, but should be taken out of their original containers and mixed with coffee grinds or kitty litter or otherwise made unpalatable. A few drugs should be flushed down the toilet for safety reasons, but may impact our water supplies. Drugs such as powerful narcotic pain relievers and other controlled substances carry instructions for flushing to reduce the danger of unintentional use or overdose and abuse. This nationwide prescription drug “Take-Back” day is to prevent pill abuse and theft. According to the DEA, prescription drug abuse in the United States is increasing, as are the number of accidental poisonings and overdoses. Studies cited by the DEA show that a majority of abused prescription drugs are obtained from family and friends, including from the home medicine cabinet. So now is your chance to clean out your medicine cabinet without damaging the environment.

Despite the safety reasons for flushing some drugs, waste water treatment systems were simply not designed to handle chemicals and drugs. Recent studies have found trace levels of drug residues in surface water, such as rivers and lakes, and in our drinking water supplies coming from the Potomac and Occoquan Reservoir. Waste water treatment systems including septic systems are not designed to remove drug residue and traces of contaminants are being found in some groundwater aquifers nationwide. However, many scientists report that the main way drug residues enter water systems is by human waste-people taking medications which are not complexly metabolized and then naturally allowing the drugs to pass through their bodies.

The technology used for chemical analysis has advanced to the point that it is possible to detect and quantify nearly any compound known to human kind down to less than a nanogram per liter or parts per trillion (1/1,000,000,000,000). This enhanced analytical ability has allowed scientists to discover that trace levels of pharmaceuticals, potential endocrine disrupting compounds (EDC) and other emerging contaminants exist in much of our nation’s surface water and is appearing in some groundwater and persists in the water through conventional and some advanced water treatments to also appear in our drinking water. Fairfax Water that supplies water to parts of Prince William County has examined their drinking water for some of these emerging contaminants and found traces of some contaminants in both their source water and finished water.

The implications of this ubiquitous exposure are unknown, but of concern. The detection of a chemical does not mean that it will cause health effects or disease, but we really do not know. The guiding principal of toxicology is that there is a relationship between a toxic reaction (the response) and the amount of a substance received (the dose). An important assumption in this relationship is that there is almost always a dose below which no response occurs or can be measured. So if the concentration of the contaminant was low enough there would be no toxic reaction, but that principal is being tested with endocrine disruption, and advances in analysis.

 Meanwhile, water utilities and citizens are left not knowing how to address findings of emerging contaminants in their source and finished drinking water. A study conducted by the Water Research Foundation concluded that using a combination of ozone and granular activated carbon in addition to coagulation, sedimentation, filtration and disinfection is effective in removing some of the broad categories of endocrine disrupters, personal care products and pharmaceuticals found in drinking water. Both the Washington Aqueduct and Fairfax water now treat their water supplies with ozone, but it is best to keep drug and other substance out of our groundwater and surface water in the first place. Begin by not flushing chemicals and drugs down the toilet. Bring your unused pills and capsules to the 6th National DEA Prescription Drug Take-Back Day. Dispose of chemicals and household hazardous waste at the Prince William Landfill on Wednesdays and Saturdays.