Resisting Antibiotic-Resistant Bacteria

The Food and Drug Administration (FDA) announced new regulations on February 5, 2003 to encourage physicians to prescribe antibiotics correctly. The plan will require antibiotic manufacturers to include information in the professional product labeling, or “package insert,” for all antibiotics on the appropriate prescribing of these drugs to reduce the development of drug-resistant bacteria.

Unquestionably, when prescribed and used appropriately, antibiotics can be lifesaving. Unfortunately, the inappropriate prescribing and use of antibiotics in recent years has contributed to a dramatic increase in the prevalence of antibiotic-resistant bacterial infections. Antibiotic resistance is a serious and growing public health problem in the U.S. and worldwide. Many bacteria, including the ones that cause pneumonia and other respiratory tract infections, meningitis (infection of the lining of the brain), and sexually transmitted diseases, are becoming increasingly resistant to the antibiotics used to treat them. Some bacteria are now resistant to every antibiotic on the market. This severely limits treatment, and what were once relatively routine infections to treat are now, in some cases, life-threatening.

The extent of the inappropriate prescribing of antibiotics is staggering. The Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics estimated in a report published in the journal Pediatrics in 1998 that half of the 100 million antibiotic prescriptions a year written in physicians’ offices in the U.S. are unnecessary because they are prescribed for the common cold and other viral infections, against which antibiotics are ineffective.

In addition to the negative health consequences of inappropriate antibiotic prescribing, there is an economic downside for individual patients and the healthcare system at large. In 2001, 13 of the top 200 selling brand name drugs in the U.S. were antibiotics and accounted for almost $7 billion in drug sales. Appropriate prescribing of just this one family of drugs, antibiotics, would save about $3.5 billion a year. This assumes these 13 are a typical cross-section of mis-prescribed antibiotics. Better prescribing of all drugs would go a long way in paying for a sustainable prescription drug benefit for senior citizens.

We have listed three of these 13 top-selling antibiotics, amounting to almost $500 million in sales in 2001, as Do Not Use drugs. Nitrofurantoin (MACROBID) has been on the Do Not Use list since the publication of the first edition of Worst Pills, Best Pills in 1988. The fluoroquinolone antibiotic moxifloxacin (AVELOX) was listed as a Do Not Use drug in the February 2000 issue of Worst Pills, Best Pills News and gatifloxacin (TEQUIN), also a fluoroquinolone antibiotic, was added to the list of Do Not Use drugs in the July 2002 newsletter.

Under the new regulations that are due to take effect in February 2004, statements about antibiotic resistance would be in four locations on the labeling so that physicians would not miss the message.

The context and wording of each of the four statements is different. The statement that will appear under the antibiotic’s name emphasizes that the goal of reducing the development of drug-resistant bacteria and maintaining the effectiveness of antibiotics can be accomplished by using antibiotics only to treat infections that are proven or strongly suspected to be caused by bacteria. The statement in the Precautions section of the labeling warns that prescribing antibiotics other than to treat a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient. The Indications and Usage section is where the physician looks to find the FDA-approved uses for the antibiotic. It is the most frequently consulted portion of the labeling. The statement in this section advises physicians to consider culture and susceptibility information and local epidemiology and susceptibility patterns when prescribing antibiotics.

The last section of the labeling that will contain the new information is the Information for Patients section. The name of this section is ironic as patients almost never receive this information. The FDA mandated this section of the professional labeling in the hope that physicians would actually tell their patients about the drugs they are being prescribed.

This section will state that patients should be counseled that antibiotics, including the antibiotic prescribed, should only be used to treat bacterial infections and that they do not treat viral infections, such as the common cold. This section must state that when an antibiotic is prescribed to treat a bacterial infection, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. The labeling must also advise physicians to counsel patients that skipping doses or not completing the full course of therapy may 1) decrease the effectiveness of the immediate treatment, and 2) increase the likelihood that bacteria will develop resistance and will not be treatable by the antibacterial drug product or other antibacterial drugs in the future.

The new FDA regulations embody the principles we wrote about 14 years ago in the first edition of Worst Pills, Best Pills on how you can avoid the unnecessary use of antibiotics:

1. Establish that an antibiotic is necessary. This means that your infection has to be the type that can be effectively treated by an antibiotic. Antibiotics are used specifically to treat bacterial infections. Antibiotics do not treat viral infections, such as the common cold.

2. Choose the correct antibiotic. It must be effective against the most likely organisms that can cause your infection.

3. Take a culture before using an antibiotic. A culture should be taken from where you have an infection, such as your throat, urine or blood, and then grown to determine the specific organism that is causing your infection and whether it is susceptible to the preferred antibiotic. For example, if you have a urinary tract infection, the doctor should take a urine specimen and send it for culture before treating your infection. This does not mean that your infection cannot be treated right away, only that a culture is sent before you start antibiotics. In this way, if your infection persists, your doctor can determine which alternative antibiotic can be used against the bacteria. Your doctor may find out that you do not have an infection and do not require antibiotics.

4. Consider the cost of the antibiotic. This should be done when everything else is equal. If several antibiotics are equally effective, their cost should be taken into consideration when selecting a drug to use. Newer drugs on patent are much more expensive than older antibiotics that are often just as effective and have been on the market for some time.

A final crucial point that we covered in the first Worst Pills, Best Pills and with each succeeding edition is the importance, in general, of completing a full course of therapy. It is important with any antibiotic to take the entire amount of the drug that your doctor prescribes. Often, after the first few days of taking antibiotics, you will begin to feel better. Perhaps you think that you do not have to finish your course of treatment since you are, after all, feeling healthy. This is not the case. The length of the regimen that your doctor prescribes for you is designed to eliminate all of the bacteria that are causing your illness. If you do not take all of your medication, the bacteria will not be completely eliminated and can quickly multiply, causing another infection. This infection may then be resistant to the original antibiotic.

What You Should Do

You should only be taking an antibiotic if there is a likelihood that the infection is caused by a bacterium. Antibiotics are ineffective against viral infections such as the common cold.