Compounding pharmacies, which make at least 30 million prescriptions in the United States each year, may be turning out medications that are contaminated, too potent or altogether ineffective. While the majority of these state-regulated pharmacies do produce quality products, concerns have been raised because they are not held to the same quality or safety rules as FDA-regulated pharmaceutical companies. This means that compounding pharmacies are typically not required to:

• Check final products for potency or sterility

• Report problems with their drugs
  

There are at least 3,000 of these pharmacies in the United States, according to the Food and Drug Administration (FDA), some of which act more like drug manufacturers, turning out millions of doses of medications ranging from dermatological treatments to injectable painkillers.

Respiratory drugs, which can generate profit margins of 75 percent or more, are another major product group produced by compounding pharmacies. Often, neither patients nor their doctors are aware of the source of the drugs, so a network of doctors and consumer advocates plans to petition the FDA to require that respiratory drugs made at compounding pharmacies carry labels stating that they are not FDA-approved and have not been tested for safety or efficacy.

While no deaths have been reported from pharmacy-made respiratory drugs, there have been other health concerns (and concerns surrounding other types of drugs) including:

• Med 4 Home pharmacy in Kansas City, Mo. recalled respiratory drugs in 2003 after state regulators found they were contaminated with bacteria.

• Tests of respiratory drugs from a Puerto Rican pharmacy found the actual amounts didn’t match the information on the labels.

• Four out of five pharmacy-made respiratory drugs tested by drug maker AstraZeneca failed potency tests.

• Since 1990, over 200 adverse events related to compounded drugs have been reported to the FDA.

• There have been three deaths and 13 hospitalizations from a compounded injectable painkiller.

Some Patients Choose Compounded Drugs, Others are Unaware

There are times when patients and doctors deliberately choose drugs made by compounding pharmacies. That’s because the pharmacies can produce special dosages or mixtures that wouldn’t otherwise be available. For instance, they can produce flavored syrups for those who can’t take pills, combine drugs so that patients can take them more quickly or make dye-free products for those with allergies to dyes.

Other times, a pharmacy may make a request to switch a patient to a compounded drug to the doctor directly, so the patient does not know their medication has been switched to a compounding pharmacy until they see a new vial or label.

Compounded drugs are allowed in all 50 states and by the FDA. However, patient advocates say that at the very least, patients and doctors should be specifically informed that their drugs are pharmacy-made so they can weigh the pros and the cons and make an informed decision.

USA Today March 24, 2005

Dr. Mercola's Comments:

The article uses the example of an observant mom whose asthmatic son relies on prescription medications dispensed through a tabletop machine. After changing pharmacies, the mother noticed the new asthma prescription looked and smelled different than her previous scripts for Pulmicort. While the pharmacist assured the woman her son's drug was merely generic, there was never a generic made for Pulmicort. Instead, the drug was made by a compounding pharmacy, which is why it had changed forms. This is just another inevitable complication of using a flawed paradigm to treat disease. Even if you received the best quality and absolute perfect form of the drug to use, the drug has a serious chance of causing you more harm than good. That certainly was true for the 55,000 users of Vioxx. But in addition to using a substance that was never designed to solve the foundational cause of the disease there are multiple possibilities to cause further complications. Obvious ones that kill patients every day, is receiving the wrong medication or dose through a physician or pharmacist mix-up. And now, as this article points out, there is yet another variable that can increase potential complications and that is medicines that are compounded by the pharmacists rather than the manufacturer. Please understand that I have many friends who are compounding pharmacists and who read this newsletter. I completely understand that there are many good reliable and reputable pharmacists out there, but of course, just like physicians, there are a number of rotten ones out there and as this article identifies, you have to be careful as your life may be on the line here. What many people do not realize is that it is possible to maintain and optimize your health by avoiding unnecessary drugs. That comes by gaining a comprehensive, clear and researched understanding of good nutrition and proper lifestyle choices. There are a number of ways to achieve optimal health (without the use of harmful drugs) that seem to hold true for all people: Eliminate sugar and grains. Consume unprocessed, high-quality foods--organic if possible--for your body's unique metabolic type. Eat your food as close to raw as possible. Take a high-quality fish or cod liver oil daily. Exercise regularly. Reduce stress in your life as much as possible. Related Articles: Fake Drugs are Byproduct of the Traditional Model Drugs and Doctors May be the Leading Cause of Death in U.S. Modern Health Care System is the Leading Cause of Death