Medication adverse events and compounding

The November 2007 issue of America's pharmacist (a trade magazine geared towards pharmacists) highlighted the recent surge in fatalities and adverse drug events related to prescription and OTC medication. Top drugs linked to fatalities and serious adverse events from 1998 to 2005 included the following:

oxycodone 5548 fatalities
fentanyl 3545 fatalities
clozapine 3277 fatalities
morphine 1616 fatalities
acetaminophen 1393 fatalities

estrogens 11,514 serious nonfatal
insulin 9597 serious nonfatal
infliximab 8754 serious nonfatal
interferon beta 8320 serious nonfatal
paroxetine 8095 serious nonfatal

The above chart illustrates how dangerous medication can be. By comparison, pharmacist compounded medications have an excellent safety profile. While there have been side effects and safety issues in the past, the vast majority of those individually compounded preparations for patients have been dispensed with few safety issues.

One of the most vocal arguements against compounding is that there is no reporting system for errors and side effects. The arguement then goes "How do we know the real number of compouned preparations adverse events?" The compounding industry is working on a serious adverse events reporting system. Once this system starts, we will all get to see what the compounded medication safety profile is. This system should help quiet the fears and reporting concerns of compounding pharmacy critics and illustrate how seriously the pharmacists consider their patients care and well being.

Take Care,
Rich

FDA and BHRT The Saga Continues

Well, the battle lines have been drawn. On one side, the FDA, Wyeth, and the organizations that rely on pharmaceutical manufacturers, and on the other, compounding pharmacy, independent physicians, and hundreds of thousands of patients. Obviously you know what side I am on in David vs. Goliath struggle.

There is not enough space here to go into all of the details, and that is what the FDA et. al. is counting on. The idea is that the issues are too complex and involved for the average folk to understand.

The FDA recently wrote letter to 7 pharmacies and told them to stop making false claims about Bio-Identical hormones, to stop calling them Bio-Identical hormones, and to stop using Estriol in their preparations, because they don’t have any data on the safety and effectiveness of Estriol. The FDA did not even visit these places, they just looked at their web sites.

Counterpoints to the FDA’s claims are several, and more compelling than the original arguements. Let me first say that it is not appropriate to make false claims and to mislead the public about safety and effectiveness. On that much everyone agrees.

The source of the data is where the fight is. There are volumes of data that show the “claims” that are made about bio-identicals can be justified. The FDA may not like that data, so they can use terms that marginalize the data.

As for the term Bio-Identical, what else should we call the hormones….Iso-molecular?, Same as endogenous?. They all mean the same thing. Even manufacturers use the descriptive term Bio-Identical. So what is the real harm is using this term?

The data on the safety of Estriol is also voluminous. This item is used all over the world. Estriol has an official United States Pharmacopeia monograph (which means it is recognized by the authority over drug manufacturing as well as compounding). Estriol is even in the final stages of study for FDA approval for safety and effectiveness for a commercial drug manufacturer.

The idea that an item needs to have the FDA seal of approval brings up several points. There are several medications that are available that have not had FDA approval. There are less than in the past, but they are still there. A couple that come to mind are aspirin, and phenobarbital. I believe that digoxin is on that list as well. Each of these items plays an important roll in our society without the FDA 'ok'.

Having the FDA approve a medicine as safe and effective, is no guarantee of either. Many drugs have been removed from the market because they are not safe, or are not effective. Just this past week, a study on a heavily advertised cholesterol drug was released that showed there was no benefit to taking the medicine, and there might even be a problem if taken with another popular drug.

The bottom line is that you need to make informed choices about your medicine, and you’re health care in general. The FDA and drug manufacturers can be a part of that equation, just as compounding pharmacies like ours can be, but they should absolutely not control your care and your choices. This is something that we must all fight for!

Take care,

Rich

Weighing In on BHRT

As you know, we offer practitioners and women the choice of compounded Bio-Identical Hormone Replacement Therapy (BHRT) at our pharmacies. We don’t go out of our way to market BHRT, but we certainly do not turn down the opportunity to help provide care for our clients.

The controversy over hormones will not be resolved any time soon. The discussion can be separated into two basic ideas: Should we treat or not treat menopause, and should we use synthetic or bio-identical preparations.

There are studies that show that some of the synthetic products cause cancer. Does estrogen (bio-identical) cause cancer? We will not have the definitive answer for decades.I would like to mention we all need hormones to exist. Whatever the hormone of discussion is (be it insulin, thyroid, testosterone, estrogen, progesterone, cortisol or any other choices), the body cannot function without them. We treat conditions that require these hormones with bio-identical preparations! We also know that each hormone can be dangerous if it is given in excess in any situation. Insulin overdose can be fatal quickly. Thyroid excess can kill over time. Testosterone and cortisol excess can cause a numerous range of problems. In order to treat patients using insulin or thyroid, lab values are taken and analyzed, and treatment adjusted. Treatment for BHRT should be monitored and adjusted in the same way.

The critics statements on BHRT often cite the lack of studies. This argument is at best naïve and at worst disingenuous. There is a wealth of data on BHRT. One just needs to look for it. It is just that simple. In addition, many of these critics have a direct relationship with entities that would benefit from fewer hormone therapy choices. Others will argue that there is no quality in compounding because the FDA is not involved in it. This implies that everything is perfect only if the governement has a hand in it. As we all know, there are drug recalls for a variety of reasons all of the time, illustrating that neither the manufacturing process or compounding is perfect.

In conclusion, I would say if BHRT by compounded pharmacies was not effective, or was of poor quality (a view which flies in the face of reams of data), thousands of women over the last decade would not have choosen (or continued) this therapy.


Richard B. Moon, PharmD, RPh, FIACP