Editorial: Discrimination Towards Patients by Insurance Companies!

The September 18, 2007 issue of the NCPA e-News Weekly has a story entitled "Insurer Stopping Reimbursement for Some Compounded Drugs."

My first reaction to this was negative and in my mind I thought "Well, what else is new!" The story goes further to state that Aetna will stop covering bioidentical (human) hormones and thyroid compounded drugs as of October 1, 2007. Aetna said it will consider compounded product medically necessary only if it:

1. Contains at least one prescription product approved by the FDA
2. Is not a copy of a commercially available FDA-approved product
   and
3. "The safety and effectiveness of use for the prescribed indication is supported by FDA approval or adequate medical and scientific evidence in the medical literature"

Addressing No. 1:
Actually, since most human hormone replacement therapy involves estradiol, estrone, progesterone, and testosterone that are contained in prescription products approved by the FDA, this may not be a problem. Also, I suppose it may be possible that there may be a small or miniscule amount of estriol in Premarin tablets (but who knows?).

Addressing No. 2:
Copies of commercially available FDA-approved products are not compounded. If an alternative is compounded due to an allergy to some component, different strength, combination of ingredients, etc., these would not be commercially available.

Addressing No. 3:
The safety and effectiveness of use is supported by the FDA approval of the commercial products on the market already. This phrase cannot refer to "compounded preparations" because they are not subject to the FDA approval process, and we cannot compound preparations identical to products the FDA has approved.

So, unless there is a different interpretation and some "fine print," I'm not sure that this will really impact much of the compounding of human hormone replacement therapy preparations.

However, the principle here is that they have unilaterally decided that some patients may be discriminated against with no scientific or medical evidence to support their decision; just economical.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Just this week, two stories related to deaths that have previously occurred have been in the pharmaceutical news publications.

First, FDA and Cephalon Inc. claim that failures to strictly follow instructions in the labeling for Fentora fentanyl buccal tablets are behind recently reported deaths and other adverse events in patients who received the product.

Second, the death of a 3-week old infant that died due to a mistake in a TPN where 330 mg rather than 330 mcg were used.

These events are heartbreaking and sad�but it is noteworthy that they did not receive the media coverage that any of the deaths related to community pharmacy compounding have in recent years.

Public demand for natural and healthy flavors has led to efforts to find natural proteins with high sweetness and taste-modifying properties. IJPC's November/December 2007 issue includes an article that reviews the properties of natural protein sweeteners and taste-modifying protein sweeteners. Compounding pharmacists should find this article informative and useful for their patients.

Subscribe today online at www.IJPC.com/Subscriptions or call 800-757-4572.

Keep up and get ready!
The FDA is already encouraging genetics-aided warfarin dosing. Warfarin has a number of different strengths (1-, 2-, 2.5-, 3-, 4-, 5-, 6-, 7.5-, and 10-mg tablets). Consequently, dosing with commercially available tablets may not be a problem. However, which drug is next that is available only in limited strengths? As pharmacogenomics- and genetics-aided therapy grows, so will the need for "individualized medications."