Letters to the editor: September 17, 2007

September 17, 2007

An extended-release form of Depakote does not have enteric coating, as an author from FDA claims. So charges a pharmacist who wrote to us.

Delayed-release drug not enteric-coated

In your July 23 FDA Safety Page, "Delayed-release vs. extended-release Rxs," Ms. Holquist and Mr. Fava accurately report how multiple formulations of the same medication can lead to medication errors. However, twice the authors refer to Depakote (delayed-release) and Depakote ER (extended-release) as enteric-coated tablets. Although the delayed-release Depakote formulation is an enteric-coated product, Depakote ER is not. Depakote ER features a hydrophilic polymer matrix system that controls drug release primarily by the process of polymer swelling, erosion, and drug diffusion. Specifically, the tablet film coating dissolves upon entering the stomach, exposing the hydrophilic polymer matrix tablet. The outer layer of the matrix becomes partially hydrated, forming a gel layer, and the drug begins to be released. As fluid permeates the tablet, the gel layer increases in thickness, extending the release of drug. Once the outer layer becomes fully hydrated, it erodes and is released from the tablet. Fluid continues to penetrate toward the tablet core. When the hydration process is complete, the last of the drug is absorbed 18 to 24 hours following ingestion.

After administration, absorption occurs immediately; however, since the absorption is considered multi-phasic, only about 15% of the dose is absorbed in the first two hours. Within 12 hours, about 53% of the total dose is absorbed, with complete absorption occurring over 20 to 24 hours. The article does a thorough job of defining and describing the difference between delayed-release and extended-release formulations, but enteric coating and an extended-release delivery system are not the same.

Reply from the authors: The authors incorrectly identified Depakote ER as an enteric-coated product. Depakote ER is not enteric-coated; however, Depakote delayed-release is enteric-coated. The authors did not state or imply that enteric-coated is the same as extended-release. The information presented on the bioavailability differences between Depakote delayed-release and Depakote extended-release is accurate.

R.Ph.s losing out on MTM payment

Over the past year I have read a lot about medication therapy management (MTM), and I think that on the whole it is a good thing-not just for the pharmacy profession but also for patients. Hopefully, it will lead to patients being better informed and put pharmacists in a better position to do what they have been trained to do and to be reimbursed for it. It might also put pharmacy in a position to make a major shift in terms of daily duties in a retail pharmacy.

I work for one of the major chains. In the past month I have noticed that the stores I have worked in have been assigned national provider identifier (NPI) numbers. This puzzles me because I know from reading up on MTM that a pharmacy or pharmacist needs that to bill for MTM services. Then I noticed some e-mails assigning pharmacists to cases through the CommunityMTM site.

I fear that pharmacists are going to be transitioning from dispensing to setting up appointments to counsel-yet still be expected to do all their ordinary duties as retail R.Ph.s. I don't think most pharmacists even realize the opportunity they are losing out on in terms of reimbursement for services. (Some people could argue that if the chains are setting up these programs, they deserve the reimbursement and that patients in the end are the ones who will benefit. However, I don't think that was the original intention of getting all of these new CPT codes and whatnot.)

It is extremely disappointing to see a turn like this for pharmacists, and there doesn't seem to be any organization with a strong enough spine to fight for pharmacists. Demand has really been the determining factor for continued increases in wages. Working conditions could be slightly better, and I definitely have the numbers on my side for arguing my point (errors attributed to long hours, lack of breaks, etc.). What is it going to take for this profession to have the intestinal fortitude to actually stick up for itself against the chains? It's not all about the money, but it would be nice to get compensated for the extra duties (scheduling appointments, counseling, documentation, billing for services) that MTM will entail.

Seth DePasquale, R.Ph.
Lexington, Ky.