The Blurred Line Between "Topical" and "Transdermal", Part D

This week, we will look at some clinical implications of "topicals" and "transdermals"; approximate quantities that can be reasonably used.

How much should be applied?

Generally, 0.5 g of a preparation will treat two palms of an adult. General guidelines are given in the following table but must be used with caution due to patient variables and the area to be covered:

The above numbers apply to a "typical" patient with a total BSA of about 1.8m². Also, if the preparation is fluid, it tends to cover more area easier. This table is a reasonable guide for creams, gels, ointments, and pastes.

Next week we will look at the types of formulations for different skin types.

Compounders' Resource Directory

By now you should have received the Compounder's Resource Directory with your January/February issue of IJPC. If you don't subscribe, you can still have access to The Compounder's Resource Directory and purchase products and services for compounding directly from vendors that understand and support compounding. These are IJPC's core advertisers. You can always go to www.IJPC.com or www.CompoundingToday.com and find the directory.

News

CMS Surveyor Guidance on Compounding in Critical Access Hospitals Updated
CMS routinely updates the State Operations Manual (SOM) for surveyors who assess whether providers enrolled in Medicare are meeting all the Conditions of Participation of the program. CMS is establishing the USP-NF chapters on compounding as the minimum threshold for quality that critical access hospitals (CAHs) must meet under the Medicare program. CMS also encourages the use of 503B facilities for outsourced compounded products. CMS does not require the use of 503B facilities for compounded products that are not prepared at CAHs, but the SOM does require that CAHs obtaining compounded medications from a compounding pharmacy demonstrate that the vendor is adhering to USP Chapters <795> and <797>.
http://www.ashp.org/DocLibrary/Advocacy/CMS-Updates-Compounding-Guidance-for-Critical-Access-Hospitals.pdf

FDA Simplifies its Compassionate-use Process
The FDA has announced changes to its "compassionate-use" process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients. It is reported that the old method may take up to 100 hours, and the revised method may only take one hour. These changes will affect a significant number of patients each year. For example, in 2014, FDA processed 1,758 single-patient INDs and emergency INDs—97% of all expanded access requests.
http://www.raps.org/Regulatory-Focus/News/2015/02/04/21243/From-100-Hours-to-1-FDA-Dramatically-Simplifies-its-Compassionate-Use-Process/

FDA Commissioner Margaret Hamburg to Step Down in March
Dr. Margaret A. Hamburg, commissioner of the U.S. FDA, has decided to resign from her post sometime in March. The FDA chief scientist, Dr. Stephen Ostroff, will temporarily fill the top post while waiting for congressional approval of the new agency commissioner.
http://www.wsj.com/articles/u-s-fda-commissioner-to-resign-1423120471

Sanofi Launches Inhaled Insulin
Afrezza, an inhalable insulin, has been launched by Sanofi. It was developed by Mannkind Corp and will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin. It promises to be faster acting and much more convenient than injections; however, an inhaled product failed in the past, and there are concerns about the potential risks associated with breathing powdered insulin.
http://www.reuters.com/article/2015/02/03/sanofi-diabetes-insulin-idUSL6N0VC36T20150203

Aetna Must Correct Actions to Comply With U.S. Pharmacy Rules
Aetna has been ordered by U.S. regulators to fix its Medicare drug program after shutting some qualified pharmacies out of its network in violation of federal regulations. Aetna, the third-largest U.S. health insurer, didn't allow any pharmacy that met its plan's terms and conditions to participate in its network. Aetna must develop a plan to follow the regulation or face potential fines or other sanctions, the agency said.
http://www.bloomberg.com/news/articles/2015-02-04/aetna-told-to-correct-actions-to-comply-with-u-s-pharmacy-rules

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Did You Know ...

�that there was a data breach this week at health insurer Anthem where tens of millions of records were exposed? This is too much personal information entrusted to a company that isn't taking care of it; it takes months and sometimes years to get your personal information straightened up after it has been misused!

�If PBMs are going to practice medicine by dictating what drug is to be used (by only paying for certain ones), then maybe they should go to medical school and get licensed and be subject to all the laws and regulations of each of the states in which they approve/disapprove medications. After all, they seem to be "prescribing without a license!"

Tip of the Week

There have been 19 new SOPs related to cleaning and disinfecting added to the www.CompoundingToday.com website.

Looking Back

When frisky
With whiskey,
Don't drive,
It's risky!
     Burma Shave