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

The skin is a highly complex organ that regulates heat and water loss from the body while preventing the ingress of noxious chemicals or microorganisms. It is about 10% of the body mass and covers about 1.7m² in the average person. It is large and accessible and provides a reasonable site to administer therapeutic agents for both local and systemic effects; it is also highly efficient at "self-repairing" and is designed to "keep the insides in and the outsides out"!

The USP <1151> Glossary defines "Topical" as "a route of administration characterized by application to the outer surface of the body." It does not define "Transdermal" but does define a "Transdermal System." The chapter states that "Ointments are semisolid preparations intended for external application to the skin or mucous membranes. APIs delivered in ointments are intended for local action or for systemic absorption."

Pharmaceutics textbooks and specialized reference books state:

"Topical preparations are used for both local and systemic effects. Systemic drug absorption should always be considered if the patient is pregnant or nursing�"

"Topical applications can be designed for either local effects or systemic absorption."

Also, we read the following:

"The following distinction is an important one with regard to dermatologic applications. A topical dermatological product is designed to deliver drug into the skin in treating dermal disorders, with the skin as the target organ. A transdermal product is designed to deliver drugs through the skin (percutaneous absorption) to the general circulation for system effects, with the skin not being the target organ."

As is evident, there are differences in these two terms with clinical implications. We will continue this discussion next week.

News

NECC: U.S. Seizes $18.3 Million
The U.S. government has seized more than $18 million from bank accounts tied to the owners of NECC, the compounding pharmacy blamed for a deadly meningitis outbreak. The seizures involve accounts connected to Barry J. Cadden, head pharmacist of NECC, Carla Conigliaro, the company's majority shareholder, and her husband, Douglas A. Conigliaro. The trio is included in the list of 14 people who face criminal charges; the three have pleaded not guilty.
http://www.bostonglobe.com/metro/2015/01/07/million-seized-from-necc-owners/uZilN6PThT0NYR1Kig5vAK/story.html

Do Not Administer Wallcur IV Solutions
The FDA has issued an alert not to inject human or animal patients with Wallcur, LLC, IV products, which are for training purposes only. Reports have been received of serious adverse events associated with the use of some of these products, such as Wallcur's Practi IV Solution Bags. The training products may bear the words "for clinical simulation" and should not be administered to patients.
http://www.pharmacytimes.com/product-news/FDA-Warns-Health-Care-Professionals-Not-to-Administer-Wallcur-IV-Solutions

Money to Doctors for Drug Promotion
Beginning in 2014, the federal government mandated that pharmaceutical and medical device manufacturers publicly report their payments to doctors and teaching hospitals. The manufacturers of Pradaxa, Xarelto, and Eliquis have been wooing physicians in part by paying for meals, promotional speeches, consulting gigs, and educational gifts. In the last five months of 2013, the companies spent nearly $19.4 million on doctors and teaching hospitals, according to ProPublica's analysis of federal data released last fall.

According to ProPublica's analysis, Victoza, a diabetes medication made by Novo Nordisk, was the drug associated with the most payments to doctors, by dollar amount. The company spent more than $9 million on physician interactions related to Victoza in the last five months of 2013.
http://www.propublica.org/article/vying-for-market-share-companies-heavily-promote-me-too-drugs

Harvard Faculty Supported the ACA but now Complain About Costs!
Harvard's experts on health economics and policy have provided advice to presidents and Congress for years, including the ACA. Now, those remedies are being applied to the Harvard faculty, and the professors are in an uproar as the changes require them and other Harvard employees to pay more for health care. They recently voted overwhelmingly in November to oppose these changes that would require them to pay more for health care.
http://www.nytimes.com/2015/01/06/us/health-care-fixes-backed-by-harvards-experts-now-roil-its-faculty.html?smid=pl-share&_r=1

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Did You Know ...

�that discussions and surveys vary as to whether print or digital books/magazines/etc. is preferred? Students generally prefer print over digital for texts; practitioners often prefer digital over print for newsletters, notices, announcements; etc. One problem is that it is difficult to search for earlier information on digital websites once it has been deleted or overwritten with current information.

Tip of the Week

If involved in digital distribution of information, consider retaining older information and designate it as older and archive the information for those that need access to it.

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Looking Back

Bachelor's quarters,
Dog on the rug.
Whiskers to blame,
No one to hug!
     Burma Shave