Out of the Gates 
  E-Newsletter from Gates Healthcare Associates
January 2014
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Happy New Year! We are ushering in 2014 with another edition of our Out of the Gates newsletter.
 
I'll be the first to admit that it takes me some time to adapt to new technology. A smartphone can outsmart you, given all of its bells, whistles and widgets. But it's even more difficult to function successfully without such a gadget these days.

So that's why one of my New Year's resolutions is to embrace technology, because the evolution of our healthcare system -- along with the people and businesses that function within it -- depends upon digital advances. Through these developments, we are becoming more intricately connected, and we are finding new levels of interaction, analysis and treatment.

May your own resolutions meet with success in the year ahead.        

Sincerely,
Ernest P. Gates Jr., R.Ph, FASCP, FIACP, FACA
What We Learned at ASHP Meeting

Ken Latta and Ken Speidel, Senior Associates at Gates Healthcare, were among the 20,000 who attended the American Society of Health-System Pharmacists Midyear Clinical Meeting last month in Orlando, Fla.

 

The ASHP setting allowed Latta and Speidel to meet with several current Gates clients as well as connect with select vendors featuring innovative equipment and products to better serve their clients.

KEN SPEIDEL

 

"Drug shortages, which is always a topic of discussion at ASHP, seemed to have an additional sense of urgency," Speidel said. "And more so than in other years, there was significant interest in compounding pharmacy practices and regulations. What became clear is that hospitals are taking the changes very seriously but many hospital pharmacies have facilities and practices that will be challenging to change."

 

KEN LATTA

Latta noted that many attendees were particularly interested in a session on compounding with hazardous chemicals, which is the focus of the new USP Chapter 800 set to be executed this year, as well as new regulations on the way in California, Maryland and North Carolina. The session covered facility design, personal protective equipment, environmental monitoring and cleaning, and personnel training.

 

The ASHP vendor meetings unveiled interesting new technologies in environmental monitoring for compounding facilities and equipment. "It was clear that the monitoring of particulates, microbes, humidity, and temperatures in facilities, refrigerators and freezers, as well as shipped packages, now have improved options," said Latta, adding that new designs and innovations in Automated Compounding Devices, preparation validation (weight, visual and assay), and automated packaging were of significant interest. 
Did You Know?

In order to lawfully compound a controlled substance for "office use," a traditional compounding pharmacy must register with the Drug Enforcement Administration as a manufacturer.

 

DEA regulations allow for compounding of a controlled substance, but the medication must be dispensed to the end user pursuant to a valid prescription. Selling a compounded medication to another practitioner for office use does not meet these requirements.

 

For questions on this issue, please contact one of our consultants

  

-- Bill Mixon, R.Ph, MS, FIACP, Senior Associate  

 

Gates Re-elected to IACP Board
Ernest P. Gates has been re-elected to the 2014 Board of Directors of the International Academy of Compounding Pharmacists, as a representative for District II that includes Massachusetts.

"I believe strongly in IACP's mission of protecting, promoting and advancing compounding pharmacy," Gates stated. "I understand the challenges facing today's compounder and I am proud to offer my expertise and experience to IACP and its dedicated members."

Gates Healthcare Associates is a pharmaceutical and healthcare consulting firm that provides extensive clinical, programmatic, and regulatory knowledge and insight to an array of organizations nationally and abroad. We help our clients confront and overcome challenges and obstacles to growth, positioning them for long term business success.

 

 

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