Sunday, September 22, 2013

IACP Position on the Compounding Clarity Act of 2013


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Washington, D.C. (September 20, 2013) – The International Academy of Compounding Pharmacists (IACP) today acknowledges the introduction in the U.S. House of Representatives of the Compounding Clarity Act of 2013, a bill aimed at addressing problems of the type associated with last year’s deadly outbreak of meningitis linked to the now-closed New England Compounding Center in Framingham, MA. The IACP, a global professional association representing compounding pharmacists and practitioners, continues to work collaboratively with members of Congress and their staff, providing input and expertise on the issues surrounding the practice and regulation of pharmacy compounding.

We believe the House bill makes many key improvements over legislation introduced earlier this year in the U.S. Senate. These improvements include the creation of a compounding advisory committee within the FDA as well as a communication system between the FDA and state boards of pharmacy to ensure that government regulators are working together rather than separately. While we support the general direction of the House bill, we do have several specific concerns that we are committed to resolving so that compounding pharmacists and physicians may continue to provide patients with the customized medications they need in an effective, timely and safe manner.

First, the bill requires that, for compounded medications to be administered in a physician’s office, those administering the medications would be required to gather the names of individuals receiving the medication within seven days. The form and requirements of a prescription have traditionally been left to the legislative authority of the states and not the federal government. While well intended, we believe that this new mandate would create confusion between existing and evolving state policies on the provision of compounded preparations to physicians and other prescribers. IACP believes that individual state authority over, and regulation of, office-use medications must be recognized at the federal level.

Second, the proposed legislation enables the FDA to prohibit the preparation of “demonstrably difficult” compounded medications. We believe that this provision needs to spell out the criteria by which the FDA makes the decision to put compounded medications on its list of these prohibited
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materials, as “demonstrably difficult” is not defined by the new law. Without such specifics, this provision is likely to lead to confusion as well as costly and unnecessary legal challenges. IACP supports clear language that enables the prohibition of compounded preparations based on clear scientific evidence of either safety or efficacy concerns.

IACP believes that these and other concerns about language within the Compounding Clarity Act (H 3089) can be resolved so that the final legislation will appropriately and adequately safeguard the American public while not adversely affecting our profession’s commitment and ability to serve patients.

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About The International Academy of Compounding Pharmacists
The International Academy of Compounding Pharmacists (IACP) is an association representing more than 3,600 pharmacists, technicians, student pharmacists, and members of the pharmacy community who focus on the specialty practice of medication compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose health care needs cannot be met by manufactured medications. 

Friday, September 20, 2013

FDA Finalizes New System to Identify Medical Devices


Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. 
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.  
 
“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
 
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.

Wednesday, September 18, 2013

UPhA: Pharmacist or Pharmacy?


What is in a name? What does it tell you about an individual, team, or organization? The name of a person, place, or thing can indicate much. A name can invoke feelings of curiosity, affirmation, inclusion, and perhaps even trust. A name is often the result of much thought and reflection. One may have to search for the history of why the name was given, but nonetheless, the reasons are there. Think of your own given name. Why was it chosen? What does it mean to you and your family?

A name can be the reference point for many characteristics and attributes. These can be strengths [or weaknesses,] depending on the point of view. The selection of a name should be conducted carefully.

The name of our Association is currently UPhA – Utah Pharmacists Association. What does this imply? Only pharmacists are involved? Realistically, that could be how many in, and outside of our Association, interpret the name. But in fact, our Association is made up of pharmacists, pharmacy technicians, and pharmacy interns pursuing either technician or pharmacist licenses/degrees, and others associated with our field.

The elected Board members of UPhA have discussed and voted on whether or not to change the name.

The board has voted unanimously to change the name to reflect a broader scope of pharmacy. The name the Board has selected is Utah Pharmacy Association. The symbol, or abbreviation, will remain the same: UPhA. There have been sixteen other states that have revised their Association name from ‘pharmacist’ to ‘pharmacy.’
Some of the challenges of changing our Association name could include cost: issues such as changing name on advertisement items, and possible waste of time and resources. We considered that ‘pharmacy’ could possibly appear less personable. There are new actions concerning representation to consider. And some folks, for personal reasons, may just not like the change.

Taking into account the possible ‘cons,’ we the Board feel like the ‘pros’ of revising the name to show that our Association encompasses all members of the pharmacy community in Utah is timely and appropriate. In the ensuing months and years, we feel like this is the right call at the right time. Pharmacists are obviously essential to our Association and cause. But technicians and interns are just as indispensable. We feel like the cohesiveness and unity this name change is motivated by is potentially invaluable. In the pharmacy community, we are a network of caring and concerned individuals, focused on the health and welfare of our patients. In enlarging our circle, we hope to foster a commitment and focus among all our members. In Utah, we hope to be a force for good for the professionals within our Association, and a strength and resource to our community as a whole, down to each and every individual patient. 

President's Message


We have been on a wild ride as we have executed the management change this year.  We wanted to take a moment in our Newscapsule and thank everyone in the Pharmacy Community in the State of Utah for their help and support in this transition.  The support of the pharmacists, technicians and industry representatives has been wonderful.  Change is never easy to experience, but we truly believe that it was the right decision, at the right time for our profession.  Great progress has been made in many areas.  We are more financially sound than we have been in years, we have experienced an increase in involvement from members on our teams, and it has been a great learning experience for all of us involved.   If you have a desire to be involved on one of our teams, please contact us and we will make sure to get you involved.  Our teams have been strengthened greatly by an influx of new support this year.  We have also enjoyed a renewed relationship with USHP and look forward to working directly with them in the future.
We would also like to thank the team at Association Solutions for their guidance and leadership and helping the transition to go more smoothly than we could have ever expected.  It is never perfect timing with 3 large events per year.  They were great to step in and with very short notice, pull off a great event in St. George this year.  We really do have a team of support now working towards our common goals.  We encourage you to reach out and get to know them.  They have a wealth of experience in many areas from finance to legislation.  If you have not yet been able to attend any of our events since February, we invite you to come and join us.  We promise that you will notice a difference.  Their professionalism and desire to help us improve as an organization is stellar. 
We invite your feedback.  As the current President, I would invite you to send your feedback directly to me.  I can be reached via email at paigepatterick@icloud.com or through my cell at 801-664-7613.  Please help us really work to bring the profession of pharmacy to a new level. 


Paige Patterick 

Monday, September 9, 2013

Working with Pharmacies Across America


Pharmacies across America are stepping up to help you understand and get ready for the Health Insurance Marketplace. And I want to say “thank you!”

Families throughout our country look to their pharmacy as a place they can go to for honest, straightforward advice they can trust. 

Today, I was in Hoboken, New Jersey, as Rite Aid announced they would take an active role in outreach and education to help their customers learn more about the Marketplace with a range of resources in their stores and online.  And others, too, have agreed to spread the word. 

Companies such as Thrift White Pharmacy, BI-LO Pharmacy, Winn-Dixie Pharmacy, SoloHealth, StayHealthy, and CVS, are willing to help out because they know that quality affordable health coverage is important.


Friday, September 6, 2013

FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen


Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information.  Today’s Topic: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
Timothy Kim, a pharmacist in the Division, will provide you with additional information about this communication.
Dr. Kim: On August 1, 2013, the FDA issued a Drug Safety Communication informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens- Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal.  Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter products.

Wednesday, September 4, 2013

HIPAA Has New Rule Changes Effective September 23, 2013. Is Your Pharmacy Ready?


There are several changes to the HIPAA Rules that go into effective September 23rd.  Pharmacies need to take action now to avoid repercussions of non-compliance.  All pharmacies should review, revise and/or replace their existing HIPAA Compliance Program.
Who do the Changes Affect?
HIPAA business associates, including a wide range of vendors who contract with pharmacies and access protected health information (PHI). So if you do business with an organization that comes into contact with Personal Health Information from your pharmacy, make sure you have a business associate agreement on file!
What Action is Required? 
So, if your pharmacy cannot locate your HIPAA Manual or Procedures, or if these procedures have never been reviewed or revised, they need to be updated now to be compliant.  

At a minimum: