How H.R. 3204 will affect most pharmacists

President Barack Obama has signed the Drug Quality and Security Act (H.R. 3204) into law. What are the practical implications for most pharmacists of the new compounding and track-and-trace legislation?

The short answer is that the compounding part of the legislation, which became effective upon enactment, will affect very few pharmacists. The track-and-trace part of the legislation will affect all pharmacists to some extent, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.

Of course, the language in the legislation is not the last word. FDA has to decide how to implement it through the regulatory process. Traditional community pharmacies are “probably” not going to be affected by the compounding part of the law “unless we get more stringent regulation from the FDA,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the BakerHostetler law firm in Washington, DC. “While we got by with 3204, we may not necessarily get by with the regulations proposed by FDA.”

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The Great American Smokeout

A statement by HHS Secretary Kathleen Sebelius

Today, as we celebrate the Great American Smokeout, I encourage all smokers to join the millions of others around the country who have committed to living a tobacco-free life. Quitting smoking is one of the most impactful things a person can do to improve health, lower risk for a range of diseases, and increase longevity.

Smoking is still the single largest preventable cause of disease, disability, and premature death in the United States. Each year, more than 440,000 people in the U.S. die from smoking or exposure to secondhand smoke, and more than 8 million Americans are living with a serious illness caused by smoking.

By quitting, smokers can reclaim their health. The benefits begin the day a smoker quits and continue for the rest of his or her life. Over the last several years the Obama administration and the Department of Health and Human Services (HHS) have taken concrete steps to reduce tobacco use. In 2012, the Centers for Disease Control and Prevention (CDC) launched a successful media campaign encouraging people to quit smoking by highlighting the toll that smoking-related illnesses take on smokers and their loved ones. CDC estimates that 1.6 million Americans tried to quit smoking because of the 2012 Tips From Former Smokers campaign, and at a minimum, more than 100,000 Americans quit smoking long-term because of the campaign.

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Proposed Rule Changes to the Pharmacy Practice Act Rule

Over the past year the Utah State Board of Pharmacy has been working on changes to the Pharmacy Practice Act Rule that needed to be updated due to legislative changes during the 2013 Legislative Session. 

The changes are because of the passage of S.B. 14 and S.B. 194 during the 2013 General Legislative Session. S.B. 14 (2013) exempted research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of pharmacy technician. S.B. 194 (2013) amended the following: 1) definition of pharmaceutical wholesaler or distributor; 2) definition of the "practice as a licensed pharmacy technician"; and 3) pharmacy technician licensure qualifications. Both S.B. 14 and S.B. 194 granted authority to the Division to adopt amendments and the rule filing establishes those amendments. Other amendments were proposed at the request of the Utah State Board of Pharmacy.

Guidelines for Dispensing Controlled Substances

 As Pharmacists of the Utah Pharmacists Association we are part of a vital healthcare team and serve as gatekeepers to ensure, with the prescribing practitioner, that a prescription for a controlled substance is issued for a legitimate medical purpose by the individual practitioner acting in the usual course of professional practice.

We have seen various questions, recommendations and guidelines from our members regarding controlled substance. The guidelines below have been provided as a guide and recommedation to UPhA from one of our own members. These guidelines come from a retail pharmacy with stores both in and out of Utah. They may not be the best recommendations for you and your pharmacy. They are intended to provide general advice and should not be considered policy and procedure. We do recommend that UPhA members develop their specific practices and policy & procedures for their business and also always recommend seeking the appropriate legal counsel. Federal and local Utah laws regarding the proper dispensing of controlled substances must always be followed.

Recommendations

Communication Works for Those Who Work at It

“Communication works for those who work at it”-  John Powell

All of us know the importance of communication from experience-the effect of lack of or poor communication, as well as the benefit of good communication. 

The two words 'information' and 'communication' are often used interchangeably, but they signify quite different things.  Information is giving out; communication is getting through. - Sydney J. Harris

That being said….with the News Capsule, the communications team would like to provide information that is both current and beneficial to the UPHA community.  Understanding that good communication involves listening as a key component, we invite you to submit any idea as far as topics of discussion, news that is important to our field of practice and any interesting bit of information that would be beneficial to pass along.  We would like to provide current news on new regulations that are in the works as well as those that are already approved, and share ideas on how they will affect us in our scope of practice.

What is the shortest word in the English language that contains the letters: abcdef? Answer: feedback.  Don't forget that feedback is one of the essential elements of good communication. - Anonymous

Please let us know what works and what needs to be changed.  Your feedback is essential to our success!

Submit your Feedback, Ideas, Request and More Here.

Happy Holidays from Your Executive Team

Happy Holidays! 

As we head into the holiday season, many take the tradition to reflect on the events of the year.  This has indeed been an exciting year for UPhA!  As Paige talked about in the last newsletter, we made the transition to Association Solutions for our day to day management.  In addition, we also changed the way in which the Board of Trustees functions, breaking into “teams” focusing on different aspects such as legislation, education and events, membership, etc.  As I reflect on the year, it has been successful and there great optimism in the air for the continued direction of UPhA.   We successfully staged three CE events, we had a good fall golf outing (once it warmed up) raising monies for our scholarship fund and delivered over 300 pounds of food to the food bank.  As we close out 2013 and begin 2014, we invite all pharmacists in Utah to become a member join in the effort of making this one of the best and strongest pharmacy associations in America! 

Diabetes Surge Hits Every Nation

BRUSSELS, BELGIUM--(Marketwired - Nov. 14, 2013) - One in ten of the world's population will have diabetes by 2035 according to the International Diabetes Federation (IDF). The latest edition IDF Diabetes Atlas, published today on World Diabetes Day, estimates that people living with diabetes will surge from 382 million to 592 million people by 2035, many in low and middle income countries and the majority under 60. This surge will form the backdrop of the World Diabetes Congress (#WDC2013) in Melbourne, Australia this December.

FDA takes action to speed safety information updates on generic drugs

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

 

Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.

 

The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.

 

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

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