UPhA President's Message December 2015

I hope everyone has a very Merry Christmas and a prosperous New Year.  This is a great time of the year to celebrate with family, friends and co-workers. Thank you for the opportunity to serve this last year as the President of UPhA.    It has been a pleasure to get to know many of you at the conventions and at our board meetings.  I want to thank Adam Jones, our executive director, and all of the staff at Association Solutions for the hard work and professionalism they have brought to UPhA. 

The UPhA board, along with our lobbyist Wayne Jones, is working hard to represent your voice on Capitol Hill.  There are several bills coming up in the next session that we are following closely, including a medical marijuana bill being sponsored by Senator Vickers.  Check the UPhA website for updates and details on these bills.  I encourage you to get involved, get to know your state representatives, and let them know how you feel about the issues that affect you and your livelihood.  Pharmacy Day on Capitol Hill will be on Thursday, February 25, 2016.  Put the date on your calendar and plan to attend, even if you can only stay for an hour.  There is power in numbers and we need to demonstrate the importance of our profession to our legislators. 

Our annual convention in St. George is scheduled for April 14^th through the 16^th.  Please come and enjoy great education, entertainment, and networking with your friends and colleagues.

Thanks again for your support.  As we work together, we can make a difference in this great profession.

Mike Chamberlain

Revised Dispenser Compliance Policy - Extended to March 1, 2016

The Drug Supply Chain Security Act (DSCSA) required dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. 

 

FDA has issued a guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised), announcing that it is extending a previously issued Compliance Policy from November 1, 2015 to March 1, 2016 because some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time.  

 

FDA previously published a Compliance Policy on July 6, 2015. It stated FDA did not intend to take action until November 1, 2015, against dispensers that accepted ownership of product without receiving the product tracing information or who did not capture and maintain the product tracing information as required by the law. 

 

Please check http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm for the latest activities on the DSCSA.

Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone

AUDIENCE: Pain Management, Anesthesiology

ISSUE: FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use. 

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

BACKGROUND: To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

RECOMMENDATION: Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, includng a link to the FDA Drug Safety Communications, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm

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Pharmacists Increasingly Take On Clinical Roles

By Anna Gorman

KHN Staff Writer

Feb 11, 2014

NORTHRIDGE, Calif. -- Jill Freedman felt like her heart was jumping out of her chest. She knew her blood pressure was too high and feared having a heart attack or a stroke.
"I was freaking out," said Freedman, 55. "You get very emotional when you think you could drop dead at any moment."
Her doctor doubled one of her medications, she said, but that only made her feel worse. So Freedman turned to the one person she knew she could count on -- her pharmacist.
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American Heart Month

Heart disease is responsible for 1 of every 4 deaths in the United States, making it the leading cause of death in our nation. As we observe American Heart Month, there are some key steps you and your loved ones can take to protect against heart disease.

By maintaining a healthy diet, getting regular exercise and not smoking, you can dramatically reduce the risk of premature death or disability due to heart disease. Awareness of risk factors is also critical to preventing heart disease. Far too many people who are at high risk for heart disease don’t know it. That is why it is so important to get your blood pressure and cholesterol checked regularly and to speak with your doctor about your health history.

When a Small Reminder Makes a Big Difference

Have you ever had one of those little warning icons light up on your car’s dash and you don’t know what it means?  You know that some signals require attention right away and others can wait.  The thing is, most of the time you have to look up the icon to make that decision.

When it comes to medicines and people’s lives, there is no substitute for being clear about a warning, and for injectable drugs the stakes are particularly high.  Beginning December 1st, manufacturers of injectable drugs will have to comply with new labeling standards that help ensure that important warnings — warnings that can help prevent life-threatening situations — are obvious and clear.  The standards were established by the U.S. Pharmacopeial Convention (USP).  USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

In short, this USP standard states that warning messages – for example, “Warning – Paralyzing Agent” or “Dilute Before Using” – are the only markings that should appear on ferrules and cap overseals of injectable drugs.  The ferrules and cap overseals must remain clear of any markings, including logos, except for markings intended to prevent an imminent life-threatening situation.  The standard goes on to say that warnings must be printed in contrasting color and clearly visible under ordinary conditions of use.  Finally, products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent.

With the new USP labeling standard, if a healthcare provider sees a warning on a ferrule or cap overseal, he or she will know immediately that it is a vital, possibly life-saving piece of information that must be observed and acted upon before administering the drug to the patient.

Warning messages on ferrules and cap overseals may go a very long way to helping practitioners protect their patients from harm.

The Legislative Session to Begin January 27th

The holidays are over and the New Year is fresh out of the gates.  With it comes change:  large and small, internal and external, desired and endured.  This is also the time of the year that the lawmakers of the state prepare to make changes – often changes that directly affect us in the way we practice pharmacy.  As the legislative session convenes, we need to be prepared to weigh in on those bills that relate to how we do business – for good or for ill.

Many people don’t get involved because they don’t know how.  They are afraid of doing the wrong thing or making things worse.  Others feel that they are just one voice – what good can they do?  That is the point of being part of a professional association.  If one representative gets one e-mail from one constituent, it will have a small effect.  If dozens get e-mails from dozens of constituents, it will have a larger effect.  In that spirit, here are some tips for contacting those who represent you.

2014 to Offer Continued Success for UPhA

What a wonderful year it has been for the Utah Pharmacy Association.  We are excited as we enter the New Year and look forward to the new opportunities that the New Year will bring to the profession of pharmacy. 

On the National pharmacy front we continue to see much discussion about provider status and how we as pharmacists can and should play a larger role in the direct care of our patients…and get paid for that care.  The American Pharmacists Association and other National pharmacy associations are deeply committed to helping pharmacists receive provider status.  There is much discussion as to how that would and could change our roles as pharmacists. 

As professionals, we need to be aware of these ideas and goals on a national basis, but more importantly, we need to be involved locally.  We are only days away from our 2014 Utah Legislative Session.  We are aware of a few items that have already been introduced that will affect our profession.  We cannot continue to sit idle on the side lines and expect that someone else will take care of our needs.  Now is the time to be involved.  Your first step should be to offer your services and knowledge to your State Senator and Representative.  They should know you and know that you can be a resource for them if they have pharmacy or health care related questions.

HHS announces Affordable Care Act mental health services funding

$50 million from the health care law will expand mental health and substance use disorder services in approximately 200 Community Health Centers nationwide

The U.S. Department of Health and Human Services (HHS) today announced that it plans to issue a $50 million funding opportunity announcement to help Community Health Centers establish or expand behavioral health services for people living with mental illness, and drug and alcohol problems.  Community Health Centers will be able to use these new funds, made available through the Affordable Care Act, for efforts such as hiring new mental health and substance use disorder professionals, adding mental health and substance use disorder services, and employing team-based models of care. 

“Most behavioral health conditions are treatable, yet too many Americans are not able to get needed treatment,” said Health Resources and Services Administration (HRSA) Administrator Mary K. Wakefield, Ph.D., R.N.  “These new Affordable Care Act funds will expand the capacity of our network of community health centers to respond to the mental health needs in their communities.”

Read More 

Pharmacists Report Soaring Generic Drug Purchasing Prices

Alexandria, Va. Dec. 9, 2013 - Pharmacy acquisition costs for scores of generic drugs have spiked by as much as 600%, 1,000% or more in 2013, a problem that is harming patient care and pharmacists, according to a survey of more than 1,000 community pharmacists conducted by the National Community Pharmacists Association (NCPA).

"Once generic drugs become available, lower costs typically follow and community pharmacists are leading the way to maximize the savings for patients and health plans from the proper use of generics," said B. Douglas Hoey, RPh, MBA. "However, pharmacy acquisition costs for more and more generic drugs are rising in rapid, breathtaking fashion. This is having a negative impact on a number of patients, particularly Medicare beneficiaries. Meanwhile, reimbursement from pharmacy benefit managers (PBMs) is not keeping up, leaving pharmacists out in the cold and putting patient access to pharmacist care on unsustainable footing."

Secretary Sebelius announces new HHS regional director

HHS Secretary Kathleen Sebelius announced today that Kim Gillan will be appointed Region VIII Director of the U.S. Department of Health and Human Services.

"I am excited to welcome Kim Gillan to the team at HHS,” said Secretary Sebelius. “Kim is a long-time public servant, who brings with her a wealth of experience from her time in both the Montana House of Representatives and the Montana Senate, as well as at Montana State University.  She has been actively engaged on a number of health related policy initiatives and has worked at the regional level to improve the health and well-being of all Montanans.  Kim will join our team of regional directors who work tirelessly with state, local and tribal officials and external stakeholders on a wide range of health and social service issues, particularly as we continue to implement the Affordable Care Act. We look forward to adding Kim’s many strengths to the HHS team.”

Fight the Fakes - Fake Medicines Put Patients and the Public at Risk

Counterfeit and substandard medicines have reached global health crisis proportions, and present a real danger to all of us.  In a concerted effort to help protect people from fake medicines, the United States Pharmacopeial Convention (USP) is joining other global health organizations, including two USP Member organizations (International Council of Nurses and International Federation of Pharmaceutical Manufacturers and Associations), in a campaign to raise awareness and mobilize strategic partners to address this growing problem. 

New Resource from CDC on Pharmacists in Team Based Care

The Center for Disease Control and Prevention (CDC) recently released a set of tools to inform health care providers, decision-makers, insurers, and pharmacists about the role of pharmacists in team based care. These documents, called translational tools because they translate the research about pharmacists’ patient care services into a guide for policy change, include strategies and case examples of how pharmacists and other health care providers can better serve patients through collaborative practice agreements and collaborative drug therapy management. The translational tools were developed with content from the APhA Foundation’s consortium on collaborative practice agreements and pharmacists’ patient care services held in January of 2012. More information about these resources can be found in the APhA Foundation’s press release and on the CDC’s website.

FDA Releases Compounding Guidances

Agency moving quickly, aggressively to implement DQSA

FDA yesterday issued three guidances in draft form that implement the newly signed Drug Quality and Safety Act (DQSA). FDA is taking an aggressive stance in regulating the industry and traditional pharmacies, including a surprising reliance on USP Chapters <795> and <797> in the pharmacy compounding guidance that has potentially far-reaching impact on practice.

“The pharmacy compounding guidance revokes the 1998 and 2002 current good manufacturing practices (cGMPs) from FDA that regulated traditional pharmacy compounding and replaces them with this document,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the Baker-Hostetler law firm in Washington, DC, in describing the impact of these regulations if they are adopted unchanged. “By doing so, FDA has provided 10 conditions that must be met before a compounded drug meets the exemption under Section 503A [of the Federal Food, Drug, and Cosmetic Act]. One condition references both USP chapter <795> and USP chapter <797>. These are the chapters for both nonsterile and sterile pharmacy compounding. In other words, all compounding—including mixing powder antibiotics with water—must be done under USP standards.”

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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.