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.”

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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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