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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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.

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