Pharmacists work with doctors to assess patients, spot medication errors and even write prescriptions as the face of health care in the USA continues to change

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Pharmacists work with doctors to assess patients, spot medication errors and even write prescriptions as the face of health care in the USA continues to change
Anna Gorman, Kaiser Health News 12:29 p.m. EST February 7, 2014

NORTHRIDGE, Calif. — Jill Freedman felt as if 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,” says Freedman, 55. “You get very emotional when you think you could drop dead at any moment.”

Her doctor doubled one of her medications, she says, but that only made her feel worse. So Freedman turned to the one person she knew she could count on — her pharmacist.

“It was Diana who figured out what the problem was,” says Freedman, referring to her longtime pharmacist, Diana Arouchanova. “Had she not been on top of what I’m going through, God knows how many more weeks this could have potentially gone on.”

Arouchanova, who owns Clinicare Pharmacy, reviewed Freedman’s medications and realized that her problem stemmed from the dangerous combination of two prescriptions. She got the physician to change the medications and started checking Freedman’s blood pressure daily. Soon, it began to drop.

Once limited to filling and dispensing drugs, pharmacists are increasingly providing direct care to patients. Across the country, they work with doctors to give immunizations and help patients safely manage medications. In some places, they can write prescriptions after a physician’s diagnosis.

California is among the states to give pharmacists the greatest flexibility, partly because of a law that took effect this year. Other states, including New Mexico and North Carolina, also allow pharmacists to take on more clinical responsibilities.

It’s all part of a push by druggists and pharmacies to take a greater role in guiding patients and promoting good health. One prominent example is CVS Caremark’s announcement this past week that it will stop selling tobacco products to help customers become healthier — an image shift that the company says will serve it in the long term.

At the same time, health officials are looking for ways to ease the strain on overloaded doctors, improve care and contain costs. With millions of people gaining coverage under the nation’s health law, experts say pharmacists can fill gaps in primary care and help avoid unnecessary hospital admissions.

Read Full Article Here: http://www.usatoday.com/story/news/nation/2014/02/07/pharmacies-healthcare-clinical-medicine-rx/5262645/

FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market

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FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market
January 29, 2014 5:20 PM

A Food and Drug Administration (FDA) decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients (APIs) from the company’s facility in Toansa, India, for use in FDA-regulated drug products. An inspection of the facility on January 11, 2014, identified significant current good manufacturing practice violations, including retesting of raw materials, intermediate drug products, and finished APIs in order to produce acceptable findings after items failed analytical testing and specifications. According to an FDA press release, the facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.

Under the decree, FDA has issued an order prohibiting Ranbaxy from:
◾Distributing drugs manufactured using APIs from Toansa in the United States, including drugs made by Ranbaxy’s Ohm laboratories in New Jersey;
◾Manufacturing APIs at its Toansa facility for FDA-regulated drug products;
◾Exporting APIs from Toansa to the US for any purpose; and
◾Providing APIs from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

If FDA determines that a medically necessary drug is in shortage or at risk of shortage as a result of this action, the agency may modify this order in order to preserve patient access to the drugs manufactured under controls that are sufficient to assure quality, safety, and effectiveness, indicates the press release.

Read Full Article: http://www.nabp.net/news/fda-prohibits-facility-from-producing-and-distributing-drug-ingredients-for-us-market

Ranbaxy’s repeat violation elicits swift FDA action

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Ranbaxy’s repeat violation elicits swift FDA action

During an inspection of Ranbaxy Laboratories’ key active pharmaceutical ingredient plant more than a year ago, plant officials were warned: Lock down access to a standalone computerized system so unauthorized workers couldn’t mess with data. But in an inspection earlier this month, FDA investigators not only found that their directions had been ignored but they also uncovered evidence that what they feared would happen, the deletion of data, had in fact taken place. The response from Washington was swift and severe this time. Last week the FDA banned the API plant from shipping any more products to the U.S.

The API plant in Toansa, India, now joins Ranbaxy formulation plants in Mohali, Dewas and Paonta Sahib in India that are banned from shipping products to the U.S. The FDA made 8 observations during the Jan. 5 through Jan. 11 inspection of Toansa, according to a Form 483 inspection report the FDA posted publicly on Monday. Particularly troubling, the FDA said, was that workers at the plant had been retesting products that failed analytics until they got the results that were needed, overwriting the old results in its database. Proper analysis procedures were not followed, and equipment was not properly calibrated.

In terms of plant condition and sanitation, inspectors noted that a refrigerator where samples were stored was dripping, leaving a pool of water beneath it. They also said cabinets where important documents were stored were broken and didn’t close. In addition, windows in the quality-control analytics lab could not be closed, allowing in flies “Too Numerous To Count.” The FDA is not having the generic drugmaker pull products already on the market and is assessing what the ban will mean in terms of potential drug shortages

Read more: Ranbaxy’s repeat violation elicits swift FDA action – FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/ranbaxys-repeat-violation-elicits-swift-fda-action/2014-01-27#ixzz2rklMLOdE
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NACDS: Medication management is key measurement for exchange health plans

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NACDS: Medication management is key measurement for exchange health plans
January 23, 2014 | By Antoinette Alexander

ARLINGTON, Va. — When selecting an exchange health plan under the Affordable Care Act, consumers should be able to evaluate plans’ success in medication management, among other quality measures, the National Association of Chain Drug Stores stated in comments to the Centers for Medicare and Medicaid Services.

Specifically, NACDS urged CMS to adopt measures related to medication adherence and appropriate medication use as part of its Quality Rating System for Qualified Health Plans, which are offered through health insurance exchanges.

The letter emphasized the importance of strong and consistent quality medication measures across federal and state programs to help drive and improve accountability and transparency. NACDS’ letter also noted the success of medication measures in the Medicare Star Ratings program in driving improved patient outcomes.

Including stronger medication measures will “provide powerful incentives to improve quality of care and patient outcomes, as well as meaningful consumer protections regarding affordable, quality health care and meaningful, reliable and actionable rating information,” NACDS stated in the letter.

NACDS also emphasized that medication measures are closely linked to improved patient outcomes and lower total medical costs. Citing a recent CMS study within the Medicare Part D program, the letter highlights that medication therapy management can lead to improved drug therapy outcomes and significantly reduce catastrophic care and emergency room costs.

NACDS urged the agency to align medication management measures with Medicare as it implements health exchanges. To that end, NACDS noted, “Given the beneficial impact of MTM to the Medicare Part D program, we believe MTM should also become the cornerstone of drug coverage in QHPs.”

“A lack of alignment on medication management standards undermines consumer education efforts and diminishes the ability of individuals to have a consistent understanding of the state and federal quality and performance measures with respect to safe, consistent and appropriate medication use,” NACDS stated in the letter.

In its continuing efforts in support of MTM, NACDS points to a growing body of evidence that improving medication adherence — including use of MTM to help patients take medications as prescribed — helps to enhance patient health and improve health care affordability.

Reports by the Congressional Budget Office and the Centers for Medicare and Medicaid Services, as well as articles in Health Affairs, the Journal of American Pharmacists and the Journal of Managed Care Pharmacy, offer further support that appropriate medication use can improve health while lowering costs.

The increasing focus on MTM also has included action in the executive and legislative branches of government. Earlier this year, CMS published a proposed rule that would improve eligibility criteria for MTM within Medicare, making MTM available to 18 million beneficiaries instead of the current 2.5 million, according to CMS estimates. Bipartisan support continues to grow for the proposed Medication Therapy Management Empowerment Act of 2013 (H.R. 1024 and S. 557). The legislation enjoys the co-sponsorship of 159 members of the U.S. House of Representatives and 30 members of the U.S. Senate — more than 35% of the Congress.

Full Article: http://www.drugstorenews.com/article/nacds-medication-management-key-measurement-exchange-health-plans