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Old 05-16-2019   #875
florida80
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FDA calls out kratom use risks; new AHA/ACC guidelines redefine high blood pressure; community pharmacists enhance care in patient-centered medical home; PTCB names SSgt Mary Johnson CPhT of the Year










































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FDA calls out kratom use risks


FDA issued a public health advisory in November warning consumers about the risks associated with kratom, a botanical substance that is being used to treat a host of conditions ranging from pain and opioid withdrawal to anxiety and depression. The plant-based product has gained popularity in the United States, with some marketers touting it as a safe treatment with broad healing properties.

However, according to FDA, calls to U.S. poison control centers in which kratom was involved increased 10-fold from 2010 to 2015. FDA said it was aware of 36 deaths associated with use of kratom-containing products.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders,” wrote FDA Commissioner Scott Gottlieb in a statement. “But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

FDA has an established process in place for evaluating botanical drug products for which parties seek to make therapeutic claims. In the statement, Gottlieb said the agency is committed to facilitating development of botanical products that can help improve people’s health, but consumers should know that no FDA-approved therapeutic uses of kratom currently exist.






New AHA/ACC guidelines redefine high blood pressure


High blood pressure is now defined as a reading of 130/80 mm Hg, according to the first new comprehensive guidelines in more than a decade from the American Heart Association (AHA) and the American College of Cardiology (ACC).

The new guidelines eliminate the category of prehypertension, which was used for blood pressures between 120–139 mm Hg over 80–89 mm Hg. Patients with those readings now will be categorized as having either elevated blood pressure (120–129/<80 mm Hg) or Stage 1 hypertension (130–139/80–89 mm Hg). Readings of measures at or above 140/90 mm Hg are considered Stage 2 hypertension under the new guidelines.

The guidelines strongly recommend a team-based care approach to treatment and include pharmacists in the discussion.

“There is high-quality evidence demonstrating that team-based care models, particularly with pharmacists and nurses, improve hypertension treatment and control,” said Eric MacLaughlin, PharmD, FASHP, FCCP, BCPS, who coauthored the new guidelines as APhA’s representative member of the Guideline Writing Committee. “With the formal recommendation to use a team-based approach for care of hypertension patients, there would be [an] expanded role and opportunities [for pharmacists].”





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While more Americans will be classified as having high blood pressure under the new guidelines, only a small percentage more may need medication in addition to the lifestyle changes that are emphasized in the recommendations. The guidelines point out that patients with Stage 1 high blood pressure (130–139/80–89 mm Hg) who also have other issues that increase their risk for heart attack and stroke, such as diabetes, should start medication while also making lifestyle changes. These patients are also advised to re-evaluate with a physician monthly until their numbers have improved.

Those with Stage 2 high blood pressure are being advised under the guidelines to start medication—likely two medications—while making healthy lifestyle changes. These patients will then re-evaluate monthly with a physician until their blood pressure is under control.

As for patients with elevated blood pressure (120–129/<80 mm Hg) or Stage 1 high blood pressure (130–139/80–89 mm Hg) who are otherwise healthy, the guidelines say they should make healthy lifestyle changes.

The new guidelines incorporate data from the Systolic Blood Pressure Intervention Trial (SPRINT), a large, randomized, controlled trial designed to assess the impact of more aggressive versus standard blood pressure goals on hard cardiovascular outcomes. In addition, the authors analyzed more than 900 research studies in developing the guidelines, excluding those that did not meet strict research requirements.





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APhA supports the guidelines and is committed to advancing pharmacists’ roles in hypertension management in a coordinated team-based care environment. APhA will be providing education for pharmacists on the new guidelines in various capacities, including at the 2018 APhA Annual Meeting & Exposition in downtown Nashville on March 16–19.
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