Preston Pharmacy News - November 2010
November is American Diabetes Month, a time to recognize the seriousness of diabetes and its complications as well as focus on prevention and control of this disease. There are nearly 24 million adults and children in the U.S. who have diabetes and 57 million Americans with pre-diabetes. Diabetes was the seventh leading cause of death in the U.S. in 2006 and its complications include heart disease and stroke, blindness, kidney disease, and neuropathy. The American Diabetes Association (ADA) estimates that the total national cost of diabetes in the U.S. is $174 billion.1 The ADA has recently introduced a national movement to Stop Diabetes.™ To learn more about how you can get involved, visit www.diabetes.org.
Avandia use Restricted by FDA
In late September the FDA announced that the use of the diabetes medication Avandia (Rosiglitazone) will be restricted due to data that indicate increased cardiovascular (CV) risk. The FDA has required the manufacturer to develop a risk evaluation and mitigation strategy (REMS) in order to ensure that the benefits of this medication outweigh the risks. Under the new restrictions, Avandia will remain available to current users if they appear to be benefiting from it and new patients who are unable to control their glucose on other medications and cannot take Actos (Piogltiazone). Physicians will have to attest to and document the patient’s eligibility and patients will be required to review statements describing the CV risks associated with Avandia and acknowledge their understanding.2
Safety Review of Actos
The FDA has announced that it is reviewing data to evaluate whether Actos (Pioglitazone) is associated with an increased risk of bladder cancer. Actos is a medication used to improve glycemic control in Type 2 diabetics by reducing insulin resistance. Findings suggest this is a topic that needs further review and the FDA has not concluded that Actos increases the risk of bladder cancer. The review is ongoing, and the FDA is recommending that patients continue to take Actos unless told otherwise by their health professional and to speak with their provider if they have concerns about the potential risk.3
Kansas Chosen as Site for Funding
The Centers for Disease Control and Prevention (CDC) announced that Shawnee County was one of five communities in the U.S. chosen to receive funding for sodium reduction efforts. Other recipients included counties in California and New York. The communities are expected to create “healthier food environments and help reduce sodium intake in the population” during the three-year funding period. On average, American adults consume more sodium than the daily recommendations, 77% of which the CDC states comes from processed and restaurant foods. The projects will “support the implementation of at least one major sodium reduction policy as well as evaluation activities.” Examples may include working with restaurants, schools, or hospitals to develop low sodium food policies or media campaigns to raise awareness of the dangers of too much sodium in the diet. Excess sodium can contribute to high blood pressure, a risk factor for stroke, heart attack, coronary heart disease, and heart and kidney failure. Studies suggest limiting sodium intake to 1500mg/day could prevent 16 million cases of high blood pressure and save an estimated $26 billion/year in health care costs.4 For more information on sodium and blood pressure, visit www.cdc.gov/salt or the American Heart Association at www.heart.org.
Great American Smokeout
November 18, 2010 is the Great American Smokeout, a day for smokers to quit smoking or make a plan to quit. According to the American Cancer Society, “half of all smokers who keep smoking will end up dying from a smoking-related illness.” Some of the complications of smoking include cancer (lung, mouth, larynx, esophagus, bladder, kidney, pancreas, cervical, and stomach to name a few); lung disease; heart disease; erectile dysfunction; and increased risk for macular degeneration.5 Benefits of quitting begin within 20 minutes when the heart rate and blood pressure begin to drop and continue up to 15 years after quitting at which time the risk of coronary heart disease is the same as a non-smoker.6 Quitting is not easy, it is important for smokers to know there are resources available to them. For more information, visit the American Cancer Society at www.cancer.org.
Controlled Substance Update
The DEA has announced policy changes that will now recognize nurses who work in long term care facilities (LTCF) as agents of physicians who prescribe certain medications regulated under the Controlled Substances Act. Once an agency relationship is established, a nurse at a LTCF acting as an agent of the prescribing practitioner may communicate to a pharmacy prescription orders for Schedule C-III, CIV, and CV medications.7
New Drugs/Formulations
Krystexxa (Pegloticase) – FDA approved for the treatment of gout in adult patients who do not respond or cannot tolerate conventional therapy. It is administered every 2 weeks as an IV infusion. Of note, 25% of patients in the clinical trials experienced a severe allergic reaction when receiving an infusion. A corticosteroid and antihistamine should be included in the regimen to reduce the risk. A REMS and Medication Guide have been developed to communicate the risk for severe allergic reactions.8,9
Gilenya (Fingolimod) – the first oral drug approved for the treatment of relapsing forms of multiple sclerosis to decrease relapses and delay disability progression. A REMS has been developed to ensure the benefits outweigh the risks of using this medication.10,11
Tekamlo (Aliskiren and Amlodipine) – combination tablet approved for the treatment of hypertension as: initial therapy in patients likely to require multiple meds to achieve blood pressure goal, or patients not adequately controlled with monotherapy, or as a substitute for its titrated components. 12
Tribenzor (Olmesartan, Amlodipine, HCTZ) – once daily combination tablet approved as second-line agent for the management of hypertension. Indicated for patients not adequately controlled on any two of the following drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics.13
Withdrawals/Recalls
Meridia (Sibutramine) – On Oct 8, 2010 the FDA announced the voluntary withdrawal of Meridia from the U.S. market by Abbott Laboratories due to clinical trial data showing an increased risk for stroke and heart attack. Meridia is a drug used for weight loss. Providers are advised to stop prescribing Meridia; patients should stop taking this medication and speak with their health care provider about alternative options.14
Quote of the Month
“A good plan today is better than a perfect plan tomorrow” – General George S. Patton
References for November 2010 Issue
- American Diabetes Association. Diabetes statistics.
Available at: http://www.diabetes.org/. Accessed October 1, 2010.
- American Pharmacists Association. FDA announces ‘significant’ restrictions on Avandia. Available at: http://www.pharmacist.com. Accessed October 1, 2010.
- U.S. Food and Drug Administration. Actos (pioglitazone): ongoing safety review – potential increased
risk of bladder cancer. Available at: http://www.fda.gov. Accessed October 8, 2010.
- CDC awards $1.9 million for state and local sodium reduction initiatives [press release].
Centers for Disease Control and Prevention; October 1, 2010.
- American Cancer Society. Why should I quit? Available at: http://www.cancer.org.
Accessed October 8, 2010.
- American Cancer Society. When smokers quit – what are the benefits over time?
Available at: http://www.cancer.org/. Accessed October 8, 2010.
- American Society of Consultant Pharmacists. DEA announces policy change recognizing long-term
care nurses as agents of the prescriber. Available at: http://www.ascp.com.
Accessed October 15, 2010.
- American Pharmacists Association. FDA approves new gout drug from Savient.
Available at: http://www.pharmacist.com. Accessed October 1, 2010.
- Krystexxa Web Site. Available at: www.krystexxa.com. Accessed October 8, 2010.
- U.S. Food and Drug Administration. FDA approves first oral drug to reduce MS relapses.
Available at: http://www.fda.gov. Accessed October 8, 2010.
- Gilenya Web Site. Available at: www.gilenya.com. Accessed October 8, 2010.
- Tekamlo Web Site. Available at: www.tekamlo.com. Accessed October 15, 2010.
- Tribenzor Web Site. Available at: www.tribenzor.com. Accessed October 15, 2010.
- 14. U.S. Food and Drug Administration. Meridia (sibutramine): market wiethdrawal due to risk
of serious cardiovascular events. Available at: http://www.fda.gov. Accessed October 15, 2010.
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