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Last week the FDA approved Sublocade, a once monthly injection of extended release buprenorphine, for the treatment of moderate and severe opioid abuse disorder in adults. The injection can only be administered by a healthcare provider and the patient must also enroll in a treatment program that includes counseling and psychosocial support. Sublocade (buprenorphine) works by binding and occupying opioid receptors in the brain and preventing true opioids (heroin/painkillers/etc) from binding and having effect for 30 days. The net result is that with the opioid receptors occupied, drug abusers begin to stop liking and wanting opioids, allowing them to break the cycle of addiction with the combined counseling and therapy. It is estimated by the CDC that from 2000-2015 more than 500,000 people have died from drug overdose, and in 2017 an average of 91 Americans die from an opioid overdose daily. Sublocade is set to become available in early 2018.
For more information please visit MedScape.
Do you have any patients, family, or friends struggling with opioid addiction who could benefit from treatment with Sublocade? What plans need to be put into place for the dispensing and administration of Sublocade at the retail level?
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There is currently no drug treatment for sleep apnea, a sleep breathing disorder. If untreated there is an increased risk of heart disease, diabetes, sleepiness, cognitive impairment and motor vehicle accidents. Researchers at Northwestern Medicine and the University of Illinois at Chicago studied the effect of dronabinol, a synthetic version of Delta-9 THC which is found in cannabis. Dronabinol targets the brain and nerves that regulate the upper airway muscles rather than the physical problem of collapsing airways. The 6-week study included 73 adult patients with moderate to severe sleep apnea, finding that the higher dose of dronabinol (10mg) was associated with a lower frequency of apneas or hyponeas (overly shallow breathing) during sleep, decreased subjective sleepiness, and had a greater overall treatment satisfaction compared to placebo. The severity of the disorder was reduced 33% compared to complete compliance with the CPAP device, which targets the physical problem. Larger scale clinical trials are needed to figure out best approach to cannabinoid therapy in obstructive sleep apnea, but this study shows promise of a potential new therapy for sleep apnea.
For more information visit ScienceDaily.
Do you or someone you know have sleep apnea? Have you ever counseled patients using a CPAP device? What are your thoughts on these findings?
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A new collaborative study from Stanford Burnham Prebys Medical Discovery Institute (SBP) and UC San Diego School of Medicine has found that Chloroquine, a medication used in the prevention and treatment of malaria, may also be effective for the Zika virus. Chloroquine has been around for a long time, is relatively inexpensive, and most importantly is safe to use during pregnancy. The researchers utilized pregnant mice, who were infected with the Zika virus, and found that Chloroquine reduced the amount of virus in the maternal blood and in the fetal brain cells. Even though the virus was not completely cleared, the drug reduced the viral load, suggesting it could limit the neurological damage in newborns who are infected by the virus. Additional studies are needed to determine Chlororquine’s effectiveness against the Zika virus in humans, but this is a step in the direction towards finding a possible cure.
For more information visit ScienceDaily.
Do you know which areas are high risk of Zika virus? Have you traveled to an area with a high risk of Zika virus? Do you know where to find more information about Zika virus?
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Preliminary results from a safety clinical trial showed an increased risk of heart-related death with Febuxostat (Uloric) compared to another medication used for gout called Allopurinol. Clinical trials conducted prior to the drug approval showed a higher rate of heart-related problems including heart attack, stroke, and heart-related deaths in patients treated with Febuxostat compared to Allopurinol. As a result, the FDA required the drug manufacturer, Takeda Pharmaceuticals, to conduct an additional safety clinical trial in 2009 after the drug was approved. This trial was recently finished, showing an increased risk of heart-related deaths and death from all causes. Once the final results from the manufacturer are received, the FDA will conduct a review and update the public with any new information.
For more information visit FDA.gov.
Do you know anyone taking Febuxostat (Uloric)? Why do you think the drug was approved even though it showed a higher rate of heart related problems? As a healthcare professional, do you know how and where to report adverse effects related to medications your patients are taking?
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The Massachusetts State Senate, by a vote of 27-0, has approved a bill that will ensure access to no-copay birth control once signed by Governor Baker. The bill will cover pills, devices, emergency contraception, and female sterilization procedures without co-pay. The new bill expands upon the current Affordable Care Act by forcing insurance companies to allow women to fill a 12 month supply of birth control once they have completed a 3 month trial period. The bill was created in response to an executive order in October that would allow employers to claim religious or moral objections and deny birth control coverage, and is expected to cost the healthcare system nearly $2-6 million annually. The no-cost birth control measures provided in this bill will not apply to the self-insured market.
For more information please visit the Boston Globe, and Bill H4009.
Do you agree that all forms of FDA approved female birth control should be available cost-free to patients? Do you think that filling a 12-month supply of birth control at one time will be beneficial for patients?
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The American Heart Association (AHA) and the American College of Cardiology released new guidelines redefining high blood pressure as a reading of 130/80mmHg. The new guidelines eliminated the category pre-hypertension (120-139/80-89mmHg). Now categorizing those patients with either elevated blood pressure (120-129/<80mmHg) or Stage 1 hypertension (130-139/80-89mmHg). The guidelines incorporate data from the SPRINT trial, which demonstrated a 25% lower relative risk of a major cardiovascular event (myocardial infarction, stroke, heart failure, or death attributable to cardiovascular disease), 43% lower risk of death from cardiovascular causes, and 27% lower risk of death from any cause with a lower blood pressure goal of <120/80mmHg. The new blood pressure goal for all adults, including those older than 65, is <130/80mmHg.
For more information visit The American Heart Association
According to the new guidelines do you have high blood pressure? Do you think this new blood pressure goal is too aggressive?
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Emergency department physicians provide a comparatively small portion of opioid prescriptions dispensed in the US, but this is where most patients receive their first opioid therapy. Many acute pain patients, that are not expected to have recurrent chronic pain wind up continuing opioid therapy longer than expected. A clinical trial of 416 patients with acute extremity pain compared acetaminophen plus an opioid (5mg oxycodone, 5mg hydrocodone or 30mg codeine) versus acetaminophen plus ibuprofen 400mg. The one-time administration of acetaminophen with ibuprofen produced a similar acute pain reduction to an opioid combination when measured 2 hours after administration. The combination of ibuprofen and acetaminophen with different mechanisms of action provides additive analgesic effects while reducing the short-term risk for adverse effects (sedation, constipation, dry mouth). More studies are needed, but this is a step in the right direction toward reducing the number of opioids prescribed.
For more information visit JAMA.
What percent of your patients pick up opioid prescriptions for acute pain daily? How long does it take to become addicted to an opioid? Do you know where to find more information on opioid addiction?
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First price elevations now malfunctions on the device? On Tuesday, Pfizer was given a warning letter from the F.D.A. stating that the agency within Pfizer, Meridian Medical Technologies, did not properly look into problems with the mechanism on the device that ensures firing and delivering of the dose. The company received numerous complaints about the issues including incidents where patients died or became severely ill when the device failed to work. Only after multiple discussions with the F.D.A. did Pfizer and Mylan recall 13 lots of the product earlier this year.
Questions: Do you think pharmaceutical companies should be reprimanded by the F.D.A. for delayed recalls on malfunctions? What are ways in which consumers could be alerted faster about malfunctions?
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Leukemia is a cancer where not every patient responds with current drug therapy. Today, the FDA approved the new therapy, Kymriah, by Norvartis to target those who do not respond to current therapy. Kymriah works by sending T cells from the patient to a lab to modify it to have a new gene which will target and kill leukemia cells and then infusing them back into the patient to treat their leukemia. While no exact price is set for the new treatment there are speculations about the anticipated high cost for the treatment.
For additional information, please see The Washington Post.
Questions: Do you think the high price will keep patients from possible new lifesaving treatment? Will this new treatment method be helpful in other disease states?