‘Management’ Tagged Posts

Dsuvia Accepted for Administration of Acute Ache in Healthcare Settings

Da Hee Han, PharmD November 02, 2018 Dsuvia will not be available in retail pharmacies or for outpatient use AcelRx announced that the Food and D...

 

November 02, 2018

Dsuvia will not be available in retail pharmacies or for outpatient use

Dsuvia will not be available in retail pharmacies or for outpatient use

AcelRx announced that the Food and Drug Administration (FDA) has approved Dsuvia (sufentanil) sublingual tablets for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours.

The sublingual formulation of sufentanil offers a new treatment option for patients with nothing by mouth (NPO) status and patients with difficult IV access (eg, obese, burn, elderly, needle-phobic patients) to manage acute pain. The single-unit packaging and single-strength sublingual tablets are intended to mitigate the possibility of dosing errors, misuse, and diversion. “Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research.

Dsuvia was evaluated in a randomized, double-blind, placebo-controlled study (N=161) involving patients with acute postoperative pain after abdominal surgery (studied up to 48hrs). Study patients were randomized to Dsuvia 30mcg or placebo as needed with dosing at least 60mins apart; IV morphine sulfate was available as rescue medication. 

The data showed a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared with placebo. The difference in pain intensity from baseline was superior to that of the placebo group within 15 minutes. Also, a smaller proportion of patients in the Dsuvia group took rescue medication within the first 12 hours of the treatment phase, as compared with the placebo group (22% vs 65%). Regarding safety, the most commonly reported adverse reactions were nausea, headache, vomiting, dizziness, and hypotension. 

In a statement, the FDA’s Commissioner Scott Gottlieb, MD, said, “The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise […] I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”

Dsuvia, a Schedule II substance, will be available as 30mcg strength sublingual tablets in a single-dose, pre-filled applicator for administration by a healthcare professional only in certified medically supervised settings. Distribution is expected in the first quarter of 2019 only to healthcare settings certified in the Dsuvia Risk Evaluation Mitigation Strategy (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use.

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For more information call (650) 216-3500 or visit AcelRx.com.

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AGA: New Opioid-Induced Constipation Administration Tips Obtainable

 

October 18, 2018

The recommendations have been published in the AGA's official journal, Gastroenterology

The recommendations have been published in the AGA’s official journal, Gastroenterology

The American Gastroenterological Association (AGA) has issued new guidelines on the medical management of opioid-induced constipation (OIC). The recommendations have been published in the AGA’s official journal, Gastroenterology.

“These guidelines presume that patients have been appropriately diagnosed and that they have either a prolonged requirement or dependence on opioids,” write the authors. “Therefore, one of the first steps to managing patients with OIC is to ensure that the indication for opioid therapy is appropriate, that patients are participating in a pain management program (ideally in conjunction with a pain specialist), and that they are taking the minimum necessary opioid dose.”

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The recommendations were developed using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, with a strong recommendation indicating that most patients should receive the recommended course of action; a conditional recommendation would mean that different choices may apply depending on the patient, and a clinician may need to spend extra time to work toward a decision.

In the management of OIC, the new guidelines state the following:

  • In patients with OIC, the use of laxatives as first-line agents is recommended (Strong; moderate-quality evidence)
  • In patients with laxative refractory OIC, naldemedine is recommended over no treatment (Strong; high-quality evidence)
  • In patients with laxative refractory OIC, naloxegol is recommended over no treatment (Strong; moderate-quality evidence)
  • In patients with laxative refractory OIC, methylnaltrexone is suggested over no treatment (Conditional; low-quality evidence)
  • The AGA makes no recommendation for the use of lubiprostone in OIC (No recommendation; evidence gap)
  • The AGA makes no recommendation for the use of prucalopride in OIC (No recommendation; evidence gap)

Addressing their recommendations on newer agents (intestinal secretagogues, selective 5-HT agonists), the guideline panel writes that given the lack of published data on long-term use, additional studies are needed to establish the benefits of these drugs.

“Physicians have struggled with treating this condition due to previous lack of clinical guidance,” said Seth D. Crockett, MD, MPH, lead author of the guideline, University of North Carolina School of Medicine, Chapel Hill. “The new AGA guideline clarifies existing data and provides clear direction for physicians on how to best treat opioid-induced constipation.”

For more information visit gastrojournal.org.

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Anavip Now Out there for the Administration of Rattlesnake Envenomation

 
Anavip is an equine-derived antivenin

Anavip is an equine-derived antivenin

Anavip (crotalidae immune F(ab’)2 [equine]) has been made available by Rare Disease Therapeutics for the management of adult and pediatric patients with North American rattlesnake envenomation.

While treatment with antivenom during the acute phase of pit viper envenomation may correct potential coagulation disorders such as hypofibrinogenemia and thrombocytopenia, there have been reports of delayed coagulopathy that could potentially result in hemorrhage or death. Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. Because the treatment has a long half-life, it reduces the likelihood of coagulopathic effects, and eliminates the need for additional doses commonly required with shorter-acting antivenom.

“From our experience as participants in the clinical trials for Anavip, it appears that this new antivenom works very well to reverse the symptoms associated with acute rattlesnake bite, and may have less issues with symptom recurrence than the presently approved antivenom,” said Richard Clark, MD, Director of Medical Toxicology at UCSD Medical Center and Medical Director of the San Diego Division of the California Poison Control System.

Anavip is supplied as a sterile lyophilized preparation in single-use vials. When reconstituted with 10mL of 0.9% NaCl solution, each vial contains not more than 12mg per mL of protein, and will neutralize not less 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay. Treatment should be administered as soon as possible after rattlesnake bite in patients who develop any signs of envenomation.

Peripheral Neuropathy Administration: A Information for Main Care Clinicians

 
Peripheral neuropathy is tied to significant morbidity and decrease in quality of life

Peripheral neuropathy is tied to vital morbidity and reduce in high quality of life

Peripheral neuropathy is a neurologic situation that impacts roughly eight% of adults over the age of 55.1 Though it is likely one of the commonest neurologic issues seen within the major care setting, recognizing and evaluating peripheral neuropathy in a affected person might be difficult on account of its various shows. As a result of peripheral neuropathy is related to vital morbidity and decreased high quality of life, it’s crucial for major care suppliers to effectively prognosis and handle sufferers with suspected neuropathy. In a current evaluation, Doughty and Sadjadi mentioned a standardized method to guage, diagnose, and handle a affected person with suspected neuropathy.

Diagnosing a affected person with peripheral neuropathy usually includes acquiring an intensive affected person historical past, conducting a neurologic examination, and presumably confirming findings with nerve conduction research and/or an electromyography (EMG).1 Use of neuroimaging and electrodiagnostic analysis is debatable for many sufferers with suspected neuropathy, nonetheless, is beneficial for sufferers the place no particular prognosis might be made.

Though assessing signs alone has a poor diagnostic accuracy, it is vital for a supplier to guage each the kind of signs current in addition to the tempo of their development.1Desk 1 lists frequent indicators and signs seen in sufferers with peripheral neuropathy. Usually, sensory indicators and signs current previous to motor and autonomic ones. Though uncommon, autonomic signs stands out as the most distinguished or solely signs a affected person has which point out neuropathy.

A neurologic examination can be an important part within the prognosis of peripheral neuropathy.1Desk 2 summarizes examination findings based mostly on the kind of peripheral neuropathy current. The supplier ought to decide the anatomic areas affected, the diploma of motor and sensory impairment, in addition to the presence or absence of reflexes. The motor examination ought to assess weak point and/or muscle atrophy whereas the sensory examination ought to consider vibration, proprioception, ache, and temperature sensation. Screening instruments which are typically utilized in the course of the examination embrace the Romberg signal to evaluate sensory ataxia, the 10-g Semmes-Weinstein monofilament to guage giant fiber sensory dysfunction, and the 128-Hz tuning fork to guage vibratory sensation. 

Following a longtime prognosis of neuropathy, it is vital for the supplier to find out the underlying etiology of the illness.1 To exclude exterior elements, suppliers ought to start by reviewing the affected person’s medicines, household historical past, and occupational exposures, in addition to think about screening for alcohol abuse. The diagnostic work-up and applicable laboratory assessments range based mostly on the kind of neuropathy a affected person has. For instance, laboratory assessments which are beneficial for a affected person with distal symmetric polyneuropathy embrace hemoglobin A1c and/or oral glucose tolerance check, vitamin B12, methylmalonic acid, serum protein electrophoresis with immunofixation, TSH, and a complete metabolic panel full blood rely. If the preliminary work-up doesn’t yield a particular prognosis, extra testing tailor-made to the precise affected person must be thought-about.

ADA ‘Deeply Involved’ by New ACP Suggestions for Diabetes Administration

 

March 09, 2018

Both groups agree that care should be individualized and that the focus should be on patients

Each teams agree that care ought to be individualized and that the main focus ought to be on sufferers

The American Diabetes Affiliation has responded with ‘deep’ concern to a latest hemoglobin A1C goal steering authored by the American School of Physicians (ACP). 

The ACP steering states that for ‘most’ diabetes sufferers, clinicians ought to goal to attain an HbA1c degree of between 7 to eight%. Of their response, the ADA has referred to as the goal ‘not reflective of the long-term advantages of decrease A1C targets’. Though the ADA agrees with many areas of the ACP steering, there are a number of important areas that differentiate from the ADA’s 2018 Requirements of Care. 

Based mostly on worldwide scientific trials (ACCORD, ADVANCE, VADT and UKPDS), the ADA recommends an affordable A1C aim for adults with kind 2 diabetes of ≤7%. The ACP steering doesn’t think about the long-term advantages of decrease A1C targets, which may cut back diabetes problems, says the ADA. Opposite to this, the ACP steering states that for sufferers who obtain HbA1c ranges of ≤6.5%, clinicians ought to think about deintensifying pharmacologic remedy. 

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In sufferers of superior age, each organizations usually agree on end-of-life suggestions, nevertheless the ADA disagrees with the ACP advice that HbA1c targets ought to be prevented in sufferers with a life expectancy of ≤10 years (≥80 years previous), residence in nursing properties, or in these with continual circumstances. The ADA states that every case ought to be thought of individually as, ‘an individual dwelling in a nursing house or with a continual situation could but have some years to stay, and would seemingly choose to stay them with out diabetes problems.’

“By lumping ‘most’ folks with kind 2 diabetes right into a 7 to eight p.c goal vary, ACP’s new steering might trigger elevated complication charges for many who could safely profit from decrease evidence-based targets,” mentioned ADA’s Chief Scientific Officer, William T. Cefalu, MD.

Along with the ADA, the American Affiliation of Scientific Endocrinologists (AACE), the American Affiliation of Diabetes Educators (AADE), and the Endocrine Society have all launched statements ‘strongly’ disagreeing with the ACP steering.

For extra info go to Diabetes.org.

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