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Monday, July 07, 2014

By Christine Butts, MD

We have been taking a close look at the RADiUS protocol for the past several months, but now it’s time to put all of the pieces of the protocol together in assessing patients. RADiUS — rapid assessment of dyspnea with ultrasound — evaluates the heart, IVC, pleura, and lung parenchyma. It is a useful bedside tool for quickly assessing patients with undifferentiated shortness of breath, an extremely valuable tool for emergency physicians. These patients are challenging and require speedy appraisal and treatment.

A 60-year-old man is brought to the ED by EMS complaining of shortness of breath for a past day. EMS has little history, but carries a bag of the patient’s medications, which includes two inhalers, a diuretic, and an ACE inhibitor. The patient is in some distress, and is only able to speak a word or two at a time. His blood pressure is 180/90 mm Hg, heart rate is 120 bpm, respiratory rate is 40 bpm, and SpO2 is 80%. He is obese, and his breath sounds are diminished throughout but no wheezing is noted. He has questionable edema to his lower extremities, although his size makes this difficult to assess.

Using the RADiUS protocol, we begin by evaluating his heart for overall contractility, pericardial effusion, and evidence of right heart strain. Video 1 shows that his overall left ventricular function is severely decreased. No effusion or right heart strain is noted.

Shifting gears, we examine the IVC for overall size and change with respiration. Video 2 reveals that the IVC is enlarged, and shows very little change with respiration. These findings correlate with an elevated central venous pressure.

Using the high-frequency transducer, the pleura are assessed for sliding to evaluate for a possible pneumothorax. Video 3 shows that the patient has normal lung sliding bilaterally, ruling out a pneumothorax. An M-mode tracing of the patient’s pleura can be seen in Image 1, further confirming a normal pleural interface.


Finally, evaluation of the lung parenchyma shows the presence of diffuse bilateral B-lines (Image 2), consistent with the interstitial syndrome.

Putting all of these findings together gives a likely diagnosis of cardiogenic pulmonary edema, allowing the EP to initiate the correct treatment pathway rapidly. It also enables the EP to rule out other life-threatening causes of dyspnea, such as pericardial effusion.

Dr. Butts is the director of the division of emergency ultrasound and a clinical assistant professor of emergency medicine at Louisiana State University at New Orleans. Follow her @EMNSpeedofSound, and read her past columns at http://bit.ly/ButtsSpeedofSound.


Monday, May 12, 2014

This editorial is a companion piece to EMN’s May Special Report, “EPs a Casualty of Turkish Uprising.

By William T. Durkin Jr., MD, MBA

You notice a person fall to the ground and appear to be in some distress while attending a political rally. You immediately rush to his aid. But as you go toward him, you remember that you need permission from the government before you can provide any assistance. If you proceed without it, you will be subjected to a large fine ($100,000) or imprisoned — or both.

As incredulous as this seems, it is actually the law in Turkey. Enacted in January of this year, the law forbids a physician from administering any sort of first aid without the approval of a bureaucrat. The law has since been amended to state that care could not be given until emergency services arrive. It also bans doctors from practicing outside of state medical institutions, and aims to prevent them from opening private clinics. Signed by President Abdullah Gül, the bill is seen by many as an attempt to criminalize emergency health care and prevent physicians from treating injured protesters.

I couldn’t believe when I first heard this that a country such as Turkey would even consider such heinous legislation. I knew Libya had such restrictions and Bahrain also did for a period of time, but to see this in a democratic, secular government was astonishing. This is a tactic that dissuades political opponents from staging rallies and demonstrations because acute care may not be readily available if someone attending should fall ill or become injured.

Physicians are bound by the Hippocratic Oath and to ignore someone in extremis is inhumane and goes against any sense of decency. Every individual should have unencumbered access to quality emergency care provided by a specialist in emergency medicine. The American Academy of Emergency Medicine, Physicians for Human Rights, the World Medical Association, the German Medical Association, the Committee of European Doctors, and the British Medical Association sent a letter to President Gül asking him to reconsider these provisions that hinder his citizens’ access to emergency medical care. Unfortunately, this law is still in place in Turkey with the predictable decline in political rallies and protests.

Physicians in Turkey are government employees. Their employer has now dictated when, where, and how they may and may not treat patients. The populace is being denied the basic human right of health care by order of the government.

It is very disturbing to see governments of at least three countries enact laws that deny basic emergency care to its citizens, mostly as a means of discouraging political opposition, setting a dangerous precedent. What is to stop an unethical government after an election from denying basic medical care to those who opposed the victors? It is a formal animus to those of us who believe that health care is a basic human right. It suggests a new era, one where governments can leverage their control of health care to manipulate the behavior of its citizenry. Seeing such behavior in a totalitarian regime such as North Korea would be one thing, but it is something else in a modern democratic country — something rougher, darker, more frightening.

It suggests that it might not be such a grand idea for the government to be controlling health care and those who provide it.

It illustrates the need for all members of the medical community to speak up and stand behind the physicians of these lands.

It tells us that it might occur elsewhere.

It tells us it may not be over.

Dr. Durkin is the immediate past president of the American Academy of Emergency Medicine.


Tuesday, April 29, 2014
By James R. Roberts, MD
 
Treatment for sepsis has been continually scrutinized, and remarkable advances have been made ever since the study by Rivers et al. was published more than 12 years ago. That single-center trial reported that patients with severe sepsis and septic shock had lower mortality when a six-hour protocol of early goal-directed therapy (EGDT) was initiated in the ED. (New Engl J Med 2001;345[19]:1368.)
 
The mortality rate in the study was 30.5 percent for EGDT and 46.5 percent for non-protocol therapy, giving rise to a medical gospel that outlined critical actions for the early treatment of sepsis. The original EGDT protocol used a central venous catheter (CVC) and monitored central venous oxygen saturation (ScvO2) and central venous pressure (CVP) to guide intravenous fluids, vasopressors, antibiotics, and packed red blood cells. Certain trigger points required interventions. Fluids were infused, for example, if the CVP was less than 8 mm Hg. Transfusion of packed red cells to targeted hematocrits was mandated if the ScvO2 was less than 70%. Dobutamine or other inotropic agents were initiated if the hematocrit was already 30%.
 
EGDT rapidly became the mantra of sepsis investigators, and every hospital rushed to provide similar interventions to be current. All of the interventions were suggested as being critical because no one was certain which had the most beneficial effects.
 
Much has been learned since the initial publication of EGDT for sepsis and severe septic shock. Most EDs have dramatically improved early detection and have instituted early aggressive sepsis monitoring and therapies. Aggressive timely assessment and therapy were considered lacking before this. It was later determined, however, that dobutamine did not improve microvascular profusion in septic shock, that transfusions to a hematocrit of 30% appeared harmful in some critically ill patients, and that lactate measurements soon became an adequate substitute for invasively obtained parameters. The ProCESS trial, a long overdue multicenter randomized trial, was done to assess the efficacy of the elements of the EGDT protocol.
 
A Randomized Trial of Protocol-Based Care for Early Septic Shock: The ProCESS Investigators
N Engl J Med
March 18, 2014 (PMID: 24635773)
 
The authors note that more than 750,000 cases of severe sepsis and septic shock occur in the United States each year, with most patients receiving their initial care in the ED. The short-term mortality rate is 20 percent or more, but mortality rates declined in 2001 after Rivers et al. reported success when sepsis was treated according to the six-hour early goal-directed therapy protocol. The EGDT concept assumed that the then-standard therapy was lax and failed to intervene with aggressive and timely assessment and treatment. The authors concluded that central monitoring to review oxygen saturation and venous pressure measurements to guide the use of IV fluids, vasopressors, pack cells, and dobutamine were all beneficial. The question addressed in the ProCESS study was whether all of the elements are still necessary.
 
It made sense to assess whether the protocol-driven intervention was superior to standard care, though current garden-variety regimens reflected already-instituted clinical advancements. Particularly of concern were invasive monitoring techniques that are time-consuming and associated with complications when performed in the ED. These authors’ randomized trial, the Protocolized Care for Early Septic Shock (ProCESS), was conducted at 31 U.S. hospitals, and was originated and published by the University of Pittsburgh.
 
Importantly, all of the participating sites were academic EDs with voluminous resources and intense continuing education. The treating clinicians entered and studied patients with criteria for the systemic inflammatory response syndrome and those who had refractory hypotension or a serum lactate 4 mmol per liter or higher. Refractory hypotension was defined as less than 90 mm Hg or requiring vasopressors to maintain blood pressure above that level after an IV fluid challenge of 20 mls/kg or more.
 
Patients were randomly assigned to one of three treatment groups in an equal ratio: a formal protocol-based EGDT, a protocol based on current albeit improved standard therapy, or so-called non-protocol standard care. Patients assigned to the EGDT group had a central venous catheter to monitor CVP pressures and ScvO2 promptly placed, and clinicians initiated the EGDT protocol to determine the amount and timing of IV fluid administration, and they followed the criteria for vasopressors, dobutamine, or packed red cells.
 
The second group, the protocol-based standard study arm, used similar but less aggressive criteria than the formal EGDT. It also utilized adequate peripheral venous access instead of a central line and gauged the administration of fluids and vasoactive agents to reach goals for systemic blood pressure. In contrast to the formal EGDT protocol, red cell transfusions were only given if the hemoglobin was less than 7.5 g/dL. The amount of fluid administered was decided by the team to be enough to replace the loss and provide adequate volume resuscitation.
 
Bedside providers directed all care on their own clinical estimates of needs and requirements for the third usual-care group. The individuals monitoring the care could not suggest various interventions or therapies.
 
The primary outcome of the study was the rate of in-hospital death from any cause in 60 days. Further outcomes included duration of acute cardiovascular failure, the need for vasopressors, acute respiratory failure, acute renal failure, and duration of hospital stay. A total of 1341 patients were enrolled and analyzed over five years. All three groups were well matched at baseline. The leading diagnoses were pneumonia, urinary tract infection, intra-abdominal infection, and skin soft tissue infection. One of the main differences in therapy was the volume of intravenous fluids administered over six hours.
 
During the initial treatment, the protocol-based EGDT group received 2.8 liters, the protocol-based standard therapy group received the greatest fluid load of 3.3 liters, and the usual-care group received the least fluid, 2.3 liters. Crystalloid was the predominant fluid in all groups. Patients in the two protocol groups received vasopressors more often, while the standard group received vasopressors significantly less frequently. Central catheters were eventually placed in about half of the non-EGDT patients. The use of antibiotics, corticosteroids, and activated protein C was similar across all groups. All patients received low-tidal volume ventilation and moderate glycemic control.
 
The number of patients dying in each group was statistically the same, around 20 percent, after 30 days. No difference in 90-day and one-year mortality was seen. No significant differences were seen among any of the groups in length of ICU stay, duration of cardiovascular failure or respiratory failure, or in length of hospital stay. Measuring serial lactates was not inferior to the prior goal-directed ScvO2 monitoring.
 
These authors concluded that this multicenter randomized trial resulted in similar antibiotic use and other resuscitation measures. Patients in the two protocol-driven arms had greater CVP use as well as more intravenous fluids, vasoactive agents, and blood transfusions. Mortality and morbidity rates were good without the use of routine initial intravenous catheterizations or central hemodynamic monitoring. The authors found no benefit of protocol-based resuscitation guidelines over usual bedside care provided according to the treating physician’s clinical judgment for patients identified as being in septic shock in the ED. No specific benefit of routine central venous catheterization could be found.
 
Comment: Just when one has mastered the art of early goal-directed therapy, the actual value of adhering to the exact protocol becomes less obvious. Lactate measurements have largely replaced venous pressure monitoring in the ED, and educating physicians about early use of adequate fluid resuscitation and broad-spectrum antibiotics is probably the most important in providing a better outcome. It’s a relief when a central line and complicated testing are not needed to obtain the same outcome, and it seems that good old physician judgment, albeit newly informed and educated, appears to fit the bill.
 
Keep in mind that all patients were treated in academic medical centers where state-of-the-art care should be extant. The middle group in this study was actually a mild hybrid of EGDT. The bar has been raised regarding so-called standard care, especially for sepsis and septic shock, based largely on the original EGDT. But it is less certain whether all EGDT is feasible or if it has filtered through to smaller community or rural hospital EDs. The usual-care group actually received the smallest volume resuscitations, but all groups in reality received aggressive care compared with 10 years ago. Care was clearly stellar in these academic centers. A total of 97 percent of patients received antibiotics and 76 percent had antimicrobials within six hours of arrival, even before they were randomized.
 
We still have not figured out how to get patients out of the ED rapidly, and transfer of care to the ICU team is still problematic. This is still probably the biggest deficit to be tackled. Patients in septic shock are pounced on and aggressively treated by most ED staffs with broad-spectrum antibiotics and adequate fluids. Even the patient who seems to be stable or the one about to decompensate can be readily prognosticated by an elevated lactate.
 
It is rather interesting that all three treatment methods, though using similar approaches, demonstrated the same survival rate at numerous medical centers. Much of this can be credited to the alacrity of recognition and the aggressive initial care by the ED staff. The so-called usual standard care, not always present at every hospital, performed as well as sophisticated and intense protocols. Early sepsis is still frustrating to identify, predict, diagnose, and treat adequately. Unidentified patients can decompensate in a very short time while the ED staff lollygags around other seemingly more important patients.
 
Eschewing the initial central venous catheter to monitor CVP and oxygen levels is good news to most EPs. CVP monitoring, however, is likely still very important for assessing ongoing fluid resuscitation and need for vasopressors in the ICU. This study goes a long way in resolving the longstanding clinical debates about how to manage sepsis patients best within the first few hours of treatment because good results were reported in academic EDs even when doctors did not follow specific protocols. The fancy initial invasive monitoring techniques add little to the final outcome as long as sepsis is recognized promptly and patients are adequately treated with fluids and antibiotics.
 
Two other sacred cows for treating sepsis seem to have been put out to pasture, though they are not generally ED-related. The first is the routine use of high- or even low-dose steroids. Some intensivists still administer hydrocortisone to patients with a systolic blood pressure less than 90 that persists despite adequate fluid resuscitation and vasopressor administration, but this is still questioned by many. The second previously praised bromide is tight glycemic control in critically ill patients. Both interventions have been found to be ineffective and potentially harmful, but these issues are largely out of the realm of emergency medicine. The once-hallowed ACTH stimulation test may be unreliable in critically ill patients, and the optimal level of cortisol necessary to survive critical illness is unclear. Finally, results have recently demonstrated that etomidate when used as a single dose for intubation in the ED is not harmful, though it may initially suppress the hypopituitary adrenal axis.
 
Dr. Roberts is the chairman of emergency medicine and the director of the division of toxicology at Mercy Catholic Medical Center, and a professor of emergency medicine and toxicology at the Drexel University College of Medicine in Philadelphia. Read the Procedural Pause, a blog by Dr. Roberts and his daughter, Martha Roberts, ACNP, CEN, at http://bit.ly/ProceduralPause, and read his past columns at http://bit.ly/RobertsInFocus.
 
 

Monday, April 21, 2014
Emergency physicians aren’t the highest earners in medicine, but they aren’t the lowest either, and overall most say they are satisfied with their career and income, according to Medscape's annual salary survey.
 
More than 1,400 emergency physicians participated in the 2013 Medscape Compensation Report, about six percent of the 24,075 physicians in 25 specialties who responded.
 
Orthopedists led all specialties in income in 2013, pulling in $413,000 a year, beating emergency physicians by $141,000 and bringing in $239,000 a year more the lowest earning specialty, HIV/infectious disease specialists.
 
Emergency physicians earned $272,000 on average in 2013, falling about halfway through the pack: they ranked 13th in a field of 25 specialties. Emergency physician salaries rose by one percent over 2012, according to the Medscape report, well below the specialty with the biggest increase — 15 percent for rheumatology — but well above the specialty with largest decrease — down eight percent for nephrology.
 
Salaries for emergency physicians were highest in Arkansas, Oklahoma, and Texas ($295,000) and in Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, and Tennessee ($293,000). Coming in third were EPs in Iowa, Kansas, Missouri, Nebraska, North Dakota, and South Dakota ($286,000) followed by those in Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin ($279,000). Emergency medicine salaries in California and Hawaii averaged $274,000 followed by Alaska, Idaho, Montana, Oregon, Washington State, and Wyoming at $265,000. EPs in Arizona, Colorado, Nevada, New Mexico, and Utah followed with an average salary of $261,000. The lowest emergency medicine earners were in Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont at $248,000, and just above them were those in Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, Washington, D.C., and West Virginia at $259,000.
 
Male emergency physicians make more than female EPs, earning $283,000 to $235,000, though female emergency physicians said they feel slightly more satisfied with their income than men: 62 percent vs. 60 percent. Emergency physicians overall are more content with their salaries compared with all physicians, however. Sixty-one percent of emergency physicians said they feel fairly compensated, coming in behind only dermatologists at 64 percent. At the bottom, only 37 percent of plastic surgeons said they were fairly compensated; plastic surgeons make an average of $321,000 a year, 18 percent more than EPs..
 
Thirty-eight percent of emergency physicians said being good at what they do and making good money (18%) were the most rewarding parts of their jobs. Fifteen percent pointed to relationships with patients as most fulfilling, and 13 percent said "making the world a better place" was most rewarding. Three percent said they found nothing rewarding about their profession.
 
Sixty-one percent of emergency clinicians said they would choose medicine again, and 46 percent said they would choose emergency medicine again. Income did not seem to influence whether a physician would choose medicine again, according to the Medscape report. Plastic surgeons, orthopedists, radiologists, and anesthesiologists were the least likely to choose medicine again but were among the top earners.
 
Self-employed emergency physicians earned more on average than employed EPs: $305,000 vs. $248,000. Twenty-three percent of emergency physicians reported to Medscape that they participate in Accountable Care Organizations, and five percent said they will be joining one this year. A majority of EPs — 68 percent — said they regularly or occasionally discuss costs with patients.
 
Sixty-six percent of emergency physicians said they spend 40 hours or less seeing patients each week while 34 percent said they spend more than 40 hours a week seeing patients. Seventy-nine percent of anesthesiologists (average salary: $338,000), in comparison, said they spend more than 40 hours a week seeing patients while only 22 percent of pathologists (average salary: $239,000) and 27 percent of dermatologists (average salary: $308,000) said they spend more than 40 hours a week with patients.
 
More than a third of EPs — 38 percent — said they have between 25 and 75 patient visits per week. Forty-five percent said they have between 76 and 124 visits a week. Fourteen percent said they have more than 125 visits each week. Emergency physicians also spend considerable time on paperwork and administrative tasks each week: 26 percent of employed EPs and 15 percent of self-employed EPs reported spending at least 10 hours per week completing those tasks.
 
Fifty-three percent of emergency physicians were not sure whether they would participate in health insurance exchanges in 2014, the same percentage as that reported by all physicians, the report said. “Only 28 percent were certain that they would participate in the exchanges, and 19 percent were sure that they wouldn't,” according to Medscape. “Reasons cited were lower compensation, higher workload, decline in quality of patient care and access, and reduced ability to make decisions.” More than half said they did not expect their salaries to change under health insurance exchanges while nine percent expected them to increase and 40 percent said they expected them to decrease.
 
Read the full Medscape report at http://bit.ly/EMsalaries.

Wednesday, April 09, 2014
By James R. Roberts, MD
 
The overuse and overprescribing of opioid analgesics is a continuing issue in medicine. Addiction to and morbidity from prescription opioids have skyrocketed, as have deaths and ED visits. Numerous government agencies have attempted to limit prescribing and to close pain centers dedicated only to providing opioids to anyone who walks in the door. These actions have been helpful, but none has solved the burgeoning problem.
 
The FDA recently approved an extended-release hydrocodone called Zohydro ER (Zogenix, Inc.). This is a high-potency analgesic containing only hydrocodone with no acetaminophen. The FDA has also proposed changing the DEA scheduling of regular hydrocodone with acetaminophen from a Schedule III drug to a Schedule II drug. Hydrocodone mixtures used to be Schedule III, meaning they could be obtained with a phone call while a Schedule II drug required a formal prescription. This article provides an overview of this new drug, specifically its advantages and disadvantages, the potential for overdose, and how to treat those who have overdosed in the ED.
 
Extended-Release Hydrocodone: Gift or Curse?
Krashin D, Murinova N, Trescot AM
J Pain Res
2013;6:53
 
This article reviews the current role of hydrocodone and puts the potential advantages and disadvantages of the recently approved long-acting hydrocodone preparation into perspective. The authors note that hydrocodone, a semi-synthetic opioid, has been used for decades as a short-acting analgesic, and it’s combined with acetaminophen or ibuprofen. The advantages of any hydrocodone product is that it is familiar to many physicians, but adding acetaminophen and ibuprofen limits the safe use of high doses of currently available formulations. The obvious potential problem with high-dose hydrocodone is its potential to cause addiction and overdose.
 
Hydrocodone-acetaminophen is currently the most commonly prescribed opioid in the United States, marketed under a variety of names such as Vicodin and Lortab. The short-acting hydrocodone was previously mixed with 325 to 750 mg acetaminophen per tablet. Current products have a dosing schedule of every four to six hours, with the number of tablets per day limited primarily by the acetaminophen dose. The new maximum recommended dose for chronic acetaminophen use is only 3000 mg a day, which corresponds to about four to nine tablets per day of the mixed hydrocodone-acetaminophen products. High-dose acetaminophen can cause liver failure, of course, and the FDA mandated in 2011 that combination products contain no more than 325 mg of acetaminophen per tablet.
 
The DEA had previously classified hydrocodone combined with acetaminophen or ibuprofen as a Schedule III drug, meaning it can be phoned into a pharmacy with up to six refills. Schedule II oxycodone preparations cannot be phoned in and cannot be written for more than a one-month supply, and an appropriate prescription must be presented at the pharmacy to obtain the medication. Rescheduling the current hydrocodone products is currently in the works.
 
The use of opioids by even middle school or high school students has risen in the United States, but hydrocodone has one of the lowest rates of abuse given its volume of prescribing. It is also available in cough medicine, and changing it to a schedule II drug has been opposed by some medical personnel and pharmacies.
 
The most commonly used high-dose, extended-release opioids are morphine (MS-Contin, Purdue Pharma) and oxycodone (Oxycontin-Purdue Pharma). These medications are available in a variety of dosage forms without any acetaminophen, and these analgesics are a godsend to those in chronic pain. Both are frequently diverted, stolen, and highly abused. Long-acting transdermal fentanyl is another example of a sustained-release opioid that must be used by only the most sagacious clinician. (Read Dr. Roberts’ column about fentanyl abuse at http://bit.ly/18XH1bv.)
 
It is common practice among pain specialists to advance patients with chronic pain to daily long-acting opioids supplemented by short-acting opioids for breakthrough pain. Current information is insufficient to draw any firm conclusions about the relative role of long-acting versus short-acting opioid analgesics. It is generally thought that long-acting opioids have a higher incidence of abuse, and they certainly can cause addiction. Many chronic pain patients become addicted through genuine and honest attempts to treat them adequately.
 
The positive side of a long-acting hydrocodone is obvious. This drug has been used for acute and chronic pain for decades. The availability of the long-acting higher dose formulation might provide additional options for patients who cannot tolerate morphine or oxycodone, but that’s an unusual scenario. The lack of acetaminophen in higher dose hydrocodone decreases the risk for liver damage in those who require long-term maintenance.
 
The potential for abuse among morphine, oxycodone, and hydrocodone is similar. The longer acting drugs, such as MS-Contin and Oxycontin, had solid abuse monikers when the abuser crushed and dissolved the tablets to release all the opioid at once, and then they snort or inject the easily made liquid. Long-acting opioids were chemically reformulated in 2010 to resist this type of tampering. One side effect of hydrocodone is a sensorineural hearing loss that has been reported in patients taking high doses of the drug. Hearing loss did not respond well to discontinuing the drug or to corticosteroid therapy, and higher doses of hydrocodone could pose a more significant risk of hearing loss.
 
These authors call for prudence and adherence to best practices in opioid prescribing designed to reap the benefits of these medications without producing harm. Conscientious prescribing likely helps to reduce diversion and misuse. It’s best to prescribe any long-acting opioid only for suitable patients. Emergency physicians should be rarely prescribing them. Appropriate indications and patient instructions will certainly be necessary. The authors suggest a number of parameters that would negate giving long-acting hydrocodone to patients, including an unstable or abusive living situation, inadequate social support, patients with poorly defined pain complaints, and those with limited response to moderate opioid dosages.
 
Comment: Zohydro ER has not met with great enthusiasm by all. In fact, a recent letter submitted to the Department of Health and Human Services seeks to overturn its FDA approval. That approval was granted last October despite an 11-2 vote against it in committee, an unusual outcome. The concern was that introducing long-acting hydrocodone essentially rolls out the welcome mat to a new, more powerful, and more easily abused super drug while policymakers and law enforcement officials are waging war on the growing prescription drug crisis. The abuse-deterrent mechanism that prevents users from crushing, chewing, injecting, or snorting other long-acting opioids is not present in this hydrocodone preparation, and may not be seen for years.
 
The abuse of prescription opioids is not a minor issue. It was reported in 2010 that seven million individuals 12 and older had abused prescription pain medication in the previous month. About eight percent of 12th graders reported in 2011 that they had abused Vicodin the previous year.
 
This new pure hydrocodone medication is classified as schedule II. Zogenix, the company making Zohydro ER, has made the drug available in 10, 15, 20, 30, 40, and 50 mg tablets, which they said are not for PRN use. The cost of 100 of the 10 mg tablets is about $700. The starting dose of hydrocodone ER is 10 mg. That’s equivalent to 10 mg of oxycodone, 10 mg of methadone, 15 mg of morphine, or 100 mg of codeine. The manufacturer provided a full black box warning about addiction and abuse in the safety information, and it also highlights misuse, respiratory depression, accidental exposure, and adverse interaction with alcohol.
 
The approval of Zohydro ER was a surprise to many lawmakers. An FDA advisory panel overwhelmingly voted against the recommendation for approval in December 2012. The FDA is not required to follow the panel’s recommendation, but it usually does. Given the well-known problems with opioid prescriptions, it was thought that the FDA would probably go along with the panel’s decision. Zohydro ER will be available sometime later in 2014.
EPs will likely see overdoses of this new opiate. It should respond to naloxone, but larger doses and repeated reversals will likely be required. Anyone presenting with an overdose of this product will have to be carefully observed for 18-24 hours, and one cannot release a patient who does not have immediate symptoms or seems totally reversed with 1 dose of naloxone.
 
Purdue Pharma, which makes tamper-proof extended-release oxycodone (Oxycontin), has stated that it plans to apply for regulatory approval for a tamper-resistant form of high-dose hydrocodone, a safety feature not found in Zohydro ER. Some U.S. senators have also lobbied the FDA requesting that Zohydro be removed from the market because the medication is not tamper-proof and can have substantial abuse potential when crushed, snorted, or injected.
 
Read this article in its entirety in the May issue of EMN.