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Thursday, August 21, 2014

By James R. Roberts, MD

 

It’s certainly no secret that opioid abuse and its associated morbidity and mortality has markedly increased in the United States over the past 10 years. No ED clinician can work a shift without seeing some opioid-related problem, be it an overdose, withdrawal, or a less-than-clandestine attempt by a drug aficionado to obtain more opioids by prescription.

 

Emergency physicians often get into arguments with patients, and then complaints are registered with the hospital’s PR department and state organizations by the savvy and demanding ones. The frustration of emergency physicians is palpable. Our hospital alone had three visits over the past two years from the State of Pennsylvania, which is charged with investigating all complaints. All three involved the delay of opioid use in the ED or failure to prescribe opioids in sufficient amounts or at all to demanding patients. Patients know their rights, and frequently use multiple resources to further their drug use. Clinicians should consider two opposing, rather inexplicable, mandates: the well-publicized underuse of opioids for pain control versus the gargantuan issue of opioid abuse.

 

Emergency clinicians are a minor contributor to the opioid epidemic in this country. Physicians’ offices and pain clinics dispense huge doses of opioids to multiple patients, often without a physical examination or verification of a problem, but even these have come under scrutiny by the DEA. Following the crackdown on prescription opioids, opioid abusers have turned to street heroin, which is easier to get and cheaper than oxycodone (OxyContin). Overdoses from heroin have skyrocketed, and to make matters worse, heroin additives or substitutes, such as fentanyl, make an injection even more lethal.

 

My July column discussed the intranasal use of naloxone by EMS, and noted that it generally works well and is often a fine substitute for IM or IV opioid reversal. (http://bit.ly/1mEXEOK.) This month’s column discusses an outreach program where naloxone has sporadically been and will increasingly be supplied to non-medical personnel, including police officers and family members, but also to individuals addicted to drugs. Such a concept is not without its critics, similar to the opposition in providing condoms to school students and offering clean needles to patients at risk for contracting AIDS.

 

Community-Based Opioid Overdose Prevention Program Providing Naloxone — United States, 2010

MMWR

2012;61(6):101

 

This article by Morbidity and Mortality Weekly Report has noted that a number of programs since the mid-1990s have been providing the opioid antagonist naloxone to non-medical personnel. The Harm Reduction Coalition, a national advocacy program, surveyed sites in 2010 known to distribute naloxone to people who use drugs or to those who might be present at an opioid overdose. The authors note that about a third of all heroin users experience an unintentional drug overdose at some point during their addiction.

 

Community programs began combatting this problem by offering naloxone and other opioid overdose services to persons who use drugs, their family and friends, substance abuse programs, and homeless shelters. A total of 188 local opioid OD prevention programs distributed naloxone in 15 states in 2010, but their activity has remained largely under the public and physician radar. Most do not even know of this initiative.

 

MMWR identified 50 programs that provided such services since 1996. Survey results revealed that more than 50,000 persons, all non-medical, had obtained naloxone for out-of-hospital use. These programs reported about 10,000 overdose reversals using naloxone. The authors conclude that the distribution of naloxone and training non-medical personnel how to administer it may well have prevented numerous deaths from opioid overdose.

 

Recognizing the potential value of providing naloxone to a layperson, many states have recently passed laws and changed regulations to provide limited liability for prescribers who work in programs that provide naloxone to drug addicts. Most of the programs reported problems obtaining naloxone because of the cost and supply chain. These programs have provided naloxone for injection in multi- and single-dose vials. The concentration is the standard 0.4 mg/ml. Some of the vials have been adapted for intranasal injection using an atomization device that delivers 2 mg of naloxone through the nose via a spray. An increasingly common route of administration by EMS and naloxone distribution programs is the intranasal spray, utilizing 1 mg sprayed in each nostril. The response is generally quite good, within eight to 12 minutes, and the duration of action can be up to two hours.

 

Comment: Most clinicians have no idea this concept exists or of the entities that prescribe naloxone to drug addicts. Heroin use has shifted from an inner-city, low-income, minority-centered urban problem over the past 20 years to one that has widespread distribution, involving primarily affluent white men and women in their late 20s who live outside urban areas. Part of the problem has been the increase in prescription-related oxycodone use, and making opioids available by inhalation and IV injection. The idea behind providing naloxone to addicts is that drug addiction cannot be cured, society pays a great price for it, and the problem is largely unsolvable.

 

Recently, police have been supplied with nasal naloxone, and use of this antidote by the lay public has also escalated. A single-use auto-injector (Evzio) was approved by the FDA in April via a fast-track effort, and it delivers 0.4 mg of naloxone either intramuscularly or subcutaneously, resulting in drug levels comparable with standard syringe administration. The device is equipped with visual and voice instructions, and is prescribed to family members and caregivers. It’s sort of like an epinephrine auto-injector for opioid overdose. Distribution is currently very limited, and Mark Herzog, a vice president for the manufacturer Kaléo, said the wholesale price for two auto-injectors is $575. Out-of-pocket costs for patients are expected to be in the typical co-pay range, and the company has a patient assistance program for those unable to afford the product.

 

The fear of legal repercussions has always been a barrier to layperson use of naloxone, and many states do not have a Good Samaritan law to protect families and fellow drug users who might intervene. Given the increasing purity of heroin and potent additives such as fentanyl, it is unclear if a single 0.4 mg injection would be adequate for all ODs. Most of the more potent concoctions will be lethal quickly, and would require much more naloxone for reversal.

 

Overdose Rescue by Trained and Untrained Participants and Change in Opioid Use among Substance Using Participants in Overdose Education and Naloxone Distribution Programs: A Retrospective Cohort Study

Doe-Simkins M, Quinn E, et al

BMC Public Health

2014;14:297

www.biomedcentral.com/1471-2458/14/297

 

This article coins a new term — Overdose Education and Naloxone Distribution (OEND), which is a program that has been in existence since 2006 — and describes the results of the program from 2006 to 2010. OEND programs have been implemented primarily to give naloxone in a rescue kit to substance users who are at high risk for overdose or to those likely to witness another person overdosing. The article states that opinions about the right level of training and the availability of naloxone rescue still exist. Options include giving naloxone to drug users (essentially to those without any medical training) and to giving it only to trained medical personnel.

 

It is always a concern, of course, to provide drug users with the skills to recognize and respond to an opioid overdose. Many believe that readily available naloxone may increase opioid use or delay entry into an addiction program. This is an intuitive concern; no data from existing OEND programs have yet demonstrated increased drug use by the participants. This report attempted to evaluate the management of opioid overdose by trained and untrained rescuers reporting the use of out-of-hospital naloxone. It also attempted to address how opioid use changed after receiving opioid education and naloxone distribution.

 

The study evaluated approximately 500 substance abusers who participated in a Massachusetts program. About eight percent of the subjects reported administering naloxone during an overdose rescue. The program provided training sessions to potential bystanders to opioid overdose. The participants received a naloxone rescue kit that contained two prefilled syringes of naloxone, 2 mg/2 ml, and two mucosal atomization devices. The participants were instructed to deliver 1 ml (1 mg) to each nostril of the overdose victim. The second dose was used if the first one was not effective. A total of 599 overdose rescues occurred, most frequently by friends of the victim. Most of the overdoses occurred in a private setting, and the majority were managed with only one dose of intranasal naloxone. About half of the victims received rescue breathing, rescuers called 911 in a quarter of cases, and most of the rescuers stayed with the victim and turned over care to emergency medical personnel.

 

Overall, there were no statistically significant differences in the overdose treatment by those who were trained and untrained. No clear increase in use of heroin was seen after receiving OEND services. It was not determined whether naloxone rescue kits would meet an over-the-counter standard, and it was concluded that the OEND programs should be expanded because no increased heroin use occurred.

 

Comment: Deaths in towns that had the OEND programs were reduced 27 to 40 percent. The authors noted that no statistical difference was seen in trained versus untrained participants in their attempts to seek help, the institution of rescue breathing, staying with the victim, or success in naloxone administration. Interestingly, no increase in the use of opioids or other drugs of abuse was found following resuscitation. One of the theoretical objections to such programs is that naloxone distribution would increase opioid use by giving recipients a sense of security, enabling risky behavior, but two studies evaluating such criticisms found a decrease in drug use following naloxone distribution. (J Urban Health 2005;82[2]:303; Int J Drug Policy 2010;21[3]:186.)

 

Many positive points support expanding the distribution of naloxone to laypeople, and opinions abound on the rationale for such an intervention. The decreased death rate with no abuse potential and the rare adverse reactions to naloxone are all positive. The studies have demonstrated that no significant training is required, and overdose prevention can be undertaken by the vast majority of drug addicts and their friends. The precipitation of withdrawal was not addressed, but no significant interactions occurred where naloxone administration kept victims from receiving EMS/hospital care. Overall, only limited negative social consequences were seen for providing naloxone for out-of-hospital opioid overdose.

 

California recently passed a bill that allows health care providers to prescribe, dispense, and issue standing orders for an opioid antagonist to those at risk for an overdose, their family members, and their associates who are in a position to assist patients at risk. Such individuals would not be liable under civil or criminal statutes if they acted with reasonable care. The American College of Medical Toxicology has submitted a proposal to members advocating wide use of education, legal protection, and naloxone distribution to try to halt the burgeoning increase in opioid deaths. This concept will likely garner significant interest, and have advocates as well as detractors. Simply stated, opioid use is a chronic illness with usually no cure, similar to diabetes and hypertension. One wonders if ED clinicians will be soon be expected to prescribe naloxone to those resuscitated by the ED.

 

Whether this concept garners praise or criticism, one thing is certain: Opioid use is largely a medical illness, like alcoholism, but this understanding is still overshadowed by misconceptions that drug use is a moral weakness or entirely a willful choice. (JAMA 2014;311[14]:1393.) Methadone and buprenorphine programs have been successful in extending the life of many opioid users, and many official organizations support medication-assisted treatment.

 

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.

 

 


Wednesday, August 20, 2014

Researchers can perform imaging exams using robotic arms controlled remotely via the Internet, according to two papers published in the August issue of JACC: Cardiovascular Imaging.

 

Partho Sengupta, MD, the director of cardiac ultrasound research at Icahn School of Medicine at Mount Sinai in New York, used a computer from Germany in one study to perform a robot-assisted ultrasound on a patient in Boston. He and his colleagues were able to complete a robotic ultrasound exam of a patient's carotid artery in four minutes.

 

Kurt Boman, MD, of Umea University of Sweden, in cooperation with Mount Sinai, used the robotic device in a second study to perform an echocardiography on patients in a remote location 135 miles away. Boman and colleagues were able to reduce the total diagnostic time for heart-failure patients receiving remote consultation from 114 to 27 days.

 

More details are available at http://bit.ly/1oUZoVb.

 


Tuesday, August 19, 2014

MedEx Ambulance Service, an Illinois-based health care transportation company, is experimenting with Google Glass in an effort to provide better care for patients.

 

The company has acquired two pairs of Google Glass installed with software and connected to the Internet, allowing paramedics to transmit live video and audio from an ambulance to a doctor in an emergency room who will be able to watch the video stream on a tablet or desktop computer.

 

Google Glass does not comply with Health Insurance Portability and Accountability Act, the federal privacy law, but Pristine, Inc., a startup based in Austin, TX, has customized the device for the medical profession in a way that the company said meets data security and patient privacy standards.

 

Read more about this at http://bit.ly/1tgGmNc, and read EMN’s article on Google Glass use in the ED at http://bit.ly/MRV4ve.


Monday, August 18, 2014

Twenty percent of adolescent girls and 12.5 percent of adolescent boys who visited the emergency department in the past year have reported dating violence, according to a study published online June 29 by Annals of Emergency Medicine.

 

Nearly 73 percent of 4,089 adolescents seeking care in a suburban ED for dating violence were Caucasian, 86.9 percent were enrolled in school, and 25.8 percent were on public assistance, according to the study, “Dating Violence Among Male and Female Youth Seeking Emergency Department Care.” (http://bit.ly/1rjCJs2.)

 

Adolescents who experienced violence in their dating lives were strongly associated with alcohol and illicit drug use or depression. Young women reporting prior dating violence were more likely to be on public assistance, have a D average or below, and have visited the ED in the past year for an intentional injury.


Friday, August 15, 2014

More than 40 percent of Social Security Disability Insurance (SSDI) recipients take opioid pain relievers, while the prevalence of chronic opioid use is more than 20 percent and rising, reported a study in the September issue of Medical Care. (2014;52[9]:852; http://bit.ly/1t2VoWT.)

 

The high proportion of SSDI recipients who are chronic opioid users — in many, at high and very high daily doses — “is worrisome in light of established and growing evidence that intense opioid use to treat nonmalignant pain may not be effective and may confer important risk,” wrote Nancy Elizabeth Morden, MD, and colleagues of the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, NH.

 

The researchers analyzed trends in use of prescription opioids among disabled Medicare beneficiaries under age 65 between 2007 and 2011. Nearly all under-65 Medicare beneficiaries are SSDI recipients; patients who go on SSDI are eligible for Medicare after two years.

 

Consistent with reports of an “opioid epidemic” in the United States, the results showed high and rising prevalence of opioid use by SSDI recipients. The percentage of beneficiaries taking opioids increased from 2007 through 2010. Prevalence dipped slightly to 43.7 percent in 2011, the most recent year for which data were available.

 

The percentage of these beneficiaries with chronic opioid use rose steadily, from 21.4 percent in 2007 to 23.1 percent in 2011. Chronic opioid users received numerous opioid prescriptions — at least six and generally 13 per year — typically prescribed by multiple doctors. Women were at greater risk of becoming chronic opioid users than men.

 

The average “morphine-equivalent dose” (MED) also dipped in 2011 among chronic opioid users. Still, nearly 20 percent of chronic users were taking a dose of at least 100 mg MED, while 10 percent were taking 200 mg. “Opioid use of this intensity has been associated with risk of overdose death in the general U.S. population and more specifically in disabled workers,” Dr. Morden and colleagues wrote.

 

The researchers also found variations in opioid use across U.S. health care regions. The regional prevalence of opioid use among SSDI recipients ranged from 33.0 to 58.6 percent; chronic use ranged from 14.0 to 36.6 percent. Drug dosage and specific opioids prescribed also varied by region.

 

The high prevalence and intensity of opioid use among SSDI recipients parallels the preponderance of musculoskeletal disorders, such as back pain — some type of musculoskeletal condition was present in 94 percent of chronic opioid users. The researchers also note the high rate of depression, 38 percent, among patients taking chronic opioids.

 

Dr. Morden and colleagues voiced concern about the trends in opioid use by SSDI recipients, particularly chronic use at potentially hazardous doses. “We are not suggesting that all chronic opioid use is more harmful than beneficial,” they wrote, “but rather that the common and increasing chronic use we observed seems inconsistent with the uncertainties surrounding such prescribing practice.”

 

The regional variation identified in the study “shows a lack of standardized approach, and revealed regions with mean MED levels associated with overdose risk,” the researchers added. They urged further study to assess the clinical outcomes of opioid use by under-65 disabled workers and factors associated with chronic opioid use. They also call for the development of policies and programs that balance safety with high-quality pain management for this complex group of patients.