It has been a stubborn issue for years, but there is now a growing consensus among most stakeholders that nothing short of systematic change will be successful in curbing the misuse of opioid drugs and the growing number of deaths attributed to such overdoses. New data suggest it’s a problem that has reached epidemic proportions, and that it is leaving few areas unscathed.
Perhaps most troubling to providers, the Centers for Disease Control and Prevention (CDC) reports that overdose deaths related to prescription opioids reached an all-time high in 2014, nearing the 19,000 mark. The figure represents an increase of 16% over 2013, according to the National Center for Health Statistics.
While deaths from heroin reached 10,574 in 2014, three times the number of overdose deaths from heroin reported in 2010, the CDC notes the sharpest increases in overdose deaths resulted from the use of synthetic opioids such as oxycodone and hydrocodone. The CDC adds that deaths resulting, at least in part, from these drugs reached 5500 in 2014, nearly double the figure reported in 2013. Overall, the agency reports that drug overdose deaths reached 47,055 in 2014, up from 43,982 the year before, and more than half of these deaths (61%) involved the use of opioids.
Consider draft guidelines
There is no question that stemming this dangerous tide will be complicated. Officials note that while physicians are prescribing fewer opioids than they have in the past, the result is that many patients are turning to illicit sources. Indeed, the CDC reports that misuse of prescription opioids is the most reliable predictor of heroin abuse. (See sidebar below: “Opioid-naive patients at higher risk.")
What can emergency providers and other healthcare professionals do to make a dent in this problem? There is no shortage of suggestions. For instance, the CDC has issued draft recommendations, suggesting that physicians turn to non-opioid alternatives, such as physical therapy and non-opioid analgesics, to treat chronic pain — at least before considering more powerful pain relievers. Further, when opioids must be used, the recommendations direct prescribers to select shorter-acting rather than extended-release versions and to prescribe the lowest possible dose for shorter terms.
In another, perhaps more controversial, suggestion, the recommendations call for physicians to ask patients to take urine tests before prescribing opioids and to continue requiring urine tests at least once per year if patients continue taking the drugs. This is to make sure that patients are not taking other opioids or illegal substances in addition to their prescribed dosage.
The CDC notes that opioid abuse frequently begins with treatment for acute pain, and that three or fewer days on the drugs is usually enough for non-traumatic pain that is not related to major surgery. When prescribing opioids, the agency said that physicians should incorporate strategies to mitigate risk. In particular, the draft guidelines suggest offering naloxone — a drug that can quickly reverse the effects of an opioid overdose — to patients who are on high doses of opioids, have had overdoses in the past, or have a history of substance abuse.
When releasing the draft guidelines in the federal register for review in mid-December, CDC Director Tom Frieden, MD, MPH, said the agency wants physicians to understand that starting a patient on an opioid is a “momentous decision.” He added that while the benefits are unproven, the risks include addiction and death. To view or comment on the draft guidelines, open the docket in the federal register through this link: Regulations.gov (docket # CDC-2015-0112).
Recognize scope of the problem
In a research letter published in JAMA Internal Medicine in mid-December, Jonathan Chen, MD, PhD, an instructor in the Department of Medicine at Stanford University, and colleagues made the case that the prescription drug abuse problem is not a matter of a few healthcare professionals prescribing too many drugs. Rather, the researchers found that a broad section of medical professionals prescribe opioids, including nurse practitioners, physician assistants, and dentists, as well as physicians. The authors said that the over-prescribing of opioids is a problem many healthcare professionals share. Consequently, the authors made the case that fixing the problem will require large-scale changes in the way providers prescribe these powerful drugs.1
Chen and colleagues based their findings on an examination of Medicare claims from 2013 to see which providers were prescribing opioids as well as how many prescriptions they were writing. While previous research has suggested a small group of providers write most opioid prescriptions, Chen and colleagues found that 57% of the prescriptions are written by 10% of physicians, nurse practitioners, physician assistants, and dentists.
The authors noted that this figure is in line with prescriptions for other types of drugs. They noted that 10% of physicians are generally responsible for 63% of prescriptions overall. What this told the researchers, according to Chen, is that there is “nothing special about opioids,” and that addressing the problem will require public health initiatives that focus on all providers as opposed to a small subset of providers.
Choose evidence-based solutions
Even before the CDC unveiled its draft guidelines for providers, a panel of experts, led by researchers from the Johns Hopkins Bloomberg School of Public Health, unveiled a sweeping report on the prescription opioid epidemic, calling for changes on multiple levels. The report, “The Prescription Opioid Epidemic: An Evidence-based Approach,” recommends improvements in the way opioids are prescribed and dispensed as well as in the way patients with addictions or overdoses are identified and managed in the healthcare system. (The full report is available at: http://www.jhsph.edu/research/centers-and-institutes/center-for-drug-safety-and-effectiveness/opioid-epidemic-town-hall-2015/2015-prescription-opioid-epidemic-report.pdf.)
“Drug overdose deaths in the United States outnumber deaths from firearms and motor vehicle crashes. Gunshot deaths, vehicle crashes, and opioid overdoses are all preventable injuries, but only one — the prescription opioid problem — originates in the healthcare system,” noted Michael Botticelli, MEd, director of the White House Office of National Drug Control Policy, at a forum to discuss the new report on Nov. 17, 2015.
“We know the opioid crisis is far from over,” Botticelli continued. “We also know that the public health consequences of this crisis stretch beyond overdoses and include new cases of substance use disorders requiring treatment, babies born exposed to opioids and requiring treatment for withdrawal in the neonatal intensive care unit, and outbreaks of injection-related infections, including HIV and hepatitis C.”
Shannon Frattaroli, PhD, MPH, the editor of the report and an associate professor at the Johns Hopkins Bloomberg School of Public Health, notes that in formulating the recommendations, the authors wanted to make sure that research findings were translated into actionable recommendations and policies.
“We agreed on three guiding principles to take us forward that included making sure that we respected and recognized the need for people who are in chronic pain to have safe access to these drugs,” she says. “We wanted to make sure that our efforts were comprehensive in nature so that we could take a full approach to the problem. We also wanted to make sure that we came away from this process with some real, actionable recommendations so that the science could inform how policymakers, community members, and stakeholders in this process could act to stem the tide.”
Frattaroli adds that in injury prevention, researchers and policymakers have had a number of successes with intervening in problems that cause injury and death across the population.
“We are very focused on understanding the problem, identifying interventions, and bringing those interventions to the population,” she says. “It is an approach that starts at the manufacturing stage and ends at the community stage with everything in between, a comprehensive approach to figuring out how the science can best inform solutions to some of our most pressing public health problems.”
The report offers 37 specific recommendations that are broken down into seven categories, including:
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prescribing guidelines;
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prescription drug monitoring programs (PDMP);
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pharmacy benefit managers and pharmacies;
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engineering strategies;
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overdose education and naloxone distribution programs;
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addiction treatment;
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community-based prevention strategies.
Consider alternative treatments
Of particular importance to providers, the report calls for the repeal of existing “permissive and lax prescription laws and rules.” It also calls for the oversight of pain treatment and for physician training in both pain management as well as opioid prescribing in particular. In addition, the report recommends the creation of a residency in pain medicine for medical school graduates.
The authors stated that the use of PDMPs should be mandated, and that PDMP data should be accessible to licensing boards and law enforcement when investigating “high-risk prescribers and dispensers.”
Christopher Jones, PharmD, MPH, the director of science policy in the U.S. Department of Health and Human Services (HHS) in Washington, DC, notes that while the recommendations represent a comprehensive approach to the prescription opioid problem, the suggested changes focused on access to addiction treatment align most forcefully with HHS initiatives.
“We have an evidence-based modality that is not being provided and historically has not been pursued in the same way that we have pursued other evidence-based treatments,” he says, referring to medication-assisted treatment. “Part of that is the stigma issue, part of it is providers understanding what it is, and part of it is patients understanding what it is.”
Jones observes that the report spells out a number of recommendations that address these issues, including a call to educate both prescribers and pharmacists on how to prevent, identify, and treat opioid addiction, and a suggestion to develop and disseminate a public education campaign to boost awareness about the role of treatment in addressing opioid addiction.
“Certainly there is a fundamental lack of education around appropriate pain management — not just in the use of opiates, but in multidisciplinary care [and] the use of non-pharmacological interventions or non-opioid interventions,” Jones says, noting that federal funds are going toward the development of curricula on pain management. “It has to happen in concert with the work that we are doing around opioid prescribing guidelines that the CDC has been working on.”
Jones adds that clinicians need to be provided with the education and tools to make informed prescribing decisions. “The data reflect that some people who have plenty of access to opioids have not received quality pain management. It is really about what is the right modality or modalities for a particular patient,” he says. “In some cases that may be opioids; in some cases it may be taking [the patients] off opioids and putting them on a therapy that may be better for them.”
Botticelli observes that the report’s recommendations strike a good balance between emphasizing the need for physicians to consider alternatives to opioids while also recognizing that patients need appropriate access to an array of pain management strategies.
“We need to be careful that the pendulum doesn’t swing in the opposite direction,” he adds.
Providers also need to do a better job of communicating with patients about why they are receiving a particular treatment for pain, what they can expect from the treatment, and what the risks are, Jones says. For instance, he explains that patients need to know what other conditions or drugs they have that could contribute to their risk of experiencing an overdose, and they need direction on how to store and dispose of the drugs properly. Further, he stresses that patients need to understand the importance of not sharing their drugs with friends or family members.
“That [practice] certainly is contributing to the public health problem,” he adds.
Joshua Sharfstein, MD, the associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health and a signatory to the report, adds that providers also need to specify to patients when it is time to stop taking their drugs, noting that this point is not always clear.
Facilitate treatment
Under the category of addiction treatment, the report recommends investments in the surveillance of opioid addiction, the expansion of access to buprenorphine treatment, more treatment funding for communities with high rates of opioid addiction, and a requirement that federally funded treatment programs provide patients with access to buprenorphine or methadone.
“When we look at who is dying, a significant fraction of those people have an underlying substance use disorder. We know from the data that providing medication-assisted treatment for those patients can reduce their overdose risk, and it is not being done,” Jones says.
Botticelli echoes these sentiments, noting that buprenorphine and methadone were designed to be delivered in primary care settings, not in specialty clinics.
“Unfortunately, we have too few physicians who have taken up prescribing these [drugs],” he says.
Consequently, Botticelli says HHS is exploring how best to increase the number of providers who are able to prescribe these drugs as well as increasing the capacity within the primary healthcare system — especially within community health centers.
Sharfstein acknowledges that he has interacted with many physicians who were initially reluctant to involve themselves in addiction treatment or to take the steps necessary to prescribe buprenorphine or methadone.
“But they find it very satisfying because they are really helping their patients. Also, it is easier to treat the underlying condition,” he says. “There is evidence that you can treat HIV, chronic liver disease, and other conditions better if the person is also in effective addiction treatment.”
Botticelli agrees with this point, noting that many people with substance use disorders have comorbid medical conditions as well, particularly HIV and viral hepatitis.
“Being able to get holistic, integrated care in one setting becomes really important because we know that to get good outcomes in any one of those domains you have to be looking at good treatment across domains,” he explains.
Sharfstein observes that while PDMPs enable providers to find out whether patients are doctor shopping or potentially misusing prescription opioids, the information is not necessarily used to help patients access needed treatment for addiction problems. Jones agrees, noting that as a pharmacist, he is pretty good at identifying people who are misusing drugs, and that PDMPs can help with that, but his formal training did not prepare him on how to proceed from there.
“Education is fundamental in what we do next. We certainly know that discharging patients from a practice if they have an addiction doesn’t change the fact that they have an addiction, and certainly it doesn’t get them into treatment,” Jones notes. “It does public health no good just to say [to a patient] that [he or she] is out of your practice. It doesn’t solve the problem. It perpetuates the problem.”
Jones adds that education initiatives need to offer providers information on how to leverage the information they receive from PDMPs most effectively and how to connect patients with the care they need. He further points out that providers need to know the treatment resources in their communities, and that more providers need to be data-waived to provide buprenorphine.
“There are opportunities to link the upstream concerns around prescribing with connecting patients into treatment,” he says.
Botticelli agrees that providers are missing multiple intervention points with people who have misused prescription pain medications, but he observes that there are some innovative programs at the state and local levels through which pharmacists and providers who identify people with a problem are able to refer them into treatment programs.
“They have cemented that relationship between prescribers and treatment programs to accelerate and increase the probability that someone is getting into care,” he offers. “Part of what we know about the increase in heroin use is that four-fifths of newer users to heroin started by misusing a pain medication. While we know we need to diminish the supply and the prescribing, we also have to make sure people have access to care and treatment. We don’t want people moving to heroin because it is cheap and readily available in many parts of the country.”
Make naloxone accessible, affordable
With respect to naloxone, the report calls on developers to design formulations of the drug that are both easier to use by non-medical personnel and less expensive to deliver, and it recommends better coverage for naloxone products. The authors also called for the development of consensus guidelines on the co-prescription of naloxone with prescription opioids.
“One of the recommendations that the report makes is to look at the co-prescription of naloxone with certain opioids at certain doses,” Frattaroli says. “It is one of those areas we can get very specific about where this resource should be targeted to specific populations who are receiving these very high doses of opioids.”
Jones adds that there is, in fact, a general consensus that certain types of patients should be receiving naloxone, including people who have experienced a previous overdose and people leaving EDs following treatment for an overdose.
“A previous overdose is probably the strongest predictor of a future overdose,” he says.
However, Jones also acknowledges that the high cost of naloxone remains a significant barrier.
“One of the things we have been trying to do at the federal level is to make sure that either existing grant programs or new grant streams are available for naloxone purchase at the community level,” he says. “We do have some limited money and part of the president’s budget proposal in fiscal year 2016 will continue to look at additional dollars for naloxone purchases.”
The experts speaking at the forum agreed that patients with an addiction problem often require a number of different treatments or services.
“[They] often have many co-occurring conditions, so giving them buprenorphine, methadone, or naltrexone is going to address one side of it and potentially stabilize them to address the other issues,” Jones notes. “It is important to consider counseling and other diversion mitigation measures as well … to make sure high quality care is being offered. The data show that there is clearly a benefit of providing buprenorphine or methadone or naltrexone, but we get the most robust response, and a holistic patient response, when we have additional behavioral health and medical measures.”
REFERENCE
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Chen J, et al. Distribution of opioids by different types of Medicare prescribers. JAMA Intern Med 2015; doi:10.1001/jamainternmed.2015.6662.
SOURCES
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Michael Botticelli, MEd, Director, White House Office of National Drug Control Policy, Washington, DC. E-mail via www.whitehouse.gov/contact. Phone: (202) 456-1414.
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Jonathan Chen, MD, PhD, Instructor, Department of Medicine, Stanford University, Stanford, CA. E-mail: [email protected]
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Shannon Frattaroli, PhD, MPH, Associate Professor, Johns Hopkins Bloomberg School of Public Health, Baltimore. E-mail: [email protected]
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Christopher Jones, PharmD, MPH, Director, Science Policy, U.S. Department of Health and Human Services, Washington, DC. E-mail: [email protected]
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Joshua Sharfstein, MD, Associate Dean, Public Health, Practice, and Training, Johns Hopkins Bloomberg School of Public Health, Baltimore. E-mail: [email protected]
