University Times

Unintentional drug overdose death rates have been rising in the United States from about 1 per 100,000 people in the 1970s to 9 per 100,000 in 2006, according to the Centers for Disease Control and Prevention (CDC). While cocaine and heroin are among the most common causes of fatal overdoses, deaths due to opioid painkillers have surpassed the two combined, due in part to misuse of prescription drugs such as oxycodone, hydrocodone and methadone.

Representatives from Beth Israel Medical Center’s Baron Edmond de Rothschild Chemical Dependency Institute discussed legislative proposals that would affect addiction treatment and the community’s role in preventing overdose deaths as part of a recent panel discussion, “Ethical Considerations in Addiction Treatment and Overdose Prevention,” hosted by the School of Pharmacy in conjunction with the Allegheny County Overdose and Prevention Initiative.

Rothschild Institute director Robert G. Newman, professor of epidemiology and population health and professor of psychiatry at Yeshiva University’s Albert Einstein College of Medicine, noted that concerns about the role of methadone in overdose fatalities often fail to differentiate between methadone given as a treatment for addiction and methadone prescribed for pain. He attributed the increase in part to rising numbers of prescriptions for methadone for pain and dosage recommendations that until recently were dangerously high.

Newman said until November 2006 — the period of the greatest increase in prescribing methadone for pain and in related deaths — the FDA’s dosage recommendations “were unequivocally able to cause death.”

He explained, “The recommended dosage was up to 80 milligrams per day, no mention about tolerance, no mention about caution for new patients, it simply said the recommended dose of methadone for the treatment of pain is a range up to 80 milligrams, and even said in some cases you might have to go even higher.

“So the FDA and manufacturer recommended, in this period of tremendous growth in prescribing, a dose of methadone that we know can kill and inevitably, I’m sure, did kill.”

In 2006, the FDA and the manufacturer lowered the recommended dosage to a maximum of 30 milligrams per day — a move Newman said was not well publicized. “I’m sure to this day, there are probably physicians with the best of intentions who are prescribing methadone for pain who are going by the recommendations that existed until three years ago.”

CDC and state studies show “overwhelmingly the methadone that is involved [in unintentional overdose deaths] … is methadone that has been prescribed for pain and not methadone that is given for the treatment of opium dependence,” Newman said.

“Unfortunately that perspective is lost and generally when the public and the politicians and some health care providers speak about this terrible increase in methadone-related deaths, the assumption … is that this is due to methadone coming from methadone programs.”

Government intrusion

Citing bills pending in Pennsylvania that are representative of legislation proposed elsewhere in the nation, Newman also expressed concern about the intrusion of government into medical decisions related to addiction treatment, in particular, bills that single out methadone treatment programs.

“We’re talking about a set of rules and a mindset with regard to addiction treatment and methadone treatment that is absolutely unbelievable in any other field,” Newman said. “I believe it’s really the obligation of anyone who has concern about addiction, who is a provider of addiction treatment or any other kind of treatment, to take on the challenge of saying this is ridiculous, not only because of the impact on people who want and need and may die without this treatment, but because it runs against the interest of every single person in the community.

“If you deny care, or if you impose such restrictions that it has the same effect, everybody pays the same price.”

One legislative proposal calls in part for the establishment of a death review team to examine the role of methadone in fatalities.

“What in the world do we look to the medical examiner for if not to determine the cause of death?” Newman questioned.

Another bill, he said, proposes establishing eligibility criteria for methadone treatment that would limit programs to patients who had been dependent on opium-based narcotics drugs for at least one year and were unable to stay drug-free after at least two attempts at appropriate treatment in residential or outpatient programs.

“Who ever heard of an eligibility for a medical treatment? And especially eligibility determined by legislators?” he asked.

Newman imagined the absurdity of a doctor telling a patient who sought treatment after 11 months of addiction: “If you survive one more month, then you’ll be eligible,” labeling the eligibility requirement “unthinkable” in other fields of medical care.

Another bill, Newman said, singles out methadone treatment providers by requiring they provide information on alternative treatments. “Every provider of drug-free treatment should provide exactly the same thing for the same reason,” he said. “How can you have informed consent if you don’t tell the prospective patient what the alternatives are?”

Noting that there is a standard federal form that patients must sign in order to be accepted into methadone treatment programs, Newman said, more distressing is the fact that no such informed consent requirement exists for patients when they quit treatment.

“Termination of treatment has repeatedly and consistently been shown to be associated with a massive increased risk of overdose in the initial weeks and over the longer term for patients whose treatment has ended,” Newman said. “When somebody’s getting ready to leave they should be told, they should be warned:  You have an exceptionally high risk of overdose,” he said.

He also cited drug courts as another intrusion by the government into the practice of medicine. Although many addiction treatment colleagues favor drug courts, which order treatment rather than incarceration for someone arrested on drug offenses, Newman opposes taking clinical decisions out of the hands of the treatment providers.

“The decision, the diagnosis and determination of need for treatment is suddenly taken over by judges and prosecutors and parole officers and probation officers,” Newman said.

Treatment teams be may have a good news/bad news diagnosis for a person referred by a drug court: The good news is that they aren’t dependent; the bad news is that because they aren’t eligible for treatment, their alternative is jail.

He also noted that some drug courts automatically exclude people who are undergoing methadone treatment or set thresholds for how much methadone makes a person ineligible. Likewise, some 12-step programs, liver transplant wait lists or dual-diagnosis treatment programs won’t accept methadone program participants, Newman said.

“I would urge that you consider how would the same issue play out with regard to any other form of medical treatments. Do you want the legislature to determine who should get treatment for depression? Should the legislature determine what type of treatment is going to be okay for hypertension or for asthma, perhaps related to smoking? If the government said, ‘We’re not going to allow public funds to be used to treat asthma in a smoker until the smoker has been totally free of smoking for six months,’ it’s not a question of whether it’s good or bad to smoke, but for the legislature to take away from physicians the ability to reach clinical decisions is just appalling,” he said.

“If you apply the same type of thinking for this field of medicine and this treatment as to all other forms of chronic illness or all other forms of medical management, you’ll come up with the right answer.”

Overdose prevention

Given simple training and tools, community members can play an important role in preventing overdose deaths, said Holly Catania, project director at the institute’s International Center for Advancement of Addiction Treatment.

“We’ve been seeing dramatic increases in overdose deaths, particularly overdose deaths related to opioids and prescription opioids,” Catania said, touting the role of naloxone distribution in community-based overdose prevention programs as a way to enable witnesses to a drug overdose to intervene and save a life.

Naloxone, marketed under the name Narcan, is an injectible or nasally administered prescription medication used to reverse the effects of opioid overdose. Naloxone temporarily displaces opioids from their receptors, creating a window of opportunity for an overdose victim to get care.

While naloxone is used in medical settings to reverse opioid overdoses, a growing number of programs in the United States also are equipping non-medical personnel with naloxone kits to prevent overdose deaths.

“Overdose prevention in the community is empowering drug users, their friends, family members, anyone who may be present and witnessing the overdoses to be able to prevent them from becoming fatal,” Catania said. “This isn’t something to do instead of seeking help, but it’s something to do to save someone’s life until they can get medical attention.”

The first such broad naloxone distribution program began in 2002 in Chicago, Catania said. Distribution of 3,500 kits resulted in 319 overdose reversals, with one unsuccessful revival, she said.

Some pilot programs, dubbed Project Lazarus, provide naloxone kits for people who receive prescriptions for opioid drugs.

The New York-based project SKOOP (Skills and Knowledge on Overdose Prevention) consists of a 10-20 minute training program that can be done on street corners. Training includes preventing and recognizing overdoses, demonstration of rescue breathing techniques and distribution of a naloxone kit with instructions on how to administer it.

“The most important elements of the training are prevention of overdose,” Catania said. SKOOP educators discuss the importance of not mixing drugs, explain how tolerance is reduced with irregular drug use and advise users not to use drugs when they are alone.

Participants are taught to recognize symptoms (such as having blue lips or nail beds, slow or no breathing, or snoring) and that overdose often is not immediate.

In addition, participants are taught what to do should they witness an overdose. Often panic or fear of the police prevent witnesses from seeking help for the victim, she said.

In addition to instructions on administering naloxone, participants are taught what to say when dialing 911 — including simply saying “my friend is unconscious” or “not breathing” to describe the problem. “That’s easier to say that than having to say the word overdose because some people fear — and probably rightfully so — that EMS or ambulances might be slower to respond to someone with a drug overdose rather than someone who just is not breathing,” Catania said.

“Some people think that if you provide naloxone to drug users, they’ll just be more irresponsible in drug use,” she said. “That’s certainly not borne out by the evidence.”

Catania praised local nonprofit Prevention Point Pittsburgh, which does not offer widespread distribution of naloxone kits but conducts overdose prevention training and provides naloxone to opioid users who are considered at risk of overdose. Since 2002, the program has trained 8,000 people in overdose prevention, including 5,500 Allegheny County Jail inmates, she said.

According to the nonprofit’s web site, some 400 people received naloxone between July 2005 and Oct. 1, 2008, and as of May 2008, there were first-hand reports of 220 successful overdose reversals.

Catania reiterated that overdose prevention by non-medical personnel is feasible, safe and effective. Although the United States typically isn’t considered a leader in drug policy innovation, in this case it is influencing other nations’ approaches, “not by just restricting the access to opioids for pain, or addiction treatment, but really empowering people to be able to save lives where they’re at.”

Some facts about overdoses

Holly Catania, project director at the International Center for Advancement of Addiction Treatment at Beth Israel Medical Center’s Baron Edmond de Rothschild Chemical Dependency Institute, shared some facts about opioid overdoses and who is at increased risk.

Opioids affect the urge to breathe, which can lead to respiratory depression and death, she said, noting that overdoses generally happen over the course of 1-3 hours.

“The stereotypical person dying with the needle in her arm is very rare,” occurring in about 15 percent of the cases, Catania said, adding that it’s important to know that there is time to save overdose victims.

While concern for young users overdosing is an issue, only about 17 percent of overdose victims are new users. “The majority of people who die are long-term, experienced drug users,” she said.

Overdoses often are witnessed, Catania said, noting that one study found that 75-80 percent of injecting drug users reported having witnessed an overdose and more than half said they knew someone who had died of an overdose.

Abstinent drug users (due to incarceration, hospitalization or detoxification treatments) are at highest risk of dying of an overdose, Catania said, adding that a previous history of overdose is a major predictor of risk for a fatal overdose.

Those who inject drugs rather than inhale them, those who mix classes of drugs or those who don’t know the strength of the drug being taken are at higher risk of overdose, as are people with depression or illnesses such as HIV, AIDS or cirrhosis.

—Kimberly K. Barlow