AT Forum Volume 22, #3 Summer 2012 Newsletter

Methadone Dosing During Pregnancy: Does Anyone Have a Clue? John J. McCarthy, MD, Guest Author

Methadone treatment of the pregnant, opioid-addicted mother is routinely cited in research studies as causing a neonatal abstinence syndrome (NAS). But this is an oversimplification of the effects on the fetus of the mother’s drug use before, and sometimes during, methadone treatment.

There are limits to what we really know about the effects of opioid abuse on the developing fetus. Even more complicated are the effects of additional use of nicotine, alcohol, stimulants, and benzodiazepines. We know something about the effects of cycles of opioid intoxication and withdrawal on the health of the fetus and newborn, but we can’t routinely identify or measure these effects.  We can only wonder if maternal addiction can truly be “without harm”—leaving only methadone withdrawal as the cause of the newborn’s ill health.

Despite all this uncertainty, methadone has become identified as “the cause” of NAS. Here’s how this chain of events typically unfolds. The mother arrives at a hospital on methadone. The baby has NAS. The doctors know nothing about what the baby has been exposed to during the pregnancy, beyond some vague drug abuse history before methadone treatment—but not what drugs, what amount, or for how long. And if doctors see a sick baby, they look for a cause: there is methadone.

It is almost as if addiction never happened. Despite exaggerated claims about how potentially deadly methadone withdrawal is,* in an ongoing study in our pregnancy program the majority of newborns experience NAS that is so mild it does not require treatment. Uncomplicated opioid withdrawal that is more severe is very treatable; only medical neglect would endanger the life of the neonate! What really was life-threatening was fetal withdrawal in the pre-methadone era, for it did result in fetal and neonatal death.*

But opioid withdrawal, when complicated by the harmful effects of poly-drug addiction and repeated episodes of withdrawal on the fetus, might not be easily treated.  It is more complicated than simple methadone withdrawal.

As for how we reduce risks for the neonatal illness called NAS, I suggest the following:  1.) treat the maternal addiction, and stop the fetal exposure to drugs and drug withdrawal; 2.) stabilize the disordered maternal and fetal brain chemistry, using the dose of methadone that will keep the mother and fetus out of withdrawal; and 3.) treat the more severe cases of NAS after birth, if needed, when the newborn’s symptoms are easy to monitor. There is evidence that avoiding neonatal intensive care units and encouraging rooming-in, with frequent skin-to-skin contact between mother and newborn, starting at birth, along with breastfeeding, can reduce NAS symptoms.*

In reality, risks aren’t always reduced by such evidence-based practices, however. We have mothers put through withdrawal during pregnancy “to prevent NAS.”* This practice shifts the burden of withdrawal onto the fetus, where we can’t see what’s happening, because our limited tools of fetal monitoring show us almost nothing of actual fetal withdrawal physiology. Because maternal withdrawal is linked to fetal withdrawal, the fetus can develop an intrauterine abstinence syndrome (IAS).* Maternal/fetal opioid withdrawal can cause restriction of placental blood flow and fetal hypoxia (reduced levels of oxygen in the brain), and fetal brain damage.  Some authors have also encouraged mothers to stay on low doses of methadone and endure withdrawal “to protect the fetus.”* I would ask  what the fetus is being protected from when it is suffering withdrawal in utero; how making the mother sick helps the pregnancy; and how fetal withdrawal helps the baby.

In summary, we have no consensus on the goals of methadone treatment in pregnancy.

Part of the confusion relates to the question of whether giving the mother high doses of methadone worsens NAS. A recent meta-analysis of 67 studies found this not to be the case.* The fetus is not exposed to the maternal dose; it is exposed to the maternal plasma level. We know that plasma levels vary significantly, depending on genetics. And pregnant women metabolize methadone more quickly, necessitating dose increases—but these increases do not necessarily increase fetal exposure to methadone.

One mother in our pregnancy program required 270 mg/day of methadone, in four divided doses. Her plasma level, before the morning dose one week before delivery, was undetectable. After birth, the baby required no treatment for NAS. We don’t know how many physicians are willing to prescribe these high, split doses to keep the mother and fetus out of withdrawal. We don’t know whether programs use maternal plasma methadone levels to monitor changes in maternal metabolism and fetal exposure.

In pregnancy, split doses of methadone protect the fetus from exposure to daily cycles of peaks and troughs, which have been shown to have negative physiologic effects on the fetus.* Even high doses, when given as single daily doses, can result in fetal withdrawal distress before the next day’s dose. That may be why high doses, at times, seem to cause more cases of NAS: The fetus may be sensitized to daily episodes of withdrawal.* Some mothers, like our patient who received 270 mg daily, are ultra-rapid metabolizers; the methadone exposure for their fetuses is far more consistent and physiologic when dosing is four times a day.

While the MOTHER study showed that hospitalization stays were shorter and NAS less severe for the newborns when the mother was on buprenorphine, compared to methadone, this doesn’t answer the question about induction on buprenorphine, which itself raises medical concerns. Maternal treatment with buprenorphine is complicated by buprenorphine’s narcotic antagonist properties, which require mother and fetus to be in withdrawal before the first dose is given. If they are not, buprenorphine may cause acute withdrawal, a threat to the safety of the pregnancy. Methadone inductions are far safer for the fetus.

The MOTHER study did not use split doses of methadone, introducing a potential bias in the methadone arm. Furthermore, the study used comparatively low doses of methadone, averaging 79 mg/day. If the goal of treatment is to use doses high enough to keep the mother and fetus out of withdrawal, our experience is that the average daily dose must be much higher. The average in our ongoing study is 140 mg/day, always split, given two to four times a day. With this approach, only 28 percent of our current cohort of babies (N=53) have required treatment for NAS. The MOTHER study found about a 50 percent treatment rate for both methadone and buprenorphine.

As far as buprenorphine’s having a less severe withdrawal, a Norwegian study found a treatment rate of 67 percent in neonates undergoing buprenorphine withdrawal.* And a study from Finland reported “severe” NAS with a 57 percent rate of morphine treatment, as well as a high number of sudden infant  deaths, in buprenorphine-exposed neonates!* These ”real world” studies  must temper  conclusions about any proposed superiority of buprenorphine over methadone. The etiology of NAS is likely more complicated than a simple choice of one medication or others.

The low treatment rate and relative mildness of NAS in the majority of our babies certainly is not conclusive evidence for the use of our protocol. Ours is one approach that has good theoretical support, and seems to be associated with reduced risk of NAS. It may not be widely used, but we have no true idea of current practices.

Dr. McCarthy, a specialist in addiction medicine, is the Executive/Medical Director of the Bi-Valley Medical Clinic in Sacramento, CA. He is a diplomate of the American Board of Psychiatry and Neurology and the American Board of Addiction Medicine, and an assistant professor of psychiatry at the University of California, Davis. His research publications have focused on opioid addiction in pregnancy.

Dr. McCarthy and AT Forum would deeply appreciate feedback from you, our readers, about your program’s current practices and guidelines for mothers taking methadone during pregnancy.
Please take our survey.

For a list of Dr. McCarthy’s publications and presentations, go to:


1.  Jones HE, Kaltenbach K, Heil SH, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010;363:2320–2331. DOI: 10.1056/NEJMoa1005359.

2.  Zuspan FP, Gumpel JA, Mejia-Zelaya A, et al. Fetal stress from methadone withdrawal.  Am J Obstet Gynecol. 1975;122(1):43-46. PMID 1130446.

3.  Hodgson ZG, Abrahams, RR. A rooming-in program to mitigate the need to treat for opiate withdrawal in the newborn. J Obstet Gynaecol Can. 2012;34(5):475–481. PMID 22555142.

4.  Dashe JS, Jackson GL, Olscher DA, et al.  Opioid detoxification in pregnancy. Obstet Gynecol. 1998;92(5):854-858. PMID 9794682.

5.  McCarthy JJ. Intrauterine abstinence syndrome (IAS) during buprenorphine inductions and methadone tapers: can we assure the safety of the fetus? J Matern Fetal Neonatal Med. 2012;25(2):109–112. PMID 21867403.

6.  Lim S, Prasad MR, Samuels P, et al. High-dose methadone in pregnant women and its effect on duration of neonatal abstinence syndrome. Am J Obstet Gynecol. 2009;200:70.el-5. PMID 18976737.

7.  Cleary BJ, Donnelly J, Strawbridge J, et al. Methadone dose and neonatal abstinence syndrome—systematic review and meta-analysis. Addiction. 2010;105(12):2071–2084. PMID 20840198.

8.  Wittmann BK, Segal S. A comparison of the effects of single- and split-dose methadone administration on the fetus: ultrasound evaluation. Int J Addict. 1991;26(2):213–218. PMID 1889920.

9.  Rothwell PE, Gewirtz JC, Thomas MJ. Episodic withdrawal promotes psychomotor sensitization to morphine. Neuropsychopharmacology. 2010;35(13):2579–2589. doi:  10.1038/npp.2010.134.

10.  Bakstad B, Sarfi M, Welle-Strand GK, et al. Opioid maintenance treatment during pregnancy: occurrence and severity of neonatal abstinence syndrome. A national prospective study. Eur Addict Res. 2009;15(3):128–134. PMID 19332991.

11. Kahila H, Saisto T, Kivitie-Kallio S, et al. A prospective study on buprenorphine use during pregnancy: effects on maternal and neonatal outcome. Acta Obstet Gynecol Scand. 2007;86(2):185-190. PMID 17364281.


Hearing Bad Things about Methadone Treatment? Thank “Dr. Drew”

Why is it that most opioid-dependent patients aren’t enrolled in medication-assisted treatment (MAT), despite its proven effectiveness?

One reason is the link between so-called reality television and negative perceptions about methadone and buprenorphine. That’s the thinking of the authors of “Messages About Methadone and Buprenorphine in Reality Television: A Content Analysis of Celebrity Rehab with Dr. Drew.” Published online in Substance Use & Misuse, January 8, 2012, the article analyzes all episodes in the first four seasons of Celebrity Rehab with Dr. Drew.

First aired in January 2008, the show features Dr. Drew’s interactions with celebrities being treated at the Pasadena Recovery Center, a residential facility in California. One wonders what motivates patients to go “on camera”—such as the woman who allowed her withdrawal convulsions to be shown to hundreds of thousands of viewers.

Linking reality TV and attitudes toward MAT seems logical. TV exposes us to nuances—tone of voice, facial expression. When a fatherly “Dr. Drew” softly confides, “methadone just takes your soul away. It’s no way to live,” people listen intently, and many take it to heart.

Study Design

Researchers analyzed the quantity and slant of the show’s messages about treating opioid dependence with methadone and buprenorphine. They watched all 39 episodes of the first four seasons of Celebrity Rehab with Dr. Drew, and coded the data using scientifically accepted methods.


Of the 33 patients portrayed, 13—about 40 percent—were using or had used opioids. Of these, 4—about 30 percent—used methadone or buprenorphine.

The two main messages: methadone and buprenorphine are primarily drugs of abuse, and are not acceptable treatment options.

References to Methadone and Buprenorphine

Times referred to
As a drug of abuse
17 (85)*
7 (87.5)
Rejected as a treatment option
13 (15)
Endorsed as treatment option for opioid dependence
*times (%)

Mentions of methadone and buprenorphine in Dr. Drew’s show “highlighted harmful effects and focused on how and why patients should stop using them,” the authors found.

For example, Dr. Drew advised a patient trying to cope with opioid withdrawal symptoms that methadone can create another addiction. Thus he “reaffirmed a negative perception that has been cited as a reason for forgoing enrollment in medication-assisted treatment,” the authors noted. Dr. Drew also said some patients develop severe methadone withdrawal that “leads to medical and psychiatric complications that require hospitalizations.”

Authors’ Comments

The authors found that Celebrity Rehab with Dr. Drew reinforces negative stereotypes, presents misinformation, may perpetuate existing stigma toward addiction and its treatment, and undercuts support for its expansion.

Roose R, Fuentes L, Cheema M. Messages about methadone and buprenorphine in reality television: A content analysis of celebrity rehab with Dr. Drew [published online ahead of print, 2012]. Substance Use & Misuse. doi: 10.3109/10826084.2012.680172.


AT Forum Opinion: What’s Behind Dr. Drew’s Attitude

What’s behind Dr. Drew’s attitude? Surfing the Web and watching him in action provides clues. The folksy “Dr. Drew” (“Dr. Drew Pinsky”) is at times a showman, at times a controlling father-figure, and at times seemingly a friend—but always an authority who is not to be questioned.

Dr. Drew is fully credentialed: board-certified by the American Board of Internal Medicine and American Board of Addiction Medicine, licensed private practitioner, assistant clinical professor of psychiatry at the University of Southern California.

In his 2009 book, The Mirror Effect, Dr. Drew admits that he has some traits of a “closet narcissist,” having scored a 16 on the Narcissistic Personality Inventory. He has been a TV series actor. Has starred on several reality shows, including Sex . . . With Mom and Dad. The New York Times has described Dr. Drew’s combined career in medicine and mass media as requiring him to navigate “a precarious balance of professionalism and salaciousness.” In a 2009 interview, the Times questioned Dr. Drew about his practice of paying addicts to attend rehab—asking if luring cast members with promises of money and exposure didn’t cast doubt on their commitment to sobriety. “My whole thing is bait and switch,” Dr. Drew explained. “Whatever motivates them to come in, that’s fine. Then we can get them involved with the process.”

But where are the data for his methods? Dr. Drew doesn’t cite any studies in the huge body of evidence matching patients with treatment. Nor does he mention the ASAM criteria, which list methadone and buprenorphine as treatments of choice for opioid addiction.

There’s a big difference between obtaining exposure and publicity, and providing treatment for substance use disorders. We shouldn’t confuse them, as Dr. Drew does—buying exposure in the guise of treatment.

If there’s a place for the methods and opinions of the Dr. Drews of this world, it’s not in the realm of evidence-based addiction medicine.

Habit OPCO Helps Educate the Criminal Justice System about Medication-Assisted Treatment

Although it’s well known that many people wind up in the criminal justice system because they are addicted to opioids, there is still work to be done in educating the system about the value of medication-assisted treatment (MAT). Jonathon Wasp, MS, director of Pennsylvania operations for Habit OPCO opioid treatment programs (OTPs), has a background in management of addiction treatment in the correctional system, and is helping to do just that.

Mr. Wasp, formerly associated with MinSec, a private community correctional services provider focusing on behavioral health care, said that the criminal justice system—especially corrections—has made strides in recent years in recognizing the importance of addiction treatment.

“By reaching out to drug-treatment courts and probation and parole officers, and requesting an opportunity to speak with them about criminal justice and addiction, we are opening the doors,” he said. But there are still barriers. As much as criminal justice officials are aware of the fact that they have people who are addicted in probation, parole, and prisons and jails, many “don’t understand the neurobiology of addiction. The way they see it, these people could just stop. They are missing the science. If you don’t understand the basic concepts, you won’t understand how methadone is important in providing addiction treatment.”

Re-entry and Drug Courts

One focus of the Habit OPCO criminal justice initiative is re-entry—treating people who are about to be released from prison and were addicted to opioids prior to their incarceration. Under the federal guidelines, a patient who met the criteria for admission to an OTP immediately before incarceration can be admitted to a program, because incarceration is “forced remission,” he said. Forced abstinence is not the same as treatment, and federal studies have shown the value of admitting inmates into OTPs prior to their release, and continuing with treatment after release. So Habit OPCO is working with prison officials on getting inmates who were addicted to opioids into treatment before their release.

Another focus of Habit OPCO is preventing people from going to prison or jail by providing them treatment up front in collaboration with a drug court or probation. But focusing on this population also means that addiction treatment providers must educate themselves about “criminogenic” thinking and risks, he said, citing the work of Edward Latessa, PhD, who developed a correctional program checklist assessment—and this can be used in community corrections as well. (Community corrections are those that take place outside of prison or jail, such as with probation and parole.)

Addiction–Crime Overlap and Dichotomy

The overlap between addiction and criminal justice involvement is so big—as many as 80 percent of inmates are incarcerated because of a drug or alcohol problem—that the treatment and criminal justice systems should understand they are dealing with the same people, he said, adding that all addiction treatment providers should do a “risk-need-responsivity” assessment for criminal behavior. Substance abuse is one of the seven risks for criminal behavior under this model, first developed in the 1980s. Others include social isolation, poor education, and distrust of or lack of adherence to authority, he said. Interestingly, these risks are also relapse triggers.

“At the end of the day, not only are we serving the same people, but we’re supposed to be serving them in the same way—and we’re not. We never got away from the dichotomy that addiction treatment is for public health and criminal justice is for public safety.” The biggest danger of this dichotomy is that the criminal justice system “looks at treatment agencies as completely separate, and we don’t advance at all. So our purpose at Habit OPCO is to show that not only are we serving the same people, but we have the same vested interest.” Public safety is improved by people getting MAT, and that’s the message that he is taking to corrections, probation, and parole officials.

There is no reason to separate patients who are referred from drug courts or pretrial diversion—not convicted—from other patients in an OTP, he said. “They’re not incarcerated, they’re supervised by a probation officer.”

But it’s important to understand the different mindset of someone who is coming into an OTP after months of incarceration, he said. Even if they had been unfairly incarcerated, they were in the prison system, and that inevitably had an effect on them.

The ‘Substitution’ Question

Many criminal justice practitioners view methadone as a substitute for heroin, and while there is some truth in that, when we look at the neurobiology of opiate dependence, the substitution “debate” is overly simplistic. It ignores a substantial body of evidence that suggests that this treatment modality, which also provides extensive individual and group interventions, addresses the stressors and causes of addiction. At the same time, it ensures that the opiate dependent person is physiologically stabilized with a substance that does not provide the euphoric effects of heroin.

Mr. Wasp related a particularly poignant example of the need for education. A medical provider of correctional treatment services in Pennsylvania was looking for a provider for pregnant opioid-dependent women. So the prison physician toured an OTP. “I could tell he had something on his mind; I could tell from his body language,” said Mr. Wasp. “I said that methadone is a tool, part of the recovery process. But clearly my agenda and his were not in sync.

“So I asked him, ‘What did you expect to get from coming here today?’” The physician—whom Wasp declined to identify—responded, “How would you answer the question, which I will be asked by my superiors, ‘Why should we substitute these people’s heroin addiction on the taxpayer’s dollar?’” Mr. Wasp answered, “With all due respect, you’re going to pay one way or another.” He noted that treatment with MAT is much less expensive than being incarcerated.

Other ways Habit OPCO reaches out to the criminal justice system, in addition to providing tours for county correctional administrators and health care administrators, include:

1)    providing information to corrections, probation, and parole staff members by purchasing and staffing a booth at the Pennsylvania Probation Parole and Corrections annual state-wide conference;

2)    attending and presenting information to the Lackawanna County Criminal Justice Advisory Board (a board comprised of sentencing judges, county probation, county corrections, county investigators, the District Attorney’s office, and Pennsylvania state police);

3)    inviting our local state parole office to host their monthly staff meeting at our facility (encouraging parole agents to tour the facility while on site); and

4)    creating and presenting a four-hour training to county probation staff on the benefits of medication-assisted treatment with the criminal justice population.

“In many cases, we have handed out the AT Forum White Paper on medication-assisted treatment and criminal justice,” said Mr. Wasp. “In this day and age, with evidence-based practices being the buzz in criminal justice, it’s nice to be able to hand them the evidence in a well-done, prepackaged document.”

Because of his experience with the criminal justice system, Mr. Wasp sympathized with the physician who questioned the value of MAT. “There is not a single institution anywhere in this country where there’s not some level of a rub between the security professionals in a jail and the medical people,” he said. “Corrections officers believe that it’s their job to do custody and control. And there’s the treatment people, who say it’s their job to help people be more productive.”

OTP Victory in Berwyn Hoped to Discourage Other Localities From Discriminating

The city of Berwyn, Illinois will never pick a fight with an opioid treatment program (OTP) again. In July, it settled with Elizabeth Buonauro and Sal Sottile, current owners of an OTP in Evanston, Illinois that will now be allowed to open a second clinic in Berwyn, for $650,000. The saga is one of discrimination against methadone patients, of the illegality of that discrimination, and of the foolhardiness of localities in persisting in that discrimination to the point of fiscal irresponsibility. At the root of that foolhardiness is the craven fear of politicians that they will lose their jobs if they don’t do what voters want—even if they know the voters are wrong.

The Berwyn City Council first voted in 2008 to allow the clinic to open in a medical building, but NIMBY (Not In My Back Yard) -ism soon crept in, with residents opposing it. The City Council reversed their decision. In November of 2008, the clinic’s owners sued the city.

The Americans with Disabilities Act (ADA) is a powerful ally of OTPs. When authorities so obviously target people in treatment for drug addiction—a specifically protected class under the federal law—they really have no defense, and if they are taken to court, they inevitably lose. This was seen last year in Warren, Maine, when CRC Health Group won its battle for an OTP there, and the town’s insurance company had to pay $320,000.

“The court’s decision that the City of Berwyn violated federal anti-discrimination laws is the latest of a string of federal court decisions holding that zoning out methadone programs violates federal law,” said Sally Friedman, legal director of the Legal Action Center. “What’s striking about this case is the substantial $650,000 settlement.  This large sum of money should awaken other municipalities to the fact that that discrimination is costly, as well as illegal.”

Between its first vote and the second, Berwyn Council members were pressured by residents to keep the OTP from opening. Knowing that a lawsuit was possible, and that the city had no legal grounds to stand on, the Berwyn Council members nevertheless gave in to residents, who said that the OTP would lower their property values and bring crime into the neighborhood. In April of 2011, the city denied the clinic a business license, even though it had passed all zoning requirements.

The Ruling

The ruling by Judge Sharon Johnson Coleman of U.S. District Court on May 11 held that Berwyn violated the ADA when it passed an ordinance banning OTPs. The ordinance was illegal, because of “the city’s ongoing discriminatory intent in the zoning decisions,” Judge Coleman noted.

“Federal courts have consistently held that a municipality violates the [ADA] by subjecting a substance abuse clinic to differential zoning treatment because of its association with individuals recovering from an addiction. There is ample evidence that Berwyn’s zoning decisions regarding the plaintiffs’ clinic were motivated by an intent to treat its clients differently from other medical patients.”

Key to the case was a video tape in 2008 in which city aldermen clearly perceived that they might lose their seats if they voted for the clinic. “The reactions of (Fourth Ward Alderman) Michele Skryd, (then-Seventh Ward Alderman and now Mayor) Robert Lovero, and (First Ward Alderman) Nona Chapman to the community’s hostility towards the clinic in 2008 are evidence of a perceived voter animus so strong that it could only be ignored at the council’s political peril in later years,” Judge Coleman wrote.

The judge ordered that Berwyn pay the OTP’s legal fees, issue a business license, and not block the clinic with any zoning changes.

But as of September 4 Ms. Buonauro still did not have a business license – Berwyn was stalling, even though the judge said to “immediately” grant the license, she said. “I pay the lease but I don’t have a key, I don’t want the liability,” she said. “I’m not going to do a buildout and have Berwyn do something else to me.”

It was a long 4 ½ years, and now there is a victory, but the battle isn’t over for Ms. Buonauro. “They talk about NIMBY,” she told AT Forum. “This is my back yard. I live within 2 blocks.” However, she proudly describes the facility is perfect,–the second story of a bank building, with a rear entrance for privacy for patients, and other medical offices in the building.

Judge Coleman also said that ordinances and zoning rules designed to keep OTPs out of municipalities are illegal, a ruling that will hold for much of Illinois. (The ruling, while in federal court, applies only in the district that it covered.) “A zoning provision that discriminates against methadone clinics violates the ADA even if it merely provides a location restriction rather than an outright ban, and even if the provisions offer a process for relief from that restriction,” the ruling stated.

The decision to settle the lawsuit was made in a 4-3 vote.

Now that there is no chance of a legal appeal by Berwyn, they are finally ready to open their new facility.  It was unclear at press time how many patients the facility would have or when it would open. “Another program might have given up in the face of the opposition,” said Richard Weisskopf, State Opioid Treatment Authority for Illinois, in an e-mail to AT Forum. “Not Ms. Buonauro!” But it was abundantly clear that where other programs might have given up in the face of the opposition, Liz Buonauro would not. And this perseverance paid off, for herself and her patients.

AATOD Issues Prescription Monitoring Program Guidelines for OTPs

The American Association for the Treatment of Opioid Dependence (AATOD), issued guidance this June to opioid treatment programs (OTPs) encouraging them to “utilize prescription monitoring programs (PMPs) as an additional resource to maximize safety in patient care pursuant to applicable state guidelines.”

When OTPs do access state PMP data bases, they should do so for therapeutic reasons, not for the purpose of restricting access to treatment, according to AATOD. “OTPs are discouraged from using such data for the sole purpose of restricting treatment access or for responding in a punitive fashion to the needs of patients in treatment.”

OTPs Should Not Report Confidential Data

OTPs, because of confidentiality law applying specifically to treatment for addiction, should not report anything that could identify their patients to PMPs, said AATOD, citing guidance from the Substance Abuse and Mental Health Services Administration (SAMHSA). Under 42 CFR Part 2, the federal regulation protecting the confidentiality of substance abuse treatment records, treatment programs may not divulge patient-identifying information without the patient’s written, specific consent. That was the point SAMHSA’s H. Westley Clark, MD, JD, was making in his September 27, 2011 Dear Colleague letter (See AT Forum Fall, 2011). SAMHSA administers 42 CFR Part 2.

However, no patient consent is required for the OTP—or anyone else—to request information from the PMP about a patient. Under 42 CFR Part 2, making such a request does not constitute disclosing a patient’s status as a substance abuse treatment patient.

But AATOD does recommend that OTPs notify a patient when they are accessing a PMP database, even though SAMHSA says this isn’t necessary. “The OTP should inform patients that they are accessing PMP databases by posting information or by distributing information to patients, explaining what a PMP does and why the program is requesting the data,” according to AATOD.

SAMHSA is expected to issue additional guidance on PMPs to OTPs.

According to AATOD, there are concerns that some people want to weaken 42 CFR Part 2 to make it possible for other physicians to access information about OTP patients. “As I understand it, someone from the Centers for Disease Control and Prevention may have recommended this idea about one year ago,” Mark W. Parrino, MPA, AATOD president, told AT Forum in an e-mail. “I also know that a number of physicians who work in emergency rooms have made similar recommendations.”

If a PMP re-discloses identifying data to interested parties about a patient, individuals could be discouraged from accessing medication-assisted treatment, according to AATOD.

So far, 49 of the 50 states either have active PMPs or legislation approving the use of PMPs.

The AATOD Guidance document can be accessed at:

PMPs Need to be More ‘User-Friendly’ for Physicians, Study Finds

There are barriers to prescribers’ use of prescription monitoring programs (PMPs), according to researchers from the American College of Medical Toxicology (ACMT). In a June 21 New England Journal of Medicine Perspective article, Jeanmarie Perrone, MD, and Lewis Nelson, MD, found that PMPs, with some simple improvements, could be much more useful to physicians.

The most frustrating aspect of PMPs is the time it takes to use these programs. “Even if it takes only three minutes per patient, in a busy emergency department or office practice, having to do this multiple times daily amounts to a substantial time investment,” said Dr. Lewis in a press release from the ACMT. Much of the time is spent navigating to the correct web portal, they found. The physicians need to recall the password—and reset it. And many physicians found that once they did gain access, up-to-date information was not available for each patient.

Because time is the major barrier to physician use of PMPs, it would be helpful to have programs be more user-friendly, the researchers found.

Despite the barriers, the potential benefits of PMPs are great, the researchers said, noting that with enhancements to systems, these programs may help reduce prescription drug abuse.

For the research, Drs. Perrone and Lewis looked at opioid prescribing practices of ACMT members, and presented their results at the March national meeting.

For the free full-text article, go to

Federal Government Tests New PDMP Projects in Indiana and Ohio

A new pilot program launched by the federal Department of Health and Human Services (HHS) will make prescription drug data available to prescribers and pharmacists in both ambulatory and emergency departments in Indiana and Ohio. The pilot projects, which will be run by the Office of the National Coordinator for Health Information Technology (ONC), will measure how expanding prescription drug monitoring programs (PDMPs), as the government refers to them, will help reduce prescription drug abuse.

Farzad Mostashari, MD, national coordinator for Health Information Technology (Health IT), said that the pilot projects will help emergency department staff identify a patient’s controlled substance history “at the point of care, to enable better targeting appropriate treatments and reduce the potential of an overdose, or even death.”

“Technology plays a critical role in our comprehensive efforts to address our nation’s prescription drug abuse epidemic,” said Gil Kerlikowske, director of The Office of National Drug Control Policy (ONDCP), in a press statement issued June 21 as the programs were launched. “We hope these innovative pilots will help usher in an era of ‘PDMPs 2.0’ across the nation,” he said. The goals are to improve real-time data sharing, increase interoperability among states, and increase the number of people using PDMPs.

Study Finds Methadone Take-homes Reduce Acute Care Hospitalizations

It’s been known that among patients receiving methadone maintenance treatment (MMT) for opioid dependence, take-home privileges and methadone doses of at least 80 mg/day are associated with better treatment outcomes. But what hasn’t been known is whether patients with take-homes also have fewer acute care admissions, and consequently lower health care costs, or whether they have better health to begin with, thus fewer admissions.

Researchers at three leading academic centers designed a study to find out.

They conducted a retrospective medical record review of 138 patients enrolled in the MMT program at Boston Public Health Commission between 2006 and 2008. The study adjusted for differences in age, sex, race/gender, HIV infection, chronic medical illness, mental illness, and polysubstance use at admission. Thus, patients with these conditions were equally represented in the take-home group and the non-take-home group.

The study found that patients with take-homes had one-fourth the odds of hospital admission of those without take-homes. As expected, medical illness was associated with higher odds of hospital admission. Common diagnoses at hospitalization included pneumonia, upper respiratory infection, cardiac conditions, gastrointestinal conditions, infections, asthma, chronic obstructive pulmonary disease, and trauma. Methadone dose of at least 80 mg/day was not associated with decreased hospital admissions.

The authors wrote, “Although this analysis does not determine whether take-home status directly reduces hospitalization or is a marker of other unmeasured factors, it does account for other known predictors of hospital admission . . . ”  So a difference in health status does not account for the fewer admissions of those with take-homes.

Key Finding: Fewer Admissions Are Not Related to Better Health at Study Entry

“By demonstrating an association between take-home status and hospitalization, an important medical and health system cost outcome, this study supports consideration of take-home status as a useful performance measure reflecting direct benefit to individual patients and the wider health care system.”

In other words, they found the answer to their question: patients with take-homes also have fewer acute care admissions, and consequently lower health care costs, and it is not because they have better health to begin with.

The finding of significantly lower odds of hospital admission carried an adjusted odds ratio of 0.26; 95% confidence interval 0.11-0.62 means that the results are considered statistically valid, regardless of the number of patients.

Authors of the study were seven investigators from Boston University, Vanderbilt University, and Brown University. The National Institute on Drug Abuse provided partial funding. The Journal of Addiction Medicine published the study online June 12.

Walley AY, Cheng DM, Pierce CE, et al. Methadone dose, take home status, and hospital admission among methadone maintenance patients. J Addict Med. 2012. June 12. [E pub ahead of print.]

The Abstract is available at:


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