Revision of SAMHSA’s 42 CFR Part 2: Better Coordination of Care Balanced with Patient Privacy

The federal law holds providers of services to patients with mental health and substance use disorders to a higher standard of privacy than ordinary medical providers. While other providers must obey HIPPA privacy laws, physicians in our field have always had to meet the more stringent 42 CFR standards.

This year, long-standing rules guarding the confidentiality of patients in treatment for substance use disorders were revised, with the intent of allowing better coordination of care for these patients.

Last week, a group of medical providers who work in North Carolina’s opioid treatment programs met on a teleconference when this issue was discussed. (Pre-COVID we held a conference once a month; now we meet once a week). It was obvious that most of us, including me, didn’t know the exact changes made in the revision. Out of curiosity, I decided to dive deeper into this issue and thought I’d pass it along on my blog.

SAMHSA has a great Fact Sheet that describes all of these changes at this website: https://www.hhs.gov/about/news/2020/07/13/fact-sheet-samhsa-42-cfr-part-2-revised-rule.html

The major changes boil down to a few items. Chief among them is that non-opioid treatment program providers can query a central registry of patients receiving care at opioid treatment programs, in order to prevent double enrollment and (hopefully) prevent adverse drug interactions. In the past, providers who didn’t work at opioid treatment programs didn’t have access to this sensitive information.

On the plus side, advocates of this change say that patients being prescribed methadone or buprenorphine at opioid treatment programs will get better care, because their non-OTP doctors will see which of their patients are receiving methadone or buprenorphine from opioid treatment programs, and won’t prescribe medications which may interact.

On the negative side, we worry patients on methadone or buprenorphine could face discrimination and judgmental attitudes from providers who don’t know any better.

I don’t think this revision will change anything at all. It’s difficult enough getting physicians and other providers to check our state’s prescription monitoring program. I doubt any providers will be savvy enough to know they can get access to our state’s central registry of patients in opioid treatment programs, let alone have the enthusiasm to access this registry.

And speaking of prescription monitoring programs…under the revision, opioid treatment programs are now permitted to report the medications they dispense (nearly always methadone or buprenorphine) to their state’s prescription monitoring program.

Again, proponents of this new rule say it will allow for better coordination of care and will prevent medication interactions. Opponents say, as mentioned for the other change outlined above, that it could lead to discrimination against patients getting treatment for opioid use disorder with medications.

Of course, the wording of the revised CFR 42 says the OTP “may” report prescribing data, not that they “must” report. For now, it’s up to the OTP to decide. At present, I don’t think a system is in place to receive this data anyway. During our latest teleconference here in NC, none of the providers said their OTP was reporting to the state’s PMP.

My opinion – and why have a blog in the first place if I can’t blather about my views – is that this new rule is a mistake. I am opposed to OTPs reporting their dispensing data to the prescription monitoring program.

In my county, patients are sometimes treated differently by medical personnel after they reveal they have opioid use disorder and are in treatment with us. And by differently, I don’t mean they are congratulated on their recovery and offered words of encouragement. Instead, they are told something like, “I hope you aren’t here to ask for any pain medication because I’m not going to prescribe it,” even if they are at a routine office visit for treatment of hypertension.

In some cases, patients are told they can’t be accepted as a new patient because the doctor isn’t comfortable treating them. These providers pretend that the patient’s issues are just so complicated that they don’t have the medical expertise. This is an excuse meant to hide an attitude of judgment and contempt for our patient who have the disease of opioid use disorder, and who are viewed as “difficult” patients.

I don’t think patients know about this recent change to privacy law, and I worry they won’t be happy about it. I hope it won’t deter people from entering treatment at opioid treatment programs. Before these changes become operational, we should tell our OTP patients, so they won’t be caught off guard. Of course, patients receiving buprenorphine products at doctors’ offices (so-called office-based practices) already have their data reported to the state’s prescription monitoring program, so it won’t be any change for them.

This revision also said that natural disasters which disrupt treatment facilities should be considered medical emergencies, allowing for patient information to be disclosed without patient consent. I interpret that to mean that if our facility is swallowed by a giant sink hole (not an unreasonable fear in our little town), we could send patient data to another OTP so that our patients could be dosed, without waiting for individual consent forms to be signed. This would streamline care and be more practical. We could also give patient data to hospital emergency departments or other facilities helping those patients during emergencies.

The revision document takes pains to declare that many things have not changed under this revised rule. For example, the document clearly states that law enforcement is still prohibited from obtaining substance use disorder treatment records without a court order. In other words, random police officers can’t come into the OTP and ask if an individual is a patient. We are still prohibited from releasing this information.

This is how things are at the federal level. At state levels, there are different laws about who can access prescription monitoring programs.

In North Carolina, the law changed in 2018, with the HOPE (Heroin and Opioid Prevention and Enforcement) Act. Prior to this, law enforcement had to have a court order to look at a subject’s data on the prescription monitoring program. After HOPE was passed, law enforcement officers can access PMP data if they have a “reasonable, good-faith belief based on specific facts and circumstances,” to access the data. The law has a few safeguards in place; the officer has to a “certified diversion investigator” before given access to the PMP.

I don’t know how this law slipped past me. I don’t like it. It makes me uneasy. With the previous court-ordered access, at least there was a judge who balanced (thoughtfully, one would hope) patient privacy against legitimate law enforcement goals. Now it appears to be left to the judgment of law enforcement officers who may be predisposed to believe their goal is justified.

I remember all the caution that abounded in 2007, when the NC prescription monitoring program first became operational. There was argument about whether the NC PMP could be accessed without patient consent (it could). I was told not to store the printed record of a patient’s PMP report with the rest of the chart, least it inadvertently be forwarded with any request to send records to other providers. The prescription monitoring program was hush-hush private, only for doctors’ eyes, and only to be used to provide better healthcare.

Now, law enforcement doesn’t even need a court order to access it.

I worry law enforcement officers won’t be able to interpret the data they find on the prescription monitoring program. For example, if they look at one of my patients being prescribe buprenorphine/naloxone films, will they look at the “overdose score” that is usually very high for patients on buprenorphine products? Despite warnings from the American Society of Addiction Medicine and other experts, who say it’s not possible to assign an MME (morphine milligram equivalent) to buprenorphine…our prescription monitoring program does just that, thereby implying a patient on sixteen milligrams of buprenorphine is more likely to overdose than a patient on oxycodone and a benzodiazepine. Ridiculous.

I’d like to hear from readers about how you feel about the changes to privacy laws. I don’t think patients, at least in North Carolina, know about the HOPE law that passed in 2018.

Depraved Indifference or Reckless Disregard?

 

 

 

 

 

I have a weird affinity for old “Law and Order” reruns. I’m not talking the lesser “Law and Order” spin offs like Criminal Intent and SVU…I prefer the originals. With a total of twenty seasons, there’s almost always an episode being broadcast on one channel or another.

I recently watched – for perhaps the third or fourth time – an episode about a man with serious mental illness who killed a woman by hitting her on the head with a rock. This man had auditory hallucinations due to schizophrenia. As he described it, his “bad uncle up in Yonkers” told him to kill people. Of course, he wasn’t guilty, by reason of insanity.

But the show rambled on, and detectives discovered this person was recently released from jail at Riker’s Island, where he hadn’t received much in the way of medical care. He hadn’t been properly treated for his schizophrenia, due to cost containment strategies of the company that provided medical care for prisoners. After he served his sentence, this sick man was dropped off with no medication and no plans for follow up medical care.

Jack McCoy, indignant and outraged (as he so often is on “Law and Order”), decided to charge the owner of the healthcare company with manslaughter. The physician assigned to treat the schizophrenic man was initially investigated, but he was able to prove he was threatened with being fired if he used expensive drugs or sent patients to the hospital. So then the owner of the company became the focus of Jack’s ire.

I don’t remember the exact count he was charged with, but the jury found him guilty, and he was sentenced to about a year’s incarceration. – in the very jail that his company contracted with to provide healthcare. The chief District Attorney, Nora Lewin, jokes that his immune system had better be good, because prisoners there don’t receive good health care.

I was thinking again about numerous news reports of patients with substance use disorders who die in jail, and it made me wish we had a few Jack McCoys in various locations.

Do you remember the case of David Stojcevski? I blogged about this horrible case on 10/20/2015, and again 2/25/2016. As a reminder, David was sentenced to thirty days in jail for non-payment of traffic tickets. He died on the seventeenth day of his sentence from what the autopsy said was “Acute withdrawal from chronic benzodiazepine, methadone, and opiate medication.” He had been on physician-prescribed methadone, clonazepam, and alprazolam, but was denied all of these medications during his incarceration. He was also not treated for the predictable withdrawal from these medications.

The family released videotape of his immense suffering (he had been moved to a “monitored” cell when he began to exhibit delirium) and are suing Macomb County, Michigan, where this jail was located. They are also suing Correct Care Solutions, the healthcare provider contracted to attend to the health of inmates.

The Justice Department investigated to see if criminal charges should be levied against the people who allowed David to die by denying him medical care. They investigated the charge of “deliberate indifference” on the part of jail staff and Correct Care Solutions personnel. Last year, the U.S. Attorney for that area announced they couldn’t find evidence for criminal intent on the part of jail workers and Correct Care Solutions that met the standard of beyond a reasonable doubt, so criminal charges were not brought.

Several days ago. the FBI was forced to release part of the documents regarding their investigation.

From the little that was released, the FBI discovered David had no intake of food during the last five days of his life, and that there were no medical visits from medical staff for the last 48 hours of his life. One guard said he got the impression from medical staff that they believed he was “faking” withdrawal symptoms.

The physician employed by Correct Care Solutions, after observing David, said he was not having seizures, and that he was faking those symptoms. An FBI physician said David should have been started on a withdrawal protocol, and that his fifty-pound weight loss and dehydration should have raised alarms. His opinion was that David died because of deliberate indifference to his medical needs.

The FBI’s records on their investigation showed there were medical visits that weren’t documented, or had poor documentation. Other news reports say 12 people have died in that county jail since 2012.

Even though there will be no criminal charges against the people who should have prevented David’s death by providing routine medical care, and the family’s civil case will proceed – at a snail’s pace.

I don’t understand the decision of the Justice Department. How can jails and prisons legally deny medical care to inmates? Isn’t that against the law? And if an inmate dies from lack of medical care from a completely preventable cause, shouldn’t that be illegal? Doesn’t this violate the 8^th Amendment?

There’s a phrase I learned from “Law and Order.” It is res ipsa loquitor, and means “the thing speaks for itself.”

Surely the death of David Stojcevski from a treatable condition speaks for itself.

My question is this: how much louder do similar tragedies need to speak before changes are made to the disgraceful way inmates are treated?

Judges Behaving Badly

 

Methadone and buprenorphine treatment for opioid use disorders saves lives. Over five decades, we’ve accumulated more studies to support this treatment than any other medication, device, or intervention that I can think of. And yet, opioid use disorder appears to be the only disease where medically untrained people dictate medical treatment. The above memo from a judge of the 24^th District Court in North Carolina illustrates this all too well.

Let’s change that sentence in the middle of Judge Ginn’s memo: “Therefore, effective immediately, the use of insulin as a treatment for diabetes will no longer be allowed as a part of any probationary sentence in the 24^th Judicial District.”

It wouldn’t make any sense, would it? People would wonder why a judge was involved in a patient’s medical care. They might even be tempted to believe a judge had no authority to dictate medical care.

I worked in Boone, North Carolina, when this memo was issued, and it caused a great deal of suffering for patients. These patients, contrary to the judge’s beliefs, were doing well on medication-assisted treatments. They were no longer injecting drugs or committing crimes to support their active addiction. Their involvement with criminal justice system almost always pre-dated their entry into treatment. Yet the judge proclaimed they must stop the very medications that were helping them become productive members of society again!

I wrote letters of advocacy and information, citing studies that support MAT. I encouraged patients, and told them to expect their lawyer to advocate for them on this issue. The patients said their lawyers often advised them just to do what would make the judge happy. Patients, understandably, were timid about pushing against a judge with so much power over their lives.

Ironically, many of the people Judge Ginn thought were doing well in his court were also our patients. It was widely known that probation officers’ drug tests didn’t detect methadone or buprenorphine at that time. Unless the offender told the truth about being in treatment on buprenorphine or methadone, the court never knew. I’d estimate that dozens of people successfully passed through Judge Ginn’s court while being treated with buprenorphine or methadone, without him ever knowing about it, due to inadequate drug testing. The people who told the truth were penalized by being told to quit life-saving medication.

I know Judge Ginn is now retired, but I suspect attitudes and beliefs of the judiciary in that area haven’t changed much.

One of the opioid treatment programs in the area tried to advocate for their patients, by seeking some sort of censure against Judge Ginn, but I don’t know what came from that.

The National Institute on Drug Abuse (NIDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) both strongly recommend expanding opioid addiction treatment with medications to criminal justice participants. Congress just passed a bill that recommends spending money to treat opioid addiction in jails and prisons That bill pushes for people with opioid use disorder to get treatment instead of jail sentences. Experts everywhere advocate for expanding medication-assisted treatments to patients involved with the legal system, whether in jail, on parole, or on probation.

All of these actions are great. But Judge Ginn is an example of the many obstacles to implementation of the evidence-based treatments that experts recommend. Particularly in rural Appalachian areas, people in positions of power actively thwart life-saving medical treatments.

I don’t understand how judges can get away with such irresponsible actions. To me, it appears Judge Ginn practiced medicine without a license. If I somehow lost my medical license but continued to practice, I’d be committing a felony.

What if Judge Ginn commanded a patient stop buprenorphine or methadone, and the patient died in a relapse? Would Judge Ginn have any liability, civil or criminal?

I don’t know what can be done about judges like him, but don’t they have to answer to someone? Are they appointed, or elected? If elected, perhaps we need to start understanding judges’ positions on medical treatments before we vote for them.

Inmate Dies From Withdrawal, FBI will investigate

An interesting article from this week’s issue of Alcoholism & Drug Abuse Weekly caught my eye today. On page 4 is the article, “Video of jail drug-withdrawal death leads to FBI inquiry.” This seized my attention, since I view the awful treatment of U.S. prisoners as one of our nation’s biggest moral failings. I get particularly agitated when patients enrolled in medication-assisted treatment for addiction are denied access to medical care.

This story is heart-wrenching.

In June of 2014, David Stojcevski , 32 years old, was jailed in the Macomb County, Michigan, jail for thirty days for failure to pay a traffic ticket. He was denied access to his usual medications; news sources said he was being prescribed methadone, Klonopin, and Xanax for the treatment of addiction. No mention was made of whether he was a patient of an opioid treatment program.

David died seventeen days into his thirty day sentence. His autopsy listed the cause of death as “Acute withdrawal from chronic benzodiazepine, methadone, and opiate medication,” and also mentioned seizures and dehydration as contributing factors.

A jail nurse, noting his medical condition upon intake to the jail, recommended he be sent to a medical detox unit, but her recommendations were not heeded. Instead, when Mr. Stojcevski began behaving in unusual ways, he was sent to a mental health cell, where he was monitored with video around the clock. He was supposed to have personnel checking on him every fifteen minutes. Apparently his withdrawal symptoms were so severe he declined meals and lost 50 pounds within these eleven days. He had what appear to be seizures as he lay on the jail floor dying.

Understandably, David’s family was livid. In order to illustrate the jail’s indifference to their son’s suffering, they posted all 240 hours of the video monitoring on the internet, where it went viral. David’s family is seeking to change the way prisoners on medications are treated, to avoid senseless deaths like David’s. They have also filed a wrongful death lawsuit against the county and against Correct Care Solutions, the company which was supposed to have provided medical care to prisoners in the county jail.

I have often heard my patients describe the callous indifference jailers have toward them as they withdrawal from legally prescribed medication, but it’s quite another thing to actually watch this man die slowly. I only saw a few clips from the local news program above, and was horrified. It does not take any medical knowledge to see how this man was suffering. He became thinner, wasn’t eating, and didn’t get off the jail floor for the last two days of his life. At the very end, he has some agonal respirations, what looks to me like seizure activity, and then becomes still.

Then jail personnel crowd into his cell.

Too little, too late. He’s already dead and can’t be revived.

Some of the frames were televised on the area’s local news segment and can be seen here: http://www.clickondetroit.com/news/man-jailed-for-ticket-dies-in-custody/35452790
Be warned this segment is not for the faint of heart.

This man died from a treatable condition, opioid and benzodiazepine withdrawal.

An addiction expert interviewed by the area’s local television statement called the treatment of this man “unconscionable.”

I could quibble about the appropriateness of prescribing two benzodiazepines to a person with addiction in the first place, but since that’s not the point of this blog post, that’s all I’ll say about that.

Just yesterday, local TV news said the ACLU had filed a request for a formal Justice Department investigation of the Macomb County jail, saying prisoners are having their civil rights violated by the actions at the jail. The ACLU has also asked for an investigation into the judge’s decision to imprison David after he was unable to pay his traffic ticket, creating what was in essence a “debtor’s prison.”

A representative of the ACLU said anyone watching the video could deduce there was “Something systemically wrong at the Macomb County Jail.”

Recently, the Justice Department in Washington, D.C. contacted the FBI, asking them to investigate this case for evidence of criminal behavior on the part of Macomb County jail staff.

Macomb County officials steadfastly maintain they did nothing wrong, have nothing to hide, and welcome investigations into David Stojcevski’s death.

What I saw on this video clip appears criminal to me. The neglect, the reckless disregard for the wellbeing of another human is a far more serious crime than David’s traffic ticket. Every person who worked in that jail who turned a blind eye to the dying man belongs on the other side of the bars.

I am grateful to David’s family for their decision to post this painful video. That had to be a hard decision, but David’s graphic suffering causes more impact than written descriptions. I wonder if the ACLU, Justice Department, and FBI would have gotten involved had his family not publicized David’s gradual death, and had it not gone viral.

This behavior on the part of law enforcement is stupid, inhumane, and egregious. Do these law enforcement personnel have no shame, no basic human decency? Are we in a third world country where prisoners have no rights?

I will follow this story and give updates when possible.

I’d love to see the FBI investigate, and I hope criminal charges are filed. I hope the family sues and wins millions of dollars. I hope something can finally change in county jails across the nation, so that people who are incarcerated are no longer denied medical care.

Methadone and Buprenorphine During Incarceration

I recently got this comment to my blog and I hope the writer won’t mind that I’m highlighting his comment. This comment represents one of my pet peeves: patients in recovery from opioid addiction who dose with methadone/buprenorphine are frequently denied their medication if incarcerated.

“Hello, i was recently convicted of an addiction related crime that happened over a year ago, since the indecent I’ve cleaned up my act, have been taking suboxone for over 12 months, 8mg, 3 times a day and now have to go to jail were I’m going to be denied my medication by jail officials/laws, I’ve been in jail before and i kno they do next to nothing for withdrawing opioid patients? From what i hear, it could take months for that type of dosage to get out of my system? Now being a former i/v heroin user of about 7 years, I’ve done a#on my body and feel my health isn’t exactly top notch, i am legitimately concerned about this withdrawal! Should there be sum kind of law protecting us patients? Aren’t these dangerous withdrawal symptoms? Thanks in advance for your response in this matter!”
I am so sick of hearing about patients on methadone or buprenorphine being denied their treatment while incarcerated! I’d love to see someone sue the excrement out of a jail or prison for denying this life-saving medical treatment.

Most counties jails in rural North Carolina won’t allow patients who are prescribed methadone or Suboxone for opioid addiction to take their medication while in jail. I hear (second-hand) that some jails allow chronic pain patients with opioid prescriptions to take their medication, though this may vary according to the county.

As a health care provider, of course I’m opposed to any refusal to treatment a patient while incarcerated. I think it’s a violation of the 8th Amendment about cruel and unusual punishment, but since I’m no legal scholar, I’ve searched the internet for more information about this situation. I found a great article co-authored by a doctor and a lawyer. They make the point that opioid addiction is a complex illness, and forced withdrawal causes severe physical and psychological suffering. Also, because opioid withdrawal makes people especially vulnerable, they may be coerced into giving testimony that incriminates themselves. They are less able to make decisions. (1)

Prisons are charged to provide as much care as is available to prisoners as general population, yet opioid addicts are denied access to medication-assisted treatments for addiction. These treatments are, as you probably know if you’re a regular reader of this blog, one of the most evidenced-based medical treatments in all of medicine.

Jails face legal implications for the prisoners under their control if adverse health consequences occur during withdrawal. A healthy young person usually won’t die from opioid withdrawal, but a medically fragile patient may die. Then the jail can be sued successfully for wrongful death, as happened in Orange County, Florida. But what a shame that it has to come to that to see any change in jail protocol.

A few years ago, I wrote to both the Tennessee and North Carolina chapters of the ACLU (American Civil Liberties Union), thinking if any legal organization would be willing to take up this issue, it may be them. One person with the NC chapter wrote back that in order to take up a case, they need a specific person with a specific case, and that person needs a local lawyer with whom they can work.

I other words, as a physician, I can’t get something stirred up. It has to be a person who is denied treatment with methadone or buprenorphine while in jail.

That’s what I’m hoping to do with my blog post. My readers know many people. If you are reading this and know someone facing incarceration who will be denied their usual medical treatment of methadone or buprenorphine while incarcerated, encourage them to get a lawyer, and ask that lawyer to ask for outside help.

Here’s the website for North Carolina: http://www.acluofnc.org/

As one might imagine, Tennessee’s chapter of the ACLU has many issues to keep them busy, so check it out at http://www.aclu-tn.org/ On their homepage, there’s an article about Tennessee’s contract with a corrections company that operates facilities in that state. It’s interesting reading, and may help us make sense of some of Tennessee’s horrible decisions around addiction issues (follow the money!). Also check out the TN ACLU’s article of protest against the recent law that makes using drugs during pregnancy a crime instead of a health issue.

I know that AATOD (American Association for the Treatment of Opioid Dependence) works with the Legal Action Center in New York, and they have a great website: http://www.lac.org You can read about their advocacy efforts nationwide, and check out their blog, which has advocacy information about this specific issue of medication-assisted treatment behind bars. I believe that the Legal Action Center works with local lawyers nationwide to serve as a resource. I don’t think the LAC actually takes on the cases of patients in states other than New York, but they also may be able to offer help and resources to other lawyers.

My patients tell me it’s difficult to find a local lawyer willing to take on the case of medication-assisted treatment behind bars. Often, such patients are seen as “bad” for having the disease of addiction. Some lawyers may not want to risk the working relationships they have with the judges in their area by advocating for an issue that the lawyer may not find compelling.
Additionally, it’s easy to intimidate many patients on MAT because they already feel shame and stigma. They have a legitimate fear of making their situation worse if they protest poor treatment by the criminal justice system.

I understand all of that, and I’d probably feel the same way. But what’s being done to patients on MAT – forced withdrawal from life-saving treatments of methadone/buprenorphine – isn’t right, and it’s an abomination to human rights. Let’s support these patients in every way possible. Get lawyers, ask them to advocate for you. If they won’t, contact some of the above resources and write back to me about what their response was.

If you are a friend or relative of a person in such a situation, make noise. Write politicians, call the jails, and call judges, particularly those that are elected. Tell jailers how appalled you are at the senseless suffering of patients denied their usual medical treatment.

Most importantly for this issue and others: register to vote. Find out your elected officials’ positions on the legal issues surrounding addiction, and vote accordingly. If you are an addict in recovery, vote. If you are a friend or family member of someone in recovery or in addiction, vote. Let politicians know you will vote against them if they fail to make good laws based on science.

As for me, I have a standard letter I’m willing to send to my patients’ lawyers and to the judges hearing their cases, advocating strongly for them to be allowed to continue their evidence-based treatment with methadone/buprenorphine.

And yes, I vote.

1.Bruce RD and Schleifer, RA, “Ethical and Human Rights Imperatives to Ensure Medication-Assisted Treatment for Opioid Dependence in Prisons and Pre-trial Detention, International Journal of Drug Policy, 2008, February; 19(1): 17-23.

Criminally Pregnant In Tennessee, Part II

Today my guest blogger Dr. Fedup weighs in on my last entry, “Criminally Pregnant,” with his own unique point of view. He gives counterpoints to my arguments, as he feels Tennessee’s law is a good idea. I’ll let him explain his reasoning. His political leanings are somewhat right of center, as you will read.

“I applaud Tennessee’s new law, which makes it a crime to expose a pre-born baby (I don’t believe in using that word fetus, since life begins at conception) to drugs. Too many babies are born with neonatal abstinence syndrome, so obviously Tennessee has grown too soft on crime for this to be happening.

“Bill number 1391, already passed by the state’s legislature, needs only the governor’s signature to become law. In short, this bill says a mother can be prosecuted for “an assaultive offense or homicide if she illegally takes a narcotic drug while pregnant and the child is born addicted, is harmed, or dies because of the drug.”

“Their governor, Bill Haslam, goofed last year when he passed that Safe Harbor Law, which eliminated criminal charges for pregnant women who went into treatment. This new law corrects and cancels that law. Some people have said that’s inconsistent, and not enough time passed since the Safe Harbor Law to see if it was going to work or not.

“I say it’s OK to be inconsistent so long as you are putting people in jail.

“There’s nothing in the new bill to prevent pregnant, opioid addicted women who are in methadone or buprenorphine programs from being prosecuted as well, though bill 1391 does say, “Illegally take a narcotic drug while pregnant.” Women who enter such treatments have already taken illegal narcotics while pregnant, or they wouldn’t need treatment.

“My only problem with the new bill, SB 1391, is that it doesn’t go far enough. We should put the drug addict babies in jail, too.

“Think about it. You know those little suckers enjoyed the drugs they were getting through the placenta, and they need to be punished for that. They’re born addicts. Start punishing them right out of the womb. That way, the state can teach them right from wrong as they grow up, right there in the prison system, like we do with all other inmates in Tennessee jails.

“Some people criticize my idea. Some people say we already put too many people in jail. But I say if U.S. history teaches us anything, it’s that taxpayers are always happy to spend more money on jails.

“We must be willing to incarcerate more people, because U.S. citizens are more evil and criminal than people in other parts of the world. They must be, because we put more people in jail per capita than anywhere else. Circular logic? I don’t care, as long as it puts bad people in jail.

“It was a happy day when the U.S. could finally brag that we incarcerate more people per capita, than even Russia or Rwanda. We’re Number One! We put 716 people out of 100,000 into jails or prisons, and Russia only puts 484 out of 100,000 in prisons. We’re beating them almost two to one! [1]

“Lots of bleeding heart liberals will complain about how Tennessee jails aren’t set up for infants. I say we can fix that. After all, aren’t play pens just jail cells, only prettier? These addict babies don’t deserve anything too pretty, and they’ll get used to the bars soon enough.

“No measure is too severe if it will fix the drug problem. My critics point to all the information collected since the 1950’s which indicates incarcerating addicts does nothing to help addiction rates. But I’m telling you that this new send-an-addict-baby-to-jail program will work.

“While we are on the topic of evil pregnant women who harm their babies, let’s discuss nicotine addiction. There’s more medical evidence to show tobacco smoking harms babies than there is to show cocaine harms babies. Let’s put all those mothers who smoke into jail, too, since they are intentionally harming their pre-borns.

“Then let’s take this train of thought to its logical conclusion. In the latest issue of the Journal of the American Medical Association, there was a great article about the harm maternal obesity does to the fetus. This article reviewed all of the studies of how obesity affects fetal death and infant death. The conclusion was, “Even modest increases in maternal BMI were associated with increased risk of fetal death, stillbirth, and neonatal, perinatal, and infant death.” [2]

“Sounds to me like it’s time to build jails for the fatties, too. Because the state of Tennessee believes that jail time corrects bad behavior.

1. http://en.wikipedia.org/wiki/List_of_countries_by_incarceration_rate
2. Aune, et al, “Maternal Body Mass Index and the Risk of Fetal Death, Stillbirth, and Infant Death: a Systematic Review and Meta-analysis,” JAMA, 2014; 311(15):1536-1546.

Criminally Pregnant

I usually don’t post a new entry so soon after the last, but this topic is time-sensitive.

I’m getting tired of writing about Tennessee’s crazy politicians but this time their insanity is so egregious that I can’t let it pass without comment.

The Tennessee house and senate passed a bill that allows a woman to be criminally charged if her baby is born drug dependent. If their Governor Haslam signs this bill, it will become law.

As we know, Tennessee has a terrible opioid addiction problem with one of the highest overdose death rates in the nation. Opioid addiction afflicts men and women in nearly equal numbers, and most of those women are in their child-bearing years. Thus, Tennessee has many pregnant women who have the disease of drug addiction.

Naturally, hospitals have seen a growing number of infants born with opioid withdrawal. Small rural hospitals may not have physicians who are educated about how to treat these babies. It’s a frightening situation, and the response is fear-based: make drug use during pregnancy a crime.
Politicians promote draconian laws that will punish these women, who are probably the most vilified segment of society, and gain favor with voters who don’t understand the underlying issues.

So now Tennessee has a law that makes getting pregnant a crime, if you have the disease of addiction. (By the way, there are other illnesses that can harm the fetus if the mom becomes pregnant, but we have no laws making pregnancy illegal for those patients.)

Supporters of this new insane law probably say it should encourage pregnant addicts to get help before their babies are born. That could be true, if Tennessee had adequate treatment programs in place. As we know, methadone and buprenorphine are the best treatments for opioid-addicted pregnant women, yet under this law, this gold-standard of treatment may also be considered illegal.

So should pregnant moms “just say no” and stop using opioids? We know that going through opioid withdrawal while pregnant is associated with bad outcomes for mom and fetus, what with increased risks of preterm labor, placental abruption, and low birth weights. Over the last fifty years, multiple studies repeatedly show better outcomes when you maintain the mom of a stable dose of methadone, or more recently buprenorphine, during the pregnancy.

If this bill is signed into law by Tennessee’s governor, we can predict what will happen.

After all, what would you do, if you are a pregnant addict and know you will be prosecuted if anyone discovers you’re drug user? You avoid prenatal care. Maybe you get an abortion, even if you really want a baby, because you don’t want to go to jail. Maybe you try to stop using opioids on your own, go into withdrawal, and have one of the complications we know to be common in such a situation. Maybe you have preterm labor at 30 weeks and your baby ends up in the intensive care unit for many months. Worse, maybe your baby doesn’t make it. Or your baby does make it, but is taken away from you at birth, because authorities say an addict can’t care for a baby. Your baby enters the foster care system, with its pitfalls.

In short, this law discourages medical care in the very population of women who can benefit the most from medical care and treatment of addiction!

But wait…this law says the woman can be charged if the baby is born dependent. What about pregnant women who smoke? The infants are technically dependent on nicotine, so that meets this law’s criteria. These women can also be criminally charged. Probably Tennessee would have to build a new jail just for those women, and of course Tennessee’s taxpayers would be happy to pay for their incarceration, right?

In the past, laws against drug use in pregnancy have been unevenly implemented. If you look at the cases that have been prosecuted, nearly all involved poor, non-white mothers. Maybe that’s because law enforcement knows that people of higher socioeconomic status can afford hire a lawyer to defend themselves against these ridiculous laws, which always get struck down on appeal, though that can take years.

Policies that inflict criminal penalties on pregnant women with the treatable disease of addiction cause harm to everyone. Hospitals have higher costs when a mom with no prenatal care arrives on their door step ready to deliver, with much higher rates of perinatal complications. Taxpayers end up paying the high costs of incarceration for these women. But most of all, the babies and their moms are harmed.

Let Governor Haslam know how you feel by writing to him: bill.haslam@tn.gov or call at: (615-741-2001)

A Really Good Book – For Free

If you haven’t read CASA’s (Center on Addiction and Substance Abuse, at Columbia University) masterpiece publication from June, 2012, titled “Addiction Medicine: Closing the Gap between Science and Practice,” you should do so. This publication can be downloaded for free, and has essential information about addiction and its treatment. http://www.casacolumbia.org/addiction-research/reports/addiction-medicine

Casa also has other free and informative publications about other issues, like how to reduce the risk of addiction in teens (“The Importance of Family Dinners” series), the cost and impact of untreated addiction on society (“Shoveling Up”), substance abuse and the U.S. prison population (“Behind Bars” series), and the availability of drugs on the internet ( “You’ve got Drugs” series). All of these contain useful and thought-provoking data.

“Addiction Medicine: Closing the Gap between Science and Practice” outlines all aspects of what is wrong with addiction treatment in the U.S., along with recommendations about how we can fix this broken system. When it was published in June of 2012, I thought it would be would be widely read and discussed. However, I’ve only heard it mentioned once, and that was at an ASAM meeting. I wish popular press, so eager to write sensationalistic pieces about addiction, would write more fact-based information.

Every politician should read it. Every parent should read it. Physicians and treatment center personnel should read it. Anyone who is concerned about the extent of addiction and its poor treatment in the U.S. should read it.

CASA describes their key findings of the drawbacks of the U.S. system – or non-system – of addiction treatment. This nation is doing many things wrong, to the detriment of people afflicted with addiction, their families and their communities. Our mistakes are based on ignorance, misperceptions, and prejudice. All of these impede our ability to help our people with addiction. The CASA report describes these factors and how they have contributed to our present situation.
Our nation hasn’t waged a war on drugs, but rather on people who use drugs.

The CASA report describes how public opinion about addiction isn’t based on science. Science proves addiction is a brain disease, yet this fact is still debated. We know that continued use of addicting substances alters the structure and function of the brain, affecting judgment and behavior about the continued use of drugs even when bad consequences occur. We know that half of the risk for developing addiction is determined by genetic makeup. Yet surveys show that about a third of U.S. citizens still feel addiction is due to lack of willpower and self-control. Why are public attitudes so disconnected from science?

Addiction is a complicated diagnosis, existing as it does at the end of the continuum from occasional drug use to regular use to compulsive use. People often compare a drug user with a drug addict. They say that since the drug user was able to stop when he wanted that the drug addict should be able to stop when he wanted. This compares apples to oranges. If someone can comfortably stop using drugs when given a good enough reason to do so, this person isn’t an addict. They may be a drug abuser, a problem user, and at high risk for addiction, but they haven’t crossed the line into uncontrollable use.

The CASA report pointed out that most addiction treatment and prevention isn’t done by physicians and health professionals. Most addiction treatment is provided by counselors who, for the most part, aren’t required to have any medical training. Only six states require a bachelor’s degree to become an addiction counselor, and only one (Alabama, go figure) requires a master’s degree.

Even when physicians are involved in the treatment of addiction, most of us have very little, if any, training in medical school or residencies about addiction prevention or treatment. Ironically, most of our training focuses on treating the consequences of addiction.

In medical school and residency, I spent countless hours learning about the proper treatment of cirrhosis, gastritis, anemia, pancreatitis, dementia, and peripheral neuropathy from alcohol addiction. I had little if any training about how to treat alcohol addiction, and none about how to prevent it.

We know brief interventions by physicians during office visits can reduce problem drinking and are an effective way to prevent problems before they occur. Yet few physicians are trained to do this brief intervention. Even if they are trained, primary care physicians and physician extenders are being asked to do more and more at each visit with patients, and asked to do it with less and less time. Primary care providers may not be adequately paid for screening and brief intervention for problem drinking and drugging, and valuable opportunities are lost. Yet that same patient may consume hundreds of thousands of healthcare dollars during only one hospital admission for medical consequences of problem alcohol use.

When I practiced in primary care, I often thought about how I never got to the root of the problem. I would – literally – give patients with serious addiction strikingly absurd advice. “Please stop injecting heroin. You got that heart valve infection from injecting heroin and you need to quit.” I could see it was ineffective, but I didn’t know any better way at the time. I assumed if there was a better way to treat addiction, I’d have learned about it in my training.

Wrong. The doctors who trained me couldn’t teach what they didn’t know themselves.

In my Internal Medicine residency, I admitted many patients to the hospital for endocarditis (infected heart valve) contracted from IV heroin use. Each time, this required six month of intravenous antibiotics. Back then we kept such patients in the hospital the whole time. You can imagine the cost of a six week hospital stay, not that these addicts had any money to pay. Just a fraction of that amount could have paid for treatment at a methadone clinic, the most effective way to treat heroin addiction, and prevent dozens of medical problems.

But I never referred them to the methadone clinic available in that city. I didn’t know anything about methadone or the medical-assisted treatment of opioid addiction, and apparently my attending physicians, responsible for my training, didn’t know about it either. It was a shame, because in those years, the late 1980’s, we were making new diagnoses of HIV almost daily among IV drug users. Since then, a study showed a patient using IV heroin drops his risk of contracting HIV by more than threefold if he enrolls in a methadone clinic.

I didn’t learn about the evidence-based treatment of opioid addiction until I agreed to work at a methadone clinic for a few days, covering for a friend of mine when he wanted to go on vacation. I was amazed to learn about decades of evidence showing the benefits of such treatment.

Most addiction-related medical expenses are paid for from public funds. In fact, over ten percent of all federal, state, and local government dollars are spent on risky substance use and addiction problems. Sadly, over 95% of this money is spent on the consequences of drug use and abuse. Only 2% is spent on treatment or prevention.

Untreated addiction costs mightily. People with untreated addiction incur more health care costs than nearly any other group. An estimated one third of all costs from inpatient medical treatment are related to substance abuse and addiction. Untreated addicts (I include alcohol addicts with drug addicts) go to the hospital more often, are admitted for longer than people without addiction, and require more expensive heath care than hospitalized non-addicts. The complications these people suffer could be from underlying poor physical health and lack of regular preventive healthcare, but most of the cost is incurred treating the medical problems directly caused by addiction and risky substance use.

Family members of people with untreated addiction have higher health costs, too. Families of people with addiction have 30% higher health care costs than families with no addicted member. I presume that’s from the stress of living and dealing with a loved one in active addiction. Often family members are so caught up in trying to control the chaos caused by active addiction that they don’t take time for routine health visits.

The costs of untreated addiction aren’t only financial. Addiction and risky drug use are the leading causes of preventable deaths in the U.S. Around 2.9 million people died in 2009, and well over a half million of these deaths were attributable to tobacco, alcohol, and other drugs. Overdose deaths alone have increased five-fold since 1990.

We know addiction is a chronic disease, yet we spend far less on it than other chronic diseases.
For example, the CASA report says that in the U.S., around 26 million people have diabetes, and we spend nearly 44 billion dollars per year to treat these patients. Similarly, just over 19 million have cancer, and we spend over 87 billion for treatment of that disease. In the U.S., 27 million people have heart disease, and we spend 107 billion dollars on treatment.

But when it comes to addiction, we spend only 28 billion to treat the estimated 40.3 million people with addiction, and that includes nicotine!

Most of the money we do spend is paid by public insurance. For other chronic diseases, about 56% of medical expenses are covered by private payers, meaning private insurance or self-pay. But for addiction treatment, only 21% of expenses are paid from private insurance or self-pay. This suggests that private insurance companies aren’t adequately covering the expense of addiction treatment. Indeed, patients being treated with private insurance for addiction are three to six times less likely to get specialty addiction treatment than those with public insurance such as Medicaid or Medicare. Hopefully we will see a change since the parity law was passed. (which told insurance companies they had to cover mental health and substance addiction to the same degree they cover other health problems)

In the U.S., we don’t treat addiction as the public health problem that it is. Some people still don’t believe it’s an illness but rather a moral failing. Doctors, not knowing any better, often have an attitude of therapeutic nihilism, feeling that addiction treatment doesn’t work and it’s hopeless to try.

Families and medical professionals often expect addiction to behave like an acute illness. We may mistakenly think addiction should be resolved with a single treatment episode. If that episode fails, it means treatment is worthless. Families want to put their addicted loved one into a 28-day treatment program and expect them to be fixed forever when they get out. They’re disappointed and angry if their loved one relapses.

This reminds me of an elderly man I treated for high blood pressure many years ago. I gave him a month’s prescription of blood pressure medication, and when he came back, his blood pressure was good. I was pleased, and I wanted to keep him on the medication. He was angry. He said he was going to find another doctor. He thought the one prescription should have cured his high blood pressure so that he would never have to take pills again, and was disappointed with my treatment.
If we keep our same attitude toward addiction treatment, we are doomed to be as disappointed as my patient with high blood pressure. Addiction behaves like a chronic disease, with period of remission and episodes of relapse.

We have a lot of work to do. As this CASA publication shows, we have to change public attitudes with scientific information and do a much better job of training physicians and other health care providers. We should pay for evidence-based, high-quality addiction treatment, rather than spend billions on the medical problems caused by addiction as we are now doing.

Check out this landmark publication at CASA’s website: http://www.casacolumbia.org

Bad Science on “Homeland”

Bad Science on “Homeland”

I’d like to announce my willingness to serve as a media consultant on topics relating to opioid addiction. I’m prompted to do this after another bit of bad science on TV.

There I was, catching up on recorded episodes of “Homeland,” one of my favorites. One of the main characters, Brody, was on the run since he was suspected of planting the bomb that blew up the CIA. He survived an abdominal gunshot wound, and then was imprisoned in a weird high rise for the homeless in Venezuela by a mysterious group of people who may or may not have his best interests at heart. To treat both his physical and mental pain, he was encouraged to shoot up opioids, and he became addicted.

Saul, acting head of the CIA, flies to Venezuela to fetch Brody back to the U.S. for a top secret mission. He found Brody, strung out of opioids, living in squalor, and in terrible shape. He’s so appalled by the smell in Brody’s cell that he does the male equivalent of a pearl clutch…he puts a handkerchief to his nose. Brody is transported back to the states, where he goes into terrible opioid withdrawal. He’s screaming, groaning, and stewing in secretions.

Saul needs him to be well in order to take part in a clandestine mission in Iran. Saul asks his staff if there’s any way to get Brody back into shape and out of withdrawal faster. One of the team mentions methadone, and Saul says something like no, we need for him to be functional.

No one mentions buprenorphine.

Shifty CIA operative Dar Adal pipes up that ibogaine will cure Brody but will have bad side effects like hallucinations. A sidekick adds, “Yes, violent, mind-bending hallucinations.” Adal then mysterious says (everything he says is mysterious) “Take my word for it.”

So they give poor Brody ibogaine, and he has violent, mind-bending hallucinations. He screams. He cries. He has terrifying hallucinations of his old war buddy, now dead. At one point presses his face to the window of his cell, screaming, “What did you give me??”

I guess such histrionics make better TV than seeing Brody look normal after several days of methadone or buprenorphine.

After the agony of the ibogaine, Brody is well enough to start running and getting back into shape.

Now for the truth: Ibogaine is a hallucinogenic psychoactive substance found in some species of plants that grow in Africa. It’s been used in religious ceremonies, chewed to give a mild stimulant effect. With increased doses, this substance has hallucinogenic effects. Ibogaine has effects on at least three types of brain receptors. Ibogaine’s metabolite, noribogaine, has serotonin reuptake inhibition properties, like found in many antidepressants. It also has a weak opioid effect on the mu opioid receptors and a stronger effect at the kappa opioid receptors, causing less dopamine to be released. It also has effects on at least two other receptor types.

Limited studies show that since the drug does block the release of dopamine, it may have some benefit in the treatment of addiction. Both animal studies and case reports suggest ibogaine may reduce withdrawal symptoms of opioid addiction and craving for cocaine. But so far there have been no good scientific trials of the drug. This drug has been outlawed in the U.S. and in most European countries due to concerns about the drug’s side effects and case reports of death. (See my blog post of June 1, 2013) Ibogaine’s supporters claim this drug can cure addiction to alcohol, cocaine, opioids, and nicotine.

In other words, there are case reports of possible benefits of ibogaine, but it is not at present an evidence-based treatment for opioid addiction.

I’m really getting annoyed with Homeland. It was my favorite show in the past, but started to drag this season. (Don’t get me started on the booooring Dana storyline.) Now it has me snorting in disgust at bad science.

Thin ice, Homeland…you are on thin ice with me. If you need a medical consultant, I’m available.

Medical Care in Opioid Treatment Programs: Red Tape

At recent meetings of OTP medical directors in my state, we’ve had renewed discussions about how to provide primary care and psychiatric care to program patients.

Opioid treatment centers that are able to offer a wider array of services than just dosing with methadone show better patient retention in treatment and better patient outcomes. This means that the more services that are added, like psychiatric care, primary medical care, help with employment, and family counseling services, patients in those programs have better outcomes than patients in programs that offer only medication and individual counseling. This shouldn’t be a surprise; it makes sense to me. (1)

The problem is, of course, these extra services cost more to the treatment program. If you want to offer psychiatric services, a psychiatrist must be hired, usually on a contract basis, to be available during dosing hours. If the program’s medical director is a psychiatrist, that doctor has to be paid for the extra time it takes to provide the extra care. More commonly, patients are referred to other places for low-cost psychiatric help.

It’s the same with medical care. In order to offer any level of primary care, you have to hire a doctor, unless patients are asked to pay extra for this. Most patients can barely afford basic treatment, so extra expenses can’t be obtained.

At both of the programs where I work, I used to offer some level of primary and psychiatric care. I used to try to treat uncomplicated mental illness like depression and anxiety disorders, and non-chronic, low-intensity primary care illnesses. Of course I referred patients who needed ongoing medical or psychiatric care, but was able to provide them some level of care until they got an appointment, or were able to afford an appointment. I already knew their history of addiction and didn’t prescribe anything that would interact with methadone or buprenorphine, of course. It didn’t cost the patient anything to see me for these extra services, so it saved patients money. I saw six or seven such patients each time I worked at the clinic, and they didn’t necessarily need any appointment. It seems like a good thing all around.

But then came time for us to have our first CARF survey in one program.

Treatment centers want to be certified by the Commission of the Accreditation of Rehabilitation Facilities (CARF). CARF personnel are invited to facilities for a voluntary inspection. These OTPs hope to be given a sort of seal of approval by this agency. The CARF agency inspects mental health, substance abuse treatment, and physical rehabilitation facilities, as well as youth and family service facilities. Accreditation is important because it demonstrates the facility is providing good care.

Our CARF survey went fair in most regards. We got a one-year accreditation, and the CARF surveyors had good things to say about our clinic regarding our dedication to our mission to help our patients. They said great things about the staff enthusiasm and outlook. But they did not like how I was providing primary physical and mental healthcare. The CARF people supported the idea of providing primary care to patients, but they had many recommendations about how to do it. They wanted implementation of a few policies and procedures. This is what they recommended, verbatim:

F.2.a.(1) through F.2.b.(16)
It is recommended that ongoing documented training and education on medications be provided to the person served, family members, individuals identified by the person served, the team, and service providers. This ongoing training should include how the medication works; risks associated with each medicine; the intended benefits as related to the behavior or symptom targeted by the medication; side effects, contraindications, and potential implications between medications and diet/exercise; risks associated with pregnancy; the importance of taking medications as prescribed, including, when applicable, the identification of potential obstacles to adherence; the need for laboratory monitoring; the rationale for each medication; early signs of relapse related to medication efficacy; signs of nonadherence to medication prescriptions, including alcohol, tobacco, caffeine, illicit drugs, and alternative medications; instructions on self-administration, when applicable; wellness management and recovery planning; and the availability of financial supports and resources to assist the persons served with handling the cost associated with medications.

F.a.(1) through F.4.c.(3)
It is recommended that, when medications are prescribed for or provided to a person served (including those self-administered medications), an up-to-date individual record of all medications, including nonprescription and non-psychoactive medications, include the name of the medication; the dosage; the frequency; instructions for use, including the method/route of administration; and the prescribing professional. The program should provide ready access to the telephone number of a poison control center to the program personnel and the person served. Written procedures that address how the medication will be integrated into the overall plan of the person served should be available. There should be a process for identifying, responding to, documenting, and reporting medication reactions and actions to be followed in case of emergencies related to the use of medication.

F.5.a.through F.5.n.
It is recommended that, as the organization prescribes medications, it implement written procedures that include compliance with all applicable local, state or provincial and federal laws and regulations pertaining to medications and controlled substances, including on-site pharmacy services and dispensing. Written procedures should include the active involvement of the persons served, when able, or their parents or guardians, when appropriate, in making decisions related to the use of medications; the availability of a physician, pharmacist, or qualified professional licensed to prescribe for consultation 24 hours a day, 7 days a week; documentation and reporting of observed and/or reported medication reactions and medication errors; and a review of past medication use, including effectiveness, side effects, and allergies or adverse reactions. Written procedures should include the identification of alcohol, tobacco, and other drug use; use of over-the-counter medications; use of medications by women of childbearing age; use of medications during pregnancy; special dietary needs and restrictions associated with medication use; necessary laboratory studies, tests, or other procedures, when applicable; documented assessment of abnormal involuntary movements at the initiation of treatment and every six months thereafter for persons served receiving typical antipsychotic medications; when possible, coordination with the physician(s) providing primary care needs; and review of medication use activities, including medication errors and drug reactions, as part of the quality monitoring and improvement system.

F.6.a. through F.6.f.
If the organization provides prescribing of medications, it is recommended that it implement written procedures that include screening for common medical co-morbidities using evidence- or consensus-based protocols; evaluation of co-existing medical conditions for potential medications impact; identifying potential drug interactions, including the use of over the counter or homeopathic supplements; documentation or confirmation of informed consent for each medication prescribed, when possible; continuing a prescribed medication if a generic medication is not available; and continuity of medication use, when identified as a need in a transition plan for a person served.

F.7.a.through F.7.b.(2)
It is recommended that, as an organization that provides prescribing of medications, it demonstrate, to the extent possible, the use of treatment guidelines and protocols to promote state-of-the-art prescribing and ensure the safety of the person served. It is also recommended that a program of medication utilization evaluation include measures of effectiveness and satisfaction of the person served.

F.8.a. through F.8.e.(2)
As an organization that provides prescribing of medications, a documented peer review should be conducted at least annually on a representative sample of records of persons for whom prescriptions were provided in order to assess the appropriateness of each medication as determined by the needs and preferences of each person served and the efficacy of the medication. It should be used to determine if the presence of side effects, unusual effects, and contraindications were identified and addressed and if necessary tests were conducted and used to identify the use of multiple simultaneous medications and medication interactions.

F.9.a. through F.9.c.
It is recommended that information collected from the peer review process be reported to applicable staff, used to improve the quality of the services provided, and incorporated into the organization’s performance improvement system.

Huh?
I was overwhelmed. I’m a relatively intelligent person, but I’m still fuzzy on exactly what they mean. Here are some of my concerns:
-I already record a full history and physical on each patient, and have a record of all medications each patient takes. But apparently the way I’m doing this isn’t adequate, and I’m left to wonder what the specifics of their recommendations would look like.
-Get a signed informed consent in order for me to write a prescription? This is not generally done in primary care. Maybe if I were administering chemotherapy…but I was prescribing things like penicillin for an infected tooth. I’m not sure what the justification for this is in a methadone clinic population.
-Apparently I need to give each patient a written summary of all side effects of a prescribed medication. I don’t do this in primary care, because the pharmacy does all of that. Each time a prescription is filled, they give a long sheet of possible side effects. What’s the rationale for redundancy?

When faced with the task of complying with all of these recommendations, the owners of this clinic said forget it. They told me to prescribe only the methadone and buprenorphine, and when I saw other medical problems, provide a referral to doctors in the community. That way, the opioid treatment center won’t be penalized by CARF for not implementing…well, the byzantine recommendations above. I still don’t know exactly what CARF meant. Maybe I should say I don’t know what their recommendations would look like in real life.

Not providing any primary care took pressure off of me, but our patients were left with less medical care than they already have, which is little. It’s really hard to “coordinate care” for patients who have no insurance and no money. Yes, I know there are free clinics available in many areas, but they only provide a limited amount of care and follow-up. And specialty care is unattainable.

At our next CARF survey a year later, our program got good marks from CARF, and a three-year accreditation, instead of only one year. Without requirements around primary care to meet, it was simple.

CARF does a needed service, but in many matters I think it’s important to pull back to see the whole picture. Plus, drop the jargon and use words that make sense, please. It’s similar to the paperwork requirements for Medicaid – most of this paperwork is probably needed in some form or fashion, but I’ve seen the repetition. Leave counselors time to counsel.

Regulations are important. But don’t make the regulations so obscure and onerous that most clinics stop providing any extra care because of the difficulty meeting these requirements.

I’d love to see my state’s methadone authority work with the CARF organization. Maybe together they could issue new guidelines for primary care in opioid treatment programs that make sense. Then programs may be more likely to offer extra services.

(1) McLellan AT, Arndt IO, Metzger DS, Woody GE, O’Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA 1993;269(15):1953-59