Talk about your unintended consequences

Opioid Prescriber Monitoring May Increase Overdose Deaths

http://www.medscape.com/viewarticle/836489

AVENTURA, Florida ― Surveillance of opioid prescribers, designed to prevent opioid overdose deaths, may actually be having the opposite effect, new research suggests.

 
Sonia Mendoza

The qualitative study, aimed at assessing doctor-patient interactions after a prescription monitoring program (PMP) known as “I-STOP,” which was mandated by New York State in 2013, showed that Staten Island prescribers of opioids are refusing patient requests for the drugs, “are abruptly discontinuing long-term narcotic treatment, and are refusing to accept new patients who are at risk of nonmedical narcotic use,” report investigators.

In addition, clinicians predicted that effects of the program will lead to an increase in the use of heroin and illicit opioids by those dependent on prescription opioids, as well as an increase in state border crossings to obtain prescriptions.

Lead author Sonia Mendoza, research coordinator at New York University and the Nathan Kline Institute for Psychiatric Research, in New York City, told Medscape Medical News that although increased transparency from PMPs offers benefits, this particular program has also led to an increase in discharges upon discovery of diversion.

“We found that a lot of prescribers were afraid that patients would simply go to New Jersey because they had no access to New Jersey’s monitoring program,” said Mendoza.

“They thought it did increase honesty and transparency regarding patients’ behaviors. But at the same time, they didn’t have comprehensive care for the patients, which led to discharges without proper referrals,” she added.

The study was presented here at the American Academy of Addiction Psychiatry (AAAP) 25th Annual Meeting and Symposium.

Opioid Overdose Epidemic

The investigators report that Staten Island has four times the number of opioid overdose deaths of any other New York City borough. As a result, enhanced surveillance by law enforcement has been instituted for opioid prescribers.

Operational PMPs are now in place in 48 states. In New York, the PMP is known as the Internet System for Tracking Over-Prescribing (I-STOP) and is a registry for all prescriptions of Schedule II, III, and IV controlled substances.

For the study, the investigators recruited clinicians through the Substance Abuse and Mental Health Services Administration (SAMSHA), which lists all opioid maintenance–certified prescribers in Staten Island and the other boroughs of New York City. Community-based buprenorphine-certified prescribers and patients underwent semistructured interviews and “ethnographic observations.”

“We wanted to look at the impact especially in primary care physicians who don’t have a background in addiction psychiatry,” said Mendoza.

 Results showed that after I-STOP was put in place, providers have reported discharges, but sometimes without proper referral.

One prescriber noted during the study that 20% of these patients were discharged from his practice. “You find that they go to different doctors and are not honest. They’ve taken more medicine than they’re supposed to do. You have to sit down and talk to them for a long time [and] give them a chance to be honest,” he said.

“You’re reigning in the people who are making money on the side, and if I can fix [patients] rather then throw them back out there, I try. Sometimes it works, sometimes it doesn’t,” said another study interviewee. “The moment you find diversion, you let them go; I-STOP is to detect diversion.”

 Regarding whether patients might cross state borders to get prescriptions, one prescriber said, “they can go to Jersey and I-STOP won’t know,” and another said, “they cross the bridge and get a prescription; if they want to do something, they do it.”

Interestingly, both providers and patients reported ambivalence about I-STOP’s overall effect on patient behaviors.

The program “has caused a major heroin problem in Staten Island. They turned a pill problem into a heroin problem,” said one prescriber.

 

However, another countered that he felt that he was on the right track. “It’s validating and has improved the link and communication between patients and doctors.”

Fear-Driven?

Overall, the findings suggest that “drug policies that target prescribers for sanctions in an effort to maintain boundaries around ‘legitimate’ medical use of opioids may paradoxically be leading patients to use illicit drug markets and to higher risk narcotic use,” write the investigators.

 

Mendoza added that many of the interviewed prescribers said that “clamping down on opioid analgesics” was correlated with increased heroin use or their patients turning to the streets for illicit opioids.

“And that has been confirmed in the latest Department of Health data from New York State,” she said.

“They are also aware that the DEA is closely monitoring. So if a patient is deviant, they discharge them because they are just afraid of the consequences to themselves.”

Mendoza noted that specific protocols need to be created to better guide clinicians.

“Additional interventions to educate prescribers and provide support for substance abuse treatment, patient referrals, and harm reduction interventions such as naloxone kits…are needed to complement prescription monitoring programs,” write the investigators.

 

In addition, Mendoza reported that some of the most successful interviewees described having contracts with patients for periodic urine tests and random pill counts.

“Also, having better relationships with their patients and longer consultations were important.”

Need for Checks and Balances

Maria Sullivan, MD, PhD, associate professor of psychiatry at Columbia University Medical Center in New York City, told Medscape Medical News that the study authors called attention to the increased burden on prescribers, in terms of time and effort, to comply with the state’s 2013 mandate.

 
Dr Maria Sullivan

“I would agree that there is a higher burden on providers. However, the intention of this electronic monitoring program is to reduce the very substantial overdose death rates that have been occurring. And there is some preliminary evidence that it is beginning to have a positive impact,” she said.

 

Dr Sullivan, who was not involved with this research, is also chair of the AAAP research committee and chair of the clinical expert panel for the Providers’ Clinical Support System for Medication Assisted Treatment.

She noted that although there is some variability in the way different states have adopted these programs, “it’s really checking at the point of each prescribing that ensures that there is not multiple providers involved.”

“I think that the balance is clearly in favor of implementing electronic prescribing in terms of improved patient outcomes and reducing public health costs.”

 Dr Sullivan added that fear is “an unfortunate response” from some prescribers and noted that there are current initiatives sponsored by SAMHSA to train providers who have not previously felt comfortable prescribing buprenorphine or naltrexone for opioid dependence.

“Ultimately, these programs are protective for the physician as well, because you can have a higher confidence level that the opioids you’re prescribing are not being diverted or misused,” she said.

“I really think these are necessary checks and balances trying to stem the tide of the current opioid epidemic.”

 The study authors have reported no relevant financial relationships. Dr Sullivan reported having received medication study samples from Alkermes.

American Academy of Addiction Psychiatry (AAAP) 25th Annual Meeting and Symposium: Abstract 44, presented December 6, 2014.

3 Responses

  1. However, the intention of this electronic monitoring program is to reduce the very substantial overdose death rates that have been occurring. And there is some preliminary evidence that it is beginning to have a positive impact,” she said.

    I hate it when people lie or use misleading statements to support their positions. The preliminary “evidence” she’s talking about was created by highly suspicious sources, and the positive impact shown is a very low percentage of reductions in overdoses. And the “evidence” shows correlation, not causation. You’d think doctors would know the difference, but apparently not.

    In some states with a long-standing PDMP, the problems have actually increased, which just goes to show you that Dr. Sullivan doesn’t know what she’s talking about — or she’s using questionable results to further her own political agenda and ambitions.

  2. Depending on whom one speaks to, these are mostly bad actors or are mostly made up of legitimate chronicle pain patients who were either discharged and/or under-medicated. This issue has become so politically charged that the truth is difficult to determine. The truth is that it is probably an almagam of all those populations. The result is that we either have what is described in both quoted blocks below. Once and again we find the State compelling the prescribers and the pharmacists to be fully engaged in dealing with a huge problem that is of the State’s creation. This is all just another variation of the DEA’s perennial favorite, a game known as Whack a Mole.

    “Mendoza added that many of the interviewed prescribers said that “clamping down on opioid analgesics” was correlated with increased heroin use or their patients turning to the streets for illicit opioids.”

    AND

    “Regarding whether patients might cross state borders to get prescriptions, one prescriber said, “they can go to Jersey and I-STOP won’t know,” and another said, “they cross the bridge and get a prescription; if they want to do something, they do it.”

    For the sake of the myriad of innicents that are harmed or killed in this futile Prohibitionist group of opioidophobiic policies and the resulting laws, this madness needs to stop and we need to try something else. Anything that moves significantly away from the black market, the violence, the badges, guns and cages of the current policies, and for those that want to quit, towards education, hospital beds, detox and rehab; a safer supply with safer places for those that don’t wish to quit abusing the opioids needs to be a piece of this model too. I asking that we consider tossing out the Prohibitionist model and replace it with a Harm Reduction Model.

  3. I just saw a 38-year-old gentleman with congenital hypotonia. He’s been followed by Dr. Kathy L. He’s been on a high dose opiate pain relievers for over 10 years. Dr. L apparently retired from St. P medical group. She is now going to serve the VA.
    Apparently this patient’s new physician at St. Peter’s Dr. F is refusing to manage him. He was referred to Dr. M who was willing to give him about a third of his previous medication dose. Dr. M recommended he get a medical marijuana card.
    This patient has been on disability for many years. Medications , including his opiate pain relievers currently cost him three dollars a month. He and his mother and his father that he lives with are all on very low fixed incomes.

    Patient came to me today because he’d heard that I would be able to help him.
    Alas, given the hostile regulatory environment in which we find ourselves, I am unwilling to risk my license, health, and freedom as the only doctor in Montana willing to prescribe medications at this kind of level.

    Patient was tearful and upset as was his mother. The reason I’m communicating this to you is at the bottom of the page of the electronic medical records from Dr. L, it indicates “patient centered medical home”.

    When I think of the concept of the home, I think of a roof over one’s head
    walls
    insulation
    heat
    running water
    and above all, safety.

    I refilled all of his medications in a quite extensive list. Then I recommend he return to Saint peters medical group and his so-called “patient centered medical home”. I’m thinking he could consider his abandonment by Saint peters medical group as a violation of the Americans for disabilities act.
    Once again I recommended that he contact the governors office,
    Senator tester
    Senator Daines
    representative Zinke
    and local media.

    This patient is bereft. I ackknowledged with him the severity of the situation in which he finds himself. I did Fill out his medical marijuana paperwork, The patient is skeptical that that will do any good and upset at the fact that his safe and stable opiate program that is easily affordable for him is now being disrupted.
    I did a DNA test on him, I’m fairly certain he’s and ultra rapid metabolizer of opiates.

    Given his congenital hypotonia I do not consider him a candidate for gabapentin or Lyrica. Given the recent cardiovascular complications noted around anti-inflammatories I cannot in good faith recommend that for him either. He is on cymbalta

    . The physicians of the BOME should know the severity and desperation that patients in pain in Montana keep finding themselves in.

    If this is what a medical home is, then we have a quarter of our population currently medically homeless.

    We are torturing the most vulnerable in our population, and it is unconscionable.

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