A Case for Increased Regulation

 

It is a generally accepted fact that we (US & Canada) are experiencing an “Opioid Epidemic.” The President of the United States, Donald Trump, recently declared this epidemic a National Health Emergency and signed an Executive Order to provide authority to various government departments regarding a rapid response plan. The Center for Disease Control and Prevention reports that around 1,000 people a day need to be treated in relation to the effects of opioid use and 33,000 people died during the year of the study (CDC, 2015). Worse still is a death rate of 52,000 during the following year as reported by Attorney General Jeff Sessions. The situation continues to deteriorate due to the illegal market using additives such a carfentanil to increase the effect of street Heroin while lowering the cost. This synthetic opioid is so powerful that two crystals similar in size to salt is lethal. Clandestine manufacturers do not have the pharmaceutical expertise to transform the crystalline substance to powder and blend it with the Heroin in consistent measured doses, making it inevitable that the strength varies significantly even within small quantities such as 1 gram. Accidental lethal doses are now becoming common, increasing the already disastrous mortality rate.ODMedical prescribers are also a huge part of this complicated problem. In the 15 years preceding the report of opioid deaths, prescriptions for opioids quadrupled but there was no change in the amount of pain reported, and significantly, the number of deaths involving prescription opioid overdoses also quadrupled (CDC, 2016). The role of pharmaceutical companies is also significant as their sales reps are the primary source of information for a lot of woefully under trained doctors.

The amount of overdose events is so prolific that it is common for fire and police departments to administer a revival drug (opioid antagonist) called naloxone (Narcan) in addition to paramedics. This requires additional training and accountability depending on the route of administration. There is a nasal mist, an intermuscular injection device similar to an epi-pen and intravenous injection.

What we have here is a situation that is out of control and growing worse over time. Doctors, feeling societal pressure, have drastically reduced their prescribing of opioids but unfortunately this has had the effect of legitimate pain management patients to be undertreated and often being forced to turn to the illegal market for relief; compounding the problem.

This is an instance that calls for more government regulation. Doctors should be certified before prescribing opioids and the training must be consistent and meet specific  national and eventually international standards. First responders also need standardized training, not only on administering revival medication but on the nature of addiction and the need to stop seeing addiction as a crime in and of itself. Addicts will commit crimes to pay for their drugs but an education is desperately needed to combat current biases and treat addicts as people in need of assistance instead of prison. Then we have the problem of the criminal element that manufactures, imports and distributes opioids. In addition to narcotic interdiction and more security at our borders, a change in criminal enforcement policy as well as drug classification changes need to be addressed if we are to eliminate the illegal drug trade and the criminality associated with it. This can only be accomplished through government regulation which will, in some cases, result in less criminal sanctions and more evidence based treatment programs as well as substance use education. Indeed, more regulation will lead to less criminal enforcement but it is only through regulation that standards can be set for a transfer of responsibility from law enforcement to health care. Opioids are a particular class of narcotics that have far reaching effects when a human becomes physically dependent. When the drug dose is reduced or stopped, the physical and mental distress of the patient is extreme. The abstinence syndrome or “withdrawal” period can last for weeks or months. The ordeal is so onerous that 30-91% of those opioid dependent persons attempting a detoxification program give up and drop out (Singh and Basu, 2004) only to return to opioid use and the risk of adverse consequences up to and including death by overdose. The trauma this causes families, loved ones and colleagues cannot be measured accurately. A government’s first responsibility is to the safety of its citizens. The Opioid Epidemic is most emphatically a Public Safety issue and it is the responsibility of the government to serve its citizens and put regulations in place.opioid injection

I am suggesting a 7 point strategy:

  • Treatment: Treat the physical dependence and provide psychological counselling to the patients.
  • Education: Initiate an education program that begins at an early age all the way through high school in an effort to prevent this from reoccurring. Prevention is preferable to treatment after the fact.
  • Decriminalization: Initiate Drug Courts to refer drug related cases to treatment programs without the stigma of a criminal record that could adversely affect the citizen for life. [This will meet with public resistance and may take time to develop an ethical coercion campaign to educate them on the benefits]
  • Regulation: Pharmaceutical companies need to be regulated and held accountable for both their production and marketing of opioid medications.
  • Certification: Doctors need to be trained and certified in pain management and treatment requiring recertification to ensure best practices and avoid undertreating legitimate pain patients.
  • Interdiction: Increase interdiction of illegal narcotics domestically while securing international borders.
  • Legislation: Introduce legislation making it legal and safe for Certified Doctors to prescribe pharmaceutical Heroin (diamorphine) to those patients who can forensically be verified as being physically dependent on illegal street Heroin. Diamorphine has been a pharmaceutical product in Britain since the 1920s and many European countries for decades. Switzerland has conducted many large scale studies showing the efficacy of the treatment which eventually convinced Germany to follow suit. This will eliminate the underground criminal market and will ensure that the citizen who is diagnosed with Opioid Use Disorder has a safe and consistent dose of the drug with the agreement that a conversation begin. In order to get a week’s supply of Heroin prescribed, the patient would need to give up one hour of his time a week to chat with a drug counsellor. There is no end date but the objective would be to have the patient detoxify if possible but other managed options should also be available such as replacing the heroin injections with a long acting oral opioid like Methadone or Buprenorphine. It has to be the patient’s decision to seek treatment since the patient’s participation is absolutely required for success. Should the patient be unable to bear the distress of a lengthy withdrawal, they should be allowed to demand an exit from the program and return to their current prescription opioid. They may try as often as they are willing, with no penalty if unsuccessful. Relapse is part of the journey to recovery. There is a third option for intervening in this Epidemic/National Health Emergency which brings us back to strategy point one; treatment.

The Case for Ultra-Rapid Opioid Detoxification as an Intervention Strategy for the Global Community

Earlier I described the horrific suffering involved with withdrawal from a strong opioid and the understandably high dropout rate from this natural detoxification process. Although the withdrawal is not fatal, the distress can be so bad that patients at times may find death preferable to another day of this intense mental and physical trauma. The symptoms of withdrawal include acute diarrhea, vomiting, intense sweating, goosebumps, extreme depression, flu-like malaise, cramping, skin nerve reactions that feel like bugs crawling on or under the skin. Suffice it to say that it’s an ordeal for the patient. Many describe it as the sickest they’ve felt in their life.

Ultra-Rapid Opioid Detoxification (UROD) is a medical procedure whereby the opioid dependent patient is put to sleep under anesthesia and given a drug called Naltrexone which blocks the opioid receptor in the brain, almost instantly starving the brain of the opioid and causing an acute abstinence syndrome or accelerated withdrawal. The patient is not conscious and is unaware of the traumatic withdrawal symptoms. During this time the vital signs are closely monitored as well as the signs of the intensity of the withdrawal. When the withdrawal has subsided to a tolerable level, the patient is relieved of the anesthetic and is heavily sedated. Other drugs are given to offset the residual withdrawal symptoms and the patient is kept sedated and comfortable. After 48 hours, the patient is given some prescriptions to take for the next week or so and can be released into the care of family or a home care worker to recover from the procedure. While the patient is under anesthesia, a slow release pellet of the drug Naltrexone that was used to induce withdrawal is inserted in the fatty layer under the skin in the lower abdomen and will continue to block the opioid receptors for up to 6 months so that the cravings stop and even if they relapsed and used an opioid again, they wouldn’t get high because the neurotransmitter is blocked. To illustrate the strength of Naltrexone, consider Heroin to be masking tape in terms of its “stickiness” and think of Naltrexone as Velcro. The Heroin doesn’t have the binding ability to overpower the Naltrexone. Detoxification will be 100% complete and Behavioral Therapy (Cognitive or Dialectical) can move forward.

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Because this procedure needs to take place in a fully functioning medical environment for anesthesia, the cost is high and it wouldn’t make sense to build these clinics in smaller communities. Since the expertise is very limited it would make more sense to build treatment centers in larger metropolitan cities in each state or province and have the patients travel to the center for the treatment. By centralizing specialists in large clinics, it could also function as a center for natural detoxification and psychological counselling. Each Center could be a teaching hospital so that others could get certified.

There have been problems in the past with this procedure because it was unregulated. The level of care was inconsistent and some people died needlessly. But peer reviewed articles have shown the procedure to be both safe and effective (Salimi Al, Safari F, Mohajerani SA, Hashemian M, Kolahi AA, Mottaghi K, 2014). Traditional methods such as weaning or titrating, even when substituting Methadone, are usually unsuccessful. Also, because the experience causes such distress, it deters people from attempting it (Kaye, et al. 2003). There are detractors who say that there is no benefit to using the procedure; that the risks of anesthesia are high and will not recommend it ( Gowing L, Ali R, White JM, 2010). If the procedure was regulated, a standard of care could be maintained and as was shown earlier, the benefits are very evident both to society (legal, medical costs and crime rates) and the patient (stable, crime free life) who is suffering with the disorder.

Another potential roadblock to wide acceptance of UROD is the entrenched bias of addiction clinic medical doctors who make a living prescribing Methadone and Buprenorphine substitution medications. These patients represent regular customers for life. The pharmaceutical companies who manufacture and sell these long acting substitution opioids are also potential lobbyists against the treatment because as noted earlier, this would be a lifelong treatment and represents significant profits. The only way to counter the propaganda of the pharmaceutical companies targeting public opinion would be a social media campaign. Ten years ago it would not have been possible to compete with television advertising but with the spread of social media it is now possible, especially with an issue that has the spotlight on it like the Opioid Epidemic does. People on substitution medications are still Opioid dependent; one opioid was simply switched for another one. There are health benefits compared to using street drugs, to be sure. Substitution is not a treatment for addiction. If pharmaceutical Heroin was available, the harm reduction delivered by the substitution drug is less, due to the decreased risk of a pharmaceutically manufactured drug. Also it is much more difficult to detox from the long acting opioids because of their extended half life. Detoxification completely eliminates the opioids from the body. Naltrexone stops the cravings and blocks the actions of future opioid use. A person free from the dependence can focus on behavioral therapy (CBT or DBT) to deal with the absence of the drug and the potential significant positive changes in their lives, including their family and colleagues.

Peter MacNeil

2 thoughts on “A Case for Increased Regulation

  1. Peter provides an excellent analysis of the opioid epidemic currently engulfing the USA and Canada and also puts forward a comprehensive 7 point plan to deal with the issues at all levels. It is always heartening to read articles where the author goes beyond the issues and provides strategies and solutions for discussion. Well done Peter and I look forward to other readers more knowledgable than myself in this area joining the discussion.

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