Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
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6/5/24  7:45 pm
Commenter: Anonymous

Kratom safety and mortality vs traditional opioids (revised)
 

### Comparing Overdose Deaths: Traditional Opioids vs. Kratom

#### Traditional Opioids (Including Fentanyl) Overdose Deaths
The opioid crisis has caused a dramatic increase in overdose deaths in the United States over the past decade. Key statistics highlight the severity of this crisis:

1. **Overall Opioid Overdose Deaths**:
- More than 760,000 people have died from drug overdoses since 1999, with opioids being the primary cause of these deaths. In 2020 alone, nearly 75% of the 93,000 drug overdose deaths involved opioids [oai_citation:1,Opioid Facts and Statistics | HHS.gov](https://www.hhs.gov/opioids/statistics/index.html) [Understanding the Opioid Overdose Epidemic | Overdose Prevention | CDC](https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html).

2. **Fentanyl and Synthetic Opioids**:
- Fentanyl, a synthetic opioid, has significantly contributed to the surge in overdose deaths. In 2022, there were approximately 73,654 deaths involving fentanyl, more than double the number from three years earlier in 2019 [www.cdc.gov](https://www.cdc.gov/nchs/data/databriefs/db491.pdf#:~:text=URL%3A%20https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Fdata%2Fdatabriefs%2Fdb491.pdf%0AVisible%3A%200%25%20) [oai_citation:4,Opioid Facts and Statistics | HHS.gov](https://www.hhs.gov/opioids/statistics/index.html).
- Synthetic opioids other than methadone, primarily fentanyl, were involved in 48,006 overdose deaths in a 12-month period ending June 2020 [Understanding the Opioid Overdose Epidemic | Overdose Prevention | CDC](https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html).

3. **Historical Trends**:
- The death rate from opioid overdoses has increased dramatically over the past decade. From 2010 to 2020, deaths involving synthetic opioids like fentanyl increased by over 30 times [oai_citation:6,Opioid Facts and Statistics | HHS.gov](https://www.hhs.gov/opioids/statistics/index.html) [Understanding the Opioid Overdose Epidemic | Overdose Prevention | CDC](https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html).

#### Kratom-Related Deaths
In contrast, the number of confirmed kratom-related deaths is significantly lower:

1. **FDA and CDC Reports**:
- According to reports from the FDA and CDC, there have been fewer than 50 confirmed deaths involving kratom between 2011 and 2017. Many of these cases involved polydrug use, where kratom was one of several substances found in the deceased's system [Opioid Facts and Statistics | HHS.gov](https://www.hhs.gov/opioids/statistics/index.html).

2. **Kratom's Safety Profile**:
- Kratom is considered to have a lower risk profile compared to traditional opioids. The relative rarity of kratom-related deaths, especially when compared to opioids like fentanyl, underscores its significantly lower lethality. In the rare cases of kratom-associated deaths, other substances, including potent opioids and benzodiazepines, were often involved, complicating the determination of kratom as the sole cause of death [oai_citation:9,Opioid Facts and Statistics | HHS.gov](https://www.hhs.gov/opioids/statistics/index.html) [Understanding the Opioid Overdose Epidemic | Overdose Prevention | CDC](https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html).

### Conclusion
While both traditional opioids and kratom interact with opioid receptors, the public health data clearly show a stark difference in their associated risks. Traditional opioids, especially synthetic ones like fentanyl, are linked to tens of thousands of deaths annually. In contrast, kratom, even with its widespread use, is linked to a fraction of the deaths and typically in cases involving multiple substances.

The significantly lower number of kratom-related deaths, combined with its potential therapeutic benefits and reduced risk of severe side effects, strongly suggests that kratom should not be classified as a Schedule 1 substance. A more nuanced regulatory approach that acknowledges its lower risk profile and potential for harm reduction in the context of the opioid crisis would be more appropriate.

CommentID: 225462