OXYCODONE
1.- Source of the product
Oxycodone is a semi-synthetic opioid medication derived from thebaine, which is an alkaloid found in
opium poppy. It has been administered to human beings intravenously, intramuscularly, intranasally,
subcutaneously, rectally, epidurally, and orally using immediate release solutions and immediate and
controlled-release tablets. The transdermal route of administration has also been tested in animals. Today
oxycodone is mainly used as controlled-release tablets for chronic pain. The immediate- release solution
and tablets are used for acute pain or for breakthrough pain. Parenteral oxycodone is a good alternative
when opioids cannot be administered orally.
Derivation:
Opium have two chemical classes of alkaloids, the phenantrenes and benzyl-isoquinolines; the
phenantrene alkaloids that come from the interest of the oxycodone is the thebaine.
Figure 1 Papaver somniferum 0.2–0.8% Of
content of Thebaine
Figure 2 Papaver bracteatum 90% of
content of Thebaine
{Papaver bracteatum (Iranian Poppy):
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Origin: Papaver bracteatum, also known as the Iranian Poppy, is native to Iran.
Distribution: It is primarily found in regions of Iran and Afghanistan.
Alkaloid Content: Thebaine Dominance, Papaver bracteatum is notable for its high thebaine
content. Thebaine is an alkaloid that is less sought after for its analgesic properties but is a
precursor in the synthesis of certain opioids.
Cultivation and Use: While Papaver bracteatum is cultivated, it is not as extensively used for
medicinal purposes as Papaver somniferum. The high thebaine content makes it less desirable for
opioid production for pain relief.
Papaver somniferum (Opium Poppy):
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Origin: Papaver somniferum, commonly known as the Opium Poppy, is believed to have
originated in the Mediterranean region.
Distribution: It is cultivated in various parts of the world for its medicinal properties.
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Alkaloid Content: Variability: Papaver somniferum contains a variety of alkaloids, including
morphine, codeine, and thebaine. Morphine and codeine are well-known for their analgesic
properties and are used in pain management.
Cultivation and Use: Medicinal and Recreational Use: Papaver somniferum is a highly valued plant
for the production of opiates. It has been cultivated for centuries for medicinal purposes, providing
compounds like morphine and codeine used in pain relief. However, it is also a source of
recreational drugs and has been associated with the production of illicit substances like heroin.}
Extremely toxic and lacks analgesic properties
Oxycodone was derived from thebaine in 1916 and it was introduced into clinical practice in Germany in
1917 It was used in northern Europe mainly for acute pain
Australia, and the United States, it was used mainly as a combination drug with acetaminophen,
phenacetin, and caffeine for moderate pain. In Finland, oxycodone has been used as the main parenteral
opioid for acute pain since the 1960s.
{ The process of deriving oxycodone from thebaine involves chemical modifications to the thebaine
molecule to create a compound with improved pharmacological properties, including increased analgesic
effects and reduced toxicity. This is achieved through a series of chemical reactions and modifications in a
laboratory setting. }
From: https://pubs.rsc.org/en/content/articlehtml/2012/ra/c2ra21693k - Improved synthesis of 14hydroxy opioid pharmaceuticals and intermediates
2.- Ethical Issues
Oxycodone as an entry drug
The main problem of Oxycodone is the capability of in some cases make that persons develop
tolerance to the analgesic effect, which involve the necessity of higher doses to reach the
painkiller effect, which at the same time leads to the farmaco dependency of this, which mean
addiction, and in some cases, this drive to the search of more potent drugs like heroin, so this is
a snowball effect.
Here a few points found in the SAMHSA [Substance Abuse and mental health Services
administration] related to the consume of Oxycodone and his relation between entry drug and
impact in the society
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Anecdotal reports and localized small-scale studies have suggested that some individuals who had
been abusing OxyContin® switched to heroin after the reformulation in late 2010 that made
OxyContin more difficult to crush.
Data showed that the street price of the new formulation was nearly 20 to 30 percent lower than
that of the old formulation, indicating lower demand for the new formulation. However, the
reformulation may have led potential abusers of OxyContin to switch to heroin.
An exploratory qualitative study, which collected data during the period between 2008 and 2009
from young injection drug users (aged 16 to 25) in New York and Los Angeles, suggested that
prescription opioid use was the main factor for predicting injection drug use or heroin use.
A study of predominantly urban dwelling, male, Caucasian, and economically disadvantaged active
nonmedical users of opioids (aged 16 or older) from Cumberland County, Maine, has shown that
within first year of initiation, polyopioid use including OxyContin led to a quicker transition to
heroin and injection drug use (IDU)
For instance, a qualitative study of 25 street opioid injectors in Toronto revealed that their first
injection experiences were followed by transition to prescription opioids.
An additional study used a retrospective chart review of 178 patients in a methadone maintenance
treatment program found that 35 percent used heroin prior to initiating pain reliever use.
A study of clients attending substance use treatment programs from 2005 to 2008 found that
women were more likely than men to report medical use as well as abuse of prescription opioids.
Use of Oxycodone in paediatrics: Support for Responsible Use in Pain Management or Concerns About
Risks and Overuse.
From the solicitude to the European Medicines Agency decision and his response we can see that the
use of oxycodone in paediatrics is also debatable
Ethical use of oxycodone in paediatrics is justifiable when prescribed responsibly and under strict medical
supervision.
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Pain Relief: Oxycodone is an effective opioid analgesic that can provide much-needed pain relief for
paediatric patients facing severe pain due to medical conditions, surgeries, or cancer.
Improved Quality of Life: When used appropriately, oxycodone can enhance the quality of life for
paediatric patients by managing pain and promoting overall well-being.
Individualized Care: Each paediatric case is unique, and decisions about oxycodone use should be
made on an individualized basis, considering the child's medical condition, pain severity, and potential
benefits
Ethical concerns about the use of oxycodone in paediatrics, highlighting the potential risks and the broader
societal issues related to opioid misuse.
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Risk of Dependency: Opioids, including oxycodone, carry the risk of dependence, even when
prescribed for legitimate medical reasons. This raises ethical concerns about exposing paediatric
patients to the potential long-term consequences of opioid use.
Opioid Epidemic: The broader societal impact of the opioid epidemic is a significant ethical
consideration. Overprescribing opioids may contribute to the larger public health crisis of opioid
misuse and addiction.
Exploring Alternatives: Ethical practice involves considering and prioritizing non-opioid alternatives for
paediatric pain management to minimize the risks associated with opioid use.
{The Paediatric Committee has given an opinion on the granting of a product-specific waiver"
Paediatric Committee:
This refers to a group or committee, likely within a regulatory or healthcare organization, that specializes
in paediatrics (the branch of medicine focused on children). Such committees often play a role in
evaluating medical products, treatments, or interventions related to children's health.
Opinion:
The committee has expressed its opinion, which implies that it has reviewed information, considered
relevant factors, and formed a judgment or viewpoint on a particular matter.
Granting of a Product-Specific Waiver:
The subject of the committee's opinion is the granting of a waiver specific to a product. In the context of
regulatory processes, a waiver may involve an exemption or relaxation of certain requirements or
obligations for a particular product. A "product-specific waiver" suggests that this exemption is tailored to
a specific medical product.}
Bibliography:
1. Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States
[https://www.samhsa.gov/data/sites/default/files/DR006/DR006/nonmedical-pain-relieveruse-2013.htm#endnote14] August 2013
2. EUROPEANS MEDICINES AGENCY [EMA] [European Medicines Agency decision] [Granting of a
product specific waiver for morphine / oxycodone] 21 January 2013
3. Royal Society of chemistry [Improved synthesis of 14-hydroxy opioid pharmaceuticals and
intermediates] Gaik B. Kok and Peter J. Scammells, August 2012
4. Oxycodone [Eija Kalso, MD, DMedSci] January 5, 2005