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> Summary of Medical Examiner Reports on Oxycodone-Related Deaths
Summary of Medical Examiner
Reports on
Oxycodone-Related Deaths
Preface:
The following is a summary of an ongoing study of medical examiner data
regarding OxyContin® that is being conducted by the Drug Enforcement
Administration (DEA).
The DEA wrote letters to 775 medical
examiners (MEs) from the National Association of Medical Examiners (NAME)
requesting their reports (autopsy, toxicology, and ME investigative
reports) on all deaths induced by, associated with, or related to
oxycodone and/or, specifically, the oxycodone product, OxyContin® for
2000 and 2001. Based on the criteria described below, the reports received
were categorized into four groups: 1) OxyContin® verified deaths; 2)
OxyContin® likely deaths; 3) undetermined deaths; and 4) incomplete
reports.
Some jurisdictions have
"coroners" which are "elected officials" of the local
governments, while others refer to their medical examiners as
"coroners". The elected officials are not necessarily medical
doctors. In these cases, the coroners are merely the state’s competent
authority to certify that a death has occurred for legal purposes (such as
social security, life insurance and testate cases, etc.). These legal
authorities do not make the determinations of "cause of death"
and do not perform the autopsies. In Kentucky, for example, under the
jurisdiction of county coroner’s the "cause of death" is
determined by a medical doctor. If the death is suspected to be "drug
related" the toxicology samples are sent to the States Forensic
Laboratories for analysis. The county coroner only certifies for the state
that the "John Doe" has died.
The toxicology reports alone do not
discriminate between the presence of any one specific product of the 59
Schedule II oxycodone-containing products available in the United States.
However, there are currently only a limited number of single entity
oxycodone products that do not also contain the pain relievers
acetaminophen (the active ingredient in Tylenol® ) or salicylates
(aspirin). Of the 7,185,000 prescriptions of these single-entity oxycodone
products sold in 2000, approximately 5.8 million were for OxyContin® -
81.4% of the single entity product market. In addition, the oxycodone
product Intensol® (20 mg) and an oxycodone generic product (30 mg) are
the only other dosage forms containing oxycodone in excess of the standard
dosage strengths. There were approximately 24,000 and 1,000 total
prescriptions of these two products, respectively, dispensed in 2000. With
these facts in mind, any oxycodone positive toxicology without the
presence of acetaminophen or salicylates was categorized as an "OxyContin®
likely" death.
Medical Examiners most typically
classify deaths by drug substance only. Therefore, until recently,
OxyContin® toxicity was not listed as a cause of death, but rather
oxycodone-toxicity. Since its request, DEA is now receiving more ME
reports that list "OxyContin® overdose" as the specific cause
of death.
Oxycodone-positive autopsy reports
that described tablet contents in the gastrointestinal tract that, upon
analysis, could be identified as OxyContin® were re-categorized by DEA as
"OxyContin® verified" deaths. OxyContin® tablets have a
unique, trade-specific logo – "OC" on one side, and a number
"10", "20", "40", "80" or
"160" on the other side. They are also color-coded and have
different sizes that can accurately discriminate between these specific
products and others containing oxycodone. In addition, the ME
investigative reports were scrutinized for the presence of an OxyContin®
prescription or tablet at the crime scene, on the person, or reported to
be consumed by the decedent, a family member or any other credible witness
present at the death. If found, these oxycodone-positive deaths were also
re-categorized by DEA as "OxyContin® verified".
As of February 14, 2002, DEA has
received 1,304 complete ME reports from 32 states. One hundred thirty four
(134) complete reports with oxycodone positive toxicologies were excluded
because the deaths were attributed to processes not under review, such as
-
self-inflicted gun shot wound to
the head while intoxicated with oxycodone
-
cancer
-
Complications from Acquired
Immune Deficiency Syndrome
-
Blunt trauma, etc.
Two hundred twenty one (221)
additional ME summaries, without toxicology reports, were received but
were not included in this study because they were incomplete and of
limited usefulness.
Of the 949 complete ME reports
received by DEA and using the above criteria, 146 deaths were categorized
as "OxyContin® verified" deaths; 318 deaths were re-categorized
as "OxyContin® likely". The remainder were categorized as
undetermined deaths (i.e., DEA was not able to determine whether or not
OxyContin® was involved in the deaths).
These data suggest that 49% (464 out
of 949) of all oxycodone positive toxicology reports were likely related
to the specific oxycodone product, OxyContin® . In addition, 15% of all
oxycodone positive toxicology reports received were verified to be
OxyContin® (146 out of 949).
Of the 949 complete medical examiner
reports received, the majority were associated with polydrug toxicologies.
More than 40% contained a benzodiazepine (Valium-like drugs);
approximately 40% contained an opiate in addition to oxycodone; about 30%
contained an antidepressant; about 14% contained over-the-counter
antihistamines or cold medications; about 15% contained cocaine or its
metabolites. These drugs reflect the typical drug combination patterns
described in the published scientific literature associated with opiate
addiction/dependence and show up as common "drug mentions" in
the Drug Abuse Warning Network (DAWN) emergency department mentions of
heroin/morphine episodes. Limiting the comparison to just the 464
OxyContin® likely and OxyContin® verified toxicologies showed a similar
pattern of polydrug use.
A critical point to note is that of
the 464 deaths linked, or most likely linked, to OxyContin® there were
only 88 that had quantifiable levels of blood alcohol at the time of
death. Contrary to some reports, the documented evidence clearly shows
that only 19% of the OxyContin® deaths can be verified to be the result
of a alcohol-drug interaction. Important also is the fact that only nine
(9) deaths were associated with the presence of a "recent injection
site", and only one death associated with snorting the drug; the vast
majority of deaths have been associated with oral consumption of the drug.
An additional caveat must be made
regarding standard OxyContin® treatment regimens as they apply to
poly-drug use. OxyContin®, by its design and indications-for-use can be
viewed as an "entourage" prescription. That is, OxyContin® is
indicated for the treatment of moderate to severe pain of long duration
such as cancer, severe forms of arthritis, or for "chronic pain
syndromes". According to the manufacturers product information, most
of these patients receiving around the clock opiate therapy will need to
have immediate release medications available for "rescue" from
breakthrough pain or to prevent pain that occurs predictably during
certain patient activities (typically referred to as "incident pain).
Incident pain may occur as a result of the performance of normal
activities of daily living, physical therapy, or simply ambulation to the
physician’s office for treatment. Rescue medications are suggested to be
immediate-release opiate formulations either alone or in combination with
acetaminophen, aspirin, or other non-steroidal anti-inflammatory drugs (NSAID’s).
These would include drugs like Vicodin®, Lortab®, Percodan®, Ketoprofen®,
etc. The manufacturer’s product information clearly states, "Food
has no significant effect on the extent of absorption from OxyContin®".
There is no adverse reaction notification for the co-administration of
OxyContin® and nicotine from cigarette smoking or with caffeine – a
psychoactive drug found in many food products, including coffee. By these
treatment designs a "normal" patient receiving a standard
OxyContin® prescription regimen approved by the Food and Drug
Administration may be a poly-drug user. One treatment strategy recommended
for "chronic pain" patients is the co-administration of opioids
with anti-depressants – again, a treatment strategy, by its design,
results in polydrug usage. With these facts in mind it was not surprising
to find that many of the OxyContin® deaths were associated with polydrug
toxicologies. This does not minimize the significance of the role of
OxyContin® in these deaths.
This ongoing effort will continue to
collect and analyze reports received from the MEs. DEA can verify 146
deaths in which OxyContin® was the direct "cause of" or a
contributing factor to the deaths; an additional 318 deaths lacking
acetaminophen and/or salicylates in the toxicology findings most likely
involved OxyContin® , as well.
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