Summary of Medical Examiner Reports on Oxycodone-Related Deaths

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Drugs and Chemicals of Concern

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.

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 November 30 2001, DEA has received 803 complete ME reports from 31 states. Two hundred ninety three (293) 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 803 complete ME reports received by DEA and using the above criteria, 117 deaths were categorized as "OxyContin® verified" deaths; 179 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 37% (296 out of 803) 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® (117 out of 803).

Of the 803 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; and approximately 20% were alcohol positive. 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 296 OxyContin® likely toxicologies showed a similar pattern of polydrug use. Less than 10 deaths could be associated with the injection of OxyContin® and only one death associated with snorting the drug; the vast majority of deaths have been associated with oral consumption of the tablet.

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 117 deaths in which OxyContin® was the "cause of" or a contributing factor to the deaths. The extreme media reports of "hundreds of deaths" attributed to OxyContin® cannot be verified at this time, but the ME reports received thus far suggest that such numbers are possible if more detailed confirmations were conducted as part of routine ME reporting.
              
http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycontin7.htm