In a 2018 report titled, Quantifying the Epidemic of Prescription Opioid Overdose Deaths, four senior analysts of the Centers for Disease Control and Prevention (CDC), including the head of the Epidemiology and Surveillance Branch, acknowledged for the first time that the number of prescription opioid overdose deaths reported by the CDC in 2016 was erroneous. The error, they said, was caused by miscoding deaths involving illicitly manufactured fentanyl (IMF) as deaths involving prescribed fentanyl. To understand what caused this error, the authors examined the CDC's methodology for compiling drug-related mortality data, beginning with the source data obtained from approximately 2.8 million death certificates received each year from state vital statistics registrars. Systemic problems often begin outside the CDC, with a surprisingly high rate of errors and omissions in the source data. Using the CDC's explanation for what caused the error, the authors show why an international program used by the CDC for reporting mortality is ill-suited for compiling and reporting drug overdose deaths. Except for heroin, methadone, and opium, each of which has an individual program code, all other opioids are separated in just two program codes according to whether they are synthetic or semisynthetic/opiates. Methadone-involved deaths pose a special problem for the CDC because methadone has dual indications for treating pain and for treating opioid use disorder (OUD). In 2019, more than seven times more methadone was administered or dispensed for OUD treatment than was prescribed for pain, yet all methadone-involved deaths are coded by the CDC as involving the prescribed form of the drug. The authors conclude that the CDC was at fault for failing to recognize and correct this problem before 2016. Public policy consequences of this failure are briefly mentioned.
Keywords: Centers for Disease Control and Prevention (CDC); Death certificates; Illicitly manufactured fentanyl (IMF); International Classification of Diseases (ICD); Methadone; Prescription opioid overdose deaths.
Fig. 1 How mortality source data are collected in the U.S. and converted into vital statistics. (source: Robert N. Anderson, Ph.D., Chief, Mortality Statistics Branch, Centers for Disease Control and Prevention; permission granted 02/25/2021)
Fig. 2 A chart showing the T-codes for opioids as categorized by the International Classification of Diseases, Tenth Edition, 1999–2022 (ICD-10) (Chart source: )
Fig. 3 National drug-involved overdose deaths (including unintentional drug poisoning, suicide drug poisoning, homicide drug poisoning, or drug poisoning of undetermined intent as coded according to the International Classification of Diseases, 10th edition (ICD-10). Data are from Centers for Disease Control and Prevention (CDC, National Center for Health Statistics; Multiple Cause of Death 1999–2019 on CDC WONDER Online Database, released 12/2020; available at: https://wonder.cdc.gov/. (Permission to use graph granted by Josie Anderson, MA, Digital Media Manager, National Institute on Drug Abuse, National Institutes of Health to author John J. Coleman, Ph.D., on 02.25.2021). Original NIDA graphic adapted for use in Fig. 3 is available at: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates
Fig. 5 Prescribing volumes in grams of four popular T-40.4 “synthetic opioids other than methadone” for years 2013, 2014, 2015, and 2016. Data are from Retail Drug Summary Reports of the Automated Reports and Consolidated Orders System (ARCOS) that is managed by the Drug Enforcement Administration (DEA). They reflect distributions to U.S. retail pharmacies for use in filling prescriptions. These reports are available online at: https://www.deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html
Department of Health and Human Services. National Center for Health Statistics, DHHS, CDC: Celebrating 50 years. 2010 [April 22, 2020]; Available from: https://www.cdc.gov/nchs/data/about/nchs_50th_brochure.pdf.
National Vital Statistics System (CDC). A Reference Guide for Completing the Death Certificate for Drug Toxicity Deaths. 2019 [October 17, 2020]; Available from: https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg02-508.pdf.
Centers for Disease Control and Prevention. Coroner/Medical Examiner Laws, by State. 2016 [October 17, 2020]; Available from: https://www.cdc.gov/phlp/publications/topic/coroner.html.
Robert Anderson. Chief, Mortality Statistics Branch, CDC; Maternal deaths in the National Vital Statistics System (PPT presentation to the NCHS Board of Scientific Counselors, Hyattsville, MD, May 9–10, 2019). 2019 [January 12, 2021]; Available from: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.cdc.....
Krywanczyk A, et al. Autopsy service death certificate review. Arch Pathol Lab Med. 2020;144(9):1092–1096. doi: 10.5858/arpa.2019-0452-OA. - DOI - PubMed
Jessica Priest, One in 3 death certificates were wrong before coronavirus. It's about to get even worse, in USA Today (April 25 ed.). 2020.
Horon IL, et al. Standard death certificates versus enhanced surveillance to identify heroin overdose-related deaths. Am J Public Health. 2018;108(6):777–781. doi: 10.2105/AJPH.2018.304385. - DOI - PMC - PubMed
Buchanich JM, et al. The effect of incomplete death certificates on estimates of unintentional opioid-related overdose deaths in the united states, 1999–2015. Public Health Rep. 2018;133(4):423–431. doi: 10.1177/0033354918774330. - DOI - PMC - PubMed
Fugelstad A, et al. Drug-related deaths: statistics based on death certificates miss one-third of cases. Scand J Public Health. 2017;0(0):1403494817745187. - PubMed
Fischtein D, Cina SJ. Errors on death certificates requiring amendments: the Broward County experience. Am J Forensic Med Pathol. 2011;32(2):146–148. doi: 10.1097/PAF.0b013e31820c2ee6. - DOI - PubMed
Jessica Priest, One in 3 death certificates were wrong before coronavirus. It's about to get even worse (Corrected Copy by USA Today), in USA Today (April 25 ed.). 2020
Centers for Disease Control and Prevention. National Vital Statistics System: Mortality Statistics. 2021 [January 17, 2021]; Available from: https://www.cdc.gov/nchs/nvss/deaths.htm.
Centers for Disease Control and Prevention. Instruction Manual, Part 11, Computer Edits for Mortality Data, Including Separate Section for Fetal Deaths Effective 2010 2009 [January 17, 2021].
Centers for Disease Control and Prevention. National Center for Health Statistics: Accidents or Unintentional Injuries. 2020 [August 16, 2020]; Available from: https://www.cdc.gov/nchs/fastats/accidental-injury.htm.
Weathermon R, Crabb DW. Alcohol and medication interactions. Alcohol Res Health. 1999;23(1):40–54. - PMC - PubMed
Ogbu UC, Lotfipour S, Chakravarthy B. Polysubstance abuse: alcohol, opioids and benzodiazepines require coordinated engagement by society, patients, and physicians. West J Emerg Med. 2015;16(1):76–79. doi: 10.5811/westjem.2014.11.24720. - DOI - PMC - PubMed
Centers for Disease Control and Prevention. Instructions for Completing the Cause-of-Death Section of the Death Certificate. 2004 [September 22, 2020]; Available from: https://www.cdc.gov/nchs/data/dvs/blue_form.pdf.
Taylor A, Frischer M, Goldberg D. Non-fatal overdosing is related to polydrug use in Glasgow. BMJ. 1996;313(7069):1400–1401. doi: 10.1136/bmj.313.7069.1400b. - DOI - PMC - PubMed
Grider DJ. Preparing For ICD-10-CM: make the transition manageable. Chicago: American Medical Association; 2010.
World Health Organization, International Classification of Diseases. ICD-10 Version: 2016: Chapter XIX, T40 Poisoning by narcotics and psychodysleptics [hallucinogens]. 2016 [November 11, 2018]; Available from: http://apps.who.int/classifications/icd10/browse/2016/en#T40.5.
Centers for Disease Control and Prevention. ICD-10-CM Table of Drugs and Chemicals. 2019 [January 30, 2019]; Available from: ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2019/i....
Seth P, et al. Quantifying the epidemic of prescription opioid overdose deaths. Am J Public Health. 2018;108(4):500–502. doi: 10.2105/AJPH.2017.304265. - DOI - PMC - PubMed
Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report (June 20, 2014/ 63(24);531): Notes from the Field: Increase in Fentanyl-Related Overdose Deaths — Rhode Island, November 2013–March 2014. 2014 [November 21, 2018]; Available from: https://www.cdc.gov/mmwr/pdf/wk/mm6324.pdf. - PMC - PubMed
Centers for Disease Control and Prevention Notes from the field: acetyl fentanyl overdose fatalities: Rhode Island, March–May 2013. Morb Mortal Wkly Rep. 2013;62(34):703–704. - PMC - PubMed
U.S. Congress. Support for Patients and Communities Act, H.R. 6, 115th Congress, Public Law No. 115–271 (Oct. 24, 2018). 2018 [December 24, 2018]; Available from: https://www.congress.gov/bill/115th-congress/house-bill/6/actions?q=%7B%....
National Institute On Drug Abuse. Overdose Death Rates. 2020 [November 21, 2020]; Available from: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-r....
U.S. District Court, District of Utah. USA v. Arron Michael Shamo, et al.; Case 2:16-cr-00631-PMW, Doc. #32 (Superseding Indictment). Filed 05/31/2017. 2017; Available from: https://ecf.utd.uscourts.gov/doc1/18313985299.
Drug Enforcement Administration. Champaign man sentenced to 13 years in prison for trafficking. 2020 [January 16, 2021]; Available from: https://www.dea.gov/press-releases/2020/01/06/champaign-man-sentenced-13....
Controlled Substances Act. Title 21, United States Code, Sect. 812; Schedules of controlled substances. 1970 [May 8, 2017]; Available from: http://uscode.house.gov/search/criteria.shtml.
Drug Enforcement Administration. Drug Fact Sheet: Cocaine. 2020 [October 22, 2020]; Available from: https://www.dea.gov/factsheets/cocaine.
Substance Abuse and Mental Health Services Administration. Methadone. 2020 [October 10, 2020]; Available from: https://www.samhsa.gov/medication-assisted-treatment/medications-counsel....
Code of Federal Regulations. 21 CFR 1306.o4 Purpose of Issue of Prescription. 2020 [October 13, 2020]; Available from: https://www.ecfr.gov/cgi-bin/text-idx?SID=6ca40ca4231f0186f9b323f4e1f232....
U.S. Code. Title 21, Section 823(g) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualifications; waiver. 2020 [October 13, 2020]; Available from: https://www.govinfo.gov/content/pkg/USCODE-2018-title21/pdf/USCODE-2018-....
Code of Federal Regulations. Title 42, CFR Sect. 8.12 Federal opioid treatment standards. 2019 [September 29, 2020]; Available from: https://www.govinfo.gov/content/pkg/CFR-2019-title42-vol1/pdf/CFR-2019-t....
Department of Health and Human Health Services. Resources for Opioid Treatment Providers. 2020 [September 29, 2020]; Available from: https://www.hhs.gov/opioids/treatment/resources-opioid-treatment-provide....
Varenbut M, et al. Tampering by office-based methadone maintenance patients with methadone take home privileges: a pilot study. Harm Reduct J. 2007;4:15. doi: 10.1186/1477-7517-4-15. - DOI - PMC - PubMe
Prudente, T., Those addicted to drugs are being sent home with more methadone than ever, in The Washington Post. 2020.
Centers for Disease Control and Prevention Methadone prescribing and overdose and the association with Medicaid preferred drug list policies—United States, 2007–2014. Morb Mortal Wkly Rep (MMWR) 2017;66(12):320–323. doi: 10.15585/mmwr.mm6612a2. - DOI - PMC - PubMed
Faul M, Bohm M, Alexander C. Methadone prescribing and overdose and the association with Medicaid preferred drug list policies—United States, 2007–2014. Morb Mortal Wkly Rep (MMWR) 2017;66:12. doi: 10.15585/mmwr.mm6601a2. - DOI - PMC - PubMed
Drug Enforcement Administration. Office of Diversion Control: ARCOS Retail Drug Summary Reports. 2020 [November 25, 2020]; Available from: https://www.deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html.
Seth, P., RE: Inquiry re: CDC reporting of prescription opioid overdose deaths (email dated Oct. 6, 2020), J.J. Coleman, Editor. 2020: Unpub.
Paulozzi LJ, Weisler RH, Patkar AA. A national epidemic of unintentional prescription opioid overdose deaths: how physicians can help control it. J Clin Psychiatry. 2011;72(5):589–592. doi: 10.4088/JCP.10com06560. - DOI - PubMed
Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006;15(9):618–627. doi: 10.1002/pds.1276. - DOI - PubMed
Johnson H, et al. Decline in drug overdose deaths after state policy changes—Florida, 2010–2012. MMWR Morb Mortal Wkly Rep. 2014;63(26):569–574. - PMC - PubMed
Substance Abuse and Mental Health Services Administration. Buprenorphine. 2020; Available from: https://www.samhsa.gov/medication-assisted-treatment/medications-counsel....
Federal Register. Final Rule - Drug Enforcement Administration: Schedules of Controlled Substances: Rescheduling of Buprenorphine From Schedule V to Schedule III [67FR62354]. 2002 [October 15, 2020]; Available from: https://www.govinfo.gov/content/pkg/FR-2002-10-07/pdf/02-25293.pdf. - PubMed
Roehler DR, Guy GP, Jr, Jones CM. Buprenorphine prescription dispensing rates and characteristics following federal changes in prescribing policy, 2017–2018: a cross-sectional study. Drug Alcohol Depend. 2020;213:108083. doi: 10.1016/j.drugalcdep.2020.108083. - DOI - PubMed
Office of National Drug Control Policy. National Drug Control Strategy: FY 2020 Budget Summary. 2020 [September 25, 2020]; Available from: https://www.whitehouse.gov/wp-content/uploads/2020/02/FY-2021-National-D....
Centers for Medicare and Medicaid Services. Final FY2021 ICD-10 Code Updates - Summary of Changes – IPF-PPS. 2020 [November 30, 2020]; Available from: https://www.cms.gov/files/document/fy-2021-addendum-b-ipf-pps-final-rule....
Centers for Disease Control and Prevention. Overdose Deaths Accelerating During COVID-19. 2021 [January 17, 2021]; Available from: https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html.
Julie O'Donnell CDC. Vital signs: characteristics of drug overdose deaths involving opioids and stimulants—24 states and the district of Columbia, January–June 2019. Morb Mortal Wkly Rep. 2020;69(35):1189–1197. doi: 10.15585/mmwr.mm6935a1. - DOI - PMC - PubMed
The White House. Epidemic: Responding to America's Prescription Drug Abuse Crisis. 2011 [April 28, 2020]; Available from: https://www.hsdl.org/?view&did=4609.
Coleman, J.J. (2019) Why Death Certificates are Unreliable Source Data for Compiling and Reporting Drug-Related Mortality (PPT presentation given June 9, 2019, at the International Conference on Opioids, Joseph B. Martin Conference Center at Harvard Medical School, Boston, MA) [September 24, 2020].