Tuesday, March 26, 2019

Fentanyl Linked Deaths are on the Rise - When Will the Idea of Treatment Instead of a Supply Interdiction Begin to Take Hold

 
 
 
The “opioid crisis” has been an unfortunate event in the recent history of medicine.  However, what has been more tragic than the deaths and destruction it has left in its wake is the ongoing problems that no one seems interested in solving.
 
It seems that everyone in a government position has opted “all in” on stopping the over prescribing of opioids, which is in and of itself a good thing, but what they are failing to take into consideration is the individuals who are caught in the middle of this issue.  Big pharma created a huge number of people who became dependent on opioids through no fault of their own.  These folks are caught in a terrible limbo of being addicted and then being cut off from their supply of medication with no consideration of what will happen to them.
 
Legislators and professional licensing boards have put severe clamps on prescribing which has helped shut down “pill mills” and those unethical practitioners who wrote prescriptions for thousands of pills just to line their own pockets.  However, as the supply of legally available medications has dwindled, caught in the cross fire of those wishing to end the “opioid epidemic” are the individuals who have been left dependent on those medications and unable to get those medications.  Those poor individuals are left to twist in the wind in the horrible throes of withdrawal.
 
It seems to me that the one thing lacking in this whole fight has been a focus, even a remote focus, on the patients who are forced to go on a cold turkey withdrawal.  That is as medically unethical as the over prescribing that created their dependence in the first place.  Instead the focus of those who want to solve the problem has been on decreasing the supply.
 
Unfortunately, be decreasing the supply and access to these drugs, the problems “fixers” have created an entire population that has 2 choices, suffer the indescribable tortures of withdrawal or find another source of drugs that keeps the withdrawal at bay.  Since no one in power has seen fit to be concerned about helping these people by providing detox treatment, many of these sufferers have taken it upon themselves to seek drugs on the street.
 
Now we are seeing a new crisis in development, deaths due to overdose of drugs obtained through illegal sources.  If those in power truly want to end the drug problems in the US, they have to focus on treating the individual who are afflicted with this disease and/or dependence.  Trying to limit the supply simply doesn’t work.  We’ve been fighting a “war on drugs” since the Nixon administration and despite the hundreds of billions of dollars spent on interdiction, the problem continues.  The focus needs to change to treatment and not supply stifling or jail time.
 
The CDC has released an article that discusses the increase in deaths due to street Fentanyl purchased by those abandoned in the “war on drugs” and left to fend for themselves.  Trying to limit the supply will just force people to seek relief illegally and that is by far much more dangerous.  Read on for CDC's take.  If you would like access to the entire study, complete with graphs and references, it can be read on the CDC website in pdf
 
Abstract Objectives—Fentanyl, a synthetic opioid, has been increasingly identified in drug overdose deaths. This report describes trends in drug overdose deaths involving fentanyl by demographic characteristics and geographic regions from 2011 through 2016.
 
Methods—Drug overdose deaths were identified from the National Vital Statistics System—Mortality (NVSS–M) multiple cause-of-death files (2011–2016) using International Classification of Diseases, 10th Revision underlying causes of death (codes X40–X44, X60–X64, X85, or Y10–Y14). NVSS–M records for drug overdose deaths were linked with literal text from death certificates. Drug overdose deaths involving fentanyl were identified using a methodology established collaboratively by the National Center for Health Statistics and U.S. Food and Drug Administration—referred to as the Drugs Mentioned with Involvement (DMI) methodology—supplemented with search terms identified using text analytics software. Fentanyl involvement was determined by the presence of any string term or phrase listing fentanyl, or any fentanyl metabolite, precursor, analog, or misspelling identified in the death certificate literal text fields (i.e., the causes of death from Part I, significant conditions contributing to death from Part II, and a description of how the injury occurred). Trends were evaluated using the National Cancer Institute’s Joinpoint Regression Program.
 
Results—The number of drug overdose deaths involving fentanyl was stable in 2011 (1,663) and 2012 (1,615), and began to increase in 2013, rising to 18,335 deaths in 2016. The ageadjusted rate increased from 0.5 per 100,000 standard population in 2011 to 5.9 per 100,000 in 2016, with the increase starting in 2013 (0.6 in 2013 to 1.3 in 2014 and 2.6 in 2015). Numbers and rates increased for all sex, age, and racial and ethnic subgroups, and most public health regions. Adjustment for improved drug reporting over the study period did not change the trend patterns observed. Conclusions—This report illustrates the rise in drug overdose deaths involving fentanyl from 2011 through 2016 nationally, and by age, sex, race and ethnicity, and public health region. Understanding national trends and patterns for drug overdose deaths involving fentanyl may inform public health policies and practices. Keywords: National Vital Statistics System • national trends • mortality • death certificate literal text
 
Introduction
Fentanyl is a synthetic opioid that has been involved increasingly in drug overdose deaths (1–11). In 2011 and 2012, fentanyl was involved in roughly 1,600 drug overdose deaths each year, but from 2012 through 2014, the number of drug overdose deaths involving fentanyl more than doubled each year (1). State-based analyses suggest that the recent increase in overdose deaths involving fentanyl may be related to increased availability of illicitly manufactured fentanyl (3,4,9–11). Illicitly manufactured fentanyl includes various analogs (e.g., acetylfentanyl, carfentanil, furanyl fentanyl) that vary in potency and can be lethal in very low concentrations (3). National mortality statistics on drug overdose deaths have traditionally used the International Classification of Diseases, 10th Revision (ICD–10) to classify and monitor drugs involved in deaths (12). However, ICD–10 is limited to broader categories (e.g., synthetic opioids other than methadone) that make it difficult to identify deaths involving specific drugs of interest (e.g., fentanyl or illicitly manufactured fentanyl analogs). The National Center for Health Statistics (NCHS) and the U.S. Food and Drug Administration (FDA) collaboratively developed methods, referred to as the Drugs Mentioned with Involvement (DMI) methodology, to analyze literal text data from death certificates to identify specific drugs involved in deaths (13). A recent study using the DMI methodology found that fentanyl was the ninth most frequently mentioned drug involved in overdose deaths in 2013 and the most frequently mentioned drug in 2016 (2). It also showed that deaths involving fentanyl often involved other drugs. For example, in 2016, nearly 70% of deaths involving fentanyl also involved one or more other drugs, such as heroin or cocaine (2).
 
This report describes the trends in drug overdose deaths involving fentanyl from 2011 through 2016, using mortality data from the National Vital Statistics System linked to literal text information from death certificates. Temporal trends, geographic patterns, and differences among demographic groups are presented.
 
This descriptive study analyzed National Vital Statistics System mortality (NVSS–M) multiple cause-of-death data from 2011 through 2016. NVSS–M contains information extracted from death certificates on cause of death and demographic and geographic factors (14). The study population was limited to U.S. residents. Drug overdose deaths were identified using ICD–10 underlying cause-of-death codes X40–X44, X60–X64, X85, and Y10–Y14. These underlying-cause codes identify the deaths due to acute toxicity from drugs (i.e., drug overdose) rather than to chronic exposure leading to death (e.g., liver toxicity) or adverse effects from therapeutic or prophylactic dosages of drugs. Drug overdose deaths include all intents (i.e., unintentional, suicide, homicide, and undetermined intent). Use of these underlying cause-of-death codes is consistent with other NCHS publications on drug overdose deaths and facilitates comparisons with other analyses using ICD–10-coded data (1,2,15).
 
NVSS–M records for drug overdose deaths were linked to literal text data from death certificates. The literal text is the written information provided by the medical certifier, usually a medical examiner or coroner in the case of drug overdose deaths, that describes the cause of death as well as other factors or circumstances that contributed to the death (16,17). Literal text from three fields of the death certificate—the causes of death from Part I, the other significant conditions contributing to death from Part II, and the description of how the injury occurred—was analyzed to identify the specific drugs involved in the overdose death.
 
Identifying drug overdose deaths involving fentanyl
 
results from an exploratory analysis of the literal text using SAS Contextual Analysis software (18). The DMI methodology (13) searches the literal text fields of NVSS–M data for mentions of drugs and for terms that provide context about involvement of the drug in the death (i.e., whether the drug contributed to the death). Drugs mentioned in the death certificate literal text are assumed to be involved in the death unless contextual information suggests otherwise (13). For example, “METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION” does not suggest drug involvement in mortality, but rather a type of bacterial infection. Similarly, the phrase “NOT DRUG RELATED” clearly indicates that drugs were not involved in the death even though “DRUG” is included in the phrase.
 
To supplement the DMI methodology, SAS Contextual Analysis software (18) was used to identify additional search terms. Linguistic rules were defined to search for new drug misspellings; precursors; metabolites; analogs of fentanyl, including those containing special characters, numbers, and dashes; and to identify forms that may be illicit (e.g., acetylfentanyl, carfentanil) or are brand or prescription forms of fentanyl (e.g., duragesic, sufentanil, remifentanil). The additional search terms identified using the contextual software were incorporated into the DMI methodology and are described in the Technical Notes. With the expanded list of search terms, the total number of drug overdose deaths identified as involving fentanyl was slightly higher than previously reported (7 deaths in 2011, 10 deaths in 2012, 14 deaths in 2013, and 23 deaths in 2014) (1). 
 
Analysis For this report, the label “drug overdose deaths involving fentanyl” includes drug overdose deaths involving fentanyl, whether prescription or illicitly manufactured, as well as deaths involving any fentanyl metabolites, precursors, or analogs as identified in the death certificate literal text (see Technical Notes). The numbers and rates for drug overdoses involving fentanyl were calculated and compared by demographic and geographic region. Bridged-race vintage postcensal resident population estimates were used to calculate death rates (14). Age-adjusted death rates were calculated using the direct method and the 2000 standard U.S. population (14). Unless otherwise noted, rates in the text refer to age-adjusted rates.
Geographic patterns in overdose deaths involving fentanyl are presented by the U.S. Department of Health and Human Services (HHS) 10 public health regions. These regions are used for public health prevention, preparedness, and agency-wide coordination of HHS programs and policies (19). These regions, excluding U.S. territories, are:
 
• Region 1—Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont
• Region 2—New Jersey, New York, New York City
• Region 3—Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia
• Region 4—Alabama, Florida, Georgia, Kentucky, Mississippi, South Carolina, Tennessee
• Region 5—Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin
• Region 6—Arkansas, Louisiana, New Mexico, Oklahoma, Texas
• Region 7—Iowa, Kansas, Missouri, Nebraska
• Region 8—Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming
• Region 9—Arizona, California, Hawaii, Nevada
• Region 10—Alaska, Idaho, Oregon, Washington
 
Trends in rates for drug overdose deaths involving fentanyl were evaluated using the National Cancer Institute’s Joinpoint Regression Program Version 4.6.0.0 (20). Joinpoint software fitted weighted least-squares regression models to the rates on the log transform scale. Allowing one observed time point at each end and two for the middle line segments, the Grid Search Algorithm searched for a maximum of two joinpoints at an overall alpha level of p < 0.05 (21). Pairwise comparisons of trend segments among subgroups were also analyzed, with Bonferonni adjustment (20). Rates between subgroups were compared using a z test at the 0.05 level of significance (14). Unless otherwise stated, any mention of an increase in rates indicates a statistically significant change.
 
Assessment for improved reporting on death certificates
 
The ICD–10 multiple-cause codes T36–T50.8 provide information on the types of drugs or drug classes involved in the death. The ICD–10 multiple-cause code T50.9 indicates a nonspecific reference to a drug (e.g., “multidrug,” “polypharmacy,” “drug”). The percentage of deaths with an underlying cause of X40–X44, X60–X64, X85, or Y10–Y14 that had a multiple-cause code of T36–T50.8 is a measure of the specificity of reporting drugs or drug classes in drug overdose deaths. This measure was used to assess possible changes in reporting of specific drugs and drug classes through the years of the study. The percentage of drug overdose deaths coded with T36–T50.8 increased each year (75.0% in 2011, 76.0% in 2012, 77.9% in 2013, 80.7% in 2014, 83.1% in 2015, and 85.4% in 2016) (21,22).
 
To assess the possible impact of lower reporting of specific drugs in the years prior to 2016, an adjustment factor accounting for improved reporting of specific drugs over the time period was applied to each age-adjusted rate for drug overdose deaths involving fentanyl (i.e., by year, sex, age, race and ethnicity, and public health region). The adjustment factor assumed that the specificity of drug reporting had remained constant from 2011 through 2016 at the 2016 drug specificity rate; the adjustment factor was recalculated and applied to each age-adjusted rate for the stratified analyses (i.e., demographic and geographic groups). Results from this analysis show similar trends for both the observed and adjusted values (see Technical Notes). The following results reflect the numbers and rates based on observed values. The number of drug overdose deaths involving any particular drug in any particular year should be considered the minimum number, as there may be additional deaths in which the drug was involved but not specified on the death certificate literal text. All results should be interpreted in light of the improved reporting of specific drugs in the literal text over time.
 
Results
Number and percentage of drug overdose deaths involving fentanyl
 
Annually, the number of drug overdose deaths involving fentanyl was stable in 2011 (1,663) and 2012 (1,615), and began to increase in 2013 (1,919), rising to 18,335 deaths in 2016 (Table 1). From 2013 through 2016, the number of deaths approximately doubled each year. From 2011 through the third quarter of 2013, there were fewer than 500 fentanyl-involved deaths per quarter (Figure 1, Table 1). Beginning in the last quarter of 2013 through 2016, the number of deaths involving fentanyl increased nearly every quarter to more than 5,800 deaths.
 
Crude and age-adjusted rates of drug overdose deaths involving fentanyl
 
The age-adjusted rate of drug overdose deaths involving fentanyl was 0.5 per 100,000 in 2011 and 2012, and approximately doubled each year from 0.6 (2013) to 1.3 (2014) to 2.6 (2015) to 5.9 (2016) (Figure 2, Table 2). From 2011 through 2013, there was no statistical change in the age-adjusted rates, but from 2013 through 2016, the rates increased on average by about 113% per year. The crude rates were similar to the age-adjusted rates for the study period.
 
Rates of drug overdose deaths involving fentanyl by sex of decedent
 
For males, age-adjusted rates for drug overdose deaths were stable from 2011 through 2013, and then increased by 125.6% per year from 2013 through 2016 (Figure 3, Tables 2 and 3). For females, the age-adjusted rates increased exponentially from 2011 through 2016. In 2011, 2012, and 2013, the rates for males and females were similar at 0.6 to 0.7 per 100,000 for males, and 0.4 to 0.5 for females. Starting in 2013, the rates diverged, with the rate for males increasing more rapidly than the rate for females. By 2016, the rate for males (8.6) was 2.8 times the rate for females (3.1). 
 
Rates of drug overdose deaths involving fentanyl by age group
 
Exponential increases in rates from 2011 through 2016 were observed among all age groups (Figure 4, Tables 2 and 3). The largest average annual percent change from 2011 through 2016 occurred among young adults aged 25–34 (100.0% per year) and 15–24 (93.9% per year). The smallest average annual percent change occurred among adults aged 65 and over (41.6% per year). The rate for adults aged 35–44 was stable from 2011 through 2013, then increased by 123.7% per year from 2013 through 2016. In 2016, the rates were highest among adults aged 25–34 and 35–44 at 13.4 and 11.4 per 100,000, respectively.
 
Rates of drug overdose deaths involving fentanyl by race and ethnicity
 
The age-adjusted rates for drug overdose deaths involving fentanyl increased exponentially among all the racial and ethnic subgroups examined (Figure 5, Tables 2 and 3). Rates for non-Hispanic white persons ranged from 0.7 to 0.8 per 100,000 from 2011 through 2013, then increased by 108.8% from 2013 through 2016. Non-Hispanic black persons had the largest annual percentage increase in rates from 2011 through 2016 (140.6% per year), followed by Hispanic persons (118.3% per year). Rates for non-Hispanic white persons were greater than other subgroups throughout the study period. The rates for non-Hispanic black and Hispanic persons were similar from 2011 through 2013, then diverged from 2014 through 2016. In 2016, the rates were highest among non-Hispanic white persons (7.7), followed by non-Hispanic black (5.6) and Hispanic (2.5) persons.
 
Rates of drug overdose deaths involving fentanyl by public health region
 
Rates of drug overdose deaths involving fentanyl increased exponentially from 2011 through 2016 for most public health regions (Figure 6, Tables 2 and 3). The greatest rate increases were in Region 1 (CT, ME, MA, NH, RI, and VT), Region 2 (NJ, NY, and NYC), Region 3 (DE, DC, MD, PA, VA, and WV), and Region 5 (IL, IN, MI, MN, OH, and WI), which increased 113.9%, 110.9%, 103.6%, and 102.2% per year, respectively. Rates were similar across all public health regions in 2011. In 2016, the rates for Regions 1, 2, 3, 4, and 5 were higher than for Regions 6, 8, 9, and 10. In 2016, rates ranged from 0.8 per 100,000 (Region 9) to 19.8 (Region 1).
 
Discussion
 
This report illustrates the rise in drug overdose deaths involving fentanyl in the United States from 2011 through 2016. The number of drug overdose deaths involving fentanyl increased from 1,663 in 2011 to 18,335 in 2016. Beginning in the fourth quarter of 2013, the number of deaths increased every quarter. From 2013 through 2014, the death rate more than doubled.
 
The absence of drug-specific information on the death certificate does not mean that fentanyl was not present; rather, it may suggest that toxicology tests were not performed or were inadequate to detect the drug. Also, new fentanyl analogs are being identified with increasing frequency and are often lethal in very low concentrations. Detection of these substances requires new testing materials and continuous recalibration of toxicology laboratory equipment (16), both of which can be complicated and expensive, thus further contributing to variation in death reporting across the country.
 
The need to understand the factors influencing overdoses and deaths involving fentanyl has resulted in collaboration among public health agencies, medical examiners and coroners, and public safety agencies. These collaborations will contribute to better detection and reporting on death certificates, which in turn, will help improve quality of local, state, and national vital statistics data.
 
Conclusion
 
Fentanyl is increasingly involved in drug overdose deaths nationally. This report uses NVSS–M data, enhanced with literal text from death certificates, to provide a picture of temporal trends, demographic characteristics, and geographic patterns of fentanyl-involved drug overdose deaths in the United States from 2011 through 2016.
 

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