OpiateUseAbuseReport_020312_Draft

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Opiate Use and Misuse Trends in Texas
Abuse of pharmaceuticals is increasing in the United States. According to the National Drug
Threat Assessment report, opioid pain relievers are the most widely misused or abused controlled
prescription drugs and contribute to most controlled prescription drug-related unintentional
poisoning deaths. By 2006, overdoses of opioid analgesics caused more deaths than overdoses of
cocaine and heroin combined.1 This report describes the national trends of prescription opiate use
and misuse and the corollary trends in Texas.
National Problem Scope
From 1999 to 2007, the number of U.S. poisoning deaths involving any opioid analgesic (e.g.,
oxycodone, methadone, or hydrocodone) more than tripled, from 4,041 to 14,459, or 36 percent of
the 40,059 total poisoning deaths in 2007 (Figure 1). In 1999, opioid analgesics were involved in
20 percent of the 19,741 poisoning deaths.
Figure 1: Number of Poisoning Deaths Involving Opioid Analgesics and Other Drugs or
Substances—United States, 1999—20072
In 2009, 1.2 million emergency department (ED) visits involved the nonmedical use of
pharmaceuticals or dietary supplements. The most frequently reported drugs in the nonmedical
use category of ED visits were opiate/opioid analgesics, present in 50 percent of nonmedical-use
ED visits; and psychotherapeutic agents, (commonly used to treat anxiety and sleep disorders),
were present in more than one-third of nonmedical ED visits. Among the frequently reported
opioids were single-ingredient formulations (e.g., oxycodone) and combination forms (e.g.,
1
Harmon, K.; Prescription Drug Deaths Increase Dramatically; Scientific American. Available:
http://www.scientificamerican.com/article.cfm?id=prescription-drug-deaths
2
QuickStats: Number of Poisoning Deaths Involving Opioid Analgesics and Other Drugs or Substances --- United States, 1999—2007; Centers for
Disease Control; Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5932a6.htm?s_cid=mm5932a6_w
DRAFT
1
hydrocodone with acetaminophen). Oxycodone, alone or in combination accounted for 175,949
Emergency Department visits; hydrocodone and methadone accounted for 104, 490 and 70,637
visits respectively.3
From 1991—2009, opioid prescriptions increased four-fold (Figure 2).
Figure 2: Total Number of Prescriptions for Hydrocodone and Oxycodone Products Dispensed by
U.S. Retail Pharmacies, 1991-20094
Research demonstrates that high opioid prescriptions rates were positively associated with high
overdose rates and nonmedical use.5 Nonmedical use of opioid prescriptions costs insurance
companies up to $72.5 billion annually in healthcare costs.6
CDC Data
The Centers for Disease Control (CDC) Morbidity and Mortality Weekly Report (MMWR) describes
the prescription drug overdose problem as an epidemic which has worsened enough that by 2008,
drug overdose deaths (36,450) were approaching the number of deaths from motor vehicle
crashes (39,973), the leading cause of injury death in the United States. The MMWR describes a
four fold increase in opiate pain sales between 2010 and 1999. In 2010, opiate sales were
equivalent to 710 mg per person in the United States and enough hydrocodone to medicate every
American Adult with 5mg every 4 hours for 1 month. The MMWR also suggests that opiate
prescriptions have had a negative impact on mortality based on evidence of increased in opiate
prescription sales, opiate abuse treatment, and in admissions to emergency departments.7
3
NIDA InfoFacts: Drug-Related Hospital Emergency Room Visits, National Institute on Drug Abuse, Available:
http://www.drugabuse.gov/infofacts/HospitalVisits.html
4
Strategic Plan, National Institute on Drug Abuse, Available: http://www.nida.nih.gov/PDF/StratPlan.pdf
5
Paulozzi, L., Jones, C., Mack, K., Rudd, R.; Vital Signs: Overdoses of Prescription Opioid
Pain Relievers—United States, 1999-2008; Centers for Disease Control Morbidity and Mortality Weekly Report; 60(43);1487-1492; Available:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm
6
Ibid.
7
Ibid.
DRAFT
2
In addition to the MMWR, the CDC publishes annual reports on drug poisoning deaths in the
United States. These reports track drug poisonings resulting from unintentional or intentional
overdoses of a drug, being given the wrong drug, taking the wrong drug in error, or taking a drug
inadvertently. Deaths were classified using the International Classification of Diseases (ICD),
Tenth Revision (ICD-10). The report classified unintentional poising deaths as accidental
overdose of drug, wrong drug given or taken in error, and drug taken inadvertently accidents in the
use of drugs using the ICD-10 Causes of Death codes X40-X44.8 The CDC used the following
ICD-10 codes to identify drug poisoning as the underlying cause: only nonspecified drug(s) (only
T50.9); specified drug(s) other than opioid prescription (codes T36–T50.8); and any opioid
prescription (codes T40.2–T40.4); and natural and semi-synthetic opioid prescription (T40.2);
methadone (T40.3); synthetic opioid, excluding methadone (T40.4); heroin (T40.1); and cocaine
(T40.5). The CDC report also evaluated deaths using an age-adjusted death rate which a death
rate that controls for the effects of differences in population age distributions.
The CDC report found that the incidence of age-adjusted death rate for drug poising deaths has
increased from 6.1 deaths per 100,000 to 11.9 deaths per 100,000 (Table 1).
Table 1: Age-Adjusted Drug Poisoning Death Rates, by Demographic Characteristics and Intent:
United States, 1999–20089
Year
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Total
6.1
6.2
6.8
8.1
8.9
9.3
10.0
11.4
11.8
11.9
Male
8.2
8.3
9.0
10.5
11.4
11.7
12.7
14.6
14.8
14.8
Female
3.9
4.1
4.7
5.8
6.4
6.9
7.3
8.2
8.9
9.0
Hispanic
5.5
4.6
4.4
5.3
5.6
5.2
5.7
6.2
5.9
5.9
Non-Hispanic
White
6.1
6.6
7.4
9.2
10.1
10.9
11.7
13.5
14.4
14.7
Non-Hispanic
Black
7.5
7.3
7.6
8.2
8.2
8.3
9.4
10.9
9.8
8.5
Non-Hispanic
American
Indian or
Alaska Native
6.0
5.5
6.8
8.4
10.6
12.3
12.9
13.9
13.9
15.6
Non-Hispanic
1.2
1.0
1.2
1.4
1.4
1.5
1.7
1.9
1.9
1.8
Sex
Race and Ethnicity
8
X40 Accidental poisoning by and exposure to nonopioid analgesics, antipyretics and antirheumatics; X41
Accidental poisoning by and exposure to antiepileptic, sedative-hypnotic, antiparkinsonism and psychotropic drugs, not elsewhere classified; X42
Accidental poisoning by and exposure to narcotics and psychodysleptics [hallucinogens], not elsewhere classified; X43 Accidental poisoning by and
exposure to other drugs acting on the autonomic nervous system; X44 Accidental poisoning by and exposure to other and unspecified drugs,
medicaments and biological substances.
9
Warner, M., Chen, L., Makuc, D., et al.; Drug Poisoning Deaths in the United States, 1980–2008; National Center for Health Statistics Data Brief
Number 81, December 2011; Available: http://www.cdc.gov/nchs/data/databriefs/db81.htm
DRAFT
3
Asian or Pacific
Islander
Intent
Unintentional
4.0
4.2
4.6
5.7
6.3
6.8
7.5
8.8
9.1
9.2
Suicide
1.1
1.2
1.2
1.3
1.3
1.4
1.4
1.5
1.5
1.6
Undetermined
0.9
0.9
1.0
1.1
1.2
1.1
1.0
1.1
1.2
1.1
The CDC data also demonstrates that white and Non-Hispanic American Indian or Alaska Native
men are disproportionately affected by drug poising deaths, and most of these deaths are
accidental. Men have a 7.7 prescription drug death rate, 5.9 opiate drug death rate, and 4.3 illegal
drug death rate. This compares to women who have rates of 5.3, 3.7, and 1.4 respectively.10 For
non-Hispanic whites, the rates are 8.4, 6.3, and 2.9. For Blacks, the rates were 3.0, 1.9, and 4.0.
11
Other studies reflect findings similar to those from the CDC.
West Virginia
A study in West Virginia identified all state residents who died on unintentional drug overdose in
the state in 2005. Of unintentional pharmaceutical overdose fatalities, 63 percent of the deaths
were from pharmaceuticals obtained without a prescription. The West Virginia Office of the Chief
Medical Examiner (OCME) found that 21 percent of deceased individuals had five or more
clinicians prescribe controlled substances in the year prior to death (“doctor shopping”). Middleaged white men had the highest risk of overdose from prescription drugs. Women were more
likely to have evidence of doctor shopping than men.12 Apparent diversions (persons with no
prescribed opioids) were more likely to have a history of substance abuse. Doctor shopping was
associated with a history of a previous overdose but a lower risk of prior alcohol use.13 The West
Virginia study found that ages 18 through 24 were had the highest prevalence of illegal diversion;
while, ages 35 through 44 had the greatest association with doctor shopping.14
Age
The CDC data demonstrates that drug poisoning death rates have risen over the past decade and
that persons in the prime of their lives, ages 35-54, are disproportionately affected (Figure 3).15
10
Ibid at 5.
Ibid at 5.
12
Hall, Aron; Logan, Joseph; et al. Patterns of Abuse Among Unintentional Pharmaceutical Overdose Fatalities. Journal of the American Medical
Association; Vol 300 No 22 (2008):2613-2620.
13
Ibid.
14
Ibid.
15
Ibid at 9.
11
DRAFT
4
Figure 3 Drug Poisoning Death Rates by Age: United States, 1999-200816
Veterans Health Administration (VHA)
Research from the Veterans Health Administration (VHA) from 2004 through 2008 underscore the
conclusion that white men are more likely to have an opioid overdose death. Of a total of 750
opioid overdose decedents, 700 were men, 625 were white, and 610 were between the ages of
40-59. The study examined all opioid overdose deaths matched to a random sample of VHA
patients who received opioid therapy for pain. The study found that opioid overdoses were more
likely to have chronic or acute pain, substance use disorders, and psychiatric diagnoses; this
group was less likely to have cancer. The overdose rate was higher when the maximum dailyprescribed dose was higher. The overdose rate was highest when a patient had concurrent
prescriptions (current prescription and a refill) for opioid prescriptions.17
Surveillance Data, Inc. (SDI) Health
Investigation of data from Surveillance Data, Inc. (SDI) Health, a data warehouse with access to
50 percent of the national retail prescription data, confirms that most opioid prescriptions (45.7
percent) are for individuals between 40 and 59 years old. Most prescriptions were for
hydrocodone and oxycodone (84.9 percent) and issued for 2-3 week courses (65.4 percent). The
data demonstrated that most prescribers were primary care physicians who prescribed 28.8
percent of the total prescriptions in 2009. Researchers also demonstrated that 56.4 percent of all
prescriptions were dispensed to patients who had already filled at least one opioid prescription
within the past month.18
16
Ibid at 9.
Bohnert, A., Valenstein, M., Bair, M., et al.; Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths; Journal of the
American Medical Association; Vol 305, No. 13 (2011): 1315-1321.
18
Volkow, N., McLellan, T., Cotto, J.; Characteristics of Opioid Prescriptions in 2009; Journal of the American Medical Association; Vol 305, No.
13 (2011): 1299-1301.
17
DRAFT
5
Texas Opiate Data
Texas has seen opiate use and misuse trends that mirror those on the national level. A study of
the opioid abuse calls to the Texas Poison Center Network (TPCN) confirms Texas has seen
increases in opioid abuse similar to national statistics. This system is comprised of the six poison
centers that cover the entire state. It is a telephone consultation service that assists in the
management of exposures to a variety of substances, including prescription opioids. A single
electronic database collects demographic and clinical information on all calls. From 2000-2010
opioid abuse calls increased 160 percent.
Hydrocodone, tramadol, morphine, fentanyl,
buprenorphine, and hydromorphone calls all increased during that time period; hydrocodone use
was associated with almost 60 percent of reported opioid calls to Texas poison centers.19
This section will examine Texas opiate use and misuse trends using data from the Department of
State Health Services Center for Vital Statistics, the Texas Poison Center Network, the Drug
Enforcement Administration Automation of Reports and Consolidated Orders System, and the
Texas Department of Public Safety.
Hydrocodone
The Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System
(ARCOS) data collects data about retail drug distribution. ARCOS data on hydrocodone retail
distribution shows that Texas has increased three and a half-fold over the last ten years (Figure 4).
Figure 4: Hydrocodone retail distribution per 100,00020
20,000.00
Grams
15,000.00
10,000.00
5,000.00
0.00
1997 1998
1999
2000 2001
2002 2003
2004
2005 2006
Year
Texas has always been among the top ten states for hydrocodone distribution. The only states
that consistently have similar rates to Texas are West Virginia, Florida, Kentucky, and Tennessee.
These states have been increasingly targeted by the DEA as states with diversion problems.
California and Pennsylvania, which have similar population to Texas, have significantly lower rates
than Texas.
19
20
Forrester, M.; Opioid Analgesic Abuse in Texas; Department of State Health Services.
Drug Enforcement Administration Automation of Reports and Consolidated Orders System (ARCOS) data
DRAFT
6
As retail distribution of hydrocodone increased, data from the TPCN demonstrates a 67 percent
increase in hydrocodone exposure calls from 2000 to 2010 (Figure 5). TPCN data also indicates that
60 percent of all calls to the TPCN are for hydrocodone.
Figure 5: Hydrocodone calls received by the Texas Poison Center Network by month 21
2000
Number of calls
1800
1600
1400
1200
1000
800
600
400
Ja
n98
Ju
l-9
8
Ja
n99
Ju
l-9
9
Ja
n00
Ju
l-0
0
Ja
n01
Ju
l-0
1
Ja
n02
Ju
l-0
2
Ja
n03
Ju
l-0
3
Ja
n04
Ju
l-0
4
Ja
n05
Ju
l-0
5
Ja
n06
Ju
l-0
6
Ja
n07
Ju
l-0
7
Ja
n08
Ju
l-0
8
200
0
Month
Other Opioids, Including Codeine, Morphine, and Oxycodone
From 1999 to 2009, the number of other opioid deaths, including codeine, morphine, and
oxycodone deaths increased nearly fivefold, while the Texas population increased by only 25
percent. In a 10-year period the other opioid deaths, including codeine, morphine, and oxycodone
deaths increased from 122 to 555.22 The 2009 other opioid, death data shows that the population
abusing these prescriptions is predominantly white (79.63 percent), male (54.77 percent), and
between the ages of 40-55 (41 percent) (Figure 6).
21
Department of State Health Services Texas Poison Center Network data
Department of State Health Services, Center Vital Statistics data; ICD-10 code T40.2–other opioids includes poisoning by codeine, morphine,
oxycodone, vicodin, etc. opioids other than opium (T40.0), heroin (T40.1)
22
DRAFT
7
Figure 6: Texas Other Opioids, including codeine, morphine, and oxycodone deaths by age23
No. of Deaths
100
80
60
40
20
-8
4
80
-7
9
75
-7
4
70
-6
9
65
-6
4
60
-5
9
55
-5
4
50
-4
9
45
-4
4
40
-3
9
35
-3
4
30
-2
9
25
-2
4
20
4
-1
9
15
--1
10
0-
-9
0
Age
The data also reveals that the greater Houston metropolitan region24 has a higher number of other
opioids, including codeine, morphine, and oxycodone deaths than the similarly sized DallasFt.Worth Metroplex (Figure 7).25 The 12 counties that comprise the Dallas-Ft.Worth Metroplex
account for only 88 deaths of the total 555 deaths in 2009; the 10 counties that comprise the
greater Houston metropolitan region account for 275 deaths of the 555.
23
Ibid
United States Census Bureau greater Houston metropolitan region definitions: Harris, Fort Bend, Montgomery, Brazoria, Galveston, Liberty,
Waller, Chambers, Austin, and San Jacinto Counties.
25
United States Census Bureau Dallas Ft. Worth Metroplex definitions: Collin, Dallas, Delta, Denton, Ellis, Hunt, Johnson, Kaufman, Parker,
Rockwall, Tarrant, and Wise Counties.
24
DRAFT
8
Figure 7: Other Opioids, Including Codeine, Morphine, and Oxycodone deaths per 100,00026
Over the past 10 years, national Oxycodone retail distribution has increased eight-fold (Figure 8).
26
Ibid.
DRAFT
9
Figure 8: Oxycodone retail distribution per 100,00027
5000
Grams
4000
3000
2000
1000
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Year
From 2000 to 2010, the TPCN reported a 165 percent increase in the number of total exposure
calls for oxycodone (Figure 9).
Figure 9: Oxycodone calls received by the Texas Poison Center Network by month 28
300
Number of calls
250
200
150
100
50
Ja
n98
Ju
l-9
Ja 8
n99
Ju
l-9
Ja 9
n00
Ju
l-0
0
Ja
n01
Ju
l-0
1
Ja
n02
Ju
l-0
2
Ja
n03
Ju
l-0
Ja 3
n04
Ju
l-0
Ja 4
n05
Ju
l-0
5
Ja
n06
Ju
l-0
6
Ja
n07
Ju
l-0
7
Ja
n08
Ju
l-0
8
0
Month
While some of the exposure calls, hospital admissions for oxycodone are from illegally obtained
prescriptions, legal oxycodone prescribing in Texas increased 6.5 percent from 2007, 442,255
27
28
Drug Enforcement Administration Automation of Reports and Consolidated Orders System (ARCOS) data
Department of State Health Services Texas Poison Center Network data
DRAFT
10
prescriptions, to 2010 to 471,588 per year.29 Exposure calls increased 32.5 percent during that
same time period from 298 calls in 2007 to 395 calls in 2010.30
Methadone
Deaths from methadone prescribed for pain have increased 8-fold during 1999-2007 (from 27 in
1999 to 224 in 2007) and then leveled off to just under a 7-fold increase by 2009 (183) (Figure
10).31
Figure 10: Methadone Deaths per Year
250
No. of Deaths
200
150
100
50
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Year
The distribution of the deaths is not as regionally concentrated as the deaths for other opioids
(Figure 11). There are a handful of counties with high death rates; however, those counties have
relatively small populations.
29
Department of Public Safety Texas Prescription Monitoring Program data.
Department of State Health Services Texas Poison Center Network data
31
Department of State Health Services, Center Vital Statistics data; ICD-10 code T40.3 Methadone
30
DRAFT
11
Figure 11: Methadone Death Rate per 100,00032
ARCOS data of methadone by distribution by population in Texas has increased nearly 14 fold
(Figure 12).
32
Department of State Health Services, Center Vital Statistics data; ICD-10 code T40.3 Methadone
DRAFT
12
Figure 12: Methadone retail distribution per 100,00033
1600
1400
Grams
1200
1000
800
600
400
200
0
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
Year
TPCN data demonstrates a 168 percent increase in Methadone exposure calls between 2000 and
2010 (Figure 13).
Figure 13: Methadone calls received by the Texas Poison Center Network by month 34
140
Number of calls
120
100
80
60
40
20
Ja
n98
Ju
l-9
Ja 8
n99
Ju
l-9
Ja 9
n00
Ju
l-0
Ja 0
n01
Ju
l-0
Ja 1
n02
Ju
l-0
Ja 2
n03
Ju
l-0
Ja 3
n04
Ju
l-0
Ja 4
n05
Ju
l-0
5
Ja
n06
Ju
l-0
Ja 6
n07
Ju
l-0
7
Ja
n08
Ju
l-0
8
0
Month
33
34
Drug Enforcement Administration Automation of Reports and Consolidated Orders System (ARCOS) data
Department of State Health Services Texas Poison Center Network data
DRAFT
13
Buprenorphine, Fentanyl, Meperidine
Deaths of persons using buprenorphine, fentanyl, meperidine more closely tracked than the
geographic distribution of the deaths involving other opioids including codeine, morphine, and
oxycodone (Figure 14). Buprenorphine is typically used to treat opioid addiction in higher dosages
and to control acute pain and moderate chronic pain in lower doses. Fentanyl and Meperidine are
used mainly to treat acute and chronic pain.
Figure 14: Buprenorphine, Fentanyl, Meperidine Death Rate per 100,000 35
35
Department of State Health Services, Center Vital Statistics data; ICD-10 code T40.4 Buprenorphine, Fentanyl, and Meperidine
DRAFT
14
While buprenorphine exposure calls have increased 2900 percent from 2000 to 2010 (from 5 calls
in 2000 to 150 in 2010), meperidine exposure calls have decreased by 59 percent during that
same time. However, meperidine exposure calls hardly exceeded two or three dozen calls per
year. Fentanyl exposure calls increased 181 percent during that time (from 26 calls to 73 calls).
While the fentanyl graph appears to show much more variability month to month in the number of
calls, the total number of calls is far below those of other prescriptions and the variability is only an
artifact of the smaller sample (Figure 15).
Figure 15: Fentanyl calls received by the Texas Poison Center Network by month 36
Number of calls
25
20
15
10
5
Ja
n98
Ju
l-9
8
Ja
n99
Ju
l-9
9
Ja
n00
Ju
l-0
0
Ja
n01
Ju
l-0
1
Ja
n02
Ju
l-0
2
Ja
n03
Ju
l-0
3
Ja
n04
Ju
l-0
4
Ja
n05
Ju
l-0
5
Ja
n06
Ju
l-0
6
Ja
n07
Ju
l-0
7
Ja
n08
Ju
l-0
8
0
Month
Unspecified Deaths
In Texas, many overdose deaths will not specify any particular drug. This lack of uniformity in how
drug deaths may be coded leads undercounts the number of deaths for any specific drug
category.
Geographical mapping of unspecified drug deaths demonstrates that the east Texas counties of
Montgomery, Orange, Jefferson, and Liberty are disproportionately affected (Figure 16). This
distribution mirrors that of the deaths by other opiates. The distribution also reflects DPS and DEA
reports of pill mill problems in that region. Unspecified drug deaths have nearly doubled from 1999
to 2009.
36
Department of State Health Services Texas Poison Center Network data
DRAFT
15
Figure 16: Unspecified Drug Death Rate per 100,00037
Mechanisms of Diversion
Most pharmaceuticals diverted in the U.S. are diverted by doctor shopping, forged prescriptions,
theft, and through the internet.38 Doctor shopping is when individuals visit numerous doctors
(usually defined as five or more) in an attempt to obtain multiple prescriptions for the drugs,
particularly prescription narcotics. Prescription fraud includes a variety mechanisms used to divert
37
Department of State Health Services, Center Vital Statistics data; ICD-10 code T50.9 Unspecified Drug Death
Kraman, P.; Trends Alert: Drug Abuse in America –Prescription Drug Diversion; The Council of State Governments (2004); Available:
http://www.csg.org/knowledgecenter/docs/TA0404DrugDiversion.pdf
38
DRAFT
16
pharmaceuticals such as forging or altering prescriptions, producing counterfeit prescriptions, and
calling in fictitious prescriptions to pharmacies by impersonating a physician.39
Prescription Drug Monitoring
As of October 2011, 37 states have PDMPs that have the capacity to receive and distribute
controlled substance prescription information to authorized users.40 Eleven states (Alaska,
Arkansas, Delaware, Georgia, Maryland, Montana, Nebraska, New Jersey, South Dakota,
Washington, and Wisconsin) and one U.S. territory (Guam), have enacted legislation to establish a
PDMP, but are not fully operational.
In 1982, the Texas Legislature created the Texas Prescription Program to monitor Schedule II
controlled substance prescriptions. The program was created to be an efficient, cost effective tool
for investigating and preventing drug diversion. In 2008, the Texas Legislature expanded the
Program to include the monitoring of Schedule III through Schedule V controlled substance
prescriptions. The Texas Department of Public Safety (DPS) operates the Texas Prescription
Program. Practitioners and pharmacists can use this program to verify their own records and to
inquire about their patients, as well as to generate and disseminate information regarding
prescription trends. Access to information is statutorily restricted. It is available to practitioners
and pharmacists who are inquiring about their patients and to various regulatory and law
enforcement personnel via mail or facsimile request. An electronic request system is expected to
be activated in 2012.
Other Legislation
SB 911 (81R) requires pain management clinics to register and be certified by the Texas Medical
Board in order to operate within the state. It also allows the Medical Board to inspect and fine
facilities that are in violation of the statute.41
The Texas Medical Board now licenses and
regulates pain management clinics that operate in Texas. SB 158 (82R) creates criminal penalties
for individuals who “doctor shop” for narcotic medication.42
The rapid increase of deaths and “pill mills” prompted a recent collaborative enforcement effort by
the Texas Medical Board (TMB), the Department of Public Safety (DPS), and the Drug
Enforcement Administration (DEA) to investigate pill mills, storefronts that often provide powerful
narcotics without thorough patient exams often on a cash-only basis. The east Texas area, in
particular, has seen a number of investigations of pill mills.
In addition, the DEA tracks the prescription medications from the manufacturer to the dispenser.
DEA tracks up to the pharmacy. This tracking information can be communicated to DPS. And the
DEA may also inform DPS of unusual amounts of prescriptions shipped to a pharmacy. In Texas,
DPS tracks prescription medical from the pharmacy to the user. Licensing boards may use the
39
Ibid.
Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,
Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, and Wyoming; Available:
http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm
41
http://www.capitol.state.tx.us/tlodocs/81R/billtext/pdf/SB00911F.pdf#navpanes=0
42
http://www.capitol.state.tx.us/tlodocs/82R/billtext/pdf/SB00158F.pdf#navpanes=0
40
DRAFT
17
prescription information and registrants can use it for themselves or for their patients. DPS also
tracks the shipping of prescription medications if the prescription is manufactured in Texas.
Best Practices
The American Academy of Pain Medicine recently developed best practice guidelines on the initial
prescription and subsequent monitoring of opioids. Best practices should include the following:
1. Standardized screening procedures and special provisions for managing pain in those
most at risk for abuse;
2. indications for when and for how long to prescribe opioids vs nonopioids;
3. guidelines for when to prescribe short vs long-acting opioids;
4. limits on the number of pills prescribed so that it matches the number of treatment days
required;
5. when and how to use urine screening to manage risk of diversion, abuse, and addiction;
6. when an how to use patient contracts to manage risk;
7. proper use of prescription drug monitoring programs to reduce doctor shopping; and
8. criteria for deciding whether and under what circumstances to refill or discontinue opioid
prescriptions.43
The Affordable Care Act provides states new authority to monitor diversion in the Medicaid
program. It allows states to establish enrollment moratorium periods when providers are
suspected as being a risk for diverting drugs. It also requires states to suspend payment and
billing when there is a credible allegation of diversion.44
CMS has guidelines about appropriate management of diversion in the Medicaid program. CMS
advocates using a Drug Utilization Review (DUR) process that has access to a database of all
controlled substance prescriptions filled. It allows regulatory agencies identify outliers in
prescriptions and utilization. CMS recommends greater coordination with state and national
prescription drug regulatory agencies.45
A GAO report titled Medicare Part D: Instances of Questionable Access to Prescription Drugs
identified that there was evidence of doctor shopping in the Medicare Part D program. The report
found that 1.8 percent of the beneficiaries acquired frequently abused drugs (including
hydrocodone and oxycodone) from five or more medical practitioners during 2008 accounting for
$148 million in drug costs. The report indicated that a DUR process in conjunction with a
restricted recipient program has been effective in curtailing prescription drug abuse and misuse. A
restricted recipient program restricts beneficiaries who have been identified as drug abusers to
one prescriber, one pharmacy, or both for receiving prescriptions.46
Experts recommend individuals dispose of their unused prescription medication. Unless the
medication indicates that can be flushed away, prescriptions should be disposed of in the manner
43
Volkow, N., McLellan, T.; Curtailing Diversion and Abuse of Opioid Analgesics Without Jeopardizing Pain Treatment; Journal of the American
Medical Association; Vol 305, No. 13 (2011): 1346-1347.
44
Centers for Medicare & Medicaid Services; Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in
Medicaid; Available: https://www.cms.gov/MedicaidIntegrityProgram/Downloads/drugdiversion.pdf
45
Ibid.
46
United States Government Accountability Office; Medicare Part D: Instances of Questionable Access to Prescription Drugs; Report to
Congressional Requesters; (2011): Available: http://www.gao.gov/assets/590/585424.pdf
DRAFT
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indicated on the label. This may mean removing the medication from its container and mixing it
with coffee grounds or other undesirable substances to make the medication less appealing to
children or people who may intentionally go through trash.
Unfortunately, there is no provision in the Controlled Substances Act or Code of Federal
Regulations (CFR) for a DEA registrant, pharmacy, physician, to acquire unused dispensed
prescriptions from an individual patient. DEA registrants can return the controlled substance to the
pharmaceutical manufacturer who, as a service to its customers, accepts returns of
outdated/damaged controlled substances. Under 21 CFR 1307.21, a registrant may request
permission to dispose of controlled substances without the benefit of a DEA or State witness. In
some cases, the DEA may issue ongoing permission for disposal of controlled substances. The
DEA must authorize the disposal in writing and may require a set schedule. Other registrants are
granted disposal authority on a case-by-case basis. DEA normally requires that the registrant
provide two designated responsible individuals to accompany the drugs to the disposal site and
witness the destruction. The DEA also allows a distributor, dispenser, or manufacturer to distribute
controlled substances to a reverse distributor to take control of the controlled substances for the
purpose of returning them to the manufacturer or, if necessary, disposing of them.47 There are two
DEA registered reverse distributors in Texas: one in Fort Wroth and another northeast of the
Dallas–Fort Worth Metroplex. A Controlled Substances Act exemption allows law enforcement to
collect previously dispensed prescription drugs.48 Individuals can dispose of medications
themselves or they can participate in some of the National Drug Take Back activities.49 The Texas
Tech School of Pharmacy also operates a medication disposal service with assistance from law
enforcement.50
Next Steps
1) Create a workgroup of law enforcement, regulatory entities, public benefits programs, and
providers to create solutions for increase collaboration and eliminating service and
information gaps.
2) Conduct quality of care studies by providers in Texas.
3) Increase the speed of data from the Texas Prescription Program.
4) Increase educational programs for providers/prescribers and the public.
5) Partner with insurers (public and private) and prescription drug monitoring plans to
evaluate use in different populations.
6) Consider setting guidelines for providers about requirements for maximum prescribed
dosages, specialist consultation, pain management agreements, and required follow-up for
pain medication prescriptions. Look to best practice models in other states or entities such
as Washington State.
7) Implement best practices programs around the state.
47
http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0502.htm
http://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr0121.htm
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/takeback_102911.html
50
http://medicationcleanout.com/default.aspx
48
49
DRAFT
19
Conclusion
Achieving the appropriate balance between therapeutic mitigation of pain and unintended abuse
and misuse of opiates will require coordination between law enforcement, professional trade
groups, community health providers, Texas Medicaid, and many other groups and entities. Their
collaboration will allow Texas to monitor prescription drug diversion, emphasize appropriate
treatment guidelines, target opiate abuse treatment, and assist in responsible disposal of
prescriptions.
DRAFT
20
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