Pain Medicine 2015; 16: 2031–2035 Wiley Periodicals, Inc.

REHABILITATION SECTION Brief Research Report Increased Incidence of Spinal Abscess and Substance Abuse after Implementation of State Mandated Prescription Drug Legislation

*Department of Physical Medicine and Rehabilitation, University of Kentucky, Lexington, Kentucky, USA; † Department of Physical Medicine and Rehabilitation, Cardinal Hill Rehabilitation Hospital, University of Kentucky, Lexington, Kentucky, USA; ‡Department of Physical Medicine and Rehabilitation, Spinal Cord and Brain Injury Research Center, University of Kentucky, Lexington, Kentucky, USA Reprint requests to: Vittal R Nagar, MD, PhDc; Resident Physician/Doctoral Candidate, Department of Physical Medicine and Rehabilitation, University of Kentucky, Lexington, KY, USA. Tel: 210-863-4055; Fax: 859-323-1123; E-mail: [email protected]. Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the content and writing of the paper.

Abstract Objectives. To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled “House Bill 1” (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012. Design. A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame.

Results. The incidence of intraspinal abscess increased 1.56-fold in 2011 (n 5 26) and 2012 (n 5 25) relative to 2010 (n 5 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold (n 5 38) and then 4.19-fold (n 5 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 (n 5 3) and 2012 (n 5 3). However, it increased twofold (n 5 7) in 2013 and then ninefold (n 5 27) in 2014. A correlation coefficient (rSAD) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse. Conclusions. The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account. Key Words. Pain Management; Spinal Cord; Substance Abuse; Addiction; Narcotics; Rehabilitation Medicine Introduction Spinal infection occurs in 2–4% of bone infections and can be pyogenic (bacterial), granulomatous (tuberculous or fungal), or parasitic [1,2]. The clinical symptoms include fever, back pain, neurologic complications, and pathologic fracture with kyphosis. One of the most common symptoms is moderate to severe back pain, which is found in as high as 95–100% of individuals with spinal infections [3]. Hematogenous spread is one of the most common routes for spinal infection [3,4], and infections involving the lumbar spine, anterior elements, and a 2031

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Vittal R. Nagar, MD, PhDc,*,† Joe E. Springer, PhD,*,†,‡ and Sara Salles, DO*,†

Nagar et al. single segment are more common than involvement of the thoracic and cervical spine, posterior elements, and multiple segments [5]. The risk factors for spinal infection include age (mean of 50–60 years of age), diabetes mellitus, malignancy, alcoholism, immunosuppression (steroid use, organ transplant, HIV infection, and chronic renal failure), genitourethral manipulation, dental procedure, recent abdominal operation, systemic infection, and intravenous abuse of controlled substances [6,7]. Abuse of intravenous drugs has been associated with a higher prevalence of spinal abscess due, in part, to hematogenous spread of bacteria from contaminated syringes and needles [8]. Several studies have documented primary pyogenic infection of the spine in intravenous drug users [9,10], and several case studies have reported spinal abscess in patients who are heroin addicts [11–13].

Patients and Methods An uncontrolled retrospective case series study design was used to examine the incidence of intraspinal abscess and drug abuse diagnoses admissions before and after the passage and implementation of HB1 legislation. We retrieved the number of admissions with principal or secondary diagnosis of intraspinal abscess; and intraspinal abscess and drug abuse diagnoses using electronic medical records coding from July 1, 2010 to June 30, 2014 at our tertiary care hospital. In addition, we also obtained patient admission data for spinal cord injured individuals with a diagnosis of epidural abscess and epidural abscess with substance abuse at our freestanding rehabilitation hospital. All patient data were deidentified and coded using subject identification numbers assigned to each individual’s 2032

The diagnostic codes corresponding to Drug Abuse Diagnoses (Qualifying Drug Diagnosis) included 292.0— drug withdrawal; 304.00—opioid dependence-unspec; 304.01—opioid dependence-contin; 304.02—opioid dependence-episod; 304.03—opioid dependenceremiss; 304.10—sedhypanxiolyt dep-nos; 304.21— cocaine depend-contin; 304.41—amphetamin dependcontin; 304.90—drug depend nos-unspec; 305.50— opioid abuse-unspec; 305.51—opioid abusecontinuous; 305.53—opioid abuse-in remiss; 305.60— cocaine abuse-unspec; 305.61—cocaine abusecontinuous; 305.70 -amphetamine abuse-unspec; 305.90—drug abuse nec-unspec; 305.91—drug abuse nec-contin; 305.93—drug abuse nec-in remiss. Substance abuse subjects who are in remission have a high risk for infection/abscess and, therefore, were grouped with current substance abuse patients. The outcome variable diagnosis code included 324.1 Intraspinal Abscesses and Intraspinal Abscess and Drug Abuse Diagnosis. Statistical analyses were conducted using the Statistical Package for Social Sciences 20.0 for Windows. Descriptive data for each year were generated and simple linear regression analysis of Intraspinal Abscess and Drug Abuse Diagnoses over time was calculated. Results In 2010, two years before the passage of HB1 legislation, a total of 16 spinal abscesses were diagnosed at the tertiary care hospital. Of these, a total of three cases of spinal abscess with substance abuse were diagnosed (Tables 1 and 2, and Figure 1). The number of spinal abscesses increased to 26 in 2011 and remained relatively the same in 2012 (n 5 25). Over this time frame, the number of spinal abscess cases with substance abuse diagnoses remained relatively flat (n 5 5 in 2011 and n 5 3 in 2012). However, in 2013, the year after implementation of HB1 legislation, there were 38 diagnoses of spinal abscess, of which seven were also diagnosed with substance abuse (Figure 1, Tables 1 and 2). This represents a 2.4fold increase in the total number of spinal abscess in 2013 relative to 2010. Interestingly, the incidence of spinal abscesses increased to 67 cases in 2014 and the number of cases of spinal abscess with substance abuse increased to 27 (Tables 1 and 2, and Figure 1).

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The state of Kentucky ranks 26th in population in the United States, but fourth in terms of the number of prescribed scheduled medications [14]. In July of 2012, the Kentucky general assembly passed House Bill 1 (HB1), which focuses on the strict monitoring and regulation of pain clinics and prescription drug abuse in Kentucky [15]. This landmark piece of legislation mandated that the Kentucky medical board promulgate regulations on a host of issues relating to the prescribing of controlled substances. One of the important changes that came into existence as a result of HB1 legislation is mandatory registration of all physicians with the state’s Kentucky All Schedule Prescription Electronic Reporting system, known as KASPER. Mandatory use of KASPER is required prior to prescribing a schedule II or III controlled substance, as well as many Schedule IV controlled substances [16]. While HB1 legislation has proven effective in reducing the abuse of prescription medications, there is evidence of a surge in the use of illegal, nonprescription drugs, in particular intravenous use of heroin, possibly as a means to compensate for limited availability of medically approved controlled substances [17]. We report here the results of an uncontrolled retrospective study investigating the incidence of patients with spinal abscess and drug abuse diagnoses before and after passage of HB1 legislation.

data set, and each subjects’ name was excluded from the processed data. No potential risk for subjects was anticipated as no identifiable Protected Health Information (PHI) was collected. Research data were acquired using medical record codes, and the collected study records and data were stored on a password protected office computer in a locked office. No data were transmitted outside of our facilities, and all data/records will be retained for 6 years after completion of the study. The study was approved by the Institutional Review Board Committee of the respective tertiary care and freestanding rehabilitation hospitals.

Increased Incidence of Spinal Abscess

Table 1 Cases with a principal or secondary diagnosis of intraspinal abscesses. FY-for year Month July August September October November December January February March April May June

FY11

1 1 2

3 2 2 2 3 16

2 1 1 1 3 3

3 6 3 3 26

FY12 2 6 1 3 1 1 2 4 2 2 1 25

FY13

FY14

1 3 4 4 6 5 5 2 2 3 3 38

7 4 9 1 9 5 5 3 8 4 6 6 67

This corresponds to a 4.2-fold increase in the number of spinal abscess cases and a ninefold increase in the number of spinal abscess with a diagnosis of substance abuse in 2014 compared with 2010. A similar trend was seen in patients admitted to our freestanding rehabilitation hospital with spinal cord injury and diagnoses coded for both epidural abscess and substance abuse (2011: 1; 2012: 1; 2013: 4; 2014: 9). As also shown in Figure 2, the ratio of cases with spinal abscess plus substance abuse diagnoses relative to those with spinal abscess alone remains relatively flat over years 2010–2013. However, the ratio more than doubled in 2014, indicating that the increase in spinal abscess cases with substance abuse is not simply due to an overall increase in incidence of spinal abscess. Finally, the total admissions remained relatively level

Figure 1 Number of total admissions and admissions specific to spinal abscesses with or without drug abuse diagnoses from 2010 to 2014. Note the increasing trend in spinal abscess and drug abuse after implementation of HB1 legislation (2012) mandating stricter prescription oversight of controlled substances. over the same time periods (Figure 1), indicating that the increase in the number of cases with spinal abscess associated with drug abuse is not due to an increase in overall admissions. The correlation coefficient (rSAD) for intraspinal abscess and drug abuse over time was found to be 0.775. Based on the regression formula and in the absence of any subsequent intervention or change in behavior, it is predicted that 49 cases of intraspinal abscess and substance abuse diagnoses will occur in 2020 at our

Table 2 Cases with a principal or secondary diagnosis of intraspinal abscess and drug abuse diagnosis. FY-for year

1 2 3 4 5 6 7 8 9 10 11 12 Total

Month

FY10

FY11

July August September October November December January February March April May June

1 1

1

FY12

FY13

FY14

1

1 2 5

3

5

1 1 1

1

1 1 2

3

5

1 1 1

3

7

3 2 3 1 3 2 27

Figure 2 Ratio of spinal abscess plus drug abuse relative to total spinal abscess. In 2014, the ratio reflects an increase in spinal abscess cases with substance abuse relative to the total number of spinal abscess cases. 2033

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1 2 3 4 5 6 7 8 9 10 11 12 Total

FY10

Nagar et al. tertiary care hospital. This projected number of cases is 16.33-fold greater than the number of cases observed in 2010. Discussion

It is tempting to speculate that the increased incidence is related to an overall increase in the abuse of schedule I substances (e.g., heroin) in response to legislation limiting the availability of similarly acting prescription medications. The Kentucky Office of Drug Control Policy reports that the total doses of all controlled substances has dropped 10.4% as HB1 took effect in 2012 [18]. In addition, a recent study has reported that the number of deaths due to drug overdoses in the state of Kentucky have stayed relatively level between 2010 and 2012 [19]. However, while drug overdose deaths due to oxymorphine, hydrocodone, and oxycodone have decreased 1.3-fold between 2010 and 2012, overdose deaths due to heroin have increased over threefold over the same time period [18]. Finally, the detection of heroin in urine samples collected in state-funded substance abuse treatment facilities obtained from patients in the state of Kentucky increased by 211% from 2010 to 2012 [20]. It is not clear if HB1 legislation has been a contributing factor to this pattern, as it was not implemented until 2012, which is the last year data are available on usage and deaths due to drug overdose. Regardless, these observations indicate that the broad sweeping mandates associated with HB1 legislation have been successful in limiting the availability and abuse of schedule II and III prescription medications across the state, especially the highly abused opioid-based prescriptions. While implementation of stricter legislation may be a contributing factor leading to increased cases of spinal abscess associated with substance abuse, the retrospective design used in our study does not allow for firm conclusions related to causation. Rather, it is highly likely that the increased incidence is due to many factors. For example, a recent study reports an increase in heroin usage and overdose deaths due to heroin across the United States, and this trend includes several states that do not have legislative measures mandating stricter 2034

Strict laws for controlled substance prescriptions have been supported as an effective means to control abuse, drug dependence, and death. However, there are no published studies that examine the impact of the prescription drug abuse legislation perpetuating unhealthy behaviors. The purpose of this study was to determine the incidence of drug abuse and spinal abscess prevalence over recent years after HB1 came into existence in Kentucky. While it is not possible to draw firm conclusions between HB1 legislation and the increased incidence reported here, the results of this study have potential relevance to physicians and patients living in other states that have similar potential drug abuse problems, especially given the national increase in heroin usage. Finally, the findings reported here also may be of relevance to other complications related to intravenous drug abuse such as infective endocarditis, sepsis, hepatitis C, and stroke. Limitations This study utilized a retrospective chart review that has several limitations including missing data, absence of appropriate control group(s), and the possibility of nonreporters of drug abuse with intraspinal abscess. Therefore, the data presented here should be considered as a conservative assessment of the incidence. In addition, it is possible that the incidence of spinal abscess in substance abuse patients may be due to events unrelated to recent passage of legislation. Therefore, future hypothesis driven prospective studies using a more controlled study design, different tools, patient population(s), and additional time points may reveal the significance of this observation. Conclusion We report an increased incidence of intraspinal abscess with drug abuse after HB1 legislation was passed in 2012 in the state of Kentucky. This increased trend may be related to the strict state controlled substances prescription drug abuse legislation, although other factors must be taken into account. Regardless, given the nationwide increase in heroin usage, the results of this study are of relevance to physicians and patients living in other states that are experiencing similar drug abuse problems.

Acknowledgments The authors thank Dr. Andrew Bernard, Mr. Ryan L. Korosec, and Ms. Joyce Todd for their assistance during data collection.

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The results of this study suggest an increased incidence of intraspinal abscess with substance abuse in patients admitted to a tertiary acute care hospital in Kentucky from 2010 to 2014. This increase occurred primarily in 2014, two years after legislation went into effect mandating stricter control over prescription medication, and was not due to any change in the overall number of admissions over the same time period. It is possible that these observations are unique to the patient population and/or those who are referred to our tertiary care hospital. However, we observed a similar trend in spinal cord injured patients admitted to our freestanding rehabilitation hospital with diagnoses coded for both epidural abscess and substance abuse.

oversight of prescriptions for controlled substances [21]. Factors other than implementation of stricter legislation contributing to the increased incidence of spinal abscess due to drug abuse include the availability and relatively lower cost of heroin over opioid-based prescription medications [17].

Increased Incidence of Spinal Abscess References 1 Lifeso RM. Pyogenic spinal sepsis in adults. Spine (Phila Pa 1976) 1990;15:1265–71. 2 Schinkel C, Gottwald M, Andress HJ. Surgical treatment of spondylodiscitis. Surg Infect (Larchmt) 2003;4:387–91. 3 Friedman JA, Maher CO, Quast LM, McClelland RL, Ebersold MJ. Spontaneous disc space infections in adults. Surg Neurol 2002;57:81–6. 4 Calderone RR, Larsen JM. Overview and classification of spinal infections. Orthop Clin North Am 1996; 27:1–8.

6 Koppel BS, Tuchman AJ, Mangiardi JR, Daras M, Weitzner I. Epidural spinal infection in intravenous drug abusers. Arch Neurol 1988;45:1331–7. 7 Rath SA, Neff U, Schneider O, Richter HP. Neurosurgical management of thoracic and lumbar vertebral osteomyelitis and discitis in adults: A review of 43 consecutive surgically treated patients. Neurosurgery 1996;38:926–33. 8 Reihsaus E, Waldbaur H, Seeling W. Spinal epidural abscess: A meta-analysis of 915 patients. Neurosurg Rev 2000;23:175–204. 9 Chuo CY, Fu YC, Lu YM, et al. Spinal infection in intravenous drug abusers. J Spinal Disord Tech 2007;20:324–8.

13 Sverzut JM, Laval C, Smadja P, et al. Spinal cord abscess in a heroin addict: Case report. Neuroradiology 1998;40:455–8. 14 Cohron P. The commonwealth’s response to kentucky’s pill mill problem. Kentucky Law J Online 2013–2014;102:1–7. 15 Kentucky General Assembly. House Bill 1. April 2012. Available at: http://kbml.ky.gov/hb1/Pages/ default.aspx (accessed October 2014). 16 Kentucky Cabinet for Health and Human Services. KASPER (Kentucky All Schedule Prescription Electronic Reporting). 2015. Available at: http://www. chfs.ky.gov/os/oig/KASPER.htm (accessed January 2015). 17 Office of Drug Control Policy. The heroin epidemic. Frankfort, KY: 2014. Available at: http://odcp.ky. gov/Pages/The-Heroin-Epidemic.aspx (accessed January 2015). 18 Office of Drug Control Policy. Overdose fatality report. Frankfort, KY: 2014. Available at: http:// odcp.ky.gov/Pages/Overdose-Fatality-Report.aspx (accessed January 2015). 19 Slavova S, Bunn T, Lambert J. Drug overdose deaths, hospitalizations, and emergency department visits in Kentucky 2000-2012. Lexington, KY: Kentucky Injury Prevention and Research Center; 2014. Available at: http://www.mc.uky.edu/kiprc/pdf/drugoverdose-report-released.pdf (accessed January 2015).

10 Wang Z, Lenehan B, Itshayek E, et al. Primary pyogenic infection of the spine in intravenous drug users: A prospective observational study. Spine (Phila Pa 1976) 2012;37:685–92.

20 Office of the Attorney General. Frankfort, KY: 2013. Available at: http://migration.kentucky.gov/Newsroom/ag/heroinpsa.htm (accessed February 2015).

11 Finsterer J, Seemann-Hlawati B, Konigswieser H. Recovery from a staphylococcus aureus–induced spinal epidural abscess despite late surgical decompression in a heroin addict. Subst Abus 2011;32:153–6.

21 Rudd RA, Paulozzi LJ, Bauer MJ, et al. Increases in heroin overdose deaths–28 states, 2010 to 2012. MMWR Morb Mortal Wkly Rep 2014;63: 849–54.

2035

Downloaded from http://painmedicine.oxfordjournals.org/ by guest on June 5, 2016

5 Klockner C, Valencia R. Sagittal alignment after anterior debridement and fusion with or without additional posterior instrumentation in the treatment of pyogenic and tuberculous spondylodiscitis. Spine (Phila Pa 1976) 2003;28:1036–42.

12 Silvani V, Brambilla G, Rainoldi F, Gaetani P, Denaro V. Vertebral osteomyelitis with chronic cervical extradural abscess in a heroin addict. Neurochirurgia (Stuttg) 1987;30:91–4.

Increased Incidence of Spinal Abscess and Substance Abuse after Implementation of State Mandated Prescription Drug Legislation.

To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled "House Bill 1" (HB1) man...
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