Journal of Dermatological Treatment

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Use of opioid analgesics in skin disorders: Results from a nationally representative US sample Madhulika A. Gupta, Aditya K. Gupta, Branka Vujcic & Meghan Piccinin To cite this article: Madhulika A. Gupta, Aditya K. Gupta, Branka Vujcic & Meghan Piccinin (2015) Use of opioid analgesics in skin disorders: Results from a nationally representative US sample, Journal of Dermatological Treatment, 26:3, 269-274 To link to this article: http://dx.doi.org/10.3109/09546634.2014.951304

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Date: 06 November 2015, At: 01:27

http://informahealthcare.com/jdt ISSN: 0954-6634 (print), 1471-1753 (electronic) J Dermatolog Treat, 2015; 26(3): 269–274 ! 2014 Informa Healthcare USA, Inc. DOI: 10.3109/09546634.2014.951304

ORIGINAL ARTICLE

Use of opioid analgesics in skin disorders: Results from a nationally representative US sample Madhulika A. Gupta1,2, Aditya K. Gupta3, Branka Vujcic1,2, and Meghan Piccinin1,2 Department of Psychiatry, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada, 2Psychmed Research, London, Ontario, Canada, and 3Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

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Abstract

Keywords

Introduction: Increasing and inappropriate use of opioid analgesics (OA) have been declared a public health concern in the United States. There are no epidemiologic studies of OA use in skin disorders. We examined OA use in a nationally representative sample of US patient visits with only physician-diagnosed skin disorders. Methods: Retrospective cross-sectional study of 56 751 patient visits from 1995 to 2010 (International Classification of Diseases, 9th Revision, Clinical Modification codes 680–709 denoting ‘‘Diseases of the Skin and Subcutaneous Tissue’’; 172, 173, 216 and 232 denoting malignant and benign skin neoplasms). Results: An estimated 3.1% ± 0.2% of skin disorders visits were associated with OA use; 52.7% ± 5.4% were Schedule III opioids; 11.4% ± 1.4% of OA visits involved skin neoplasms and 45.4% ± 2.3% cellulitis and abscess. OA use increased from 1995 to 2010 (adjusted OR ¼ 1.82, 95% CI: 1.49–2.22), even after controlling for increase in the frequency of skin infections from 1995 to 2010. Discussion: The most frequent use OA for cellulitis and abscess is entirely consistent with their Food and Drug Administration (FDA)-approved indications for pain management. The almost two-fold increase in OA use in skin disorders from 1995 to 2010 may suggest that OA are being considered for pain management earlier in therapy. Conclusions: Only a minority of patient visits with OA had primary dermatologic disease. OA are being used in dermatology primarily for FDA-approved indications.

Dermatology, epidemiology, narcotics, opioid analgesics, pain, skin cancer, skin disease

Introduction Opioid or narcotic analgesics (OA) are US Food and Drug Administration (FDA) approved for the symptomatic relief of pain in acute and chronic conditions (1). The prescription rates of OA in the US have increased significantly since 1989, and their possible inappropriate off-label use is a public health concern (2,3). A recent prospective study (4) of 212 adult patients who underwent a single skin excision for mainly cutaneous malignancies revealed that opioids were prescribed to 72 or 34% of patients; among the patients who were prescribed opioids 35% did not use them and 86% had left over pills (4). The authors comment that opioids were being overprescribed after dermatologic surgery (4). Most of the research literature on the use of OA in dermatologic disorders has focused on topical use of these drugs (5–15). To our knowledge, there are no commercially available topically acting OA formulations. There are no studies that have examined the use of OA in an epidemiologically representative sample of patients with skin disorders. In this study, we examined the use of OA in a nationally representative sample of patient visits in the US from 1995 to 2010 who were diagnosed with only a skin disorder at the time of

History Received 25 April 2014 Revised 18 July 2014 Accepted 19 July 2014 Published online 26 August 2014

visit. We tested the hypothesis that the use of OA in a nationally representative sample of patient visits with skin disorders parallels the overall trends (increase in use and off-label or inappropriate use) (2,3) in OA use in the United States.

Methods Data collected from 1995 to 2010 by the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) (16) were examined using a retrospective, cross-sectional design. A recent study (17) has shown that databases like the NAMCS provide a generalizable sample that can be used in studies of dermatology outpatient treatment. The University of Western Ontario Office of Research Ethics determined that ethics approval was not required for research involving publicly accessible information such as the NAMCS/NHAMCS databases. A detailed description of the databases and methods used have been described elsewhere (18,19). Variables studied Dermatologic disorders

Correspondence: Madhulika A. Gupta, MD, FRCPC, 585 Springbank Drive, Suite 101, London, Ontario, Canada, N6J 1H3. Tel: 519-641-1001. Fax: 519-641-1033. E-mail: [email protected]

In this study, we have examined patient visits where 1 diagnoses (ranging from one to three possible dermatologic diagnoses per visit) were coded using the International Classification of

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Table 1. Demographics of patient visits for skin disorders (ICD9-CM codes 680–709 and 172, 173, 232 and 216) with and without opioid analgesics (OA) use.

Demographic factor

OA not used (non-OA group) (n ¼ 52 873)

Age (mean ± SE) years

43.22 ± 0.65

42.71 ± 0.32

Sex% (±SE)

52.9% ± 1.3% female, 47.1% ± 1.3% male 24.2% ± 1.6% ‘‘black’’; 75.8% ± 1.6% ‘‘white’’

55.3% ± 0.4% female, 44.7% ± 0.4% male 19.6% ± 0.8% ‘‘black’’; 80.4% ± 0.8% ‘‘white’’

Metropolitan statistical area (MSA): non-MSA versus MSA

18.2% ± 3.3% non-MSA, 81.8% ± 3.3% MSA

12.4% ± 1.9% non-MSA, 87.6% ± 1.9% MSA

Setting type: Emergency (NHAMCS-ED) versus outpatient (NHAMCS-OPD, NAMCS)

39.7% ± 1.8% NHAMCS-ED 7.8% ± 0.8% NHAMCS-OPD 52.5% ± 1.9% NAMCS

5.0% ± 0.1% NHAMCS-ED 5.8% ± 0.3% NHAMCS-OPD 89.2% ± 0.4% NAMCS

Race% (±SE)

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OA used (OA group) (n ¼ 3878)

Comparison of ‘‘OA group’’ versus ‘‘non-OA group’’ (unadjusted odds ratio ¼ OR) OR (40 versus 540 years) ¼ 0.98 (0.84–1.13) OR (female versus male) ¼ 0.91 (0.80–1.03) OR (‘‘black’’ versus ‘‘white’’) ¼ 2.12 (95% CI: 1.73–2.60), p50.001 OR (non-MSA versus MSA) ¼ 1.58 (95% CI: 1.22–2.04), p ¼ 0.005 OR (emergency versus non-emergency visits) ¼ 12.58 (95% CI: 10.62–14.90), p50.001

Diseases, 9th Revision, Clinical Modification (ICD9-CM) codes (20) 680–709 which represent ‘‘Diseases of the Skin and Subcutaneous Tissue’’ and/or, ICD9-CM codes 172 (Malignant melanoma of skin), 173 (Other malignant neoplasm of the skin), 216 (Benign neoplasm of skin) and 232 (Carcinoma in situ of skin). Non-dermatologic comorbidities were excluded for this initial study of OA in skin disorders, so that OA use could be attributed to a skin disorder alone.

As NAMCS and NHAMCS transitioned from coding six medications to coding upto eight possible medications per patient visit starting in 2003, we performed an additional analysis where we considered only the first six medications for each patient visit for the entire period from 1995 to 2010 to ensure that the increase observed in the frequency of OA use during 2003–2010 versus 1995–2002 was not due to the fact that a greater number of medications were recorded during the 2003–2010 time period.

Demographic factors

Infections of skin and subcutaneous tissue

(i) Age was categorized as the 540 years versus 40 years; the cut-off of 40 years was chosen as it was close to the mean age of the sample; (ii) ‘‘Race’’: the imputed race variable (16) was used to create a dichotomous race variable that examined the ‘‘white’’ and ‘‘black’’ categories; 4.2% ± 0.4% of patient visits that were classified as ‘‘other’’ race were excluded from this variable (Table 1). Race was examined as previous studies of opioid use in the United States have reported differences in frequency of opioid use by race (21–23); (iii) metropolitan statistical areas (MSA) versus non-MSA: the frequencies of OA use in dermatology patients from metropolitan (largely urban) versus non-metropolitan regions were examined; (iv) setting type: OA use in more acute and emergency settings (NHAMCS-ED) (likely to be an index of the acuteness and severity of the skin disorder) versus non-emergency outpatient settings (NHAMCS-OPD and NAMCS) was examined.

Cellulitis and abscess were most commonly associated with the use of OA (Table 2). As there has been a documented increase from 1993 to 2005 in the frequency of patient visits for soft-tissue infections (25), we controlled for the possible confounding effect of the increase in the frequency of skin infections (25) during our study period with a variable created using ICD9-CM codes 680– 686 to denote ‘‘Infections of the Skin and Subcutaneous Tissue’’.

Opioid analgesics The Ambulatory Care Drug Database System (ACDDS) (24) used to classify drugs in the NAMCS and NHAMCS classifies opioids under ‘‘Narcotic Analgesics’’ (ACDDS class 060) and ‘‘Narcotic Analgesic Combinations’’ (ACDDS class 191). We included all narcotic analgesics and narcotic analgesic combinations representing all listed Drug Enforcement Administration (DEA) categories in our analysis (i.e. Schedule I–V, no control, undetermined and multiple schedules) (24). There were 128 individual medication codes for ‘‘Narcotic Analgesics’’ and 156 codes for ‘‘Narcotic Analgesic Combinations’’, which were combined into one ‘‘Opioid Analgesics’’ variable. Time periods Trends in opioid use from 1995 to 2010 were examined by creating a dichotomous variable comparing the period of years 2003–2010 to years 1995–2002.

Statistical analysis All analyses were conducted using the Complex Samples module of SPSS version 22.0 (26) to account for the multistage probability sampling design used by the NAMCS/NHAMCS. Two sample t-tests were used to evaluate the difference between continuous variables and a Chi-square test to evaluate differences between categorical variables. Logistic regression analysis was used to examine the relation of opioid use to time periods (2003– 2010 versus 1995–2002) and demographic factors (Table 1) while controlling for the potential confounding effect of the increase in infections of the skin and subcutaneous tissue (also one of the major groups of skin disorders where OA were used) during our study period (25).

Results There were 56 751 patient visits with a diagnosis of only skin disorders (ICD9-CM codes 680–709, 172, 173, 216 or 232) representing over 800 million (estimate ± SE: 800, 890, 909 ± 35, 168, 252) patient visits from 1995 to 2010, to physicians’ offices (NAMCS) and hospital outpatient departments (NHAMCS-OPD) and emergency rooms (NHAMCS-ED) in the United States. An estimated 3.1% ± 0.2% (unweighted count ¼ 3878) of these primarily skin disease-related visits were associated with the use of OA. Some demographic and clinical characteristics of patient visits associated with OA use (OA group) versus patient visits without OA use (non-OA group) use are summarized

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Table 2. Skin disorders most commonly associated with the use of an OA. Frequency (% total ± SE in OA Group)

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ICD9-CM diagnostic code and diagnosis (unweighted patient count)

11.4% ± 1.4%

Skin neoplasms (222) 172 Malignant melanoma of skin (45) 173 Other malignant neoplasms of skin (145) 216 Benign neoplasm of skin (33) 681 Cellulitis and abscess of finger and toe (229) 681.00 Cellulitis and abscess, unspecified (75) 681.02 Onychia and paronychia of finger (59) 681.9 Cellulitis and abscess of unspecified digit (44) 682 Other cellulitis and abscess (2194) 682.0 Face cellulitis and abscess (151) 682.1 Neck cellulitis and abscess (40) 682.2 Trunk cellulitis and abscess (203) 682.3 Upper arm and forearm cellulitis and abscess (297) 682.4 Hand except fingers and thumb cellulitis and abscess (69) 682.5 Buttock cellulitis and abscess (202) 682.6 Leg except foot cellulitis and abscess (426) 682.7 Foot except toes cellulitis and abscess (101) 682.9 Cellulitis and abscess of unspecified site (733) 685 Pilonidal cyst (177) 685.0 Pilonidal cyst with abscess (72) 685.1 Pilonidal cyst without mention of abscess (105) 686 Other local infections of skin and subcutaneous tissue (127) 686.9 Unspecified local infection of skin and subcutaneous tissue (117) 692 Contact dermatitis and other eczema (105) 692.71 Sunburn (30) 692.9 Contact dermatitis and other eczema due to unspecified cause (61) 701 Other hypertrophic and atrophic conditions of skin (54) 703 Diseases of nail (132) 703.0 Ingrowing nail (130) 706 Disorders of sebaceous glands (199) 706.2 Sebaceous cyst (188) 707 Ulcer (201) 707.9 Chronic ulcer of unspecified site (30)

3.7% ± 0.4%

41.7% ± 1.9%

3.3% ± 0.4% 3.5% ± 0.7% 4.5% ± 0.9% 3.7% ± 0.6% 5.2% ± 0.8% 6.8% ± 0.7% 4.6% ± 0.8%

Table 3. Specific opioid analgesics most frequently associated with skin disorders. ACDDS drug entry classa 34 110 08 470 92 180 23 385 32 920 19 650 96 045 09 600 14 955 98 036

Trade name

Generic-equivalent name

% Total ± SE

DEA schedule statusb

Vicodin DarvocetNc Lortab Percocet-5 Tylenol No.3 Morphine Demerol Dilaudid Hydrocodone Norco

Acetaminophen-hydrocodone Acetaminophen-propoxyphene Acetaminophen-hydrocodone Acetaminophen-oxycodone Acetaminophen-codeine Morphine Meperidine Hydromorphone Hydrocodone Acetaminophen-hydrocodone

29.7% ± 1.9% 14.8% ± 1.5% 14.1% ± 2.1% 8.4% ± 0.6% 6.5% ± 0.7% 4.5% ± 0.5% 3.1% ± 0.4% 2.9% ± 0.4% 2.4% ± 0.7% 2.4% ± 0.7%

III IV III II III II II II II III

a

Ambulatory Care Drug Database System (24). Drug Enforcement Administration, United States. Darvocet was taken off the market in the United States in November 2010 (27); however, in NAMCS/NHAMCS, it was mentioned continuously from 1995 to December 2010 and was therefore included in our analysis, as it was still being used during our study period.

b c

in Table 1. There were no missing data for the OA and demographic variables (Table 1). There was no significant difference in mean age or sex between the two groups. The OA group (Table 1) was more likely to be from a non-MSA (unadjusted OR ¼ 1.58, 95% CI: 1.22–2.04) and over 12-times as likely to be seen in an emergency department rather than in a doctor’s office or hospital outpatient department (unadjusted OR ¼ 12.58, 95% CI: 10.62–14.90). Overall, the OA-group was about twice as likely to be ‘‘black’’ versus ‘‘white’’ (unadjusted OR ¼ 2.12, 95% CI: 1.73–2.60); 45.4% ± 2.3% of the diagnoses in the OA-group (Table 2) consisted of cellulitis and abscess

affecting various body regions (ICD9-CM codes 681 or 682). Skin cancers constituted 11.4% ± 1.4% of the OA group (Table 2). The most commonly used OA formulations were schedule III opioids, and the most common drug was an OA-combination product of hydrocodone and acetaminophen (trade name Vicodin; Table 3) (27). Logistic regression analysis (Table 4) using the skin disorders with OA use (OA-group) versus skin disorders without OA use (non-OA group) as the dependent variable (Table 4) revealed that OA were used significantly more frequently during the time period of 2003–2010 versus 1995–2002 (OR ¼ 1.82, 95%

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Table 4. Logistic regression analysis using ‘‘OA group’’ versus ‘‘non-OA group’’ as the dependent variable.

Independent variables Time period from [2003 to 2010] versus [1995 to 2002] Sex (female versus male) Age (40 years versus 540 years) Race (‘‘black’’ versus ‘‘white’’) Metropolitan statistical area (non-MSA) versus MSA Setting type (emergency [NHAMCS-ED] versus outpatient [NAMCS and NHAMCS-OPD]) ‘‘Infections of the skin and subcutaneous tissue’’ (ICD9-CM 680–686)

Adjusted odds ratio for ‘‘OA group’’ versus ‘‘Non-OA group’’ (95% confidence interval)a

Wald statistic (Wald F)

Significance level (LSD correction)

34.74 0.73 21.69 6.13 12.11 398.64

50.001 0.39 50.001 0.013 0.001 50.001

1.82 1.06 1.43 1.33 1.48 5.65

214.48

50.001

4.53 (3.70–5.54)

(1.49–2.22) (0.93–1.22) (1.23–1.66) (1.06–1.67) (1.19–1.85) (4.77–6.70)

a

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Model significant at p50.001; Nagelkerke ¼ 0.193.

Figure 1. Frequency of opioid analgesic (OA) use in patient visits with a skin disease only diagnosis. Data from NAMCS/NHAMCS 1995-2010.

CI: 1.49–2.22) (Figure 1), among ‘‘black’’ versus ‘‘white’’ patient visits (OR ¼ 1.33, 95% CI: 1.06–1.67), among individuals 40 years of age versus 540 (OR ¼ 1.43, 95% CI: 1.23–1.66), individuals residing in non-MSA versus MSA (OR ¼ 1.48, 95% CI: 1.19–1.85) and in patient visits to emergency departments versus outpatient settings (OR ¼ 5.65, 95% CI: 4.77–6.70), even after controlling for the increase in the frequency of infections of the skin and subcutaneous tissue (the group of conditions most commonly associated with OA use; Table 2) from 1995 to 2010 (25). There was no significant sex difference in the OA group versus non-OA group. The second analysis, which took into consideration only the first six medications coded for the entire study period from 1995 to 2010, revealed a similar increase in OA use (OR ¼ 1.49, 95% CI: 1.21–1.83) from 1995 to 2002 versus 2003 to 2010 using the same logistic regression model (Table 4).

Discussion We examined the frequency of opioid analgesic use in a nationally representative sample of patient visits for only skin disorders in the United States from 1995 to 2010. Our findings, in part, support our initial hypothesis as we observed that the trends in OA use among a nationally representative sample of patient visits with skin disorders from 1995 to 2010

increased almost two-fold (Table 4) and paralleled the overall increase in OA use in the United States over this period. However, in contrast to the general trends in the inappropriate and off-label use of OA during this period (2,3), in our skin disorders only sample, over 45% of the diagnoses for which opioids were used involved cellulitis and abscess (ICD9-CM codes 681 and 682) (Table 2), and OA were used most frequently in emergency room visits (Table 1). This is entirely consistent with the FDAapproved indications of OA for pain management and not indicative of off-label or inappropriate use. Malignant and benign neoplasms constituted about 11% of patient visits with OA (Table 2). Only a minority of patient visits for primary dermatologic disease (Table 2) were associated with OA use. Table 2 has summarized the individual dermatologic diagnoses associated with OA use that consisted of at least 30 unweighted patient visits (28). Over 85% of all dermatologic diagnoses associated with OA use are summarized in Table 2. The conditions listed in Table 2 are either associated with pain or require pain management in their treatment. Therefore, the use of OA in these conditions is consistent with the general FDA-approved indications for OA use. There was almost a two-fold increase (OR ¼ 1.82, 95% CI: 1.49–2.22) in the odds of OA use in patients with skin disease from 1995 to 2010, even after controlling for the increase in frequency of infections of the skin and subcutaneous tissue over

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DOI: 10.3109/09546634.2014.951304

this period (the group of dermatologic disorders where OA were most frequently used; Table 2). The most commonly (450%; Table 3) prescribed OA in patients with skin disease were schedule III agents (29), which are defined as drugs with a moderate to low potential for physical and psychological dependence. The Schedule II agents, which are defined as drugs with a high potential for abuse (29), represented about 20% of OA in our skin disorders only sample. The most commonly used OA was the hydrocodone–acetaminophen combination product Vicodin (Table 3), a finding which parallels recent reports that this combination OA was one of the most commonly prescribed medications in the United States (30). Some of the limitations of our study include the fact that our unit of analysis was a patient visit, and it is possible that some patients may have been counted more than once, during a repeat visit. Another limitation is the fact that information about the duration and dosage of OA use are lacking. It is also not possible to determine whether the increase in frequency of OA use from 1995 to 2010 reflects progressively greater disease severity in dermatology patients requiring pain management during this period. We have tried to control for disease severity by controlling for visits to the emergency department (which likely represent more severe and acute disease) versus outpatient settings. In this epidemiologic study of OA use in skin disorders, we chose to examine patient visits with only skin disorders and therefore excluded the large number of patient visits where a skin disorder was comorbid with a non-dermatologic condition. The skin disorders only sample was studied so that we could attribute the OA use to a skin condition; however, this may not be representative of the typical patient with a skin disorder that is treated in a clinical setting. Our findings of OA use in skin disorders are therefore conservative. In summary, our findings from an epidemiologically representative sample of patient visits with only dermatologic disorders indicate that opiate analgesics are being used in only a minority of primary dermatologic diseases such as skin neoplasms (Table 2). OA are being largely used for the management of infections of the skin and subcutaneous tissue (e.g. cellulitis and abscess; Table 2) in emergency room settings, which is entirely consistent with their FDA-approved use for pain management. The majority of OA used in skin disorders are schedule III agents, which are associated with a moderate to low potential for physical and psychological dependence and low abuse potential. The almost two-fold increase in frequency of use of OA from 1995 to 2010 may be an indication that opioids are being considered as a treatment option for pain management earlier in the course of treatment. Our findings among a sample of patient visits with a skin disorder only diagnosis are most likely conservative.

Declaration of interest The authors have no conflicts of interest to declare. There was no external funding for compiling the database upon which the study is based.

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Use of opioid analgesics in skin disorders: Results from a nationally representative US sample.

Increasing and inappropriate use of opioid analgesics (OA) have been declared a public health concern in the United States. There are no epidemiologic...
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