Opioid Prescribing to Medicare Part D Enrollees, 2013-2017: Shifting Responsibility to Pain Management Providers.

OBJECTIVE: To examine opioid prescribing frequency and trends to Medicare Part D enrollees from 2013 to 2017 by medical specialty and provider type. METHODS: We conducted a retrospective, cross-sectional, specialty- and provider-level analysis of Medicare Part D prescriber data for opioid claims from 2013 to 2017. We analyzed opioid claims and prescribing trends for specialties accounting for ≥1% of all opioid claims. RESULTS: From 2013 to 2017, pain management providers increased Medicare Part D opioid claims by 27.3% to 1,140 mean claims per provider in 2017; physical medicine and rehabilitation providers increased opioid claims 16.9% to 511 mean claims per provider in 2017. Every other medical specialty decreased opioid claims over this period, with emergency medicine (-19.9%) and orthopedic surgery (-16.0%) dropping opioid claims more than any specialty. Physicians overall decreased opioid claims per provider by -5.2%. Meanwhile, opioid claims among both dentists (+5.6%) and nonphysician providers (+10.2%) increased during this period. CONCLUSIONS: From 2013 to 2017, pain management and PMR increased opioid claims to Medicare Part D enrollees, whereas physicians in every other specialty decreased opioid prescribing. Dentists and nonphysician providers also increased opioid prescribing. Overall, opioid claims to Medicare Part D enrollees decreased and continue to drop at faster rates.

Mexiletine Usage in a Chronic Pain Clinic: Indications, Tolerability, and Side Effects.

BACKGROUND: Intravenous lidocaine has multiple applications in the management of acute and chronic pain. Mexiletine, an oral lidocaine analogue, has been used in a number of chronic pain conditions although its use is not well characterized. OBJECTIVES: To report our experience using mexiletine in a chronic pain population, specifically looking at tolerability, side effects, and EKG changes. STUDY DESIGN: Retrospective, cohort study. SETTING: Three chronic pain clinics within a hospital system in Detroit, MI. METHODS: All patients who had a mexiletine prescription between August 2015 and August 2016 were queried via the electronic medical record. Each chart was examined for demographics, QTc changes on EKG, length of use, and reasons for stoppage. RESULTS: There were 74 total patients identified in the chronic pain management clinics as receiving at least 1 mexiletine prescription over the 1-year time period. Twice as many women as men received mexiletine prescriptions. Neuropathic pain was the most common primary diagnosis (64%) which included diabetic neuropathy, radiculopathy, and others. Fibromyalgia was the next most common primary diagnosis (28%). A QTc change on the EKG showed a mean decrease of 0.1 ms and median increase of 1.5 ms. At 6 months (180 days), approximately 30% of the patients remained on mexiletine therapy, and 28% remained on the therapy at 1 year (360 days). Median duration of use was 60 days and the mean was 288 days. Neurologic and gastrointestinal side effects were the most commons reason for stoppage. All side effects were mild and resolved with stoppage. After side effects, lack of response, or loss of efficacy, were the next most common reasons for stoppage. LIMITATIONS: Pain relief and outcomes were not specifically examined due to confounding factors including interventional treatments and multiple treatment modalities. This was a retrospective, cohort study limited to our specific clinic population with a relatively high loss to follow-up rate. CONCLUSION: Mexiletine is rarely a first line option for chronic pain management and is often used when multiple other modalities have failed. By reporting our experience, we hope other clinicians may have more familiarity with the drug's use in a chronic pain practice. It appears reasonably tolerable, may not require frequent EKG monitoring, and can be an appropriate adjunct in the chronic pain population. More research is needed regarding efficacy and dose titration for mexiletine in chronic pain. KEY WORDS: Chronic pain, mexiletine, IV lidocaine, pain, neuropathic pain, neuropathy, fibromyalgia, QTc, tolerability.

Vestibular flap urethroplasty in women with recurrent distal intramural urethral pathology.

INTRODUCTION: To report our experience with vestibular flap urethroplasty in case of recurrence of distal intramural urethral pathology (DIU) after unsuccessful urethral dilation under anesthesia. METHODS: Following Independent Review Board approval, charts of non-neurogenic women who underwent urethroplasty for DIU were reviewed. Vestibular flap urethroplasty was offered to patients who failed one or two dilations. Success was defined as improvement on the single quality of life questionnaire (QoL, rated 1-10) with either a final score three or less, or a decrease of four QoL points from baseline and no related repeat procedure at any time during follow-up, with a minimum follow-up at 6 months. RESULTS: From 1998 to 2012, 28/30 patients had adequate follow-up and 19 met the criteria for success. Mean age at time of urethroplasty was 51 in both the success and failure groups. Mean follow-up was 52 ± 49 months in the success group and mean time to failure was 17 ± 20 months in the failure group. Mean QoL in the success group improved from 7.0 ± 2.1 preoperatively to 2.0 ± 1.7 postoperatively. Mean QoL in the failure group did not improve (from 7.0 ± 1.6 to 6.4 ± 1.5). Urethral wall fibrosis was confirmed in all tissue samples excised. No patient experienced new onset or exacerbation of stress urinary incontinence. Failure group was managed by repeat urethroplasty, clean intermittent catheterization or other methods. CONCLUSION: Vestibular flap urethroplasty is a viable long-term treatment option in women with DIU who have failed at least one dilation.

Risk stratification of pubertal children and postpubertal adolescents with clinical stage I testicular nonseminomatous germ cell tumors.

PURPOSE: The COG (Children's Oncology Group) currently recommends surveillance for all children and adolescents with clinical stage I testicular germ cell tumors. However, up to 30% of adults with clinical stage I testicular germ cell tumors harbor occult metastatic disease. In adults with clinical stage I nonseminoma some groups advocate a risk stratified approach. Occult metastases were noted in 50% of patients with features such as lymphovascular invasion or embryonal carcinoma predominance in the orchiectomy. However, to our knowledge there are no data on the impact of high risk features in such pubertal children and postpubertal adolescents. MATERIALS AND METHODS: We reviewed an institutional testis cancer database for pubertal children and postpubertal adolescents younger than 21 years. We tested the hypothesis that lymphovascular invasion, or 40% or greater embryonal carcinoma in the orchiectomy specimen, would increase the risk of occult metastases, ie relapse during surveillance or positive nodes on retroperitoneal lymph node dissection. RESULTS: We identified 23 patients with a median age of 18.6 years (range 7.1 to 20.9) at diagnosis. Of these patients 14 (60.9%) were on surveillance, 9 (39.1%) underwent primary retroperitoneal lymph node dissection and none received initial chemotherapy. Seven patients (30.4%) had occult metastatic disease. High risk pathological features were found in the orchiectomy specimen in 12 patients (52.2%), including all 12 (52.2%) with 40% or greater embryonal carcinoma and 3 (13.0%) with lymphovascular invasion. Seven patients (58.3%) with high risk features had occult metastatic disease vs none (0%) without high risk features (log rank p = 0.031). CONCLUSIONS: Approximately half of pubertal children and postpubertal adolescents with high risk clinical stage I testicular germ cell tumors harbor occult metastatic disease. These results may be useful when discussing prognosis and treatment with patients and families.

A comparison of pediatric, adolescent, and adult testicular germ cell malignancy.

BACKGROUND: Testicular germ cell tumors (T-GCTs) occur from infancy to adulthood, and are the most common solid tumor in adolescent and young adult males. Traditionally, pediatric T-GCTs were perceived as more indolent than adult T-GCTs. However, there are few studies comparing these groups and none that specifically evaluate adolescents. METHODS: An institutional database of T-GCT patients was reviewed and patients were categorized into Pediatric, aged 0-12 years, Adolescent, aged 13-19 years, and Adult, older than 20 years, cohorts. Demographics, tumor characteristics, disease stage, treatment, event-free survival (EFS), and overall survival (OS) were compared between groups. RESULTS: Overall, 413 patients (20 pediatric, 39 adolescent, 354 adult) met study criteria and were followed for a median of 2.0 years (0.1-23.6). Adolescents presented with more advanced stage than children (P = 0.018) or adults (P = 0.008). There was a higher rate of events in Adolescents (13, 33.3%) than in Adults (61, 17.2%) or Children (2, 10.0%). Three-year EFS was 87.2% in the Pediatric group, 59.9% in Adolescents and 80.0% in Adults (P = 0.011). In a multivariate analysis, controlling for stage, IGCCCG risk, and histology, the hazard ratio (HR) for an event was: 1 (Reference) for Adults, HR = 0.82 (95% CI 0.19-3.46; P = 0.33) for the Pediatric group, and HR = 2.22 (95% CI 1.21-4.07; P = 0.01) for Adolescents. Five-year OS was 100% in the Pediatric group, 84.8% in Adolescents, and 92.8% in Adults (P = 0.388). CONCLUSION: Lower EFS in adolescent T-GCT patients was observed than in either children or adults. Elucidating factors associated with inferior outcomes in adolescents is an important focus of future research.

Distal intramural urethral pathology in women.

PURPOSE: We reviewed the evaluation of distal intramural urethral pathology in women and its management using urethral dilation and general anesthesia. MATERIALS AND METHODS: After receiving institutional review board approval we reviewed consecutive charts of women who underwent urethral dilation under general anesthesia for distal intramural urethral pathology. The pathological condition was defined as bothersome lower urinary tract symptoms with distal urethral narrowing and proximal ballooning on lateral voiding cystourethrogram. Patients with extramural, intraluminal or nondistal urethral pathology or neurogenic bladder were excluded from study. Success was defined as complete or major lower urinary tract symptom improvement 6 months after 1 urethral dilation using general anesthesia and no need for a repeat or another procedure. RESULTS: Eight of 101 cases (8%) reviewed between 1998 and 2010 were lost to followup at less than 6 months. Of the remaining 93 patients with a mean ± SD age of 52 ± 16 years and a mean followup of 46 ± 37 months 47 (51%) were classified as success. The failure group had a mean age of 50 ± 16 years and a mean time to failure of 8 ± 12 months. A history of urethral dilation was more common in the failure group (17% vs 39% cases, p = 0.02). CONCLUSIONS: Urethral dilation using general anesthesia is effective in some women with distal intramural urethral pathology diagnosed after extensive evaluation, including imaging and urodynamics. Distal intramural urethral pathology is a rare entity and these results are not applicable to women with nonspecific lower urinary tract symptoms.

Effect of testicular germ cell tumor therapy on renal function.

OBJECTIVE: To assess the pre- and post-therapy glomerular filtration rate in patients with testicular germ cell tumors to determine its effect on the natural history of renal function. METHODS: We reviewed an institutional database of patients with testicular germ cell tumor, with pre- and post-therapy serum creatinine levels available. The renal function was estimated using a calculated glomerular filtration rate. We compared the patients treated without chemotherapy (orchiectomy with or without radiotherapy or retroperitoneal lymph node dissection) with those who received systemic chemotherapy. We analyzed the data for the outcome of new-onset chronic kidney disease (CKD) stage 3 between these groups. Kaplan-Meier curves were constructed and compared using a log-rank test. RESULTS: A total of 144 patients were reviewed. The testicular germ cell tumor stage distribution was stage I in 78 (54.2%), stage II in 28 (19.4%), and stage III in 38 (26.4%). Overall, the median creatinine and estimated glomerular filtration rate at diagnosis was 0.9 mg/dL (range 0.5-1.5) and 104.0 mL/min/1.73 m(2) (range 58.7-235), respectively. Of the 144 patients, 102 (70.8%) had CKD stage 0-1, 41 (28.5%) stage 2, and 1 (0.7%) stage 3. The median creatinine and estimated glomerular filtration rate at the last follow-up visit was 1.0 mg/dL (range 0.6-2.6) and 95.5 mL/min/1.73 m(2) (range 31.5-167.6), respectively. This difference between the pre- and post-therapy estimated glomerular filtration rate was significant (P < .01). A total of 81 patients (56.3%) received chemotherapy (median 4 cycles, range 1-12), and 63 (43.7%) were treated without chemotherapy. Of the 81 patients who received chemotherapy, 8 (9.9%) developed new-onset CKD 3 compared with none in the nonchemotherapy group (P = .01). CONCLUSION: Patients with testicular germ cell tumor receiving chemotherapy experienced a significant decrease in the estimated glomerular filtration rate and had a significantly increased risk of developing CKD stage 3 compared with those treated without chemotherapy. These findings offer insight into the long-term risks of testicular germ cell tumor survivorship and will be useful in counseling patients.