Prescriber and pharmacist understanding of revised Rhode Island pain management regulations.

INTRODUCTION: Federal agencies and national associations have implemented action plans in response to the opioid crisis. Furthermore, over 30 states have enacted legislation with opioid-related restrictions, guidance, or requirements. Following recommendations from the governor-appointed Overdose Prevention and Intervention Task Force, the Rhode Island Department of Health developed an original and updated version of Pain Management Regulations in March 2017 and July 2018, respectively. Our study aimed to identify disparities in interpretation and misconceptions of the updated Rhode Island Department of Health new Pain Management Regulations. METHODS: Our 29-question survey evaluated pharmacist and prescriber knowledge of regulations, with special attention given to pain management in patients with cancer. RESULTS: Thirty-two prescribers and 33 pharmacists completed the survey. The survey identified significant variance in regulation knowledge. Pharmacists correctly identified diagnosis exclusions 13-84% of the time, with a much greater understanding when diagnosis language was used instead of ICD-10 codes. Prescribers correctly identified exclusions 24-46% of the time, with little difference noted when using diagnosis language versus ICD-10 codes. The majority (59.3%) of pharmacists misclassified patients with no prescription dispensed in 30 days as patients who would be considered opioid-naïve. Both prescribers and pharmacists commonly misidentified the frequency with which the prescription drug monitoring program needs to be checked, although in both scenarios were stricter than the regulations themselves. In addition, there were significant differences in interpretation regarding naloxone co-prescribing requirements and patient awareness of naloxone co-prescribing between prescribers and pharmacists. CONCLUSION: Our findings outline several misinterpretations that affect access to chronic and cancer-related pain opioid prescriptions, despite several Rhode Island Department of Health-initiated interventions. When adopting regulations, states should proactively develop educational initiatives to avoid access challenges for patients with diagnoses of exclusion.

Successful Model for Guideline Implementation to Prevent Cancer-Associated Thrombosis: Venous Thromboembolism Prevention in the Ambulatory Cancer Clinic.

PURPOSE: Guidelines recommend venous thromboembolism (VTE) risk assessment in outpatients with cancer and pharmacologic thromboprophylaxis in selected patients at high risk for VTE. Although validated risk stratification tools are available, < 10% of oncologists use a risk assessment tool, and rates of VTE prophylaxis in high-risk patients are low in practice. We hypothesized that implementation of a systems-based program that uses the electronic health record (EHR) and offers personalized VTE prophylaxis recommendations would increase VTE risk assessment rates in patients initiating outpatient chemotherapy. PATIENTS AND METHODS: Venous Thromboembolism Prevention in the Ambulatory Cancer Clinic (VTEPACC) was a multidisciplinary program implemented by nurses, oncologists, pharmacists, hematologists, advanced practice providers, and quality partners. We prospectively identified high-risk patients using the Khorana and Protecht scores (≥ 3 points) via an EHR-based risk assessment tool. Patients with a predicted high risk of VTE during treatment were offered a hematology consultation to consider VTE prophylaxis. Results of the consultation were communicated to the treating oncologist, and clinical outcomes were tracked. RESULTS: A total of 918 outpatients with cancer initiating cancer-directed therapy were evaluated. VTE monthly education rates increased from < 5% before VTEPACC to 81.6% (standard deviation [SD], 11.9; range, 63.6%-97.7%) during the implementation phase and 94.7% (SD, 4.9; range, 82.1%-100%) for the full 2-year postimplementation phase. In the postimplementation phase, 213 patients (23.2%) were identified as being at high risk for developing a VTE. Referrals to hematology were offered to 151 patients (71%), with 141 patients (93%) being assessed and 93.8% receiving VTE prophylaxis. CONCLUSION: VTEPACC is a successful model for guideline implementation to provide VTE risk assessment and prophylaxis to prevent cancer-associated thrombosis in outpatients. Methods applied can readily translate into practice and overcome the current implementation gaps between guidelines and clinical practice.

Chemotherapy-Induced Peripheral Neuropathy: Causative Agents, Preventative Strategies, and Treatment Approaches.

Chemotherapy-induced peripheral neuropathy (CIPN) is a chronic symptom associated with chemotherapy treatment. Symptoms and severity vary based on chemotherapeutic agent used and dose. At present, effective options for the prevention and treatment of CIPN are inadequate and clinical guidance is limited. Unknown mechanism of action, lack of efficacy in many traditional neuropathic pain medications, and inconsistent evidence in regard to drug therapy have further complicated evaluation of therapeutic options. Twenty-five studies were identified and evaluated for CIPN prevention and treatment potential. Findings for CIPN pharmacological prevention were inconclusive as literature was largely conflicting. Exercise may be an effective non-pharmacological CIPN prevention method with limited adverse effects, however additional supporting data is still required. For treatment of CIPN, pharmacological agents duloxetine and topical combination product containing baclofen, amitriptyline, and ketamine have data supporting use. Early stage trials have shown initial promise for non-pharmacological therapies Scrambler Therapy and Photobiomodulation. Significant research is required as CIPN symptoms can lead to decreased quality of life, chemotherapy dose reduction, and discontinuation of drug therapy.

Prospective evaluation of drug-drug interactions in ambulatory cancer patients initiated on prophylactic anticoagulation.

INTRODUCTION: Drug options for VTE prophylaxis are increasing for ambulatory cancer patients and data regarding anticoagulant-drug interactions and their relationship to VTE and bleeding are needed to improve care. METHODS: Over one year, 108 cancer patients with high VTE risk were prospectively identified. Potential anticoagulant-drug interactions were ascertained by chart review and graded on need for intervention. Providers selected anticoagulant prophylaxis based on potential drug interactions and patient-provider discussion. A cross-sectional analysis was performed thereafter to evaluate VTE and bleeding endpoints within one year of anticoagulant initiation. RESULTS: The average number of potential drug interactions per patient was higher for warfarin than others (3.04 vs. 1.28 (apixaban), 1.02 (rivaroxaban), and 0.98 (LMWH)). The severity of the interactions based on grade was, for apixaban: 1.6% grade X, 50.8% grade D, and 47.5% grade C; for rivaroxaban: 2.1% grade X, 64.9% grade D, 33.0% grade C; for LMWH, 0% grade X, 66.7% grade D, 33.3% grade C; and for warfarin, 0% grade X, 29.4% grade D, 70.6% grade C. At the end of the investigational period, 11 bleeds and 7 VTEs were reported. Drug combinations significantly associated with an increased bleeding risk were crizotinib with apixaban or rivaroxaban and PPIs with warfarin. The use of sulfamethoxazole-trimethoprim with warfarin was associated with an increased VTE risk. CONCLUSIONS: DOACs had fewer DDIs than warfarin, although interaction severity differed between anticoagulants. Some anticoagulant-drug interactions were associated with bleeding or VTE. Although not powered for analysis, DDI severity did not affect bleeding rates and inversely correlated with VTE risk.

Oral Anticancer Therapy: Management of Drug Interactions.

Oral anticancer therapy is increasingly integrated into the care of patients with cancer. Recognition and management of drug-drug interactions (DDIs) is critical to providing efficacious and safe anticancer treatment. DDIs with QTc-prolonging agents, anticoagulants, enzyme inducers and inhibitors, antidepressants, and acid suppressants are commonly encountered with anticancer therapies. Here, we review frequently observed DDIs and outline literature-supported suggestions for their management.

Blinatumomab: enlisting serial killer T-cells in the war against hematologic malignancies.

INTRODUCTION: The approval of blinatumomab signals the long awaited arrival of immunotherapy for acute lymphoblastic leukemia (ALL). Previous options for relapsed or refractory disease were restricted to cytotoxic chemotherapy with limited efficacy and significant toxicity. Through an innovative mechanism of action, blinatumomab stimulates a polyclonal antitumor T-cell response, yielding unprecedented single agent efficacy in the relapsed/refractory setting. Success comes at the cost of immunological toxicities rarely encountered with previous therapies and challenging administration logistics requiring clinical expertise. AREAS COVERED: All published clinical and preclinical studies using blinatumomab were reviewed in addition to all registered ongoing clinical trials and data published in abstract form. The search was limited to the English language. The pharmacology, clinical efficacy, toxicity profile, and logistical considerations for drug administration are discussed. EXPERT OPINION: Blinatumomab is an exciting addition to the treatment armamentarium for relapsed/refractory ALL, yet several questions remain regarding optimal implementation into the current treatment paradigm. A unique toxicity profile should be weighed against promising benefits in a poor prognosis population. Other emerging therapies, such as chimeric antigen receptor-modified T-cells and inotuzumab ozogamicin, with different side effect profiles and administration schedules, may prove to be more beneficial for specific patient populations.