Class of 2014 Abstract / Specific Aims: To compare trends in user demographics, clinical effects, and clinical outcomes associated with the use of synthetic cannabinoids and cathinones before and after signing into law the Synthetic Drug Abuse Prevention Act of 2012 on July 9, 2012. Methods: Reports generated by the National Poison and Drug Information Center’s Toxic Exposure Surveillance System were used to isolate calls regarding patients who reportedly used either synthetic cannabinoids or synthetic cathinones from July 2011 to March 2013. Clinical effects, clinical outcomes, and demographic information of patients associated with these calls from July 9, 2011 to July 8, 2012, were compared to that of patients associated with calls from July 9, 2012 to July 8, 2013. Main Results: Pending Conclusion: Pending

PURPOSE: Develop and evaluate a chart review tool (CRT) to improve the safety and effectiveness of prescribing controlled substances in a primary care setting. METHODS: A Controlled Substance Review Committee, consisting of volunteer primary care physicians and a clinical pharmacist, developed a CRT to assess compliance with a primary care clinic’s controlled substance prescribing policy and effectiveness of therapy. The CRT was based on existing clinic policies and American Pain Society/American Academy of Pain Medicine clinical guidelines for opioid prescribing. Every month, committee physicians used the CRT to review medical records of patients prescribed controlled substances chronically. The CRT tracked factors from the previous 6 months, including morphine equivalent dose (MED) prescribed, indication for treatment, documentation of treatment effectiveness, the Opioid Risk Tool score (ORT score), results from urine drug testing (UDT) and patient violations of the clinic’s controlled substance policy. These findings are used to provide the treating physician constructive, non-punitive feedback. We also assessed if the use of the CRT resulted in change in MED prescribed. RESULTS: Ninety-nine patient charts from 14 different physicians were reviewed over 1 year. Eighty-eight of these patients were receiving opioids for chronic pain, with an average dose in MED 72.6 mg/day (SD 89). Twenty-nine percent of charts had documentation that the controlled substance was improving the patient’s quality of life or decreasing their pain. Sixty percent of patients had at least one violation of the clinic’s controlled substance treatment agreement in the prior 6 months, and half of the violations were due to missed appointments with specialists to help manage pain. Patients were more likely to have a violation of controlled substance policy in the past 6 months if they were prescribed both a benzodiazepine (BZD) and an opioid (p=0.04), had a documented treatment agreement (p=0.002), or were high risk per ORT score (p=0.001). The mean dose of opioids, for the 88 patients who were prescribed opioids, decreased 2.6 mg/day MED from time of chart review until the end of study (mean duration 6.3 months), compared to a 6.9 mg/day MED increase that occurred from 12 months prior to chart review to the time of chart review (p=0.01). CONCLUSION: Development and implementation of a CRT in an urban primary care clinic provided helpful insight on prescribing practices, and has promise to improve quality of opioid prescribing. The most common violation of the clinic policy was missed appointments with specialists, and patients prescribed both BZD and an opioid or were high risk per ORT were most likely to have violations. Documentation of effectiveness of therapy was lacking.

Class of 2006 Abstract / Objectives: To determine the economic impact of controlled substance destruction in multiple long term care facilities in Southern Arizona and to identify related demographic characteristics of the patients and facilities. Methods: Subjects had controlled substance prescriptions destroyed at nursing homes serviced by a pharmacy nursing home provider in Tucson, Arizona. Controlled substances destruction records and existing prescription records were reviewed and data was collected on the name, strength, number of units destroyed, date of destruction and schedule of each controlled medication that was destroyed for a particular patient over the course of a year. Demographic data was collected on patient gender, age, type of insurance coverage and the size of the nursing home facilities. Results: A total of 1095 controlled substance prescriptions were destroyed during the time period of the study and the total cost of destroyed medication was $26,886.37. The average cost of destroyed medication per prescription was $24.55 ± 60.38 (mean ± SD). Schedule II controlled substances accounted for the highest total cost per prescription destroyed and destruction of unused controlled substances cost indigent insurance programs more than any of the other payers studied. There was no difference in mean cost per prescription destroyed by facility, therapeutic class or between women and men. Conclusions: The value of controlled substance destruction in long term care facilities is sizeable. To reduce waste, prescribers and pharmacy providers should initially dispense moderate quantities of controlled substances until it is apparent that the medication is tolerable and efficacious for the patient.

Controlled substance use, particularly among the rising elderly population, places these patients at a much higher risk of falls, injuries, and hospitalization. This study examines the association between preinjury controlled substance prescription and clinical outcomes of older adults after a ground-level fall. A total of 5,930 patients were included. Their home medication list was analyzed to record active opioids, benzodiazepines, narcotics, or other substances defined as controlled according to the Drug Enforcement Agency. Almost half (45%) of the patients were taking controlled substances. Sixty-seven percent of those were females. Total hospital days, Injury Severity Score (ISS), and mortality outcomes were not significantly different between groups. However, intensive care unit (ICU) days, days on mechanical ventilation (MV), and discharge destination were significantly different for patients taking controlled substances versus those not taking controlled substances. Patients taking controlled substances were more likely to be discharged to short- and long-term care facilities versus patients not taking controlled substances (P≤0.001).

INTRODUCTION: Pain is common in cancer. Pain can present at the time of diagnosis or it can develop during treatment. Cancer-related chronic pain is often treated with long-term (3 or more consecutive refills) opioid prescriptions. Opioids are a controlled substance and are thus regulated at the federal, state, and local levels. OBJECTIVES: The first goal of this study is to examine Boston Children's Hospital's general compliance with federal, state, and local opioid prescribing policies. The second goal of this study is to distinguish cancer patients requiring long-term opioids from non-cancer patients requiring long-term opioids. METHODS: This study was a retrospective chart review using summative qualitative content analysis. This is the process where content is grouped into themes and then is further quantified within each theme. RESULTS: Documents required to ensure compliance with opioid prescribing regulations at the local level are not always well documented. These include the Long-Term Opioid Agreement and the risk evaluation of opioid misuse and abuse using one of several tools annually. At Boston Children's Hospital (BCH), the CRAFFT (car, relax, alone, forget, friends, trouble) questionnaires are used for this purpose. State policies require that, if a patient is not seen at least once every 6 months, physicians must document explicitly why a clinic visit was not possible. These reasons are never clearly listed within the medical record. Additionally, data shows that cancer patients using long-term opioids tend to be younger (mean age 14.4) than non-cancer patients (mean age 26.7). Cancer pain can present either at diagnosis, during treatment, or be present during both. Where n=16 cancer patients, 62.53% experienced pain both at diagnosis and during treatment, 25% experienced pain only during treatment, and 12.5% experience pain only at diagnosis. Finally, data also show that anxiety and comorbidity are common, 34.6% of n=29 patients in both cancer and non-cancer patients using long-term opioids. 34.6% of patients experienced comorbidities of either anxiety or depression. CONCLUSIONS: Despite these discrepancies with documentation, review of patients on long-term opioids revealed those with complex and painful medical conditions generally had valid reasons to require long-term opioids. Therefore, there is no evidence that BCH prescribers are involved in any sort of inappropriate opioid prescribing. Finally, no meaningful conclusions were drawn from data regarding pain score and weight because of inconsistencies in electronic medical record documentation in these areas.

The legalization of medical marijuana has been a complicated and confusing process. The drug is used for medical purposes yet is only semi-legal and not approved by the federal government. This piece will observe the legal medical history of this drug in the United States. It will analyze the growth of the medical marijuana movement up to the present with a special emphasis to the importance of federal, state and local supremacy. It will observe important court cases that have been decisive in defining the reach of federal power under the Commerce Clause and the 1970 Controlled Substance Act. This analysis will look at the current legal standing of medical marijuana as well as the legal hurdles to achieve full legal status and medical recognition from state federal and local levels of government. A special focus will be given to the state of California because it has the largest medical marijuana market and has taken center stage in the movement to legalize marijuana as a medicine. This paper will also cover the growth of the state condoned medical marijuana black market and the complications that arise from taxing, and licensing semi-legal businesses. This paper will assess the monetary and personal costs of this movement and the political elements of resisting the medical development and scientific understanding of this drug. It will seek to suggest a solution to the current impasse and explain why medical marijuana in this instance has been bad medicine and dangerous policy.

Objectives. We quantified controlled substance donations via permanent drug donation boxes over 2 years in a region with high prescription abuse, assessing medication characteristics, time between dispensing and donation, and weight of medications donated per capita. Methods. In partnership with Drug Enforcement Administration and local law enforcement, we analyzed permanent drug donation box collections in 8 Northeast Tennessee locations from June 2012 to April 2014. We recorded controlled substance dosage units along with the product dispensing date. Results. We collected 4841 pounds of pharmaceutical waste, 4.9% (238.5 pounds) of which were controlled substances, totaling 106 464 controlled substance doses. Analysis of dispensing dates for controlled substances indicated a median of 34 months lapsed from dispensing to donation (range = 1–484 months). The mean controlled substance donation rate was 1.39 pounds per 1000 residents. Communities with fewer than 10 000 residents had a statistically higher controlled substance donation rate (P = .002) compared with communities with 10 000 or more residents. Conclusions. Permanent drug donation boxes can be an effective mechanism to remove controlled substances from community settings. Rural and urban community residents should be provided convenient and timely access to drug disposal options.

Background Gabapentinoids (gabapentin and pregabalin), a class of FDA-approved antiepileptic medications with expanded indications for certain neuropathic pain conditions, have been prescribed off-label for almost all types of pain in the US opioid epidemic. Methods We used IBM® MarketScan® Research Databases (2015-2018) and collected primary data. In Aim 1, we described the geographic variation in gabapentinoids and opioids for pain by US state and metropolitan statistical area (MSA). In Aim 2, we implemented a controlled multiple baseline interrupted time series analysis and assessed the impact of including gabapentin in states’ prescription drug monitoring programs (PDMP) and listing gabapentin as a Schedule V controlled substance. In Aim 3, we developed an algorithm to identify potential gabapentin misuse and/or abuse in administrative claims data. Results The pattern of the geographic variation in gabapentinoids was similar to that of opioids across states and MSAs. Including gabapentin in PDMPs and Schedule V controlled ABSTRACT viii substance classification were effective in curbing the growth of gabapentin use and reducing opioid-related adverse events. Our algorithm identified approximately one in six patients with gabapentin use as having potentially misused and/or abused gabapentin. Multiple comorbidities and drug use were associated with gabapentin misuse and/or abuse. Conclusions Gabapentinoids may have been widely used as alternative or adjuvant analgesics to opioids for pain across the US. Policy makers should consider including gabapentin in proactive PDMPs and scheduling of gabapentin. Monitoring requirements and individualized safety measures should be put in place for patients who potentially misuse and/or abuse gabapentin.

Background: Community pharmacists are legally required to evaluate and confirm the legitimacy of prescription opioids (POs) prior to dispensing. Yet, previous research has indicated community pharmacists perceive nearly 50% of dispensed POs to be issued lacking a legitimate medical purpose. Objective: To analyze correlates of PO legitimacy judgments across pharmacist and pharmacy setting characteristics. Methods: A cross-sectional study of 2000 Tennessee pharmacists was conducted during October and November of 2012. Community pharmacists' self-reported attitudes, beliefs, and behaviors specific to PO legitimacy were elicited. Step-wise multinomial logistic regression techniques were used to model correlates of PO legitimacy across low, moderate and high PO legitimacy estimations. Results: Being female, practicing in a chain or independent practice setting, fear of employer disciplinary action if PO legitimacy is questioned, and self-confidence in one's ability to detect PO abuse increased the odds of low (vs. high) PO legitimacy estimation (p < 0.05). Employment in chain and independent pharmacies, having POs as a greater percent of total prescriptions filled, and having the perception of PO abuse as a problem in the practice setting were significant positive correlates of moderate (vs high) PO legitimacy estimation (p < 0.05). Conclusions: Both modifiable and non-modifiable correlates were statistically significantly associated with PO legitimacy judgments. Distinct correlates were noted across low and moderate as compared to high estimations of PO legitimacy. Legitimacy judgments can inform theoretical exploration of PO dispensing behaviors and inform intervention development targeted at reducing and preventing prescription drug abuse.