Class of 2015 Abstract / Objectives: To characterize the types of renal dosing recommendations provided in the prescribing information (aka package insert) before and after the FDA guidance for industry document regarding renal dosing, released in 1998. Methods: The prescribing information (PI) for all new molecular entities (NMEs) for three time periods was collected from the FDA website. Time period 1 was January 1995 to December 1997 and represents dosing recommendations prior to the FDA guidance statement. Time period 2 was January 2000 to December 2002 and time period 3 was January 2011 to December 2013. These represent recommendations after the FDA guidance statement. The renal dosing recommendations for each NME were reviewed and classified as either specific (includes CrCl, serum creatinine), nonspecific (mild, moderate, or severe impairment), caution, unnecessary, no information or other by two investigators independently. A further analysis was conducted for NMEs in time periods 1 and 2 with LexiComp and the most recent PIs located on FDA or company website. Presence of dialysis (hemodialysis or peritoneal) dosing recommendations was also recorded. Results: Time period 1 had significantly less NMEs characterized as No information in Lexicomp in comparison to original PIs (p= 0.02). A statistically significant decrease in original PIs characterized as Caution was observed between time periods 2 and 3 (p= .0004) and time periods 1 and 3 (p= 0.001). Conclusions: Terminology used in renal dosing recommendations in PIs does not seem to be clearer over the past years. There remains a need for improved quality of dosing information within PIs.

Class of 2015 Abstract / Objectives: To determine whether disparities exist among mental health patients admitted to the emergency department in regards to the prescribing patterns of injectable benzodiazepines and antipsychotics. Methods: A retrospective chart review was performed to evaluate patients with mental health diagnoses who received an injectable antipsychotic or benzodiazepine while in the emergency department of an academic medical center. A report was generated of all injectable antipsychotics and benzodiazepines removed from the emergency department Pyxis machines from November 1, 2013 to January 31, 2014. Data from the patient medical record included the patient’s age, height, weight, gender, race/ethnicity, insurance information, mental health diagnosis, evidence of substance abuse, how they arrived in the emergency department, their length of stay in the emergency department, any signs of aggressive behavior (adapted from the Overt Aggression Scale), information about each injectable antipsychotic or benzodiazepine that was administered was recorded including the name of the medication, dose, route of administration. If the patient received multiple doses of the same medication during their stay, the total dose and the total time receiving the medication was also recorded. The prescriber’s gender and whether they were a resident or an attending physician was also recorded for each medication administered. Results: A total of 98 patient charts were reviewed and analyzed. Mental health diagnoses were broken down into categories of psychiatric disorders (39.8%), bipolar disorders (74.5%), mood disorders (40.8%), and personality disorders 54.1%). Of the 98 patients reviewed, 68% had a documented substance abuse, with 62% having a positive urinalysis for alcohol, illicit drugs, or opiates. The majority of the patients were white (64.3%). The next largest racial/ethnic categories were Hispanics (12.2%), Native Americans (8.2%), and African Americans (6.1%). There were 54 males and 44 females. Benzodiazepines comprised 74% of the medications administered with lorazepam being the most frequently administered medication overall at 63.4%. Haloperidol was the second most frequently administered medication at 22%. Initial Chi Square analysis did not yield any significant results with regards to race and prescribing patterns, gender and prescribing patterns, or insurance and prescribing patterns. Conclusions: Patients with mental health diagnoses suffer from disparities within health care, and when these patients fall under other demographic groups such as racial/ethnic minorities and low socioeconomic status, the disparate treatment they receive could be even greater. Several limitations to this study including a small sample size and lack of geographical diversity resulted in a lack of statistically significant results, and our findings may not be generalizable to other patient populations.

Class of 2016 Abstract / Objectives: To identify which types of mid-level practitioners have prescribing authority in each state in the United States (US), compare the types of prescriptive authority for scheduled medications for mid-level practitioners, and delineate differences between state and federal requirements for electronic prescribing (e-prescribing) for mid-level practitioners in each state. Methods: A data extraction tool was developed and utilized to collect e-prescribing requirements and mid-level practitioner prescriptive authority from publically accessible state and federal websites. Dependent variables were analyzed using frequencies and percentages. A comparison of regional mid-level practitioner prescriptive authority patterns was conducted. Results: Mid-level practitioner prescriptive authority and e-prescribing requirements were collected from 50 states, the District of Columbia, and the Drug Enforcement Administration (DEA). For e-prescribing requirements, 19 (37%) states listed federal law requirements, 28 (55%) states listed requirements in addition to federal law, and 4 states (8%) did not specify requirements. Overall, over half of the US had more stringent e-prescribing requirements than federal law. States varied in which mid-level practitioners had authority to prescribe controlled substances: 98% of states allow nurse practitioners to prescribe; 96% allow physician assistants; 84% allow optometrists; 14% allow naturopathic doctors; 12% allow registered pharmacists; 8% allow certified nurse midwives, 4% allow homeopathic physicians, medical psychologists, and nursing homes; and 2% allow doctors of oriental medicine, certified chiropractors, clinical nurse specialists and/or advanced practice registered nurses. Conclusions: There are differences in e-prescribing requirements and varying levels of prescriptive authority for mid-level practitioners between US states.

Class of 2016 Abstract / Objectives: To determine if prescribers took into consideration patients’ metabolic risk factors when prescribing a low, medium or high risk second generation antipsychotic and if non-metabolic risk factors influenced prescribing. Methods: Adults 18 years or older who were admitted to an acute inpatient psychiatry unit and ordered at least one SGA were included in the study. Each patient’s metabolic syndrome risk score was determined using retrospective chart review and they were subsequently divided into low or high-risk groups. Clozapine and olanzapine were categorized as high risk for causing weight gain and diabetes, risperidone and quetiapine were moderate risk, and all others were considered low risk. A chi square test compared the two groups in regard to type of SGA selected, gender, and race, while an independent t-test analyzed the differences in age. Results: 300 patients were analyzed and divided into high (n=57) and low (n=253) risk groups. For the low risk group, 10.7%, 55.1%, and 34.2% were prescribed a low, moderate, or high risk SGA, respectively. For the high-risk group 17.5%, 56.1%, and 26.3% were prescribed a low, moderate, or high risk SGA, respectively. The type of SGA selected was not significantly different between the groups (p=0.262). Equivalence was shown between the two groups in terms of gender and race (p=0.68, p=0.65 respectively). Age was significantly different (p< 0.01). Conclusions: Prescribers may not consider metabolic risk factors when prescribing high risk SGAs such as clozapine and olanzapine.

Class of 2017 Abstract / Objectives: To evaluate the perceptions of the pharmacy staff on prescription errors, efficiency, and difficulty of use before and after implementation of a new pharmacy computer system. Subjects: Employees of El Rio Community Health Center outpatient pharmacies located at the Congress, Northwest, and El Pueblo Clinics. Methods: This study was of a retrospective pre-post design. A 5-question survey on error rates and workflow efficiency was distributed to pharmacists and technicians 6 months after a new computer system had been implemented. Participants of the study included employees of El Rio Community Health Center outpatient pharmacies who were employed with El Rio during the time of transition between the old and new computer systems. Results: Questionnaire responses were completed by 10 (41.7%) technicians and 6 (66.7%) pharmacists at three El Rio Clinics. There was an increase in perceived efficiency between the new (Liberty) (n=17, 94.4%) and old (QS1) (n=11, 61.1%) computer systems (p<0.05). There were no significant differences in perceived difficulty of use, most common types of errors, error rates, and time to fix detected errors. Conclusions: While there were no significant differences between Liberty and QS1 in perceived difficulty of use, most common types of errors, error rates, and time to correct detected errors, there was a significant difference in the perceived efficiency, which may have beneficial implications.

Acute respiratory tract infection (ARI) is the most common reason for outpatient medical visits in the United States, and frequently results in treatment with an antibiotic. Most ARIs have a viral etiology, thus antibiotic therapy will have little clinical benefit in these cases. It is estimated as much as one-half of all antibiotic utilization for ARI in outpatient settings is inappropriate. Importantly, this misuse is thought to be the primary driver of antibiotic resistance development among bacteria. Antibiotic resistant infections cause an estimated 2 million illnesses and 23,000 deaths annually in the United States, and associated costs exceed $30 billion. Despite our current understanding of relevant predictors of appropriate antibiotic use, less is known regarding seasonality. This dissertation explores effects of seasonality on antibiotic prescribing in three aspects: 1) seasonal variation in appropriateness of prescribing, and antibiotics prescribed among common ARIs; 2) specific predictors of observed seasonal variation in prescribing practices; and 3) implications of seasonality for guideline concordance & quality of care. Findings generated herein, could help inform interventions designed to promote more judicious use of antibiotics in healthcare.

<div> This dissertation consists of three essays examining the nature of pricing in the pharmaceutical industry and the behavior of physicians prescribing drugs. I use a combination of structural modeling and reduced-form econometric techniques to illuminate how factors such as bargaining, competition, and network membership can affect prices and prescribing behavior. Ultimately, these insights can be used to influence public policy goals such as reducing prescription drug costs for patients or limiting unnecessary prescribing. </div><div> </div><div> In Chapter One, which is joint work with Sebastian Linde and Ralph Siebert, I focus on the determinants and effects of bargaining power on wholesale pharmaceutical drug prices. We estimate a structural bargaining model and find that large differences in bargaining power explain drug price heterogeneities across buyers, drug classes, and time periods. Our results show that transaction-specific determinants between buyers and sellers (such as transaction volume, buyer's loyalty, multiple drug purchases from the same seller, etc.) exert strong effects on buyer bargaining power and drug prices. Our counterfactuals show that group purchasing organizations achieve price reductions that vary across drug classes and that these price reductions primarily depend on buyer price sensitivity.</div><div> </div><div> In the second chapter, joint with G\"unter Hitsch, Sebastian Linde, and Ralph Siebert, I turn to the retail prescription drug market. Here, we show that there is a significant amount of price variation for prescription drugs in the retail pharmaceutical market. Both negotiated prices (price between retail pharmacies and third-party insurers) and out of pocket prices (prices between retail pharmacies and insured patients) for a drug exhibit a high degree of price variation even when controlling for drug manufacturer, geographic location, pharmacy chain, etc. Furthermore, the nature of this price variation changes depending on if a drug is branded or generic. </div><div> </div><div> In the third chapter, joint with Svetlana Beilfuss and Sebastian Linde, I examine the problem of antimicrobial resistance and how physician membership in Accountable Care Organizations (ACOs) can influence antibiotic prescribing behavior. We use a two-part structural model that accounts for selection into treatment (the ACO group), and non-treatment (control group). We then compare physician antibiotic prescribing across these groups with adjustment for volume, patient, physician, and institutional characteristics. We find that ACO affiliation reduces antibiotic prescribing by about 23\% per year. Furthermore, we show that failure to account for selection into treatment results in an understating of the average treatment effect.</div>

Prescription drug abuse has been a growing problem in Indiana and around the nation for almost two decades. In recent years, prescription drug overdoses have pushed drug poisonings ahead of motor vehicle crashes as the leading cause of injury death. However, deaths due to overdoses of prescription drugs are only the tip of the iceberg when it comes to the much larger problem of abuse. This study has characterized prescription drug abuse in Indiana and taken an in-depth look at how it is and can be addressed both through organizational policies and state legislation. Opioid painkillers such as hydrocodone, oxycodone, and methadone are the most commonly abused prescription drugs, and most of these prescriptions are written by primary care physicians. Because more than 70% of Indiana’s family medicine residents will remain in the state to practice medicine following the conclusion of their residencies, it is worthwhile to take a look at how these residents are being educated during their training. St. Vincent’s Family Medicine Residency program in Indianapolis is one of several residency programs in Indiana training their residents on best practices of prescribing controlled substances. A review of residents’ prescribing patterns before and after training on the subject went into effect showed significant reductions in the number of opioid painkillers being prescribed, and showed the same reductions for alprazolam, a benzodiazepine anxiolytic.

Indiana University-Purdue University Indianapolis (IUPUI) / In 2017, the United States government declared that the opioid epidemic was a public health emergency. Among responses to address the epidemic, the Centers for Disease Control and Prevention released a set of opioid prescribing guidelines for primary care clinicians. Since their release, federal agencies and experts have been interested and concerned about their application in policy and clinical practice. This dissertation examines how some of these federal recommendations were implemented in clinic practice and state law, as well as the effects of related prescribing laws. This dissertation includes three studies 1) a qualitative analysis of clinician and patient discussions about opioid-related risks, benefits, and treatment goals, 2) a policy surveillance study of state tapering laws and their consistency with the CDC guideline’s opioid tapering recommendations, and 3) an empirical study of the effects of morphine milligram equivalent daily dose laws and acute opioid prescribing laws on pain medication prescribing for patients with Medicaid. Overall, this dissertation attempts to understand the translation of national opioid prescribing guidelines into policy and their effects on healthcare delivery. / 2021-02-28

no / The National Audit Office (NAO) has produced prescribing indicators that Primary Care Trusts (PCTs) can use to judge their performance. One of the indicators is for the antiplatelet clopidogrel, measured as defined daily dose (DDD) per cardiovascular Specific Therapeutic Age Related Prescribing Unit (STAR-PU). Clopidogrel is used as an indicator because it is a more expensive medicine than the alternative (aspirin) and there may be scope for cost reduction. We aimed to establish if the NAO indicator for clopidogrel prescribing is a valid measure of prescribing performance. Methods Prescribing data for 152 PCTs and a range of explanatory variables were obtained. Correlation between variables was determined. A regression analysis was conducted to compare the dependent variable (prescribing) with the explanatory variables identified. Results The percentage of patients on the coronary heart disease register and Index of Multiple Deprivation explained 30% of the variation in prescribing (DDD/STAR-PU) between PCTs. Even though DDD/STAR-PU is adjusted for age and sex other measures of need still have an impact on prescribing. Conclusions Using DDD/STAR-PU alone as a prescribing indicator might misidentify some PCTs, which are under- and over-using clopidogrel. Poor ranking against other PCTs using the NAO indicator should be fully explored taking into account other variables (cardiovascular morbidity and deprivation) before any corrective action is taken.