Pharmacy Administration, Policy and Regulation Commons^™

Reducing Medication Errors In Pneumonia Patients During Transitions Of Care, Laressa Bethishou, Noah Fang, Lisa Shieh

Pharmacy Faculty Articles and Research

Purpose: At Stanford Health Care, as part of a hospital-wide initiative to reduce pneumonia readmission rates, an interdisciplinary collaborative effort was created between physicians and transitions of care (ToC) pharmacists to optimize discharge planning and medication management for pneumonia patients. The purpose of this study was to describe the impact of the ToC pharmacist in identifying and reducing medication errors on discharge for pneumonia patients.

Methodology: Retrospective chart review was conducted on patients discharged with a pneumonia diagnosis between December 2015 to Feb 2016. Patients were stratified based on whether they received ToC pharmacist medication review vs. standard …

A Course On Patient Safety: Pharmacy Student And Community Partner Perceptions, Maryam Noureldin, Chelsea M. Anderson, Patricia L. Darbishire

Purdue Journal of Service-Learning and International Engagement

The authors of this article developed and piloted a three-week intensive elective course for students in their third professional years in the Doctor of Pharmacy program. The goal of this course was to provide students with an opportunity to apply patient safety concepts in a real-world setting using service-learning as the pedagogy and to evaluate student perceptions of the course for potential implementation in the curriculum. Seven pharmacy students were enrolled in the pilot course and divided into three groups. Each group of two to three students was assigned to one of three predetermined community partner sites. Students were instructed …

Expanding The Horizon: Global Health Management For Pharmacy Students, Alice C. Chang, Monica L. Miller, Ellen M. Schellhase

Purdue Journal of Service-Learning and International Engagement

The advancement of global engagement opportunities will promote pharmacy students’ cultural awareness and sensitivity, expose students to treatment of diseases not commonly seen in modern Western medicine, and cultivate future leadership for the growth of global pharmacy practice. At Purdue University College of Pharmacy (PUCOP), limited opportunities exist for student pharmacists. As a result, identifying the needs and expanding student pharmacist access to global engagement experiences are critical to meet the changing needs of the US population. A survey was developed and distributed to 460 students at PUCOP, and 148 of them participated. Of those students, 89.2% were interested in …

Influence Of Pharmaceutical Marketing On Medicare Prescriptions In The District Of Columbia, Susan Wood, Joanna Podrasky, Meghan Mcmonagle, Janani Raveendran, Tyler Bysshe, Alycia Hogenmiller, Adriane Fugh-Berman

Health Policy and Management Faculty Publications

Importance

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

Objective

To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Design

Gifts data from the District of Columbia’s (DC) AccessRx program and the …

Heroin Use Onset Among Nonmedical Prescription Opioid Users In The Club Scene, Hilary L. Surratt, Steven P. Kurtz, Mance Buttram, Maria A. Levi-Minzi, Maria E. Pagano, Theodore J. Cicero

Center for Health Services Research Faculty Publications

Background—Nonmedical prescription opioid use (NMPOU) is well documented among participants in the club scene, yet prior studies have not examined transition to heroin use. We prospectively examined heroin initiation among a sample of young adults with drug involvement associated with participation in the club scene, to understand factors that influence transition from NMPOU to heroin and to identify opportunities for intervention.

Methods—Data were drawn from a randomized trial that enrolled 750 Miami-based club and prescription drug users through respondent driven sampling, and tested the efficacy of assessment interventions in reducing risk. Participants reported current substance use at baseline, …

Managing Risk To The Patient: Recoding Quality Risk Management For The Pharmaceutical And Biopharmaceutical Industries, Kelly Waldron

Doctoral

This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are better protected since the publication of ICH Q9, a commonly employed guidance on the application of QRM; second, to characterize the industry with regard to QRM maturity, including …

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

MaineHealth Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …

Leadership And Management Are One And The Same, Neelam Azad, H. Glenn Anderson Jr., Amie Brooks, Oscar Garza, Christine O’Neil, Misty M. Stutz, Jenelle L. Sobotka

Pharmacy Practice & Administration

Defining the attributes of change catalysts within high functioning organizations, including the academic enterprise, is desirable. An understanding of these attributes within our academy may foster faculty interest and engagement in seeking administrative roles and serve to bolster succession planning within our schools. On one hand, there have been numerous publications teasing out the purported differences between leadership and management. On the other hand, does segregating these important characteristics based upon arbitrary distinctions do more harm than good? This commentary represents the work of a group of academic leaders participating in the 2015-2016 AACP Academic Leadership Fellowship Program. This work …

Exploring The Potential For Using Drug Indications To Prevent Look-Alike And Sound-Alike Drug Errors, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff

Pharmacy Faculty Articles and Research

Background: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs.

Research design and methods: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities. To assess potential for differentiating LASA drug pairs, we compared the following drug characteristics: generic name, therapeutic class, health problem, and FDA-approved indication.

Results: …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

Authority And Scope Of Vaccination: How States Differ, Sharon Xavioer, Jeff Goad

Pharmacy Faculty Articles and Research

"Despite all this, vaccine rates still fall short of desirable goals, such as those outlined in the Healthy People 2020 national initiative.⁷ Although the CDC and APhA promote the “immunization neighborhood” concept, meaning all appropriate professions should coordinate, communicate, and collaborate to increase immunization rates, challenges are still evident for pharmacies.⁸ One major factor is the variability in state laws and regulations that govern vaccine administration by pharmacists.⁵ Significant regulation differences limit which vaccines are permitted, which age groups of patients can be immunized, and which practice model pharmacists may operate under.⁹"

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

United States Food and Drug Administration: Publications

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-^_D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae …

Buprenorphine Physician Supply: Relationship With State-Level Prescription Opioid Mortality, Hannah K. Knudsen, Jennifer R. Havens, Michelle R. Lofwall, Jamie L. Studts, Sharon L. Walsh

Behavioral Science Faculty Publications

Background: Buprenorphine is an effective treatment for opioid use disorder but the supply of buprenorphine physicians is currently inadequate to address the nation’s prescription opioid crisis. Perception of need due to rising opioid overdose rates is one possible reason for physicians to adopt buprenorphine. This study examined associations between rates of growth in buprenorphine physicians and prescription opioid overdose mortality rates in US states.

Methods: The total buprenorphine physician supply and number of physicians approved to treat 100 patients (per 100,000 population) were measured from June 2013 to January 2016. States were divided into two groups: those with rates of …

Utilizing Three Years Of Epidemiological Data From Medical Missions In Cambodia To Shape The Mobile Medical Clinic Formulary, Jeany Kim Jun, Junia S. Koo, Amy Y. Kang, Deborah B. Chien, Albert Shim, Dale Knutson, Eda M. Kim

Pharmacy Faculty Articles and Research

Objective: The purpose of this project was to gather epidemiological data on common diseases and medications dispensed during medical mission teams to Cambodia to shape the mobile medical clinic formulary.

Methods: Data for patients seen during week-long, mobile, medical clinics was collected in Cambodia during Septembers 2012 to 2014. Patient’s gender, age, weight, blood pressure, glucose, pertinent laboratory values, diagnoses, and medications dispensed were collected. Blood pressure and glucose were measured in patients 18 years and above. Data collected onto paper intake forms were transferred onto spreadsheets without patient identifying information and analyzed for aggregate means, common diseases, and most …

Quetiapine Misuse And Abuse: Is It An Atypical Paradigm Of Drug Seeking Behavior?, Sean Hyungwoo Kim, Gayoung Lee, Eric Kim, Hyejin Jung, Jongwha Chang

Institute for Pharmaceutical Outcomes and Policy Faculty Publications

Recent case reports in medical literatures suggest that more and more second-generation atypical antipsychotics (AAs) have been prescribed for off-label use; quetiapine (Brand name: Seroquel^®) showed increase in its trend for off-label use. Little is known about the reasons behind this trend, although historical sedative and hypnotic prescription patterns suggest that despite relatively superior safety profiles of quetiapine (especially for movement disorders), it may be used for treating substance abuse disorder. In addition, recent studies have shown a strong potential for misuse and abuse (MUA) of quetiapine beyond Food and Drug Administration-approved indications. This includes drug-seeking behaviors, such …

Ethical Imperatives Of Timely Access To Orphan Drugs: Is Possible To Reconcile Economic Incentives And Patients’ Health Needs?, Rosa Rodriguez-Monguio, T. Spargo, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

Background

More than 6,800 rare diseases and conditions have been identified in the US, which affect 25–30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs.

Methods

Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of …

Variation In Organ-Specific Pik3ca And Kras Mutant Levels In Normal Human Tissues Correlates With Mutation Prevalence In Corresponding Carcinomas, Barbara L. Parsons, Karen L. Mckim, Meagan B. Myers

United States Food and Drug Administration: Publications

Large-scale sequencing efforts have described the mutational complexity of individual cancers and identified mutations prevalent in different cancers. As a complementary approach, allele specific competitive blocker PCR (ACB-PCR) is being used to quantify levels of hotspot cancer driver mutations (CDMs) with high sensitivity, to elucidate the tissue-specific properties of CDMs, their occurrence as tumor cell subpopulations, and their occurrence in normal tissues. Here we report measurements of PIK3CA H1047R mutant fraction (MF) in normal colonic mucosa, normal lung, colonic adenomas, colonic adenocarcinomas, and lung adenocarcinomas. We report PIK3CA E545K MF measurements in those tissues, as well as in normal breast, …

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

United States Food and Drug Administration: Publications

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae when exposure began …

Detection Of Allergen Markers In Food: Analytical Methods, Girdhari M. Sharma, Sefat E. Khuda, Christine H. Parker, Anne C. Eischeid, Marion Pereira

United States Food and Drug Administration: Publications

Food allergens are proteins that are well tolerated by most, but can cause severe reactions in sensitive individuals. Since there is no cure for food allergy, strict adherence to an allergen-free diet is the only safe choice currently available for allergic consumers. Accurate food labeling can help consumers avoid foods containing an allergenic ingredient. Regulatory agencies have mandated the labeling of major food allergens on packaged foods to help with safe food choices. However, the inadvertent presence of an allergen in food due to cross-contact and labeling error can jeopardize consumer health. Analytical methods are developed for allergen detection and …