Pharmacy Administration, Policy and Regulation Commons^™

Evaluating The Market Withdrawal Of Andexanet Alfa, Jordyn Linfield, Addisyn Cooper, Alexander Defranco, Emma Gerding, Jessica Kelley, Tyler Henney, Connor Dains, Brenna Hissong, Brittany Bates

Pharmacy and Wellness Review

The coagulation cascade comprises intrinsic, extrinsic, and common pathways that converge when thrombin converts fibrinogen (factor I) into fibrin, leading to fibrin mesh formation, stabilization of the platelet plug, and ultimately thrombus formation. Inhibition of the coagulation cascade can be achieved with a variety of anticoagulant medications, including direct oral anticoagulants (DOACs). The mechanism of action of DOACs is to inhibit either factor Xa or thrombin. Reversal of anticoagulation remains an important clinical consideration when managing patients on DOACs who experience serious bleeding events. Andexanet alfa is a recombinant, modified human factor Xa protein previously indicated for patients receiving rivaroxaban …

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

Bioactive Constituents And Pharmacological Activities Of Curcuma Zedoaria: A Mini-Review, Abdulmutalib Allaq, Muneer M. Saleh Mohammed Saleh Alsayadi, Mustapha Salihu, Hasan M. Agha, Amena Hassan Hassan Gheeth, Fatimah Salim, Norrizah Jaafar Jaafar Sidik

AUIQ Complementary Biological System

Curcuma zedoaria Rosc. (white turmeric) is a rhizomatous medicinal plant in the Zingiberaceae family, widely used in traditional Asian medicine. In recent years, increasing scientific attention has focused on its diverse pharmacological properties and bioactive constituents. This mini review summarises current knowledge of the phytochemical composition and biological activities of C. zedoaria, with particular emphasis on its antimicrobial, antioxidant, anti-inflammatory, and anticancer effects. Phytochemical investigations using analytical techniques such as GC–MS and HPLC have revealed the presence of numerous bioactive compounds, including sesquiterpenes (example, germacrone, curzerenone, and curdione) and curcuminoids, which contribute to its therapeutic potential. Experimental studies demonstrate …

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

The Revised Cdc Chronic Pain Guidelines And Payer Opioid Analgesic Policies In Michigan, Victoria Tutag Lehr, Cynthia L. Arfken

Michigan Journal of Public Health

Abstract

The 2016 publication of A Guideline for Prescribing Opioids for Chronic Pain by the Centers for Disease Control and Prevention motivated commercial and Medicaid payers to restrict their opioid prescribing policies including the imposition of hard limits on opioid daily dosages and duration. One result of these policies was an increase in abrupt opioid discontinuation and rapid tapering events for patients receiving long-term opioid therapy. Responding to this misapplication of the 2016 guideline, the 2022 revised guidelines emphasized individualized opioid therapy and exclusion of certain chronic diseases. However, it is not known if the payers changed their policies to …

Opioid Prescription Rates Before And After Alto Program And Various Factors Affecting Emergency Department Opioid Prescription Rates, Neel B. Patel, James F. Baird

Rowan-Virtua Research Day

Opioid prescription rates vary between patient population, diagnosis, location, and emergency department characteristics. High prescription rates offer an avenue for potential opioid addiction and overdoses. Alternatives to opioids (ALTO) is a new program already implemented in certain emergency departments to help change opioid prescription rates by introducing new protocols for first line treatments for pain management. With current trends still showing that South Jersey opioids prescription rates are the highest in the state of New Jersey, ALTO was introduced at Inspira Health Network located in South Jersey. This study retrospectively analyzed opioids prescription rates for abdominal pain, renal colic, migraines, …

A Closer Look At The Humanistic Aspects Of The Opioid Epidemic And Its Implications For Pharmaceutical Ethics And Law, Eriel Burns

Gaines Fellow Senior Theses

This paper elucidates the humanistic elements of this crisis, that is, the ethical challenges it poses and the role of culture in it. The opioid crisis disturbs several bioethics principles as indicated by the fact that it burgeoned out of the health care system as opposed to the illicit environments of the underground market. The book Dreamland by investigative journalist and storyteller, Sam Quinones encapsulates the complexity of the opioid epidemic through research and interviews with important figures related to the crisis such as physicians, people with opioid use disorder, and pharmaceutical sales representatives, among others. Quinones details that the …

Decreasing Unintentional Pregnancies For Tennesseans, Paula M. Todd

Electronic Theses and Dissertations

In 2018, 49% of all pregnancies in the United States were unintended, with women with a lower- income status being five times more likely to experience an unplanned pregnancy. Tennessee has a high rate of unintended pregnancies, particularly among the uninsured, low-income, and rural teen populations; some 22% of these unintended pregnancies end in abortion. Oral or transdermal contraceptives that are affordable and accessible for women of childbearing age can reduce unintentional pregnancies. The addressed gap in clinical practice was that contraceptives are not currently available over the counter in Tennessee pharmacies without a prescription, which necessitates a costly medical …

Incompatibility Group I1 (Inci1) Plasmids: Their Genetics, Biology, And Public Health Relevance, Steven L. Foley, Pravin R. Kaldhone, Steven C. Ricke, Jing Han

United States Food and Drug Administration: Publications

Bacterial plasmids are extrachromosomal genetic elements that often carry antimicrobial resistance (AMR) genes and genes encoding increased virulence and can be transmissible among bacteria by conjugation. One key group of plasmids is the incompatibility group I1 (IncI1) plasmids, which have been isolated from multiple Enterobacteriaceae of food animal origin and clinically ill human patients. The IncI group of plasmids were initially characterized due to their sensitivity to the filamentous bacteriophage If1. Two prototypical IncI1 plasmids, R64 and pColIb-P9, have been extensively studied, and the plasmids consist of unique regions associated with plasmid replication, plasmid stability/maintenance, transfer machinery apparatus, single-stranded DNA …

Association Of Electronic Prescription In Controlled Substances Used, Archana Suwal, Jemima Akinyi Okonjo

Theses, Dissertations and Capstones

Introduction: Controlled substances have been described as pharmaceuticals or illegal medicines that act primarily on the central nervous system and could cause physical and mental dependence, eventually leading to addiction. Prescription opioids were a significant contributor to the opioid epidemic, accounting for more than 70,000 opioid-related overdose deaths, including illicit and prescription opioids, between 2018 and 2019. The Electronic Prescriptions for Controlled Substances (EPCS) initiative recently aimed to reduce rates of prescription opioid addiction, abuse, diversion, and death. The system for controlled substances had become more widely used as providers and governments trying to combat the opioid problem. Because …

Opioid Use Disorder: The Timeline For Medication Assisted Therapy, Alexander Cristofori

Capstone Showcase

Opioid Use Disorder is patterns of opioid use leading to withdrawal, giving up important life events in order to use opioids, and excessive time spent using opioids, to name a few diagnostic criteria. The clinical progression of the disorder involves periods of acute exacerbation and remission that are cyclic in nature. Treatment is most effective when it includes both pharmacological and psychosocial modalities, referred to as medication assisted therapy (MAT). Three drugs used commonly in MAT-based treatment for OUD from oldest to newest include Methadone, Buprenorphine-naloxone, and Naltrexone. Treatment program models that prioritize total abstinence from the addictive substance attached …

Importance Of Awareness Of Adverse Drug Reaction Reporting During The Covid-19 Pandemic, Heather Ellis, Hale Z. Toklu

HCA Healthcare Journal of Medicine

Health care professionals hold the responsibility of reporting any adverse drug reactions in order to learn about new therapy and how best to safely care for our patients. The information derived from case publications and FDA MedWatch reports are essential to accumulate information and increase awareness for the possible risks of new drugs.

Survival Of A Serotype 4b Strain And A Serotype 1/2a Strain Of Listeria T Monocytogenes, Isolated From A Stone Fruit Outbreak Investigation, On Whole Stone Fruit At 4 °C, Antonio J. De Jesus, Ishani Sheth, Hee Jin Kwon, Zhujun Gao, Jessica Palmer, Minji Hur, Thomas S. Hammack, Dumitru Macarisin, Yi Chen

United States Food and Drug Administration: Publications

In the summer of 2014, a multistate outbreak of listeriosis associated with contaminated stone fruit (peach and nectarine) was reported. A serotype 4b variant Listeria monocytogenes (Lm) strain of singleton Sequence Type (ST) 382 was isolated from clinical samples and stone fruit associated with the outbreak. A serotype 1/2b Lm strain of ST5, Clonal Complex 5 was isolated only from outbreak-associated stone fruit, not from clinical samples. Here we investigated the fate of the serotype 4b and 1/2b strains, at two inoculation levels (high level at 3.7 logCFU/fruit and low level at 2.7 logCFU/fruit), on the surfaces of white peach, …

Adult Perceptions Of The Relative Harm Of Tobacco Products And Subsequent T Tobacco Product Use: Longitudinal Findings From Waves 1 And 2 Of The Population Assessment Of Tobacco And Health (Path) Study, Tara Elton-Marshall, Pete Driezen, Geoffrey T. Fong, K. Michael Cummings, Alexander Persoskie, Olivia Wackowski, Kelvin Choi, Annette Kaufman, David Strong, Shannon Gravely, Kristie Kristie, Jonathan Kwan, Maansi Bansal-Travers, Mark Travers, Andrew Hyland

United States Food and Drug Administration: Publications

Objectives: To examine: (1) How perceptions of harm for seven non-cigarette tobacco products predict sub- sequent use; (2) How change in use is associated with changes in perceptions of product harm; (3) Whether sociodemographic variables moderate the association between perceptions and use.

Methods: Data are from the adult sample (18+) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort survey conducted September 2013-December 2014 (Wave 1 (W1) n = 32,320) and October 2014-October 2015 (Wave 2 (W2) n = 28,362).

Results: Wave 1 users and non-users of e-cigarettes, filtered cigars, cigarillos, and pipes, who …

An Evaluation Of The Usda's Policy To Reduce Listeria Illnesses In Ready‐To‐Eat Meat And Poultry Products, Travis Minor, Matt Parrett

United States Food and Drug Administration: Publications

Using 1998–2008 data collected by the Centers for Disease Control and Prevention on foodborne illnesses and outbreaks, we examine the economic impact of the United States Department of Agriculture's proposed and final rules to reduce the incidence of Listeria monocytogenes (Lm) in ready‐to‐ eat meat and poultry products. Using a difference‐in‐ differences approach, we find that these rules together reduced meat‐related Lm illnesses by about 60 per year, which we attribute to reductions in both the number and average size of meat‐related Lm outbreaks. We then monetize this illness reduction using an underreporting and underdiagnosis multiplier of 2.3 and an …

Genomics-Based Re-Examination Of The Taxonomy And Phylogeny Of Human And Simian Mastadenoviruses: An Evolving Whole Genomes Approach, Revealing Putative Zoonosis, Anthroponosis, And Amphizoonosis, June Kang, Ashrafali Mohamed Ismail, Shoaleh Dehghan, Jaya Rajaiya, Marc W. Allard, Haw Chuan Lim, David W. Dyer, James Chodosh, Donald Seto

United States Food and Drug Administration: Publications

With the advent of high-resolution and cost-effective genomics and bioinformatics tools and methods contributing to a large database of both human (HAdV) and simian (SAdV) adenoviruses, a genomics-based re-evaluation of their taxonomy is warranted. Interest in these particular adenoviruses is growing in part due to the applications of both in gene transfer protocols, including gene therapy and vaccines, as well in oncolytic protocols. In particular, the re-evaluation of SAdVs as appropriate vectors in humans is important as zoonosis precludes the assumption that human immune system may be na€ıve to these vectors. Additionally, as impor- tant pathogens, adenoviruses are a model …

The Impact Of The Abuse-Deterrent Reformulation Of Extended-Release T Oxycontin On Prescription Pain Reliever Misuse And Heroin Initiation, Carolyn Wolff, William N. Dowd, Mir M. Ali, Chandler Mcclellan, Angelica Meinhofer, Lukas Glos, Ryan Mutter, Matthew Rosenberg, Andreas Schikc

United States Food and Drug Administration: Publications

The introduction of abuse-deterrent OxyContin in 2010 was intended to reduce its misuse by making it more tamper resistant. However, some studies have suggested that this reformulation might have had unintended consequences, such as increases in heroin-related deaths. We used the 2005–2014 cross-sectional U.S. National Survey on Drug Use and Health to explore the impact of this reformulation on intermediate outcomes that precede heroin-related deaths for individuals with a history of OxyContin misuse. Our study sample consisted of adults who misused any prescription pain reliever prior to the reformulation of OxyContin (n = 81,400). Those who misused OxyContin prior to …

Development Of A Nicotinic Acetylcholine Receptor Nachr Α7 Binding Activity Prediction Model, Sugunadevi Sakkiah, Carmine Leggett, Bohu Pan, Wenjing Guo, Luis G. Valerio Jr., Huixiao Hong

United States Food and Drug Administration: Publications

Despite the well-known adverse health effects associated with tobacco use, addiction to nicotine found in tobacco products causes difficulty in quitting among users. Nicotinic acetylcholine receptors (nAChRs) are the physiological targets of nicotine and facilitate addiction to tobacco products. The nAChR-α7 subtype plays an important role in addiction; therefore, predicting the binding activity of tobacco constituents to nAChR-α7 is an important component for assessing addictive potential of tobacco constituents. We developed an α7 binding activity prediction model based on a large training data set of 843 chemicals with human α7 binding activity data extracted from PubChem and ChEMBL. The model …

Long-Term Negative Emotional Outcomes Of Warzone Tbi, Jennifer J. Vasterling, Mihaela Aslan, Susan P. Proctor, John Ko, Xenia Leviyah, John Concato

United States Food and Drug Administration: Publications

Objective: Many veterans of the Iraq and Afghanistan Wars have experienced traumatic brain injury (TBI). Although prior work has examined associations between TBI and development of psychi- atric syndromes, less is known about associations between TBI and component emotions constituting these syndromes, especially in the long term. The purpose of this study was to examine the long-term emotional consequences of deployment-related TBI.

Methods: As part of VA Cooperative Studies Program #566, we assessed a sample of n1⁄4456US Army soldiers prior to an index deployment to Iraq, and again an average of 8.3 years (SD1⁄42.4years) after their deployment for a long-term …

Pharmaceutical Manufacturing In The 21st Century: Identification And Analysis Of Key Elements, Robert N. Mills

Honors Program: Senior Projects (Public)

The availability of quality pharmaceutical products impacts the lives of the global population on a daily basis. The importance of product availability and quality within pharmaceutical manufacturing requires that quality systems put into place are capable of accurately and robustly capturing the quality compliance, or lack thereof, of the various stages of production. This review intends to analyze current expert-recommended best practices within key elements of a pharmaceutical manufacturing quality control system and provide recommendations throughout. The quality elements discussed include Quality by Design method validation, necessary equipment determination, and equipment qualification, followed by documentation control and data flow.

Naming Convention, Interchangeability, And Patient Interest In Biosimilars, Mariana P. Socal, Jace B. Garrett, William B. Tayler, Ge Bai, Gerard F. Anderson

Faculty Publications

Although biosimilars may offer cost savings over their comparable biologics, use of biosimilars in the United States remains relatively low. This study investigates two barriers to uptake of biosimilars in the United States. First, the U.S. Food and Drug Administration requires that four-letter suffixes be added to the nonproprietary names of all biosimilars, as well as to the nonproprietary names of all biologics approved after March 2020. Second, biosimilars are not interchangeable with their reference biologic product at the pharmacy counter; a new prescription is needed for the biosimilar to be dispensed in place of the biologic. We conducted two …

Market Claims And Efficacy Information In Direct‐To‐Consumer Prescription Drug Print Advertisements, Kathryn J. Aikin Phd, Kevin R. Betts Phd, Aysha Keisler Phd, Kathryn Schaefer Ziemer Phd

United States Food and Drug Administration: Publications

This study examined the impact of “New” and “#1 Prescribed” market claims and quantitative efficacy information on perceptions of a hypothetical prescription drug in a direct‐to‐consumer (DTC) print advertisement. We examined two market claims (New and #1 Prescribed), two efficacy levels (higher and lower), and a control condition without this information. Participants with diabetes were randomized to review one ad version and asked their perceptions of the ad's message, the drug's benefits, side effects and risks, doctors' opinions about the drug, and behavioral intention to use the drug, as well as recall and recognition of drug benefits and risks. Results …

Youth Perception Of Harm And Addictiveness Of Tobacco Products: Findings From The Population Assessment Of Tobacco And Health Study (Wave 1), David R. Strong, Karen Messer, Martha White, Yuyan Shi, Madison Noble, David B. Portnoy, Alexander Persoskie, Annette R. Kaufman, Kelvin Choi, Charles Carusi, Maansi Bansal-Travers, Andrew Hyland, John Pierce

United States Food and Drug Administration: Publications

Purpose: We provide a US national assessment of youth perceptions of the harm and addictiveness of six separate tobacco products, identifying a continuum of perceived harm associated with a range of products in relation to patterns of current use, former use, and susceptibility to use tobacco products.

Methods: We evaluated youth respondents (N=13,651) ages 12–17 from Wave 1 (2013–2014) of the Population Assessment of Tobacco and Health (PATH) Study. Analyses (2015–2016) focused on refining mea- sures of perceived harm for each product and delineating youth characteristics (demographic, tobacco use status) associated with beliefs about the harmfulness and addictiveness of tobacco …

Associations Of Risk Factors Of E-Cigarette And Cigarette Use And Susceptibility To Use Among Baseline Path Study Youth Participants (2013–2014), Michael D. Sawdey, Hannah R. Day, Blair Coleman, Lisa D. Gardner, Sarah E. Johnson, Jean Limpert, Hoda T. Hammad, Macieji L. Goniewicz, David B. Abrams, Cassandra A. Stanton, Jennifer L. Pearson, Annette R. Kaufman, Heather L. Kimmel, Cristine D. Delnevo, Wilson M. Compton, Maansi Bansal-Travers, Raymond S. Niaura, Andrew Hyland, Bridget K. Ambrose

United States Food and Drug Administration: Publications

Introduction: Improved understanding of the distribution of traditional risk factors of cigarette smoking among youth who have ever used or are susceptible to e-cigarettes and cigarettes will inform future longitudinal studies examining transitions in use.

Methods: Multiple logistic regression analysis was conducted using data from youth (ages 12–17 years) who had ever heard of e-cigarettes at baseline of the PATH Study (n = 12,460) to compare the distribution of risk factors for cigarette smoking among seven mutually exclusive groups based on ever cigarette/e-cigarette use and sus- ceptibility status.

Results: Compared to committed never users, youth susceptible to e-cigarettes, cigarettes, or …

Selection And Consumption Of Lunches By National School Lunch Program T Participants, Janet G. Peckham, Jaclyn D. Kropp, Thomas A. Mroz, Vivian Haley-Zitlin, Ellen M. Granberg

United States Food and Drug Administration: Publications

The Healthy, Hunger-Free Kids Act of 2010 requires schools participating in the National School Lunch Program (NSLP) to offer a variety of healthy food options each day. Using digital photography data collected from two suburban elementary schools in the spring of 2013, we examine NSLP participant's selection and consumption of all five NSLP lunch components ((1) milk, (2) vegetable, (3) fruit, (4) meat/meat alternate (MA), and (5) grain). We use logit regressions to analyze the selection of the various lunch components by race/ethnicity, gender, grade, and household income level. In addition, ordinary least squares regressions are used to analyze the …

Examining The Role Of Menthol Cigarettes In Progression To Established T Smoking Among Youth, James Nonnemaker, Shari P. Feirman, Anna Macmonegle, Bridget K. Ambrose, Kia J. Jackson, Megan J. Schroeder, Alexandria A. Smith, William Ridgeway, Olga Rass

United States Food and Drug Administration: Publications

Background: Menthol, a flavoring compound added to cigarettes, makes cigarettes more appealing to youth and inexperienced smokers and increases cigarettes' abuse liability. However, limited studies are available on menthol's role in smoking progression.

Methods: To assess the association between menthol in cigarettes and progression to established smoking, we used five waves of data from the Evaluation of Public Education Campaign on Teen Tobacco Cohort Study, a nationally representative longitudinal survey of U.S. youth conducted as part of “The Real Cost” evaluation. We used discrete time survival analysis to model the occurrence of two event outcomes—progression to established, current smoking and …

U.S. Adult Perceptions Of The Harmfulness Of Tobacco Products: Descriptive T Findings From The 2013–14 Baseline Wave 1 Of The Path Study, Geoffrey T. Fong, Tara Elton-Marshall, Pete Driezen, Annette R. Kaufman, K. Michael Cummings, Kelvin Choi, Jonathan Kwan, Amber Koblitz, Andrew Hyland, Maansi Bansal-Travers, Charles Carusi, Mary E. Thompson

United States Food and Drug Administration: Publications

Introduction: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products.

Methods: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014.

Results: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe …

At Risk Alcohol Consumption With Smoking By National Background: Results From The Hispanic Community Health Study/Study Of Latinos, Frank C. Bandiera, Eliseo J. Pérez-Stable, Folefac Atem, Raul Caetano, Denise C. Vidot, Marc D. Gellman, Elena L. Navas-Nacher, Jianwen Cai, Gregory Talavera, Neil Schneiderman, Robert Kaplan

United States Food and Drug Administration: Publications

Introduction: Tobacco smoking and binge or excess drinking are unhealthy behaviors that frequently co-occur. Studies of Hispanics/Latinos have mostly been of Mexican Americans although there are substantial differences in smoking and drinking by heritage background. Associated with co-use by 5 subpopulations.

Methods: Cross-sectional data of 16,412 Hispanics/Latinos from Miami, the Bronx, Chicago and San Diego collected between 2008 and 2011 as part of the HCHS/SOL were analyzed. Smoking and alcohol consumption and demographic data were measured by self-report. Prevalence of smoking and alcohol consumption and co-use were reported. Logistic regression models examined the odds of co-use of smoking and binge …

Comparing Methods For Clinical Investigator Site Inspection Selection: A Comparison Of Site Selection Methods Of Investigators In Clinical Trials, Nicholas Hein, Elena Rantou, Paul Schuette

United States Food and Drug Administration: Publications

Background During the past two decades, the number and complexity of clinical trials have risen dramatically increasing the difficulty of choosing sites for inspection. FDA’s resources are limited and so sites should be chosen with care.

Purpose To determine if data mining techniques and/or unsupervised statistical monitoring can assist with the process of identifying potential clinical sites for inspection.

Methods Five summary-level clinical site datasets from four new drug applications (NDA) and one biologics license application (BLA), where the FDA had performed or had planned site inspections, were used. The num- ber of sites inspected and the results of the …

Parent Perspectives On Health And Functioning Of School-Aged Adolescents With Disabilities, Gavin Colquit Edd, Cape, Cscs, Ashley D. Walker Phd, Ches, Moya L. Alfonso Phd, Msph, Maria Olivas Mph, Bethrand Ugwu Mph, Theophile Dipita Dr, Ph

United States Food and Drug Administration: Publications

BACKGROUND: Youth living with disabilities are at risk of experiencing poor health outcomes. Coordinated school health programs have an opportunity to help youth with disabilities and their families through health education, health services, and community engagement. The World Health Organization developed the International Classification of Functioning, Disability, and Health (ICF) as a framework to analyze factors related to health conditions. We used the ICF to examine parental perceptions of health and function among students with disabilities living in rural and urban areas.

METHODS: We surveyed parents (N = 71) using the parent-report versions of the Pediatric Outcomes Data Collection Instrument …