Pharmacy Administration, Policy and Regulation Commons^™

A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene

Level 3

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …

Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane

Level 3

Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.

Change Management Is A Consideration Beyond The Pandemic, Kenneth Maxik, Craig Kimble, Alberto Coustasse

Pharmacy Practice & Administration

Change management (CM) is a well-organized framework for managing the people side of change. It includes practices, processes, and planned activities designed to facilitate and lead organizations to move from the present state to a desired state. The goal of CM is not to eliminate resistance but to anticipate it, proactively plan for it, continuously manage it, and mitigate the consequences.

Obstetrician-Gynecologist Perceptions And Utilization Of Prescription Drug Monitoring Programs: A Survey Study, Amie Goodin, Jungjun Bae, Chris Delcher, Joshua Brown, Dikea Roussos-Ross

Pharmacy Practice and Science Faculty Publications

Query of Prescription Drug Monitoring Programs (PDMPs) is recommended before prescribing opioids by the US Centers for Disease Control and Prevention, to inform clinical practice and aid diversion prevention. Many states mandate prescriber PDMP use; however, little is known about PDMP perception of utility and use among Obstetricians-Gynecologists (OB/GYN), who are the primary provider for most women during pregnancy.

This study examined OB/GYN perceptions and utilization of their state PDMP.

Survey items were developed by expert consensus. A voluntary anonymous survey was emailed to a random sample of 5000 OB/GYNs (adjusted participants n = 1470, minus unread/refusals). Responses were stratified …

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 …

Let Your Pharmacist Be Your Guide: Navigating Barriers To Pharmaceutical Access, Jennifer Ko, Miranda Steinkopf, Sharon E. Connor

Pharmacy Faculty Books and Book Chapters

At the end of this case, students will be able to: • Describe policy, organizational, and individual factors that contribute to barriers to accessing medications and pharmaceutical care • Identify resources to improve access to affordable medications for uninsured and underinsured patients • Recommend appropriate resources for obtaining affordable medications

The Place And Role Of Pharmacy Benefit Management (Pbm) Companies In Us Healthcare System, George Mattis Ii

Electronic Theses and Dissertations

On average, prescription drugs cost US consumers more than any other developed country in the world. US drug makers claim that intermediaries in the prescription drug supply chain, companies called pharmacy benefit managers (PBM), are forcing them to increase their drug prices. PBMs counter that the discounts they receive from drug makers are channeled to insurers. This thesis will examine the role that PBMs play in the prescription drug supply chain and determine what effect they have on drug prices. This thesis will utilize a comparative static model, Structure, Conduct, Performance (SCP) framework to analyze the pharmaceutical manufacturing and the …

Pharmacist Provision Of Contraception Services In Kentucky: Opinions And Policy Interventions, Dustin K. Miracle

Theses and Dissertations--Pharmacy

Unintended pregnancy continues to be a prevalent issue across the United States, impacting millions of women annually. While several states have enacted policies expanding pharmacist services to allow for provision of hormonal contraception, Kentucky has yet to do so. Likewise, although provision of nonprescription hormonal contraception could be authorized under Kentucky regulation, prior to this study, this had yet to be done. The objectives of this study were to 1) understand the opinions of Kentucky pharmacists and student pharmacists regarding provision of hormonal contraception services through a board-authorized protocol, 2) understand the opinions of Kentucky pharmacists and student pharmacists regarding …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

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 …

Guidelines On Prescriptive Authority For Nurses 2021, David Stewart, Madrean Schober, Lisa Nissen, Elissa Ladd, Kimberley Lamarche, Marie-Lyne Bournival, Deborah Gray, Sonia Sevilla, Marieke Kroezen, Frances Wong

Ellmer School of Nursing Faculty Publications

[First paragraph] Nurse prescribing has existed for over 50 years in some regions of the world. The diverse global nurse prescriptive authority landscape will be highlighted in this important publication. A framework embedding core components for safe and competent prescribers necessitates appropriate education, aligned regulatory authority and continuing professional development to uphold competencies. Evidence-informed models of nurse prescribing will weave in organisational and team support considerations required.

Association Of Incident Cancer To Low-Value Care And Healthcare Cost Burden Among Elderly Medicare Beneficiaries, Chibuzo Iloabuchi

Graduate Theses, Dissertations, and Problem Reports (ETD)

In the United States (US), 25% of healthcare spending is considered wasteful because it is spent reimbursing low-value care. Low-value care is the utilization of healthcare services, medical tests, and procedures that have unclear or no clinical benefit to patients but still exposes them to risk. World-wide, low-value care imposes a significant economic burden on patients, payers, governments, and society. Cancer care among older adults > 65 years is one of the biggest drivers of healthcare expenditure in the US and accounts for nearly 40% of all spending, and low-value care among cancer patients is prevalent and contributes to the financial …