Pharmacy Administration, Policy and Regulation Commons^™

Actionable Patient Safety Solution (Apss) #3d: Pediatric Adverse Drug Events, Ron Jordan, Jerika Lam, Nathaniel Sims, Anne Lyren, Coco Yang

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a "program to reduce the incidence of pediatric adverse drug events (pADEs) and harm ... [that] combine[s] leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education)" to protect pediatric patients.

Actionable Patient Safety Solution (Apss) #3b: Antimicrobial Stewardship: The Role Of A Pharmacy And The Microbiology Lab In Patient Safety, Jerika Lam, Jason Yamaki, Ron Jordan, Celine Peters, Steven Barker, Michael Ramsay, Ariana Longley, Joe Kiani

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing an Antimicrobial Stewardship Plan (ASP) to combat the inappopriate use of antimicrobial drugs, which are a significant cause of patient morbidity and mortality.

Implementing Pharmacy-Based Travel Health Services: Insight And Guidance From Frontline Practitioners, Tania Gregorian, Albert Bach, Karl Hess, Keri Hurley, Edith Mirzaian, Jeff Goad

Pharmacy Faculty Articles and Research

PURPOSE In California, the passage of SB493 in July of 2013 was a milestone in advancing pharmacy practice. Among other things, the new legislation allows pharmacists to provide routine immunizations without a protocol and furnish medications for international travelers for conditions not requiring a diagnosis. When developing a pharmacist-run travel health service, consideration must be given to multiple important factors, including pharmacist training, physician partnership, logistics, from scheduling to documentation, and the resources necessary to provide a travel health service.5 This article sets out to provide guidance and insight to pharmacists seeking to implement a travel health service.

SUMMARY Travel …

Actionable Patient Safety Solution (Apss) #3a: Medication Errors, Ron Jordan, Jerika Lam, Anne Lyren, Nathaniel Sims, Coco Yang

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a program to reduce medication errors, which are a major cause of patient morbidity and mortality.

Comparison Of Outcomes Following A Switch From A Brand To An Authorized Vs. Independent Generic Drug, Richard Hansen, Jingjing Qian, Richard L. Berg, James G. Linneman, Enrique Seoane-Vazquez, Sarah Dutcher, Saeid Raofi, C. David Page, Peggy L. Peissig

Pharmacy Faculty Articles and Research

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999-2014, 5,234 unique patients were on brand drug prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12-months following the brand-to-generic switch, patients …

Incorporating Indications Into Medication Ordering — Time To Enter The Age Of Reason, Gordon Schiff, Enrique Seoane-Vazquez, Adam Wright

Pharmacy Faculty Articles and Research

"In our current era of transparent, patient-centered medicine, such sentiments would hardly be accepted. Unfortunately, patients are often still in the dark regarding the purposes of their medications. It is said that there are five “rights” required for safe medication ordering and use: the right patient, the right drug, the right dose, the right time, and the right route. But there’s a sixth element that must be correct — and we believe it’s time to add to each prescription an ingredient that’s currently conspicuously missing: the right indication. This pivotal element affects and complements the other five, and considering it …

The Role Of Community Pharmacy-Based Vaccination In The Usa: Current Practice And Future Directions, Albert Bach, Jeffery A. Goad

Pharmacy Faculty Articles and Research

Community pharmacy-based provision of immunizations in the USA has become commonplace in the last few decades, with success in increasing rates of immunizations. Community pharmacy-based vaccination services are provided by pharmacists educated in the practice of immunization delivery and provide a convenient and accessible option for receiving immunizations. The pharmacist's role in immunization practice has been described as serving in the roles of educator, facilitator, and immunizer. With a majority of pharmacist-provided vaccinations occurring in the community pharmacy setting, there are many examples of community pharmacists serving in these immunization roles with successful outcomes. Different community pharmacies employ a number …

Bridging The Location Gap: Physician Perspectives Of Physician-Pharmacist Collaboration In Patient Care (Bridge Phase Ii), Keri D. Hager, Donald Uden, Daniel M. Tomaszewski

Pharmacy Faculty Articles and Research

Background: To optimize patient outcomes, the patient-centred medical home model emphasizes comprehensive team-based care. Pharmacists are qualified to enhance appropriate medication use and help improve patient outcomes through provision of medication therapy management (MTM) services. To optimally provide MTM, pharmacists must effectively collaborate with physicians. This study explored factors that influence pharmacist-physician collaboration.

Methods and Findings: A convenience sample of five physicians participated in semi-structured interviews and the resulting data were analyzed using qualitative methods. Transcripts of the interviews were independently coded for themes by two researchers. Five themes emerged: trustworthiness, role specification, relationship initiation, effects on practice, …

Applying The Pharmacists’ Patient Care Process To Immunization Services: A Resource Guide For Pharmacists, Albert Bach, Jeff Goad, Mitchel Rothholz, Brian Wall, Anne Burns, Liza Chapman, Jean-Venable “Kelly” R. Goode, Sheila Seed, Rebecca Snead

Pharmacy Faculty Articles and Research

"This guidance document has been written and formatted to align comprehensive components of a pharmacy-based immunization patient encounter Collect Assess Plan Implement Follow-Up 6 American Pharmacists Association and recommendations from the National Vaccine Advisory Committee (NVAC) the Standards for Adult Immunization Practice with the original framework of the PPCP.5 The colored columns to the right throughout this document are the PPCP steps as they have been published by JCPP, and the main document text describes how to integrate each PPCP step into immunization services."

Compliance To The Consort Statement On Participant Flow Diagrams In Infectious Disease Randomized Clinical Trials, Onyeka P. Godwin, Brandon Dyson, Paul S. Lee, Soon Park, Euni Lee

Pharmacy Faculty Articles and Research

Background: The Consolidated Standard of Reporting Trials (CONSORT) Guidelines were developed to support adequate reporting of randomized controlled trials (RCTs).

Method: A systematic review was conducted including RCTs of infectious diseases published in the top general medical and infectious disease journals in 2010. The level of compliance to flow diagram and its association with the CONSORT endorsement by the journals were evaluated.

Results: A total of 67 studies were included in the analysis and a half of the studies were HIV/AIDS RCTs. About 78% of the studies included the flow diagram and 66% of the studies described …

Transgender Patients: Communication Pearls For Pharmacists, Emmanuelle Schwartzmann, Thomas Kleyn

Pharmacy Faculty Articles and Research

Understanding the unique communication needs of transgender patients is critical in order to minimize health disparities and patient barriers to care. As this population gains more social and political acceptance, pharmacists must be equipped to provide medical acceptance through knowledge of how to appropriately communicate with these patients through active listening, empathy, and sensitivity, while maintaining a high standard of respect and privacy.

Implementation Of A Pharmacy-Based Adult Vaccine Benefit: Recommendations For A Commercial Health Plan Benefit, Jeffery A. Goad, Kelly J. Ko, Rolin L. Wade, Hsing-Ting Yu, Ross M. Miller, Bruce Sherman

Pharmacy Faculty Articles and Research

BACKGROUND: Although vaccination rates in children exceed 90% in the United States, adults are vaccinated at far lower rates. In order to address this issue, additional community immunizers are needed, and pharmacists are in an ideal position to fill this void.

OBJECTIVES: To explore issues and barriers related to implementation of a pharmacy-based adult vaccine benefit and develop recommendations supporting a pathway for benefit expansion.

METHODS: A literature review on the current environment surrounding pharmacy-based adult vaccinations and structured interviews were conducted to inform an expert panel meeting using a modified Delphi process (pre/post survey). The goal …

Collaborative Pharmacy Practice: An Update, Anandi V. Law, Eric K. Gupta, Micah Hata, Karl M. Hess, Roger S. Klotz, Quang A. Le, Emmanuelle Schwartzmann, Bik-Wai Bilvick Tai

Pharmacy Faculty Articles and Research

Collaborative practice among health professionals is slowly coming of age, given the global focus on efficiency and effectiveness of care to achieve positive patient outcomes and to reduce the economic burden of fragmented care. Collaborative pharmacy practice (CPP) is accordingly evolving within different models including: disease management, medication therapy management, patient centered medical home, and accountable care organizations. Pharmacist roles in these models relate to drug therapy management and include therapy introduction, adjustment, or discontinuation, patient counseling and education, and identification, resolution, and prevention of problems leading to drug interactions and adverse reactions. Most forms of CPP occur with physicians …

Medication Therapy Management, Challenges: The Pharmacist’S Emerging Role, Parth D. Shah, Jeffery A. Goad, Edith Mirzaian, Melissa Durham

Pharmacy Faculty Articles and Research

"The pharmacist's role on the healthcare team has received much attention lately as the new Affordable Care Act (ACA) healthcare legislation creates opportunities for pharmacists. lnterprofessional collaboration will transform the way pharmacists deliver health services to patients with respect to their medications. In the community, pharmacist-provided services have been moving away from the traditional role of dispensing to cognitive services that maximize the patient's safe and effective use of medications. The current movement in medical care within the United States is to adopt a model that is patient-centric. The Patient-Centered Primary Care Collaborative (PCPCC) recognizes that "patient-centric" systems are evolving, …

Fairness-Trust-Loyalty Relationship Under Varying Conditions Of Supplier-Buyer Interdependence, Thani Jambulingam, Ravi Kathuria, John R. Nevin

Business Faculty Articles and Research

Relationship marketing plays a significant role in supply chain practice and academic studies. Using the resource advantage theory within the relationship marketing framework, we studied the mediating role of trust as a governance mechanism in the fairness-loyalty relationship under different types of interdependence structure between suppliers (wholesalers) and buyers (retailers). Our findings, based on data from retail pharmacies, demonstrate that only under conditions of symmetric independence, trust, as a governance mechanism, completely mediate the relationship between fairness and loyalty. Under conditions of both perceived independence (i.e., lack of interdependence) and asymmetric buyer dependence, however, trust does not mediate but fairness …

How Fairness Garners Loyalty In The Pharmaceutical Supply Chain: Role Of Trust In The Wholesaler-Pharmacy Relationship, Thani Jambulingam, Ravi Kathuria, John R. Nevin

Business Faculty Articles and Research

Purpose

– The purpose of this paper is to understand how fairness garners loyalty by breeding trust in the pharmaceutical wholesaler‐pharmacy relationship. Specifically, the paper seeks to understand if the two dimensions of fairness – procedural and distributive – contribute differently in fostering the two types of trust – credibility and benevolence. The paper further aims to examine how the two dimensions of trust mediate the fairness‐loyalty relationship.

Design/methodology/approach

– Data from 156 retail pharmacies on their relationship with the pharmaceutical wholesalers are used to test the hypotheses. The mediation models are tested using the Barron and Kenny procedure.

Findings …

Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria

Pharmacy Faculty Articles and Research

Background: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.

Methods: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during …

Drug Selection And Adverse Drug Reactions: Balancing Outcomes And Costs, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Regulatory agencies approve drugs for marketing when the ratio of risk to benefit of the drugs is positive, i.e. the potential benefit of using the drug justifies the risk of drug related adverse reactions (ADR). At the point of approval of a drug there is not adequate information about all possible negative outcomes arising from its use in clinical practice. The information is even more limited for patient subgroups, diseases and treatment combinations that were not evaluated in the clinical trials required for approval. Therefore, performing post-marketing pharmacoepidemiological studies is necessary for a better understanding of drug use in usual …

Entrepreneurial Orientation As A Basis For Classification Within A Service Industry: The Case Of Retail Pharmacy Industry, Thanigavelan Jambulingam, Ravi Kathuria, William R. Doucette

Business Faculty Articles and Research

To date, service classification research has primarily taken a macro view, creating service typologies or taxonomies by using dimensions such as customer contact or degree of labor intensity. Such classification schemes, though helpful in deciphering critical management issues and positioning strategies between service industries, tend to treat an entire industry, such as airlines, as a single homogenous entity. However, organizations in the same industry often use intangible resources, such as entrepreneurial orientation processes, to compete with one another. Resource-advantage theory suggests that organizations utilize intangible resources to build long-term strategies and a sustainable competitive advantage leading to superior performance. We …

Purchasing Pharmaceuticals (Health, Nutrition And Population (Hnp) Discussion Paper), Ulrika Enemark, Anita Alban, Enrique Seoane-Vazquez

Pharmacy Faculty Books and Book Chapters

This paper discusses the purchasing of pharmaceuticals as a key component of costeffective and equitable healthcare delivery. Pharmaceuticals account for a high, sometimes the dominant share of health expenditures in developing countries, but the desired health outcomes can only be achieved if the adequate medicines reach the right people and are used in the correct way. This requires purchasing arrangements that take into account the information asymmetry between patients and providers, ensure selection of effective, safe and affordable medicines and set economic incentives in a way that encourages rational drug use. The organizational and institutional frameworks define the roles of …

Price Of Pharmaceuticals, Value, R&D, And Intergenerational Equity, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"A few issues are more debated today than the price of pharmaceuticals. The debate is prompted by the lack of drug access for the world's population, the high expenditures of pharmaceutical companies in marketing and profits, and the need for research and development of new drugs."

White Paper: Certification, Credentials, And Credentialing In Pharmacy, Donald Kishi, Jeffery A. Goad, Nancy Korman, Teresa Miller, Mary Ferrill, Holly Strom

Pharmacy Faculty Articles and Research

The rapid evolution of the health care system has provided the pharmacy profession with opportunities to expand existing and develop new direct patient care roles. Two critical challenges that the pharmacy profession must contend with to ensure the continued expansion and acceptance of pharmacists in advanced practice roles (e.g. direct patient care roles) are: (1) To develop and implement a credible, systematic, standards-based, and profession-wide plan that includes a system for identifying the types of pharmacists' practices requiring credentials, a validated certification process, and a computerized credentialing process that is current, comprehensive, and easily accessible; (2) To establish the credibility …

Reimbursement For Pharmaceutical Care Services: The California Experience, Jeffery A. Goad, Kathleen Johnson, Michael Rudolph

Pharmacy Faculty Articles and Research

"While it is true that pharmacists are changing their practice habits, they are doing so for the betterment of their patients’ drug therapy outcomes and the healthcare system. The pharmacist serves as the vital link between the patient, physician, and healthcare system. By working with patients and physicians, pharmacists have demonstrated in the literature that they can improve patient drug therapy outcomes, thus preventing unnecessary healthcare expenditures (Fincham, 1998). Pharmacists have long been held in highest esteem by patients, being voted the number one trusted professional for 10 consecutive years. The evidence is clear that pharmacists provide a valuable service …