A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.

A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Exposure (ADE) [synonymous with the Permitted Daily Exposure (PDE)] and operational considerations associated with implementation are outlined here. The EU guidance states that all active pharmaceutical ingredients (API) require an ADE; however, other substances such as starting materials, process intermediates, and cleaning agents may benefit from an ADE.

Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.

This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical cleaning limits. Implementation of health-based cleaning limits, as distinct from other standards such as 1/1000th of the lowest clinical dose, is a concept recently introduced into regulatory domains. While there is a great deal of technical detail in the written framework underpinning the use of Acceptable Daily Exposures (ADEs) in cleaning (for example ISPE, 2010; Sargent et al.

Communication and outcomes of visits between older patients and nurse practitioners.

Background: Effective patient-clinician communication is at the heart of good healthcare and may be even more vital for older patients and their nurse practitioners (NPs).

Objectives: The objectives of this study were to examine 1)contributions of older patients' and NPs' characteristics and the content and relationship components of their communication to patients' proximal outcomes (satisfaction and intention to adhere) and longer term outcomes (changes in presenting problems, physical health, and mental health), and 2) contributions of proximal outcomes to longer term outcomes.

Methods: Visits were video-recorded for a statewide sample of 31 NPs and 155 older patients.

Alliance not compliance: coaching strategies to improve type 2 diabetes outcomes.

Purpose: To explore strategies for improving patient outcomes in type 2 diabetes.

Data Sources: The literature related to type 2 diabetes management, behavior change, communication, diabetes self-management, and coaching.

Conclusions: The strategies currently suggested for improving patient outcomes, e.

From the sidelines: coaching as a nurse practitioner strategy for improving health outcomes.

Purpose: The purposes of this study were to explore coaching as a nurse practitioner (NP) strategy for improving patient health outcomes and to lay a foundation for validating coaching benefits.

Data Sources: Review of coaching literature in psychology, sports, business, and nursing.

Conclusions: Coaching has been reported as successful in psychology, sports, business, and more recently nursing, for assisting people to achieve goals that are important to them.

Nurse practitioners and managed care: patient satisfaction and intention to adhere to nurse practitioner plan of care.

Purpose: To explore patient satisfaction, intention to adhere to nurse practitioner (NP) plan of care, and the impact of managed care on NPs' patients in multiple settings, the final phase of a three-part study of NPs and managed care.

Data Sources: Postvisit questionnaires and narrative comments about patient satisfaction with NP communication, overall satisfaction with visit, recall of plan of care, intention to adhere to NP's recommendations, and impact of managed care on ease of obtaining healthcare resources.

Conclusions: Patients were very satisfied with NP communication and with their healthcare visit.

Embattled and embittered or empowered and evolving: nurse practitioner attitudes toward managed care.

Purpose: To explore the attitudes of nurse practitioners (NPs) toward managed care and to identify the sources of negative attitudes and the factors that may ameliorate them.

Data Sources: NPs, members of the Massachusetts Coalition of NPs, participated in in-depth interviews about the impact of managed care on their practice.

Conclusions: The sources of NP negativity about managed care for many study participants lay in their not appreciating the importance of the business aspects of practice and the provider's role in controlling healthcare costs, reluctance to work with what they perceived as a rigid "system," and lack of support for them to navigate it.

Promoting nurse practitioner practice through research: opportunities, challenges, and lessons.

Purpose: To discuss the opportunities derived, challenges faced, and lessons learned in the research process, including recruiting and retaining nurse practitioner (NP) participants, obtaining institutional approval, and solving research team issues in a National Institutes of Health/National Institute of Nursing Research (NIH/NINR)-funded study of communication between NPs and their older patients in managed care and non-managed care settings.

Data Sources: The video-taped interactions between 30 NPs and 150 patients, research team experiences in conducting the research, and a review of relevant literature.

Conclusions: Key factors in NP study participation included recognizing the importance of research in demonstrating the effectiveness of the NP role and for advancing the profession, having participated in previous research, enjoying the research process, employer incentives, membership in NP professional organizations, relationships with the university and the school of nursing conducting the research, and knowledge of the coinvestigator's work.

Human pharmaceuticals in US surface waters: a human health risk assessment.

The detection of low levels of pharmaceuticals in rivers and streams, drinking water, and groundwater has raised questions as to whether these levels may affect human health. This report presents human health risk assessments for 26 active pharmaceutical ingredients (APIs) and/or their metabolites, representing 14 different drug classes, for which environmental monitoring data are available for the United States. Acceptable daily intakes (ADIs) are derived using the considerable data that are available for APIs.

Screening analysis of human pharmaceutical compounds in U.S. surface waters.

The PhATE (Pharmaceutical Assessment and Transport Evaluation) model presented in this paper was developed as a tool to estimate concentrations of active pharmaceutical ingredients (APIs) in U.S. surface waters that result from patient use (or consumption) of medicines.

A strategy to reduce the numbers of fish used in acute ecotoxicity testing of pharmaceuticals.

The pharmaceutical industry gives high priority to animal welfare in the process of drug discovery and safety assessment. In the context of environmental assessments of active pharmaceutical ingredients (APIs), existing U.S.

Nurse practitioner self-confidence and attitudes regarding managed care.

Purpose: To examine the relationship between nurse practitioner (NP) perceived self-confidence in performing managed care tasks and NP attitudes toward managed care.

Data Sources: A random sample of NPs--members of the Massachusetts Coalition of Nurse Practitioners--completed a demographic survey, responded to questions measuring self-confidence in performing managed care tasks and attitudes toward managed care, and wrote about their managed care experiences.

Conclusions: NPs were only moderately confident in performing managed care tasks and had mostly negative attitudes toward managed care.

Impact of war on American adolescents.

Problem: The impact of the Persian Gulf war on adolescents in Columbia, Charleston, and Sumter, SC.

Methods: Four semiannual surveys measured adolescents' exposure to and evaluations of the Persian Gulf war, and the relationship between this exposure and mental distress.

Findings: Of the sample, 814 (65.

Challenge and opportunity: nurse practitioner programs partnering with managed care.

Purpose: To examine the experiences of nurse practitioner (NP) students who participated in a collaborative educational program between the University of Massachusetts, Amherst, and Health New England (HNE) Health Plan, Springfield, MA. Nurse practitioner faculty and managed care executives shared resources to educate NP students and to address their perceptions about managed care.

Data Sources: Verbatim transcriptions and journal writings of students specifically designated as "Partnerships for Quality Education (PQE) trainees" and reports of their fellow classmates, all of whom received varying extent of access to managed care theory, administrative, and clinical experiences within the HNE plan.

The master's portfolio: validating a career in advanced practice nursing.

Purpose: To describe the process of portfolio development and faculty review that offers graduate credit within a framework of structural empowerment and mentoring for documented educational and clinical accomplishments for family nurse practitioners (FNPs).

Data Sources: Selected literature and examples from one student's portfolio to illustrate the process.

Conclusions: The degree granting process assists certified FNPs to fulfill career aspirations through achieving graduate level education at the University of Massachusetts, Amherst, School of Nursing.