Generic drug competition: The pharmaceutical industry “gaming” controversy

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the lead in encouraging increased competition in the nation’s prescription drug marketplace, most recently with its release of the agency’s Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/1/basr12186_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/2/basr12186.pd

Evolution of Self-Care Education

During the past 15 years, the curriculum content for nonprescription medication and self-care therapeutics has expanded significantly. Self-care courses ranging from stand-alone, required courses to therapeutic content and skills laboratories, have evolved in colleges and schools of pharmacy to accommodate rapid changes related to nonprescription medications and to meet the needs of students. The design of and content delivery methods used in self-care courses vary among institutions. Teaching innovations such as team-based learning, role playing/vignettes, videos, and social media, as well as interdisciplinary learning have enhanced delivery of this content. Given that faculty members train future pharmacists, they should be familiar with the new paradigms of Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative, nonprescription medications for chronic diseases, and the growing trends of health and wellness in advancing patient-care initiatives. This paper reviews the significant changes that may be impacting self-care curriculums in the United States

Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations

Background In 1996, the U.S. Food and Drug Administration approved regulations authorizing an exception from informed consent (EFIC) for research conducted in emergency settings when obtaining prospective informed consent is not possible due to the potential subject's critical illness or injury. The regulations require that investigators conduct community consultation (CC) efforts before initiating a study and require that institutional review boards review the results of CC prior to approving a study. However, little is known about how communities view EFIC research or the CC process. Objectives The objective was to assess the views of CC meeting attendees regarding the CC process, their understanding and views of EFIC research relating to the specific research trial under discussion, and their level of trust in physician‐investigators. Methods Following CC meetings at two study sites (San Francisco and Atlanta) for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), an active comparison, randomized trial of prehospital treatment for status epilepticus, the authors administered a pair of surveys to participants. One survey focused on CC experiences (CC survey) and trust in physician‐investigators; the second assessed participants' understanding of EFIC and the RAMPART clinical trial design (EFIC survey). Results A total of 317 individuals participated in one of the two most popular types of CC meetings (group meetings and focus group sessions) at both sites. A total of 189 participants (59%) completed the CC survey and trust questions, and 297 (92%) completed the EFIC survey. Of those who completed the CC survey, 173 of 189 (92%) were very satisfied with the meeting, and 174 of 189 (92%) felt that they learned a lot about research at the meeting. A total of 169 of 189 participants (88%) felt that researchers heard the community's concerns, while only 106 of 189 (56%) said researchers would be willing to make changes to the study based on their concerns. Of those who completed the EFIC survey, 261 of 297 (88%) supported the study, 207 of 297 (70%) said they would agree to participate in the study, and 203 of 297 (68%) reported that they would agree to consent a loved one into the study. On a recently validated scale measuring trust in physician‐investigators, participants at both sites seemed to have higher levels of trust in physician‐investigators than the validation study population. Conclusions Overall, members of these two communities expressed satisfaction with the CC session and had relatively high levels of support for the study and trust in physician‐investigators. Resumen La Excepción del Consentimiento Informado en la Investigación en Medicina de Urgencias y Emergencias ‐ Evaluación de las Consultas a la Comunidad Introducción En 1996, la United States Food and Drug Administration aprobó las regulaciones que autorizaban la excepción del consentimiento informado (EDCI) para la investigación llevada a cabo en el ámbito de la medicina de urgencias y emergencias cuando la obtención del consentimiento informado de forma prospectiva no era posible debido a enfermedad o lesión potencialmente crítica del sujeto. Las regulaciones requieren que los investigadores hagan el esfuerzo de llevar a cabo una consulta comunitaria (CC) antes del inicio de un estudio, y requieren que el comité de revisores de la institución revise los resultados de la CC previamente a aprobación. Sin embargo, existe escasa información del punto de vista de las comunidades sobre la investigación con EDCI o el proceso de CC. Objetivos Valorar los puntos de vista de los asistentes a una reunión de CC respecto al proceso de CC, su grado de comprensión, su parecer respecto a la investigación con EDCI en relación al ensayo clínico en discusión y su nivel de confianza en los médicos investigadores. Método Tras las reuniones de CC en dos lugares (San Francisco y Atlanta) para evaluar el estudio Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), un ensayo clínico con comparación activa y asignación aleatorizada del tratamiento prehospitalario para el estatus epiléptico, los autores administraron un par de encuestas a los participantes de la CC. Una encuesta se enfocó a las experiencias de CC (encuesta CC) y la confianza en los médicos investigadores; la segunda valoró el grado de comprensión de los participantes acerca de la EDCI y el diseño del ensayo clínico RAMPART (encuesta EDCI). Resultados Un total de 317 sujetos participaron en una de las dos sesiones de CC más populares (reuniones de grupo y sesiones de grupo dirigidas) en ambos lugares. Ciento ochenta y nueve participantes (59%) completaron la encuesta CC y las preguntas sobre el grado de confianza, y 297 (92%) completaron la encuesta EDCI. De aquéllos que completaron la encuesta CC, 173 de 189 (92%) estaban muy satisfechos con la reunión, y 174 de 189 (92%) expresaron que habían aprendido mucho sobre la investigación en la reunión. Ciento sesenta y seis de 189 participantes (88%) sintieron que los investigadores escucharon las inquietudes de la comunidad, mientras que sólo 106 de 189 (56%) afirmaron que los investigadores desearían realizar cambios en el estudio basándose en sus inquietudes. De aquéllos que completaron la encuesta EDCI, 261 de 297 (88%) apoyaron el estudio, 207 de 297(70%) dijeron que estarían de acuerdo en participar en el estudio, y 203 de 297 (68%) expresaron que estarían de acuerdo en dar el consentimiento de un ser querido para el estudio. Según una escala para medir la confianza en los médicos investigadores validada recientemente, los participantes de ambos lugares parecían tener mayores niveles de confianza en los médicos investigadores que la población de validación del estudio. Conclusiones En definitiva, los miembros de estas dos comunidades expresaron satisfacción con la sesión de CC y tuvieron niveles relativamente altos de aprobación del estudio y de confianza en los médicos investigadores.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/96243/1/acem12039-sup-0003-DataSupplementS3.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/96243/2/acem12039-sup-0001-DataSupplementS1.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/96243/3/acem12039.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/96243/4/acem12039-sup-0002-DataSupplementS2.pd

Trends in Folic Acid Awareness and Behavior in the United States: The Gallup Organization for the March of Dimes Foundation Surveys, 1995–2005

Objective: To summarize changes in folic acid awareness, knowledge, and behavior among women of childbearing age in the United States since the U.S. Public Health Service (USPHS) 1992 folic acid recommendation and later fortification. Methods: Random-digit dialed telephone surveys were conducted of approximately 2000 women (per survey year) aged 18–45 years from 1995–2005 in the United States. Results: The percentage of women reporting having heard or read about folic acid steadily increased from 52% in 1995 to 84% in 2005. Of all women surveyed in 2005, 19% knew folic acid prevented birth defects, an increase from 4% in 1995. The proportion of women who reported learning about folic acid from health care providers increased from 13% in 1995 to 26% in 2005. The proportion of all women who reported taking a vitamin supplement containing folic acid increased slightly from 28% in 1995 to 33% in 2005. Among women who were not pregnant at the time of the survey in 2005, 31% reported taking a vitamin containing folic acid daily compared with 25% in 1995. Conclusions: The percentage of women taking folic acid daily has increased modestly since 1995. Despite this increase, the data show that the majority of women of childbearing age still do not take a vitamin containing folic acid daily. Health care providers and maternal child health professionals must continue to promote preconceptional health among all women of childbearing age, and encourage them to take a vitamin containing folic acid daily

"I suddenly felt I'd aged": A qualitative study of patient experiences of polymyalgia rheumatica (PMR).

To explore patient experiences of living with, and receiving treatment for, PMR

Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly : a systematic review

The review aims to determine how head shape is measured and describes the use of orthoses in the management of deformational plagiocephaly. A systematic review was conducted and papers published in English up to and including 2006 were sourced from nine databases. Initial screening of papers retrieved was conducted and consensus for inclusion reached according to specified criiteria. Twenty papers were included; three literature reviews and 17 original papers. Of the original papers, eight concerned the method of head shape measurement. Measurements are important in determining clinical classification and treatment modality of deformational plagiocephaly. All studies were appraised and assigned a level of evidence according to the Scottish Intercollegiate Guidelines Network. Methodological quality was inadequate. Publications involving the use of cranial orthoses used convenience samples, were not blinded, and used different measurement techniques. No control groups were included and participants were not randomised. Evidence suggests that conservative treatments might reduce skull deformity although the quality is poor. Clinical studies investigating the use of cranial orthoses reported beneficial effects. Further research of appropriate design is required to identify the efficacy of cranial orthoses in the treatment of deformational plagiocephaly based on a standardised measurement technique to facilitate classification of deformational plagiocephaly

Parental confidence in managing food allergy:development of the Food Allergy Self-Efficacy Scale for parents (FASE-P)

Background: Food allergy is often a life-long condition that requires constant vigilance in order to prevent accidental exposure and avoid potentially life-threatening symptoms. Parents’ confidence in managing their child’s food allergy may relate to the poor quality of life anxiety and worry reported by parents of food allergic children. Objective: The aim of the current study was to develop and validate the first scale to measure parental confidence (self-efficacy) in managing food allergy in their child. Methods: The Food Allergy Self-Efficacy Scale for Parents (FASE-P) was developed through interviews with 53 parents, consultation of the literature and experts in the area. The FASE-P was then completed by 434 parents of food allergic children from a general population sample in addition to the General Self-Efficacy Scale (GSES), the Food Allergy Quality of Life Parental Burden Scale (FAQL-PB), the General Health Questionnaire (GHQ12) and the Food Allergy Impact Measure (FAIM). A total of 250 parents completed the re-test of the FASE-P. Results: Factor and reliability analysis resulted in a 21 item scale with 5 sub-scales. The overall scale and sub-scales has good to excellent internal consistency (α’s of 0.63-0.89) and the scale is stable over time. There were low to moderate significant correlations with the GSES, FAIM and GHQ12 and strong correlations with the FAQL-PB, with better parental confidence relating to better general self-efficacy, better quality of life and better mental health in the parent. Poorer self-efficacy was related to egg and milk allergy; self-efficacy was not related to severity of allergy. Conclusions and clinical relevance: The FASE-P is a reliable and valid scale for use with parents from a general population. Its application within clinical settings could aid provision of advice and improve targeted interventions by identifying areas where parents have less confidence in managing their child’s food allergy