The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.

The Japanese Postmarketing Relief System provides for compensation to patients with adverse reactions, based on the acknowledgment that unpredicted adverse events occur inevitably once a drug is marketed. The system also provides new knowledge about the benefit-risk profile of a drug that may be incorporated into product labeling. The system relies on causality assessments that are based on sound clinical pharmacology principles. The system may serve as a model for other countries' healthcare systems.

Advanced Practice Pharmacists: a retrospective evaluation of the efficacy and cost of ClinicaL Pharmacist PractitionErs managing ambulatory Medicare patients in North Carolina (APPLE-NC).

BACKGROUND: Clinical Pharmacist Practitioners are advanced practicing pharmacists in North Carolina that provide disease-specific management. The purpose of this retrospective cohort study was to compare the efficacy and charges from referrals to a Clinical Pharmacist Practitioner by the primary care provider, to those managed by a primary care provider alone. METHODS: Patients were separated into cohorts depending if they had at least two appointments with a Clinical Pharmacist Practitioner from November 2008 to November 2011. A primary care provider saw all patients at least twice during the study period. Cohorts were then matched by age, gender, and disease states. Medicare billed data was evaluated from outpatient visits related to hypertension, diabetes mellitus, and peripheral neuropathy, as well as emergency department visits and inpatient admissions. Cost of medications was estimated using 2009 AWP data corresponding to medication histories within the electronic medical record. Efficacy was defined as ability to reach disease state goal determined using national guidelines and reduction in pain score. Efficacy was analyzed by difference-in-differences test and all other numerical data tested by paired t-tests. RESULTS: The Clinical Pharmacist Practitioners cohort experienced more outpatient visits (1338 vs. 858, p < 0.001), fewer emergency department visits (115 vs. 190, p < 0.05), and similar inpatient admissions (88 vs. 117, p > 0.05) than the primary care providers cohort, respectively. The Clinical Pharmacist Practitioners cohort showed changes in charges of +22.6 % for outpatient visits, -45.5 % emergency department visits, and -13.2 % inpatient admissions relative to the primary care provider cohort. There was no difference in average daily medication cost (Clinical Pharmacist Practitioners $38.52 vs. primary care providers $38.23, p = 0.97) or achievement of disease state goals. CONCLUSION: APPLE-NC demonstrated that through referrals, Clinical Pharmacist Practitioners provide services comparable in charges and efficacy to primary care providers. Consequently, the current increased need for primary care practitioners can be met in part by increasing the utilization of advanced practice pharmacists for chronic disease management. TRIAL REGISTRATION: This does not apply for this retrospective cohort study.

Tratamiento farmacológico para la Osteoporosis y su influencia en el proceso de consolidación de las fracturas / Pharmacologic treatment for osteoporosis and its influence on fracture healing

Las fracturas por fragilidad o secundarias a la osteoporosis se pueden considerar como un importante problema de Salud Pública por las consecuencias en términos de mortalidad y morbilidad que generan. Y las previsiones para el futuro, teniendo en cuenta el progresivo envejecimiento de la población y el aumento de la esperanza de vida, no son nada optimistas. Suponen y supondrán un importante consumo de recursos. Una de las estrategias que ha demostrado eficacia para su prevención, es el tratamiento farmacológico. Pero este tratamiento puede afectar de una manera u otra al proceso de consolidación, uno de los objetivos primarios fundamentales en su manejo. En este trabajo de revisión queremos establecer, en base a la evidencia actual, cómo afectan todos y cada uno de los fármacos indicados para el tratamiento de la osteoporosis al proceso de consolidación de las fracturas por fragilidad, una cuestión que genera dudas e incertidumbres en el traumatólogo, cuya responsabilidad y papel en el escenario de la prevención, es fundamental

Osteoporotic fragility fractures can be seen as a major public health problem because their consequences in terms of mortality and morbidity. Taking into account the progressive ageing of the population and the increase in life expectancy, the expectative in the next future are not optimistic. They are and will be an important focus of health resources consumption. One of the strategies that have proven be effective for fracture prevention, is the antiosteoporotic pharmacological treatment. This type of treatments can affect bone healing process in one way or another. In this review, based on the current scientific evidence, we want to establish how each one of the drugs prescribed for the osteoporosis treatment affects the bone healing process of fragility fractures, an issue that generates doubts and uncertainties in the orthopaedic surgeon, whom responsibility and role in fracture prevention is essential

No more excuses: why pharmacists need to take their e-savvy up a Notch.

While e-prescribing is not a new concept in health care, long-term care has been slow to adopt this technology, even as facilities, practitioners, and others have embraced electronic health records (EHRs). Despite the benefits of e-prescribing, including fewer adverse events and medication-related problems, issues such as lack of interoperability created barriers to widespread and effective use of this technology. However, new regulations and the growing use of EHRs in long-term care have created a new urgency for the use of e-prescribing. Many pharmacists already are taking a leadership role on this and encouraging their colleagues to follow suit.

The economics of polypharmacology: fixed dose combinations and drug cocktails.

The history of Fixed Dose Combination (FDC) oral drug products has been tumultuous over its history. Some FDCs were prepared for marketing purposes and others for clinical improvements. Often, the products prepared for marketing advantage ended up causing negative outcomes. However, in recent years, there has been a resurgence of FDCs as clinicians have found them adventitious for treatment of AIDS/HIV and for oral contraceptives, just to name two examples. International regulatory Agencies and most major drug regulatory agencies have established guidelines along with regulations concerning preparation, labeling and marketing for FDCs. The advantages of FDCs are said to be in the clinical realm where simplified therapy regimens are thought to enhance patient's medication taking compliance. On the financial side, health insurers and other payers normally save money from a decreased number of dispensing fees, the use of fewer bottles, labels, etc., and from the possible situation where the price of the FDC is less than the medication price of the two separate ingredients dispensed individually. Overall, there is a great deal of evidence in favor of appropriate FDCs.

Improving care transitions: current practice and future opportunities for pharmacists.

During the past decade, patient safety issues during care transitions have gained greater attention at both the local and national level. Readmission rates to U.S. hospitals are high, often because of poor care transitions. Serious adverse drug events (ADEs) caused by an incomplete understanding of changes in complex drug regimens can be an important factor contributing to readmission rates. This paper describes the roles and responsibilities of pharmacists in ensuring optimal outcomes from drug therapy during care transitions. Barriers to effective care transitions, including inadequate communication, poor care coordination, and the lack of one clinician ultimately responsible for these transitions, are discussed. This paper also identifies specific patient populations at high risk of ADEs during care transitions. Several national initiatives and newer care transition models are discussed, including multi- and interdisciplinary programs with pharmacists as key members. Among their potential roles, pharmacists should participate on medical rounds where available, perform medication reconciliation and admission drug histories, apply their knowledge of drug therapy to anticipate and resolve problems during transitions, communicate changes in drug regimens between providers and care settings, assess the appropriateness and patient understanding of drug regimens, promote adherence, and assess health literacy. In addition, this paper identifies barriers and ongoing challenges limiting greater involvement of pharmacists from different practice settings during care transitions. Professional degree programs and residency training programs should increase their emphasis on pharmacists' roles, especially as part of interdisciplinary teams, in improving patient safety during care transitions in diverse practice settings. This paper also recommends that Accreditation Council for Pharmacy Education (ACPE) standards include specific language regarding the exposure of students to issues regarding care transitions and that students have several opportunities to practice the skills needed for effective care transitions. Moreover, reimbursement mechanisms that permit greater pharmacist involvement in providing medication assistance to patients going through care transitions should be explored. Although health information technology offers the potential for safer care transitions, pharmacists' use of information technology must be integrated into the national initiatives for pharmacists to be effectively involved in care transitions. This paper concludes with a discussion about the importance of recognizing and addressing health literacy issues to promote patient empowerment during and after care transitions.

Interacciones entre fármacos en una oficina de farmacia comunitaria / No disponible

Objetivo: cuantificar, valorar y analizar las interacciones farmacológicas en los pacientes que acuden a una oficina de farmacia.Método: Estudio transversal de un año en una oficina de farmacia de Valencia. Las interacciones se detectaron con el programa BotPlus del Consejo General de Colegios Oficiales de Farmacéuticos.Resultados: El 63,64% de las interacciones se produjeron en mujeres. Más del 63% aparecieron en mayores de 56 años. El 57,94% fueron de tipo farmacodinámico. El 69,16% fueron importantes o potencialmente importantes. El 57,01% afectaban a la seguridad. En un 69,16% se recomendaba un control clínico del paciente. La interacción de antiinflamatorios no esteroideos y diuréticos fue la que apareció con una mayor frecuencia.Conclusiones: Es necesario establecer un plan de actuación con protocolos normalizados de trabajo ante posibles interacciones y con intervenciones en la educación de los pacientes para minimizar la aparición de problemas relacionados con medicamentos(AU)

Objective: To quantify, to value and to analyze the pharmacological interactions in the patients who come to a community pharmacy.Method: Cross-sectional study of one year in a community pharmacy of Valencia. The interactions were detected by the program BotPlus of the General Council of Pharmacists’ Official Colleges.Results: 63,64 % of the interactions took place in women. More than 63 % appeared in major of 56 years. 57,94 % were pharmacodinamic type. 69,16 % were important or potentially important. 57,01 % were concerning the safety. In 69,16 % a clinical control of the patient was recommended. The interaction of anti-inflammatories-non-steroidal and diuretics it was the one that appeared with a major frequency.Conclusions: It is necessary to establish an action plan with standard operating protocols to possible interactions and interventions in the education of patients to minimize the occurrence of drug-related problems(AU)

ASCPT Task Force for advancing pharmacometrics and integration into drug development.

Traditionally, medical and biostatistical experts have played a central role in ensuring validity of pharmaceutical testing. The science of pharmacometrics provides powerful approaches for supporting important drug development and regulatory decisions. Numerous case studies published by academic, industry, and US Food and Drug Administration scientists attest to the significant contribution of pharmacometrics to decision making. The economic and public health benefits of applying this discipline to clinical trials far outweigh the cost associated with its implementation. The purpose of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Task Force is to build on the momentum and accelerate dissemination of its impact and adoption into drug development. We describe briefly the contributions of pharmacometrics and the specific goals of the Task Force.